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Cochrane Database of Systematic Reviews

Acupuncture for dysmenorrhoea (Review)


Smith CA, Armour M, Zhu X, Li X, Lu ZY, Song J

Smith CA, Armour M, Zhu X, Li X, Lu ZY, Song J.


Acupuncture for dysmenorrhoea.
Cochrane Database of Systematic Reviews 2016, Issue 4. Art. No.: CD007854.
DOI: 10.1002/14651858.CD007854.pub3.

www.cochranelibrary.com

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . .
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Figure 1.
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Figure 2.
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Figure 3.
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Figure 4.
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Figure 5.
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ADDITIONAL SUMMARY OF FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . .
DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
ACKNOWLEDGEMENTS
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REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.1. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 1 Pain score. . . . . . .
Analysis 1.2. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 2 Improvement in menstrual
symptoms. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.3. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 3 Use of additional medication.
Analysis 1.4. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 4 Restriction of daily living
activities. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Analysis 1.5. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 5 Quality of life: physical health.
Analysis 1.6. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 6 Quality of life: mental health.
Analysis 1.7. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 7 Quality of life: bodily pain.
Analysis 1.8. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 8 Quality of life: general health.
Analysis 1.9. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 9 Quality of life: vitality. . .
Analysis 1.10. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 10 Quality of life: social function.
Analysis 1.11. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 11 Quality of life: role emotional.
Analysis 2.1. Comparison 2 Acupuncture versus medication, Outcome 1 Pain score. . . . . . . . . . . . .
Analysis 2.2. Comparison 2 Acupuncture versus medication, Outcome 2 Pain relief. . . . . . . . . . . . .
Analysis 2.3. Comparison 2 Acupuncture versus medication, Outcome 3 Menstrual symptom score. . . . . . .
Analysis 2.4. Comparison 2 Acupuncture versus medication, Outcome 4 Use of additional medication. . . . . .
Analysis 2.5. Comparison 2 Acupuncture versus medication, Outcome 5 Quality of life. . . . . . . . . . .
Analysis 2.6. Comparison 2 Acupuncture versus medication, Outcome 6 Adverse events. . . . . . . . . . .
Analysis 3.1. Comparison 3 Acupuncture versus Chinese herbs, Outcome 1 Pain score. . . . . . . . . . . .
Analysis 3.2. Comparison 3 Acupuncture versus Chinese herbs, Outcome 2 Menstrual symptom improvement. . .
Analysis 4.1. Comparison 4 Acupuncture versus no treatment, Outcome 1 Pain score. . . . . . . . . . . .
Analysis 4.2. Comparison 4 Acupuncture versus no treatment, Outcome 2 Severity of menstrual symptoms. . . .
Analysis 5.1. Comparison 5 Acupuncture versus usual care, Outcome 1 Pain score. . . . . . . . . . . . .
Analysis 5.2. Comparison 5 Acupuncture versus usual care, Outcome 2 Absence from work or school. . . . . .
Analysis 5.3. Comparison 5 Acupuncture versus usual care, Outcome 3 Quality of life physical health. . . . . .
Analysis 5.4. Comparison 5 Acupuncture versus usual care, Outcome 4 Quality of life: mental health. . . . . .
Analysis 5.5. Comparison 5 Acupuncture versus usual care, Outcome 5 Quality of life: bodily pain. . . . . . .
Analysis 5.6. Comparison 5 Acupuncture versus usual care, Outcome 6 Quality of life: general health. . . . . .
Analysis 5.7. Comparison 5 Acupuncture versus usual care, Outcome 7 Quality of life: vitality. . . . . . . . .
Analysis 5.8. Comparison 5 Acupuncture versus usual care, Outcome 8 Quality of life: social function. . . . . .
Acupuncture for dysmenorrhoea (Review)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Analysis 5.9. Comparison 5 Acupuncture versus usual care, Outcome 9 Qualit of life: role emotional. . .
Analysis 5.10. Comparison 5 Acupuncture versus usual care, Outcome 10 Adverse events. . . . . . .
Analysis 6.1. Comparison 6 Acupressure versus sham/placebo, Outcome 1 Pain score (VAS 0 - 10). . .
Analysis 6.2. Comparison 6 Acupressure versus sham/placebo, Outcome 2 Severity of menstrual symptoms.
Analysis 7.1. Comparison 7 Acupressure versus medication (NSAIDs), Outcome 1 Pain score. . . . .
Analysis 8.1. Comparison 8 Acupressure versus no treatment, Outcome 1 Pain score (VAS 0 - 10). . . .
Analysis 8.2. Comparison 8 Acupressure versus no treatment, Outcome 2 Menstrual symptoms (MDQ).
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . .
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . .
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
INDEX TERMS
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Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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[Intervention Review]

Acupuncture for dysmenorrhoea


Caroline A Smith1 , Mike Armour1 , Xiaoshu Zhu1 , Xun Li2 , Zhi Yong Lu3 , Jing Song4
1 National Institute of Complementary Medicine (NICM), Western Sydney University, Sydney, Australia. 2 Centre for Evidence-Based
Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China. 3 School of Science and Health, University of Western
Sydney, Sydney, Australia. 4 Obstetrician and Gynaecologist, Campbelltown and Camden Hospitals, Campbelltown, Australia

Contact address: Caroline A Smith, National Institute of Complementary Medicine (NICM), Western Sydney University, Locked Bag
1797, Sydney, New South Wales, 2751, Australia. caroline.smith@westernsydney.edu.au.
Editorial group: Cochrane Gynaecology and Fertility Group.
Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 4, 2016.
Review content assessed as up-to-date: 1 September 2015.
Citation: Smith CA, Armour M, Zhu X, Li X, Lu ZY, Song J. Acupuncture for dysmenorrhoea. Cochrane Database of Systematic
Reviews 2016, Issue 4. Art. No.: CD007854. DOI: 10.1002/14651858.CD007854.pub3.
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
Background
Primary dysmenorrhoea is the most common form of period pain and affects up to three-quarters of women at some stage of their
reproductive life. Primary dysmenorrhoea is pain in the absence of any organic cause and is characterised by cramping pain in the lower
abdomen, starting within the first eight to 72 hours of menstruation.This review examines the currently available evidence supporting
the use of acupuncture (stimulation of points on the body using needles) and acupressure (stimulation of points on the body using
pressure) to treat primary dysmenorrhoea.
Objectives
To determine the effectiveness and safety of acupuncture and acupressure in the treatment of primary dysmenorrhoea when compared
with a placebo, no treatment, or conventional medical treatment.
Search methods
We searched the following databases: the Cochrane Menstrual Disorders and Subfertility Group Trials Register (to September 2015),
Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE, EMBASE, PsycINFO, CINAHL
and Chinese databases including Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI),
VIP database and registers of ongoing trials.
Selection criteria
We included all published and unpublished randomised controlled trials (RCTs) comparing acupuncture with sham acupuncture or
placebo control, usual care, pharmacological treatment or no treatment. We included the following modes of treatment: acupuncture,
electro-acupuncture, and acupressure. Participants were women of reproductive age with primary dysmenorrhoea during the majority
of the menstrual cycles or for three consecutive menstrual cycles, and moderate to severe symptoms.
Data collection and analysis
We calculated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) or standardised mean differences (SMDs) for
continuous outcomes, with 95% confidence intervals (CIs). We pooled the data where appropriate. Our primary outcomes was pain.
Secondary outcomes included menstrual symptoms, quality of life, and adverse effects.
Acupuncture for dysmenorrhoea (Review)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Main results
We included 42 RCTs (4640 women). Acupuncture or acupressure was compared with a sham/placebo group, medication, no treatment
or other treatment. Many of the continuous data were not suitable for calculation of means, mainly due to evidence of skew.
1. Acupuncture studies
Acupuncture versus sham or placebo control (6 RCTs)
Findings were inconsistent and inconclusive. However, the only study in the review that was at low risk of bias in all domains found no
evidence of a difference between the groups at three, six or 12 months. The overall quality of the evidence was low. No studies reported
adverse events.
Acupuncture versus NSAIDs
Seven studies reported visual analogue scale (VAS) pain scores, but were unsuitable for pooling due to extreme heterogeneity (I = 94%).
In all studies the scores were lower in the acupuncture group, with the mean difference varying across studies from 0.64 to 4 points on
a VAS 0 - 10 scale (low-quality evidence). Four RCTs reported rates of pain relief, and found a benefit for the acupuncture group (OR
4.99, 95% CI 2.82 to 8.82, 352 women, I = 0%, low-quality evidence). Adverse events were less common in the acupuncture group
(OR 0.10, 95% CI 0.02 to 0.44, 4 RCTs, 239 women, 4 trials, I = 15%, low-quality evidence).
Acupuncture versus no treatment
Data were unsuitable for analysis, but pain scores were lower in the acupuncture group in all six studies reporting this outcome. The
quality of the evidence was low. No studies reported adverse events.
2. Acupressure studies
No studies of acupressure reported adverse events.
Acupressure versus sham or placebo control
Data were unsuitable for pooling, but two studies reported a mean benefit of one to three points on a 0 - 10 VAS pain scale. Another
four studies reported data unsuitable for analysis: all found that pain scores were lower in the acupuncture group. No studies reported
adverse events. The quality of the evidence was low.
Acupressure versus NSAIDs
One study reported this outcome, using a 0 - 3 pain scale. The score was higher (indicating more pain) in the acupressure group (MD
0.39 points, 95% CI 0.21 to 0.57, 136 women, very low-quality evidence).
Acupressure versus no treatment
There was no clear evidence of a difference between the groups on a VAS 0 - 10 pain scale (MD -0.96 points, 95% CI -2.54 to 0.62,
2 trials, 140 women, I = 83%, very low-quality evidence).
Authors conclusions
There is insufficient evidence to demonstrate whether or not acupuncture or acupressure are effective in treating primary dysmenorrhoea,
and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons.
The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias.

PLAIN LANGUAGE SUMMARY


Acupuncture for period pain
Review question
Cochrane researchers reviewed the evidence about the effect of acupuncture and acupressure versus a control to reduce menstrual pain
and symptoms in all women of reproductive age with primary dysmenorrhoea. Primary dysmenorrhoea is defined as pain without any
underlying cause.
Background
Acupuncture for dysmenorrhoea (Review)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Dysmenorrhoea, also known as period pain, is commonly experienced by younger women. Symptoms may include cramping pain
in the lower abdomen that may spread to the lower back or front thigh, nausea, vomiting, diarrhoea, headache, fatigue, anxiety, and
dizziness. Use of conventional treatments is high, but 20% to 25% of women still have inadequate pain relief. We therefore need other
approaches to effectively manage symptoms of period pain. Acupuncture (the stimulation of points on the body using needles) and
acupressure (stimulation of points on the body using pressure) are used to treat period pain, although we do not know how effective it
is in reducing such pain.
Study characteristics
We have included 42 trials of acupuncture and acupressure compared to a control (sham/placebo, medication, Chinese herbs, no
treatment or usual care) in a total of 4640 women of reproductive age with period pain. Twenty-two studies were undertaken in China.
Eight studies were undertaken in Iran, four studies in Taiwan, two studies in Korea, and one each in Australia, Germany, Hong Kong,
Thailand, Turkey, and the USA.The evidence is current to September 2015.
Key results
There was insufficient evidence to demonstrate whether or not acupuncture or acupressure is effective in treating primary dysmenorrhoea,
and for most comparisons no information was available on adverse events.
Quality of the evidence
The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency
and risk of publication bias.

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]

Acupuncture compared with placebo, no treatment or active controls for primary dysmenorrhoea
Population: wom en with prim ary dysm enorrhoea
Settings: outpatient, com m unity
Intervention: acupuncture
Comparison: placebo , no treatm ent or active controls
Outcomes

Illustrative comparative risks* (95% CI)

Assumed risk

Corresponding risk

Control

Acupuncture

Relative effect
(95% CI)

Pain:
Findings were inconsistent and inconclusive:
Acupuncture
versus
1 study at low risk of bias in all dom ains
sham or placebo con- f ound no evidence of a dif f erence in pain
trol
scores at 3, 6 or 12 m onths
Follow up: 1-12 m onths
2 studies f ound no evidence of a
dif f erence in pain scores at 1 to 3 m onths
2 studies reported lower pain scores in
the intervention group at 3 m onths
1 study reported higher rates of pain
relief in the acupuncture group at 3 m onths

No of Participants
(studies)

Quality of the evidence


(GRADE)

Comments

477
(6 RCTs)

low1,2

Data unsuitable f or calculation of m eans

611
(10 RCTs)

low1,3

Continuous data unsuitable f or pooling, I =


94%. Consistent direction of ef f ect

Adverse events:
No studies reported this outcom e
Acupuncture
versus
sham or placebo control
Pain:
Pain scores were lower in the acupuncture [OR 4.99 (2.82 to 8.82)]
Acupuncture
versus group in six of seven studies (n = 389/ 449)
NSAIDs
that reported VAS scores, with the m ean dif Follow-up: 1 - 4 m onths f erence varying across studies f rom 0.64 to 4
points on a VAS 0 - 10 scale
[In 4 studies (n = 352) reporting rates of
4

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

pain relief , rates were higher in wom en having


acupuncture than in wom en having NSAIDs]
Adverse events:
83 per 1000
Acupuncture
versus
NSAIDs
Follow-up: 3 m onths
Pain:
Acupuncture versus no
treatment
Follow-up: 1 - 6 m onths

9 per 1000
(2 to 38)

Six studies reported this outcom e, using a


VAS scale. The f indings were consistent but
unsuitable f or pooling, in m ost cases because
data were skewed

OR 0.10
(0.02 to 0.44)

239
(4 RCTs)

low1,4

384
(6 RCTs)

low1,4

Data unsuitable f or calculation of m eans

Adverse events:
No studies reported this outcom e
Acupuncture versus no
treatment
* The basis f or the assumed risk is the m edian control group risk across studies. The corresponding risk (and its 95% conf idence interval) is based on the assum ed risk in the
com parison group and the relative effect of the intervention (and its 95% CI).
CI: Conf idence interval; OR: Odds ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our conf idence in the estim ate of ef f ect.
M oderate quality: Further research is likely to have an im portant im pact on our conf idence in the estim ate of ef f ect and m ay change the estim ate.
Low quality: Further research is very likely to have an im portant im pact on our conf idence in the estim ate of ef f ect and is likely to change the estim ate.
Very low quality: We are very uncertain about the estim ate.
1

Downgraded
assessed.
2 Downgraded
3 Downgraded
4 Downgraded

one level f or serious risk of bias: all or m ost studies at high or unclear risk of bias in one or m ore dom ains
one level f or serious inconsistency.
one level f or serious risk of publication bias, evident on f unnel plot.
one level f or serious im precision: low overall event rate and/ or sm all overall sam ple size.

BACKGROUND

Description of the condition


Dysmenorrhoea (period pain) can be described as painful uterine
cramps of menstrual origin (Proctor 2006) and is classified as primary or secondary dysmenorrhoea. The focus of this review is on
primary dysmenorrhoea, the most common form of period pain
in young women (French 2008), and the most frequently underreported cause of period pain (Jamieson 1996). Primary dysmenorrhoea is defined as pain in the absence of any organic cause and
is most common in women under the age of 25, with pain starting within three years of menarche (Coco 1999). Primary dysmenorrhoeas characteristic symptom is crampy, colicky spasms of
pain in the suprapubic area, occurring within eight to 72 hours of
menstruation and peaking within the first few days as menstrual
flow increases (Proctor 2006). In addition to painful cramps, many
women with primary dysmenorrhoea experience other menstrualrelated symptoms, including back and thigh pain, headaches, diarrhoea, nausea and vomiting (Proctor 2006). Studies describing the
prevalence of primary dysmenorrhoea report wide ranges of rates.
A recent review of high-quality studies found prevalence rates to
range from 16.8% to 81% (Latthe 2006). In a review of women
under 20 years of age, higher prevalence rates of 43% to 91% were
found (Zahradnik 2010).These wide-ranging rates are most likely
explained by the varying criteria used to assess dysmenorrhoea between surveys, and the descriptions used to classify the severity of
pain (Jamieson 1996).
The largest contributing physiological factor in primary dysmenorrhoea is increased amounts of prostaglandins present in the
menstrual fluid (Dawood 2006). These prostaglandins are released when the endometrial lining breaks down during menses.
Prostaglandins, especially PGF , stimulate myometrial contractions, reducing uterine blood flow and causing uterine hypoxia.
This is responsible for the painful cramping that characterises primary dysmenorrhoea (Dawood 2006). Secondary symptoms associated with primary dysmenorrhoea, such as headache, nausea and
vomiting, are due to prostaglandins and their metabolites entering
general circulation (Howard 2000), and are similar to side effects
seen in women who have induction of labour via prostaglandin
gel (Dawood 2006).

Description of the intervention


Acupuncture is a component of traditional East Asian medicine,
with various forms of acupuncture present historically in Japan,
China and Korea (White 2004). Acupuncture is the insertion of
fine needles into the body at specific acupuncture points, while
acupressure is the stimulation of acupuncture points by means of
pressure, usually applied by fingers or thumbs (Beal 1999).

Acupuncture, in common with many other non-pharmacological


therapies, is a complex intervention (MacPherson 2007). Inherent
in the idea of complex interventions is the concept that a mixture
of specific and non-specific mechanisms contribute to the action
of the therapy. Acupuncture can take place within a number of
different theoretical frameworks, with the following being most
common: Traditional Chinese, Five Element, Japanese or Biomedical (sometimes called Western) (Bovey 2005; Hopton 2012;
Robinson 2012). These frameworks dictate many facets of the
treatment, including diagnosis, point location, point selection, cointerventions such as moxibustion, needling style, retention time
for needles, and stimulation style.
A traditional Chinese medicine (TCM) acupuncture consultation
typically includes but is not limited to: history taking, self-care and
lifestyle advice, TCM diagnosis and explanation, palpation of the
pulse and other parts of the body, observation of the tongue, insertion and manipulation of needles, as well as common co-modalities, such as moxibustion and cupping (Langevin 2011). Western
or biomedical acupuncture more commonly uses a neurophysiological approach to point selection and often includes lifestyle
advice based on biomedical considerations (Hopton 2012). Ear
acupuncture, or auriculotherapy, is a relatively modern therapy
and is based on the idea that there is a reflex connection between
the ear and the rest of the body, allowing conditions to be treated
by stimulation of certain parts of the ear (Andersson 2007). Serious adverse events from acupuncture are rare; minor side effects
may include tiredness, pain at the site of needling, and headache
(MacPerson 2004).

How the intervention might work


The exact mechanism of acupuncture to treat period pain is unclear. However, there has been extensive research into the mechanisms by which acupuncture may exert its pain-relieving effects,
with current evidence suggesting that endogenous opioids, modulation of neurotransmitters (such as dopamine), and anti-inflammatory effects mediated via the hypothalamus-pituitary-adrenal
(HPA) axis may all play a role (Napadow 2008). Because of the
quick onset of the pain-relieving effect of acupuncture observed
in some studies, it is likely that the immediate analgesic effects
observed are modulated, at least in part, by endogenous opioid
release (Wang 2008).
Overall, current experimental data support three possible non-exclusive mechanisms for the observed long-term effects of acupuncture on primary dysmenorrhoea:
1. Descending pain modulation
2. An increase in uterine blood flow via ovarian sympathetic
nerve reflex
3. A change in prostaglandin levels.
Smith 2010 proposes a descending pain modulation hypothesis,
where pain relief in primary dysmenorrhoea occurs via stimulation of common acupuncture points, including REN4, SP6 and

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

SP8, that transmit signals via afferent pathways to the midbrain.


This information is integrated and changes womens perception of
pain. This alteration in descending pain modulation changes the
perceived pain intensity. Animal models suggest that needling regulates neuro-endocrine activities including levels of progesterone
(Liu 2009) and needling point SP6 has been shown to increase
ovarian blood flow via a reflex response in rats (Stener-Victorin
2006). A similar reflex response increasing uterine blood flow via
SP6 has been found in humans (Stener-Victorin 1996) and appears
to be related to some of the analgesic benefits of acupuncture in
primary dysmenorrhoea. Lin 2008 found that after three months
of acupuncture treatment there was a reduction in PGF levels. A recent meta-analysis, including Chinese-language research,
has shown that the effect of acupuncture on prostaglandins is still
unclear due to poor trial methodology and small sample sizes (Xu
2014b). It is likely that acupressure exerts its benefits via mechanisms similar to acupuncture, with pressure rather than needle
stimulation activating the pain-relieving mechanism(s). The appropriateness of using sham acupuncture as a control is currently
debated in the literature (Langevin 2011). Sham acupuncture devices deliver significant non-specific effects, greater than that of
placebo pills, so it is likely that these compromise at least some of
the therapeutic benefit that acupuncture may deliver (Kaptchuk
2006).

to reach a definitive conclusion.

OBJECTIVES
To determine the effectiveness and safety of acupuncture and acupressure in the treatment of primary dysmenorrhoea when compared with a placebo, no treatment, or conventional medical treatment.

METHODS

Criteria for considering studies for this review


Types of studies
All randomised controlled trials (RCTs) were eligible for inclusion.
We included cross-over trials if they had pre-cross-over data.
We excluded quasi-randomised trials and trials where we were
unable to ascertain if the trial was truly randomised.
Types of participants

Why it is important to do this review


Menstrual pain remains an important womens health issue and
has medical, social, and economic consequences (Dawood 1990).
Many young women do not seek help for their period pain or
are undertreated (OConnell 2006). In one study, 98% of adolescents used non-pharmacological methods such as heat, rest, or distraction, with a perceived effectiveness of 40% or less (Campbell
1999). Conventional treatments have focused on the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and the oral contraceptive pill (OCP). NSAIDs work as prostaglandin synthetase inhibitors, as do OCPs, where the progestogen component of the
OCP has a direct effect on uterine smooth muscle to reduce myometrial activity. The efficacy of these conventional treatments is
high, although 20% to 25% of women have inadequate pain relief
(Dawood 1985; Henzl 1985). NSAIDs appear to be a very effective
treatment for dysmenorrhoea, although women using them need
to be aware of the substantial risk of adverse effects (Marjoribanks
2015). There is some evidence in favour of oral contraceptives
for pain management (Wong 2009). These two drug groups are
now considered standard treatments for primary dysmenorrhoea
(Dawood 1988; Dawood 1990). Other evidence-based approaches
to effectively managing symptoms of dysmenorrhoea are therefore needed. A number of clinical trials have been performed to
study the efficacy of acupuncture for period pain, although it remains uncertain whether the existing evidence is rigorous enough

Inclusion criteria
Women needed to meet the following criteria to be included in
the review:
of reproductive age (15 to 49 years);
primary dysmenorrhoea, i.e. no identifiable pelvic
pathology as indicated by pelvic examination, ultrasound scans,
or laparoscopy;
primary dysmenorrhoea (self-reported pain) during the
majority of the menstrual cycles or for three consecutive
menstrual cycles;
moderate to severe primary dysmenorrhoea (pain that does
not respond well to analgesics, affects daily activities, or has a
high baseline score on a validated pain scale).

Exclusion criteria
If participants in the trial met any of the following exclusion criteria, we excluded the trial from the review:
diagnosed secondary dysmenorrhoea (e.g. fibroids,
endometriosis);

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dysmenorrhoea resulting from use of an intra-uterine device


(IUD);
mild or infrequent dysmenorrhoea.

Search methods for identification of studies


We sought all published and unpublished RCTs of acupuncture
and acupressure versus control, using the following search strategy,
without language restrictions and in consultation with the Menstrual Disorders and Subfertility Group (MDSG) Trials Search
Co-ordinator.

Types of interventions
Any RCT involving acupuncture (manual insertion of needles to
points located on the body, and to the ear) and electro-acupuncture
as treatment for primary dysmenorrhoea. We made an amendment
to the protocol to include trials of acupressure; this covers pressure
applied using blunt studs or seeds. We also included application
of minimal moxibustion on a small number of points, but we
excluded trials of moxibustion alone, due to a different mode of
application and action.
Interventions were compared to placebo control (including invasive and non-invasive placebo controls), no treatment, pharmacological management, other types of control groups (for example,
wait list controls, where the control group will receive the intervention after a waiting period), or other conventional treatments.

Electronic searches
We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (to September 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE, EMBASE, PsycINFO, CINAHL, and Chinese databases including Chinese Biomedical Literature Database
(CBM), China National Knowledge Infrastructure (CNKI) and
VIP database.
The search terms are presented in the appendices (Appendix 1;
Appendix 2; Appendix 3; Appendix 4; Appendix 5; Appendix 6;
Appendix 7; Appendix 8).
Searching other resources

Types of outcome measures


We required reporting of at least one of the following primary
outcomes for a trial to be included. We recorded data for each of
the following outcomes, where available:

Primary outcomes

1. Pain score, as a continuous variable measured preferably by the


visual analogue scale (VAS) or other validated scales. Pain relief,
measured as dichotomous outcomes (i.e. pain relief: yes or no).

We searched for additional studies in the reference lists of the


relevant trials identified.
We also searched ProQuest Dissertations and Theses, Web of
Knowledge, AMED (the Allied and Complementary Medicine
Database), OpenGrey, LILACS, Acubase, Google Scholar and
PubMed.
We searched the following clinical trial registries for ongoing trials: Australian and New Zealand Clinical Registry (www.anzctr.org.au/), Chinese Clinical Trial Register (www.chictr.org); Current Controlled Trials (controlledtrials.com); Clinical trials.gov (clinicaltrials.gov); ISRCTN (
www.isrctn.org/); and WHO International Clinical Trial Registration Platform search portal (www.who.int/trialsearch/).

Secondary outcomes

1. Overall improvement in generic menstrual symptoms (e.g. nausea, tiredness) measured by changes in overall dysmenorrhoeic
symptoms that were either self-reported or investigator-observed,
or any other similar measures.
2. Reported use of additional medication, measured as the proportion of women requiring analgesics.
3. Restriction of daily life activities, measured as the proportion
of women who reported activity restrictions.
4. Absence from work or school, measured as the proportion of
women reporting absences from work or school, and also as hours
and days of absence as a more selective measure.
5. Quality of life, measured by a validated scale, for example the
Short Form (SF) 36.
6. Adverse effects from treatment, measured as incidence of side
effects and types of side effects.

Data collection and analysis

Selection of studies
Two review authors (CS and MA) screened the titles and abstracts
of articles found in the search, and discarded trials that were clearly
not eligible. One review author (XL) searched for and selected
the trials from the Chinese databases. Two out of the three review
authors (CS, MA, XL) undertook trial selection.
Three review authors (XZ, XL, ZL) translated Chinese papers.
CS, MA, and XL independently assessed whether trials met the
inclusion criteria, with disagreements resolved by discussion. If articles contained insufficient information to make a decision about
eligibility, CS attempted to contact authors of the original reports
to obtain further details. If details of randomisation were unclear

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in the reporting, we contacted all trial authors to ascertain if the


study was truly randomised. We made a first contact and then sent
a reminder. We translated letters and email into Chinese.
Data extraction and management
Following an assessment for inclusion, CS, MA, XZ, XL, ZL and
JS independently extracted data. Author XZ and colleague JM reviewed the trial published by review author CS. We resolved discrepancies by discussion. For each included trial we extracted data
regarding the location of the trial, the methods of the trial (as per
assessment of risk of bias), the participants (age range, eligibility
criteria), the nature of the interventions, and data relating to the
outcomes specified above. We collected information on reported
benefits and adverse effects. We extracted data and entered them
onto a form (Appendix 9) sourced from the Cochrane Handbook for
Systematic Reviews of Interventions (Cochrane Handbook; Higgins
2011). Two review authors (CS and MA) checked and entered
data into Review Manager 5 (New Reference).
Assessment of risk of bias in included studies
Two review authors independently assessed risks of bias, using
the criteria described in the Cochrane Handbook (Higgins 2011)
(Appendix 10). The tool consists of six items, with three potential
responses: yes, no, and unclear. In all cases a judgement of yes
indicates a low risk of bias and a judgement of no indicates a high
risk of bias. If insufficient detail was reported our judgement was
usually unclear. We also made a judgement of unclear if we knew
what happened in the study but the risk of bias was unknown to
us, or if an entry was not relevant to the study at hand (particularly
for assessing blinding and incomplete outcome data, or when the
outcome being assessed by the entry had not been measured in the
study).
We assessed the following characteristics: sequence generation, allocation concealment, blinding (or masking), incomplete data assessment, selective outcome reporting, and other sources of bias.
We resolved disagreements that arose at any stage by discussion
between the review authors or with a third party, when necessary. We generated a Risk of bias assessment table for each study.
We assessed other aspects of trial quality including the extent of
blinding (if appropriate), whether groups were comparable at baseline, the extent of losses to follow-up, non-compliance, whether
the outcome assessment was standardised, and whether an intention-to-treat analysis was undertaken, according to the Cochrane
Handbook (Higgins 2011). This information is presented in the
Characteristics of included studies.

data, we expressed results for each study as odds ratios (ORs) with
corresponding 95% confidence intervals (CIs), using the MantelHaenszel method. We expressed continuous data as mean differences (MDs) with 95% CIs, or as standardised mean differences
(SMDs) if outcomes were conceptually the same but measured in
different ways in the different trials. A standard rule of thumb for
interpreting effect sizes is that 0.2 represents a small effect, 0.5 a
moderate effect and 0.8 a large effect.
Unit of analysis issues
The primary analysis was per woman randomised. We included trials with multiple arms and describe them in the Characteristics of
included studies, for example acupuncture compared with placebo
acupuncture and with no acupuncture. If there were two acupuncture groups, we combined data from both treatment arms into
one group. For studies with a placebo control and no treatment
control group, we divided the shared intervention evenly between
groups as described in the Cochrane Handbook (Higgins 2011).
Where outcomes were repeated measures, we undertook analysis
of outcomes at the end of the intervention.
Dealing with missing data
We analysed data on an intention-to-treat basis, as far as possible.
We did not impute missing data but we did report the proportion
lost to follow-up and analysed only the available data.
Assessment of heterogeneity
We identified and measured heterogeneity by visually inspecting
the overlaps of the CIs for the results of individual studies. If there
was poor overlap, this was suggestive of statistical heterogeneity
and we included a more formal Chi test. A low P value (or a
large Chi statistic relative to its degrees of freedom) provided
evidence of heterogeneity of intervention effects (variation in effect
estimates beyond chance).
We measured inconsistency across trials in the meta-analysis using
the I statistic. This describes the percentage of total variation
across studies that is due to heterogeneity rather than chance (
Higgins 2003; Higgins 2011). The interpretation of the I statistic
is as follows:
10% to 40% might not be important;
30% to 60% may represent moderate heterogeneity;
50% to 90% may represent substantial heterogeneity;
75% to 100% considerable heterogeneity.
Assessment of reporting biases

Measures of treatment effect


We performed statistical analysis in accordance with the Cochrane
Handbook (Higgins 2011). We performed statistical analysis using
Review Manager 5 software (RevMan 2014). For dichotomous

We planned to investigate potential biases of publication using


the funnel plot or other analytical methods (Egger 1997). If there
were 10 or more studies in the meta-analysis we would have investigated reporting biases (such as publication bias) using fun-

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nel plots. If visual assessment had suggested asymmetry, we would


have explored possible reasons.
Data synthesis
We combined the data using a fixed effect model in the following
comparisons:
1. Acupuncture versus control.
2. Acupressure versus control.

of evidence for the main review outcomes (pain and adverse effects), using GRADE criteria (study limitations, consistency of effect, imprecision, indirectness and publication bias). We justified,
documented and incorporated judgements about evidence quality
(high, moderate, low) into the results for each outcome.

RESULTS

Subgroup analysis and investigation of heterogeneity


We planned to undertake a subgroup analysis based on different
types of acupuncture therapies: manual acupuncture versus electro-acupuncture.

Description of studies
See Characteristics of included studies, Characteristics of excluded
studies, Characteristics of ongoing studies, and Characteristics of
studies awaiting classification.

Sensitivity analysis
In the presence of substantial heterogeneity (an I statistic greater
than 50%) we aimed to examine the causes by prespecified subgroup using a sensitivity analysis. Where subgroup analysis failed
to explain the heterogeneity, we analysed data using a random-effects model. A priori, we had planned to perform sensitivity analyses on results to look at the possible contribution of: (1) differences
in methodological quality, with trials of high quality (low risk of
bias) compared to all trials; and (2) publication bias by country.
Overall quality of the body of evidence: Summary of
findings table
We prepared Summary of findings tables using GRADEPRO
software. These tables evaluate the overall quality of the body

Results of the search


The updated search to September 2015 identified 73 potentially eligible studies of which we included 34: (Aghamiri 2005;
Bazarganipour 2010; Bu 2011; Cao 2011; Charandabi 2011;
Darabi 2010; Han 2012; Hu 2005; Kashefi 2010; Lee 2007; Li
2012b; Ma 2010; Ma 2013; Mirbagher-Ajorpaz 2011; Peng 2012;
Qiao 2013; Ruan 2011; Shi 2011; Song 2013; Sriprasert 2015;
Sun 2011; Wang 2005b; Wang 2013b; Wang 2014a; Wong 2010;
Xu 2013; Xu 2014; Yeh 2013a; Youn 2008; Yu 2014; Zafari 2011;
Zhang 2012; Zhang 2013a; Zhang 2013b), and excluded 39 trials. Two RCTs previously included in the review (Jiang 2007; Wu
2007) we now exclude from this update. We now have 42 included
and 65 excluded trials. see Figure 1.

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Figure 1. Study flow diagram: 2016 update

Included studies

Study location and sources of women


Twenty-two studies were undertaken in China. Eight studies were
undertaken in Iran, four studies in Taiwan, two studies in Korea, and one each in Australia, Germany, Hong Kong, Thailand,
Turkey, and the USA.

Study design and setting


The review includes 42 studies. Forty studies were parallel design
and two studies were cluster-randomised trials. Twenty-eight trials
had two study groups. Eight trials had three groups and six trials
had four arms.

Participants
The studies included 4640 women with primary dysmenorrhoea.
Twenty studies recruited participants from gynaecology hospital

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11

clinics. Fifteen trials recruited college or high school students,


and five trials recruited from the community. Details were not reported in two trials. Women with secondary dysmenorrhoea were
excluded, although this diagnosis was not clearly reported. One
study used cancer or carbohydrate antigen 125 (CA 125) to eliminate a diagnosis of endometriosis (Wang 2009a). Evidence of a
physical assessment confirming the diagnosis of primary dysmenorrhoea was reported in six trials, confirmed by ultrasound and
physical examination. In all other 36 trials no clear, specific details
were reported on how pelvic pathology was eliminated.

Interventions
Ten trials used acupressure and 32 trials provided stimulation using
acupuncture (including manual and electro-acupuncture). Three
of these acupuncture trials also reported using moxa (warming
needle). Acupuncture and acupressure varied in point selection,
frequency of treatment, and number of treatments. A summary of
the characteristics of the acupuncture and acupressure interventions is described in Appendix 11.
Comparative and control groups varied between studies. Nine trials used placebo controls. Placebo techniques varied between invasive and non-invasive techniques. It is possible that the 11 control
groups that used invasive pressure or needle stimulation may have
had some physiological action. Comparisons with medication using NSAIDs and oral contraceptives were used in 15 trials. Eight
trials used a no-treatment control. One trial used Chinese herbal
medicine. Two studies reported unspecified usual care. One trial
used rest. One trial used visits or social support. Three trials used
a mixture of no treatment and active sham points. One trial used
two groups comprising sham and medication.

Outcomes
All studies assessed the primary outcome of pain. VAS scales were
widely used. Nine studies used a subjective assessment of pain and
other menstrual symptoms. Six studies reported adverse events in
a form that could be entered into meta-analysis (Cao 2011; Peng
2012; Ruan 2011; Sriprasert 2015; Witt 2008; Zhang 2013a).

Excluded studies
We excluded 64 trials. Seventeen trials did not meet the inclusion
criteria for the intervention; for example, the use of point injection
acupuncture, use of moxibustion alone, or laser acupuncture. Nine
trials did not meet the inclusion criteria for the control group; for
example, comparisons between acupuncture versus acupuncture
at another point. We exclude 35 trials due to insufficient reporting
of randomisation; we were unable to ascertain the true randomisation status from the author, or trials were quasi-randomised. No
clinically relevant outcomes were reported in three trials. One trial
did not meet the age criteria for participants. We present further
background information on these trials in the table Characteristics
of excluded studies.

Risk of bias in included studies


See Figure 2 and Figure 3 for a graphical summary of the Risk
of bias assessments of the included studies made by the review
authors, based on the six Risk of bias domains. Overall we judged
one trial to be at a low risk of bias on all domains, 32 trials at
high risk of bias in at least one domain and 12 trials rated as at an
unclear risk of bias in one or more domains (but with no domains
rated as at high risk).

Figure 2. Methodological quality graph: review authors judgements about each methodological quality
item presented as percentages across all included studies.

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Figure 3. Risk of bias summary: review authors judgements about each risk of bias item for each included
study.

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13

Allocation
Using the Cochrane criteria, which rate the adequacy of randomisation allocation and concealment, we rated most trials (36) at
a low risk of bias with adequate generation of randomisation sequence. In 11 trials the sequence was computer-generated (Han
2012; Ma 2010; Ma 2013; Ruan 2011; Shi 2011; Smith 2010;
Song 2013; Sriprasert 2015; Wang 2009a; Witt 2008; Zhi 2007).
The sequence was drawn by lot in three trials (Chen 2004; Chen
2010; Zhang 2013a) and from random-number tables in 20 trials
(Bazarganipour 2010; Cao 2011; Helms 1987; Hu 2005; Kashefi
2010; Li 2008; Li 2012b; Lee 2007; Mirbagher-Ajorpaz 2011;
Qiao 2013; Sun 2011; Wang 2005b; Wang 2013b; Wang 2014a;
Youn 2008; Xu 2013; Xu 2014; Yu 2014; Zhang 2012; Zhang
2013b), and coin toss in one trial (Yeh 2013a). The risk was unclear in six trials.
We rated allocation concealment at low risk of bias in 12 trials
(27%). Central randomisation was undertaken in seven trials (
Han 2012; Ma 2010; Ma 2013; Ruan 2011; Smith 2010; Song
2013; Witt 2008) and using sealed envelopes in five trials (Chen
2004; Chen 2010; Sun 2011; Sriprasert 2015; Wang 2009a). We
assessed all other studies (30) to be at an unclear risk of bias due
to insufficient reporting.

Blinding
We rated blinding at low risk of bias in three trials (Ma 2010;
Smith 2010; Wang 2009a). All these trials were assessed as doubleblind with blinding of analyst and participants. Twenty-eight trials
were at high risk of bias, and the risk of bias was unclear in 11
trials.

Incomplete outcome data


We assessed incomplete outcome reporting to be at a low risk of
bias in 30 trials (Bu 2011; Cao 2011; Charandabi 2011; Han 2012;
Helms 1987; Li 2008; Li 2012b; Ma 2010; Mirbagher-Ajorpaz
2011; Peng 2012; Qiao 2013; Ruan 2011; Shi 2011; Smith 2010;
Song 2013; Sun 2011; Wang 2005b; Wang 2009a; Wang 2013b;
Wang 2014a; Witt 2008; Wong 2010; Xu 2013; Yu 2014; Zafari
2011; Zhang 2012; Zhang 2013a; Zhang 2013b; Zhi 2007; Xu
2014). Nine trials were at high risk of bias, of which Chen 2004
had a 50% dropout rate (Aghamiri 2005; Bazarganipour 2010;
Chen 2004; Chen 2010; Lee 2007; Ma 2013; Sriprasert 2015;
Yeh 2013a; Youn 2008). We rated three trials as unclear, due to
incomplete reporting (Darabi 2010; Hu 2005; Kashefi 2010).

Selective reporting

We rated the risk of selective reporting as low risk in one trial for
which we were able to obtain the protocol published on a clinical
trial registry (Smith 2010). We judged six other trials to be at low
risk, due to receipt of entire theses. One study we rated at high
risk because not all their secondary outcomes were reported. We
assessed 34 trials to be unclear risk of bias.

Other potential sources of bias


We rated the risk of bias from other sources as low in five trials
(Qiao 2013; Smith 2010; Song 2013; Wang 2013b; Witt 2008).
We found one trial to be at high risk due to imbalances at baseline
(Han 2012). We rated all other 36 trials as being at unclear risk of
bias.
There were imbalances at randomisation in two trials. Smith 2010
reported imbalances in body mass index, smoking, and socio-economic indices, and these were adjusted for in the primary analyses. Witt 2008 reported imbalances at randomisation for physical
functioning, bodily pain, and physical component score of the
SF36. For the majority of studies these data were not reported.
Five trials conducted and reported an intention-to-treat analysis
(Ma 2013; Ruan 2011; Smith 2010; Wang 2014a; Witt 2008).
Four trials reported the source of funding. Three trials received
government research funding (Chen 2004; Chen 2010; Smith
2010) and one trial received funding from health insurance organisations (Witt 2008).

Effects of interventions
See: Summary of findings for the main comparison Summary
of findings: acupuncture for primary dysmenorrhoea; Summary
of findings 2 Summary of findings: acupressure for primary
dysmenorrhoea
We present results separately for acupuncture and acupressure, and
by type of control group. Data were excluded from Charandabi
2011 due to data presented within subcategories of dysmenorrhoea. We could not obtain raw data for Helms 1987; Lee 2007;
Ma 2010; Wang 2013b; Youn 2008, and present a narrative reports of their results.

1) Acupuncture versus sham/placebo control


Data were presented for pain outcomes reported after the intervention and at one to three months.

1.1 Primary outcome: Pain

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1.1.1 Outcome: pain score

Five studies reported this outcome (Darabi 2010; Lee 2007; Smith
2010; Song 2013; Youn 2008). Data were unsuitable for pooling,
in most cases because standard deviations (SDs) were not reported
or data were skewed.
One study reported no evidence of a difference between the groups
(Lee 2007) at one month.
Two studies reported evidence of a benefit in the intervention
group at three months (Darabi 2010; Song 2013), but two (Smith
2010; Youn 2008) found no evidence of a benefit at this time
point.
The single study with longer follow-up reported no evidence of a
difference between the groups at six or 12 months (Smith 2010).
Details of findings and rationale for not pooling are presented in
Table 1.

(OR 1.51, 95% CI 0.62 to 1.3.7). A reduction in medication use


was found at six months for women in the acupuncture group
(OR 0.34, 95% CI 0.14 to 0.79).
Helms 1987 reported that mean daily strength of analgesic medication (calculated using a study-defined measure) dropped 41%
in the intervention group after treatment, but increased among
controls (48 women) (data not reported in meta-analysis).
Darabi 2010 reported less use of medication in the acupuncture group compared with the control at three months (data not
shown).

1.4 Outcome: restriction of daily living activities

There was no evidence of a difference between the groups at the


end of the trial (OR 0.72, 95% CI 0.29 to 1.81, 92 women, 1
trial) (Analysis 1.4).

1.1.2 Outcome: pain relief

One study (Helms 1987) reported this outcome. After treatment


for three cycles the rate of post-treatment pain relief was higher
in the acupuncture group (OR 17.5, 95% CI 1.6 to 191.9; 22
women).

Secondary outcomes

1.5 Outcome: absence from school or work

No trials reported on this outcome.

1.6 Outcome: quality of life

There was no evidence of a difference between groups on any


quality of life domain, measured using the SF36 (92 women, 1
trial, high-quality evidence) (Analysis 1.5, Analysis 1.6; Analysis
1.7; Analysis 1.8; Analysis 1.9; Analysis 1.10; Analysis 1.11).

1.2 Outcome: overall improvement in menstrual symptoms

One trial (Smith 2010) compared acupuncture with a sham


acupuncture control and found no evidence of a difference between the groups in the number of women reporting an improvement in menstrual symptoms at three months (OR 1.57, 95%
0.61 to 4.04, 92 women), six months (OR 1.47, 95% CI 0.62
to 3.48, 92 women) or at 12 months (OR 2.35, 95% CI 0.80 to
6.94) Analysis 1.2. At three months women in this study reported
fewer mood changes in the acupuncture group (53%) compared
with the control group (72%) (OR 0.72, 95% CI 0.53 to 1.00; P
= 0.05).
Lee 2007 found a reduction in the severity of menstrual symptoms
using the Menstrual Severity Symptom list, with the acupuncture
scores reduced from 60.09 to 32.48, and the control scores declining from 62.40 to 39.65. Data were unsuitable for analysis as no
standard deviations were reported.

1.3 Outcome: use of additional medication

Three trials reported on this outcome (Darabi 2010; Helms 1987;


Smith 2010).
Smith 2010 found no evidence of a difference between the groups
in the rate of additional medication use at three months (OR 0.91,
95% CI 0.40 to 2.09, 92 women) (Analysis 1.3) or at 12 months

1.7 Adverse events

No trial reported on this outcome.

2) Acupuncture versus medication


Data were presented for pain outcomes at one to three months.

2.1 Primary outcome: pain

2.1.1 Outcome: pain score

Acupuncture versus NSAIDS


Seven studies reported this outcome using a VAS 0 - 10 scale, but
data were unsuitable for pooling due to extreme heterogeneity (I
= 94%) for which there was no obvious explanation. In six of seven
studies (389 women) acupuncture was associated with reduced
pain scores compared to NSAIDs, with the mean differences varying across studies from 0.64 to 4 points (Analysis 2.1; Figure 4).
The overall quality of the evidence was very low.

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Figure 4. Forest plot of comparison: 2 Acupuncture versus medication, outcome: 2.1 Pain score.

One trial (Han 2012) used an unspecified scale and was not included in the analysis; this trial found acupuncture was associated
with reduced pain scores (MD -3.70, 95% CI -4.68 to -2.80, 120
women).
Acupuncture versus combined oral contraceptives (COC)
Combined oral contraceptives were found to be more effective
than acupuncture in reducing pain scores as measured by a 0 - 10
numeric rating scale (NRS) in one small trial (MD 2.0, 95% CI
0.59 to 3.41, 52 women; Analysis 2.1).

2.1.2 Outcome: pain relief

2.2.1 Acupuncture versus NSAIDS


Women having acupuncture reported a lower score for menstrual
symptoms than women having NSAIDs (MD -2.25 points, 95%
CI -3.33 to -1.17, 6 trials, 440 women, I = 89%, Analysis 2.3.1).
Statistical heterogeneity was high but the direction of effect was
consistent. These studies used the self-report Clinical Principle of
New Chinese Drug Clinical Research (scale unknown).
Three studies used other instruments and all reported reduced
menstrual symptoms in the acupuncture group; however the scales
of the measures used were unclear: Cao 2011 (MD -2.16, 95%
CI -3.57 to -0.75, 53 women), Xu 2013 (MD -6.32, 95% CI 7.15 to -5.49, 45 women), and Zhi 2007 (MD -2.83, 95% CI 4.25 to -1.68, 64 women)

Acupuncture versus NSAIDS


Women having acupuncture were more likely to report pain relief
than women having NSAIDs (OR 4.99, 95% CI 2.82 to 8.82, 4
trials, 352 womenI = 0%, low-quality evidence (Analysis 2.2).

2.2.2 Acupuncture versus juyuansuan tamoxifen


Women having acupuncture reported a lower score for menstrual
symptoms than women having juyuansuan tamoxifen (MD -4.22,
95% CI -5.12 to -3.32, one RCT, 80 women, Analysis 2.3.2).

Acupuncture versus combined oral contraceptives


There was no evidence of a difference between acupuncture and
combined oral contraceptives in the number of women reporting
pain relief (OR 0.39, 95% CI 0.12 to 1.21, 42 women).

2.3 Outcome: use of additional medication

2.3.1 Acupuncture versus combined oral contraceptives


Secondary outcomes

2.2 Outcome: menstrual symptoms

One trial of acupuncture compared with COC found no evidence


of a difference between the groups in the reduction from baseline
in rescue medication used at three months (MD 0.56 tablets, 95%
CI -1.03 to 2.15, 42 women, Analysis 2.4).

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2.4 Outcome: quality of life

3.3 Outcome: use of additional medication

No trials reported on this outcome.


2.4.1 Acupuncture versus combined oral contraceptives
One trial of acupuncture compared with COC found no evidence
of a difference between the groups in the quality of life at three
months, measured using the SF-36 (MD -9.14, 95% CI -19.23
to 0.95, one trial, 42 women; Analysis 2.5).

3.4 Outcome: restriction of daily living activities

No trials reported on this outcome.

3.5 Outcome: absence from work or school

No trials reported on this outcome.


2.5 Outcome: adverse events
3.6 Outcome: quality of life

2.5.1 Acupuncture versus NSAIDs


The adverse event rate was lower in the acupuncture group than in
the NSAIDs group (OR 0.10, 95% CI 0.02 to 0.44, 239 women,
4 trials, I = 15%, low-quality evidence) (Analysis 2.6.1).

No trials reported on this outcome.

3.7 Outcome: adverse events

No trials reported on this outcome.


2.5.1 Acupuncture versus combined oral contraceptives
There was no evidence of a difference in adverse events between
COCs and acupuncture (OR 1.12, 95% 0.34 to 3.63, 1 trial, 52
women, Analysis 2.6).

4) Acupuncture versus no treatment

4.1 Primary Outcome: Pain

Outcome: restriction of daily living activities

No trials reported on this outcome.

Outcome: absence from work or school

No trials reported on this outcome.


3) Acupuncture versus Chinese herbs

4.1.1 Outcome: pain score

Six studies reported this outcome, using a VAS scale, after a single
session of acupuncture (Shi 2011), three months (Song 2013; Xu
2014), four months (Sun 2011), and six months (Xu 2013; Zhang
2013b).
Data were unsuitable for pooling, in most cases because data were
skewed. All studies reported a benefit in the acupuncture group.
Details of findings at up to three months and rationale for not
pooling are reported in Table 2.

3.1 Primary outcome: Pain


Secondary outcomes
3.1.1 Pain score

Acupuncture was associated with a lower pain score (on an unspecified scale) than Chinese herbs (MD -4.58, 95% CI -5.79 to
-3.37, 1 RCT, 120 women, low-quality evidence, Analysis 3.1).

Secondary outcomes

3.2 Outcome: menstrual symptom improvement

Women having acupuncture were more likely to report improvement in menstrual symptoms than those using Chinese herbs (OR
7.00, 95% CI 2.22 to 22.06, 120 women, 1 RCT, low-quality
evidence, Analysis 3.2).

4.2 Outcome: menstrual symptoms

Five studies reported this outcome, using various measures, after


a single session of acupuncture (Shi 2011), three months (Song
2013; Xu 2014), four months (Sun 2011), and six months (Xu
2013, Zhang 2013b).
Two of the studies reported data suitable for pooling, using the
Retrospective Symptom Scale (RSS) (Sun 2011) or the CMSS
(Bu 2011). When data were pooled using the SMD, the results
suggested a moderate to large benefit in the acupuncture group
(SMD -0.81, 95% CI -1.17 to -0.45, two RCTs, 132 women, I
= 0%).
The other three studies reported data that were unsuitable for
analysis. All three studies reported a benefit in the acupuncture

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17

group. Details of the findings of these studies at up to three months


and the rationale for not pooling are reported in Table 3

4.3 Outcome: use of additional medication

No trials reported on this outcome.

4.4 Outcome: restriction of daily living activities

5.5 Outcome: absence from work or school

There was no evidence of a difference between groups in days of


absence from school or work, measured by a self-reported questionnaire (continuous) (MD 0.06, 95% CI -0.54 to 0.66, 117
women, 1 trial) (Analysis 5.2).

5.6 Outcome: quality of life

No trials reported on this outcome.


5.6.1 Outcome: quality of life: physical health
4.5 Outcome: absence from work or school

No trials reported on this outcome.

Acupuncture was associated with improved physical function compared with usual care, measured using the SF36 (MD 5.57, 95%
CI 2.68 to 8.46; 117 women, 1 trial) (Analysis 5.3).

4.6 Outcome: quality of life

No trials reported on this outcome.

4.7 Outcome: adverse events

No trials reported on this outcome.


5) Acupuncture versus usual care
One study made this comparison (Witt 2008). The usual care
group was a wait list control, but women could use any additional
conventional treatments they chose.

5.6.2.Outcome: quality of life: mental health


There was evidence that acupuncture improved mental health
compared with usual care, measured using the SF36 (MD 10.49,
95% CI 3.63 to 17.35; 117 women, 1 trial) (Analysis 5.4).

5.6.3 Outcome: quality of life: bodily pain


There was evidence that acupuncture reduced bodily pain compared with usual care, measured using the SF36 (MD 20.10, 95%
CI 9.90 to 30.30; 117 women, 1 trial) (Analysis 5.5).

5.1 Primary Outcome: Pain

5.6.4 Outcome: quality of life: general health

5.1.1 Outcome: pain score

There was no evidence of a difference in general health compared


with usual care, measured using the SF36 (MD 6.38, 95% CI 0.26 to 13.02, 117 women, 1 trial) (Analysis 5.6).

Acupuncture was associated with a lower pain score than usual care,
measured with a 0 - 10 numerical rating scale (MD -2.09, 95%
CI -2.99 to -1.19, 117 women, 1 RCT, high-quality evidence)
(Analysis 5.1).

Secondary outcomes

5.2 Outcome: menstrual symptoms

No trial reported on this outcome

5.6.5 Outcome: quality of life: vitality


Acupuncture was associated with improved vitality compared with
usual care, measured using the SF36 (MD 18.12, 95% CI 11.52
to 24.72; 117 women, 1 trial) (Analysis 5.7).

5.6.7 Outcome: quality of life: social function


There was evidence that acupuncture improved social function
compared with usual care, measured using the SF36 (MD 20.27,
95% CI 11.52 to 29.02; 117 women, 1 trial) (Analysis 5.8).

5.3 Outcome: use of additional medication

No trial reported on this outcome.

5.4 Outcome: restriction of daily living activities

No trial reported on this outcome.

5.6.8 Outcome: quality of life: emotional role


There was evidence that acupuncture improved emotional role
compared with usual care, measured using the SF36 (MD 14.16,
95% CI 1.29 to 27.03; 117 women, 1 trial) (Analysis 5.9).

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5.7 Outcome: adverse events

6.6 Outcome: quality of life

There was no evidence of a difference in self-reported side effects


in the acupuncture group compared with the usual care group
(OR 0.27, 95% CI 0.05 to 1.34; 117 women, 1 trial) (Analysis
5.10).

No trial reported on this outcome.

6.7 Outcome: adverse events

No trial reported on this outcome.


6) Acupressure versus sham/placebo control
7) Acupressure versus medication
6.1 Primary outcome: pain
Primary outcome: pain
6.1.1 Outcome: pain score

Five studies reported this outcome at two days (Yeh 2013a), one
month (Mirbagher-Ajorpaz 2011), two months (Aghamiri 2005;
Kashefi 2010) and three months (Bazarganipour 2010).
Two of the studies reported data suitable for analysis. We did not
pool them because of high heterogeneity (I = 98%). Both found
that acupressure was associated with lower pain scores, measured
on a VAS 0 - 10 scale (MD -3.50 points, 95% CI -4.10 to -2.90,
1 trial, 100 women (Aghamiri 2005); MD -1.37 points, 95% CI
-2.07 to -0.67, 1 trial, 81 women (Kashefi 2010); Analysis 6.1).
The other three studies reported data that were unsuitable for
analysis. Two found a benefit in the acupressure group. Details
of the findings of these studies are reported in Table 4. The third
trial (Bazarganipour 2010) reported pain severity as categorical
data; pain severity was lower in the acupressure group than in the
control group (P < 0.001).

7.1.1 Outcome: pain score

Acupressure versus NSAIDs


One study reported this outcome (Zafari 2011).
One study reported a higher pain score at two months in women
having acupressure than in those using ibuprofen, measured using
a 0 - 3 scale (MD 0.39, 95% CI 0.21 to 0.57, 136 women, 1 RCT)
(Analysis 7.1).

Secondary outcomes

7.2 Outcome: severity of menstrual symptoms


Secondary outcomes

No trial reported on this outcome.

7.3 Outcome: use of additional medication


6.2 Outcome: severity of menstrual symptoms

There was no evidence that acupressure improved menstrual symptoms using the Menstrual Distress Questionnaire compared with
the placebo control (MD -1.84, 95% CI -3.71 to 0.03; 171
women, 2 RCTs, I = 74%, low-quality evidence, inconsistent direction of treatment effect) (Analysis 6.2).

6.3 Outcome: use of additional medication

No trial reported on this outcome.

6.4 Outcome: restriction of daily living activities

No trial reported on this outcome.

7.4 Outcome: restriction of daily living activities

No trial reported on this outcome.

7.5 Outcome: absence from work or school

No trial reported on this outcome.

7.6 Outcome: quality of life

No trial reported on this outcome.

No trial reported on this outcome.

6.5 Outcome: absence from work or school

7.7 Outcome: adverse events

No trial reported on this outcome.

No trial reported on this outcome

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8) Acupressure versus no treatment

8.1 Primary outcome: Pain

8.1.1 Outcome: Pain score

Two studies reported this outcome, at one month (Chen 2004)


and three months (Chen 2010). There was no evidence of a difference between the acupressure and the no-treatment groups in
pain scores measured on a 0 - 10 VAS scale (MD -0.96, 95% CI 2.54 to 0.62, 2 trials, 140 women, I = 83%) (Analysis 8.1; Figure
5). Statistical heterogeneity was very high, with no obvious explanation, and findings should be regarded with caution.
Figure 5. Forest plot of comparison: 8 Acupressure versus no treatment, outcome: 8.1 Pain score (VAS 0 10).

Secondary outcomes

8.2 Outcome: menstrual symptoms

Three studies reported this outcome (Chen 2004; Chen 2010;


Wong 2010). There was no evidence of a difference between the
groups in menstrual symptom scores, measured using the Menstrual Distress Questionnaire (MD -1.90, 95% CI -5.57 to 1.77,
160 women, 3 RCTs, I = 81%). Statistical heterogeneity was very
high and the direction of effect was inconsistent, so findings should
be regarded with caution.

8.3 Outcome: use of additional medication

No trial reported on this outcome.

8.4 Outcome: restriction of daily living activities

No trial reported on this outcome.

8.5 Outcome: absence from work or school

No trial reported on this outcome.

8.6 Outcome: quality of life

No trial reported on this outcome.

8.7 Outcome: adverse events

No trial reported on this outcome.


Sensitivity analysis
We had planned, a priori, to undertake sensitivity analyses on
the results to look at the possible contribution of differences in

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20

methodological quality, with trials of high quality (low risk of bias)


compared to all trials. We did not pursue this, since only one was
at an overall low risk of bias.
Subgroup analysis
We did not undertake any subgroup analysis, as there was little
diversity by mode of stimulation of the included trials (five trials
of manual acupuncture and one trial of electro-acupuncture).
Reporting bias

There were insufficient studies to explore publication bias by visual


scanning of a funnel plot.

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Acupuncture for dysmenorrhoea (Review)


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A D D I T I O N A L S U M M A R Y O F F I N D I N G S [Explanation]

Acupressure compared with placebo, no treatment or active controls for primary dysmenorrhoea
Population: wom en with prim ary dysm enorrhoea
Settings: outpatient, com m unity
Intervention: acupressure
Comparison: placebo, no treatm ent or active controls
Outcomes

Illustrative comparative risks* (95% CI)

Quality of the evidence


(GRADE)

Comments

Pain:
All studies reported a benef it in the acupressure group. Two studies 538
Acupressure
versus reported a m ean benef it of 1 - 3 points on a 0 - 10 VAS scale
(5 RCTs)
sham or placebo control
Follow-up: 2 days to 3
m onths

low1,2

Data were unsuitable


f or pooling. I = 98%
when the 2 studies with
data suitable f or analysis were pooled

Pain:
1 study used a 0 - 3 pain scale and reported a higher score (indicating 136
Acupressure
versus m ore pain) in the acupressure group (M D 0.39 points, 0.21 to 0.57 (1 RCT)
NSAIDs
higher)
Follow-up: 3 m onths

very low3,4

Pain score:
Acupressure versus no
treatment
Follow-up: 1 - 3 m onths

very low1,2,4

Assumed risk

Corresponding risk

Control

Acupressure

Relative effect
(95% CI)

No of Participants
(studies)

There was no conclusive evidence of a dif f erence between the groups 140
on a VAS 0 - 10 scale
(2 RCTs)
M D 0.96 points lower in the acupressure group (-2.54 lower to 0.62
higher)

Adverse effects:
No studies reported this outcom e
Acupressure
versus
placebo , no treatment
or active controls

Lower scores indicate


less pain, I = 83%

22

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* The basis f or the assumed risk is the m edian control group risk across studies. The corresponding risk (and its 95% conf idence interval) is based on the assum ed risk in the
com parison group and the relative effect of the intervention (and its 95% CI).
CI: Conf idence interval; M D: m ean dif f erence
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our conf idence in the estim ate of ef f ect.
M oderate quality: Further research is likely to have an im portant im pact on our conf idence in the estim ate of ef f ect and m ay change the estim ate.
Low quality: Further research is very likely to have an im portant im pact on our conf idence in the estim ate of ef f ect and is likely to change the estim ate.
Very low quality: We are very uncertain about the estim ate.
1 Downgraded

one level f or serious risk of bias: all or m ost studies at high or unclear risk of bias in one or m ore dom ains
assessed.
2 Downgraded one level f or serious inconsistency in f indings.
3 Downgraded two levels f or very serious risk of bias: rated as at high risk in two of the six dom ains assessed.
4 Downgraded one level f or serious im precision, sm all sam ple size

23

DISCUSSION
Summary of main results
We include 42 trials and data from 4640 women in this updated
review.

Pain
For our primary outcome (pain), there was no consistent evidence
of a difference between women receiving acupuncture and those
receiving a sham control. The only study in the review that was
at low risk of bias in all domains found no evidence of a difference between the groups at three, six or 12 months. However
there was limited evidence to suggest a benefit for women receiving acupuncture compared with NSAIDs, juyuansuan tamoxifen,
Chinese herbs, no treatment, or usual care. Comparisons of the
effectiveness of acupuncture versus combined oral contraceptives
were inconsistent. There was very limited evidence to suggest a
benefit for acupressure compared with a sham control, but other
findings for acupressure were inconsistent.

Secondary review outcomes


For our secondary review outcomes (which include menstrual
symptoms, use of additional medication, restriction in activities,
quality of life and adverse events), there was no consistent evidence of a benefit from acupuncture compared with a sham control. None of these studies reported adverse events.
Acupuncture versus other comparators offered very limited evidence to suggest that it was more effective than NSAIDs, juyuansuan tamoxifen or Chinese herbs for treating menstrual symptoms,
was more effective than usual care for improving quality of life,
and was less likely than NSAIDs to cause adverse events. There
was no evidence of a difference between acupuncture and other
comparators for other secondary review outcomes.
Acupressure versus other comparators found no evidence of a difference between the groups for any secondary review outcomes.

Overall completeness and applicability of


evidence
Most of the trials did not report on outcomes other than pain,
very few reported on adverse events or quality of life, and for many
comparisons there were few data. There were also few trials with
follow-up of outcomes in the medium and long term, as most had
follow-up of three months or less.
There were variations in the eligibility criteria between trials, with
the majority lacking detail in the reporting, or excluding some criteria for primary dysmenorrhoea. However, the majority of women
in the community seeking acupuncture or acupuncture support

are unlikely to have investigative procedures to exclude secondary


dysmenorrhoea. Distinguishing between primary and secondary
dysmenorrhoea was not well reported or undertaken in some trials.
This may have impacted on the homogeneity of women included
in the trials and the severity of symptoms, and could have potentially influenced the responsiveness to acupuncture. Trials recruited women from settings similar to those where women would
access acupuncture or acupressure. Studies were conducted in different countries, and consequently reflects the different styles of
acupuncture administered in the studies.
Twenty-five of the trials were conducted in China and the applicability of their findings to women in other settings is unclear.
The characteristics of acupuncture treatment, including variations
in the duration, mode of stimulation, frequency, and selection
of acupuncture points, may influence the quality of acupuncture
and treatment effect. How acupuncture is practised varies significantly between countries, for example daily treatment is common
in China while very rare in other countries. This is reflected in
the differing treatment frequency of the included trials. It is possible that acupuncture may not have been therapeutically effective, and in some cases may not represent best clinical practice.
In contemporary clinical practice, for example, the duration of
treatment would generally be longer than one month or one menstrual cycle. Among acupuncturists trained in TCM, standardised
prescriptions would not be used and treatment would be individualised based on the diagnosis, with acupuncture treatment varying between sessions. For those trials involving comparisons with
medication, no data were reported on compliance, so it is unclear
if these study groups could have been affected by suboptimal doses
of medication. Placebo controls remain controversial, due to afferent activity arising from these applications.

Quality of the evidence


There remain almost no high-quality trials of acupuncture and
acupressure for the management of primary dysmenorrhoea, and
only one study was assessed at a low risk of bias on all domains.
The quality of reporting was poor in 70% of the trials. Many
trials were at a high risk of bias in relation to randomisation.
Rates of follow-up were high in the majority of trials, with only
a small number of trials reporting a small loss of participants. For
many studies blinding of participants and the practitioner was not
possible, and reporting indicated that the outcomes could have
been influenced by a lack of blinding, and consequently were rated
at a high risk of bias. (Figure 2; Figure 3).
Continuous measures of effectiveness varied and were not always
interpretable, and in many cases the data were skewed or unreliable, which precluded pooling them. Where pooling was possible, we found substantial unexplained heterogeneity for some outcomes. We were unable to explore the effect of study quality using
a sensitivity analysis, due to the lack of studies at low risk of bias.
We were also unable to undertake any subgroup analyses. How-

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24

ever there was clear variation in study characteristics and delivery


of the intervention that may contribute to this heterogeneity.
The quality of evidence using GRADE was low for the two
outcomes of pain relief and menstrual symptoms (Summary of
findings for the main comparison). We downgraded the outcomes
because of high statistical heterogeneity, imprecision and the risk
of bias.

Potential biases in the review process


We attempted to minimise publication bias. Although our search
was comprehensive and we included studies identified in languages
other than English, we cannot rule out the possibility that we may
have missed some studies.

Agreements and disagreements with other


studies or reviews
There are three other reviews of acupuncture to treat primary dysmenorrhoea. Cho 2010 included nine trials out of 27 trials identified, Xu 2014b included two out of 20 trials identified and Yang
2008b identified 30 trials. Cho 2010, Yang 2008b and Xu 2014b
included other modalities of TCM, which we excluded from our
review, and included trials for which we were unable to ascertain
the randomisation details or that we excluded because they did
not meet the eligibility criteria. All three reviews found promising
evidence for the use of acupuncture to treat primary dysmenorrhoea compared with pharmacological medicine or Chinese herbal
medicine. The findings from the Yang 2008b review were more
cautious, due to conflicting results, in part due to a greater number
of trials included which added to the heterogeneity of the findings. The findings from all three reviews were influenced by the
methodological flaws of the trials.

AUTHORS CONCLUSIONS
Implications for practice
There is insufficient evidence to demonstrate whether or not
acupuncture or acupressure is effective in treating primary dys-

menorrhoea, and for most comparisons no data were available on


adverse events. The quality of the evidence was low or very low
for all comparisons. The main limitations were risk of bias, poor
reporting, inconsistency and risk of publication bias.

Implications for research


Further randomised controlled trials are required to evaluate the
effectiveness, efficacy and safety of acupuncture and acupressure in
the treatment of primary dysmenorrhoea. All future randomised
trials should be adequately powered and should consider other
outcome measures as described in this review. Greater attention
should be given to methodological design and the design of the
treatment rationale, and the context of the treatment used in a
research setting. There is also a need to improve the quality of
reporting of future trials.
Future studies may need to consider the use of both comparative
effectiveness designs using medication, for example NSAIDs or
other forms of standard care, and efficacy designs using placebo
controls. Future studies should also give consideration to including
a long-term evaluation of effectiveness and the adverse effects of
acupuncture.

ACKNOWLEDGEMENTS
The review authors would like to acknowledge the Cochrane Menstrual Disorders and Subfertility Group for their assistance with
the preparation of the review, including the Trials Search Co-ordinator for assistance in developing the search strategy, the editors,
co-editors and other staff within the team. We also acknowledge
the Chinese-to-English translation assistance from Kelly Ho, Wai
Sun Lam (Malaysia), Rana Taghipouran (Auckland University)
and Song Mei Wu. We thank Julie Marker (JM) for her assistance
with review and data extraction of English-language trials, and
Karen Cheer for assisting with implementing the search strategy.
We wish to thank Lin He for his contribution to previous published versions of the review. We acknowledge the correspondence
from Claudia Witt identifying the error in data relating to pain
outcomes.

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25

REFERENCES

References to studies included in this review


Aghamiri 2005 {published data only}
Aghamiri Z, Vigeh M, Latifnezhead R, Nabavi S. Study
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Bazarganipour 2010 {published data only}
Bazarganipour F, Lamyian M, Heshmat R, Abadi MAJ,
Taghavi A. A randomized clinical trial of the efficacy of
applying a simple acupressure protocol to the Taichong
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Bu 2011 {published data only}
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primary dysmenorrhea with preconditioning acupuncture.
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Cao 2011 {published data only}
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Charandabi 2011 {published data only}
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Chen 2004 {published data only}
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Chen 2010 {published data only}
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Darabi 2010 {published data only}
Darabi R, Aghamohammadi H, Jafari A, Sadeghi F,
Haccopian G. Efficacy of acupuncture in control of primary
dysmenorrhea related pain in 15-30 years old women at the
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Han 2012 {published data only}
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Helms 1987 {published data only}
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dysmenorrhea. Obstetrics and Gynecology 1987;69(1):516.

Hu 2005 {published data only}


Hu P, Chen SJ. Clinical observation of warm acupuncture
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AR, Jafari P. Effect of acupressure at the Sanyinjiao point
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al. Effect of sa-am acupuncture treatment on dysmenorrhea
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of Primary Dysmenorrhea with Cold Coagulation and Blood
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Ma 2010 {published data only}
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Ma 2013 {published data only}
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Mirbagher-Ajorpaz 2011 {published data only}
Mirbagher-Ajorpaz N, Adib-Hajbaghery M, Mosaebi F.
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randomized controlled trial. Complementary Therapies in
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Peng 2012 {unpublished data only}
Peng M. Clinical Observation on Treating Primary
Dysmenorrhea by Acupuncture Xi Acupoints of Three Foot Yin
Meridians. Guangzhou: Guangzhou University of Chinese
Medicine, 2012.
Qiao 2013 {unpublished data only}
Qiao Li. The Optimum Scheme Selection and Preliminary
Mechanism Discussion of Primary Dysmenorrhoea. Shanxi:
Shanxi University of Chinese Medicine, 2013.

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26

Ruan 2011 {unpublished data only}


Ruan JX. A Randomised Controlled Trial of the Effects
of Acupuncture on Treatment of Primary Dysmenorrhoea.
Guangzhou University of Chinese Medicine, 2011.
Shi 2011 {published data only}

Shi GX1, Liu CZ, Zhu J, Guan LP, Wang DJ, Wu MM.
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levels in primary dysmenorrhea patients. Clinical Journal of
Pain 2011;27(3):25861.
Smith 2010 {published data only}
Smith CA, Crowther CA, Petrucco O, Beilby J, Dent
H. Acupuncture to treat primary dysmenorrhea in
women: a randomised controlled trial. Evidence-Based
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Song 2013 {published data only}
Song JS, Liu YQ, Liu CZ, Xie JP, MA LX, Wang LP, et
al. Cumulative analgesic effects of electroacupuncture
stimulation of Sanyoinjiao (Sp6) in primary dysmenorrhea
patients: a multi-centre randomised controlled trial.
Acupuncture Research 2013;38(5):3938.
Sriprasert 2015 {published data only}
Sriprasert I, Suerungruang S, Athilarp P, Matanasarawoot A,
Teekchunhatean. Efficacy of acupuncture versus combined
oral contraceptive pill in treatment of moderate to severe
dysmenorrhea: a randomised controlled trial. EvidenceBased Complementary and Alternative Medicine August
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doi.org/10.1155/2015/735690]
Sun 2011 {unpublished data only}
Sun J. Clinical and Experimental Research on the Effects of
Shenque Moxibustion and Warming Needles with Moxibustion
Treating Primary Dysmenorrhoea. Guangzhou University of
Chinese Medicine, 2011.
Wang 2005b {published data only}
Wang K, Pan WY, Duan YH. Clinical study of effect of ear
acupuncture on treating primary dysmenorrhea. Guangdong
Medical Journal 2005;26(2):17289.
Wang 2009a {published data only}
Wang MC, Hsu MC, Chein LW, Kao CH, Liu CF. Effects
of auricular acupressure on menstrual symptoms and nitric
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of Alternative and Complementary Medicine 2009;15(3):
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Wang 2013b {published data only}
Wang H, Zhao S, Li X, Ma SX, Li Q, Cui J. Efficacy
observation on wrist-ankle needle for primary dysmenorrhea
in undergraduates. Zhong Guo Zhen Jiu 2013;33:9969.
Wang 2014a {published data only}
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and moxibustion. Chinese Archives of Traditional Chinese
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Witt 2008 {published data only}
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Willich SN. Acupuncture in patients with dysmenorrhea:

a randomized study of clinical effectiveness and costeffectiveness in usual care. American Journal of Obstetrics
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Wong 2010 {published data only}
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and menstrual distress in young women with dysmenorrhea.
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Xu 2013 {published data only}
Xu SW, Yu C, Zhao J, Yang Q, Zhang R, Li G, et al.
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for primary dysmenorrhea. Chinese Journal of Information
on TCM 2013;20(8):767.
Xu 2014 {published data only}
Xu SW, Yu C, Zhao JP, Tan C, Yang QR, Zhang R, et al.
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Yeh 2013a {published data only}
Yeh M-L, Hung Y-L, Chen H-H, Wang Y-J. Auricular
acupressure for pain relief in adolescents with dysmenorrhea:
a placebo controlled study. Journal of Alternative and
Complementary Medicine 2013;19(4):3138.
Youn 2008 {published data only}
Youn HM, Kim CH, Park JH. Effect of acupuncture
treatment on primary dysmenorrhea: a study on single
blind sham acupuncture, randomised controlled clinical
trial. Journal of the Korean Acupuncture and Moxibustion
Society 2008;25:13962.
Yu 2014 {published data only}
Yu C. Clinical observation on pre-menstrual acupuncture
for improving symptoms. Shanghai Journal of Acupuncture
and Moxibustion 2014;33:73840.
Zafari 2011 {published data only}
Zafari M, Tofighi M, Aghamohammady A, Behmanesh
F, Rakhshaee Z. Comparison of the effect of acupressure,
fish oil capsules, and ibuprofen on treatment of primary
dysmenorrheal. African Journal of Pharmacy and
Pharmacology 2011;5(8):1159.
Zhang 2012 {published data only}
Zhang LM, Yang HY. Effect on primary dysmenorrhea
treated by acupuncture. Journal of Traditional Chinese
Medicine 2012;43(2):256.
Zhang 2013a {published data only}
Zhang Y. Acupuncture in the treatment of primary
dysmenorrhea randomised parallel controlled study. Journal
of Practical Traditional Chinese Internal Medicine 2013;11
(27):6971.
Zhang 2013b {published data only}
Zhang XN. The Influence of Symptomatic Marking of SFMPQ for Primary Dysmenorrhea on Pricking Shiqizhu (EXB8) in Different Intervention Time. Shandong: Shandong
TCM University, 2013.

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

27

Zhi 2007 {published data only}


Zhi L. Randomised controlled study on superficial
needling for treatment of primary dysmenorrhea. Chinese
Acupuncture and Moxibustion 2007;27(1):1821.

References to studies excluded from this review


Bing 2011 {published data only}
Bing C, Xiaaohua T. Acupuncture for primary
dysmenorrhea: a randomised controlled trial. Journal of
Acupuncture and Tuina Science 2011;9(5):2957.
Chao 2012 {published data only}
Chao M. Acupoint injection of vitamin K for primary
dysmenorrhoea: feasibility and acceptability results of
a pilot cross over trial. European Journal of Integrative
Medicine 2012;4:1356.
Chao 2014 {published data only}
Chao MT, Wade CM, Abercrombie PD, Gomolak
D. An innovative acupuncture treatment for primary
dysmenorrhea: a randomized crossover pilot study.
Alternative Therapies in Health and Medicine 2014;20(1):
4956.
Chen 2008 {published data only}
Chen B, Tu XH. Clinical observation on the efficacy of
acupuncture in treating primary dysmenorrhoea. Shanghai
Journal of Acupuncture and Moxibustion 2008;27(6):156.

Habek 2003 {published data only}


Habek D, Cerkez Habek JC, Bobi -Vukovi , Vuji
B. Efficacy of acupuncture for the treatment of primary
dysmenorrhoea. Gynakologisch-Geburtshilifiche Rundschau
2003;43(4):2503.
He 2005 {published data only}
He JW, Chang JT, Zhao JM. Clinical observation of
acupuncture and moxibustion therapy for primary
dysmenorrhea. Chinese Contempory Medicine 2005;3(3):
101.
Hu 2011 {published data only}
Hu Y, Lin Q, Li Y, Zheng X. Effects on PGF2alpha
in plasma in primary dysmenorrhea treated with eye
acupuncture. Zhong Guo Zhen Jiu 2011;31:6836.
Hu 2014 {published data only}
Hu TM, Cai J, Xiong FL, Zhu GQ. Theraputic observation
of acupoint injection and moxibustion for dysmenorrhea
with pattern of cold retention. Yunnan Journal of Traditional
Chinese Medicine 2014;35(10):589.
Huang 2013 {published data only}
Huang T, Yang L, Jia S, Mu X, Wu M, Ye H, et al. Capillary
blood flow in patients with dysmenorrhea treated with
acupuncture. Journal of Traditional Chinese Medicine 2013;
33(6):75760.

Chen 2011 {published data only}


Chen SZ, Cong Q, Zhang BF. Preliminary comparison
on the time effect rule of pain relieving in the treatment
of moderate dysmenorrhoea between acupuncture on a
single point and acupuncture on a multi point.. Chinese
Acupuncture and Moxibustion 2011;31(4):3058.

Huyou-Ping 2013 {published data only}


Huyou-Ping, Zhang X, Zhang LX, Wu J, Wang Z, Jia
XF, et al. Time effect study on instant analgesic effect
of the dragon-tiger fighting needling method on primary
dysmenorrhea. Zhongguo Zhen Jiu [Chinese Acupuncture and
Moxibustion] 2013;33(11):10059.

Chen 2014 {published data only}


Chen CL, Deng C. Clinical observation of acupuncture for
primary dysmenorrhea. Journal of New Chinese Medicine
2014;46(7):1612.

Jiang 2007 {published data only}


Jiang LY. Clinical experience for the treatment of 34 cases of
primary dysmenorrhoea. Journal of Emergency TCM 2007;
16:6201.

Gao 2014a {published data only}


Gao Y, Huang Z. Theraputic effect analysis of warm
acupuncture for primary dysmenorrhea. Asia-Pacific
Traditional Medicine 2014;10(14):601.

Jun 2004 {published data only}


Jun EM. Effects of SP6 acupressure on dysmenorrhea,
skin temperature of CV2 acupoint and temperature in the
college student. Journal of Korean Academic Nursing 2004;
34(7):134350.

Gao 2014b {published data only}


Gao XY. Effect of observation of acupuncture with TCM
nursing for primary dysmenorrhea. Chinese Journal of
Clinical Rational Drug Use 2014;7(9B):1156.
Geng 2008 {published data only}
Geng S. Effect of observation of 60 primary dysmenorrhea
treated with Chinese medicine. Beijing Journal of Traditonal
Chinese Medicine 2008;27(1):302.
Gharloghi 2012 {published data only}
Gharloghi G, Torkzahrani S, Akbarzadeh AR, Heshmat
R. The effects of acupressure on severity of primary
dysmenorrhea. Patient Preference and Adherence 2012;6:
137-42.
Guo 2008 {published data only}
Guo A, Meng Q. Acupuncture combined with spinal Tui
Na for treatment of primary dysmenorrhea in 30 cases.
Journal of Traditional Chinese Medicine 2008;28(1):79.

Jun 2007 {published data only}


Jun EM, Chang S, Kang DH, Kim S. Effects of acupressure
on dysmenorrhea and skin temperature changes in college
students: a non randomised controlled trial. International
Journal of Nursing Studies 2007;44(6):97381.
Kempf 2009 {published data only}
Kempf D, Berger D, Ausfeld-Hafter B. Laser needle
acupuncture in women with dysmenorrhoea: a
randomised controlled double blind pilot trial. Forschende
Komplementarmedizin [Research in Complementary Medicine]
2009;16(1):612.
Kim 2011 {published data only}
Kim E, Cho JH, Jung WS, Lee S, Pak SC. Effect
of acupuncture on heart rate variability in primary
dysmenorrheic women. American Journal of Chinese
Medicine 2011;39(2):2439.

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

28

Kiran 2013 {published data only}


Kiran G, Gumusalan Y, Ekerbicer HC, Kiran H. A
randomized pilot study of acupuncture treatment for
primary dysmenorrhea. European Journal of Obstetrics,
Gynecology and Reproductive Biology 2013;169(2):2925.
Li 2006 {published data only}
Li W, Liu L, Sun Li. Analysis on therapeutic effect of
substance-partitioned moxibustion at Guanyuan (CV4) and
Shenque (CV8) for treatment of primary dysmenorrhea
of cold damp type. Chinese Acupuncture and Moxibustion
2006;26(7):4812.
Li 2007 {published data only}
Li CH, Guo XX. Acupuncture in combination with herbal
plaster on umbilicus for 58 cases of primary dysmenorrhoea.
China Medical Herald 2007;12(4):1001.
Li 2011 {published data only}
Li YM, Bu YQ, Hou WJ, Chen SZ, Gao SZ. Observation
on immediate analgesic effect on acupuncture at Shiqizhui
(EX-B 8)only or multi acupoints in patients with
dysmenorrhoea: a randomised controlled trial. Chinese
Acupuncture and Moxibustion 2011;31(3):199202.
Li 2012a {published data only}
Li M-G, Li D-C, Li S-R. Acupuncture and moxibustion
combined with cupping for primary dysmenorrhea in 66
cases. World Journal of Acupuncture-Moxibustion 2012;22
(2):6870.
Lin 2008 {published data only}
Lin LL, Liu CZ, Huang BY. Clinical observation on
treatment of primary dysmenorrhea with acupuncture and
massage. Zhongguo Zhong Xi Yi Jie He Za Zhi [Chinese
Journal of Integrated Traditional and Western Medicine]
2008;28(5):41820.
Liu 2005 {published data only}
Liu YL. Clinical observation of acu-point injection with
vitamin K3 on SP6 for primary dysmenorrhea. Journal of
Chinese Medicine Liaoning 2005;32(11):11856.

45 cases. Yunnan Journal of Chinese Medicine and Herbal


Medicine 2014;35(12):445.
Mahoney 1993 {unpublished data only}
Mahoney DS. Acupressure and its use for dysmenorrhoea.
Texas Womens University, 1993.
Miao 2014 {published data only}
Miao EY, Miao MY, Kildea DG, Lao YW. Effects of
electroacupuncture and electroacupuncture plus Tao Hong
Si Wu Wan in treating primary dysmenorrhea. Journal of
Acupuncture and Meridian Studies 2014;7(1):614.
Pouresmail 2002 {published data only}
Pouresmail Z, Ibrahimzadeh R. Effects of acupressure and
Ibuprofen on the severity of primary dysmenorrhea. Journal
of Traditional Chinese Medicine 2002;23(3):20510.
Pu 2011 {published data only}
Pu Y. Observation on therapeutic effect of acupuncture at
Shiqizhui (extra) for primary dysmenorrhoea at different
time. Zhongguo Zhen Jui [Chinese Acupunsture and
Moxibustion] 2011;31(2):1102.
Reyes-Campos 2013 {published data only}
Reyes-Campos MD, Daz-Toral LG, Verdn-Tern SL,
Orozco-Surez ES, Lpez-Ramrez P, Pineda-Carranza A,
et al. Acupuncture as an adjunctive treatment for primary
dysmenorrhoea: a comparative study. Medical Acupuncture
2013;25(4):2914.
Ro 2013 {published data only}
Ro SO, Lee HY, Lee J, Kim M. Effects of auricular
acupuncture on menstrual pain, dysmenorrhea and
academic stress in women college students. Korean Journal
of Adult Nursing 2013;25(3):356364.. [DOI: 10.7475/
kjan.2013.25.3.356]
She 2008 {published data only}
She YF, Sun L, Yang J, Ge J, Li X. Effects of substance
partioned moxibustion on plasma Beta-EP content in the
patient with primary dysmenorrhea of cold damp stagnation
type in the menstrual period. Chinese Acupuncture and
Moxibustion 2008;28(10):71921.

Liu 2014a {published data only}


Liu CZ, Xie JP, Wang LP, Liu YQ, Song JS, Chen YY, et al.
A randomized controlled trial of single point acupuncture in
primary dysmenorrhea. Pain Medicine 2014;15(6):91020.

Shi 1994 {published data only}


Shi XL, Yang AM, Li FZ. Acupuncture of San Yin Jiao
for the treatment of 120 cases of primary dysmenorrhoea.
Chinese Acupuncture and Moxibustion 1994;14(5):178.

Liu 2014b {published data only}


Liu CM, Ma YX, Guo ZP, Gong CR. Real-time analgesic
effect of acupuncture at Shiqizhui (EX-B8) for primary
dysmenorrhea with different needle-retaining time.
Shanghai Journal of Acupuncture and Moxibustion 2014;33
(10):9012.

Song 1992 {published data only}


Song XZ, Ji Y. Clinical observation on the efficacy of ear
seed pressing on dysmenorrhea. Journal of Beijing College of
Traditional Chinese Medicine 1992;2:589.

Lui 1999 {published data only}


Lui AZ, Zhang CM. Study of acupuncture versus
psychological therapy for dysmenorrhea. Zhongguop Zhen
Jiu [Chinese Acupuncture and Moxibustion] 1999;19:
20910.
Luo 2014 {published data only}
Luo XW. Electronic acupuncture with moxibustion for
primary dysmenorrhea with pattern of cold retention in

Sun 2004 {published data only}


Sun LH, Ge JJ, Yang JJ, She YF. Effect observation of
substance partitioned moxibustion for 42 cases of primary
dysmenorrhea. Journal of Herbei TCM and Pharmacology
2004;19(3):37.
Sun 2008 {published data only}
Sun LH, Ge JJ, She YF, Yang JJ, Li WL, Li XH. Therapeutic
effect of substance partitioned moxibustion on 103 cases of
primary dysmenorrhea of cold damp stagnation type. Hebei
Journal of TCM 2008;30(2):1701.

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

29

Wang 2002 {published data only}


Wang HY. Auricular acupuncture for the treatment of
68 cases of primary dysmenorrhoea. Journal of Zhejiang
Traditional Chinese Medicine 2002;6:249.
Wang 2005a {published data only}
Wang SM, Li XG, Zhang LQ. Clinical observation on
96 cases of primary dysmenorrhea treated by medicineseparated moxibustion and investigation on its mechanisms.
World Journal of Acupuncture-Moxibustion 2005;15(3):137.
Wang 2009b {published data only}
Wang SX, Lu DJ, Li YH. [Observation on therapeutic
effect of acupoint application on dysmenorrhea of
excess syndrome and effect on prostaglandins]. Chinese
Acupuncture and Moxibustion 2009;29(4):2658.
Wang 2013a {published data only}
Wang YJ, Hsu CC, Yeh ML, Lin JG. Auricular acupressure
to improve menstrual pain and menstrual distress and heart
rate variability for primary dysmenorrhea in youth with
stress. Evidence-Based Complementary and Alternative
Medicine 2013; Vol. 138537. [DOI: 10.1155/2013/
138537]
Wang 2014b {published data only}
Wang GF, Yuan Y, Cui H. Clinical effect of electric
acupuncture combined with ginger-isolated moxibustion
on treating primary dysmenorrhea of 30 cases. Journal of
Clinical Acupuncture and Moxibustion 2014;30(1):301.
Wu 2007 {published data only}
Wu RD, Zhang HD, Lin LF. Observation on ear point
taping and pressing therapy for treatment of primary
dysmenorrhea. Chinese Acupuncture and Moxibustion 2007;
27(11):8157.
Xie 2003 {published data only}
Xie GT, Tan LY, Lu QQ, Zhao CJ. Clinical research on Ling
Gui Ba Fa for the treatment of primary dysmenorrhoea.
Journal of Clinical Acupuncture 2003;8:5960.
Xiong 2012 {published data only}
Xiong J, Liu F, Zhang M, Wang W, Huang GY. De-qi, not
psychological factors, determines the therapeutic efficacy of
acupuncture treatment for primary dysmenorrhea. Chinese
Journal of Integrated Medicine 2012;18(1):715.
Yang 2008a {published data only}
Yang JJ, Sun LH, She YF, Ge JJ, Li XH, Zhang RJ.
Influence of ginger partioned moxibustion on serum NO
and plasma endothelin-1 contents in patients with primary
dysmenorrhea of cold-damp stagnation types. Acupuncture
Research 2008;33(6):40912.
Yang 2014 {published data only}
Yang SX. Theraputic effect observation of acupuncture
and ear acupuncture for primary dysmenorrhea. Ningxia
Medical Journal 2014;36(8):7556.
Yeh 2013 {published data only}
Yeh ML, Hung YL, Chen HH, Lin JG, Wang YJ. Auricular
acupressure combined with an internet-based intervention
or alone for primary dysmenorrhea: a control study.

Evidence-Based Complementary and Alternative Medicine


2013; Vol. 316212. [DOI: 10.1155/2013/316212]
Yi 2005 {published data only}
Yi LH, Chen Y. Clinical observation on use of acupuncture
in combination with massage for 55 cases of primary
dysmenorrhoea. Chinese Journal of Clinical Healthcare
2005;8(2):1401.
Yu 2010 {published data only}
Yu YP, Ma LX, Ma YX, Ma YX, Liu YQ, Liu CZ, et
al. Immediate effect of acupuncture at Sanyinjiao (SP6)
and Xuanzhong (GB39) on uterine arterial blood flow
in primary dysmenorrhea. Journal of Alternative and
Complementary Medicine 2010;16(10):10738.
Yuk 2005 {published data only}
Yuk SS, Lim EM. A clinical study on the effect of crossing
over treatment of acupuncture and herbal medication for
primary dysmenorrhea. Journal of Oriental Obstetrics and
Gynecology 2005;18:14452.
Zhang 2004 {published data only}
Zhang XH, Fang RD. Clinical observation on the use of
Shao Fu Zhu Yu Tang in combination with acupuncture for
65 cases of primary dysmenorrhoea. Heilongjiang Journal of
Traditional Chinese Medicine 2004;33(3):3941.
Zhang 2014 {published data only}
Zhang SR. Clinical observation of acupuncture for primary
dysmenorrhea. Chinese Journal of Clinical Rational Drug
Use 2014;7(12):1256.
Zheng 2006 {published data only}
Zheng Z. Observation of therapeutic effect of acupuncture
on treating primary dysmenorrhea. Zhejjang Journal of
ITCWM 2006;16(2):7881.
Zheng 2014 {published data only}
Zheng YF, Wang ZH. Clinical observation of warm
acupuncture combined with electronic acupuncture for
primary dysmenorrhea. Liaoning Journal of Traditional
Chinese Medicine 2014;41(7):15101.
Zhou 2003 {published data only}
Zhou LS. Clinical observation on the efficacy of acupuncture
of Ciliao (BL32) point on primary dysmenorrhea. Hubei
Journal of Traditional Chinese Medicine 2003;8:47.
Zhou 2014 {published data only}
Zhou Y. Acupuncture with moxibustion therapy of primary
dysmenorrhea: a random parallel control study. Journal of
Practical Traditional Chinese Internal Medicine. 2014;28
(12):1335.

References to studies awaiting assessment


Han 2015 {published data only}
Han Y, Zhou Y, Guo X, Liu Y, Li H, Chen X. Analgesis
effect on primary dysmenorrhoeal treated with conventional
and sham acupuncture at Sanyinjiao (SP6). Chinese
Acupuncture and Moxibustion 2015;35:31822.
Zhang 2003 {published data only}
Zhang M, Sun ST. Clinical observation of acupuncture
therapy for 32 cases of primary dysmenorrhea. Journal of

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

30

Chinese Science, Technology and Traditional Chinese Medicine


2003;10:322.

References to ongoing studies


Armour 2013 {published data only}
Acupuncture primary dysmenorrhoea: examining the role
of frequency of treatment and mode of stimulation on
clinical outcomes. Ongoing study May 2013.

Dawood 2006
Dawood MY. Primary dysmenorrhea: advances in
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Huang 2010 {published data only}


Randomised controlled trial of acupuncture for
dysmenorrhoea. Ongoing study May 2010.

French 2008
French L. Dysmenorrhea in adolescents: diagnosis and
treatment. Paediatric Drugs. New Zealand, 2008; Vol. 10,
issue 1:17.

Witt 2012 {published data only}


Effectiveness of additional self-care acupressure for women
with menstrual pain compared to usual care. Ongoing
study December 2012.

Henzl 1985
Henzl MR. Dysmenorrhea: Achievements and challenge.
Sexual Medicine Today 1985;9:812.

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Indicates the major publication for the study

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

32

CHARACTERISTICS OF STUDIES

Characteristics of included studies [ordered by study ID]


Aghamiri 2005
Methods

RCT; parallel design of acupressure versus sham acupressure

Participants

100 medical students from Sari University, 50 in each group. Diagnosis not confirmed

Interventions

Conducted over 2 menstrual cycles


Acupressure points 23 & 24 at the waist; points 3 & 4 in abdomen; points 3 & 4 in
leg included Shenmen (points not specified from translation). Pressure applied for 15
minutes, then rested for 15 minutes and applied for a further 15 minutes
Sham acupressure applied off points. Treatment administration the same as for acupressure

Outcomes

Pain assessed using the VAS 30 - 180 minutes following treatment. Outcome recorded
at 3 hours post-treatment

Notes

Country: Iran
Language: Farsi
Conducted in 2002
ITT not mentioned, and not stated if undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Described as simple randomisation manner

Allocation concealment (selection bias)

Insufficient reporting

Unclear risk

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

Participants blinded, personnel not blind,


assessor unclear

Incomplete outcome data (attrition bias)


All outcomes

High risk

Insufficient reporting, no details reported


on the numbers analysed

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting

Acupuncture for dysmenorrhoea (Review)


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33

Bazarganipour 2010
Methods

RCT of acupressure versus placebo acupressure, 95 allocated to acupuncture and 102 to


control

Participants

253 female students assessed, 197 randomised, recruited from Nasibe Tarbiat Moallem
University, Tehran, Iran
Participants were aged 18 - 21 years, with menstrual pain, no gynaecological disease, no
other pain during menstrual cycle and not taking analgesics 4 hours before treatment

Interventions

Intervention group: Acupressure to Taichong (LIV3) point applied for 20 minutes. Mild
pain generated with clockwise movement for 1 minute, and counter clockwise for 1
minute. After 2 minutes massage to point was applied. Pressure applied so that nail
colour changed. Alternation continued for 20 minutes. Participants instructed to apply
protocol 3 - 7 days before the period for next 2 menstrual cycles
Placebo point applied on the dorsal surface of the point.
Investigator trained in acupressure.

Outcomes

Pain severity assessed using Andersch and Milsom scale.

Notes

Baseline characteristics: assessed no imbalance


Loss to follow-up: 2 intervention group, 5 placebo group due to irregular menstruation
ITT not reported and undertaken
Duration: March - Dec 2008 (1 baseline cycle, 3 treatment cycles)

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Generated from a table of random numbers

Allocation concealment (selection bias)

Not reported in text

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

Participants blinded, practitioner not blind


and one of the investigators also undertook
data analysis; no blinding reported

Incomplete outcome data (attrition bias)


All outcomes

High risk

Intervention group: 1 dropout due to fear


of side effects, 4 did not start treatment due
to personal reasons
Control group: 3 did not undergo treatment due to personal reasons, 10 dropped
out due to fear of adverse events, believed
treatment would be ineffective, sought
medical advice

Selective reporting (reporting bias)

Unclear risk

Insufficent reporting to assess

Other bias

Unclear risk

Insufficient reporting to assess

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34

Bu 2011
Methods

RCT of 3 groups, acupuncture before menstruation, acupuncture during menstruation


or untreated control group. Participants randomly
assigned on the ratio of 1:1:2 into three groups

Participants

80 women randomised to the study with primary dysmenorrhoea, women with secondary dysmenorrhoea excluded by gynaecological examination. Participants were Chinese college students. 40 women in each of the two groups

Interventions

Acupuncture points SP6, BL32, SP8, BL17 were administered to the 2 acupuncture
groups
Before-menstruation group received acupuncture 3 - 7 days before the start of menstruation. Treatment was performed daily. Needles were administered for 30 minutes. DeQi
was applied every 10 minutes
The second acupuncture group received treatment once menstruation started, with the
points, treatment duration the same as the pre-menstruation group
No-treatment group could take aspirin if their VAS score was > 80

Outcomes

The CMSS scale was used to assess the severity of pain at the end of each of 3 consecutive
cycles and monthly over a 3-month period.The Cox scale includes 17 symptoms commonly associated with menstrual distress. For each symptom, the scale measures both
intensity and duration, with a range from 0 (not perceivable) to 4 (extremely upsetting)

Notes

Country: China.
Baseline characteristics not assessed
Loss to follow-up due to students returning home, 2 dropped out from acupuncture
administered before menstruation, and 1 dropped out from the group receiving treatment
during the cycle
Compliance: not reported.
ITT not reported and not undertaken.
Duration: 3 menstrual cycles
Assessment of blinding: participant blinding not appropriate
Data from the 2 acupuncture groups were combined for the analysis

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Unclear risk


bias)

Not reported. Participants were assigned


randomly on a ratio of 1:1:2 into 3 groups

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

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Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Participants were not blind to their group


allocation, Outcomes were self reported
and not blinded, no details on the status of
the analyst.

35

Bu 2011

(Continued)

Incomplete outcome data (attrition bias)


All outcomes

Low risk

Four subjects (10%) from the acupuncture


group described as a post randomisation
exclusion

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgment of yes or No

Other bias

Unclear risk

Insufficient information to assess whether


an important risk of bias exists.

Cao 2011
Methods

Parallel RCT, manual acupuncture compared with medication

Participants

60 women randomised to the study, 30 to each group. Diagnosis based on Western and
Chinese medicine diagnosis guidelines

Interventions

3-month intervention. Manual acupuncture: Shiqizhui (EX-B8), perpendicular with 0.51 cun needle insertion depth. Ciliao, perpendicular with 1-1.5 Cun, Diji, perpendicular
with 1-1.5 Cun
Daily treatment for 30 minutes with manipulation every 10 minutes started 1 day
before menstrual cycle and finished after end of the cycle. 3 consecutive treatments were
performed in total
Control: Oral intake 1.2 - 0.4 g ibuprofen daily was prescribed during menstrual cycle
and continued for 3 cycles

Outcomes

Pain measured by VAS, overall improvement in symptoms (unspecified scale) at the end
of the intervention

Notes

Country: China
Language: Chinese
Setting: Hospital in Helongiang province
ITT not mentioned and not undertaken.

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number table

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

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Participants not blinded, insufficient reporting regarding other study personnel

36

Cao 2011

(Continued)

Incomplete outcome data (attrition bias)


All outcomes

Low risk

1 post-randomisation exclusion
acupuncture group, reason not stated

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting

in

Charandabi 2011
Methods

Cluster-randomised controlled trial of acupressure versus no treatment. Randomisation


was made at the level of 4 dormitories

Participants

228 women assessed, 72 randomised, 36 allocated to treatment and 36 to the control


group. Women were aged 18 - 22 years from Tabriz University and Tabriz University of
Medical Sciences, Iran. Regular menstruation, score of > 5 on the VAS, no evidence of
pelvic disease

Interventions

Both groups could take ibuprofen (400 mg) every 6 hours if needed
Acupressure applied to SP6 point with the thumb for 5 minutes (6-second pressure and
2 seconds rest) to an intensity where pain was tolerable. The participants were told that
at the time of pain and menstrual symptoms (for spasmodic cases during the 2 first days
of menstruation and for congestive group during the 2 days before menstruation) the
point should be pressed. This procedure should then be repeated for the other foot. The
whole routine was repeated on both feet for another 10 minutes (each foot for 2 x 5minutes)
Control group was no acupressure.

Outcomes

Menstrual symptoms questionnaire, symptom severity scale

Notes

Data were not presented in a form.


No imbalance in characteristics at baseline.
Loss to follow-up: no loss
Compliance: not reported
Duration: 2 cycles.

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Unclear risk


bias)

Cluster-randomisation stated but not specified.

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes
Acupuncture for dysmenorrhoea (Review)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Participants were not blind to group allocation, outcome assessment was subjective
and no details on analyst status were re37

Charandabi 2011

(Continued)

ported.
Incomplete outcome data (attrition bias)
All outcomes

Low risk

No loss to follow-up

Selective reporting (reporting bias)

Unclear risk

Not reported

Other bias

Unclear risk

Not reported

Chen 2004
Methods

RCT, 2 groups acupressure on SP6 (41 women), compared with rest (40 women)

Participants

81 female students participated in the study. Inclusion criteria: age < 20 years, pain
greater than 5 on VAS scale, no pain medication taken 4 hours prior to the start of the
intervention. Participants were recruited with no prior history of gynaecological disease
or secondary dysmenorrhoea, although it was not reported how this was established

Interventions

The intervention was manual acupressure, applied by researcher at the initial treatment,
then self-administered at subsequent treatments. Acupressure applied to SP6 on alternate
legs, 2 complete 5-minute cycles of pressure performed on each leg for a total of 20
minutes. The force applied initially 1.21 kg, (method of assessment of the force not
reported) increasing to 3.53 kg. Acupressure applied for 6 seconds, released for 2 seconds
without pressure. This was continued for 5 minutes on each leg, and repeated 4 times.
When cramping occurred in the initial session acupressure was applied. The intervention
was applied over 1 cycle
When cramping occurred participants were asked to rest in the school health centre for
20 minutes

Outcomes

VAS 0 - 10 cm scale measures the intensity of pain, Menstrual Distress Questionnaire,


VAS to measure anxiety: end-score

Notes

Country: Taiwan
Setting: Technical high school
Loss to follow-up: 12% loss acupressure, 35% control.
Compliance: not reported. No certainty or evidence that intervention was self-administered at all
ITT: not reported
Duration: December 2000 - August 2001
Funding: Government grant

Risk of bias
Bias

Authors judgement

Random sequence generation (selection Low risk


bias)

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Support for judgement


Drawn by lot

38

Chen 2004

(Continued)

Allocation concealment (selection bias)

Low risk

Sealed envelopes

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding of participants, or of the care


provider but outcomes said to be recorded
by a research assistant unaware of the group
assignment and administered all the instruments in the health centre

Incomplete outcome data (attrition bias)


All outcomes

High risk

50% dropout in control group

Selective reporting (reporting bias)

Unclear risk

Study protocol was not available, therefore


cannot rule out selective reporting. No
clear statement of primary or secondary
outcomes

Other bias

Unclear risk

Baseline characteristics assessed were said


to be statistically similar, but number of
participants in the groups does not add up
for analgesic usage and absent from class.
There may be imbalances at baseline

Chen 2010
Methods

RCT, 4 groups, acupressure on group 1) ST 36; group 2) LI4; group 3) LI4 plus SP6;
versus 4) no treatment.50 women allocated to each group

Participants

134 adolescents (aged < 20 years), with a pain score of > 4 on the VAS, no gynaecological
disease, or secondary diagnosis (details of diagnosis confirmation not reported). Exclusion
criteria included skin infection, haemorrhage or phlebitis.The mean age was 16 plus
years, although the standard deviation indicates some women may have been 15 years

Interventions

The 3 experimental groups were given a detailed acupressure protocol. The researcher
applied acupressure during the first menstrual period. When the VAS pain score was > 4,
participants were asked to attend the health care office for acupressure. Acupressure was
applied alternating between each leg. The force was initially 1 kg (method of assessment
of force applied not reported), increasing to 4 kg at the end of the therapy. Pressure was
applied for 6 seconds, then a rotating movement was made for 2 - 3 seconds alternating
without pressure. The process was applied 4 times over 20 minutes, over 3 days for 3
cycles. Participants in the control group had 20 minutes of bed rest. Participants in the
experimental group were taught how to apply pressure in the next menstrual cycle

Outcomes

VAS pain (0 - 10) measures the intensity of pain, Menstrual Distress Questionnaire, VAS
to measure anxiety. Assessed at 1,3 and 6 months. Data reported at 1 month

Notes

Country: Taiwan
Setting: Medical Technology University
Groups comparable at baseline.

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39

Chen 2010

(Continued)

Loss to follow-up: 40% dropout similar between groups


ITT: not reported
Compliance: not ascertained
Duration: January - August 2003
Funding: Government grant
Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Drawn by lot

Allocation concealment (selection bias)

Sealed envelopes

Low risk

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding of participants, the practitioner was not blind, and blinding of the
analyst was not reported.

Incomplete outcome data (attrition bias)


All outcomes

High risk

High dropout rates of up to 40% but similar number and reason across all groups.
Attempts made to increase return rate of
questionnaires by trained assistants

Selective reporting (reporting bias)

Unclear risk

Study protocol was not available, therefore


cannot rule out selective reporting. No clear
statement of prospective primary or secondary outcomes

Other bias

Unclear risk

Unclear from reporting

Darabi 2010
Methods

RCT, parallel design. Manual acupuncture versus sham acupuncture

Participants

100 participants, 50 in each group. Diagnosis was not clinically confirmed. Age of
participants eligible: 15 - 30
Exclusion criteria: wound in the area where acupuncture would be applied

Interventions

Intervention administered over 3 cycles.


Acupuncture: CV3, St29, CV12, CV4, Bl23 applied. 3 sessions every second day in the
week before period. A total of 9 treatments
Control: sham acupuncture with points applied away from real points. Timing as per
experimental group

Outcomes

Pain measured using the VAS, with scores reported at the end of the intervention at 3
months

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40

Darabi 2010

(Continued)

Notes

Country: Iran
Language: Farsi
Setting: Hospital clinic
Study conducted 2007 - 2008
ITT not mentioned and not stated if undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Unclear risk


bias)

Stated as randomisation but method not


reported

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

Participants were blinded, study personnel


were not blinded; no details provided on
the outcome assessor

Incomplete outcome data (attrition bias)


All outcomes

Unclear risk

Insufficient reporting

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting

Han 2012
Methods

RCT of acupuncture plus moxibustion and ibuprofen

Participants

120 women recruited, aged < 45 years. Diagnosis of primary dysmenorrhoea made by
Western and Chinese methods. 40 women in the control arm and 80 women in the
treatment group

Interventions

Daily treatment was performed 4 days prior to period, continued for 7 days and 3 cycles.
Points were Ciliao, Zhongwan, Guanyuan, Zusanli, Sanyinjiao, Taichong and Diji. The
points were manually stimulated for 10 seconds after DeQi. The needles were then
retained for another 10 - 15 minutes.
Moxibustion with self-made herbal-based materials which contained Honghua, Huoxiang, Zisuye. The herbs were ground into powder and mixed with yellow rice wine. The
shape of the object was 3 cm in diameter and 0.8 cm in thickness. Moxibustion was
performed on Guanyuan, Zusanli, Sanyinjiao and Taichong points
Participants took ibuprofen. 0.3 g taken each time and twice daily. Treatment started
from 4 days before menstrual cycle and continued for 7 days. 3 consecutive treatments
were conducted

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41

Han 2012

(Continued)

Outcomes

Pain relief, overall improvement in symptoms using unspecified scale at end of the
intervention

Notes

Country: China
Setting: 3 hospitals in Wuhan
Funding: not stated

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Computer-generated

Allocation concealment (selection bias)

Central

Low risk

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

Insufficient reporting to determine

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting to make a judgement

Other bias

High risk

Extreme imbalance at randomisation

Helms 1987
Methods

RCT, 4 groups: 1) acupuncture (11 women); 2) placebo acupuncture (11 women); 3)


standard control initial visit only (11 women; and 4) visit control (10 women)

Participants

48 women were recruited. Women had recurrent pain that started within 2 years of
regular menstruation, and in the absence of any pelvic pathology. No other details on
inclusion and exclusion criteria were stated

Interventions

1. Acupuncture group: real acupuncture with needles inserted into the skin along meridian points;
2. Placebo acupuncture with needles inserted in the same manner at points close to real
acupuncture points, but areas that were verified as having no electrical activity;
3. Standard control involved an initial meeting but then participants continued on
whatever method they used prior to the study;
4. Visit control was the same as the standard control with the addition of extra visits to
the physician during the study
1. Acupuncture points: SP4, K3, ST36, ST30, CV2, CV4, CV6, (points located on feet,
below the knee and lower abdomen). Duration: needles in place for 30 - 40 minutes,
once a week for 3 weeks a month, for 3 months
2. Placebo acupuncture needles of the same types of needles at points off acupuncture

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42

Helms 1987

(Continued)

channel (meridian) and verified as not having electrical activity. 12 needles were used
per treatment, retained for 30 minutes
3) Standard control group had no contact with the physician-investigator after initial
interview
4) Visit control visited the physician once a month after their first 3 periods and reviewed
their symptom evaluation form with him. For the subsequent 9 months forms were
completed with no special attention
Outcomes

Pain duration, pain intensity, pain scores pre-, during, post-treatment, and a menstrual
questionnaire. Improvement was arbitrarily defined as being an average post-treatment
score of less than half that of the pretreatment score

Notes

Country: USA
Setting: Gynecological clinic
Groups comparable at baseline: yes.
Loss to follow-up: 11%, 2 from visit and 1 respectively from each group
Compliance: not reported.
ITT: not stated
Duration: not stated
Funding: not reported

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Table of random numbers

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

The women in 2 groups were blinded to


their acupuncture group (blinding not assessed), but participants aware of allocation
to acupuncture or control group. The outcome analyst was blinded, the therapist was
not blinded

Incomplete outcome data (attrition bias)


All outcomes

Low risk

5 women (10%) discontinued treatment.


2 pregnancies, 2 job relocations, 1 lack of
interest. Missing outcome data balanced
across groups

Selective reporting (reporting bias)

Unclear risk

Study protocol not available and primary


outcomes were not prespecified

Other bias

Unclear risk

The study appears free of other biases.

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43

Hu 2005
Methods

RCT parallel design of manual acupuncture plus moxibustion compared with pharmacological treatment. 80 women randomised, 40 to each group

Participants

Diagnosis was based on Western and Chinese medical diagnoses. No further details
provided

Interventions

Manual acupuncture on Guan Yuan (CV4), San Yin Jiao (SP6), Tai Chong (LIV 3), and
placed 2 cm * 2 of moxa bar on the needle after DeQi. Once each day. Starting from 3
days before each cycle, for 3 days, 3 circles as 1 treatment course
Control: Juyuansuan tamoxifen, 10 mg, x 2/day for 3 days; 3 circle as 1 treatment course

Outcomes

Unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research assessed
at the end of the intervention

Notes

Country: China
Language: Chinese
Setting: Xin Gang Central Hospital of Jianxi Province
Duration: 3 months
ITT: not reported or undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number tables

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding or incomplete blinding, and


the outcome or outcome measurement is
likely to be influenced by lack of blinding

Incomplete outcome data (attrition bias)


All outcomes

Unclear risk

Insufficient reporting

Selective reporting (reporting bias)

Low risk

The study protocol is not available but it


is clear that the published reports include
all expected outcomes, including those that
were prespecified

Other bias

Unclear risk

Insufficient reporting

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44

Kashefi 2010
Methods

RCT: Acupressure versus sham acupressure

Participants

100 University medical students with no knowledge of acupuncture or acupressure were


screened, and 86 were randomised, 43 to each group. A clinical diagnosis was not confirmed. Needed to have a regular cycle, with severe pain in recent cycles, and pain coinciding with onset of bleeding (score 2/3 on non-specified scale)

Interventions

Treatment administered over 2 menstrual cycles


Experiment: manual acupressure. Point: SP6, 6 seconds with pressure applied in circular
clockwise motion applying 1.2 kg pressure, administered over 1 treatment per cycle.
Total 30 minutes of stimulation
Control: sham acupressure at non-channel points. All other aspects were the same

Outcomes

Pain was measured using the VAS scale at 30 min, 1, 2 and 3 hours post-treatment. Score
at 3 hours after end of intervention assessed

Notes

Country: Iran
Language: Farsi
Duration: 2007 - 2008
ITT not reported and not stated if undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number chart

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

Women were blinded, other personnel were


not blinded, and no details reported re the
outcome assessors

Incomplete outcome data (attrition bias)


All outcomes

Unclear risk

In the acupressure group 3 discontinued intervention because of treatment ineffectiveness, 2 in the first month and 1 in second
month. In the control group 2 discontinued the intervention because of adverse effects, 1 each in the first and second months

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting to allow an assessment

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45

Lee 2007
Methods

RCT of manual acupuncture versus minimal acupuncture

Participants

63 women screened, primary dysmenorrhoea not confirmed by examination. 23 allocated


to treatment 26 allocated to control

Interventions

Manual acupuncture: versus minimal acupuncture


Acupuncture: GB41, SI3, BL66, SI2, SP6. Duration of needle stimulation 15 minutes, 1
mm depth of insertion. 5 treatments administered. Treatment 1 1 - 4 days before period.
Treatments 2 - 5 at 5 - 8-day intervals
Minimal acupuncture: LU10, ST40, PC5, GB40.Duration of needle stimulation 15
minutes, 1 mm depth of insertion. 5 treatments administered. Treatment 1 1 - 4 days
before period. Treatments 2 - 5 at 5 - 8-day intervals
Duration: 1 month

Outcomes

Measure of Menstrual Pain questionnaire was used to assess menstrual pain and the
MSSL for menstrual symptoms at the end of the intervention

Notes

Country: Korea
Setting: Hospital
ITT not mentioned or undertaken. Per protocol analysis.
Groups comparable at baseline: not reported, but see Other bias below

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Randon number table

Allocation concealment (selection bias)

Not stated

Unclear risk

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

Insufficient information to permit judgement. Participants were blinded, personnel


and outcome assessors were not

Incomplete outcome data (attrition bias)


All outcomes

High risk

Insufficient reporting. 14 women excluded


from analysis and not reported by group.
1 irregular period, 7 dropped out, 3 did
not meet the pain criteria, 2 had another
disease, 1 took pain killers during the study.
Data on 49 women analysed

Selective reporting (reporting bias)

Unclear risk

Insufficient information reported

Other bias

Unclear risk

The experimental-group women had


shorter periods.

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46

Li 2008
Methods

RCT, 3 groups: 1) acupuncture using the 4 gates; 2) traditional acupuncture points; 3)


patented Chinese herbal medicine, 60 women in each group

Participants

180 women aged 12 - 27 were recruited. Pathology was eliminated although not specified.
No other details were reported. However no women aged less than 17 years was recruited
to the study

Interventions

The active acupuncture group used points LI4, LIV3. Additional points allowed. For qi
stagnation with blood stasis points CV6 and PC6 were added. For cold stagnation with
blood stasis CV4, CV3 were added, for severe pain BL32 and SP8 were added. Hawato
brand needles were used (0.35 x 40 mm). For LI4, LIV 3 needles were inserted and
manipulated using twirling reinforcing reducing method until DeQi obtained. Needles
were retained at an angle 45 towards the area of pain. CV6, PC6, BL32, SP8 were
manipulated using twirling and reinforcing reducing method, CV3 and CV4 were manipulated using reinforcing method. Needles manipulated for 2 minutes and retained
for 30 minutes. LI4 and LIV3 were manipulated every 10 minutes. Mild moxibustion
applied to CV3 and CV4 for 10 minutes. Treatment applied once a day starting 3 - 5
days before the start of period, and continued until the last day of bleeding
2 control groups were used. Firstly, routine acupuncture which did not meet our criteria for comparison for a control group. Secondly, the use of a Chinese patent herbal
medicine Yueyueshu. Yueyueshu granules (manufactured by Henan Wanxi Pharmaceutical company) were administered orally. Once sachet of 10 g was dissolved in hot water
and 10 at morning and night starting 1 week prior to the onset of the menstrual cycle,
until the third day of bleeding

Outcomes

Basal body temperature, improvement in dysmenorrhoea symptoms, plasma levels of


PGF . Assessment at the end of the intervention

Notes

Country: China
Setting: Henan Luohe High Medical Training School Third Affiliated Hospital and
Luohe Municipal Hospital of TCMs gynaecological department
Groups comparable at baseline: not reported
Loss to follow-up: no dropouts
Compliance: not reported
Duration: 3-month intervention
ITT: not stated
Funding: not reported

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number tables used

Allocation concealment (selection bias)

Not reported

Unclear risk

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47

Li 2008

(Continued)

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding, and outcome measurement


may be influenced by lack of blinding, no
other details reported

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient information to judge

Other bias

Unclear risk

Insufficient information to judge

Li 2012b
Methods

Parallel RCT, manual acupuncture versus medication

Participants

60 women randomised to the study from a hospital outpatients clinic, 30 in each group

Interventions

Acupunture: administered daily on Guanyuan (CV4), Qihai (CV6), Sanyinjiao (SP6),


Zhongji (CV3) points 3 days before cycle and finished 3 days after cycle. After manipulation moxibustion was performed on Guanyuan, Qihai and Zhongji points. Needles
were retained in the points for 30 minutes
Control: prescribed with ibuprofen 0.3 g when the period pain appeared. Maximum
daily dosage was controlled under 0.6 g until the syndrome disappeared

Outcomes

Pain measured by the VAS at 3 months

Notes

Country: China
Language: Chinese
Setting: Hospital in Guangzhou
Duration: 5 months (3 months experiment plus 2 months follow-up)
ITT: no mention and not undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number table

Allocation concealment (selection bias)

Not stated

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding, and outcome measurement


may be influenced by lack of blinding, no
other details reported

Incomplete outcome data (attrition bias)


All outcomes

No missing data

Low risk

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Li 2012b

(Continued)

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting

Ma 2010
Methods

RCT: electro-acupuncture at SP6 913 women), GB39 (14 women), an adjacent non
meridian point (12 women), and wait list control (13 women). 52 randomised,

Participants

52 women with primary dysmenorrhoea from 4 universities in Jinan, Shandong Province


of China and Affiliated Hospital of Shandong University of Traditional Chinese Medicine
were recruited. Women needed to be aged 15 - 30 years, normal menstrual cycle and
a score > 4 on the VAS, no use of analgesics 24 hours before the trial. Women with
secondary dysmenorrhoea were excluded

Interventions

3 treatment sessions administered, with 10 minutes in first session, then 30 minutes


in the next 2 days, and once a day for 3 days. All 3 groups were administered by the
same acupuncturist. There was no variation in the acupuncture technique. 40 x 0.25
mm disposable needles were administered to the 3 groups, with a basic lifting and
thrusting and twirling technique for 1 minute to produce the DeQi sensation. Electroacupuncture then applied with 2/100 Hz for 10 minutes to women in all 3 treatment
groups. Treatment over 1 menstrual cycle

Outcomes

VAS for pain severity, VRS the influence of pain on daily work, general symptoms and
use of analgesics

Notes

Due to the active stimulation administered to the 2 acupuncture control groups a comparison was made with the no-treatment group only. Wrote to authors for data to be
presented in a form for the meta-analysis, but no response was received
Duration: November 30, 2007 to July 15, 2008
Losses to follow-up: 1 dropped out in no treatment, SP6 1 dropped out due to inability
to attend for treatment
ITT analysis not reported and not undertaken
Baseline characteristics: no differences reported

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Computer-generated sequence

Allocation concealment (selection bias)

Central randomisation

Low risk

Blinding (performance bias and detection Low risk


bias)
All outcomes
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Participants were blinded to treatment,


as those who had history of acupuncture
treatment and knew the effects of acu49

Ma 2010

(Continued)

points were excluded. The acupuncturist


maintained neutral communications with
all participants and avoided providing cues
that might reveal whether she was performing acupuncture with real or sham acupoints. In the process of trial, only the
acupuncturist knew the treatment allocation and was separated from the imaging
technician. Moreover, the punctured area
was covered during the needle retention
time, thus blinding the imaging technician
to treatment allocation. The assessor who
recorded the results of clinical scale assessments after treatment was also blinded to
treatment allocation
Incomplete outcome data (attrition bias)
All outcomes

Low risk

2 post-randomisation exclusions, 1 from


the treated and 1 from the control group.
Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups

Selective reporting (reporting bias)

Unclear risk

Not reported

Other bias

Unclear risk

Not reported

Ma 2013
Methods

600 women with primary dysmenorrhoea were randomly assigned to the single point
group (n = 200) including group A (treating before the menstruation, n = 100) and group
B (immediately treating as soon as pain occurrence, n = 100), the multipoints group
(n = 200) including group C (treating before the menstruation, n = 100) and group D
(immediately treating as soon as pain occurrence, n = 100), or the control group, group
E (n = 200, no treatment)

Participants

Women were aged 16 - 35 years, meeting the criteria of primary dysmenorrhoea, and
symptoms experienced between 6 months and 15 years

Interventions

Treatment was administered over 3 menstrual cycles. Group A and B group single-point
received point Shiqizhui (EX-B8). The needle was inserted to a depth 0.5 to 1 cm for 30
minutes. Lift, thrust and twirling was applied every 30 seconds for 10 minutes. Groups
C and D (multipoints) received points SP6, SP8, BL32 and EXB8. Points were inserted
to a depth of 1 - 1.5 cm, with the same mode of stimulation applied. The control group
received no intervention
Groups A and C were treated before menstruation, Group B and D as soon as pain
occurred. Treatment frequencies varied between groups

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Ma 2013

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Outcomes

Cox menstrual symptom scale measured at the end of the intervention (3 months) and
follow-up at months 4,5, and 6. VAS measured at 5, 10, 20, and 30 minutes mean upon
acupuncture; 30, 60, and 120 minutes mean after needle withdrawal. Also adverse events

Notes

Country: China
Setting: University-affiliated hospitals. Five centres: Shandong University of Traditional
Chinese Medicine, Affiliated Hospital of Shandong University of Traditional Chinese
Medicine, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,
Zhejiang University of Traditional Chinese Medicine Institute of Acupuncture and Massage, Affiliated Hospital of Shandong Provincial Research Academy of Traditional Chinese Medicine
Duration: March 2008 - January 2010
ITT undertaken but per protocol reported in paper.
4 treatment groups were combined into 1 acupuncture group.

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Computer-generated

Allocation concealment (selection bias)

Central randomisation

Low risk

Blinding (performance bias and detection High risk


bias)
All outcomes

Some participants were not blinded to


group allocation and this is likely to have
introduced bias. Statistican was blinded to
group allocation

Incomplete outcome data (attrition bias)


All outcomes

High risk

Low rates of completion were reported in


the 4 intervention groups. 4 acupuncture
groups combined (72% completed), 38
discontinued, 13 non-compliant, 13 lost to
follow-up, 11 other, 1 side effects. Control
group (93% completed), 13 discontinued,
3 were non-compliant, 6 lost to follow-up,
2 side effects, 2 other reasons

Selective reporting (reporting bias)

Unclear risk

No protocol available

Other bias

Unclear risk

Sample size calculation reported

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Mirbagher-Ajorpaz 2011
Methods

RCT of acupressure versus light touch, 30 randomised, 15 in each group

Participants

The study was conducted with 30 college students residing at the dormitories of Kashan
University of Medical Sciences, Kashan, Iran. Women were aged 18 - 30 years, regular
menstruation with moderate to severe pain (score > 3 on VAS scale). Exclusion criteria
included use of the IUD, and a diagnosis of secondary dysmenorrhoea (not specified)

Interventions

In the intervention group the researcher placed both thumbs on the SP6 acupoint of
both legs simultaneously and applied strong vertical pressure for 10 second-cycles (8
seconds of acupressure and 2 seconds of rest), 120 times in a total of 20 minutes (SP6
acupressure)
In the control group, the researchers thumb was lightly placed on the SP6 sites for 20
minutes without applying any pressure for 8 seconds and 2 second-cycles of rest (placebo;
SP6 touch)

Outcomes

Pain intensity assessed using VAS at 1, 2, 3 hours after treatment following 1 cycle

Notes

Duration: 6 months during 2008


Compliance not reported.
No difference in baseline characteristics.
No loss to follow-up.
ITT not reported but undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number tables

Allocation concealment (selection bias)

Not reported.

Unclear risk

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

Participants were blinded, but blinding status of others unclear

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient rationale or evidence that an


identified problem will introduce bias

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Peng 2012
Methods

RCT of manual acupuncture compared to pharmacological treatment

Participants

60 women, 30 in each group. No details reported on how primary dysmenorrhoea was


diagnosed

Interventions

Acupuncture: Points used Diji SP8, Zhongdu GB32, Shuiquan KI5, bilaterally. Perpendicular insertion of needles. DeQi obtained. Needles retained for 20 - 30 minutes.
Treatment daily once pain started
Pharmacological treatment: ibuprofen 300 mg x 2/day. Pain relief started in first cycle
with onset of menstrual pain until the last day of menses. During 2nd and 3rd cycle pain
medication began on day 1 and continued until last day of menses

Outcomes

Pain relief measured using VAS scale, and overall improvement in generic menstrual pain
using unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research
assessed at the end of the intervention

Notes

Country: China.
Setting: Guang Zhou City Hospital outpatients and inpatients Obstetric and Gynaecological department
Duration of study: 3 menstrual cycles
ITT not reported but undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Unclear risk


bias)

Stated as randomised but no details reported.

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

Participants and some key study staff were


not blinded, and lack of blinding likely to
introduce bias

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Low risk

Study protocol not available but thesis indicates all outcomes were reported

Other bias

Unclear risk

Insufficient reporting

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53

Qiao 2013
Methods

RCT of 4 groups, acupuncture versus medication,

Participants

80 women randomised. Experiment n=20 body; Experiment n=20 wrist ankle needle;
Experiment n=20 auricular acupressure; Control n=20 anti-inflammatories

Interventions

1. Body acupuncture: Guanyuan (CV4), Sanyinjiao (SP6), Diji (SP8), Shiqizhui (Extra
point) stimulated. Needles retained for 30 minutes, and manipulated every 10 minutes.
Daily treatment started 5 days before menstrual cycle. Treatment stopped on second day
of cycle
2. Wrist ankle needle group: needles inserted to hypodermal level, at an angle 30
obliquely, retained for 30 minutes, manipulated every 10 minutes. Daily treatment
started 5 days before menstrual cycle. Treatment stopped on second day of cycle
3. Auricular plaster therapy, herbal paste made and applied to reproductive, endocrine,
subcortical, Shenmen, Liver, Kidney ear points. Instructed to press points every 3 hours.
Daily treatment started 5 days before menstrual cycle. Treatment stopped on second day
of cycle
4.Pharmacological treatment: indomethacin 25 mg x 2/day.
Groups 1 and 3 combined.

Outcomes

Pain relief as measured by VAS. Overall general improvement in menstrual pain, using an
unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research assessed
at the end of the intervention

Notes

Country: China
Setting: students recruited from a TCM school
Study duration: 3 menstrual cycles
Study period: October 2011 - October 2012
ITT undertaken but not reported

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number table

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

Study participants not blinded, and nonblinding likely to introduce bias

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Low risk

Reporting as per methods in Masters thesis


appears complete.

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Qiao 2013

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Other bias

Low risk

No apparent risk of additional bias.

Ruan 2011
Methods

Parallel RCT, manual acupuncture versus medication

Participants

60 participants randomised to the study, 30 to each group.

Interventions

3-month intervention, with 2-month follow-up


Acupuncture: Daily treatment started 5 days before menstrual cycle and ceased on 2nd
day of period arrival. Each treatment lasted for 30 minutes
Guanyuan, Guilai, Sanyinjiao were the major points for the acupuncture treatment. The
following additional points were used based on TCM pattern differentiation
*Cold and damp stagnation - Acupuncture: YinlingQuan; moxibustion: Pishu, Mingmen. Even reinforcing-reducing method was used for acupuncture treatment. Each treatment continued for 30 minutes. Moxibustion was performed 2 cm above the points and
continued for 10 minutes
*Qi stagnation and blood stasis - Taichong, Hegu, Xuehai. Even reinforcing-reducing
method was used for acupuncture. Each treatment continued for 30 minutes. Moxibustion was performed 2 cm above the points and continued for 10 minutes
*Qi and blood deficiency - Moxibustion: Zusanli, Pishu, Weishu. Moxibustion was
performed 2 cm above the points and continued for 10 minutes
Medication: prescribed ibuprofen. 0.3 g was taken each time and twice daily when period
pain occurred. The treatment ceased when the pain disappeared. During the treatment,
alcohol and drinks with caffeine were not allowed for participants in control group

Outcomes

Pain VAS scale and overall symptoms using an unspecified scale: the Clinical Principle
of New Chinese Drug Clinical Research assessed at the end of the intervention. No data
reported at 3-month follow-up

Notes

Country: China
Language: Chinese
Setting: Gynaecological clinic of TCM college in Fujian Province
Duration: 8-month study
ITT reported and undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Computer-generated

Allocation concealment (selection bias)

Central randomisation

Low risk

Blinding (performance bias and detection High risk


bias)
All outcomes
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No blinding or incomplete blinding, and


the outcome or outcome measurement is
55

Ruan 2011

(Continued)

likely to be influenced by lack of blinding


Incomplete outcome data (attrition bias)
All outcomes

Low risk

No missing data; all completed the trial and


assessments.

Selective reporting (reporting bias)

Low risk

Full thesis available and it is clear that the


published reports include all expected outcomes, including those that were prespecified

Other bias

Unclear risk

Insufficient reporting addressed in the thesis.

Shi 2011
Methods

RCT of electro-acupuncture (EA) to SP6, EA to active point not used for period pain,
and EA to sham acupuncture and no treatment

Participants

40 women aged 15 - 30 years, recruited from Tianjin, China. A history of regular


menstruation (28-day cycle 7 days). Participants experienced menstrual cramping pain
of moderate or severe intensity, varying from 40 to 100 on the VAS, and lasting at least 6
months. Participants agreed to refrain from the use of any analgesics 24 hours before the
trials. Women with underlying conditions leading to secondary dysmenorrhoea, such
as endometriosis, uterine myoma, ovarian cyst, or intrauterine synechia, intrauterine
devices, were excluded from the study. 10 women allocated to each group

Interventions

EA to SP6, or GB 39, or a non-acupuncture point. DeQi obtained for all points and EA
of 2/100 HZ stimulation applied for 30 minutes
No pain medication used in the 24 hours prior to the study beginning

Outcomes

VAS scale for pain severity, and PGE2 at the end of the intervention

Notes

Country: China
Setting: not reported
No differences in age and dysmenorrhoea at baseline
Loss to follow-up: none
Compliance: single session only
Duration: November 2007 - July 2008
ITT analysis not reported but undertaken
Due to the stimulation of EA and application of de qi to both control points, these were
viewed as being active to some degree and we used a comparison between acupuncture
and no treatment only

Risk of bias
Bias

Authors judgement

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56

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(Continued)

Random sequence generation (selection Low risk


bias)

Computer-generated

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding or incomplete blinding, and


the outcome or outcome measurement is
likely to be influenced by lack of blinding

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Not reported

Other bias

Unclear risk

Not reported

Smith 2010
Methods

RCT, 2 groups, acupuncture compared with placebo control using placebo needle, 46
women in each group

Participants

92 women aged 14 - 25 years recruited. A diagnosis of primary dysmenorrhoea was based


on self-reported severe incapacitating pain for at least 1 day of menses in 2 menstrual
cycles classified by a predefined pain score of > 6 on the McGill questionnaire. Secondary
dysmenorrhoea was excluded by clinical evidence confirming diagnosis of primary dysmenorrhoea. Other exclusion criteria included: pelvic pathology, pain associated with
IUD

Interventions

All participants received the intervention for 30 - 40 minutes, weekly for 3 weeks,
followed by a week of no treatment during the week of expected menses. Treatment was
administered over 3 months
TCM acupuncture protocol based on expert opinion, review of literature and experience
of practitioners. 9 diagnostic patterns with standardised treatment:
Qi and blood stagnation: Taichong LR3, Sanyinjiao SP6, Hegu LI4, Zhongji Ren-3,
Ciliao UB32, Xuehai SP10, Qihai Ren-6, Diji SP8, GongSun SP4.
Qi and blood Deficiency: Zusanli ST36, Sanyinjiao SP6, Guanyuan Ren -34, Qihai
Ren-6, Geshu BL17, Diji SP8, Pishu UB20, Ciliao UB32
Stagnation of cold: Shenshu UB23, Zhongji Ren-3, Qihai Ren-6, Sanyinjiao SP6, Guanyuan Ren-4, Mingmen Du-4, Lie Que LU7, Zhaohai KD6, Zusanli ST36
Accumulation of damp heat: Yanglingquan GB34, Quchi LI11, Xingjian LR2, Guilai
ST29, Ciliao UB32, Fenglong ST40, Yinlingquan SP9, Shuidao ST28, Sanyinjiao SP6,
Sanjiaoshu UB22
Kidney and liver deficiency: Zusanli ST36, Sanyinjiao SP6, Guanyuan Ren-4, Qihai
Ren-6, Geshu UB17, Ganshu UB18, Shenshu UB23, Taixi KD3
Seirin 0.2 x 30 mm acupuncture needles were inserted bilaterally to a depth of not greater
than 2 cm, and the needles were retained for 30 minutes. All participants received the
DeQi sensation following initial insertion of needles and half way through the treatment
session. Reinforcing or reducing stimulation was given according to the TCM diagnoses,

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and standardised to the individual.


The placebo control group received placebo acupuncture, with the timing and duration
of the control intervention the same as the active acupuncture group. The placebo needle
was inserted away from classical acupuncture points and meridians on the sacral area,
lower back, lower abdomen, foot, lower leg and forearm. These locations ranged from 2
to 4 cm away from an acupuncture point or meridian. Placebo acupuncture needles (0.
30 x 30 mm) were used
Outcomes

Primary and secondary endpoints were measured at 3, 6, and 12 months after trial entry.
The primary outcome measures were end-of-treatment scores for menstrual pain intensity and duration, measured by the McGill questionnaire. The overall improvement in
dysmenorrhoea (measured by change in dysmenorrhoea symptoms, for example, nausea, vomiting, and mood changes), and the proportion of women requiring additional
analgesia for pain relief were gathered by a self-report questionnaire. Subjects completed
a self report questionnaire to collect data on secondary endpoints including restriction
of daily living activities, and the Short Form 36 (SF36)

Notes

Country: South Australia


Setting: from the community through their general practitioner, gynaecologist or by self
referral
Funding: Government National Health and Medical Research Council
Groups comparable at baseline: comparable for most baseline characteristics. > 5% difference in BMI, smoking and socio-economic status (adjusted for in analysis)
Loss to follow-up: 12 months: acupuncture 0%, control 4%
Compliance: median number of treatments: acupuncture = 9, control n = 9
Duration: February 2003 - August 2005
ITT analysis undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Computer-generated using variable block


size, stratified by previous use or non-use
of acupuncture, generated by independent
statistician

Allocation concealment (selection bias)

Low risk

Central telephone randomisation procedure

Blinding (performance bias and detection Low risk


bias)
All outcomes

Participants were blinded to treatment allocation (blinding assessed), the acupuncturists were not blinded, the statistician was
blinded to group allocation.Assessment of
blinding: undertaken at the end of the trial.
41% of women receiving acupuncture believed they received acupuncture, 22% of
women in control thought they were receiving true acupuncture (P = 0.07),

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Incomplete outcome data (attrition bias)


All outcomes

Low risk

Missing outcome data: 5 from the treatment group and 2 from the control, similar
between both groups

Selective reporting (reporting bias)

Low risk

The study protocol is available and all primary and secondary endpoints were prespecified as on the Australian and New
Zealand Clinical Trial Registry

Other bias

Low risk

There was high compliance with the treatment schedule, attempts were made to encourage completion of follow-up questionnaires, the treatment protocol was representative of usual practice in terms of points,
frequency, duration and time of needle
stimulation, intervention and control participant reports (Assessment of blinding)
suggest they were genuinely blinded to
treatment allocation, and control participants had similar contact time and psychosocial experience to intervention group

Song 2013
Methods

RCT of electro-acupuncture SP36, group GB39, sham and no treatment

Participants

200 women were recruited from 4 hospitals in Beijing and Tianjing, 50 women allocated
to each group

Interventions

3 treatment groups were allocated. 3 days of treatment were performed for each month
if the VAS 40. The total course of treatment lasted for 3 months
1. Sanyinjiao (SP6) group: The needle was inserted perpendicularly about 25 - 30 mm
deep in Sanyinjiao. After DeQi feeling was achieved, the second needle was inserted
about 2.5 mm in depth 2 - 5 mm away from the first one. EA device was used to connect
both needles to enhance the stimulation. Frequency 2 Hz/100/Hz, current 0.5 - 1.6 mA.
The treatment lasted for 30 minutes
2. Unrelated Xuanzhong (GB 39) group: The needle was inserted perpendicularly about
15 - 25 mm deep in Xuanzhong. After DeQi feeling was achieved, the second needle was
inserted about 2.5 mm in depth 2 - 5 mm away from the first one. EA device was used
to connect both needles to enhance the stimulation. Frequency 2 Hz/100/Hz, current
0.5 - 1.6 mA. The treatment lasted for 30 minutes
3. Non-acupoint group. The needle was inserted perpendicularly about 15 - 25 mm
deep in non-acupoint level withXuanzhong(GB39) in between stomach and gallbladder
channels. DeQi was not required if it could not be achieved. The second needle was
inserted about 2.5 mm in depth 2 - 5 mm away from the first one. EA device was used
to connect both needles to enhance the stimulation. Frequency 2 Hz/100/Hz, current
0.5 - 1.6 mA. The treatment lasted for 30 minutes

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4. Control group: no treatment was given for 2 consecutive periods. EA treatment was
performed for control group once the 2 periods finished. All participants, 0.5 g of aspirin
was given if VAS 80
Outcomes

VAS, RSS COX 2 measured at the end of the intervention.

Notes

Country: China
Setting: Hospital.
Data from the 2 acupuncture control groups were combined for the analysis

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Computer-generated

Allocation concealment (selection bias)

Central randomisation

Low risk

Blinding (performance bias and detection High risk


bias)
All outcomes

Blinding adequate for outcome assessors,


but no blinding was performed of participants and personnel

Incomplete outcome data (attrition bias)


All outcomes

Low risk

6 post-randomisation exclusions, 1 treatment and 5 across the 3 control groups.


Reasons for missing outcome data unlikely
to be related to true outcome

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Low risk

Study appears free of other sources of bias.

Sriprasert 2015
Methods

RCT, acupuncture vs combined oral contraceptives (COC). 52 women allocated, 27 to


acupuncture, 25 to CoC

Participants

Participants aged 18 - 35 years. Inclusion criteria: a history of dysmenorrhoea within


the previous 3 consecutive months with a NRS of 5 or more, a VMSS of grade 2 or
more, and the use of rescue analgesic drug for dysmenorrhoea (at least 1 tablet during the
run-in period). Exclusion criteria were contraindications to COC or acupuncture and
underlying gynaecologic conditions associated with dysmenorrhoea. Transabdominal
ultrasonography was performed by a gynaecologist to rule out abnormal gynaecologic
conditions such as uterine myoma, endometrioma, and ovarian tumour
A run-in period of 1 month during which they discontinued all treatment for dysmenorrhoea with the exception of rescue analgesics

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Sriprasert 2015

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Interventions

All participants received a supply of rescue NSAIDs, mefenamic acid (250 mg per tablet)
, prescribed at 1 tablet as needed for dysmenorrhoea to be taken based on the perception
of pain by participants themselves and to be repeated every 4 to 6 hours in case of no
significant dysmenorrhoea pain relief
1. The acupuncture protocol used consisted of 6 acupuncture points per session. Needles
were inserted in the following order: Qi Hai (Ren 6), Zhong Ji (Ren 3), and both sides
of Di Ji (SP 8) and San Yin Jiao (SP 6). 6 sterile acupuncture needles (size 0.25 40
mm) were inserted into each point to the appropriate depth to achieve DeQi, and the
needles were retained for 20 minutes without any needle stimulation. The acupuncture
treatment was initiated on the 10th day after the first day of the LMP of each menstrual
cycle and was repeated for 3 consecutive cycles. During each cycle, the participants were
treated 3 times a week for 2 weeks to ensure that 6 sessions of acupuncture treatment were
accomplished before the initiation of the next menstrual period.18 acupuncture sessions
were scheduled during the 3 menstrual cycles. Acupuncture treatment was performed
by a certified acupuncturist who was experienced in gynaecological diseases
2. The COC group participants were treated with a daily monophasic COC containing
20 mg ethinyl estradiol and 150 mg desogestrel. They were instructed to take the first
pill within 5 days after the first day of their LMP and continue taking 1 pill every day
for 3 cycles. A pill count was conducted at every follow-up visit to assess compliance

Outcomes

Assessments by: 10-point VRS to assess pain, 0 no pain, 10 maximal pain. Number of days
experiencing dysmenorrhoea. Use of rescue medication. QoL SF36 multidimensional
scoring system to assess ability to work, systemic symptoms and use of analgesics. Grade
0, menstruation not painful and daily life activity unaffected; Grade 1, menstruation
painful but seldom inhibiting normal activity, analgesics seldom required, and mild pain;
Grade 2, daily activity affected, analgesics required and giving sufficient relief so that
absence from school is unusual, and moderate pain; Grade 3, activity clearly inhibited,
poor effect of analgesics, vegetative symptoms such as headache, fatigue, vomiting, and
diarrhoea, and severe pain
Menstrual symptoms, and use of additional medication measured as a change from
baseline to end of intervention at 3 months
Pain scores measured at the end of the intervention; 3-month data supplied by researcher
SF36 scores reported at the end of treatment at 3 months

Notes

Country: Thailand.
Setting: Community
Study duration: January 2014 - February 2014.
ITT mentioned and undertaken
Power analysis:undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Computer-generated

Allocation concealment (selection bias)

Sealed envelope

Low risk

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Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding of participants and blinding


status of analyst not reported. The outcome
or outcome measurement is likely to be influenced by lack of blinding

Incomplete outcome data (attrition bias)


All outcomes

High risk

Reason for missing outcome data likely to


be related to true outcome, with an imbalance in reasons for missing data across intervention groups; acupuncture: 6 personal
reasons, 3 lost to follow-up. CoC 1 due to
ineffectiveness

Selective reporting (reporting bias)

Unclear risk

Protocol not available

Other bias

Unclear risk

No other sources of bias identified.

Sun 2011
Methods

Parallel RCT of acupuncture, a warming needle with moxibustion and no treatment

Participants

90 women randomised to the trial, 30 in each group. Diagnosis made by pelvic examination

Interventions

Duration 4 menstrual cycles. Treatment frequency: 1st cycle: start treatment on first day
of dysmenorrhoea when VAS 40 mm to observe the timeliness of the analgesic effect
of acupuncture. 2nd, 3rd and 4th cycles: start treatment 3 days before menses, once per
day for 3 days until day of menses
Acupuncture: main point SP6, BL26, with additional points based on TCM diagnosis
1. Stasis = Ciliao BL32, Xuehai SP10.
2. Alpine stagnate dysmenorrhoea = Yinglingquan SP9, Diji SP8
3. Qi deficiency = Zusanli ST36, Qihai CV6.
4. Liver and kidney loss syndrome = Ganshu BL18, Shenshu BL23
Between 3 - 11 points selected at each treatment. Needle stimulation 30 minutes. DeQi
obtained after a further 10 minutes following needles insertion
Acupuncture needle with moxibustion.
Main points: Shenque CV8, Guanyuan BL26, Sanyinjiao SP6. Additional points for
participants with:
1. Stasis = Ciliao BL32, Xuehai SP10.
2. Alpine stagnate dysmenorrhoea = Yinglingquan SP9, Diji SP8.3. Qi deficiency =
Zusanli ST36, Qihai CV6
4. Liver and kidney loss syndrome = Ganshu BL18, Shenshu BL23
3 - 11 points selected. Needle duration 30 minutes. Frequency of treatment:
For Shenque CV8, 10 minutes after each time needle inserted (for 30 minutes) until
skin flushes
For the remaining acupuncture points, 10 minutes after each time needle inserted (for
30 minutes) until there is significant soreness at site of needle insertion
Control: No treatment

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Outcomes

Pain relief measured by VAS measured during acupuncture treatment, also includes
overall improvement in menstrual pain
RSS: evaluated on total frequency (in terms of duration) of symptoms of dysmenorrhoea,
on severity (in terms of effect on daily life) of symptoms of dysmenorrhoea.
Evaluation criteria for total frequency of symptoms of dysmenorrhoea:
0 points: none
1 point: for < 3 hours
2 points: for 3 - 7 hours
3 points: for a whole day
4 points: for a few days
Evaluation criteria for severity of symptoms of dysmenorrhoea:
0 points: no feeling
1 point: mild (mild symptom, does not quite affect normal lifestyle)
2 points: moderate (appreciable/obvious symptoms, affects normal lifestyle)
3 points: severe (symptom more severe, severely affects lifestyle)

Notes

Country: China
Language: Chinese
ITT not reported

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Randomised on case number

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding and the outcome or outcome


measurement is likely to be influenced by
lack of blinding

Incomplete outcome data (attrition bias)


All outcomes

Low risk

Reasons for missing outcome data unlikely


to be related to true outcome. 4 from intervention group, 2 from acupuncture group,
2 from control group dropped out mainly
due to personal reasons and loss to followup

Selective reporting (reporting bias)

Low risk

The study protocol is not available but it


is clear that the published reports include
all expected outcomes, including those that
were prespecified in the thesis

Other bias

Low risk

The study appears free of other sources of


bias.

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63

Wang 2013b
Methods

RCT of manual acupuncture compared with NSAIDs

Participants

90 undergraduate women with period pain, 30 women in each group

Interventions

2 treatment groups: Wrist ankle acupuncture of Xia 1 (lower 1) and Xia 2 (lower 2) This
is for another acupuncture point system known as wrist and ankle acupuncture, totally
6 in wrist (Shang 1(upper 1) - Shang 6 (upper 6), and another 6 in ankle (Xia1(lower1)
- Xia 6 (lower6)), and (2) stimulation of SP6 and CV4. Treatment began 3 days before
menstruation, once a day until pain was relieved. Treatment was administered over 3
months
Control group: ibuprofen (no further details given).

Outcomes

Pain severity assessed by a VAS at the end of the intervention

Notes

Location China
Setting: Hospital in Beijing
ITT not reported.
The 2 acupuncture groups were combined for the analysis.

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number tables

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding, and the outcome measurement could have been influenced by a lack
of blinding

Incomplete outcome data (attrition bias)


All outcomes

Low risk

Atrition for 5 women, 3 from the 2


acupuncture groups, and 2 from the control. Reasons not specified

Selective reporting (reporting bias)

Low risk

The study protocol was not available but


the report includes the expected outcomes

Other bias

Low risk

No apparent sources of bias

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64

Wang 2005b
Methods

Parallel RCT of manual acupuncture versus medication.

Participants

58 women randomised to the trial; participants were student from University clinic. 30
women in the acupuncture group and 28 in the medication group. No details reported
on diagnosis

Interventions

Acupuncture:
Ear manual acupuncture: internal reproductive, endocrine, liver and kidney correspondent sections on the ear were chosen
If TCM pattern was Qi and blood stasis, plus Erzhong correspondent section on the ear;
If TCM pattern was cold and damp stagnation, plus spleen and Sanjiao correspondent
sections on the ear;
If TCM pattern was damp heat stagnation, plus Erjian and adrenal gland correspondent
sections on the ear;
If TCM pattern was Qi and blood deficiency, plus spleen and stomach correspondent
sections on the ear;
If TCM pattern was liver and kidney deficiency, plus subcortex correspondent section
on the ear;
If the pain was getting worse, plus Shenmen, sympathetic nervous correspondent sections
on the ear;
If the participants had low back pain, plus lumbar sacral correspondent sections on the
ear
Ear acupuncture was done daily and started from 3 days before menstrual cycle. The
treatment ceased 3 days after the cycle. The needles were retained for 20 minutes and
applied with medium-level manipulation every 10 minutes
During non-period time, herbal sticker (made of herb Wang Bu Liu Xin) was applied
to internal reproductive, endocrine, liver and kidney correspondent sections on the ear.
Each sticker was kept for 3 days on 1 side alternately
The course of treatment lasted for 3 months.
Control:
Oral intake 0.25 indomethacin 3 times daily was prescribed. It started when the period
pain occurred and ceased after the pain disappeared. The course of treatment lasted for
3 months

Outcomes

Pain reported only as a dichotomous variable: pain relief yes/no

Notes

Country: China
Language: Chinese
Setting: Guangzhou TCM University
ITT not reported and unclear if undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number tables

Allocation concealment (selection bias)

Not reported

Unclear risk

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Wang 2005b

(Continued)

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding to participant and doctor, not


information provided to outcome assessors
and statisticians

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting.

Wang 2009a
Methods

RCT, 2 groups, auricular acupressure compared with placebo adhesive patch

Participants

74 women aged 18 - 28 years were recruited, 37 randomised to each group. Women


had no secondary dysmenorrhoea or other pathology, a serum CA125 level of < 35 mg/
dL, onset of primary dysmenorrhoea within 6 months of menses, menstrual pain on 3
occasions within the past 6 months, no history of smoking, not taking over-the-counter
analgesics, able to speak Chinese or Taiwanese

Interventions

Intervention: 3 auricular acupressure points were used Liver C012, Kidney CO10 and
Endocrine CO18. Acupressure was performed using acupressure seeds named Semen
vaccariae. Seeds were kept in place by opaque adhesive patch
Control group: plain adhesive patch placed on same point with no seed
Both groups had acupressure. All participants were instructed to massage each point 15
times, 3 times a day for 20 days. Patches were replaced every 5 days

Outcomes

Short form Menstrual Distress Questionnaire, and serum nitrous oxide 20 days postbaseline.Participants were asked to rate the presence of menstrual symptoms experienced
during their most recent menstrual period on a 4- point Likert-type scale, ranging from
1 (no experience of the symptom) to 4 (severe or partially disabling symptoms), assessed
3 hours after completing the intervention

Notes

Country: Taiwan
Setting: College
Groups comparable at baseline: no differences between groups
Loss to follow-up: 3, 1 treatment, 2 control groups
Compliance: not reported
ITT: not reported
Duration: not reported
Funding: not reported

Risk of bias
Bias

Authors judgement

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Support for judgement

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Wang 2009a

(Continued)

Random sequence generation (selection Low risk


bias)

Computer-generated

Allocation concealment (selection bias)

Concealed envelopes

Low risk

Blinding (performance bias and detection Low risk


bias)
All outcomes

Blinding of participants was attempted,


with both groups receiving patches. The
practitioner was not blind to group allocation, outcome was self report and analysis
was undertaken by independent researcher.
Double-blind

Incomplete outcome data (attrition bias)


All outcomes

Low risk

Data missing on 3 participants. Similar reasons due to time management across groups

Selective reporting (reporting bias)

Unclear risk

Study protocol not available.

Other bias

Unclear risk

Insufficient reporting to judge.

Wang 2014a
Methods

RCT of acupuncture versus moxibustion versus medication

Participants

93 University students randomised to the study, acupuncture n = 31, moxibustion n =


30, medication n = 32

Interventions

Treatment administered over 3 menstrual cycles.


1. Manual acupuncture: Guanyuan and Sanyinjiao (both sides) were chosen for manual
acupuncture. The needles were retained for 30 minutes after DeQi feeling. During the
treatment, even reducing and reinforcing acupuncture technique were used. Daily treatment was performed 3 days before menstrual cycle and ceased after the pain disappeared.
The course of treatment lasted for 3 menstrual cycles
2. Moxibustion: Guanyuan and Sanyinjiao (both sides) were chosen for direct manual
moxibustion. 10 minutes per point was allocated. Daily treatment was performed 3 days
before menstrual cycle and ceased after the pain disappeared. The course of treatment
lasted for 3 menstrual cycles
3. Medication: 0.3 g ibuprofen daily was prescribed. It started from 3 days before menstrual cycle and ceased after the pain disappeared

Outcomes

VAS and an unspecified scale: the Clinical Principle of New Chinese Drug Clinical
Research assessed at the end of the intervention

Notes

Country: China
Setting: Hebei United University, Herbei Province
ITT reported and undertaken.
Data from the acupuncture group versus medication were included in the analysis

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Wang 2014a

(Continued)

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number tables

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

Not reported

Incomplete outcome data (attrition bias)


All outcomes

Low risk

Reasons for missing outcome data unlikely


to be related to the outcome. 3 post-randomisation exclusions, 1 acupuncture, 2
medication

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting

Witt 2008
Methods

Pragmatic RCT, 2 groups, acupuncture or usual care

Participants

201 women were randomised to the study, 117 of them with primary dysmenorrhoea.
Inclusion criteria: aged > 18 years, primary dysmenorrhoea from the onset of menarche,
and at least for 12 months. Exclusion criteria: pain caused by inflammatory or malignant
disease. It was not stated how secondary dysmenorrhoea was excluded, although data
were presented for primary dysmenorrhoea.100 allocated to acupuncture, 101 to usual
care

Interventions

Acupuncture was administered over 3 months; participants received a maximum of


15 acupuncture sessions. The trial was undertaken in primary healthcare setting with
acupuncture performed by physicians. The trial consisted of a 3-month treatment intervention, with a 3-month follow-up. All women could use any co-interventions
Each participant received a maximum of 15 acupuncture treatments. Points and numbers
of needles selected by physician
The control group was a wait-list control (but all participants allowed to use any additional conventional treatments they chose)

Outcomes

Primary endpoint was average pain intensity measured along numerical rating scale (0 10). Responder defined as a reduction of 33%. Secondary outcomes: worst pain intensity,
QoL using the SF36, and side effects. Outcomes were measured at 3 months

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Witt 2008

(Continued)

Notes

Country: Germany
Setting: Health insurance fund
Funding: social health insurance companies
Groups comparable at baseline: imbalance SF36 scores physical functioning, bodily pain
and physical component
Loss to follow-up. Data available at 3 months, 88%, similar for both groups
Compliance: acupuncture mean 10.5 treatments, 15 treatments offered, 27% received
more than 10
Duration: January 2001 - August 2001
ITT analysis undertaken

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Computer-generated randomisation sequence

Allocation concealment (selection bias)

Central telephone randomisation procedure

Low risk

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding and the outcome measure was


self-reported and may be influenced by lack
of blinding. No other details reported

Incomplete outcome data (attrition bias)


All outcomes

Low risk

For the primary outcome of pain after 3


months, the missing data were similar for
the intervention and control groups. More
control participants did not complete the
6-month outcome questionnaires. No explanation or reason for dropouts was given
at 3 or 6 months

Selective reporting (reporting bias)

Unclear risk

Study protocol not available

Other bias

Low risk

High follow-up rates, conservative methods to deal with missing data

Wong 2010
Methods

Cluster-RCT of acupressure or no acupressure, 19 allocated to treatment and 21 to


control

Participants

Participants: 40 women randomised from 1 class to the intervention, and in another


class the control. The criteria for choosing the participants include the following: female
students aged < 25 years; have experienced dysmenorrhoea with a pain score > 5 on
the pain VAS for at least 2 months in the past half year; and have not had any prior
history of gynaecological disease, gynaecological surgery, or secondary dysmenorrhoea.

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Wong 2010

(Continued)

Participants who were pregnant, who have used contraceptive pills 6 months prior to
the study, and who have used pain medication and other relief measures 6 hours before
and during the study period were excluded
Interventions

3-month intervention, participants taught to perform the technique twice a day from
the first to third days of their menstrual cycle
Pressure applied to SP6 for 20 minutes by the researcher, alternating between each leg
at the SP6 acupoint. The SP6 acupoint was pressed using the thumb, and gently and
vertically applied to 1 leg for 15 seconds each time and then allowed to rest for 15 seconds.
This was repeated 10 times to satisfy a 5-minute intervention. It was then repeated on the
other leg and pressed for another 5 minutes. This completed a 10-minute cycle, and was
repeated twice on both legs until the 20-minute period of intervention was completed.
After the intervention, the Acupressure Teaching Booklet was given to the participants in
the acupressure group and they were taught to practice SP6 acupressure at home in order
for them to use the technique themselves. A TCM practitioner examined the content
validity of the Teaching Booklet. The pressure-sensing device was also used to train the
participants in the acupressure group. It recorded the interface pressure between the
participants SP6 acupoint and the thumb that pressed on it. The pressure and time can
be observed visually on a computer screen. The participants in the acupressure group were
required to press successively for at least 15 seconds each time, but the pressure readings
could not be seen by the participants until they achieved the correct pressing force 10
times. Participants in the acupressure group were required to perform SP6 acupressure
for 20 minutes upon waking and at bedtime during their first 3 days (average duration
of menstrual pain) of their next 3 menstrual cycles
Control group: were allowed to rest for 20 minutes accompanied by the researcher in the
room with no acupressure intervention. During the first 3 days of their next 3 menstrual
cycles, they were required to rest for 20 minutes upon waking and at bedtime

Outcomes

Pain VAS, Short Form McGill Pain Questionnaire, Short Form Menstrual Distress Questionnaire. Undertaken following the intervention, and at 1,2, 3 months follow up

Notes

Country: Hong Kong


Setting: University
Baseline characteristics: no significant differences between groups
Compliance: not reported
Duration: Not reported
ITT analysis not undertaken. Correction made in the analysis for a cluster trial

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Unclear risk


bias)

Randomisation stated but not reported

Allocation concealment (selection bias)

Not reported

Unclear risk

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Wong 2010

(Continued)

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding of participants, outcomes self


assessed and no details of blinding status of
the analyst

Incomplete outcome data (attrition bias)


All outcomes

Low risk

3 post-randomisation exclusions in the


control due to use of other interventions,
and 3 in the intervention due to dropout or
use of medication. Missing outcome data
balanced in numbers across intervention
groups, with similar reasons for missing
data across groups

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting to assess

Other bias

Unclear risk

Insufficient reporting to assess

Xu 2013
Methods

RCT, 2 groups, acupuncture versus NSAIDs

Participants

45 women, 25 in the acupuncture group and 20 in the NSAIDs group

Interventions

Acupuncture: points SP6, CV4, CV7, CV3, KD12, BL32. Plus LIV3 if Qi and blood
stagnation. Point if cold damp stagnation SP8, SP9. Daily treatment starting 7 days before
start of period, with no treatment following onset of menstruation. Needles retained for
30 minutes following sensation of DeQi
Control group: no treatment unless VAS pain score was > 8, then 0.3 g ibuprofen
prescribed; maximum daily dose was 0.6 g

Outcomes

Pain severity (VAS) over 3 cycles, and follow-up at the fourth and sixth cycles. Overall
improvement in menstrual symptoms using the RSS assessed at the end of the intervention

Notes

Country: China
Setting: Beijing Hospital
Groups at baseline unclear
Compliance: not reported
Duration: 3-month intervention and 3-month follow-up
ITT not reported
Funding not reported

Risk of bias
Bias

Authors judgement

Random sequence generation (selection Low risk


bias)
Acupuncture for dysmenorrhoea (Review)
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Support for judgement


Random-number tables

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Xu 2013

(Continued)

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

Insufficient data to make a judgement

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient data reported

Other bias

Unclear risk

Insufficient data reported

Xu 2014
Methods

RCT of manual acupuncture versus no treatment

Participants

96 women participated in the study, 48 in each group.

Interventions

Manual acupuncture: Yinjiao, Guanyuan, Zhongji, Dahe, Ciliao (both sides), Sanyinjiao
(both sides) were chosen for manual acupuncture. The needles were inserted perpendicularly and retained for 30 minutes after DeQi feeling. During the treatment, even
reducing and reinforcing acupuncture technique were used. Daily treatment was performed 7 days prior to menstrual cycle and ceased on the first day of period. The course
of treatment lasted for 3 menstrual cycles
No treatment provided for the 6 months. 0.3 g ibuprofen was prescribed if pain not
bearable, or VAS 8. Maximum daily dosage was controlled under 0.6 g

Outcomes

Pain measured by VAS, and overall improvement in symptoms monthly during intervention, and 4 - 6 months of follow-up. Data reported at 3 months

Notes

Country: China
Language: Chinese
Setting: TCM hospital in Ping Gu District, Beijing

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number table

Allocation concealment (selection bias)

Insufficient reporting

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes
Acupuncture for dysmenorrhoea (Review)
Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Participants and clinicians were not


blinded. No details reported regarding outcome assessment and analyst
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Xu 2014

(Continued)

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting

Yeh 2013a
Methods

Single-blind RCT of auricular acupressure versus sham acupressure

Participants

Community study of 113 adolescent girls from Taiwan, 59 acupuncture, 54 control

Interventions

The experimental group received auricular acupressure applied to 6 true acupoints (shenmen, Kidney, Liver, Internal Genitals, Central Rim, and Endocrine)
The control group received 6 sham acupoints without effects on dysmenorrhoea. All
participants were instructed to press each acupoint for 1 minute, 4 times a day for 2 days
Adhesive plasters were used to stick seeds to the ear. Seeds were removed after 48 hours

Outcomes

Pain severity measured along the VAS, Short Form McGill Pain Questionnaire, menstrual
Distress questionnaire assessed at the end of the 2-day intervention

Notes

Country: Taiwan
Setting: High School
Groups: comparable at baseline.
Compliance: not stated
ITT not reported.
Duration: not reported.

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Coin tossing

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

1 researcher knew the code but it was unclear who. Assessment of blinding: singleblind but unclear of integrity of blinding of
women, and who in the research team was
unblinded

Incomplete outcome data (attrition bias)


All outcomes

13 failed to complete the post-intervention


evaluation process (9 in the experimental
and 4 in the control group). Reason for

High risk

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Yeh 2013a

(Continued)

missing outcome data likely to be related


to true outcome, with either imbalance in
numbers or reasons for missing data across
intervention groups; over double the dropouts in experimental vs control group. Attrition rate 11%. No reasons were given
Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting

Youn 2008
Methods

RCT of acupuncture versus minimal acupuncture

Participants

80 women with dysmenorrhoea but no details of how diagnosis was confirmed.80 randomised, details of allocation to groups unclear

Interventions

Duration of intervention: administered over 3 menstrual cycles


Acupuncture: 6 set points, GB41, SI3, SI2, SP6, REN6, and either ST36 or LI2 depending on symptoms, needles inserted for 20 minutes, to a depth of 3 mm. 8 treatments
given 7 - 10 days apart
Minimal acupuncture: 5 non-acupuncture points given having no relation to effects on
dysmenorrhoea, treatment frequency and duration the same as treatment group

Outcomes

Pain measurement using MMP, a continuous scale. Overall symptom improvement measured by MSSL, a continuous scale

Notes

Country: Korea
Setting: Hospital
ITT analysis not mentioned and not undertaken. 25 available for analysis in treatment
and 22 in control groups

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-numbers table

Allocation concealment (selection bias)

No information reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

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Only the participants were reported as being blinded.

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Youn 2008

(Continued)

Incomplete outcome data (attrition bias)


All outcomes

High risk

30 excluded from analysis. 10 dropped out,


8 with disease, 15 no reason stated. Not
reported by group

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting

Yu 2014
Methods

RCT of acupuncture versus wait list, 96 randomised, 48 to each group

Participants

Women were recruited from an obstetrics and gynaecological clinic, with a mean age of
23 (SD 1)

Interventions

Acupuncture: Manual acupuncture administered 7 days before the period, once each
day, until deqi obtained. Acupoints were Yinjiao, Guanyuan, Zhong ji, Dahe, Ciliao
(both sides), Sanyin jiao (both sides);
For qi stagnation and blood stasis, added Taichong, Xue hai; Cold-damp added Diji,
Yinlingquan. Needle: 0.25 mm 30 ~ 40 mm. retention for 30 minutes after needling
Treatment stopped when period started
Treatment over 3 menstrual cycles. When the pain was strong, or VAS 8, prescribed
ibuprofen, 1 tablet each time, maximum 2 tablets each day
Control: wait list for 6 months, from month 7 - 9 received the same acupuncture as
intervention group. When the pain was strong, or VAS 8, prescribed ibuprofen, 1
tablet each time, maximum 2 tablets each day

Outcomes

VRS of the impact of pain on daily living. RSS describing menstrual symptoms

Notes

Country: China
Setting: Hospital, Beijing
Duration : 6 months
ITT: not reported.

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number table

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

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Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

No blinding or incomplete blinding, and


the outcome or outcome measurement is
likely to be influenced by lack of blinding;
participants were not blinded and the re75

Yu 2014

(Continued)

searchers only mentioned that they would


avoid telling participants about the allocation. No other details reported
Incomplete outcome data (attrition bias)
All outcomes

Low risk

No losses

Selective reporting (reporting bias)

Unclear risk

The study protocol is not available

Other bias

Low risk

The study appears free of bias

Zafari 2011
Methods

RCT, parallel design of fish oils versus acupressure (n = 60) versus ibuprofen (n = 76)

Participants

196 Iranian college students from the University of Mazandaran aged 18 - 22 years, with
regular menstruation, menstrual pain in the majority of cycles in the last 6 months, and
described as severe or moderate pain

Interventions

Treatment was administered over 3 menstrual cycles. The first cycle was monitoring only.
The first group received the daily dosage of 1 g of fish oil. This capsule is gelatin form
and yellow colour. It contains polyunsaturated fat (1 g), saturated fat (1 g), EPA (180
mg) and DHA (120 mg) over 2 months. A second group received 400 mg of ibuprofen
to be taken as soon as the pain started, and repeated 8 hours later if the pain persisted.
The third group received acupressure using point SP6. Students were trained to apply
pressure to SP6 for 6 seconds, release the pressure for 2 seconds and then reapply. This
continued for 5 minutes after which they applied pressure to the other leg for the same
pattern of stimulation. Pressure was applied for a total of 20 minutes

Outcomes

Severity and duration of pain, participant satisfaction, and use of sedatives at the end of
the intervention. No instruments reported

Notes

Country: Iran
Setting: College
Groups comparable at baseline: no differences in demographics and pain reported
Compliance: The student was interviewed once a week to check on correct administration
of the treatments
ITT: not stated
Duration: not reported
A pairwise analysis was undertaken with the inclusion of the 2 control groups

Risk of bias
Bias

Authors judgement

Random sequence generation (selection Unclear risk


bias)

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Support for judgement


Not reported

76

Zafari 2011

(Continued)

Allocation concealment (selection bias)

Unclear risk

Not reported

Blinding (performance bias and detection High risk


bias)
All outcomes

No participants were blind to their group


allocation. No other details were reported
on blinding

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

High risk

Some secondary outcomes were not fully


reported

Other bias

Unclear risk

Not reported

Zhang 2012
Methods

Parallel RCT of manual acupuncture compared with pharmacological treatment

Participants

90 women randomised to the study, 45 in each group.


Age range 11 - 27 years was specified as the inclusion criterion

Interventions

The treatment started when period pain occurred and continued for 3 days. The needles
were manipulated every 5 minutes and retained for 30 minutes
TCM pattern: Qi and blood stasis, Xuehai, Taichong, Hegu, Sanyinjiao, Ashi points
were chosen. The needles were inserted perpendicularly about 1 cun. Strong reducing
acupuncture technique was applied once DeQi had arrived
If TCM pattern was cold and damp stagnation, Guanyuan, Diji, Sanyinjiao, Ashi points
were chosen. The needles were inserted perpendicularly about 1 cun. Strong reducing
acupuncture technique was applied to Diji, Sanyinjiao and Ashi points once DeQi had
arrived. Guanyuan was applied with strong reinforcing technique once Deqi happened
If TCM pattern was damp heat in the liver, Hegu, Taichong, Sanyinjiao, Ashi points
were chosen. Strong reducing acupuncture technique was applied once DeQi had arrived
If TCM pattern was Qi and blood deficiency, Qihai, Xuehai, Zusanli, Xuanzhong, Ashi
points were chosen. Strong reinforcing acupuncture technique was applied once DeQi
had arrived
If TCM pattern was liver and kidney deficiency, Ganshu, Shenshu, Taixi, Taichong, Ashi
points were chosen. Strong reinforcing acupuncture technique was applied once DeQi
had arrived
Control group: indomethacin was prescribed 3 times a day for 3 days. Each time dosage
was 25 mg

Outcomes

Pain reported as dichotomous variable, relating to improvement or no improvement

Notes

Country: China
Setting: Hospital clinic
Duration: 3-month intervention
Baseline comparability: not reported

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(Continued)

Funding: not reported


Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number table

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

Participants were not blinded to group allocation. No other details reported

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Insufficient data reported to allow judgement to be made

Other bias

Unclear risk

Insufficient reporting

Zhang 2013a
Methods

RCT, parallel design of acupuncture versus diclofenac

Participants

60 women aged 16 - 47 years recruited from a community clinic, 30 in each group


Exclusion history of PID.
Women presented with patterns of Qi and blood stagnation, Qi and blood deficiency,
retention of heat and dampness, Kidney and Liver deficiency, retention of cold and
dampness

Interventions

Acupuncture: core points SP10, SP8, LIV8, KID3, SP15, SP14, KID 14, SP6. SP9
Additional points: stagnation of Qi and Blood LIV 3.
Qi and Blood deficiency: LIV13.
Retention of heat and dampness: LIV2.
Liver/Kidney deficiency:KD6.
Needles inserted to a depth 0.5 cun. duration of needling 30 minutes, moxa was administered for 5 minutes for cold patterns. Treatment began 3 days prior to expected
menstruation. Treatment duration up to 10 days
Control group: oral administration of diclofenac with the onset of period pain, 0.1 mg
daily

Outcomes

Pain score and dichotomous measures of treatment effect measured at the end of the
intervention

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Zhang 2013a

(Continued)

Notes

Country: China.
Possibility of effects from treatments administered prior to trial may not have washed
out
Groups comparable at baseline: not reported.
Compliance: not reported
ITT not stated
Durations: 3 cycles, with 3-month follow-up

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Lot drawing

Allocation concealment (selection bias)

Not reported

Unclear risk

Blinding (performance bias and detection High risk


bias)
All outcomes

No blinding and the outcome is likely to


be influenced by a lack of blinding

Incomplete outcome data (attrition bias)


All outcomes

Low risk

No missing data

Selective reporting (reporting bias)

Unclear risk

Study protocol not available

Other bias

Unclear risk

Insufficient information reported to allow


assessment

Zhang 2013b
Methods

RCT, manual acupuncture versus no treatment. 2 groups of acupuncture: 1 administered


acupuncture before period arrived and the second group administered treatment once
period arrived. 90 randomised, 30 women in each group

Participants

90 women recruited from the hospital TCM clinic

Interventions

Treatment group 1: Daily acupuncture on Shiqizhui (EX-B8) started 3 - 7 days before


menstrual cycle. Treatment ceased on the day of period arrival. Total of 3 consecutive
treatments were performed
Treatment group 2: Daily acupuncture on Shiqizhui (EX-B8) started on the day when
period pain occurred. Treatment ceased when the pain disappeared. Total of 3 consecutive
treatments were performed
Method: Performing reducing acupuncture technique in Shiqizhui (EX-B8) after DeQ
i feeling. Needles were manipulated 30 seconds for every 10 minutes. The needles were
retained in the point for 30 minutes
Control: no treatment

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Zhang 2013b

(Continued)

Outcomes

VAS to measure pain and continuous scales to measure overall improvement, Outcome
assessed at 1, 2, 3 months (end of intervention), and follow-up at 4, 5, 6 months

Notes

Country: China
Language: Chinese
Setting: Hospital in Shangdong province
Study duration: Total study duration 3months plus 2 months follow-up on treatment
groups
ITT mentioned and undertaken
For the analysis we combined treatment groups 1 and 2.

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Random-number table

Allocation concealment (selection bias)

Insufficient reporting

Unclear risk

Blinding (performance bias and detection Unclear risk


bias)
All outcomes

No blinding was performed in participants


and doctors. Not mentioned for outcome
assessors and statisticians

Incomplete outcome data (attrition bias)


All outcomes

Low risk

Post-randomisation exclusions group 1 =


2, group 2 = 3, group 3 = 1.Reasons for
missing outcome data unlikely to be related
to true outcome

Selective reporting (reporting bias)

Unclear risk

Insufficient reporting

Other bias

Unclear risk

Insufficient reporting

Zhi 2007
Methods

RCT, parallel design, 3 groups: 1) electro-acupuncture; 2) superficial acupuncture; 3)


control medication ibuprofen

Participants

171 women were recruited, 57 to each group. Women were required to meet a TCM
diagnosis of blood stasis, or Qi stagnation. Women were required to have a diagnosis of
primary dysmenorrhoea, with pain occurring in 3 consecutive menstrual cycles, affecting
womens work or lifestyle and requiring treatment
Women were excluded if they had a current psychotic condition, liver or kidney function
impairments, circulation conditions, infectious diseases, currently taking other medications that interact with the trial medications, or in the last 2 weeks having taken other
medications such as anti-inflammatories

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Zhi 2007

(Continued)

Interventions

Women received the first treatment on the first day of the cycle, thereafter treatment
began 3 days before the start of the cycle. This was continued for 3 menstrual cycles
Women who received superficial acupuncture (SA) received acupuncture bilateral stimulation to point SP6 only. Needles 0.60 mm x 32 mm were used. Needles were positioned
at 15 - 25 and inserted at a rapid speed, the needles are inserted to the needle length
of 30 mm, and the manipulating left and right in a 15 fan shape for 3 - 6 times. The
needle was removed leaving a soft cover subdermal with the base exposed. The point of
insertion was then covered and secured with a sterilised bandage
For women receiving electrostimulation the position, point location, insertion method,
manipulation method were identical to SA group. The needle was then pulled out
3 - 4 mm, and connected to electro-stimulation machines model G 6805-2 A type
(manufactured by Shanghai Medical Electrical Equipment Company), using alternating
frequency (long frequency rate 60Hz, 2.5 sec, continuous frequency 60 Hz, 5 sec),
voltage at 2 - 3 V (or until participant can feel it), the machine was turned on for 30
minutes. Needles were then removed, leaving the soft cover subdermal, with a sterilised
bandage used to cover the exposed needle base
Control group: women allocated to the medication group took oral 0.3 mg ibuprofen
sustained-release capsule (manufactured by Tianjin Pharmaceutical), twice a day for 3
days; then 3 days before the subsequent cycle (based on basal body temperature increase
for 12 days), and for 2 days into cycle, continue for the third month

Outcomes

Self-report assessment of the severity of pain and menstrual-related symptoms. Abdominal pain was assessed before, during and after the menstrual cycles. Other assessments
made of fainting, pale complexion, cold sweats, cold extremities, requiring bed rest, affects work/study, effect of usual pain relief, back ache, nausea. These items were then
assessed as recently cured, marked effect, or no effect. Measured at the end of the intervention

Notes

Country: China
Setting: Gynaecology hospital department, Jiaozuo
Groups comparable at baseline: no differences in small number of variables reported
Loss to follow-up: 1 woman from superficial acupuncture dropped out and 3 from the
medication group
Compliance: not stated
ITT not reported
Duration: September 2004 - May 2006
Funding: not reported

Risk of bias
Bias

Authors judgement

Support for judgement

Random sequence generation (selection Low risk


bias)

Computer-generated list

Allocation concealment (selection bias)

No details reported

Unclear risk

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Zhi 2007

(Continued)

Blinding (performance bias and detection High risk


bias)
All outcomes

Participants were not blinded to their group


allocation. No other details were reported

Incomplete outcome data (attrition bias)


All outcomes

Low risk

1 woman from the electro group, 2 from


superficial acupuncture, 1 from medication
failed to follow up. The risk was not enough
to have clinically relevant impact on the
intervention effect estimate

Selective reporting (reporting bias)

Unclear risk

Insufficient information to permit judgement

Other bias

Unclear risk

Insufficient information to assess

EA: electro-acupuncture
ITT: intention-to-treat
IUD: intra-uterine device
LMP: last menstrual period
MMP: measure of menstrual pain
MSSL: menstrual symptoms severity list
NRS: numeric rating scale
NSAID: non-steroidal anti-inflammatory drug
PGF : prostaglandin F2alpha
PID: pelvic inflammatory disease
QoL: quality of life
RCT: randomised controlled trial
RSS: retrospective symptom scale
TCM: traditional Chinese medicine
VAS: visual analogue scale
VMSS: verbal multidimensional scoring system
VRS: verbal rating scale

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Bing 2011

Quasi-randomised controlled trial

Chao 2012

The trial uses point injection which did not meet our inclusion criteria

Chao 2014

The trial uses point injection which did not meet our inclusion criteria

Chen 2008

We were unable to confirm any details of randomisation.

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(Continued)

Chen 2011

The trial evaluated single stimulation of acupuncture compared with a group receiving multi-stimulation
from several acupuncture points

Chen 2014

We were unable to confirm any details of randomisation.

Gao 2014a

We were unable to confirm any details on randomisation.

Gao 2014b

We were unable to confirm any details of randomisation.

Geng 2008

The study evaluated the use of acupuncture plus Chinese herbs and did not meet our inclusion criteria

Gharloghi 2012

The trial included an active control of acupressure.

Guo 2008

The trial evaluated acupuncture plus Tui Na compared with acupuncture alone as an alternate treatment

Habek 2003

We were unable to confirm any details of randomisation.

He 2005

This trial evaluated acupuncture plus moxibustion and did not meet our inclusion criteria

Hu 2011

Women less than 15 years were included in the trial, and therefore met our exclusion criteria

Hu 2014

We were unable to confirm any details of randomisation.

Huang 2013

The trial compared acupuncture to an alternative acupuncture treatment group and was non-randomised

Huyou-Ping 2013

The trial compared acupuncture to an alternative acupuncture treatment group and did not meet our inclusion
criteria

Jiang 2007

Quasi-randomised

Jun 2007

The trial used quasi-randomisation and did not meet our inclusion criteria

Jun 2004

The trial used quasi-randomisation and did not meet our inclusion criteria

Kempf 2009

The trial evaluated the use of laser acupuncture and did not meet the eligibility criteria

Kim 2011

The trial reported no clinically relevant outcomes.

Kiran 2013

Quasi-randomised

Li 2006

The trial evaluated the effect of moxibustion as the sole active intervention on acupuncture points and did
not meet the inclusion criteria

Li 2007

The trial evaluated acupuncture plus a herbal plaster and did not meet our inclusion criteria

Li 2011

The trial evaluated single stimulation of acupuncture compared with a group receiving multi-stimulation
from several acupuncture points

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(Continued)

Li 2012a

The trial compared acupuncture and moxibustion combined with cupping and did not meet our inclusion
criteria

Lin 2008

The study was non-randomised.

Liu 2005

The trial injected vitamin K3 into the acupuncture point, which did not meet the inclusion criteria

Liu 2014a

The control group did not meet our criteria, with comparison with active points or active acupuncture
stimulation

Liu 2014b

We were unable to confirm any details of randomisation.

Lui 1999

The control group did not meet our criteria for the control group

Luo 2014

We were unable to confirm any details of randomisation.

Mahoney 1993

The study was non-randomised.

Miao 2014

The trial examined electro-acupuncture plus herbal medicine and did not meet the inclusion criteria

Pouresmail 2002

We were unable to confirm details of randomisation from the author

Pu 2011

We attempted to contact the author to establish if the study was randomised. Contact was not successful. We
were unable to confirm the study was randomised

Reyes-Campos 2013

The trial was not randomised.

Ro 2013

The study was excluded because it was a pre-test post-test design

She 2008

We were unable to confirm details of randomisation from the author

Shi 1994

We were unable to obtain details from the author on the methods of concealment and allocation of randomisation

Song 1992

We were unable to obtain details from the author on the methods of concealment and allocation of randomisation

Sun 2004

This trial examined moxibustion to the acupuncture point.

Sun 2008

This trial examined moxibustion to the acupuncture point.

Wang 2002

Data reporting was incomplete and we were unable to obtain details from the author regarding randomisation

Wang 2005a

This examined the effect of moxibustion to the acupuncture point

Wang 2009b

Following translation, we found this study to be an intervention evaluating moxibustion, not acupuncture

Wang 2013a

The study was non-randomised.

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(Continued)

Wang 2014b

We were unable to confirm any details of randomisation.

Wu 2007

Quasi-randomised

Xie 2003

The trial compared acupuncture to an alternative acupuncture treatment group

Xiong 2012

The trial evaluated single stimulation of acupuncture compared with a group receiving multi-stimulation
from several acupuncture points

Yang 2008a

This trial evaluated moxibustion and did not meet our inclusion criteria

Yang 2014

We were unable to confirm any details of randomisation.

Yeh 2013

The study was non-randomised.

Yi 2005

The trial evaluated acupuncture plus massage and did not meet our inclusion criteria

Yu 2010

No clinically relevant outcomes reported, and the control group used an active acupuncture intervention

Yuk 2005

Non-randomised study.

Zhang 2004

The study did not meet our inclusion criteria.

Zhang 2014

We were unable to confirm any details of randomisation.

Zheng 2006

We were unable to obtain details from the author on the methods of concealment and allocation of randomisation

Zheng 2014

We were unable to confirm any details of randomisation.

Zhou 2003

We were unable to obtain details from the author on the methods of concealment and allocation of randomisation

Zhou 2014

We were unable to confirm any details of randomisation.

Characteristics of studies awaiting assessment [ordered by study ID]


Han 2015
Methods

Paper requiring translation

Participants
Interventions
Outcomes
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Han 2015

(Continued)

Notes
Zhang 2003
Methods

No further details available

Participants
Interventions
Outcomes
Notes

Characteristics of ongoing studies [ordered by study ID]


Armour 2013
Trial name or title

Acupuncture primary dysmenorrhoea: examining the role of frequency of treatment and mode of stimulation
on clinical outcomes

Methods

Randomised controlled trial

Participants

74 women. Age 18 - 45 years. Women with confirmed primary dysmenorrhoea, pain > 3 on a pain scale,
regular menstrual cycles

Interventions

Manual acupuncture provided by manual stimulation administered once a week starting the week after menses
and then once in the first days of the menstrual cycle for 3 cycles versus manual acupuncture delivered 3 times
in the week prior to menses, and then once in the first 2 days of menstruation, versus electro-acupuncture
once a week after menses and then for the first 2 days of menses, versus electro-acupuncture 3 times in the
week prior to menses and then in the first 2 days of the period

Outcomes

Pain intensity, duration of pain, quality of life, pain relief, participant satisfaction

Starting date

May 2013

Contact information

Mike Armour: m.armour@uws.edu.au

Notes

Recruitment complete

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86

Huang 2010
Trial name or title

Randomised controlled trial of acupuncture for dysmenorrhoea

Methods

Randomised controlled trial

Participants

Sample size: 22 women aged > 13 years who are not pregnant and meet either of the following 2 criteria:
1. Suffering from dysmenorrhoea in recent 3 menstrual periods;
2. Dysmenorrhoea with poor response to non-steroid anti-inflammation drugs

Interventions

Acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed up for another
2 months versus usual care with medication and behaviour therapy for 2 months, followed by acupuncture
for additional 2 months

Outcomes

Pain score, quality of life, use of medication, impact on daily living activities, safety

Starting date

May 2010

Contact information

Chien-Hsun Huan, National Taiwan University Hospital Yun-Lin Branch, Yun-Lin, Taiwan, 640

Notes

The study is complete

Witt 2012
Trial name or title

Effectiveness of additional self-care acupressure for women with menstrual pain compared to usual care

Methods

Randomised controlled trial

Participants

220 women. Age 18 - 25 years. Women with menstrual pain every cycle, no history of gynaecological disease
that could be a reason for dysmenorrhoea. Moderate to severe pain

Interventions

Self-care acupressure at 3 predefined points starting 5 days before menstruation, applying 1 minute for each
point, once to twice daily, when pain is present 2 to 5 times daily

Outcomes

Mean pain intensity, worst pain intensity, duration of pain, responder rate defined as 50% pain reduction,
sick leave, adverse events, self efficacy

Starting date

December 2012

Contact information

Claudia Witt: claudia.witt@charite.de

Notes

Recruiting

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DATA AND ANALYSES

Comparison 1. Acupuncture versus sham/placebo acupuncture

Outcome or subgroup title


1 Pain score
2 Improvement in menstrual
symptoms
2.1 At three months
2.2 At six months
2.3 At 12 months
3 Use of additional medication
3.1 At three months
3.2 At six months
3.3 At 12 months
4 Restriction of daily living
activities
5 Quality of life: physical health
6 Quality of life: mental health
7 Quality of life: bodily pain
8 Quality of life: general health
9 Quality of life: vitality
10 Quality of life: social function
11 Quality of life: role emotional

No. of
studies

No. of
participants

3
1

Statistical method

Effect size

Mean Difference (IV, Fixed, 95% CI)


Odds Ratio (M-H, Fixed, 95% CI)

Subtotals only
Subtotals only
1.58 [0.61, 4.04]
1.47 [0.62, 3.48]
2.35 [0.80, 6.94]
Subtotals only
0.91 [0.40, 2.09]
0.34 [0.14, 0.79]
1.51 [0.62, 3.70]
0.72 [0.29, 1.81]
-2.90 [-6.33, 0.53]
4.40 [-3.59, 12.39]
-7.5 [-16.71, 1.71]
2.30 [-6.98, 11.58]
2.20 [-6.98, 11.38]
-0.5 [-9.53, 8.53]
0.0 [-14.11, 14.11]

1
1
1
1
1
1
1
1

92
92
92
92
92
92
92

Odds Ratio (M-H, Fixed, 95% CI)


Odds Ratio (M-H, Fixed, 95% CI)
Odds Ratio (M-H, Fixed, 95% CI)
Odds Ratio (M-H, Fixed, 95% CI)
Odds Ratio (M-H, Fixed, 95% CI)
Odds Ratio (M-H, Fixed, 95% CI)
Odds Ratio (M-H, Fixed, 95% CI)
Odds Ratio (M-H, Fixed, 95% CI)

1
1
1
1
1
1
1

92
92
92
92
92
92
92

Mean Difference (IV, Fixed, 95% CI)


Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)

Comparison 2. Acupuncture versus medication

Outcome or subgroup title


1 Pain score
1.1 NSAIDs (VAS 0 - 10
scale)
1.2 Combined oral
contraceptive (NRS 0 - 10
scale)
2 Pain relief
2.1 NSAIDs
2.2 COC
3 Menstrual symptom score
3.1 NSAIDS
3.2 Juyuansuan tamoxifen
4 Use of additional medication
5 Quality of life
6 Adverse events

No. of
studies

No. of
participants

Statistical method

Effect size

8
7

Mean Difference (IV, Random, 95% CI)


Mean Difference (IV, Random, 95% CI)

Totals not selected


0.0 [0.0, 0.0]

Mean Difference (IV, Random, 95% CI)

0.0 [0.0, 0.0]

Odds Ratio (M-H, Fixed, 95% CI)


Odds Ratio (M-H, Fixed, 95% CI)
Odds Ratio (M-H, Fixed, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Random, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Odds Ratio (M-H, Fixed, 95% CI)

Subtotals only
4.99 [2.82, 8.82]
0.39 [0.12, 1.21]
Subtotals only
-2.25 [-3.33, -1.17]
-4.22 [-5.12, -3.32]
0.56 [-1.03, 2.15]
-9.14 [-19.23, 0.95]
Subtotals only

5
4
1
7
6
1
1
1
5

352
52
440
80
42
42

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6.1 NSAIDs
6.2 COC

4
1

239
52

Odds Ratio (M-H, Fixed, 95% CI)


Odds Ratio (M-H, Fixed, 95% CI)

0.10 [0.02, 0.44]


1.12 [0.34, 3.63]

Comparison 3. Acupuncture versus Chinese herbs

Outcome or subgroup title


1 Pain score
2 Menstrual symptom
improvement

No. of
studies

No. of
participants

1
1

120
120

Statistical method
Mean Difference (IV, Fixed, 95% CI)
Odds Ratio (M-H, Fixed, 95% CI)

Effect size
-4.58 [-5.79, -3.37]
7.00 [2.22, 22.06]

Comparison 4. Acupuncture versus no treatment

Outcome or subgroup title


1 Pain score
2 Severity of menstrual symptoms

No. of
studies

No. of
participants

Statistical method

Effect size

6
2

132

Std. Mean Difference (IV, Random, 95% CI)


Std. Mean Difference (IV, Fixed, 95% CI)

Subtotals only
-0.81 [-1.17, -0.45]

Statistical method

Effect size

Comparison 5. Acupuncture versus usual care

Outcome or subgroup title


1 Pain score
2 Absence from work or school
3 Quality of life physical health
4 Quality of life: mental health
5 Quality of life: bodily pain
6 Quality of life: general health
7 Quality of life: vitality
8 Quality of life: social function
9 Qualit of life: role emotional
10 Adverse events

No. of
studies

No. of
participants

1
1
1
1
1
1
1
1
1
1

117
117
117
117
117
117
117
117
117
117

Mean Difference (IV, Fixed, 95% CI)


Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Mean Difference (IV, Fixed, 95% CI)
Odds Ratio (M-H, Fixed, 95% CI)

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-2.09 [-2.99, -1.19]


0.06 [-0.54, 0.66]
5.57 [2.68, 8.46]
10.49 [3.63, 17.35]
20.10 [9.90, 30.30]
6.38 [-0.26, 13.02]
18.12 [11.52, 24.72]
20.27 [11.52, 29.02]
14.16 [1.29, 27.03]
0.27 [0.05, 1.34]

89

Comparison 6. Acupressure versus sham/placebo

Outcome or subgroup title


1 Pain score (VAS 0 - 10)
2 Severity of menstrual symptoms

No. of
studies

No. of
participants

2
2

171

Statistical method

Effect size

Mean Difference (IV, Random, 95% CI)


Mean Difference (IV, Fixed, 95% CI)

Subtotals only
-1.84 [-3.71, 0.03]

Comparison 7. Acupressure versus medication (NSAIDs)

No. of
studies

Outcome or subgroup title


1 Pain score

No. of
participants

Statistical method

Effect size

Mean Difference (IV, Random, 95% CI)

Subtotals only

Comparison 8. Acupressure versus no treatment

Outcome or subgroup title


1 Pain score (VAS 0 - 10)
2 Menstrual symptoms (MDQ)

No. of
studies

No. of
participants

2
3

140
160

Statistical method

Effect size

Mean Difference (IV, Random, 95% CI)


Mean Difference (IV, Random, 95% CI)

-0.96 [-2.54, 0.62]


-1.90 [-5.57, 1.77]

Analysis 1.1. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 1 Pain score.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 1 Pain score

Study or subgroup

Acupuncture

Mean
Difference

Placebo/sham

Weight

IV,Fixed,95% CI

Mean
Difference

Mean(SD)

Mean(SD)

IV,Fixed,95% CI

Darabi 2010 (1)

50

2.12 (1)

50

4.24 (0.91)

-2.12 [ -2.49, -1.75 ]

Smith 2010 (2)

46

2 (2.5)

46

2.6 (2.7)

-0.60 [ -1.66, 0.46 ]

Song 2013 (3)

25

4.2 (7.28)

96

8.77 (16.3)

-4.57 [ -8.90, -0.24 ]

Test for subgroup differences: Not applicable

-10

-5

Favours acupuncture

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10

Favours placebo/sham

90

(1) Measure was VAS end score


(2) Measure was the McGill pain questionnaire end score
(3) Measure was VAS end score

Analysis 1.2. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 2 Improvement in


menstrual symptoms.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 2 Improvement in menstrual symptoms

Study or subgroup

Acupuncture

Placebo/sham

Odds Ratio

n/N

n/N

M-H,Fixed,95% CI

Weight

Odds Ratio

14/46

10/46

100.0 %

1.58 [ 0.61, 4.04 ]

46

46

100.0 %

1.58 [ 0.61, 4.04 ]

18/46

14/46

100.0 %

1.47 [ 0.62, 3.48 ]

46

46

100.0 %

1.47 [ 0.62, 3.48 ]

12/46

6/46

100.0 %

2.35 [ 0.80, 6.94 ]

46

46

100.0 %

2.35 [ 0.80, 6.94 ]

M-H,Fixed,95% CI

1 At three months
Smith 2010

Subtotal (95% CI)

Total events: 14 (Acupuncture), 10 (Placebo/sham)


Heterogeneity: not applicable
Test for overall effect: Z = 0.95 (P = 0.34)
2 At six months
Smith 2010

Subtotal (95% CI)

Total events: 18 (Acupuncture), 14 (Placebo/sham)


Heterogeneity: not applicable
Test for overall effect: Z = 0.87 (P = 0.38)
3 At 12 months
Smith 2010

Subtotal (95% CI)

Total events: 12 (Acupuncture), 6 (Placebo/sham)


Heterogeneity: not applicable
Test for overall effect: Z = 1.55 (P = 0.12)
Test for subgroup differences: Chi2 = 0.48, df = 2 (P = 0.79), I2 =0.0%

0.1 0.2

0.5

Favours sham

10

Favours acupuncture

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Analysis 1.3. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 3 Use of additional
medication.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 3 Use of additional medication

Study or subgroup

Acupuncture

Sham/placebo
control

Odds Ratio

Weight

M-H,Fixed,95% CI

Odds Ratio

n/N

n/N

M-H,Fixed,95% CI

26/46

27/46

100.0 %

0.91 [ 0.40, 2.09 ]

46

46

100.0 %

0.91 [ 0.40, 2.09 ]

20/46

32/46

100.0 %

0.34 [ 0.14, 0.79 ]

46

46

100.0 %

0.34 [ 0.14, 0.79 ]

34/46

30/46

100.0 %

1.51 [ 0.62, 3.70 ]

46

46

100.0 %

1.51 [ 0.62, 3.70 ]

1 At three months
Smith 2010

Subtotal (95% CI)

Total events: 26 (Acupuncture), 27 (Sham/placebo control)


Heterogeneity: not applicable
Test for overall effect: Z = 0.21 (P = 0.83)
2 At six months
Smith 2010

Subtotal (95% CI)

Total events: 20 (Acupuncture), 32 (Sham/placebo control)


Heterogeneity: not applicable
Test for overall effect: Z = 2.49 (P = 0.013)
3 At 12 months
Smith 2010

Subtotal (95% CI)

Total events: 34 (Acupuncture), 30 (Sham/placebo control)


Heterogeneity: not applicable
Test for overall effect: Z = 0.90 (P = 0.37)
Test for subgroup differences: Chi2 = 5.93, df = 2 (P = 0.05), I2 =66%

0.1 0.2

0.5

Favours acupuncture

10

Favours sham/placebo

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Analysis 1.4. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 4 Restriction of daily
living activities.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 4 Restriction of daily living activities

Study or subgroup

Acupuncture

Sham/placebo

Odds Ratio

n/N

n/N

M-H,Fixed,95% CI

11/46

14/46

100.0 %

0.72 [ 0.29, 1.81 ]

46

46

100.0 %

0.72 [ 0.29, 1.81 ]

Smith 2010

Total (95% CI)

Weight

Odds Ratio
M-H,Fixed,95% CI

Total events: 11 (Acupuncture), 14 (Sham/placebo)


Heterogeneity: not applicable
Test for overall effect: Z = 0.70 (P = 0.48)
Test for subgroup differences: Not applicable

0.01

0.1

Favours sham/placebo

10

100

Favours acupuncture

Analysis 1.5. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 5 Quality of life:
physical health.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 5 Quality of life: physical health

Study or subgroup

Acupuncture

Smith 2010

Total (95% CI)

Mean
Difference

Plaebo/sham

Mean(SD)

Mean(SD)

46

49.6 (9.1)

46

52.5 (7.6)

46

Weight

Mean
Difference

100.0 %

-2.90 [ -6.33, 0.53 ]

100.0 %

-2.90 [ -6.33, 0.53 ]

IV,Fixed,95% CI

IV,Fixed,95% CI

46

Heterogeneity: not applicable


Test for overall effect: Z = 1.66 (P = 0.097)
Test for subgroup differences: Not applicable

-20

-10

Favours placebo/sham

Acupuncture for dysmenorrhoea (Review)


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10

20

Favours acupuncture

93

Analysis 1.6. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 6 Quality of life:
mental health.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 6 Quality of life: mental health

Study or subgroup

Acupuncture

Smith 2010

Total (95% CI)

Mean
Difference

Placebo/sham

Mean(SD)

Mean(SD)

46

71.4 (18.2)

46

67 (20.8)

46

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

46

100.0 %

4.40 [ -3.59, 12.39 ]

100.0 %

4.40 [ -3.59, 12.39 ]

Heterogeneity: not applicable


Test for overall effect: Z = 1.08 (P = 0.28)
Test for subgroup differences: Not applicable

-100

-50

Favours placebo/sham

50

100

Favours acupuncture

Analysis 1.7. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 7 Quality of life:
bodily pain.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 7 Quality of life: bodily pain

Study or subgroup

Acupuncture

Smith 2010

Total (95% CI)

Mean
Difference

Placebo/sham

Mean(SD)

Mean(SD)

46

64.4 (23.7)

46

71.9 (21.3)

46

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

100.0 %

46

-7.50 [ -16.71, 1.71 ]

100.0 % -7.50 [ -16.71, 1.71 ]

Heterogeneity: not applicable


Test for overall effect: Z = 1.60 (P = 0.11)
Test for subgroup differences: Not applicable

-100

-50

Favours placebo/sham

Acupuncture for dysmenorrhoea (Review)


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50

100

Favours acupuncture

94

Analysis 1.8. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 8 Quality of life:
general health.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 8 Quality of life: general health

Study or subgroup

Acupuncture

Smith 2010

Total (95% CI)

Mean
Difference

placebo/sham

Mean(SD)

Mean(SD)

46

69.2 (20.5)

46

66.9 (24.7)

46

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

46

100.0 %

2.30 [ -6.98, 11.58 ]

100.0 %

2.30 [ -6.98, 11.58 ]

Heterogeneity: not applicable


Test for overall effect: Z = 0.49 (P = 0.63)
Test for subgroup differences: Not applicable

-100

-50

Favours placebo/sham

50

100

Favours acupuncture

Analysis 1.9. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 9 Quality of life:
vitality.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 9 Quality of life: vitality

Study or subgroup

Acupuncture

Smith 2010

Total (95% CI)

Mean
Difference

Placebo/sham

Mean(SD)

Mean(SD)

46

55.8 (21.8)

46

53.6 (23.1)

46

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

46

100.0 %

2.20 [ -6.98, 11.38 ]

100.0 %

2.20 [ -6.98, 11.38 ]

Heterogeneity: not applicable


Test for overall effect: Z = 0.47 (P = 0.64)
Test for subgroup differences: Not applicable

-100

-50

Favours placebo/sham

Acupuncture for dysmenorrhoea (Review)


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50

100

Favours acupuncture

95

Analysis 1.10. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 10 Quality of life:
social function.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 10 Quality of life: social function

Study or subgroup

Acupuncture

Smith 2010

Total (95% CI)

Mean
Difference

Placebo/sham

Mean(SD)

Mean(SD)

46

78.8 (22.3)

46

79.3 (21.9)

46

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

46

100.0 %

-0.50 [ -9.53, 8.53 ]

100.0 %

-0.50 [ -9.53, 8.53 ]

Heterogeneity: not applicable


Test for overall effect: Z = 0.11 (P = 0.91)
Test for subgroup differences: Not applicable

-100

-50

Favours acupuncture

50

100

Favours placebo/sham

Analysis 1.11. Comparison 1 Acupuncture versus sham/placebo acupuncture, Outcome 11 Quality of life:
role emotional.
Review:

Acupuncture for dysmenorrhoea

Comparison: 1 Acupuncture versus sham/placebo acupuncture


Outcome: 11 Quality of life: role emotional

Study or subgroup

Acupuncture

Smith 2010

Total (95% CI)

Mean
Difference

Placebo/sham

Mean(SD)

Mean(SD)

46

75 (36)

46

75 (33)

46

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

46

100.0 %

0.0 [ -14.11, 14.11 ]

100.0 %

0.0 [ -14.11, 14.11 ]

Heterogeneity: not applicable


Test for overall effect: Z = 0.0 (P = 1.0)
Test for subgroup differences: Not applicable

-100

-50

Favours acupuncture

Acupuncture for dysmenorrhoea (Review)


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50

100

Favours placebo/sham

96

Analysis 2.1. Comparison 2 Acupuncture versus medication, Outcome 1 Pain score.


Review:

Acupuncture for dysmenorrhoea

Comparison: 2 Acupuncture versus medication


Outcome: 1 Pain score

Study or subgroup

Favours acupuncture

Mean
Difference

Medication

Mean
Difference

Mean(SD)

Mean(SD)

IV,Random,95% CI

IV,Random,95% CI

Cao 2011

29

2.914 (1.621)

30

6.93 (1.82)

-4.02 [ -4.90, -3.14 ]

Li 2012b

30

1.73 (1.4)

30

1.73 (1.8)

0.0 [ -0.82, 0.82 ]

Peng 2012

30

3.33 (1.02)

30

3.1 (1.24)

0.23 [ -0.34, 0.80 ]

Qiao 2013

40

2.75 (1.9)

20

3.78 (1.49)

-1.03 [ -1.91, -0.15 ]

Ruan 2011

30

1.56 (0.45)

30

3.98 (1.41)

-2.42 [ -2.95, -1.89 ]

Wang 2013b

60

3.53 (2.1)

30

4.17 (1.8)

-0.64 [ -1.47, 0.19 ]

Wang 2014a

30

3.67 (2.07)

30

4.7 (1.86)

-1.03 [ -2.03, -0.03 ]

6.04 (2.37)

25

4.04 (2.77)

2.00 [ 0.59, 3.41 ]

1 NSAIDs (VAS 0 - 10 scale)

2 Combined oral contraceptive (NRS 0 - 10 scale)


Sriprasert 2015 (1)

27

-4

-2

Favours acupuncture

Favours medication

(1) Measure was NRS

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Analysis 2.2. Comparison 2 Acupuncture versus medication, Outcome 2 Pain relief.


Review:

Acupuncture for dysmenorrhoea

Comparison: 2 Acupuncture versus medication


Outcome: 2 Pain relief
Study or subgroup

Acupuncture

Medication

Odds Ratio

n/N

n/N

M-H,Fixed,95% CI

Weight

Odds Ratio

Wang 2013b

49/60

14/30

30.1 %

5.09 [ 1.93, 13.44 ]

Wang 2005b

29/30

18/28

5.5 %

16.11 [ 1.90, 136.68 ]

Zhang 2012

42/45

32/45

18.8 %

5.69 [ 1.49, 21.66 ]

Zhi 2007

49/57

37/57

45.7 %

3.31 [ 1.31, 8.34 ]

192

160

100.0 %

4.99 [ 2.82, 8.82 ]

M-H,Fixed,95% CI

1 NSAIDs

Subtotal (95% CI)

Total events: 169 (Acupuncture), 101 (Medication)


Heterogeneity: Chi2 = 1.95, df = 3 (P = 0.58); I2 =0.0%
Test for overall effect: Z = 5.53 (P < 0.00001)
2 COC
Sriprasert 2015 (1)

8/27

13/25

100.0 %

0.39 [ 0.12, 1.21 ]

Subtotal (95% CI)

27

25

100.0 %

0.39 [ 0.12, 1.21 ]

Total events: 8 (Acupuncture), 13 (Medication)


Heterogeneity: not applicable
Test for overall effect: Z = 1.63 (P = 0.10)
Test for subgroup differences: Chi2 = 15.43, df = 1 (P = 0.00), I2 =94%

0.01

0.1

Favours acupuncture

10

100

Favours medication

(1) Measured as a decrease in baseline of at least one grade on the verbal multidimensional scoring scale (VMSS)

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98

Analysis 2.3. Comparison 2 Acupuncture versus medication, Outcome 3 Menstrual symptom score.
Review:

Acupuncture for dysmenorrhoea

Comparison: 2 Acupuncture versus medication


Outcome: 3 Menstrual symptom score

Study or subgroup

Acupuncture

Mean
Difference

Medication

Weight

IV,Random,95% CI

Mean
Difference

Mean(SD)

Mean(SD)

IV,Random,95% CI

Han 2012 (1)

80

1.7 (1.15)

40

3.03 (1.71)

20.1 %

-1.33 [ -1.92, -0.74 ]

Peng 2012 (2)

30

1.77 (0.9)

30

2.83 (0.7)

20.8 %

-1.06 [ -1.47, -0.65 ]

Qiao 2013 (3)

60

8.14 (4.16)

20

9.7 (5.55)

9.4 %

-1.56 [ -4.21, 1.09 ]

Ruan 2011 (4)

30

3.55 (1.21)

30

5.99 (2.27)

18.5 %

-2.44 [ -3.36, -1.52 ]

Wang 2014a (5)

30

5.53 (2.8)

30

7.12 (2.7)

15.8 %

-1.59 [ -2.98, -0.20 ]

Zhang 2013a (6)

30

2.29 (1.33)

30

8.21 (3.87)

15.4 %

-5.92 [ -7.38, -4.46 ]

1 NSAIDS

Subtotal (95% CI)

260

180

100.0 % -2.25 [ -3.33, -1.17 ]

Heterogeneity: Tau2 = 1.43; Chi2 = 43.81, df = 5 (P<0.00001); I2 =89%


Test for overall effect: Z = 4.07 (P = 0.000047)
2 Juyuansuan tamoxifen
Hu 2005 (7)

Subtotal (95% CI)

40

5.27 (1.96)

40

40

9.49 (2.16)

100.0 %

-4.22 [ -5.12, -3.32 ]

100.0 % -4.22 [ -5.12, -3.32 ]

40

Heterogeneity: not applicable


Test for overall effect: Z = 9.15 (P < 0.00001)
Test for subgroup differences: Chi2 = 7.50, df = 1 (P = 0.01), I2 =87%

-10

-5

Favours acupuncture

10

Favours medication

(1) Unspecified scale


(2) Unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research
(3) Unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research
(4) Unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research
(5) Unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research
(6) Unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research
(7) Unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research

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Analysis 2.4. Comparison 2 Acupuncture versus medication, Outcome 4 Use of additional medication.
Review:

Acupuncture for dysmenorrhoea

Comparison: 2 Acupuncture versus medication


Outcome: 4 Use of additional medication

Study or subgroup

Acupuncture

Mean
Difference

Coc

Mean(SD)

Mean(SD)

Sriprasert 2015

18

-1.96 (2.21)

24

-2.52 (3.04)

Total (95% CI)

18

Weight

Mean
Difference

100.0 %

0.56 [ -1.03, 2.15 ]

100.0 %

0.56 [ -1.03, 2.15 ]

IV,Fixed,95% CI

IV,Fixed,95% CI

24

Heterogeneity: not applicable


Test for overall effect: Z = 0.69 (P = 0.49)
Test for subgroup differences: Not applicable

-50

-25

Favours acupuncture

25

50

Favours CoC

Analysis 2.5. Comparison 2 Acupuncture versus medication, Outcome 5 Quality of life.


Review:

Acupuncture for dysmenorrhoea

Comparison: 2 Acupuncture versus medication


Outcome: 5 Quality of life

Study or subgroup

Acupuncture

Mean
Difference

Coc

Mean(SD)

Mean(SD)

Sriprasert 2015

18

103.74 (17.99)

24

112.88 (14.28)

Total (95% CI)

18

Weight

Mean
Difference

100.0 %

-9.14 [ -19.23, 0.95 ]

100.0 %

-9.14 [ -19.23, 0.95 ]

IV,Fixed,95% CI

IV,Fixed,95% CI

24

Heterogeneity: not applicable


Test for overall effect: Z = 1.78 (P = 0.076)
Test for subgroup differences: Not applicable

-50

-25

Favours CoC

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

25

50

Favours acupuncture

100

Analysis 2.6. Comparison 2 Acupuncture versus medication, Outcome 6 Adverse events.


Review:

Acupuncture for dysmenorrhoea

Comparison: 2 Acupuncture versus medication


Outcome: 6 Adverse events

Study or subgroup

Acupuncture

Medication

Odds Ratio

n/N

n/N

M-H,Fixed,95% CI

Weight

Odds Ratio

Cao 2011

0/29

3/30

Peng 2012

0/30

0/30

Ruan 2011

0/30

11/30

68.0 %

0.03 [ 0.00, 0.50 ]

Zhang 2013a

1/30

2/30

11.6 %

0.48 [ 0.04, 5.63 ]

119

120

100.0 %

0.10 [ 0.02, 0.44 ]

19/27

17/25

100.0 %

1.12 [ 0.34, 3.63 ]

27

25

100.0 %

1.12 [ 0.34, 3.63 ]

M-H,Fixed,95% CI

1 NSAIDs

Subtotal (95% CI)

20.4 %

0.13 [ 0.01, 2.70 ]


Not estimable

Total events: 1 (Acupuncture), 16 (Medication)


Heterogeneity: Chi2 = 2.35, df = 2 (P = 0.31); I2 =15%
Test for overall effect: Z = 3.07 (P = 0.0021)
2 COC
Sriprasert 2015

Subtotal (95% CI)

Total events: 19 (Acupuncture), 17 (Medication)


Heterogeneity: not applicable
Test for overall effect: Z = 0.19 (P = 0.85)
Test for subgroup differences: Chi2 = 6.27, df = 1 (P = 0.01), I2 =84%

0.002

0.1

Favours acupuncture

10

500

Favours medication

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Analysis 3.1. Comparison 3 Acupuncture versus Chinese herbs, Outcome 1 Pain score.
Review:

Acupuncture for dysmenorrhoea

Comparison: 3 Acupuncture versus Chinese herbs


Outcome: 1 Pain score

Study or subgroup

Acupuncture

Li 2008 (1)

Total (95% CI)

Mean
Difference

Chinese herbs

Mean(SD)

Mean(SD)

60

1.38 (2.86)

60

5.96 (3.84)

60

Weight

Mean
Difference

100.0 %

-4.58 [ -5.79, -3.37 ]

IV,Fixed,95% CI

IV,Fixed,95% CI

100.0 % -4.58 [ -5.79, -3.37 ]

60

Heterogeneity: not applicable


Test for overall effect: Z = 7.41 (P < 0.00001)
Test for subgroup differences: Not applicable

-10

-5

Favours acupuncture

10

Favours Chinese herbs

(1) Measure was self-reported pain score

Analysis 3.2. Comparison 3 Acupuncture versus Chinese herbs, Outcome 2 Menstrual symptom
improvement.
Review:

Acupuncture for dysmenorrhoea

Comparison: 3 Acupuncture versus Chinese herbs


Outcome: 2 Menstrual symptom improvement

Study or subgroup

Li 2008

Total (95% CI)

Experimental

Control

Odds Ratio

n/N

n/N

M-H,Fixed,95% CI

Weight

Odds Ratio

56/60

40/60

100.0 %

7.00 [ 2.22, 22.06 ]

60

60

100.0 %

7.00 [ 2.22, 22.06 ]

M-H,Fixed,95% CI

Total events: 56 (Experimental), 40 (Control)


Heterogeneity: not applicable
Test for overall effect: Z = 3.32 (P = 0.00089)
Test for subgroup differences: Not applicable

0.01

0.1

Favours Chinese herbs

10

100

Favours acupuncture

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Analysis 4.1. Comparison 4 Acupuncture versus no treatment, Outcome 1 Pain score.


Review:

Acupuncture for dysmenorrhoea

Comparison: 4 Acupuncture versus no treatment


Outcome: 1 Pain score

Study or subgroup

Acupuncture

Std.
Mean
Difference

No treatment

Weight

IV,Random,95% CI

Std.
Mean
Difference

Mean(SD)

Mean(SD)

Shi 2011 (1)

20

30.05 (25.62)

10

48.2 (7.25)

-0.82 [ -1.61, -0.03 ]

IV,Random,95% CI

Song 2013 (2)

25

4.2 (7.8)

48

25.23 (24.43)

-1.02 [ -1.53, -0.51 ]

Sun 2011 (3)

28

42.62 (8.14)

28

62.77 (12.15)

-1.92 [ -2.56, -1.28 ]

Xu 2013 (4)

25

2.96 (0.31)

20

7.7 (0.3)

-15.24 [ -18.58, -11.89 ]

Xu 2014 (5)

48

3 (0.19)

48

8.13 (0.21)

-25.41 [ -29.11, -21.72 ]

Zhang 2013b (6)

55

3.37 (1.64)

29

5.03 (2.37)

-0.86 [ -1.33, -0.39 ]

Test for subgroup differences: Not applicable

-20

-10

Favours acupuncture

10

20

Favours no treatment

(1) Measure was VAS


(2) Measure was VAS
(3) Measure was VAS
(4) Measure was VAS
(5) Measure was VAS
(6) Measure was VAS

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Analysis 4.2. Comparison 4 Acupuncture versus no treatment, Outcome 2 Severity of menstrual symptoms.
Review:

Acupuncture for dysmenorrhoea

Comparison: 4 Acupuncture versus no treatment


Outcome: 2 Severity of menstrual symptoms

Study or subgroup

Acupuncture

Std.
Mean
Difference

Weight

Std.
Mean
Difference

12.13 (7.14)

56.0 %

-0.96 [ -1.44, -0.48 ]

18.63 (7.99)

44.0 %

-0.62 [ -1.16, -0.09 ]

No treatment

Mean(SD)

Mean(SD)

Bu 2011 (1)

36

5.77 (5.85)

40

Sun 2011 (2)

28

13.6 (7.93)

28

Total (95% CI)

64

IV,Fixed,95% CI

IV,Fixed,95% CI

68

100.0 % -0.81 [ -1.17, -0.45 ]

Heterogeneity: Chi2 = 0.84, df = 1 (P = 0.36); I2 =0.0%


Test for overall effect: Z = 4.46 (P < 0.00001)
Test for subgroup differences: Not applicable

-4

-2

Favours acupuncture

Favours no treatment

(1) Measure was the CMSS


(2) Measured using the RSS

Analysis 5.1. Comparison 5 Acupuncture versus usual care, Outcome 1 Pain score.
Review:

Acupuncture for dysmenorrhoea

Comparison: 5 Acupuncture versus usual care


Outcome: 1 Pain score

Study or subgroup

Acupuncture

Mean
Difference

Usual care

Mean(SD)

Mean(SD)

Witt 2008 (1)

58

3.26 (2.55)

59

5.35 (2.42)

Total (95% CI)

58

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

59

100.0 %

-2.09 [ -2.99, -1.19 ]

100.0 %

-2.09 [ -2.99, -1.19 ]

Heterogeneity: not applicable


Test for overall effect: Z = 4.55 (P < 0.00001)
Test for subgroup differences: Not applicable

-10

-5

Favours Acupuncture

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Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

10

Favours usual care

104

(1) Measure was NRS

Analysis 5.2. Comparison 5 Acupuncture versus usual care, Outcome 2 Absence from work or school.
Review:

Acupuncture for dysmenorrhoea

Comparison: 5 Acupuncture versus usual care


Outcome: 2 Absence from work or school

Study or subgroup

Acupuncture

Witt 2008

Total (95% CI)

Mean
Difference

Usual care

Mean(SD)

Mean(SD)

58

1.66 (2.16)

59

1.6 (0.84)

58

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

59

100.0 %

0.06 [ -0.54, 0.66 ]

100.0 %

0.06 [ -0.54, 0.66 ]

Heterogeneity: not applicable


Test for overall effect: Z = 0.20 (P = 0.84)
Test for subgroup differences: Not applicable

-10

-5

Favours acupuncture

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Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

10

Favours usual care

105

Analysis 5.3. Comparison 5 Acupuncture versus usual care, Outcome 3 Quality of life physical health.
Review:

Acupuncture for dysmenorrhoea

Comparison: 5 Acupuncture versus usual care


Outcome: 3 Quality of life physical health

Study or subgroup

Acupuncture

Witt 2008

Total (95% CI)

Mean
Difference

Usual care

Mean(SD)

Mean(SD)

58

53.99 (5.73)

59

48.42 (9.75)

58

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

59

100.0 %

5.57 [ 2.68, 8.46 ]

100.0 %

5.57 [ 2.68, 8.46 ]

Heterogeneity: not applicable


Test for overall effect: Z = 3.77 (P = 0.00016)
Test for subgroup differences: Not applicable

-10

-5

Favours usual care

10

Favours acupuncture

Analysis 5.4. Comparison 5 Acupuncture versus usual care, Outcome 4 Quality of life: mental health.
Review:

Acupuncture for dysmenorrhoea

Comparison: 5 Acupuncture versus usual care


Outcome: 4 Quality of life: mental health

Study or subgroup

Acupuncture

Witt 2008

Total (95% CI)

Mean
Difference

Usual care

Mean(SD)

Mean(SD)

58

73.21 (16.56)

59

62.72 (21.05)

58

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

59

100.0 %

10.49 [ 3.63, 17.35 ]

100.0 %

10.49 [ 3.63, 17.35 ]

Heterogeneity: not applicable


Test for overall effect: Z = 3.00 (P = 0.0027)
Test for subgroup differences: Not applicable

-100

-50

Favours usual care

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

50

100

Favours acupuncture

106

Analysis 5.5. Comparison 5 Acupuncture versus usual care, Outcome 5 Quality of life: bodily pain.
Review:

Acupuncture for dysmenorrhoea

Comparison: 5 Acupuncture versus usual care


Outcome: 5 Quality of life: bodily pain

Study or subgroup

Acupuncture

Witt 2008

Total (95% CI)

Mean
Difference

Usual care

Mean(SD)

Mean(SD)

58

86.23 (21.43)

59

66.13 (33.63)

58

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

59

100.0 %

20.10 [ 9.90, 30.30 ]

100.0 %

20.10 [ 9.90, 30.30 ]

Heterogeneity: not applicable


Test for overall effect: Z = 3.86 (P = 0.00011)
Test for subgroup differences: Not applicable

-100

-50

Favours usual care

50

100

Favours acupuncture

Analysis 5.6. Comparison 5 Acupuncture versus usual care, Outcome 6 Quality of life: general health.
Review:

Acupuncture for dysmenorrhoea

Comparison: 5 Acupuncture versus usual care


Outcome: 6 Quality of life: general health

Study or subgroup

Acupuncture

Witt 2008

Total (95% CI)

Mean
Difference

Usual care

Mean(SD)

Mean(SD)

58

74.49 (16.43)

59

68.11 (20.08)

58

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

59

100.0 %

6.38 [ -0.26, 13.02 ]

100.0 %

6.38 [ -0.26, 13.02 ]

Heterogeneity: not applicable


Test for overall effect: Z = 1.88 (P = 0.060)
Test for subgroup differences: Not applicable

-100

-50

Favours usual care

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Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

50

100

Favours acupuncture

107

Analysis 5.7. Comparison 5 Acupuncture versus usual care, Outcome 7 Quality of life: vitality.
Review:

Acupuncture for dysmenorrhoea

Comparison: 5 Acupuncture versus usual care


Outcome: 7 Quality of life: vitality

Study or subgroup

Acupuncture

Witt 2008

Total (95% CI)

Mean
Difference

Usual care

Mean(SD)

Mean(SD)

58

64.12 (14.96)

59

46 (21.01)

58

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

59

100.0 %

18.12 [ 11.52, 24.72 ]

100.0 %

18.12 [ 11.52, 24.72 ]

Heterogeneity: not applicable


Test for overall effect: Z = 5.38 (P < 0.00001)
Test for subgroup differences: Not applicable

-100

-50

Favours usual care

50

100

Favours acupuncture

Analysis 5.8. Comparison 5 Acupuncture versus usual care, Outcome 8 Quality of life: social function.
Review:

Acupuncture for dysmenorrhoea

Comparison: 5 Acupuncture versus usual care


Outcome: 8 Quality of life: social function

Study or subgroup

Acupuncture

Witt 2008

Total (95% CI)

Mean
Difference

Usual care

Mean(SD)

Mean(SD)

58

86.79 (19.83)

59

66.52 (27.87)

58

Weight

IV,Fixed,95% CI

Mean
Difference
IV,Fixed,95% CI

59

100.0 %

20.27 [ 11.52, 29.02 ]

100.0 %

20.27 [ 11.52, 29.02 ]

Heterogeneity: not applicable


Test for overall effect: Z = 4.54 (P < 0.00001)
Test for subgroup differences: Not applicable

-100

-50

Favours usual care

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Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

50

100

Favours acupuncture

108

Analysis 5.9. Comparison 5 Acupuncture versus usual care, Outcome 9 Qualit of life: role emotional.
Review:

Acupuncture for dysmenorrhoea

Comparison: 5 Acupuncture versus usual care


Outcome: 9 Qualit of life: role emotional

Study or subgroup

Acupuncture

Witt 2008

Total (95% CI)

Mean
Difference

Usual care

Mean(SD)

Mean(SD)

58

83.97 (30.6)

59

69.81 (39.91)

58

Weight

Mean
Difference

100.0 %

14.16 [ 1.29, 27.03 ]

100.0 %

14.16 [ 1.29, 27.03 ]

IV,Fixed,95% CI

IV,Fixed,95% CI

59

Heterogeneity: not applicable


Test for overall effect: Z = 2.16 (P = 0.031)
Test for subgroup differences: Not applicable

-100

-50

Favours usual care

50

100

Favours acupuncture

Analysis 5.10. Comparison 5 Acupuncture versus usual care, Outcome 10 Adverse events.
Review:

Acupuncture for dysmenorrhoea

Comparison: 5 Acupuncture versus usual care


Outcome: 10 Adverse events

Study or subgroup

Witt 2008

Total (95% CI)

Acupuncture

Usual care

Odds Ratio

n/N

n/N

M-H,Fixed,95% CI

Weight

Odds Ratio

2/58

7/59

100.0 %

0.27 [ 0.05, 1.34 ]

58

59

100.0 %

0.27 [ 0.05, 1.34 ]

M-H,Fixed,95% CI

Total events: 2 (Acupuncture), 7 (Usual care)


Heterogeneity: not applicable
Test for overall effect: Z = 1.61 (P = 0.11)
Test for subgroup differences: Not applicable

0.01

0.1

Favours acupuncture

10

100

Favours usual care

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Analysis 6.1. Comparison 6 Acupressure versus sham/placebo, Outcome 1 Pain score (VAS 0 - 10).
Review:

Acupuncture for dysmenorrhoea

Comparison: 6 Acupressure versus sham/placebo


Outcome: 1 Pain score (VAS 0 - 10)

Sham/placebo
control

Mean
Difference

Weight

Mean
Difference

Study or subgroup

Acupressure
N

Mean(SD)

Mean(SD)

Aghamiri 2005

50

2.2 (1.8)

50

5.7 (1.2)

-3.50 [ -4.10, -2.90 ]

Kashefi 2010

40

5.67 (1.64)

41

7.04 (1.58)

-1.37 [ -2.07, -0.67 ]

IV,Random,95% CI

IV,Random,95% CI

Test for subgroup differences: Not applicable

-4

-2

Favours acupressure

Favours placebo/sham

Analysis 6.2. Comparison 6 Acupressure versus sham/placebo, Outcome 2 Severity of menstrual symptoms.
Review:

Acupuncture for dysmenorrhoea

Comparison: 6 Acupressure versus sham/placebo


Outcome: 2 Severity of menstrual symptoms

Study or subgroup

Sham/placebo
control

Acupressure

Mean
Difference

Weight

IV,Fixed,95% CI

Mean
Difference

Mean(SD)

Mean(SD)

IV,Fixed,95% CI

Wang 2009a (1)

36

52.9 (12.8)

35

60.7 (13.8)

9.1 %

-7.80 [ -14.00, -1.60 ]

Yeh 2013a (2)

50

21.16 (4.67)

50

22.4 (5.33)

90.9 %

-1.24 [ -3.20, 0.72 ]

Total (95% CI)

86

100.0 %

-1.84 [ -3.71, 0.03 ]

85

Heterogeneity: Chi2 = 3.91, df = 1 (P = 0.05); I2 =74%


Test for overall effect: Z = 1.93 (P = 0.054)
Test for subgroup differences: Not applicable

-10

-5

Favours acupressure

10

Favours sham/placebo

(1) Assessed by the menstrual distress questionnaire


(2) Assessed by the Menstrual Distress Questionnaire

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110

Analysis 7.1. Comparison 7 Acupressure versus medication (NSAIDs), Outcome 1 Pain score.
Review:

Acupuncture for dysmenorrhoea

Comparison: 7 Acupressure versus medication (NSAIDs)


Outcome: 1 Pain score

Mean
Difference

Study or subgroup

Acupressure

Medication

Mean(SD)

Mean(SD)

Zafari 2011 (1)

60

1.63 (0.54)

76

1.24 (0.49)

Weight

IV,Random,95% CI

Mean
Difference
IV,Random,95% CI
0.39 [ 0.21, 0.57 ]

Test for subgroup differences: Not applicable

-0.5

-0.25

0.25

Favours acupressure

0.5

Favours medication

(1) Measure was self-reported pain score

Analysis 8.1. Comparison 8 Acupressure versus no treatment, Outcome 1 Pain score (VAS 0 - 10).
Review:

Acupuncture for dysmenorrhoea

Comparison: 8 Acupressure versus no treatment


Outcome: 1 Pain score (VAS 0 - 10)

Study or subgroup

Acupressure

Mean
Difference

No treatment

Weight

IV,Random,95% CI

Mean
Difference

Mean(SD)

Mean(SD)

IV,Random,95% CI

Chen 2004 (1)

35

2.92 (1.68)

34

3.04 (2.54)

47.9 %

-0.12 [ -1.14, 0.90 ]

Chen 2010 (2)

36

2.87 (1.99)

35

4.6 (1.35)

52.1 %

-1.73 [ -2.52, -0.94 ]

Total (95% CI)

71

100.0 %

-0.96 [ -2.54, 0.62 ]

69

Heterogeneity: Tau2 = 1.08; Chi2 = 5.99, df = 1 (P = 0.01); I2 =83%


Test for overall effect: Z = 1.19 (P = 0.23)
Test for subgroup differences: Not applicable

-10

-5

Favours acupressure

10

Favours no treatment

(1) At 4-6 weeks


(2) At two months

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111

Analysis 8.2. Comparison 8 Acupressure versus no treatment, Outcome 2 Menstrual symptoms (MDQ).
Review:

Acupuncture for dysmenorrhoea

Comparison: 8 Acupressure versus no treatment


Outcome: 2 Menstrual symptoms (MDQ)

Study or subgroup

Acupressure

Mean
Difference

No treatment

Mean
Difference

Weight

Mean(SD)

Mean(SD)

Chen 2004

35

23.73 (5.61)

34

23.05 (5.89)

34.8 %

0.68 [ -2.04, 3.40 ]

Chen 2010

36

19.68 (2.6)

35

24.06 (3.81)

40.0 %

-4.38 [ -5.90, -2.86 ]

Wong 2010

11

25.65 (5.66)

27.17 (5.08)

25.2 %

-1.52 [ -6.23, 3.19 ]

100.0 %

-1.90 [ -5.57, 1.77 ]

Total (95% CI)

82

IV,Random,95% CI

IV,Random,95% CI

78

Heterogeneity: Tau2 = 8.14; Chi2 = 10.59, df = 2 (P = 0.01); I2 =81%


Test for overall effect: Z = 1.02 (P = 0.31)
Test for subgroup differences: Not applicable

-4

-2

Favours acupressure

Favours no treatment

ADDITIONAL TABLES
Table 1. Acupuncture versus sham/placebo control: pain score

Study

Measure

Follow-up

Acupuncture
group
Mean score

Darabi 2010

VAS (0 - 10)

3 months

2.12, SD 1, n = 50 4.24, SD 0.91, n = Yes


50

This study reported implausibly low SDs. We


assumed
that
these might be standard
errors, but recalculation
based on this assumption resulted in skewed
data

Lee 2007

Measure of Men- 1 month


strual Pain Questionnaire
(scale unclear)

4.46

4.58

Total n = 63. No SDs reported

Smith 2010

McGill
Questionnaire

2, SD 2.5, n = 46

2.6, SD 2.7, n = 46 No
P = 0.32

3 months

Control group
Mean score

Acupuncture for dysmenorrhoea (Review)


Copyright 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

P < 0.05

No

Comment

Data skewed

112

Table 1. Acupuncture versus sham/placebo control: pain score

(Continued)

Pain scale (0 - 5)
(Melzack 1975)

Song 2013

VAS (0 - 10)

6 months

2.2, SD 3

2.8, SD 2.7

No
P = 0.11

Data skewed

12 months

2.6, SD 2.7

2.8, SD 2.7

No
P = 0.60

Data skewed

3 months

4.2, SD 7.28, n = 8.77, SD 16.3, n = Yes


25
96

Data skewed

MD 0.54, 95% CI 0.12 to 1.19

Total n = 80. No primary


data reported

Measure of Men- 3 months


strual Pain Questionnaire
(scale unclear)
SD: standard deviation
Youn 2008

No

Table 2. Acupuncture versus no treatment: pain score

Study

Measure

Follow-up

Acupuncture
group
Mean score

Control group
Mean score

P < 0.05

Shi 2011

VAS

Post-treatment

30.05, SD 25.62 n 48.2, SD 7.25, n = Yes


= 20
10

Data skewed

Song 2013

VAS

3 months

4.1, SD 7.8, n = 25 25.23, SD 24.43, n Yes


= 48

Data skewed

Sun 2011

VAS

3 months

42.62, SD 8.14, n = 62.77, SD 12.15, n Yes


28
= 28

Xu 2013

VAS

3 months

2.96, SD 0.31, n = 7.7, SD 0.3, n = 20 Yes


25

This study reported implausibly low SDs

Xu 2014

VAS

3 months

3, SD 0.19, n = 48

This study reported implausibly low SDs

Zhang 2013b

VAS

3 months

3.37, SD 1.64, n = 5.03, SD 2.37, n = Yes


55
29

8.13, SD 0.21, n = Yes


48

Comment

SD: standard deviation

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Table 3. Acupuncture versus no treatment: menstrual symptom severity

Study

Measure

Follow-up

Acupuncture group
Mean score

Control group
Mean score

P < 0.05

Comment

Ma 2013

CMSS

3 months

1.56, SD 0.87, n = 2.4, SD 0.81, n = 40


382

Yes

This study reported implausibly


low SDs

Xu 2014

RSS

3 months

11.56, SD 0.25, n = 36.76, SD 2.35, n = Yes


48
48

This study reported implausibly


low SDs

Yu 2014

VAS

3 months

2.81, SD 0.16 n = 48 4.85, SD 0.19, n = 48 Yes

This study reported implausibly


low SDs.

SD: standard deviation

Table 4. Acupressure versus no treatment: menstrual symptom severity

Study

Measure

Follow-up

Acupuncture
group
Mean score

Control group
Mean score

P < 0.05

Comment

MirbagherAjorpaz 2011

VAS 0 - 10

1 month

1.66, SD 1.98, n = 4.9, SD 1.37, n = Yes


15
40

Skewed data

Yeh 2013a

VAS 0 - 10

2 days

2.03, SD 2.02, n = 3.36, SD 2.65, n = Yes


50
50

Skewed data

SD: standard deviation

APPENDICES
Appendix 1. Gynaecology and Fertility Group
Menstrual disorders and subfertility database search
Keywords CONTAINS dysmenorrhea or Dysmenorrhea-Symptoms or dysmenorrhoea or pain-dysmenorrhea or pain-pelvic
or pelvic pain or menstrual cramps or menstrual pain or primary dysmenorrhea or *Dysmenorrheaor menstrual distressor
*menstrual painor primary dysmenorrheal or Title CONTAINS dysmenorrhea or Dysmenorrhea-Symptoms or dysmenorrhoea or pain-dysmenorrhea or pain-pelvic or pelvic pain or menstrual cramps or menstrual pain or primary dysmenorrhea
or *Dysmenorrheaor menstrual distressor *menstrual pain
AND
Keywords CONTAINS acupoint or acupressure or acupressure-acupuncture therapy or acupuncture or electro-acupuncture or
electro-magnetic or electroacupuncture or electrical stimulation or moxibustion or *acupunctureor auricular acupressureor
auricular pressureor needle insertion or Title CONTAINS acupoint or acupressure or acupressure-acupuncture therapy or
acupuncture or electro-acupuncture or electro-magnetic or electroacupuncture or electrical stimulation or moxibustionor
*acupunctureor auricular acupressureor auricular pressureor needle insertion
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114

Appendix 2. CENTRAL
Database: EBM Reviews - Cochrane Central Register of Controlled Trials
Search Strategy:
1 exp Dysmenorrhea/ (329)
2 pain$ period$.tw. (69)
3 menstrua$ cramp$.tw. (17)
4 pelvi$ pain$.tw. (449)
5 (period$ adj3 cramp$).tw. (7)
6 (menstrua$ adj3 pain$).tw. (176)
7 Dysmenorr$.tw. (724)
8 or/1-7 (1257)
9 exp Acupuncture Therapy/ or exp Acupuncture, Ear/ or exp Acupuncture Points/ or exp Acupuncture Analgesia/ or exp Acupuncture/
(2489)
10 exp Acupressure/ (174)
11 exp Electroacupuncture/ (411)
12 exp Meridians/ (943)
13 exp Moxibustion/ (177)
14 Acupuncture.tw. (5332)
15 acupressure$.tw. (327)
16 (electroacupuncture or electro acupuncture or electro-acupuncture).tw. (825)
17 meridian$.tw. (403)
18 mox$.tw. (1317)
19 needling.tw. (673)
20 (acu-point$ or acu point$).tw. (7)
21 acupoint$.tw. (1133)
22 shu.tw. (127)
23 (shiatsu or tui na).tw. (5)
24 or/9-23 (8207)
25 8 and 24 (97)
26 limit 25 to yr=2010 -Current (38)

Appendix 3. MEDLINE
Database: Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R)
<1946 to Present>
Search Strategy:
1 exp Dysmenorrhea/ (3064)
2 pain$ period$.tw. (135)
3 menstrua$ cramp$.tw. (101)
4 pelvi$ pain$.tw. (5812)
5 (period$ adj3 cramp$).tw. (22)
6 (menstrua$ adj3 pain$).tw. (865)
7 Dysmenorr$.tw. (4076)
8 or/1-7 (10786)
9 exp Acupuncture Therapy/ or exp Acupuncture, Ear/ or exp Acupuncture Points/ or exp Acupuncture Analgesia/ or exp Acupuncture/
(17070)
10 exp Acupressure/ (454)
11 exp Electroacupuncture/ (2456)
12 exp Meridians/ (4121)
13 exp Moxibustion/ (1082)
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14 Acupuncture.tw. (14440)
15 acupressure$.tw. (576)
16 (electroacupuncture or electro acupuncture or electro-acupuncture).tw. (3061)
17 meridian$.tw. (3921)
18 mox$.tw. (7407)
19 needling.tw. (1571)
20 (acu-point$ or acu point$).tw. (22)
21 acupoint$.tw. (2808)
22 shu.tw. (526)
23 (shiatsu or tui na).tw. (77)
24 or/9-23 (30594)
25 8 and 24 (223)
26 randomized controlled trial.pt. (370764)
27 controlled clinical trial.pt. (88164)
28 randomized.ab. (290727)
29 randomised.ab. (58340)
30 placebo.tw. (157152)
31 clinical trials as topic.sh. (169371)
32 randomly.ab. (210819)
33 trial.ti. (124986)
34 (crossover or cross-over or cross over).tw. (60283)
35 or/26-34 (936480)
36 exp animals/ not humans.sh. (3923552)
37 35 not 36 (863648)
38 25 and 37 (124)
39 (2010$ or 2011$ or 2012$ or 2013$ or 2014$).ed. (4247951)
40 (2010$ or 2011$ or 2012$ or 2013$ or 2014$).dp. (3920946)
41 39 or 40 (4758325)
42 38 and 41 (72)

Appendix 4. EMBASE
Search Strategy:
1 exp dysmenorrhea/ (8599)
2 pain$ period$.tw. (220)
3 Dysmenorr$.tw. (5707)
4 menstrua$ cramp$.tw. (140)
5 pelvi$ pain$.tw. (9860)
6 (period$ adj3 cramp$).tw. (33)
7 (menstrua$ adj3 pain$).tw. (1266)
8 or/1-7 (19020)
9 exp acupuncture analgesia/ or exp acupuncture/ or exp acupuncture needle/ (35286)
10 exp electroacupuncture/ (4599)
11 exp moxibustion/ (1885)
12 Acupuncture.tw. (22898)
13 acupressure$.tw. (893)
14 (electroacupuncture or electro acupuncture or electro-acupuncture).tw. (4335)
15 meridian$.tw. (4846)
16 mox$.tw. (11173)
17 needling.tw. (2381)
18 (acu-point$ or acu point$).tw. (37)
19 acupoint$.tw. (4258)
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20 shu.tw. (1381)
21 (shiatsu or tui na).tw. (131)
22 or/9-21 (51415)
23 8 and 22 (552)
24 Clinical Trial/ (849581)
25 Randomized Controlled Trial/ (381395)
26 exp randomization/ (67715)
27 Single Blind Procedure/ (20861)
28 Double Blind Procedure/ (122971)
29 Crossover Procedure/ (44106)
30 Placebo/ (261711)
31 Randomi?ed controlled trial$.tw. (122193)
32 Rct.tw. (17954)
33 random allocation.tw. (1445)
34 randomly allocated.tw. (23077)
35 allocated randomly.tw. (2051)
36 (allocated adj2 random).tw. (734)
37 Single blind$.tw. (16246)
38 Double blind$.tw. (153721)
39 ((treble or triple) adj blind$).tw. (476)
40 placebo$.tw. (219097)
41 prospective study/ (304195)
42 or/24-41 (1495041)
43 case study/ (33432)
44 case report.tw. (289086)
45 abstract report/ or letter/ (935451)
46 or/43-45 (1251520)
47 42 not 46 (1455346)
48 23 and 47 (264)
49 2014$.em. or 2014$.dp. (1618058)
50 48 and 49 (35)

Appendix 5. PsycINFO
Search Strategy:
1 exp Dysmenorrhea/ (185)
2 pain$ period$.tw. (33)
3 Dysmenorr$.tw. (345)
4 menstrua$ cramp$.tw. (17)
5 pelvi$ pain$.tw. (444)
6 (period$ adj3 cramp$).tw. (2)
7 (menstrua$ adj3 pain$).tw. (183)
8 or/1-7 (946)
9 exp Acupuncture/ (1200)
10 Acupuncture.tw. (1621)
11 acupressure$.tw. (128)
12 (electroacupuncture or electro acupuncture or electro-acupuncture).tw. (277)
13 meridian$.tw. (724)
14 mox$.tw. (154)
15 needling.tw. (107)
16 (acu-point$ or acu point$).tw. (1)
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17 acupoint$.tw. (210)
18 shu.tw. (164)
19 (shiatsu or tui na).tw. (18)
20 or/9-19 (2854)
21 8 and 20 (13)
22 limit 21 to yr=2014 (1)

Appendix 6. CINAHL
CINAHL search strategy for CS1680 (EBSCO platform)

Query

Results

S40

S25 AND S39

122

S39

S26 OR S27 or S28 or S29 OR S30 OR S31 OR S32 OR S33 883,698


OR S34 OR S35 OR S36 OR S37 OR S38

S38

TX allocat* random*

3,869

S37

(MH Quantitative Studies)

11,815

S36

(MH Placebos)

8,705

S35

TX placebo*

31,362

S34

TX random* allocat*

3,869

S33

(MH Random Assignment)

37,008

S32

TX randomi* control* trial*

71,278

S31

TX ( (singl* n1 blind*) or (singl* n1 mask*) ) or TX ( (doubl* 710,419


n1 blind*) or (doubl* n1 mask*) ) or TX ( (tripl* n1 blind*)
or (tripl* n1 mask*) ) or TX ( (trebl* n1 blind*) or (trebl* n1
mask*) )

S30

TX ( (trebl* n1 blind*) or (trebl* n1 mask*) )

104

S29

TX ( (trebl* n1 blind*) or (trebl* n1 mask*) )

S28

TX clinic* n1 trial*

162,337

S27

PT Clinical trial

75,742

S26

(MH Clinical Trials+)

173,495

S25

S8 AND S24

227

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(Continued)

S24

S9 OR S10 OR S11 OR S12 OR S13 OR S14 OR S15 OR 34,744


S16 OR S17 OR S18 OR S19 OR S20 OR S21 OR S22 OR
S23

S23

TX (shiatsu or tui na)

225

S22

TX shu*

20,087

S21

TX acupoint*

535

S20

TX (acu-point* or acu point*)

10

S19

TX needling

499

S18

TX mox*

1,497

S17

TX meridian*

1,336

S16

TX (electroacupuncture or electro acupuncture or electro- 1,135


acupuncture)

S15

TX acupressure

897

S14

TX Acupuncture

12,372

S13

(MM Moxibustion)

164

S12

(MM Meridians+)

647

S11

(MM Electroacupuncture)

519

S10

(MM Acupressure+)

532

S9

(MM Acupuncture+) OR (MM Acupuncture, Ear) OR 6,739


(MM Acupuncture Points) OR (MM Acupuncture Anesthesia) OR (MM Acupuncture Analgesia)

S8

S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7

4,376

S7

TX (menstrua* N3 pain*)

256

S6

TX (period* N3 cramp*)

S5

TX (pelvi* pain*)

2,139

S4

TX (menstrua* N3 cramp*)

60

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(Continued)

S3

TX (pain* period*)

1,232

S2

TX Dysmenorr*

1,081

S1

(MM Dysmenorrhea)

476

Appendix 7. AMED
Database : AMED (Allied and Complementary Medicine)
Search Strategy:
1 exp Dysmenorrhea/ (113)
2 pain$ period$.tw. (14)
3 menstrua$ cramp$.tw. (11)
4 pelvi$ pain$.tw. (119)
5 (period$ adj3 cramp$).tw. (2)
6 (menstrua$ adj3 pain$).tw. (38)
7 Dysmenorr$.tw. (178)
8 or/1-7 (323)
9 exp Acupuncture Therapy/ or exp Acupuncture, Ear/ or exp Acupuncture Points/ or exp Acupuncture Analgesia/ or exp Acupuncture/
(9753)
10 exp Acupressure/ (287)
11 exp Electroacupuncture/ (807)
12 exp Meridians/ (449)
13 exp Moxibustion/ (505)
14 Acupuncture.tw. (9286)
15 acupressure$.tw. (369)
16 (electroacupuncture or electro acupuncture or electro-acupuncture).tw. (990)
17 meridian$.tw. (633)
18 mox$.tw. (618)
19 needling.tw. (805)
20 (acu-point$ or acu point$).tw. (10)
21 acupoint$.tw. (1855)
22 shu.tw. (84)
23 (shiatsu or tui na).tw. (332)
24 or/9-23 (10671)
25 8 and 24 (78)
26 randomized controlled trial.pt. (3283)
27 controlled clinical trial.pt. (70)
28 randomized.ab. (6712)
29 randomised.ab. (1577)
30 placebo.tw. (2598)
31 clinical trials as topic.sh. (0)
32 randomly.ab. (4825)
33 trial.ti. (3873)
34 (crossover or cross-over or cross over).tw. (917)
35 or/26-34 (15029)
36 exp animals/ not humans.sh. (8306)
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37 35 not 36 (14633)
38 25 and 37 (22)
39 limit 38 to yr=1887 - 2014 (22)

Appendix 8. Chinese databases


Chinese databases update:
Searching: 148+323+481=952
Scanning: 101+449=550
Full paper: 95+15=110
Searching terms:
#1

(dysmenorrhea)

#2

(period)

#3 (pain)
#4 #2 AND #3
#5 #1 OR #3
#6
(primary)
#7 #5 AND #6
#8

(acupuncture)

#9

(needling)

#10

(electronic acupuncture)

#11

(manual acupuncture)

#12

(needle)

#13

(finger press)

#14

(moxibustion)

#15 OR #7 to #14
#16 #7 AND #15

Appendix 9. Checklist of items to consider in data collection or data extraction


Source
Study ID (created by review author)
Report ID (created by review author)
Review author ID (created by review author)
Citation and contact details
Eligibility
Confirm eligibility for review
Reason for exclusion
Methods
Study design
Total study duration
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Sequence generation
Allocation sequence concealment
Blinding
Other concerns about bias
Participants
Total number
Setting
Diagnostic criteria
Age
Sex
Country
Co-morbidity
Socio-demographics
Ethnicity
Date of study
Interventions
Total number of intervention groups
For each intervention and comparison group of interest:
Specific intervention;
Intervention details (sufficient for replication, if feasible);
Integrity of intervention;
Outcomes
Outcomes and time points (i) collected; (ii) reported;
For each outcome of interest:
Outcome definition (with diagnostic criteria if relevant);
Unit of measurement (if relevant);
For scales: upper and lower limits, and whether high or low score is good
Results
Number of participants allocated to each intervention group
For each outcome of interest:
Sample size;
Missing participants;
Summary data for each intervention group (e.g. 2 X 2 table for dichotomous data; means and SDs for continuous data);
Estimate of effect with confidence interval; P value;
Subgroup analyses.
Miscellaneous
Key conclusions of the study authors

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Appendix 10. Risk of bias assessment tool


Criteria for judging risk of bias in the Risk of bias assessment tool
SEQUENCE GENERATION
Was the allocation sequence adequately generated?
Criteria for a judgment of YES (i.e. low risk of bias)
The investigators describe a random component in the sequence generation process such as:
referring to a random number table;
using a computer random number generator;
coin tossing;
shuffling cards or envelopes;
throwing dice;
drawing of lots.
*Minimization may be implemented without a random element, and this is considered to be equivalent to being random.
Criteria for the judgment of NO (i.e. high risk of bias)
The investigators describe a non-random component in the sequence generation process. Usually, the description would involve some
systematic, non random approach, for example: sequence generated by odd or even date of birth; sequence generated by some rule
based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number. Other non-random
approaches happen much less frequently than the systematic approaches mentioned above and tend to be obvious. They usually involve
judgement or some method of non-random categorization of participants, for example:
allocation by judgment of the clinician;
allocation by preference of the participant;
allocation based on the results of a laboratory or a series of tests;
allocation by availability of the intervention.
Criteria for the judgement of UNCLEAR (uncertain risk of bias)
Insufficient information about the sequence generation process to permit judgement Yes or No.
ALLOCATION CONCEALMENT
Was allocation adequately concealed? (Short form: Allocation concealment?).
Criteria for a judgment of YES (i.e. low risk of bias)
Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method,
was used to conceal allocation:
Central allocation (including telephone, web-based, and pharmacy controlled randomisation;
Sequentially numbered drug containers of identical appearance;
Sequentially numbered, opaque, sealed envelopes.
Criteria for the judgment of NO (i.e. high risk of bias)
Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation
based on:
Using an open random allocation schedule (e.g. a list of random numbers);
Assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non-opaque or not
sequentially numbered);
Alternation or rotation;
Date of birth;
Case record number;
Any other explicitly unconcealed procedure.
Criteria for the judgment of UNCLEAR (uncertain risk of bias)
Insufficient information about the sequence generation process to permit judgement Yes or No. This is usually the case if the method
of concealment is not described or not described in sufficient detail to allow a definitive judgement, for example if the use of assignment
envelopes is described, but it remains unclear whether envelopes were \sequentially numbered, opaque and sealed.
BLINDING OF PARTICIPANTS, PERSONNEL AND OUTCOME ASSESSORS
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Was knowledge of the allocated interventions adequately prevented during the study? (Short form: Blinding).
Criteria for a judgement of YES (i.e. low risk of bias)
Anyone of the following:
No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be influenced by
lack of blinding;
Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken;
Either participants and key study personnel were not blinded, but outcome assessment was blinded and the non-blinding of
others unlikely to introduce bias.
Criteria for the judgment of NO (i.e. high risk of bias)
Any one of the following:
No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding;
Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken;
Either participants or some key study personnel were not blinded, and the non blinding or others likely to introduce bias.
Criteria for the judgment of UNCLEAR (uncertain risk of bias)
Any one of the following:
Insufficient information to permit judgment of Yes or No;
The study did not address this outcome.
INCOMPLETE OUTCOME DATA
Were incomplete outcome data adequately addressed? (Short form: Incomplete outcome data addressed?).
Criteria for a judgment of YES (i.e. low risk of bias)
Anyone of the following:
No missing data;
Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing
bias);
Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups;
For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have
clinically relevant impact on the intervention effect estimate;
For continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing
outcomes not enough to have a clinically relevant impact on observed effect size;
Missing data have been imputed using appropriate methods.
Criteria for the judgment of NO (i.e. high risk of bias)
Any one of the following:
Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing
data across intervention groups;
For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce
clinically relevant bias in the intervention effect estimate;
For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing
outcomes enough to have a clinically relevant impact on observed effect size;
As treated analysis done with substantial departure of the intervention received from that assigned at randomisation;
Potentially inappropriate application of simple imputation.
Criteria for the judgment of UNCLEAR (uncertain risk of bias)
Any one of the following:
Insufficient reporting of attrition/exclusions to permit judgement of Yes or No (e.g. number randomised not stated, no reasons
for missing data provided);
The study did not address this outcome.
SELECTIVE OUTCOME REPORTING
Are reports of the study free of suggestion of selective outcome reporting? (Short form: Free of selective reporting?)
Criteria for a judgment of YES (i.e. low risk of bias)
Anyone of the following:
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The study protocol is available and all the studys pre-specifies (primary and secondary) outcomes that are of interest in the
review have been reported in the pre-specified way;
The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that
were pre-specified (convincing test of this nature may be uncommon);
Criteria for the judgment of NO (i.e. high risk of bias)
Any one of the following:
Not all of the studys pre-specified primary outcomes have been reported;
One or more primary outcomes is reported using measurements, analysis methods or subsets of the data (subscales) that were
not pre-specified;
One or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as
an unexpected adverse effect);
One or more outcomes of interest in the review are reported incompletely so that they cannot be entered be entered in a metaanalysis;
The study report fails to include results for a key outcome that would be expected to have been reported for such a study.
Criteria for the judgment of UNCLEAR (uncertain risk of bias)
Insufficient information to permit judgment of Yes or No. It is likely that the majority of studies will fall into this category.
OTHER POTENTIAL THREATS TO VALIDITY
Was the study apparently free of other problems that could put it at a risk of bias? (Short form: Free of other bias?)
Criteria for a judgment of YES (i.e. low risk of bias)
The study appears free of other sources of bias.
Criteria for the judgment of NO (i.e. high risk of bias)
There is at least one important risk of bias. For example, the study:
Had a potential source of bias related to the specific design used; or
Stopped early due to some data-dependent process (including a formal-stopping rule); or
Had extreme baseline imbalance; or
Has been claimed to have been fraudulent; or
Had some other problem.
Criteria for the judgment of UNCLEAR (uncertain risk of bias)
There maybe a risk of bias, but there is either:
Insufficient information to assess whether an important risk of bias exists; or
Insufficent rationale or evidence that an identified problem will introduce bias.

Appendix 11. Results: characteristics of the interventions

Acupuncture points used:


A fixed set of acupuncture points only were administered in 21 trials (Bu 2011; Cao 2011; Darabi 2010; Han 2012; Helms 1987;
Hu 2005; Lee 2007; Li 2012b; Ma 2010; Ma 2013; Peng 2012; Qiao 2013; Shi 2011; Song 2013; Sriprasert 2015; Wang 2013b;
Wang 2014a; Xu 2014; Youn 2008; Zhang 2013b; Zhi 2007). Individualised treatment was administered in nine trials (Li 2008;
Ruan 2011; Smith 2010; Sun 2011; Wang 2005b; Witt 2008; Xu 2013; Zhang 2012; Zhang 2013a). This frequently involved some
fixed points used to treat pain with additional points administered based on the diagnosis made. The combined acupuncture and
moxibustion trials used fixed points (Han 2012; Hu 2005). Four trials used electro-acupuncture. Fixed sets of acupressure points were
used in 12 trials, mostly 1 - 2 points (Aghamiri 2005; Bazarganipour 2010; Charandabi 2011; Chen 2004; Chen 2010; Kashefi 2010;
Mirbagher-Ajorpaz 2011; Wang 2009a; Wong 2010; Yeh 2013a; Zafari 2011). See Characteristics of included studies.

Treatment duration
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Seven studies were undertaken over one menstrual cycle (Chen 2004; Lee 2007; Ma 2010; Mirbagher-Ajorpaz 2011; Shi 2011; Wang
2009a; Yeh 2013a). Three studies were each administered over two cycles (Aghamiri 2005; Charandabi 2011; Kashefi 2010;). Thirty
one studies were undertaken over three menstrual cycles (Bazarganipour 2010; Bu 2011; Cao 2011; Chen 2010; Darabi 2010; Han
2012; Helms 1987; Hu 2005; Li 2008; Li 2012b; Ma 2013; Peng 2012; Qiao 2013; Ruan 2011; Smith 2010; Song 2013; Sriprasert
2015; Wang 2005b; Wang 2013b; Wang 2014a; Witt 2008; Wong 2010; Xu 2013; Yu 2014; Youn 2008; Xu 2014; Zhang 2012;
Zafari 2011; Zhang 2013a; Zhang 2013b; Zhi 2007). One trial was administered over four menstrual cycles (Sun 2011).

Number of sessions
Acupressure
Eight acupressure trials involved teaching participants to self administer (Bazarganipour 2010; Charandabi 2011; Chen 2004; Chen
2010; Wang 2009a; Wong 2010; Yeh 2013a; Zafari 2011). Bazarganipour 2010 included self application before the period was due
(3 - 7 days). Charandabi 2011 instructed women to self administer for spasmodic cases during the first two days of menstruation and
for congestive group during the two days before menstruation. Chen 2010, and Wong 2010 instructed self administration for three
days during menstruation. Researchers administered acupressure for one session per menstrual cycle (Kashefi 2010). In two trials it was
unclear, due to reporting of the process of administration (Aghamiri 2005; Cao 2011).
Acupuncture
The frequency of treatment was more varied for the acupuncture trials One session was applied only in the Shi 2011 trial. Three sessions
were given in two trials (Ma 2010; Ma 2013), five sessions in two trials (Lee 2007; Ma 2013), and seven sessions in three trials (Qiao
2013; Ruan 2011; Zhi 2007). Some studies administered treatments weekly except for the week of menses for three menstrual cycles,
and other studies administered higher frequencies due to daily treatments. Nine sessions were administered in six studies (Darabi 2010;
Helms 1987; Hu 2005; Smith 2010; Song 2013; Zhang 2012), More than 10 and up to 30 sessions were administered in 14 trials (Li
2008; Li 2012b; Sun 2011; Sriprasert 2015; Wang 2013b; Witt 2008; Wang 2005b; Wang 2014a; Xu 2013; Xu 2014; Zhang 2013b;
Youn 2008; Han 2012; Zhang 2013a).

Frequency of treatment
Acupressure
Charandabi 2011 and Yeh 2013a applied pressure for 10 minutes or less. Aghamiri 2005 applied pressure twice for 15 minutes, and 20
minutes of pressure was applied in five trials (Bazarganipour 2010; Chen 2004; Chen 2010; Mirbagher-Ajorpaz 2011; Zafari 2011).
Pressure was applied for 30 minutes in one trial (Kashefi 2010).
Acupuncture
Daily treatment was administered in 17 trials (Bu 2011; Cao 2011; Han 2012; Hu 2005; Li 2008; Li 2012b; Ma 2013; Peng 2012;
Qiao 2013; Ruan 2011; Wang 2005b; Wang 2013b; Wang 2014a; Xu 2013; Zhang 2012; Zhang 2013b; Zhi 2007).
Treatment was applied (i) prior to menstruation and (ii) during menstruation in 13 trials (Bu 2011; Han 2012; Hu 2005 Li 2008;
Li 2012b; Qiao 2013; Ruan 2011; Sun 2011; Wang 2005b; Wang 2013b; Wang 2014a; Zhang 2013a; Zhang 2013b).Treatment was
given once 1 - 4 days before menstruation and then at weekly intervals over four weeks in one trial (Lee 2007). In Ma 2013 Groups
A and C were treated once a day for about five days before menstruation until menstrual onset. Treatment was administered once
menstrual pain started in six trials (Peng 2012; Ma 2013; Song 2013; Zhang 2012; Zhi 2007; Zhang 2013b).
Treatment was given prior to menstruation: every second day in the week before menstruation (Darabi 2010), and at least once a week
in the three weeks before menses (Helms 1987; Smith 2010; Sriprasert 2015). Daily treatment was administered for seven days in the
week before menstruation in two trials (Xu 2013; Xu 2014).
Details of timing were unclear in five trials (Ma 2010; Shi 2011; Wang 2009a; Witt 2008; Youn 2008).

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WHATS NEW
Last assessed as up-to-date: 1 September 2015.

Date

Event

Description

16 February 2016

New search has been performed

Updated search: 34 new trials included and 2 previously


included trials excluded. The Results and Discussion
have been updated, and Summary of findings tables
added

16 February 2016

New citation required but conclusions have not The inclusion of new trials did not change the concluchanged
sions.

HISTORY
Protocol first published: Issue 3, 2009
Review first published: Issue 1, 2011

Date

Event

Description

11 January 2012

Amended

Correction made to data relating to outcome pain relief. Data replaced with outcome pain intensity.
Inclusion of outcome to the results and additional statements made to discussion

17 May 2010

Amended

Inclusion of acupressure trials.

23 December 2009

Amended

Changes to the protocol.


Unit of analysis: trials with multiple arms were included for example acupuncture compared with
sham acupuncture and no acupuncture. If there were two acupuncture groups data from both
treatment arms were combined into one group. For studies with a sham control and no treatment
control group, the shared intervention was divided evenly between groups. Where outcomes were
repeated measures, analysis of outcomes was undertaken at the end of the intervention
Elaboration of the objectives and comparisons.

19 November 2008

Amended

The published review: Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database of Systematic Reviews 2002, Issue 1 (Proctor 2002), has now been divided into two reviews. These are:
Transcutaneous electrical nerve stimulation for primary dysmenorrhoea and Acupuncture for
primary dysmenorrhoea

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CONTRIBUTIONS OF AUTHORS
Caroline Smith conceptualised and wrote the protocol and systematic review: she reviewed the trials, performed data extraction and
wrote the review. Caroline Smith is the guarantor of the review.
Mike Armour undertook the search, performed data extraction, contributed to writing of the review.
Xiaoshu Zhu undertook review of the trials, performed data extraction, and commented on the review.
Xun Li undertook a search of the Chinese databases, retrieved papers, undertook translations from Chinese to English, performed data
extraction and commented on the review.
Zhi Lu undertook translations from Chinese to English, performed data extraction and commented on the review.
Jing Song commented on the protocol and review, undertook data extraction and contributed to data interpretation.

DECLARATIONS OF INTEREST
CS recently completed a randomised controlled trial of acupuncture to treat primary dysmenorrhoea.
MA recently completed a randomised controlled trial of acupuncture to treat primary dysmenorrhoea.
XZ, XL, ZL and JS have no conflicts of interest..

SOURCES OF SUPPORT
Internal sources
Caroline Smith, Australia.
National Institute of Complementary Medicine, Western Sydney University
Xiao Zhu, Australia.
National Institute of Complementary Medicine Western Sydney University
Jing Song, Australia.
Campbelltown and Camden Hospitals

External sources
No sources of support supplied

INDEX TERMS
Medical Subject Headings (MeSH)
Acupuncture Therapy [adverse effects; methods]; Anti-Inflammatory Agents, Non-Steroidal [therapeutic use]; Dysmenorrhea [drug
therapy; therapy]; Randomized Controlled Trials as Topic

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MeSH check words


Adolescent; Adult; Female; Humans; Middle Aged; Young Adult

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