Acupuncture For Primary Dysmenorrhoea (Review) : Smith CA, Zhu X, He L, Song J

Acupuncture for primary dysmenorrhoea (Review)
Smith CA, Zhu X, He L, Song J
This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2011, Issue 1 http://www.thecochranelibrary.com
Acupuncture for primary dysmenorrhoea (Review) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
TABLE OF CONTENTS HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Figure 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AUTHORS CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Analysis 1.1. Comparison 1 Acupuncture versus control, Outcome 1 Pain relief short term. . . . . . . Analysis 1.2. Comparison 1 Acupuncture versus control, Outcome 2 Improvement in symptoms short term. Analysis 1.3. Comparison 1 Acupuncture versus control, Outcome 3 Use of analgesics short term. . . . . Analysis 1.4. Comparison 1 Acupuncture versus control, Outcome 4 Restricted activities. . . . . . . . Analysis 1.5. Comparison 1 Acupuncture versus control, Outcome 5 Absence from work of school. . . . Analysis 1.6. Comparison 1 Acupuncture versus control, Outcome 6 SF36 physical component short term. . Analysis 1.7. Comparison 1 Acupuncture versus control, Outcome 7 SF36 Mental health short term. . . . Analysis 1.8. Comparison 1 Acupuncture versus control, Outcome 8 SF36 Bodily Pain Short term. . . . Analysis 1.9. Comparison 1 Acupuncture versus control, Outcome 9 SF36 General health short term. . . Analysis 1.10. Comparison 1 Acupuncture versus control, Outcome 10 SF36 Vitality short term. . . . . Analysis 1.11. Comparison 1 Acupuncture versus control, Outcome 11 SF36 Social function short term. . Analysis 1.12. Comparison 1 Acupuncture versus control, Outcome 12 SF36 Role emotional short term. . Analysis 1.13. Comparison 1 Acupuncture versus control, Outcome 13 Adverse events. . . . . . . . Analysis 2.1. Comparison 2 Acupressure versus control, Outcome 1 Pain relief. . . . . . . . . . . Analysis 2.2. Comparison 2 Acupressure versus control, Outcome 2 Improvement in symptoms. . . . . APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . WHATS NEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 2 2 3 4 6 8 9 10 11 13 14 14 16 16 16 19 39 40 41 42 42 43 43 44 45 46 47 48 49 49 50 51 51 59 59 59 60 60
[Intervention Review]
Acupuncture for primary dysmenorrhoea

Caroline A Smith1 , Xiaoshu Zhu2 , Lin He3 , Jing Song4 for Complementary Medicine Research, The University of Western Sydney, Penrith South DC, Australia. 2 Center for Complementary Medicine Research, School of Biomedical and Health Science, University of Western Sydney, Sydney, Australia. 3 Books & Information Centre, West China Hospital, Sichuan University, Chengdu, China. 4 Obstetrician and Gynaecologist, Campbelltown and Camden Hospitals, Campbelltown, Australia Contact address: Caroline A Smith, Centre for Complementary Medicine Research, The University of Western Sydney, Locked Bag 1797, Penrith South DC, New South Wales, 2751, Australia. caroline.smith@uws.edu.au. Editorial group: Cochrane Menstrual Disorders and Subfertility Group. Publication status and date: New, published in Issue 1, 2011. Review content assessed as up-to-date: 11 August 2010. Citation: Smith CA, Zhu X, He L, Song J. Acupuncture for primary dysmenorrhoea. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD007854. DOI: 10.1002/14651858.CD007854.pub2. Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
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ABSTRACT Background This review examined the currently available evidence supporting the use of acupuncture to treat primary dysmenorrhoea. Objectives To determine the efcacy and safety of acupuncture in the treatment of primary dysmenorrhoea when compared with a placebo, no treatment, or conventional medical treatment (for example oral contraceptives and non-steroidal anti-inammatory medication (NSAIDs)). Search strategy The following databases were searched (from inception until March 2010): the Cochrane Menstrual Disorders and Subfertillity Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), PubMed, CINAHL, PsycINFO, Chinese Biomedical Literature Database (CBM), Chinese Medical Current Content (CMCC), China National Knowledge Infrastructure (CNKI), VIP database, Dissertation Abstracts International, BIOSIS, AMED (The Allied and Complementary Medicine Database), Acubriefs, and Acubase. Selection criteria Inclusion criteria included all published and unpublished randomised controlled trials comparing acupuncture with placebo control, usual care, and pharmacological treatment. The following modes of treatment were included: 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 Meta-analyses were performed using odds ratios (OR) for dichotomous outcomes and mean differences or standard mean differences (SMD) for continuous outcomes, with 95% condence intervals (CI). Primary outcomes were pain relief and improved menstrual symptoms, measured by self-rating scales. Other outcomes included use of analgesics, quality of life, and absence from school or work.
Acupuncture for primary dysmenorrhoea (Review) Copyright 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. 1
Main results Ten trials were included in the review with data reporting on 944 participants. Six trials reported on acupuncture (n = 673) and four trials (n = 271) reported on acupressure. There was an improvement in pain relief from acupuncture compared with a placebo control (OR 9.5, 95% CI 21.17 to 51.8), NSAIDs (SMD -0.70, 95% CI -1.08 to -0.32) and Chinese herbs (SMD -1.34, 95% CI -1.74 to 0.95). In two trials acupuncture reduced menstrual symptoms (for example nausea, back pain) compared with medication (OR 3.25, 95% CI 1.53 to 6.86); in one trial acupuncture reduced menstrual symptoms compared with Chinese herbs (OR 7.0, 95% CI 2.22, 22.06); and in one trial acupuncture improved quality of life compared with usual care. There was an improvement in pain relief from acupressure compared with a placebo control (SMD -0.99, 95% CI -1.48 to -0.49), and in one trial acupressure reduced menstrual symptoms compared with a placebo control (SMD -0.58, 95% CI -1.06 to -0.10). The risk of bias was low in 50% of trials. Authors conclusions Acupuncture may reduce period pain, however there is a need for further well-designed randomised controlled trials.
PLAIN LANGUAGE SUMMARY Acupuncture for period pain Dysmenorrhoea, known as period pain, is commonly experienced by younger women. Symptoms may include cramping pain in the lower abdomen that may radiate to the lower back or anterior thigh, nausea, vomiting, diarrhoea, headache, fatigue, anxiety, and dizziness. The review found some evidence for the use of acupuncture in managing period pain. However, these ndings should be interpreted with caution due to the small number of studies and study participants. No signicant adverse effects were identied in this review.
BACKGROUND
Women with dysmenorrhoea have increased uterine tone and high amplitude uterine contractions due to increased endometrial prostaglandin production, which reduces uterine blood ow (Kennedy 1997). The neurohypophyseal hormones vasopressin and oxytocin may also be associated with the aetiology of primary dysmenorrhoea, with women found to have increased plasma concentrations of vasopressin during early menstruation (Akerlund 1979; Stromberg 1984). Vasopressin has been shown to stimulate uterine activity and reduce uterine blood ow similar to the reduction associated with primary dysmenorrhoea (Akerlund 1976). Oxytocin has also been shown to inuence uterine vessels and the myometrium. Primary dysmenorrhoea occurs at the start of menstruation in the absence of any identied pelvic disease or disorder (Akerlund 1999). Secondary dysmenorrhoea is painful menstruation associated with pelvic pathology such as endometriosis.
Description of the condition

Primary dysmenorrhoea refers to the occurrence of painful menstrual cramps of uterine origin. It is a common gynaecological complaint that can affect as many as 50% of women; 10% of these women suffer severely enough to render them incapacitated for one to three days each menstrual cycle (Banikarim 2000; Dawood 1990). Higher prevalence rates, from 43% to 90%, are seen in women less than 25 years. This wide variation in prevalence is attributed to differing denitions by researchers and the lack of standard methods for assessing the severity of dysmenorrhoea (Jamieson 1996; Stvanberg 1981). Dysmenorrhoea is characterised by symptoms that include cramping pain in the lower abdomen with pain radiating to the lower back or anterior thigh, nausea, vomiting, diarrhoea, headache, fatigue, nervousness, and dizziness (Hillen 1999). Primary dysmenorrhoea often starts six to 12 months after menarche (onset of menstruation), when ovulatory cycles are established. The duration of pain is usually 48 to 72 hours and is associated with menstrual ow.
Description of the intervention

Acupuncture has a long history of use in South East Asia including China, Korea and Japan. Traditional Chinese medicine (TCM),
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with acupuncture as one of its major modalities, describes a state of health maintained by a balance of energy in the body. Acupuncture performed within the context of TCM is a complex intervention involving not only technical needling skills but development of a therapeutic relationship, formulation of a diagnosis, provision of lifestyle advice, and often administering of co-interventions such as gua sha (scrapping), tuina (massage), moxibustion (a type of Chinese medicine which involves burning a herb close to the skin) or electrical stimulation. In clinical practice acupuncture is usually the main modality with use of these co-interventions. Acupuncture involves use of ne needles inserted into different parts of the body to correct the imbalance of energy in the body. TCM and classical acupuncture explain disease and physiological function based on theoretical concepts of Yin and Yang and the Five Elements. A westernised medical application of acupuncture involves the use of acupuncture using trigger points, segmental points and commonly used formula points. Auricular therapy is a form of western acupuncture that involves the use of the ear to make a diagnosis and subsequent needling to points on the ear. Medical acupuncture may involve the application of acupuncture based on the principles of neurophysiology and anatomy rather than TCM principles and philosophy. The style and approach of acupuncture characterises the acupuncture point selection and related treatment parameters administered in clinical practice and research. Acupuncture points to treat dysmenorrhea are commonly located on the lower abdomen, lower back and sacrum areas, and the lower legs. Acupuncture is not entirely free of adverse side effects. Two large prospective surveys have been undertaken in the United Kingdom (MacPherson 2004; White 2001). MacPherson 2004 reported a rate of adverse effects of 107 per 1000 patients (95% CI 100 to 115). Three patients reported a serious adverse event that included severe tiredness and exhaustion, pain at the site of needling, and headache. White 2001 reported an incidence of 684 adverse events per 1000 consultations. The majority were minor events, for example bleeding, needling pain or aggravation of symptoms; a lower rate of signicant adverse events of 14 per 10,000 were reported. From these studies it appears that the risks associated with acupuncture are low.
segmental level transmits signals in the spinal cord and in the central nervous system. Lin 2008 proposes that the therapeutic effect of acupuncture for dysmenorrhoea may be through its inuence on prostaglandin F2 alpha (PGF2) levels in menstrual uid. In addition, preliminary human studies using auricular acupuncture suggest the main therapeutic actions on period pain are likely to be through increasing the level of the hormone beta-endorphin (EP) in peripheral plasma and regulation of uterine activity (Xiang 2002; Xiang 2005). Both segmental and central mechanisms of acupuncture are likely to be involved in the total effect of acupuncture (Stener-Victorin 2006). During needle stimulation of common acupuncture points for period pain, such as SP6, SP8, and Ren 4, signals are transmitted to the spinal cord and via afferent pathways to the midbrain. The perception of pain emerges from the resulting ow and integration of information among specic brain areas and may lead to a change in the perception of the pain. The descending pain modulatory system is a key anatomical network that underlies the ability to change pain intensity (Tracey 2007). We proposed that the brainstem structures involved in the descending modulation alter womens perception of pain resulting from dysmenorrhea (Smith 2010).
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 under treated (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 non-steroidal anti-inammatory 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. These two drug groups are now considered standard treatments for primary dysmenorrhoea (Dawood 1988; Dawood 1990). The efcacy of these conventional treatments is high, nevertheless 20% to 25% of women have inadequate pain relief (Dawood 1985; Henzl 1985). Other evidence-based approaches to effectively managing symptoms of dysmenorrhoea are therefore needed. A number of clinical trials have been performed to study the efcacy of acupuncture for period pain although it remains uncertain whether the existing evidence is rigorous enough to reach a denitive conclusion.
How the intervention might work

The mechanism by which acupuncture may inuence primary dysmenorrhoea is not well understood. From a TCM approach acupuncture points used to treat period pain, for example Stomach 30 (ST30), Ren 6, or Liver 3, are selected based on pattern differentiation during the diagnosis. Acupuncture has been used to treat a number of painful conditions and it is proposed that acupuncture may modify the perception of pain or alter physiological functions (Stux 1995). From a western acupuncture model, acupuncture points are selected according to the innervation of the target organ, for example the uterus. Activation of muscle afferents at this
OBJECTIVES
To determine the efcacy and safety of acupuncture in the treatment of primary dysmenorrhoea when compared with a placebo,
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no treatment, or conventional medical treatment (for example oral contraceptives and non-steriodal anti-inammatory medication (NSAIDs)).
Types of interventions Any RCT involving acupuncture (manual insertion of needles to points located on the body, and ear) and electro-acupuncture as treatment for primary dysmenorrhoea. An amendment to the protocol was made and trials of acupressure were included; this included pressure applied using blunt studs or seeds. Application of minimal moxibustion on a small number of points was included. Trials of moxibustion alone were excluded. 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 later receive the intervention, after a waiting period), or other conventional treatments. Types of outcome measures Reporting of at least one of the following primary outcomes was required for a trial to be included. Data from each of the following outcomes were recorded, where available.
METHODS
Criteria for considering studies for this review
Types of studies All randomised controlled trials (RCTs) were eligible for inclusion. Crossover trials were included if they had pre-crossover data. We excluded quasi-randomised trials and trials where we were unable to ascertain if the trial was truly randomised.
Types of participants
Primary outcomes 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 identiable 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).
1. Pain relief measured by a visual analogue scale (VAS) or other validated scales, or measured as dichotomous outcomes (i.e. pain relief: yes or no).
Secondary outcomes
Exclusion criteria
If participants in the trial met any of the following exclusion criteria, the trial was not included in the review: diagnosed secondary dysmenorrhoea (e.g. broids, endometriosis); dysmenorrhoea resulting from use of an intra-uterine device (IUD); mild or infrequent dysmenorrhoea.
1. Overall improvement in generic menstrual-related 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.
Search methods for identication of studies

All published and unpublished RCTs of acupuncture and acupressure versus control were sought using the following search strategy, without language restrictions and in consultation with the Menstrual Disorders and Subfertility Group (MDSG) Trials Search Co-ordinator.
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Electronic searches Our search of databases was from inception until March 2010. We searched the Cochrane Menstrual Disorders and Subfertillity Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), PubMed, CINAHL, and PsycINFO. The search terms are presented in the appendices (Appendix 1; Appendix 2; Appendix 3; Appendix 4; Appendix 5). Searching other resources We searched for additional studies in the reference lists of the relevant trials identied. Chinese literature databases were searched for Chinese studies: the China Academic Journal Electronic full text Database in China National Knowledge Infrastructure and the Index to Chinese Periodical Literature, Chinese Biomedical Literature Database (CBM), Chinese Medical Current Content (CMCC) (www.cmcc.org.cn), and China National Knowledge Infrastructure (CNKI). We also searched Dissertation Abstracts International, BIOSIS, AMED (the Allied and Complementary Medicine Database), Acubriefs, Acubase 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 (http://controlledtrials.com); Clinical trials.gov (http://clinicaltrials.gov); ISRCTN (http://www.isrctn.org/); National Center for Complementary and Alternative Medicine (NCCAM) (http://nccam.nih.gov/clinicaltrials/alltrials.htm), and WHO International Clinical Trial Registration Platform search portal (www.who.int/trialsearch/).
Data extraction and management Following an assessment for inclusion, CS and XZ independently extracted data using the form designed by the Review Group for this purpose. For the trial published by review author CS an additional author was employed to review this trial (JM and XZ). Discrepancies were resolved by discussion. For each included trial data were extracted regarding the location of the trial, 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 specied above. Information on reported benets and adverse effects was collected. Data were extracted and entered onto a form (Appendix 6) sourced from the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008). Two review authors (CS and XZ) checked and entered data into RevMan.
Assessment of risk of bias in included studies Risk of bias was assessed independently by two review authors using the criteria described in the Cochrane Handbook for Systematic Reviews of Interventions 5.0.0 (Higgins 2008). The tool consists of six items, with three potential responses: yes, no, and unclear. In all cases an answer yes indicated a low risk of bias and an answer no indicated high risk of bias. If insufcient detail was reported for what happened in the study the judgement was usually unclear. An unclear judgement was also made if what happened in the study was known but the risk of bias was unknown; 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). The following characteristics were assessed: sequence generation, allocation concealment, blinding (or masking), incomplete data assessment, selective outcome reporting, and other sources of bias. Disagreements that arose at any stage between review authors were resolved by discussion or with a third party, when necessary. The risk of bias was assessed using the criteria described in the Cochrane Handbook for Systematic Reviews of Interventions 5.0.0 (Higgins 2008) (Appendix 7). We generated a Risk of bias assessment table for each study. The standard checklist developed by the Menstrual Disorders and Subfertility Review Group was used to assess 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. This information is presented in the Characteristics of included studies.
Data collection and analysis
Selection of studies The titles and abstracts of articles found in the search were screened by CS and XZ, who discarded trials that were clearly not eligible. One review author (HL) searched for and selected the trials from the Chinese databases.Trial selection was undertaken by two out of the three review authors (CS, XZ, HL). Translation of Chinese papers was undertaken. CS and XZ independently assessed whether trials met the inclusion criteria, with disagreements resolved by discussion. If articles contained insufcient 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 in the reporting we contacted all authors to ascertain if the study was truly randomised. A rst contact was made and then a reminder sent. Letters and email were translated into Chinese.
Measures of treatment effect

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We performed statistical analysis in accordance with the guidelines developed by the Menstrual Disorders and Subfertility Group. Statistical analysis was performed using Review Manager (RevMan5, version 5) software (REVMAN 2008). For dichotomous data, results for each study were expressed as Peto odds ratios (OR) with corresponding 95% condence intervals (CI) using the MantelHaenszel method. We expressed continuous data as weighted mean differences (WMD) with 95% CI, or as standardised weighted mean differences (SMD) if outcomes were conceptually the same but measured in different ways in the different trials.
Data synthesis We expressed dichotomous data as ORs with corresponding 95% CI, combined for meta-analysis with RevMan 5 software. We expressed continuous data as WMD with 95% CI, or as SMD if outcomes were conceptually the same but measured in different ways. The data from primary studies was combined in the following comparisons. 1. Acupuncture versus control. 2. Acupressure versus control.
Unit of analysis issues The primary analysis was per woman randomised. Trials with multiple arms were included and are described in the Characteristics of included studies, for example acupuncture compared with placebo acupuncture and no acupuncture. If there were two acupuncture groups, data from both treatment arms were combined into one group. For studies with a placebo control and no treatment control group, the shared intervention was divided evenly between groups as described in the Cochrane Handbook (Higgins 2008). Where outcomes were repeated measures, analysis of outcomes was undertaken at the end of the intervention.
Subgroup analysis and investigation of heterogeneity In the presence of signicant heterogeneity, we aimed to examine the causes of by pre-specied subgroup analysis and also sensitivity analysis. We planned to undertake a subgroup analysis based on different types of acupuncture therapies: manual acupuncture, electro-acupuncture; and different control interventions.
Sensitivity analysis Where subgroup analysis failed to explain the heterogeneity, data were analysed using the random-effects model. A priori, it was 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. If publication bias was present we planned to undertake a sensitivity analysis excluding trials from countries where there was a greater publication bias.
Dealing with missing data Data were analysed on an intention-to-treat basis, as far as possible. We did not input data for missing data but we did report the proportion lost to follow up and analysed per protocol.
Assessment of heterogeneity We identied 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 Chi2 test. A low P value (or a large Chi2 statistic relative to its degree 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 I2 statistic. This describes the percentage of total variation across studies that is due to heterogeneity rather than chance ( Higgins 2008). The interpretation of the I2 statistic was 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.
RESULTS
Description of studies
See: Characteristics of included studies; Characteristics of excluded studies; Characteristics of studies awaiting classication; Characteristics of ongoing studies. See Characteristics of included studies, Characteristics of excluded studies, Characteristics of ongoing studies, and Characteristics of studies awaiting classication.
Results of the search The original review included TENS and acupuncture (one trial). This updated review includes acupuncture and acupressure trials only: 10 trials (1025 women) were included and 24 excluded. See Characteristics of included studies, Characteristics of excluded studies, Characteristics of studies awaiting classication, and Characteristics of ongoing studies.
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Assessment of reporting biases We planned to investigate potential biases of publication using the funnel plot or other analytical method (Egger 1997).
Included studies
Study design
(Chen 2004; Chen 2010; Jiang 2007; Li 2008; Witt 2008). One trial reported severe, incapacitating pain with a pre-dened pain score that did not respond well to analgesics (Smith 2010). All other trials reported recruiting participants with moderate pain.
All studies were parallel design. SIx trials had two study groups (Chen 2004; Jiang 2007; Smith 2010; Wang 2009; Witt 2008; Wu 2007). Two trials had three groups (Li 2008; Zhi 2007b) and two trials had four arms (Chen 2010; Helms 1987). Comparative and control groups varied. Four trials used placebo controls (Helms 1987; Smith 2010; Wang 2009; Zhi 2007b). Placebo techniques varied between invasive and non-invasive techniques. Comparisons with medication using NSAIDs were used in three trials (Jiang 2007; Wu 2007; Zhi 2007b); one trial used Chinese herbal medicine (Li 2008); one study reported unspecied usual care (Witt 2008); two trials used rest (Chen 2004; Chen 2010); and one trial used visitation or social support (Helms 1987).
Types of intervention
Four trials used acupressure and six trials provided stimulation using acupuncture (including manual and electro-acupuncture). Acupuncture and acupressure varied in point selection, frequency of treatment, and number of treatments. A xed set of acupuncture points only were administered in four trials (Helms 1987; Jiang 2007; Li 2008; Zhi 2007b); xed sets of acupressure points were used in four trials (Chen 2004; Chen 2010; Wang 2009; Wu 2007); and individualised treatment was administered in two trials (Smith 2010; Witt 2008). See Characteristics of included studies.
Sample sizes
Treatment length and follow up
Studies included in the review were relatively small, ranging from 48 (Helms 1987) to 180 (Li 2008).
Three studies were undertaken over one menstrual cycle (Chen 2004; Jiang 2007; Wang 2009). Seven studies were undertaken over three menstrual cycles (Chen 2010; Helms 1987; Li 2008; Smith 2010; Witt 2008; Wu 2007; Zhi 2007b).
Study location and sources of women
Four studies were undertaken in China (Jiang 2007; Li 2008; Wu 2007; Zhi 2007b); three studies undertaken in Taiwan (Chen 2004; Chen 2010; Wang 2009); and one each in Australia (Smith 2010), Germany (Witt 2008) and the USA (Helms 1987). The majority of studies recruited participants from gynecology clinics (Helms 1987; Jiang 2007; Li 2008; Wu 2007; Zhi 2007b), three trials recruited college students (Chen 2004; Chen 2010; Wang 2009), and two recruited from the community (Smith 2010; Witt 2008).
Outcome measures
Participants
Women with secondary dysmenorrhoea were excluded, however this diagnosis was not clearly reported. One study used cancer or carbohydrate antigen 125 (CA 125) to eliminate a diagnosis of endometriosis (Wang 2009). In seven trials no clear, specic details were reported on how pelvic pathology was eliminated ( Chen 2004; Chen 2010; Helms 1987; Li 2008; Witt 2008; Wu 2007; Zhi 2007b). Evidence of a physical assessment conrming diagnosis of primary dysmenorrhoea was reported in one trial ( Smith 2010). Jiang 2007 reported that primary dysmenorrhoea was conrmed by ultrasound and physical examination.
All studies assessed the primary outcome of pain relief. Helms 1987 used a monthly pain score based on pain intensity recorded on a zero to six scale. A pre-treatment pain score was based on an average pain score over six months. An average post-treatment pain score was described as the average of monthly pain scores obtained during the nine months after completion of acupuncture: improvement was arbitrarily described as an average posttreatment score less than half that of the pretreatment pain score. VAS scales were used in ve trials (Chen 2004; Chen 2010; Smith 2010; Wang 2009; Witt 2008). A subjective assessment of pain and other menstrual symptoms was undertaken in the remaining four studies (Jiang 2007; Li 2008; Wu 2007; Zhi 2007b).
Baseline comparability
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 the physical functioning, bodily pain, and physical component score of the SF36. No details were reported on baseline characteristics in two trials (Jiang 2007; Li 2008).
Severity of dysmenorrhoea
No quantitative measure of the severity of pain was reported in four trials (Helms 1987; Wang 2009; Wu 2007; Zhi 2007b). The severity of pain was assessed using subjective outcomes in ve trials
Intention to treat
An intention-to-treat analysis was reported and undertaken in two trials (Smith 2010; Witt 2008).
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Source of funding
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). Excluded studies Twenty-four trials were excluded (see Characteristics of excluded studies). Twelve trials did not meet the inclusion criteria for the intervention; for example, the use of acupuncture plus additional moxibustion, use of moxibustion alone, or laser acupuncture (Geng 2008; He 2005; Huo 2008; Kempf 2009; Li 2006; Li 2007; Liu 2005; Sun 2004; Sun 2008; Wang 2005; Yang 2008; Yi 2005). One trial did not meet the inclusion criteria for the control group (Xie 2003). Nine trials were excluded due to insufcient
reporting of randomisation; we were unable to ascertain the true randomisation status from the author, or trials were quasi-randomised (Chen 2008; Habek 2003; Jun 2007; Pouresmal 2002; Shi 1994; Zheng 2006; Zhou 2003). No clinically relevant outcomes were reported in one trial (She 2008). One study was a duplicate of an included trial (Zhi 2007). Further background information on these trials is presented in the table Characteristics of excluded studies.
Risk of bias in included studies

See Figure 1 and Figure 2 for a graphical summary of the risk of bias assessments of the included studies made by authors based on the six risk of bias domains. One trial was at a low risk of bias on all domains.
Figure 1. Methodological quality graph: review authors judgements about each methodological quality item presented as percentages across all included studies.
Figure 2. Risk of bias summary: review authors judgements about each risk of bias item for each included study.
Allocation Using the Cochrane criteria, which rate the adequacy of randomisation allocation and concealment, most of the trials (80%) were rated at a low risk of bias with adequate generation of randomisation sequence. In 40% of trials the sequence was computer generated (Smith 2010; Wang 2009; Witt 2008; Zhi 2007b). The sequence was drawn by lot in two trials (Chen 2004; Chen 2010) and from random number tables in two trials (Helms 1987; Li 2008). Allocation concealment was described as low risk in ve trials (50%). Central randomisation was undertaken in two trials (Smith 2010; Witt 2008) and using sealed envelopes in three trials (Chen 2004; Chen 2010; Wang 2009).
Selective reporting The risk of selective reporting was treated as low risk in one trial where we were able to obtain the protocol published on a clinical trial registry (Smith 2010). Other potential sources of bias The risk of bias from other sources of bias was rated as low in ve trials (Helms 1987; Smith 2010; Wang 2009; Witt 2008; Wu 2007).
Effects of interventions
Ten trials contributed data to the meta-analysis, from 944 participants. Results are presented separately for acupuncture and acupressure, and by type of control group. 1) Acupuncture Efcacy outcomes were available from six trials.
Blinding Blinding was assessed at low risk of bias in two trials (Smith 2010; Wang 2009). Both these trials were assessed as double blind with blinding of analyst and participants.
Incomplete outcome data Outcome reporting was assessed at a low risk of bias in 90% of trial. One trial had a 50% drop-out rate (Chen 2004).
1.1 Outcome: pain relief
Data was presented for short-term outcomes at three months ( Figure 3; Analysis 1.1).
Figure 3. Forest plot of comparison: 1 Acupuncture versus control, outcome: 1.1 Pain relief short term.
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1.1.1 Placebo acupuncture There was no difference in short-term pain outcomes at the end of three months between groups (two trials, 140 participants). The trial by Helms 1987 reported this outcome as a dichotomous variable and was not included in meta-analysis: pain relief was signicantly greater in the acupuncture group (OR 9.5, 95% CI 21.17 to 51.8; 48 participants). Smith 2010 reported on this outcome at six and 12 months follow up and found no difference between groups (92 participants); data not reported in meta-analysis. 1.1.2 Usual care One trial found a reduction in pain relief in the usual care group compared with acupuncture (SMD 0.59, 95% CI 0.22 to 0.96; 117 participants).
1.1.3 Non-steroidal anti-inammatory drugs (NSAIDs) One trial compared acupuncture with NSAIDs and found a small improvement in pain relief for acupuncture (SMD -0.70, 95% CI -1.08 to -0.32; 114 participants).
1.1.4 Chinese herbs One trial compared acupuncture with Chinese herbs and found a small improvement in pain relief for acupuncture (SMD -1.34, 95% CI -1.74 to -0.95; 120 participants).
1.2 Outcome: improvement in symptoms
See Figure 4; Analysis 1.2.
Figure 4. Forest plot of comparison: 1 Acupuncture versus control, outcome: 1.2 Improvement in symptoms short term.
1.2.1 Placebo control One trial compared acupuncture with a placebo control and found
no difference in overall improvement in symptoms at three months (92 participants). At three months women reported fewer mood
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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). Smith 2010 also reported on this outcome at six and 12 months and found no difference in symptoms between groups (data not reported in meta-analysis).
1.6 Outcome: quality of life, physical component
Two trials reported on quality of life (Analysis 1.6).
1.6.1 Placebo control There was no difference between groups (92 participants, 1 trial).
1.2.2 Non-steroidal anti-inammatory drugs (NSAIDs) Menstrual symptoms were reduced for women receiving acupuncture compared with NSAIDs (OR 3.25, 95% CI 1.53 to 6.86; 140 participants, 2 trials). 1.6.2 Usual care Acupuncture improved physical function (MD 5.57, 95% CI 2.68 to 8.46; 117 participants, 1 trial).
1.2.3 Chinese herbal medicine Menstrual symptoms were reduced for women receiving acupuncture compared with Chinese herbal medicine (OR 7.0, 95% CI 2.22 to 22.06; 120 participants, 1 trial).
1.7 Outcome: quality of life, mental health
See Analysis 1.7.
1.3 Outcome: reduced use of additional medication
See Analysis 1.3.
1.7.2 Usual care Acupuncture improved mental health compared to usual care (MD 10.49, 95% CI 3.63 to 17.35; 117 participants, 1 trial).
1.3.1 Placebo control Two trials reported on this outcome. Helms 1987 reported a reduction in the use of analgesics as continuous data with no difference between groups (48 participants) (data not reported in metaanalysis). Smith 2010 reported on this outcome at three months and found no difference between groups (92 participants); a reduction in medication use was found at six months for women in the acupuncture group (OR 0.63, 95% CI 0.43 to 0.91) but no difference at 12 months (OR 1.17, 95% CI 0.92 to 1.47) (data at six and 12 months not reported in the meta-analysis).
1.8 Outcome: quality of life, bodily pain
See Analysis 1.8.
1.8.1 Placebo control There was no difference in bodily pain between groups (92 participants, 1 trial).
1.4 Outcome: restriction of daily life activities
1.8.2 Usual care Acupuncture reduced bodily pain compared with usual care (MD 20.10, 95% CI 9.90 to 30.30; 117 participants, 1 trial).
See Analysis 1.4.
1.4.1 Placebo control There was no difference between groups at the end of the trial, and at six and 12 months (92 participants, 1 trial).
1.9 Outcome: quality of life, general health
See Analysis 1.9.
1.9.1 Placebo control

1.5 Outcome: absence from work or school
See Analysis 1.5.
There was no difference in general health between groups (92 participants, 1 trial).
1.5.1 Usual care There was no difference in days of absence from school of work (117 participants, 1 trial).
1.9.2 Usual care There was no difference in general health between groups (117 participants, 1 trial).
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1.10 Outcome: quality of life, vitality
1.12 Outcome: quality of life, role emotional
See Analysis 1.10.
See Analysis 1.12. 1.12.1 Placebo control There was no difference between groups (92 participants, 1 trial). 1.12.2 Usual care
1.10.2 Usual care Acupuncture improved vitality compared with usual care (MD 18.12, 95% CI 11.52 to 24.72; 117 participants, 1 trial).
Acupuncture improved emotional role compared with usual care (MD 14.16, 95% CI 1.29 to 27.03; 117 participants, 1 trial).
1.13 Outcome: adverse events
See Analysis 1.13.

1.11 Outcome: quality of life, social function
See Analysis 1.11.
1.13.1 Usual care Fewer side effects were found in the acupuncture group compared to usual care (OR 0.27, 95% CI 0.05 to 1.34; 117 participants, 1 trial). 2) Acupressure
1.11.2 Usual care Acupuncture improved social function compared with usual care (MD 20.27, 95% CI 11.52 to 29.02; 117 participants, 1 trial).
2.1 Outcome: pain relief
See Figure 5; Analysis 2.1.
Figure 5. Forest plot of comparison: 2 Acupressure versus control, outcome: 2.1 Pain relief.
2.1.1 Placebo control Acupressure improved pain relief compared with a placebo control (SMD -0.99, 95% CI -1.48 to -0.49; 71 participants, 1 trial).
2.1.2 Rest There was no difference in pain relief between groups (140 participants, 2 trials). There was substantial statistical heterogeneity
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(I2 = 94%). 2.1.3 Non-steroidal anti-inammatory drugs (NSAIDs) Pain relief reported as a continuous variable improved for the acupressure group compared with NSAIDs (RR 1.84, 95% CI 1.33 to 2.53; 60 participants, 1 trial) (Wu 2007).
2.2 Outcome: improvement in symptoms
See Figure 6; Analysis 2.2. Figure 6. Forest plot of comparison: 2 Acupressure versus control, outcome: 2.2 Improvement in symptoms.
2.2.1 Placebo control Acupressure improved menstrual symptoms compared with the placebo control (SMD -0.58, 95% CI -1.06 to -0.10; 71 participants, 1 trial).
Subgroup analysis No subgroup analysis was undertaken based on little diversity by mode of stimulation of the included trials (ve trials of manual acupuncture and one trial of electro-acupuncture).
2.2.2 Rest Acupressure did not improve menstrual symptoms (140 participants, 2 trials). Sensitivity analysis It was proposed, a priori, to undertake sensitivity analyses on the results to look at the possible contribution of differences in methodological quality, with trials of high quality (low risk of bias) compared to all trials. This was not done due to the small number of trials overall. Two trials were at high risk of bias due to inadequate allocation concealment and one trial at high risk with dropouts greater than 20%. There were also too few trials within comparisons to examine the inuence of publication bias. Where there was heterogeneity a random-effects model was applied.
DISCUSSION Summary of main results

Ten trials and data from 944 participants were included in the meta-analysis. The practice of acupuncture undertaken in the trial was diverse reecting styles practised in different cultural contexts. Study designs examined the effectiveness of acupuncture, rather than providing an evaluation of the efcacy of acupuncture using placebo controlled designs. There was some limited evidence of acupuncture showing a benet in relation to the primary outcomes of pain relief and reduced menstrual symptoms. There was an improvement in pain
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relief for women receiving acupuncture compared with NSAIDs (SMD -0.70, 95% CI -1.08 to -0.32) and Chinese herbs (SMD 1.34, 95% CI -1.74 to -0.95); and acupressure compared with a placebo control (SMD -0.99, 95% CI -1.48 to -0.49). Two trials of acupuncture showed reduced menstrual symptoms compared with NSAIDs (OR 3.25, 95% CI 1.53 to 6.86) and one trial compared with Chinese herbs (OR 7.0, 95% CI 2.22 to 22.06); one trial of acupressure showed reduced menstrual symptoms compared with a placebo control (SMD -0.58, 95% CI -1.06 to -0.10). Improvements in quality of life following acupuncture compared with usual care were found in one trial, with improvements to the SF36 domains of physical component, bodily pain, mental health, vitality, social function, and emotional role function. There were no differences between acupuncture and placebo acupuncture. The majority of trials did not report on outcomes other than pain, and only one trial reported on adverse events. A small number of trials were included within each comparison. This limits the power of the review to detect meaningful differences between groups and analyses, suggesting the limited benet should be interpreted with caution.
mains. 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 inuenced by a lack of blinding and consequently were rated at a high risk of bias. The small number of studies within comparisons and lack of high quality trials suggest there is insufcient evidence of a consistent treatment effect from acupuncture.
Potential biases in the review process

We attempted to minimise publication bias. Although our search was comprehensive and we included studies identied in languages other than English, we cannot rule out the possibility that some studies have been missed. We are also aware that publication bias is a possibility as the review does not include many trials from China that show a negative result. The characteristics of acupuncture treatment, including variations in the duration, frequency, and selection of acupuncture points, may inuence the quality of acupuncture and treatment effect. It is possible that acupuncture may not have been therapeutically effective, and in some cases may not represent best clinical practice. For example, in trials of acupuncture the duration of treatment would generally be longer than one month or one menstrual cycle; and among acupuncturists trained in TCM, standardised prescriptions would not be used and treatment would be individualised based on the diagnosis, and acupuncture treatment would be varied between sessions. For those trials involving comparisons with medication, no data were reported on compliance, therefore it is unclear if these study groups could have been affected by suboptimal doses of medication. Distinguishing between primary and secondary dysmenorrhea 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 inuenced the responsivness to acupuncture.
Overall completeness and applicability of evidence

There remains relatively few trials of acupuncture and acupressure that assess the role of these interventions in the management of primary dysmenorrhoea. The completeness and applicability of the evidence is limited as from the 10 included trials, three reported useful data and one was at a low risk of bias on all domains. A weakness of trials continues to be the inclusion of few outcomes and omission of quality of life outcomes and adverse events. There were also few trials with follow up of outcomes in the medium and long term. There were variations in the eligibility criteria between trials, with the majority lacking some 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. Trials recruited women from settings similar to those where women would access acupuncture or acupressure. Studies were conducted in different countries and consequently this reects the different styles of acupuncture administered in the studies.
Agreements and disagreements with other studies or reviews

There are two other reviews of acupuncture to treat primary dysmenorrhoea (Cho 2010; Yang 2008). Cho 2010 included nine trials out of 27 trials identied, and Yang 2008 identied 30 trials. Cho 2010 and Yang 2008 both included other modalities of TCM, which were excluded in our review, and included trials for which we were unable to ascertain the randomisation details or we excluded because the trials did not meet the eligibility criteria. Both reviews found promising evidence for the use of acupuncture to treat primary dysmenorrhoea compared with pharmacological medicine or Chinese herbal medicine. The ndings from the Yang 2008 review were more reserved due to conicting results, in part
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Quality of the evidence

The risk of bias table (Figure 1, Figure 2) demonstrates that acupuncture has not been consistently subjected to consistent rigorous study. The quality of reporting was poor in 20% of trials. Twenty per cent of trials were at a high risk of bias in relation to randomisation. One trial was rated at a low risk of bias on all do-
due to a greater number of trials included which added to the heterogeneity of the ndings. The ndings from both reviews were inuenced by the methodological aws of the trials.
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 effectiveness comparative designs using medication, for example NSAIDs or other forms of standard care, and efcacy designs using placebo controls. Future studies should also give consideration to including long-term evaluation of effectiveness and adverse effects of acupuncture.
AUTHORS CONCLUSIONS Implications for practice

There are insufcient data to demonstrate whether acupuncture is effective in treating primary dysmenorrhoea. However, the risk of bias was variable across studies and recommendations for practice cannot be made until further high quality research has been undertaken.
ACKNOWLEDGEMENTS
The review authors would like to acknowledge the Menstrual Disorders Review team 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 and Song Mei Wu. To Julie Marker for her assistance with review and data extraction of English language trials, and Karen Cheer for assisting with implementing the search strategy.
Implications for research

Further randomised controlled trials are required to evaluate the effectiveness of acupuncture in the treatment of primary dysmenorrhoea. All future randomised trials must 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
REFERENCES
References to studies included in this review

Chen 2004 {published data only} Chen HM, Chen CH. Effects of acupressure at the Sanyinjiao on primary dysmenorrhoea. Journal of Advanced Nursing 2004;48(4): 3807. Chen 2010 {published data only} Chen HM, Chen CH. Effects of acupressure on menstrual distress in adolescent girls: a comparison between Hegu-Sanyinjiao matched points and Hegu, Zusanli single point. Journal of Clinical Nursing 2010;19:9981007. Helms 1987 {published data only} Helms JM. Acupuncture for the management of primary dysmenorrhea. Obstetrics and Gynecology 1987;69(1):516. 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. Li 2008 {published data only} Li CH, Wang YZ, Ge XX. Clinical observation of the use of acupuncture on 4 gate points for primary dysmenorrhoea. Journal Chinese Acupuncture and Moxibustion 2008;28:18790. 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. eCAM 2010:doi:10.1093/ecam/ nep239.
Wang 2009 {published data only} Wang MC, Hsu MC, Chein LW, Kao CH, Liu CF. Effects of auricular acupressure on menstrual symptoms and nitric oxide for women with primary dysmenorrhea. Journal of Alternative and Complementary Medicine 2009;15(3):23542. Witt 2008 {published data only} Witt CM, Reinhold T, Brinkhaus B, Roll S, Jena S, Willich SN. Acupuncture in patients with dysmenorrhea: a randomized study of clinical effectiveness and cost-effectiveness in usual care. American Journal of Obstetrics and Gynecology 2008;198:166.e1166.e8. 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. Zhi 2007b {published data only} Zhi L. Randomised controlled study on supercial needling for treatment of primary dysmenorrhea. Chinese Acupuncture and Moxibustion 2007;27(1):1821.
References to studies excluded from this review

Chen 2008 {published data only} Chen B, Tu XH. Clinical observation on the efcacy of acupuncture in treating primary dysmenorrhoea. Shanghai Journal of Acupuncture and Moxibustion 2008;27(6):156.
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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. Habek 2003 {published data only} Habek D, Habek JC, Bobic-Vukovic, Vujic B. Efcacy of acupuncture for the treatment of primary dysmenorrhoea. Gynakologisch-Geburtshiliche Rundschau 2003;43:2503. 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. Huo 2008 {published data only} Huo. Clinical observation on the use of Shao Fu Zhu Yu Tang in combination with acupuncture for 65 cases of primary dysmenorrhoea. Chinese Journal of Basic Medicine 2008;14(6): 4456. 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. Li 2006 {published data only} Li W, Liu L, Sun Li. Analysis on therapeutic effect of substancepartitioned 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. 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. Pouresmal 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. 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. 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.
Song 1992 {published data only} Song XZ, Ji Y. Clinical observation on the efcacy of ear seed pressing on dysmenorrhea. Journal of Beijing College of Traditional Chinese Medicine 1992;2:589. 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 L, Ge J, She Y, et al.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. 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 2005 {published data only} Wang SM, Li XG, Zhang LQ. Clinical observation on 96 cases of primary dysmenorrhea treated by medicine-separated moxibustion and investigation on its mechanisms. World Journal of AcupunctureMoxibustion 2005;15(3):137. 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. Yang 2008 {published data only} Yang JJ, Sun LH, She YF, Ge JJ, Li XH, Zhang RJ. Inuence 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. 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. 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. Zhi 2007 {published data only} Zhi L. Randomised controlled study on supercial needling for treatment of primary dysmenorrhea. Chinese Acupuncture and Moxibustion 2007;27(1):1821. Zhou 2003 {published data only} Zhou LS. Clinical observation on the efcacy of acupuncture of Ciliao (BL32) point on primary dysmenorrhea. Hubei Journal of Traditional Chinese Medicine 2003;8:47.
References to studies awaiting assessment

Hu 2005 {published data only} Hu P, Chen SJ. Clinical observation of warm acupuncture for primary dysmenorrhea. Practical Clinical Journal of Integrated Chinese and Western Medicine 2005;5:212.
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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. Lee 2007 {published data only} Lee IS, Youn HM, Jung KK, et al.Effect of sa-am acupuncture treatment on dysmenorrhea pilot study, single blind, randomised sham acupuncture, controlled clinical trial. Journal of the Korean Acupuncture and Moxibustion Society 2008;24:6379. Lui 1999 {published data only} Lui AZ, Zhang CM. Study of acupuncture versus psychological therapy for dysmenorrhea. Zhongguop Zhenjiu 1999;19:20910. 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 prostaglandin. Chinese Acupuncture and Moxibustion 2009;4:2658. 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. 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 2003 {published data only} Zhang M, Sun ST. Clinical observation of acupuncture therapy for 32 cases of primary dysmenorrhea. Journal of Chinese Science, Technology and Traditional Chinese Medicine 2003;10:322.
antagonists and inhibitory effects on isolated myometrium from preterm and pregnant women. British Journal of Obstetrics and Gynaecology 1999;106:104753. Banikarim 2000 Banikarim C, Chacko MR, Kedler SH. Prevalence and impact of dysmenorrhoea on Hispanic female adolescents. Archives of Pediatrics & Adolescent Medicine 2000;154:12269. Campbell 1999 Campbell MA, McGrath PJ. Non pharmacological strategies used by adolescents for the management of menstrual discomfort. The Clinical Journal of Pain 1999;15:31320. Cho 2010 Cho SH, Hwang EW. Acupuncture for primary dysmenorrhoea: a systematic review. BJOG 2010;117:50921. Dawood 1985 Dawood YM. Dysmenorrhea. Pain and Analgesia 1985;1:20. Dawood 1988 Dawood MY. Nonsteroidal anti-inammatory drugs and changing attitudes towards dysmenorrhea. American Journal of Medicine 1988;84(5A):239. Dawood 1990 Dawood MY. Dysmenorrhoea. Clinical Obstetrics and Gynecology 1990;33(1):16878. Egger 1997 Egger M, Smith GD, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:62934. Henzl 1985 Henzl MR. Dysmenorrhea: Achievements and challenge. Sexual Medicine Today 1985;9:812. Higgins 2008 Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 5.0.0 [February 2008]. The Cochrane Collaboration. Hillen 1999 Hillen IJ, Grbavac SL, Johnston PJ, Straton JAY, Keogh JMF. Primary dysmenorrhoea in young Western Australian Women: Prevalence, impact and knowledge of treatment. The Journal of Adolescent Health 1999;25:405. Jamieson 1996 Jamieson DJ, Steege JF. The prevalence of dysmenorrhoea, dyspareunia, pelvic pain and irritable bowel syndrome in primary care practices. Obstetrics and Gynecology 1996;87(1):559. Kennedy 1997 Kennedy S. Primary dysmenorrhoea. Lancet 1997;349:116. Lin 2008 Lin J, Chen W. Acupuncture analgesia: a review of its mechanisms of actions. American Journal of Chinese Medicine 2008;36(4): 63545. MacPherson 2004 MacPherson H, Scullion A, Thomas K, et al.Patient reports of adverse events associated with acupuncture treatment: a prospective national survey. Quality and Safety in Health Care 2004;13:34955.
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References to ongoing studies

Gao 2009 {published data only} A clinical trial of acupuncture treatment for primary dysmenorrhoea. Ongoing study April 2008. Huang 2008 {published data only} Psychological outcomes from a study of acupuncture treatment on experimentally primary dysmenorrhoea. Ongoing study June 2009. Huang 2010 {published data only} Randomised controlled trial of acupuncture for dysmenorrhoea. Ongoing study May 2010.
Additional references
Akerlund 1976 Akerlund M, Anderson K-E. Vasopressin response and terbutaline inhibition of the uterus. Obstetrics and Gynecology 1976;47:52836. Akerlund 1979 Akerlund M, Stromberg P, Fosling ML. Primary dysmenorrhoea and vasopressin. British Journal of Obstetrics and Gynaecology 1979; 86:4847. Akerlund 1999 Akerlund M, Bossmar T, Brouard R, Kostrzewska A, Laudanski T, Lemancewicz A, et al.Receptor binding of oxytocin and vasopressin
OConnell 2006 OConnell K, Davis AR, Westhoff C. Self treatment patterns among adolescent girls with dysmenorrhoea. Journal of Pediatric & Adolescent Medicine 2000;154:12269. Proctor 2002a 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. [DOI: 10.1002/14651858] REVMAN 2008 The Nordic Cochrane Centre. Review Manager (RevMan) [Computer program].Version 5.0.. Copenhagen: The Cochrane Collaboration,, 2008. Stener-Victorin 2006 Stener-Voctorin E, Fujisawa S, Kurosawa M. Ovarian blood ow responses to electroacupuncture stimulation depend on estrous cycle and on site and frequency of stimulation in anesthetized rats. Journal of Applied Physiology 2006;101:8491. Stromberg 1984 Stromberg P, Akerlund M, Forsling ML, Granstrom E, Kindahl H. Vasopressin and prostaglandin in premenstrual pain and primary dysmenorrhoea. Acta Obstetricia et Gynecologica Scandinavica 1984; 63:5338. Stux 1995 Stux G, Pomeranz B. Basics of acupuncture. 3rd Edition. Berlin: 1995. Basics of acupuncture. 3rd Edition. Berlin: Springer-Verlag, 1995. Stvanberg 1981 Stvanberg L, Ulmsten U. The incidence of primary dysmenorrhoea in teenagers. Archives of Gynecology 1981;230:1737.
Tracey 2007 Tracey I, Mantyh PW. The cerebral signature for pain perception and its modulation. Neuron 2007;55:377391. White 2001 White A, Hayhoe S, Hart A, et al.Survey of adverse events following acupuncture (SAFA): a prospective study of 32,000 consultations. Acupuncture in Medicine 2001;19:8492. Xiang 2002 Xiang D F, Situ Y, Liang X F, Chen L, Zhang GL. Auricular acupuncture for 37 cases of dysmenorrhoea due to endometriosis. Journal of Traditional Chinese Medicine 2202;2(4):2825. Xiang 2005 Xiang D F, Si D Y. Laboratory study on inuence of auricular acupuncture in regulating?-endorphin and uterine activity on animal model of endometriosis. Guo Yi Lun Tan (Forum on Traditional Chinese Medicine) 2005;20(4):467. Yang 2008 Yang H, Liu CZ, Xiao L-X, et al.Systematic review of clinical trials of acupuncture related therapies for primary dysmenorrhea. Acta Obstetricia et Gynecologica 2008;87:111422.
References to other published versions of this review

Proctor 2002 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. [DOI: 10.1002/14651858] Indicates the major publication for the study
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CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Chen 2004 Methods Randomised controlled trial, two groups acupressure on SP6, compared with rest. Assessment of blinding: not appropriate no blinding. Groups comparable at baseline: baseline characteristics assessed were said to be statistically similar, but number of subjects in the groups does not add up for Analgesic usage and absent from class. There may be imbalances at baseline. Loss to follow up: 12% loss acupressure, 35% control. Compliance: not reported. No certainty or evidence that intervention was self-administered at all. Intention to treat: not reported. Duration: December 2000- August 2001. Eighty-one female students participated in the study. Inclusion criteria: age less than 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. 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 1.21kg, (method of assessment of the force not reported) increasing to 3.53kg. Acupressure applied for 6 seconds, released for 2 seconds without pressure. This was continued for 5 minutes on each leg, and repeated four times. When cramping occurred in the initial session acupressure was applied. When cramping occurred subjects were asked to rest in the school health centre for 20 minutes. Short Form McGill Pain Questionnaire measures the intensity of pain, Menstrual Distress Questionnaire, visual analogue scale to measures anxiety. Location: Taiwan Setting: technical high school Funding: government grant
Participants
Interventions
Outcomes
Notes
Risk of bias Item Adequate sequence generation? Allocation concealment? Authors judgement Yes Yes Description Drawn by lot. Sealed envelopes.
20
Chen 2004
(Continued)
Blinding? All outcomes
No
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. (Comparator with sham acupressure point Control was not mentioned as a consideration) 50% drop out in control group
Incomplete outcome data addressed? All outcomes Free of selective reporting?
No
Unclear
Study protocol was not available, therefore cannot rule out selective reporting. No clear statement of primary or secondary outcomes. Baseline characteristics assessed were said to be statistically similar, but number of subjects in the groups does not add up for analgesic usage and absent from class. There maybe imbalances at baseline.
Free of other bias?
Unclear
Chen 2010 Methods Randomised controlled trial, four groups, acupressure on group 1) ST 36, group 2) LI4, group 3) LI4 plus SP6, versus no treatment. Assessment of blinding: no blinding. Groups comparable at baseline. Loss to follow up: 40% drop out similar between groups. Intention to treat: not reported. Compliance: not ascertained. Duration: January- August 2003. 134 adolescents (aged <20 years), with a pain score of >4 on the VAS, no gynaecological disease, or secondary diagnosis (details of diagnosis conrmation not reported). Exclusion criteria included skin infection, haemorrhage or phlebitis. The three experimental groups were given a detailed acupressure protocol. The researcher applied acupressure during the rst menstrual period. When the VASP score was > 4, participants were asked to attend the health care ofce for acupressure. Acupressure was applied alternating between each leg. The force was initially 1kg (method of assessment of force applied not reported), increasing to 4kg at the end of the therapy. Pressure was applied for six seconds, then a rotating movement was made for 2-3 seconds alternating without pressure. The process was applied four times over 20 minutes. 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.
Participants
Interventions
21
Chen 2010
(Continued)
Outcomes
Short Form McGill Pain Questionnaire measures the intensity of pain, Menstrual Distress Questionnaire, visual analogue scale to measures anxiety. Location: Taiwan Setting: Medical Technology University. Funding: government grant
Notes
Risk of bias Item Adequate sequence generation? Allocation concealment? Blinding? All outcomes Authors judgement Yes Yes No Description Drawn by lot. Sealed envelopes. No blinding of participants, the practitioner was not blind, and blinding of the analyst was not reported. High drop-out rates of up to 40% but similar number and reason across all groups. Attempts made to increase return rate of questionnaires by trained assistants. Study protocol was not available, therefore cannot rule out selective reporting. No clear statement of prospective primary or secondary outcomes. Unclear from reporting.
Incomplete outcome data addressed? All outcomes
No
Free of selective reporting?
Unclear
Free of other bias?
Unclear
Helms 1987 Methods Randomised controlled trial, 4 groups: 1) acupuncture, 2) placebo acupuncture, 3) standard control initial visit only and 4) visitation control. Assessment of blinding: not reported. Groups comparable at baseline: yes. Loss to follow up: 11%, 2 from visitation and one respectively from each group. Compliance: not reported. Intention to treat: not stated. Duration: not stated. Forty-eight women were recruited. Women had recurrent pain that started within two years of regular menstruation, and in the absence of any pelvic pathology. No other details on inclusion and exclusion criteria were stated.
Participants
22
Helms 1987
(Continued)
Interventions
Acupuncture group: real acupuncture with needles inserted into the skin along meridian points; placebo acupuncture with needles inserted in the same manner at points close to real acupuncture points, but areas that were veried as having no electrical activity; standard control involved an initial meeting but then participants continued on what ever method they used prior to the study; visitation control was the same as the standard control with the addition of extra visits to the physician during the study. 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 min, 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 channel (meridian) and veried as not having electrical activity. Twelve needles were used per treatment, retained for 30 minutes. 3) Standard control group had no contact with the physician-investigator after initial interview. 4) Visitation control, visited the physician once a month after their rst three periods and reviewed their symptom evaluation form with him. For the subsequent nine months forms were completed with no special attention. Pain duration, pain intensity, pain scores pre, during, post, and a menstrual questionnaire. Improvement was arbitrarily dened as being an average posttreatment score of less than half that of the pretreatment score. Location: United States of America Setting: Gynecological clinic Funding: not reported
Outcomes
Notes
Risk of bias Item Adequate sequence generation? Allocation concealment? Blinding? All outcomes Authors judgement Yes Unclear No Description Table of random numbers. Not reported. The subjects in two groups were blind to their acupuncture group (blinding not assessed), but participants aware of allocation to acupuncture or control group. The outcome analyst was blind, the therapist was not blind. Five subjects (10%) discontinued treatment. Two pregnancies, 2 job relocations, one lack of interest. Missing outcome data balanced across groups. Study protocol not available and primary outcomes were not pre-specied.
23
Yes
Unclear
Helms 1987
(Continued)
Free of other bias?
Unclear
The study appears free of other biases.
Jiang 2007 Methods Randomised controlled trial, two groups, acupuncture compared with medication indomethacin. Assessment of blinding: no blinding. Groups comparable at baseline: not reported. Loss to follow up: nil. Compliance: not reported. Duration of trial: not reported. Intention to treat: not stated. Sixty-eight young women aged 15-28 years were recruited. Primary dysmenorrhoea was conrmed by ultrasound and physical examination, and the severity of pain assessed using self report questionnaire. Women were recruited from the gynaecology clinic and acupuncture department. Cases with secondary dysmenorrhoea were excluded. Acupuncture points BL31, BL32, BL33, LIV 3, SP6, SP8, PC6, ST36, were manipulated using a reinforcing method, once a day for 7 days. Needles were retained for 30 minutes and manipulated three times. No pain medication was allowed. The treatment commenced four days prior to the expected menstruation. Indomethacin tablets were administered orally 25mg three times a day for seven days. The treatment commenced four days prior to the expected menstruation. Outcome measures were unclear but categorised as cured: pain and symptoms disappeared at treatment and no relapse after three menstrual cycles; marked effect: scores have reduced by 50% at nal treatment, pain and other symptoms have lessened, return to work and no medication needed; effective: nal score reduced by 50%, symptoms improved, return to work and no pain medication needed; no effect: no change to pain and other symptoms. Location: Liaoning province, China Setting: TCM hospital Funding: not reported
Participants
Interventions
Outcomes
Notes
Risk of bias Item Adequate sequence generation? Allocation concealment? Authors judgement No No Description Sequence generation by date of admission. Procedures based on inadequate randomisation.
24
Jiang 2007
(Continued)
Blinding? All outcomes Incomplete outcome data addressed? All outcomes Free of selective reporting? Free of other bias?
No
No blinding.
Yes
No missing data.
Unclear Unclear
Insufcient information to judge. Insufcent information to make assessment.
Li 2008 Methods Randomised controlled trial, three groups: 1) acupuncture using the four gates, 2) traditional acupuncture points, 3) patented Chinese herbal medicine. Assessment of blinding: not relevant to comparison acupuncture versus herbs. Groups comparable at baseline: not reported. Loss to follow up: no drop out. Compliance: not reported. Duration: not reported. Intention to treat: not stated. One hundred and eighty women aged 12-27 were recruited. Pathology was eliminated although not specied. No other details were reported. Three month intervention. The active acupuncture group used points LI4, LIV3. Additional 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 x40mm). For LI4, LIV 3 needles were inserted and manipulated using twirling reinforcing reducing method until de qi obtained. Needles were retained at an angle 45 degrees 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 two 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 or period, and continued until the last day of bleeding. Two 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 10g was dissolved in hot water and ten at morning and night starting one week prior to the onset of the menstrual cycle, until the third day of bleeding. Basal body temperature, degree of improvement in dysmenorrhoea symptoms, plasma levels of prostaglandin F2 alpha.
Participants
Interventions
Outcomes
25
Li 2008
(Continued)
Notes
Location: China Setting: Henan Luohe High Medical Training School Third Afliated Hospital and Luohe Municipal Hospital of TCMs gynaecological department Funding: not reported
Risk of bias Item Adequate sequence generation? Allocation concealment? Blinding? All outcomes Authors judgement Yes Unclear No Description Random number tables used. Not reported. No blinding, and outcome measurement maybe inuenced by lack of blinding, no other details reported. No missing data
Incomplete outcome data addressed? All outcomes Free of selective reporting? Free of other bias?
Yes
Unclear Unclear
Insufcient information to judge. Insufcient information to judge.
Smith 2010 Methods Randomised controlled trial, two groups, acupuncture compared with placebo control using placebo needle. 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), 34%, 42% unsure of their group allocation. 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 to August 2005. Intention-to-treat analysis undertaken 92 women aged 14-25 years recruited. A diagnosis of primary dysmenorrhoea was based on self reported severe incapacitating pain for at least one day of menses in two menstrual cycles classied by a pre-dened pain score of >6 on the McGill questionnaire. Secondary dysmenorrhoea was excluded by clinical evidence conrming diagnosis of primary dysmenorrhoea. Other exclusion criteria included: pelvic pathology, pain associated with IUD. All subjects received the intervention for 30-40 minutes, weekly for three weeks, followed by a week of no treatment during the week of expected menses. Treatment was administered over three months.
26
Participants
Interventions
Smith 2010
(Continued)
TCM acupuncture protocol based on expert opinion, review or literature and experience of practitioners. Nine 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 Deciency: 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 deciency: Zusanli ST36, Sanyinjiao SP6, Guanyuan Ren-4, Qihai Ren-6, Geshu UB17, Ganshu UB18, Shenshu UB23, Taixi KD3. Seirin 0.2x30mm acupuncture needles were inserted bilaterally to a depth of not greater than 2cm, and the needles were retained for 30 minutes. All subjects received the de qi sensation following initial insertion of needles and half way through the treatment session. Reinforcing or reducing stimulation was given according to the TCM diagnoses, and standardized 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 4cm away from an acupuncture point or meridian. Placebo acupuncture needles (0.30 x 30mm) were used. Outcomes Primary and secondary endpoints were measured at three, six and 12 months after trial entry. The primary outcome measures were 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 completed by subjects. Subjects completed a self report questionnaire to collect data on secondary endpoints including restriction with daily living activities, and the Short Form 36 (SF36). Location: South Australia Setting: from the community through their general practitioner, gynaecologist or by self referral Funding: government National Health and Medical Research Council
Notes
Risk of bias Item Adequate sequence generation? Authors judgement Yes Description Computer generated using variable block size, stratied by previous use or non-use of acupuncture, generated by independent statistician.
27
Smith 2010
(Continued)
Allocation concealment?
Yes
Central telephone randomisation procedure. Participants were blind to treatment allocation (blinding assessed), the acupuncturists were not blind, the statistician was blind to group allocation. Missing outcome data balanced across groups. The study protocol is available and all study primary and secondary study endpoints were pre-specied as on the Australian and New Zealand Clinical Trial Registry. 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 patients reports (Assessment of blinding) suggest they were genuinely blinded to treatment allocation, and control patients had similar contact time and psychosocial experience to intervention group.
Yes
Incomplete outcome data addressed? All outcomes Free of selective reporting?
Yes
Yes
Free of other bias?
Yes
Wang 2009 Methods Randomised controlled trial, two groups, auricular acupressure compared with placebo adhesive patch. Assessment of blinding: not applicable. Groups comparable at baseline: no differences between groups. Loss to follow up: 3, 1 treatment, 2 control groups. Compliance: not reported. Intention to treat: not reported. Duration: not reported. Seventy-four women aged 18-28 years were recruited. Women had no secondary dysmenorrhoea or other pathology, a serum CA125 level of less than 35mg/dL, onset of primary dysmenorrhoea within six months of menses, menstrual pain on three occasions within the past six months, no history of smoking, not taking over the counter analgesics, able to speak Chinese or Taiwanese.
Participants
28
Wang 2009
(Continued)
Interventions
Intervention: three 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 subjects were instructed to massage each point 15 times, three times a day for 20 days. Patches were replaced every ve days. Short form Menstrual Distress Questionnaire, and serum nitrous oxide 20 days postbaseline. Location: Taiwan Setting: colleges Funding: not reported
Outcomes
Notes
Risk of bias Item Adequate sequence generation? Allocation concealment? Blinding? All outcomes Authors judgement Yes Yes Yes Description Computer generated. Concealed envelopes. Blinding of subjects was attempted, both received patches. The practitioner was not blind to group allocation, outcome was self report and analysis was undertaken by independent researcher. Double blind. Data missing on three subjects. Similar reasons due to time management across groups. Study protocol not available. Insufcient reporting to judge.
Yes
Free of selective reporting? Free of other bias?
Unclear Unclear
29
Witt 2008 Methods Pragmatic randomised controlled trial, two groups acupuncture or usual care. Assessment of blinding: not applicable 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. Intention-to-treat analysis: undertaken. Inclusion criteria: aged >18 years, primary dysmenorrhoea from the onset of menarche, and at least for 12 months. Exclusion criteria pain caused by inammatory or malignant disease. It was not stated how secondary dysmenorrhoea was excluded, although data were presented for primary dysmenorrhoea. 201 women were randomised to the study, 117 of these had primary dysmenorrhoea. Acupuncture was administered over three months, subjects received a maximum of 15 acupuncture sessionsThe trial was undertaken in primary health care setting with acupuncture performed by physicians. The trial consisted of a three month treatment intervention, with a three 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 patients allowed to use any additional conventional treatments they chose). Primary endpoint average pain intensity measured along numerical rating scale. Responder dened as a reduction of 33%. Secondary outcomes: worst pain intensity, quality of life using the SF36, and side effects. Outcomes were measured at 3 months. Location: Germany Setting: participants recruited from health insurance fund Funding: social health insurance companies
Participants
Interventions
Outcomes
Notes
Risk of bias Item Adequate sequence generation? Authors judgement Yes Description Computer-generated randomisation sequence. Central telephone randomisation procedure. No blinding and the outcome measure was self reported and may be inuenced by lack of blinding. No other details reported.
Allocation concealment?
Yes
No
30
Witt 2008
(Continued)
Yes
For the primary outcome of pain after 3 months, the missing data were similar for the intervention and control groups. More control patients did not complete the 6 month outcome questionnaires. No explanation or reason for drop-outs was given at 3 or 6 months. Study protocol not available. High follow-up rates, conservative methods to deal with missing data.
Free of selective reporting? Free of other bias?
Unclear Yes
Wu 2007 Methods Randomised controlled trial, two groups, ear taping and pressure compared with pharmacological intervention (Indometacin). Assessment of blinding: not applicable. Groups comparable at baseline. Loss to follow up: no drop out. Compliance: not reported. Duration: not reported. Intention to treat: not reported. Sixty women aged 14-25 years were recruited. Women were recruited if they had symptoms and diagnosis consistent with traditional Chinese medicine. Intervention: ear tapping was made on auricular ear points Shenmen, Zigong, endocrine, subcortex, sympathetic and kidney. One ear was taped at a time alternating during the day, for severe pain both ears were taped. A vaccaria seed was attached to the plaster on which pressure was applied for 0.5-1 minute. Pressure was applied 5-6 times a day for 1-2 minutes. Treatment commenced at the onset of pain and applied for three days, or until the pain sustained. In the next cycle pressure was applied for seven days. Treatment was administered over three cycles. The control group commenced oral indomexicin, 25mg three times a day until pain was alleviated. Treatment was repeated over three menstrual cycles, with treatment given over seven days if required. No valid or reliable instrument was used. Lower abdominal pain was assessed before, during and after menstruation; time periods not specied. Menstrual related symptoms were scored. A cure was dened as a score of 0 on pain for three consecutive months. Location: China Setting: Obstetric and Gynecological clinic at Yongchun Hospital, Quanzhou Funding: not reported
Participants
Interventions
Outcomes
Notes
Risk of bias
31
Wu 2007
(Continued)
Item Adequate sequence generation? Allocation concealment? Blinding? All outcomes
Authors judgement No No No
Description Alternation. Open allocation. No blinding and outcome likely to be inuenced by a lack of blinding, no other details reported. No missing data.
Incomplete outcome data addressed? All outcomes Free of selective reporting? Free of other bias?
Yes
Unclear Unclear
Study protocol not available. Insufcient information to judge.
Zhi 2007b Methods Randomised control trial, parallel design, three groups: 1) electro-acupuncture, 2) supercial acupuncture compared with 3) control medication ibuprofen. Assessment of blinding: not appropriate between acupuncture and medication comparison. Groups comparable at baseline: no differences in small number of variables reported. Loss to follow up: one woman from supercial acupuncture dropped out and 3 in the medication group. Compliance: not stated. Intention to treat: not reported. Duration: September 2004 and May 2006. 171 women were recruited. 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 three consecutive menstrual cycles, affects womens work or lifestyle and requires 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-inammatories. Women received the rst treatment on the rst day of the cycle, there after treatment commenced 3 days before the start of the cycle. This was continued for 3 menstrual cycles. Two intervention groups. Women who received supercial acupuncture (SA) received acupuncture bilateral stimulation to point SP6 only. Needles 0.60mm x 32mm were used. Needles were positioned at 15-25 degrees and inserted at a rapid speed, the needles are inserted to the needle length of 30mm, and the manipulating left and right in a 15 degree 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 sterilized bandage.
32
Participants
Interventions
Zhi 2007b
(Continued)
For women receiving electrostimulation the position, point location, insertion method, manipulation method were identical to SA group. The needle was then pulled out 34mm, 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, 2.5sec, continuous frequency 60Hz, 5sec), voltage at 2-3V (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 sterilized bandage used to cover the exposed needle base. Control group: women allocated to the medication group took oral 0.3mg ibuprufen 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. Othe assessment 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, no effect. Location: China Setting: hospital gynaecology hospital department, Jiaozuo, China Funding: not reported
Notes
Risk of bias Item Adequate sequence generation? Allocation concealment? Blinding? All outcomes Incomplete outcome data addressed? All outcomes Authors judgement Yes Unclear No Description Computer-generated list. No details reported. Participants were not blind to their group allocation. No other details were reported. One woman from the electro group, 2 from supercial acupuncture, 1 from medication failed to follow up. The risk was not enough to have clinically relevant impact on the intervention effect estimate. Insufcient information to permit judgment of yes or no. Insufcient information to assess whether an important risk of bias exists.
Yes
Unclear
Free of other bias?
Unclear
33
Characteristics of excluded studies [ordered by study ID]
Study Chen 2008 Geng 2008 Habek 2003 He 2005 Huo 2008 Jun 2007 Kempf 2009 Li 2006
Reason for exclusion We were unable to conrm any details on randomisation. The study evaluated the use of acupuncture plus Chinese herbs and did not meet our inclusion criteria. We were unable to conrm any details on randomisation. This trial evaluated acupuncture plus moxibustion and did not meet our inclusion criteria. The study did not meet our inclusion criteria. The trial used quasi-randomisation and did not meet our inclusion criteria. The trial evaluated the use of laser acupuncture. The trial evaluated the effect of moxibustion as the sole active intervention on acupuncture points and did not meet the inclusion criteria. The trial evaluated acupuncture plus a herbal plaster and did not meet our inclusion criteria. The trial injected vitamin K3 into the acupuncture point, this intervention did not meet the inclusion criteria. We were unable to conrm details on randomisation from the author. We were unable to conrm details on randomisation from the author. We were unable to obtain details from the author on the methods of concealment and allocation of randomisation. We were unable to obtain details from the author on the methods of concealment and allocation of randomisation. This trial examined moxibustion to the acupuncture point. This trial examined moxibustion to the acupuncture point. Data reporting was incomplete and we were unable to obtain details from the author regarding randomisation. This examined the effect of moxibustion to the acupuncture point. The trial compared acupuncture to an alternative acupuncture treatment group. This trial evaluated moxibustion and did not meet our inclusion criteria. The trial evaluated acupuncture plus massage and did not meet our inclusion criteria. We were unable to obtain details from the author on the methods of concealment and allocation of randomisation.
Li 2007 Liu 2005 Pouresmal 2002 She 2008 Shi 1994 Song 1992 Sun 2004 Sun 2008 Wang 2002 Wang 2005 Xie 2003 Yang 2008 Yi 2005 Zheng 2006
34
(Continued)
Zhi 2007 Zhou 2003
This is a duplicate publication. We were unable to obtain details from the author on the methods of concealment and allocation of randomisation.
Characteristics of studies awaiting assessment [ordered by study ID]

Hu 2005 Methods Participants Interventions Outcomes Notes Jun 2004 Methods Participants Interventions Outcomes Notes Lee 2007 Methods Participants Interventions Outcomes Notes Paper requiring translation Paper requiring translation Paper requiring translation
35
Lui 1999 Methods Participants Interventions Outcomes Notes Wang 2009b Methods Participants Interventions Outcomes Notes Youn 2008 Methods Participants Interventions Outcomes Notes Yuk 2005 Methods Participants Interventions Outcomes Notes Paper requiring translation Paper requiring translation Paper requiring translation Paper requiring translation
36
Zhang 2003 Methods Participants Interventions Outcomes Notes Paper requiring translation
Characteristics of ongoing studies [ordered by study ID]

Gao 2009 Trial name or title Methods Participants A clinical trial of acupuncture treatment for primary dysmenorrhoea Randomised controlled trial Sample size 600. Age 16-35 years, regular menstrual cycle, no pain killers. Exclusion criteria: secondary dysmenorrhoea Acupuncture treatment 5 days before menstruation, and during menstruation one treatment daily for three menstrual cycles. Control group, asprin. Second control group of one acupuncture point only Laboratory examination. Pain April 2008 Shuzhong Gao. gaoshuzhong@163.com Trial has nished recruitment
Interventions
Outcomes Starting date Contact information Notes Huang 2008 Trial name or title Methods Participants
Psychological outcomes from a study of acupuncture treatment on experimentally primary dysmenorrhoea Phase III randomised controlled trial Women aged 18-30 years, regular menstruation, meeting criteria for primary dysmenorrhoea, moderate to severe symptoms Acupuncture with di qi compared to acupuncture without de qi Pain intensity June 2009
Interventions Outcomes Starting date
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Huang 2008
(Continued)
Contact information Notes Huang 2010 Trial name or title Methods Participants
Gyhuang@tjh.tjmu.edu.cn
Randomised controlled trial of acupuncture for dysmenorrhoea Randomised controlled trial Minimum age 13 years, dysmenorrhoea in three previous menstrual cycles, poor response to NSAIDs. Exclusion criteria: IUD related dysmenorrhoea Acupuncture. Control mock TENS Pain. Secondary outcomes: use of additional medication, absence from work or school, restriction to daily living activities, overall improvement in symptoms, quality of life, safety May 2010 Chien-Hsun Huang dtfm29@yahoo.com.tw Recruiting
Interventions Outcomes
Starting date Contact information Notes
38
DATA AND ANALYSES
Comparison 1. Acupuncture versus control
Outcome or subgroup title 1 Pain relief short term 1.1 Placebo control 1.2 Usual care 1.3 NSAIDs 1.4 Chinese herbs 2 Improvement in symptoms short term 2.1 Placebo control 2.2 NSAIDs 2.3 Chinese herbal medicine 3 Use of analgesics short term 3.1 Placebo control 4 Restricted activities 4.1 Placebo control 5 Absence from work of school 5.1 Usual care 6 SF36 physical component short term 6.1 Placebo control 6.2 Usual care 7 SF36 Mental health short term 7.1 Placebo control 7.2 Usual care 8 SF36 Bodily Pain Short term 8.1 Placebo control 8.2 Usual care 9 SF36 General health short term 9.1 Placebo control 9.2 Usual care 10 SF36 Vitality short term 10.1 Placebo control 10.2 Usual care 11 SF36 Social function short term 11.1 Placebo control 11.2 Usual care 12 SF36 Role emotional short term 12.1 Placebo control 12.2 Usual care 13 Adverse events 13.1 Usual care
No. of studies 4 1 1 1 1 4 1 2 1 1 1 1 1 1 1 2 1 1 2 1 1 2 1 1 2 1 1 2 1 1 2 1 1 2 1 1 1 1
No. of participants
Statistical method Std. Mean Difference (IV, Fixed, 95% CI) Std. Mean Difference (IV, Fixed, 95% CI) Std. Mean Difference (IV, Fixed, 95% CI) Std. Mean Difference (IV, Fixed, 95% CI) Std. Mean Difference (IV, 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) Odds Ratio (M-H, 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) 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) 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) Odds Ratio (M-H, Fixed, 95% CI)
Effect size Subtotals only -0.23 [-0.64, 0.18] 0.59 [0.22, 0.96] -0.70 [-1.08, -0.32] -1.34 [-1.74, -0.95] Subtotals only 1.58 [0.61, 4.04] 3.25 [1.53, 6.86] 7.00 [2.22, 22.06] Subtotals only 0.91 [0.40, 2.09] Subtotals only 0.72 [0.29, 1.81] Subtotals only 0.06 [-0.54, 0.66] Subtotals only -2.90 [-6.33, 0.53] 5.57 [2.68, 8.46] Subtotals only 4.40 [-3.59, 12.39] 10.49 [3.63, 17.35] Subtotals only -7.5 [-16.71, 1.71] 20.10 [9.90, 30.30] Subtotals only 2.30 [-6.98, 11.58] 6.38 [-0.26, 13.02] Subtotals only 2.20 [-6.98, 11.38] 18.12 [11.52, 24.72] Subtotals only -0.5 [-9.53, 8.53] 20.27 [11.52, 29.02] Subtotals only Not estimable 14.16 [1.29, 27.03] Subtotals only 0.27 [0.05, 1.34]
39
92 117 114 120
92 182 120 92 92 117
92 117 92 117 92 117 92 117 92 117
92 117
92 117 117
Comparison 2. Acupressure versus control
Outcome or subgroup title 1 Pain relief 1.1 Placebo control 1.2 Rest 2 Improvement in symptoms 2.1 Placebo control 2.2 Rest
No. of studies 3 1 2 3 1 2
No. of participants
Statistical method Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI) Std. Mean Difference (IV, Random, 95% CI)
Effect size Subtotals only -0.99 [-1.48, -0.49] -0.75 [-2.23, 0.74] Subtotals only -0.58 [-1.06, -0.10] -1.07 [-3.40, 1.27]
71 140 71 140
Analysis 1.1. Comparison 1 Acupuncture versus control, Outcome 1 Pain relief short term.
Review: Acupuncture for primary dysmenorrhoea
Comparison: 1 Acupuncture versus control Outcome: 1 Pain relief short term
Study or subgroup
Acupuncture N Mean(SD)
Control N Mean(SD)
Std. Mean Difference IV,Fixed,95% CI
Weight
Std. Mean Difference IV,Fixed,95% CI
1 Placebo control Smith 2010 46 2 (2.5) 46 2.6 (2.7) 100.0 % -0.23 [ -0.64, 0.18 ]
Subtotal (95% CI)

Heterogeneity: not applicable
46
46
100.0 %
-0.23 [ -0.64, 0.18 ]
Test for overall effect: Z = 1.09 (P = 0.27) 2 Usual care Witt 2008 58 2.58 (2.71) 59 1 (2.63) 100.0 % 0.59 [ 0.22, 0.96 ]
Subtotal (95% CI)

58
59
100.0 %
0.59 [ 0.22, 0.96 ]
Test for overall effect: Z = 3.11 (P = 0.0019) 3 NSAIDs Zhi 2007b 57 1.71 (3.43) 57 4.54 (4.51) 100.0 % -0.70 [ -1.08, -0.32 ]
Subtotal (95% CI)

57
57
100.0 %
-0.70 [ -1.08, -0.32 ]
Test for overall effect: Z = 3.63 (P = 0.00028) 4 Chinese herbs Li 2008 60 1.38 (2.86) 60 5.96 (3.84) 100.0 % -1.34 [ -1.74, -0.95 ]
Subtotal (95% CI)

60
60
100.0 %
-1.34 [ -1.74, -0.95 ]
Test for overall effect: Z = 6.63 (P < 0.00001) Test for subgroup differences: Chi2 = 52.11, df = 3 (P = 0.00), I2 =94%
-10
-5
10
Favours acupuncture
Favours control
40
Analysis 1.2. Comparison 1 Acupuncture versus control, Outcome 2 Improvement in symptoms short term.
Comparison: 1 Acupuncture versus control Outcome: 2 Improvement in symptoms short term
Study or subgroup
Acupuncture n/N
Control n/N
Odds Ratio M-H,Fixed,95% CI
Weight
1 Placebo control Smith 2010 14/46 10/46 100.0 % 1.58 [ 0.61, 4.04 ]
Subtotal (95% CI)

Heterogeneity: not applicable Test for overall effect: Z = 0.95 (P = 0.34) 2 NSAIDs Jiang 2007 Zhi 2007b
46
46
100.0 %
1.58 [ 0.61, 4.04 ]
Total events: 14 (Acupuncture), 10 (Control)
30/34 49/57
24/34 37/57
35.2 % 64.8 %
3.13 [ 0.87, 11.21 ] 3.31 [ 1.31, 8.34 ]
Subtotal (95% CI)
91
91
100.0 %
3.25 [ 1.53, 6.86 ]
Total events: 79 (Acupuncture), 61 (Control) Heterogeneity: Chi2 = 0.01, df = 1 (P = 0.94); I2 =0.0% Test for overall effect: Z = 3.08 (P = 0.0021) 3 Chinese herbal medicine Li 2008 56/60 40/60 100.0 % 7.00 [ 2.22, 22.06 ]
Subtotal (95% CI)

60
60
100.0 %
7.00 [ 2.22, 22.06 ]
Total events: 56 (Acupuncture), 40 (Control) Test for overall effect: Z = 3.32 (P = 0.00089)
0.1 0.2
0.5
10
Favours control
Favours acupuncture
41
Analysis 1.3. Comparison 1 Acupuncture versus control, Outcome 3 Use of analgesics short term.
Comparison: 1 Acupuncture versus control Outcome: 3 Use of analgesics short term
Study or subgroup
Acupuncture n/N
Control n/N
Weight
0.1 0.2
0.5
10
Favours acupuncture
Favours control
Analysis 1.4. Comparison 1 Acupuncture versus control, Outcome 4 Restricted activities.

Comparison: 1 Acupuncture versus control Outcome: 4 Restricted activities
Study or subgroup
Acupuncture n/N
Control n/N
Weight
0.1 0.2
0.5
10
Favours acupuncture
Favours control
42
Analysis 1.5. Comparison 1 Acupuncture versus control, Outcome 5 Absence from work of school.
Comparison: 1 Acupuncture versus control Outcome: 5 Absence from work of school
Study or subgroup
Control N Mean(SD)
Mean Difference IV,Fixed,95% CI
Weight
1 Usual care Witt 2008 58 1.66 (2.16) 59 1.6 (0.84) 100.0 % 0.06 [ -0.54, 0.66 ]
-10
-5
10
Favours control
Favours acupuncture
Analysis 1.6. Comparison 1 Acupuncture versus control, Outcome 6 SF36 physical component short term.
Comparison: 1 Acupuncture versus control Outcome: 6 SF36 physical component short term
Study or subgroup
Control N Mean(SD)
Weight
1 Placebo control Smith 2010 46 49.6 (9.1) 46 52.5 (7.6) 100.0 % -2.90 [ -6.33, 0.53 ]
Subtotal (95% CI)

46
46
100.0 %
-2.90 [ -6.33, 0.53 ]
Test for overall effect: Z = 1.66 (P = 0.097) 2 Usual care Witt 2008 58 53.99 (5.73) 59 48.42 (9.75) 100.0 % 5.57 [ 2.68, 8.46 ]
Subtotal (95% CI)

58
59
100.0 %
5.57 [ 2.68, 8.46 ]
Test for overall effect: Z = 3.77 (P = 0.00016) Test for subgroup differences: Chi2 = 13.71, df = 1 (P = 0.00), I2 =93%
-10
-5
10
Favours control
Favours acupuncture
43
Analysis 1.7. Comparison 1 Acupuncture versus control, Outcome 7 SF36 Mental health short term.
Comparison: 1 Acupuncture versus control Outcome: 7 SF36 Mental health short term
Study or subgroup
Control N Mean(SD)
Weight
1 Placebo control Smith 2010 46 71.4 (18.2) 46 67 (20.8) 100.0 % 4.40 [ -3.59, 12.39 ]
Subtotal (95% CI)

46
46
100.0 %
4.40 [ -3.59, 12.39 ]
Subtotal (95% CI)

58
59
100.0 % 10.49 [ 3.63, 17.35 ]
-10
-5
10
Favours control
Favours acupuncture
44
Analysis 1.8. Comparison 1 Acupuncture versus control, Outcome 8 SF36 Bodily Pain Short term.
Comparison: 1 Acupuncture versus control Outcome: 8 SF36 Bodily Pain Short term
Study or subgroup
Favours control N Mean(SD)
Control N Mean(SD)
Weight
Subtotal (95% CI)

46
46
100.0 % -7.50 [ -16.71, 1.71 ]
Subtotal (95% CI)

58
59
100.0 %
20.10 [ 9.90, 30.30 ]
-10
-5
10
Favours control
Favours acupuncture
45
Analysis 1.9. Comparison 1 Acupuncture versus control, Outcome 9 SF36 General health short term.
Comparison: 1 Acupuncture versus control Outcome: 9 SF36 General health short term
Study or subgroup
Control N Mean(SD)
Weight
1 Placebo control Smith 2010 46 69.2 (20.5) 46 66.9 (24.7) 100.0 % 2.30 [ -6.98, 11.58 ]
Subtotal (95% CI)

46
46
100.0 % 2.30 [ -6.98, 11.58 ]
Test for overall effect: Z = 0.49 (P = 0.63) 2 Usual care Witt 2008 58 74.49 (16.43) 59 68.11 (20.08) 100.0 % 6.38 [ -0.26, 13.02 ]
Subtotal (95% CI)

58
59
100.0 % 6.38 [ -0.26, 13.02 ]
Test for overall effect: Z = 1.88 (P = 0.060) Test for subgroup differences: Chi2 = 0.49, df = 1 (P = 0.48), I2 =0.0%
-10
-5
10
Favours control
Favours acupuncture
46
Analysis 1.10. Comparison 1 Acupuncture versus control, Outcome 10 SF36 Vitality short term.
Comparison: 1 Acupuncture versus control Outcome: 10 SF36 Vitality short term
Study or subgroup
Control N Mean(SD)
Weight
1 Placebo control Smith 2010 46 55.8 (21.8) 46 53.6 (23.1) 100.0 % 2.20 [ -6.98, 11.38 ]
Subtotal (95% CI)

46
46
100.0 %
2.20 [ -6.98, 11.38 ]
Test for overall effect: Z = 0.47 (P = 0.64) 2 Usual care Witt 2008 58 64.12 (14.96) 59 46 (21.01) 100.0 % 18.12 [ 11.52, 24.72 ]
Subtotal (95% CI)

58
59
100.0 % 18.12 [ 11.52, 24.72 ]
-10
-5
10
Favours control
Favours acupuncture
47
Analysis 1.11. Comparison 1 Acupuncture versus control, Outcome 11 SF36 Social function short term.
Comparison: 1 Acupuncture versus control Outcome: 11 SF36 Social function short term
Study or subgroup
Control N Mean(SD)
Weight
Subtotal (95% CI)

46
46
100.0 %
-0.50 [ -9.53, 8.53 ]
Subtotal (95% CI)

58
59
100.0 % 20.27 [ 11.52, 29.02 ]
-10
-5
10
Favours control
Favours acupuncture
48
Analysis 1.12. Comparison 1 Acupuncture versus control, Outcome 12 SF36 Role emotional short term.
Comparison: 1 Acupuncture versus control Outcome: 12 SF36 Role emotional short term
Study or subgroup
Control N Mean(SD)
Weight
1 Placebo control Smith 2010 46 75 (36) 46 75 (33) 100.0 % 0.0 [ -14.11, 14.11 ]
Subtotal (95% CI)

Heterogeneity: not applicable Test for overall effect: Z = 0.0 (P = 1.0) 2 Usual care Witt 2008
46
46
100.0 %
0.0 [ -14.11, 14.11 ]
58
83.97 (30.6)
59
69.81 (39.91)
100.0 %
14.16 [ 1.29, 27.03 ]
Subtotal (95% CI)

58
59
100.0 % 14.16 [ 1.29, 27.03 ]
-10
-5
10
Favours control
Favours acupuncture
Analysis 1.13. Comparison 1 Acupuncture versus control, Outcome 13 Adverse events.

Comparison: 1 Acupuncture versus control Outcome: 13 Adverse events
Study or subgroup
Acupuncture n/N
Control n/N
Weight
1 Usual care Witt 2008 2/58 7/59 100.0 % 0.27 [ 0.05, 1.34 ]
0.1 0.2
0.5
10
Favours acupuncture
Favours control
49
Analysis 2.1. Comparison 2 Acupressure versus control, Outcome 1 Pain relief.

Comparison: 2 Acupressure versus control Outcome: 1 Pain relief
Study or subgroup
Experimental N Mean(SD)
Control N Mean(SD)
Std. Mean Difference IV,Random,95% CI
Weight
1 Placebo control Wang 2009 36 45.6 (9.19) 35 57 (13.3) 100.0 % -0.99 [ -1.48, -0.49 ]
Subtotal (95% CI)

36
35
100.0 %
-0.99 [ -1.48, -0.49 ]
Test for overall effect: Z = 3.92 (P = 0.000089) 2 Rest Chen 2004 Chen 2010 35 36 14.28 (11.69) 1.65 (1.58) 34 35 14.23 (11.49) 9.24 (6.89) 50.6 % 49.4 % 0.00 [ -0.47, 0.48 ] -1.51 [ -2.04, -0.98 ]
Subtotal (95% CI)
71
69
100.0 %
-0.75 [ -2.23, 0.74 ]
Heterogeneity: Tau2 = 1.08; Chi2 = 17.50, df = 1 (P = 0.00003); I2 =94% Test for overall effect: Z = 0.99 (P = 0.32)
-10
-5
10
Favours acupressure
Favours control
50
Analysis 2.2. Comparison 2 Acupressure versus control, Outcome 2 Improvement in symptoms.

Comparison: 2 Acupressure versus control Outcome: 2 Improvement in symptoms
Study or subgroup
Acupressure N Mean(SD)
Control N Mean(SD)
Weight
1 Placebo control Wang 2009 36 52.9 (12.8) 35 60.7 (13.8) 100.0 % -0.58 [ -1.06, -0.10 ]
Subtotal (95% CI)

36
35
100.0 %
-0.58 [ -1.06, -0.10 ]
Test for overall effect: Z = 2.39 (P = 0.017) 2 Rest Chen 2004 Chen 2010 35 36 23.73 (5.61) 19.05 (2.4) 34 35 23.05 (5.89) 24.22 (2.1) 50.7 % 49.3 % 0.12 [ -0.36, 0.59 ] -2.27 [ -2.87, -1.66 ]
Subtotal (95% CI)
71
69
100.0 %
-1.07 [ -3.40, 1.27 ]
Heterogeneity: Tau2 = 2.76; Chi2 = 37.17, df = 1 (P<0.00001); I2 =97% Test for overall effect: Z = 0.90 (P = 0.37)
-10
-5
10
Favours acupressure
Favours control
APPENDICES Appendix 1. MEDLINE

Database: Ovid MEDLINE(R) <1950 to March Week 4 2010> Search Strategy: 1 exp Dysmenorrhea/ 2 pain$ period$.tw. 3 Dysmenorr$.tw. 4 menstrua$ cramp$.tw. 5 pelvi$ pain$.tw. 6 (period$ adj3 cramp$).tw. 7 (menstrua$ adj3 pain$).tw. 8 or/1-7 9 exp Acupuncture/ 10 exp acupuncture therapy/ or exp acupressure/ or exp acupuncture analgesia/ or exp acupuncture, ear/ or exp electroacupuncture/ or exp meridians/ or exp acupuncture points/ or exp moxibustion/ 11 Acupuncture.tw. 12 acupressure$.tw. 13 (electroacupuncture or electro acupuncture or electro-acupuncture).tw. 14 meridian$.tw.
15 mox$.tw. 16 needling.tw. 17 (acu-point$ or acu point$).tw. 18 acupoint$.tw. 19 shu.tw. 20 (shiatsu or tui na).tw. 21 or/9-20 22 8 and 21 23 randomized controlled trial.pt. 24 controlled clinical trial.pt. 25 (randomized or randomised).ab. 26 placebo.ab. 27 drug therapy.fs. 28 randomly.ab. 29 trial.ab. 30 groups.ab. 31 or/23-30 32 (animals not (humans and animals)).sh. 33 31 not 32 34 22 and 33
Appendix 2. CINHAL
1 exp Dysmenorrhea/ 2 pain$ period$.tw. 3 Dysmenorr$.tw. 4 menstrua$ cramp$.tw. 5 pelvi$ pain$.tw. 6 (period$ adj3 cramp$).tw. 7 (menstrua$ adj3 pain$).tw. 8 or/1-7 9 exp Acupuncture/ 10 exp acupuncture therapy/ or exp acupressure/ or exp acupuncture analgesia/ or exp acupuncture, ear/ or exp electroacupuncture/ or exp meridians/ or exp acupuncture points/ or exp moxibustion/ 11 Acupuncture.tw. 12 acupressure$.tw. 13 (electroacupuncture or electro acupuncture or electro-acupuncture).tw. 14 meridian$.tw. 15 mox$.tw. 16 needling.tw. 17 (acu-point$ or acu point$).tw. 18 acupoint$.tw. 19 shu.tw. 20 (shiatsu or tui na).tw. 21 or/9-20 22 8 and 21 23 exp clinical trials/ 24 Clinical trial.pt. 25 (clinic$ adj trial$1).tw. 26 ((singl$ or doubl$ or trebl$ or tripl$) adj (blind$3 or mask$3)).tw. 27 Randomi?ed control$ trial$.tw. 28 Random assignment/
29 Random$ allocat$.tw. 30 Placebo$.tw. 31 Placebos/ 32 Quantitative studies/ 33 Allocat$ random$.tw. 34 or/23-33 35 22 and 34
Appendix 3. CENTRAL
Cochrane Central Register of Controlled Trials <1st Quarter 2010> Search Strategy: 1 exp Dysmenorrhea/ 2 (pain* period*) ti,ab, kw in Clinicial trials 3 (Dysmenor*) ti,ab, kw in Clinicial trials 4 (menstrua* cramp*) ti,ab, kw in Clinicial trials 5 (pelvi* pain*) ti,ab, kw in Clinicial trials 6 (period* near/3 cramp*) ti,ab, kw in Clinicial trials 7 (menstrua* near/3 pain*) ti,ab, kw in Clinicial trials 8 #1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7) in Title, Abstract or keyword 9 MESH descriptor Acupuncture, this term only 10 MeSH descriptor Acupuncture Therapy explode all trees 11 MeSH Acupressure, this term only 12 MeSH descriptor Acupuncture Analgesia, this term only 13 MeSH descriptor Acupuncture, ear, this term only 14 MeSH descriptor Meridians explode all tees 15 MeSH descriptor Acupuncture points, this term only 16 MeSH descriptor Moxibustion, this term only 17 (acupuncture) ti,ab, kw in Clinicial trials 18 (acupressure) ti,ab, kw in Clinicial trials 19 (electro NEXT acupuncture):ti,ab.kw in Clinical Trials 20 (meridian*):ti,ab, kw in Clinicial trials 283 21 (mox*): ti,ab, kw in Clinicial trials 1001 22 (neeedling):ti,ab, kw in Clinicial trials 4009 23 (acu NEXT point*) ti,ab, kw in Clinicial trials 5 24 (acupoint*):ti,ab, kw in Clinicial trials 653 25 (shu*): ti,ab, kw in Clinicial trials 1913 26 (shiatsu OR tui na): ti,ab, kw in Clinicial trials 5 27 (#9 OR #10 OR #11 OR #11 OR #12 OR #13 OR #14 OR #15 OR # 16 OR #17 OR #18 OR #19 OR #20 OR #21 OR #22 OR #23 OR #23 OR #24 OR #25 OR #26) in Title, Abstract or Keywords 11635 28 (#8 AND #27) in Title, Abstract or Keywords
53
Appendix 4. Menstrual Disorders and Subfertility Group (MDSG)

MDSG Search String for CS1680 09.12.08 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 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 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 Title CONTAINS acupoint or acupressure or acupressure-acupuncture therapy or acupuncture or electro-acupuncture or electro-magnetic or electroacupuncture or electrical stimulation or moxibustion
Appendix 5. PsycINFO
1 exp Dysmenorrhea/ 143 2 pain$ period$.tw. 370 3 Dysmenorr$.tw. 253 4 menstrua$ cramp$.tw. 14 5 pelvi$ pain$.tw. 324 6 (period$ adj3 cramp$).tw. 3 7 (menstrua$ adj3 pain$).tw. 159 8 or/1-7 1062 9 exp Acupuncture/ 828 10 Acupuncture.tw. 1112 11 acupressure$.tw. 69 12 (electroacupuncture or electro acupuncture or electro-acupuncture).tw. 179 13 meridian$.tw. 609 14 mox$.tw. 87 15 needling.tw.70 16 (acu-point$ or acu point$).tw.100 17 acupoint$.tw. 99 18 shu.tw. 82 19 (shiatsu or tui na).tw. 10 20 or/9-19 2004 22 8 and 20 11
Appendix 6. 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 Conrm eligibility for review
Reason for exclusion Methods Study design Total study duration 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: Specic intervention; Intervention details (sufcient for replication, if feasible); Integrity of intervention; Outcomes Outcomes and time points (i) collected; (ii) reported;
For each outcome of interest: Outcome denition (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. 2X2 table for dichotomous data; means and SDs for continuous data); Estimate of effect with condence interval; P value; Subgroup analyses. Miscellaneous Key conclusions of the study authors
Appendix 7. 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; shufing 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) Insufcient 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) Insufcient 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 sufcient detail to allow a denitive 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 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 inuenced 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 inuenced 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: Insufcient 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: Insufcient 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: The study protocol is available and all the studys pre-species (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specied way; The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre-specied (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-specied 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-specied; One or more reported primary outcomes were not pre-specied (unless clear justication 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) Insufcient 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 specic 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: Insufcient information to assess whether an important risk of bias exists; or Insufcent rationale or evidence that an identied problem will introduce bias.
WHATS NEW
Last assessed as up-to-date: 11 August 2010.
Date 17 May 2010 23 December 2009
Event Amended Amended
Description Inclusion of acupressure trials. 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. 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 2002a), has now been divided into two reviews. These are: Transcutaneous electrical nerve stimulation for primary dysmenorrhoea and Acupuncture for primary dysmenorrhoea.
19 November 2008
Amended
HISTORY
Protocol rst published: Issue 3, 2009 Review rst published: Issue 1, 2011
59
CONTRIBUTIONS OF AUTHORS
Caroline Smith conceptualised and wrote the protocol and systematic review: she reviewed the trials, performed data extraction and jointly wrote the review. Caroline Smith is the guarantor of the review. Xiaoshu Zhu undertook review of the trials, performed data extraction, and commented on the review. Lin He searched the Chinese databases, and commented on the protocol. Jing Song commented on the protocol and review, and contributed to data interpretation.
DECLARATIONS OF INTEREST
CS recently completed a randomised controlled trial of acupuncture to treat primary dysmenorrhoea. No other potential conicts of interest have been noted.
SOURCES OF SUPPORT Internal sources

Caroline Smith, Australia. Centre for Complementary Medicine Research, The University of Western Sydney Xiao Zhu, Australia. Centre for Complementary Medicine Research, The University of Western Sydney Lin He, China. West China Hospital, Sichuan University Jing Song, Australia. Campbelltown and Camden Hospitals
External sources
No sources of support supplied
60

Acupuncture For Primary Dysmenorrhoea (Review) : Smith CA, Zhu X, He L, Song J

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Acupuncture For Primary Dysmenorrhoea (Review) : Smith CA, Zhu X, He L, Song J

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Acupuncture for primary dysmenorrhoea (Review)

Smith CA, Zhu X, He L, Song J

Acupuncture for primary dysmenorrhoea

Description of the condition

Description of the intervention

Why it is important to do this review

How the intervention might work

Criteria for considering studies for this review

Search methods for identication of studies

Data collection and analysis

Measures of treatment effect

Treatment length and follow up

Study location and sources of women

Risk of bias in included studies

1.1 Outcome: pain relief

1.2 Outcome: improvement in symptoms

See Figure 4; Analysis 1.2.

1.6 Outcome: quality of life, physical component

Two trials reported on quality of life (Analysis 1.6).

1.7 Outcome: quality of life, mental health

See Analysis 1.7.

1.3 Outcome: reduced use of additional medication

See Analysis 1.3.

1.8 Outcome: quality of life, bodily pain

See Analysis 1.8.

1.4 Outcome: restriction of daily life activities

See Analysis 1.4.

1.9 Outcome: quality of life, general health

See Analysis 1.9.

1.9.1 Placebo control

See Analysis 1.5.

1.10 Outcome: quality of life, vitality

1.12 Outcome: quality of life, role emotional

See Analysis 1.10.

1.13 Outcome: adverse events

See Analysis 1.13.

See Analysis 1.11.

See Figure 5; Analysis 2.1.

2.2 Outcome: improvement in symptoms

DISCUSSION Summary of main results

Potential biases in the review process

Overall completeness and applicability of evidence

Agreements and disagreements with other studies or reviews

Quality of the evidence

AUTHORS CONCLUSIONS Implications for practice

Implications for research

References to studies included in this review

References to studies excluded from this review

References to studies awaiting assessment

References to ongoing studies

References to other published versions of this review

Characteristics of included studies [ordered by study ID]

Blinding? All outcomes

Incomplete outcome data addressed? All outcomes Free of selective reporting?

Free of other bias?

Incomplete outcome data addressed? All outcomes

Free of selective reporting?

Free of other bias?

Incomplete outcome data addressed? All outcomes

Free of selective reporting?

Free of other bias?

The study appears free of other biases.

Insufcient information to judge. Insufcent information to make assessment.