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Pain Medicine 2017; 18: 551564

doi: 10.1093/pm/pnw215

INTEGRATIVE MEDICINE SECTION


Review Article
Ear Acupuncture for Immediate Pain Relief
A Systematic Review and Meta-Analysis of
Randomized Controlled Trials

M. Murakami, DO,* L. Fox, MD,, and calculated. The Physiotherapy Evidence Database
Marcel P. Dijkers, PhD (PEDro) scoring system was used to assess study
quality. Meta-analysis was performed for two pri-
When work was completed, *Department of mary outcomes measurespain intensity score
Rehabilitation Medicine, Icahn School of Medicine at and analgesic requirements.
Mount Sinai NY, NY USA, Department of
Anesthesiology at University of California San Diego Results. Ten studies met inclusion criteria. Quality
per PEDro scores: four excellent, four good, two fair.
San Diego, CA USA; Department of Emergency
Based on their primary outcome measures, six stud-
Medicine, Icahn School of Medicine at Mount Sinai
ies showed EA being superior to its comparator,
NY, NY USA; Department of Rehabilitation Medicine, three showed no difference to comparators (which in
Icahn School of Medicine at Mount Sinai NY, NY USA; all cases were analgesics), and one study showed

Department of Toxicology, New York University NY, significant pain decrease at the first time point and
NY USA no significant decrease at the second. Meta-analysis
Correspondence to: M. Murakami, DO, Comprehensive was completed for the three studies that evaluated
pain intensity as a primary outcome measure, and
Spine and Sports Center 3425 South Bascom Ave.
EA was superior to comparator (MD 5 -0.96, 95% CI
Suite 200 Campbell, CA 95008 USA; E-mail:
5 -1.82 -0.11), but the MD was small. Meta-analysis
research@mikikomurakami.com. was completed for the six studies that evaluated an-
algesic requirements, and EA was superior (MD 5 -
1.08, 95% CI 5 -1.78 -0.38]), again with a small MD.
Six studies reported side effects; all were minor and
transient.
Abstract
Conclusions. Ear acupuncture may be a promising
Objective. To systematically review the literature on modality to be used for pain reduction within
the effectiveness of ear acupuncture (EA) for imme- 48 hours, with a low side effect profile. Rigorous re-
diate pain relief. search is needed to establish definitive evidence of
a clinically significant difference from controls or
Data sources. AMED, CINAHL, Cochrane Reviews, from other pain treatments.
Embase, PsycINFO, PubMed, Scopus Web of
Science, from inception through March 2015. Key Words. Acupuncture; Alternative Therapies;
Analgesic; Pain Management; Pain Medicine; Acute
Study selection. English publications, randomized Pain; Alternative Medicine; Postoperative Pain
controlled trials on human subjects involving EA as
a treatment for pain, with outcomes recorded within
48 hours. Introduction

Data extraction and design. Two authors indepen- In the United States alone, pain affects approximately
dently assessed trial eligibility, quality, results, and 100 million adults, costing $560$635 billion per year,
side effects, and extracted data; a third author which is more than the annual costs of heart disease
checked final data. Effect size (d), mean difference ($309 billion), cancer ($243 billion), and diabetes ($188
(MD), and 95% confidence interval (CI) were billion) [1]. The burden of pain extends beyond the pain

C 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com
V 551
Murakami et al.

itself, with such sequelae as lost productivity and multi- various types of pains but that further well-designed
ple side effects from analgesic medications and other studies are warranted for determining a more accurate
treatments. In the United States, 44 people per day die effect size [11]. Ashers study included nonacupuncture
from prescription painkillers [2], and 7,000 people per modalities applied to the ear, such as acupressure or a
day are treated in the emergency department (ED) for TENS unit for the ear, as well as EA combined with
misusing these medications [3]. There has been a sharp other treatments. It is very difficult to set up double-
increase in overdoses of prescription opioids paralleling blinded RCTs trials for EA, and also challenging to find
the rising sales of these medications. Prescription drug systematic literature reviews with EA being investigated
registering and monitoring policies, as well as safe pre- as the sole modality (i.e. without the additional or substi-
scribing practices, have recently been implemented [4], tuted use of body acupuncture, herbs, supplements,
but deaths related to narcotic overdoses, with statistics acupressure, ear seeds, or a TENS unit).
worsened by heroin-related deaths [5], continue to be
an ongoing epidemic. There is a need for safer, more The present authors wanted to evaluate the clinical utility
cost-effective pain remedies to be researched and im- of EA in the outpatient, perioperative, and ED settings, to
plemented in clinical practice. see if EA could relieve pain prior to and/or after dis-
charge. The existing literature reviews on EA include stud-
Many Americans are now seeking out complementary ies of non-EA modalities (i.e., modalities that stimulate the
and alternative medicine (CAM), which includes acu- Chinese meridians through the ear without the use of
puncture, to supplement their allopathic care; the top needles) and also include primary outcome measures
four reasons for seeking CAM treatments are various that are recorded many months after the treatment
pain conditions [6]. Based on the 2012 National Health [10,11]. The primary objective of the present study was to
Interview Survey, there has been a significant linear in- conduct a systematic literature review and meta-analysis
crease in use of this modality [7] (page 2). An increas- of the efficacy of EA or electro-EA as a stand-alone mo-
ing number of hospitals are also now offering dality, with primary pain outcomes recorded within
acupuncture as a result of patient demand [6]. 48 hours. The period of 48 hours was chosen, as an ex-
pedited discharge from the ED as well as expedited dis-
Ear acupuncture (EA) is less well known than full-body charge after an outpatient procedure reduces health care
acupuncture. Its history dates back to the 1950s, when costs and decreases the risk of nosocomial infection.
Paul Nogier, a French physician, created an EA map.
By the 1970s, various ear maps had appeared around Methods
the world (e.g., Germany, United States, China) [8].
World Health Organization (WHO) panels met on several Literature Search Strategy
occasions regarding the various proposed auricular
maps, and using three set criteria standardized 39 The electronic databases AMED, CINAHL, Embase (also
points in 1990. Since that time, the United States mili- using its equivalent Emtree terms), Cochrane Database
tary has introduced battlefield acupuncture (BFA) in an of Systematic Reviews, PsycINFO, PubMed (also using
effort to treat wounded soldiers in the field without se- its equivalent MeSH terms), Scopus, and Web of
dating them. After the 9/11 attacks, Richard Niemtzow, Science were searched by an experienced medical li-
a military physician, created this five-point ear protocol brarian from inception through March 2015 for the
using ASP semipermanent needles, which is now being terms/concepts ear AND acupuncture (or electro-
taught to military medical providers who are not certified auricular acupuncture) AND pain. Additional studies
or licensed acupuncturists. The military published a were identified through scanning systematic literature re-
study in 2012 to show the feasibility of bringing EA to views [10,11] on EA. All citations were imported into
the frontline of aeromedical evacuation care; trained End Note 7.2.1, and duplicates were deleted.
nurses were able to perform BFA without the protocol
interfering with their other medical duties, and wounded Study Selection
soldiers obtained pain relief, the majority stating they
would choose to receive the BFA treatment again [9]. Abstracts of articles were reviewed by two independent
authors, and studies were selected if they met the fol-
Compared with full-body acupuncture, the literature on lowing inclusion criteria based on title and abstract: 1)
EA and electro-auricular acupuncture is limited in num- involved human subjects; 2) were published in the
ber, with small sample sizes. The quality of studies also English language; 3) investigated EA or electro-auricular
varies, with prior reviews rating the quality of studies 1 acupuncture, with or without conventional analgesics,
to 4 on the Jadad scale [10] or poor to good using as the treatment for pain; 4) were randomized and con-
the US Preventive Services Task Force scale [11]. trolled; 5) had primary outcomes that measured effect
Usichenko et al. published a systematic review of ran- on pain within 48 hours.
domized controlled (RCTs) trials of EA for postoperative
pain and interpreted their results as promising but not In order to investigate EA as a sole modality for pain re-
compelling [10] (page 1343). In a systematic review duction, excluded were studies that combined EA with
and meta-analysis of EA for acute and chronic pains, body acupuncture, or EA with any other CAM modalities
Asher et al. concluded that it may be effective to treat (including herbs, supplements, exercise, manual

552
Ear Acupuncture for Pain: Systematic Review

therapies). Authors also excluded studies that stimulated Data Synthesis and Analysis
the ear using other modalities, such as seeds or TENS
units. Studies that compared EA with electro-auricular Some of the primary studies determined the effect of EA
acupuncture were also not included, as the purpose of through pain severity ratings, some by quantifying the
this study was not to determine the efficacy of adding use of supplemental analgesics, and a few used both
an electrical unit to EA. methods. Effect sizes were calculated for all studies for
which a mean and SD were available, separately for: 1)
Full-text articles of remaining citations were retrieved Analgesia requirements; 2) Pain intensity. For those
and assessed for inclusion by the same two authors us- studies with multiple data points (i.e., times of measur-
ing the same criteria. Disagreements were resolved by ing pain severity and/or quantifying analgesic use over
discussion. the first 48 hours after acupuncture administration), the
data point with the smallest effect size was used for
meta-analysis. REVMan 5.3 software was used to cal-
culate mean differences (MDs), to compute the hetero-
Data Extraction and Assessment of Study Quality geneity of study effects, and to test for the pooled
effect. Since statistical heterogeneity was evident for
A structured data extraction form was created in Excel. both types of primary outcome measures, a random-
The same two authors extracted the data independently effects model was used to pool the data from the pri-
and compared their results. A third author reviewed the mary studies.
final data, comparing them to the full texts. The data for
the outcome designated as the primary by authors of
Results
the respective studies was extracted, unless there was
both an analgesic use report and a pain level report, in
The search (Figure 1) resulted in 2,757 duplicated cita-
which case both were extracted. When insufficient data
tions (including four obtained by reading systematic liter-
for meta-analysis was provided in an article, its authors
ature reviews [13]). Ten full text articles met the
were contacted for additional information or the authors
inclusion criteria, and nine [9] studies were included in
conducted further calculations. This involved the
the meta-analysis.
following:

1. Usichenko (2007)ibuprofen and tramadol require- General Characteristics of Studies and Patients
ments were reported as median values, presumably
because of non-normal distributions. The author was The 10 studies (Table 1) were published between 1986
contacted to obtain mean and standard deviation and 2012 and performed in the outpatient, periopera-
(SD) values. tive, and ED settings. Five of the studies employed
sham acupuncture as a comparator, four used analge-
2. Usichenko (2005 pilot)median ibuprofen and tra- sics as the comparator, and one used distraction. Aside
madol use were reported. The author was contacted from two studies, all were done on both males and fe-
to obtain mean and SD values. males age 18 years or older. In terms of the PEDro
scale (Table 2), of the 10 studies, four were excellent,
3. Goertz (2006)the mean pre/post-EA difference on four were good, and two were fair in quality. Sample
a numeric rating scale (NRS) with its SD was re- sizes ranged from 20160. None of the acupuncturists
ported for EA and comparator groups. The authors were blinded; six studies attempted to blind subjects.
calculated the mean post-EA NRS using the baseline Six studies blinded the assessors who were asking pa-
mean NRS and the mean differences after the treat- tient pain levels and/or providing analgesic medications.
ment; the original SD for the post-treatment NRS dif-
ference was used.
Study Findings
4. Xudong (1993)s study was not included in the meta-
analysis because efforts to contact the author were The following summarizes the findings of the studies;
not successful. complete detail on outcomes is found in Table 3.

The methodological quality of the studies was assessed


using the Physiotherapy Evidence Database (PEDro) 1. Usichenko (2006) compared EA (N 30 patients)
Scoring System, which involves 11 items (coded 1 if with sham (N 27) for intra-operative pain from hip
present, 0 if absent); item 1 (inclusion criteria) is not arthroplasty and showed that less fentanyl was re-
scored [12]. If the paper did not include enough infor- quired in the acupuncture group [14].
mation for one of the PEDro items to be assessed, the
authors rated it as a 0. The following descriptors were 2. Usichenko (2007) compared EA (N 61) with sham
used for the methodological quality of a study: total (N 59), for postoperative pain associated with vari-
score 9 or 10 excellent; 68 good; 4 or 5 fair; ous knee surgeries and found that less ibuprofen
and less than 4 poor. was required in the acupuncture group [15].

553
Murakami et al.

Titles and abstracts idened in Addional records idened from


bibliographic database searches systemac reviews
(n = 2753) (n = 4 )

Abstracts aer duplicates removed


(n = 981)

Abstracts screened Abstracts excluded


(n = 981) (n = 871)

Full-text arcles screened Full-text arcles excluded


(n = 110) (n = 100)

RCTs included in systemac review


(n = 10)

RCTs included in meta-analysis


(n = 9)

RCT: Randomized Controlled Trial

Figure 1 Flow chart of screened, excluded, and analyzed studies. RCT randomized controlled trial.

3. Wigram (1986) contrasted postoperative EA (N 19) 7. Usichenko (2005) compared EA (N 29) with sham
with conventional treatment using an anesthetic (N 25), for postoperative hip arthroplasty pain and
(N 15) for various abdominal surgeries and con- calculated that less piritamide was required in the
cluded that the EA group required less papavere- EA group [20].
tum, but not significantly so [16]. Pain outcomes
were also recorded in this study, which revealed 8. Wang (2012) compared EA (N 120) with conventional
higher maximum visual analog scale (VAS) pain in- treatment (N 40) for pain associated with in vitro
tensity scores (P 0.01) and higher average VAS fertilization (IVF) egg retrieval and noted that pain was
scores (P 0.05) for the EA group. lower in the EA group, but not significantly so [21].

4. Usichenko (2005 Pilot) compared true EA (N 10) 9. Goertz (2006) compared EA (N 50) with distraction
to sham EA (N 8) for postoperative knee arthros- (N 50) for various acute pains presented in the ED
copy pain and showed that less ibuprofen was re- and showed that the mean pre- to post-EA NRS
quired in the acupuncture group [17]. change was significantly higher in the EA group
prior to discharge from the ED; however, 24-hour
5. Allais (2011) judged EA (N 43) against sham follow-up results showed no significant difference
(N 46), for acute migraine and concluded that [22].
pain was significantly lower in the EA group [18].
10. Taguchi (2002) compared intra-operative EA plus
6. Xudong (1993) contrasted EA (N 30) with conven- desflurane with desflurane alone in a two-phase
tional treatment using an anesthetic (N 18) for crossover study (N 10) in the intra-operative set-
pain associated with acute biliary colic and noted ting for physician-provoked leg pain under anesthe-
that pain was higher in the EA group, but not signif- sia and calculated that less desflurane was required
icantly so [19]. in the EA phase [23].

554
Table 1 Indication, setting, intervention and comparator for all studies included

Intervention group Comparator group


First author Age range Age range
(year (or mean 6 (or mean 6 Sex
published) Indication Setting Intervention SD), y Sex M#/F# Comparator SD), y M#/F#

Usichenko Hip Intra-operative 0.22 mm gauge, 1.5 mm 68 6 9 14/16 0.22 mm gauge, 1.5 mm 67 6 9 14/13
(2006) arthroplasty depth carbo needles. depth carbo needle.
Ipsilateral shenmen, hip, Four points on ipsilat-
lung, and thalamus placed eral helix placed the
the evening before sur- evening before surgery,
gery, and kept for and kept for 24 hours
24 hours after surgery. after surgery. Points
Points were stimulated were stimulated during
during surgery by anes- surgery by anesthesiol-
thesiologist, who had no ogist, who had no acu-
acupuncture experience. puncture experience.
Usichenko Knee Postoperative Disposable steel acupunc- 42 6 15 33/28 Disposable steel acu- 44 6 13 38/31
(2007) arthroscopy ture needles: 0.22 mm di- puncture needles:
ameter, 1.5 mm length. 0.22 mm diameter,
Ipsilateral knee joint point, 1.5 mm length. Three
shen men, lung point in ipsilateral points on he-
the evening before sur- lix prior to the evening
gery. Patients encouraged before surgery. Patients
to stimulate points postop- encouraged to stimu-
eratively when they expe- late points postopera-
rienced pain. Needles tively when they
removed the morning af- experienced pain.
ter surgery. Needles removed the
morning after surgery.
Wigram Various abdom- Postoperative Ear acupuncture papaver- Mean age 5/14 Papaveretum every Mean age 50.8 4/11
(1986) inal etum every 30 minutes, as 53.7 (no 30 minutes, as needed. (no SD given)
surgeries needed. Two 1/2 inch nee- SD given)
dles inserted obliquely
(unclear location) for
48 hours with pulsed e-
stim at 10Hz.
(continued)

555
Ear Acupuncture for Pain: Systematic Review
Table 1 Continued

556
Intervention group Comparator group
First author Age range Age range
(year (or mean 6 (or mean 6 Sex
published) Indication Setting Intervention SD), y Sex M#/F# Comparator SD), y M#/F#
Murakami et al.

Usichenko Knee Postoperative 0.22 mm diameter, 1.5 mm 33 6 13 4/6 0.22 mm diameter, 45 6 15 5/3
(2005 arthroscopy long steel needles in one 1.5 mm long steel nee-
Pilot) ear, on shenmen, lung, dle in three helix points,
knee, placed preopera- placed pre-operatively
tively and kept till morning and kept till morning af-
after surgery. Points were ter surgery. Points were
stimulated during surgery stimulated during sur-
by anesthesiologist, who gery by anesthesiolo-
had no acupuncture expe- gist, who had no
rience. Patients encour- acupuncture experi-
aged to stimulate points ence. Patients encour-
postoperatively when they aged to stimulate
experienced pain. points postoperatively
when they experienced
pain.
Allais (2011) Acute migraine Outpatient ASP 0.7 mm gauge, 2 mm 1560 Mean 0/43 ASP 0.7mm gauge, 2mm 16-58 Mean age 0/46
depth needle. Ipsilateral age depth needle. Bilateral 33.2 (no SD
antitragus region for 35.9 (no helix region for given)
24 hours. SD given) 24 hours.
Xudong Acute biliary Outpatient 0.2 depth, unclear gauge. 2864 Mean 9/21 IM atropine sulfate 0.5 mg 3458 Mean age 6/12
(1993) colic Erzhong point. Manual age and IM phenergan 49.8 (no SD
stimulation every 47.0 (no 25 mg. given)
20 minutes. SD given)
Usichenko Hip arthroplasy Postoperative 0.22 mm gauge, 1.5 mm 68 6 10 12/17 0.22 mm gauge, 1.5 mm 66 6 11 12/13
(2005) length carbo needles. length carbo needles.
Ipsilateral hip, shenmen, Ipsilateral nonacupunc-
lung and thalamus, placed ture points of the helix,
pre-operatively and kept placed pre-operatively
till 36 hours after surgery. and kept till 36 hours
Patients encouraged to after surgery. Patients
stimulate points postoper- encouraged to stimu-
atively when they experi- late points postopera-
enced pain. tively when they
experienced pain.
(continued)
Table 1 Continued
Intervention group Comparator group
First author Age range Age range
(year (or mean 6 (or mean 6 Sex
published) Indication Setting Intervention SD), y Sex M#/F# Comparator SD), y M#/F#

Wang IVF egg Outpatient 25 mm length, unclear NS 0/120 Pethidine Hydrochloride NS 0/40
(2012) retrieval gauge needles. Bilateral (Dolantin) 50 mg
Genitalia (TF2) and
Shenmen (TF4) with elec-
tro stimulation for duration
for surgery.
Goertz Various acute Outpatient ASP semipermanent nee- 30 6 10 29/21 Encouraged to ambulate 33 6 7 18/32
(2006) pains in ED dles at two points: cingu- in ED room to be dis-
late, thalamic, till they fell tracted from pain.
out.
Taguchi Induced nox- Intra-operative 0.2 mm gauge, 12 mm 26 6 6 9/1 Desflurane only. Same as intervention
(2002) ious leg pain depth serin needle. Right (crossover RCT)
with electric ear shenmen, thalamus,
stimuli tranquilizer, master cere-
bral points during OR
time. With Desflurane.

ED emergency department; OR operating room; RCT randomized controlled trial.

557
Ear Acupuncture for Pain: Systematic Review
Murakami et al.

Score Descriptor
Heterogeneity and Test for Overall Effect

Excellent
Excellent

Excellent

Excellent
Good
Good
Good

Good
PEDro score

As statistical heterogeneity was evident for the primary

Fair

Fair
outcomes (designated as such by authors of the re-
spective studies) in both types, a random-effects model
was used to pool the data from the studies. The overall

9
9
5
8
6
6
8
6
5
9
effect of EA was significant in the Analgesia
variability for 1

Requirement group of studies (mean difference [MD]


key outcome
measures of
measures &

-1.08, 95% confidence interval [CI] -1.78 -0.38,


P 0.003). The Pain Intensity studies had a signifi-
cantly greater pain reduction in the EA group (MD -
Point

0.96, 95% CI -1.82 -0.11, mean P 0.03) (Figure 2).


11

1
1
1
1
1
1
1
1
1
1
If Wigrams study, which utilized medication requirement
comparison

as a primary outcome and pain intensity as a secondary


Statistical

specified allocation concealed of groups of subjects therapists assessors of subjects treat analysis outcome

outcome, were included the Pain Intensity group, the


for 1

EA effect would be insignificant (MD -0.50, 95% CI


10

1
1
1
1
1
1
1
1
1
1 -1.570.58, P 0.37).
Intention-to-

Adverse Events
9

1
1
1
1
0
1
0
1
0
1

Adverse events for the EA groups were recorded in six


of the studies, consisting of local pain, bleeding, head-
Blinding of Blinding of for >85%
Outcome

ache, and intraoperative bradycardia. Adverse events in


the comparator groups consisted of intra-operative bra-
8

1
1
1
1
1
1
1
1
1
1

dycardia, local pain, nausea, dizziness, and bleeding


(Table 3). Of the six studies with side effects reported,
three were rated excellent, two good, and one fair using
the PEDro scoring system. Details are as follows:
7

1
1
0
1
1
0
1
0
0
1

Usichenko (2006)in both the ear acupuncture and


the comparator (sham acupuncture) groups, intraoper-
ative bradycardia during hip arthroplasty was noted.
6

0
0
0
0
0
0
0
0
0
0

Usichenko (2007)no adverse events in the ear acu-


puncture group. In the comparator group (sham acu-
Eligibility Random Allocation similarities Blinding

puncture), one patient reported local pain at site of


insertion. One patient noted nausea/dizziness, with
symptoms resolving within 10 minutes after withdrawal
5

1
1
0
1
1
0
1
0
0
1

of the needles. Both of these patients thought they


Baseline

had received true EA and stated they would repeat it


for future complementary perioperative analgesia.
Wigram (1986)in the electro-ear acupuncture group,
4

1
1
0
0
0
1
1
1
1
1

two patients requested that the needles be removed


PEDro item scores and total score

due to pain. A questionnaire was administered five to


seven days postoperatively, where most of the pa-
tients recalled mild discomfort and no other side ef-
3

1
1
0
1
0
0
1
0
0
1

fects were noted.


Usichenko (2005 Pilot)two patients from both the
true EA and the sham EA groups required atropine
2

1
1
1
1
1
1
1
1
1
1

due to bradycardia, but no patient-reported side ef-


fects from EA or pharmacological analgesia.
Allais (2011)two people from both the EA and sham
EA groups had local ear pain.
1

1
1
1
1
0
0
1
0
1
1

Usichenko (2005): EA was performed the night prior


Usichenko (2005 Pilot)

to hip arthroplasty. The EA group reported local pain


Usichenko (2006)
Usichenko (2007)

Usichenko (2005)

(N 1), minor ear bleeding (N 1), and headache the


(year published)

Wigram (1986)

Xudong (1993)

Taguchi (2002)

morning prior to the surgery, which resolved postop-


Goertz (2006)
Wang (2012)
Allais (2011)
First author

eratively (N 1). The sham acupuncture control group


Table 2

reported local pain (N 2) and minor ear bleeding


(N 1). Self-reported side effects were noted up to
three days postoperatively.

558
Table 3 Statistical results and original authors interpretation
Ear acupuncture Control Results

First Adverse events Adverse events


author Outcome measure(s) N Mean SD Other (# patients) N Mean SD Other (# patients) Significance Effect size

Usichenko Fentanyl requirement adjusted 30 3.9 1.4 Intraoperative 27 4.93 1.2 Intraoperative P 0.005 (-)0.76
(2006) to weight to keep cardio- bradycardia bradycardia (3)
vascular parameters within (6)
20% of baseline,
mcg/kg
Usichenko Mean ibuprofren required to 61 372 421 No adverse 59 557 409 Local pain (1) NS (-)0.4456
(2007) keep VAS < 40 mm, mg events related nausea/
Median ibuprofren required to 200 to acupuncture 600 dizziness (1) P 0.012
keep VAS < 40 mm, mg (IQR (IQR
0600) 200800)
Mean additional 0.16 0.505 0.24 0.619
tramadol required to keep
VAS < 40 mm, mg
Patients needing 1,400 1,000 P 0.57
tramadol, %
Pirtramide dose in recovery 7.6 3.7 7.7 3.5 P 0.91 (-)0.02
room, mg
Wigram Papaveretum required, mg/kg 19 1.3 0.4 Local pain (2) 15 1.4 0.6 NS P 0.55 (-)0.20
(1986) VAS maximum pain 5 2.1 3.4 1.4 P 0.01
VAS pain average 3 1.6 2 1.2 P 0.05
Usichenko Mean ibuprofren required to 10 500 356 Bradycardia (2) 8 825 198 Bradycardia (2) (-)1.029
(2005 keep VAS < 40 mm, mg
pilot) Median ibuprofren required to 500 800 P 0.043
keep VAS < 40 mm, mg
Mean additional tramadol, mg 0 0 0.25 0.463
Patients needing tramadol, % 0 25 Not significant
(no P values
provided)
Median Piritramide, mg 3.75 3.5 Not significant
(IQR (IQR (no P values
07) 05) provided)
Allais VAS after 10 min 43 1.9 1.51 Pain 46 4.3 1.49 Pain P < 0.001 (-)1.60
(2011) VAS after 30 min 1.9 1.97 5.2 1.63 (-)1.96
VAS after 60 min 2 2.16 4.2 2.17 (-)1.01
VAS after 120 min 2.1 2.43 3.7 1.9 (-)0.73
Patients with >50% VAS re- 65 13 P 0.00001
duction at 2 h, %

(continued)

559
Ear Acupuncture for Pain: Systematic Review
560
Murakami et al.

Table 3 Continued
Ear acupuncture Control Results

First Adverse events Adverse events


author Outcome measure(s) N Mean SD Other (# patients) N Mean SD Other (# patients) Significance Effect size

Patients pain free at 2 h, % 23 4 P 0.009


Xudong Pain relieved or decreased, % 30 93 NS 18 94 NS P > 0.05 Unable to
(1993) calculate
Usichenko Piritamide requirement 36 h 29 37 18 Local pain, 25 54 21 Local pain, P 0.004 (-)0.874
(2005) postoperatively, mg bleeding, bleeding
VAS pain intensity 36 h 44 17 headache 44 22 Not significant 0
postoperatively
Wang VAS 120 2.86 1.84 NS 40 3.12 2.06 NS P > 0.05 (-)0.14
(2012) Total effective analgesia rate, 93 92 Not significant
%
Goertz Difference in NRS pre- and 50 2.33 1.999 NS 50 0.15 0.591 NS P < 0.0005
(2006) immediately post-ED visit
Mean NRS immediately after 4.65 1.999 7.63 0.591 (-)2.02
intervention
Difference in NRS pre- and 41 3.415 2.32 NS 43 3.047 2.68 NS P 0.503
24 h post-ED visit
Mean NRS 24hrs after ED 3.565 2.32 4.733 2.68 (-)0.47
discharge
Taguchi Desflurane required, vol% 10 4.4 0.8 NS 10 4.9 0.7 NS P 0.003 (-)0.67
(2002)

Calculated by reviewer based on information in the text.


 Data point with smallest effect size utilized for meta-analysis.
EA ear acupuncture; ED emergency department; IQR interquartile range; NRS numeric rating scale; NS not stated; VAS visual analog scale.
Ear Acupuncture for Pain: Systematic Review

Figure 2 Meta-analysis of Pain Intensity Outcomes (Panel 1) and of Analgesia Requirement Outcomes (Panel 2). CI
confidence interval.

The four studies in which no adverse events were noted or after analgesics were given, which could explain the
did not have a system in place to record or report them, fact that less medication was used but higher pain lev-
which was listed under Methods. els were recorded in the EA group. It is also not clear if
the electro-acupuncture itself was contributing to pain
Discussion scores. In addition, for our meta-analysis of medication
use, four of the five studies were completed by the
Ear Acupuncture Effectiveness and Study Quality same author group (Usichenko), which somewhat weak-
ens our findings due of the possibility of investigator
Of the 10 studies included in this systematic review, six bias.
showed that EA was superior to the comparator, of
which five evaluated medication use as a primary out- There are also some points that strengthen our findings.
come measure [14,15,17,18,20,23] and one evaluated In the meta-analysis of primary outcome measures, the
pain level [18]. Three studies showed no significant dif- overall effect of EA was statistically significant in the
ference between EA and comparators, of which two Analgesia Requirement outcome group (P 0.003), as
evaluated medication use [16,19] and one evaluated well as in the Pain Intensity outcome group (P 0.03).
pain intensity [21]. One study that evaluated change in In this latter group, the pooled NRS difference was
pain intensity had different results at two time pointsa about one point. Although a two-point difference is gen-
significantly larger decrease in pain in the EA group erally accepted as clinically significant difference be-
while in the ED and no significant difference at 24-hour tween a pain treatment and its comparator, any
follow-up [22]. increase in difference would indicate that EA is at least
as effective as controls, which themselves have been
There are a few points that weaken our findings. One known to cause pain reduction [24,25]. Allais (2011) and
would expect an increase in medication use to be Goertz (2006) reported outcomes for multiple time
paired with a higher level of pain prior to the pain medi- points. The point with the lowest effect size was utilized
cation administration and a decrease in pain score after for the meta-analysis. If the other data points had been
medication administration. Wigrams study recorded an- utilized, EA would have been even more favored in the
algesia requirement as a primary outcome and recorded pain intensity meta-analysis.
both maximum and mean pain scores. In the analysis of
analgesic requirements, the study did show that EA was The quality of the studies, assessed using the PEDro
better than the comparator in the analysis of analgesic score, was generally good or excellent (Table 2).
requirements, but not significantly so. In the analysis of However, many had a small sample size, and none of
pain scores, the EA group had more pain (more maxi- the studies, except for one, could claim blinded acu-
mum pain, P 0.001; more mean pain, P 0.05). It is puncturists. To be clear, even for Usichenkos 2006
not clear whether or not the pain intensity scores, which study, which is presented as a double-blind study, the
were requested every eight hours, were recorded before present authors conservatively did not rate PEDro item

561
Murakami et al.

6 (blinding of all therapists who administered the ther- Despite only 60% of our studies reporting side effects,
apy) as a 1 (meaning yes), as the study used experi- given the minimal side effects reported in these studies,
enced acupuncturists, who would likely be able to and taking into consideration the EA side effect literature
identify a helix EA treatment as sham. If the GRADE review, we conclude that the side effect profile of EA is
methodology [26] were applied to our findings, the two at least as safe as, if not more safe than, allopathic
primary outcomes used would likely be designated criti- medications and procedures for pain.
cal (pain intensity) and important (analgesic medication
usage). The information on side effects is too limited to
be incorporated in a formal analysis, but it would seem Comparators Used in Ear Acupuncture
that they are neither serious nor common.
The comparators used in acupuncture studies have
The evidence for these two outcomes is based on a been long debated. Five out of 10 of our studies used
body of RCTs, the quality of which, because of lack of sham acupuncture as a comparator. Cutaneous nee-
blinding, inverse relationship of the two outcomes, lim- dling anywhere in the body, irrespective of acupuncture
ited consistency of effect sizes, and predominance of a points, has been found to result in diffuse noxious inhib-
single investigator, should be designated low to moder- itory control [24]. Traditional Chinese medicine practi-
ate. (Except for the first point, these aspects of the tioners will state that stimulating acupuncture points
quality of evidence as a whole are, by definition, not using ear seeds, TENS, or acupressure will have a posi-
captured in the PEDro ratings.) Phrasing our conclusion tive effect on pain as the Chinese meridians are being
in GRADE terminology: The true effect of EA is likely to activated.
be close to the estimate for both outcomes, but might
deviate. Both EA and full-body acupuncture are often compared
with no acupuncture and sham acupuncture. There
have been numerous studies on the effectiveness of
placebo analgesia. The expectation of being treated for
Adverse Events pain [25], physician characteristics, the color of a pill,
even the packaging of a medication [38] can all affect
The side effects of our current treatments for pain (e.g., pain. A recent meta-analyses of 25 neuroimaging stud-
acetaminophen, nonsteroidal anti-inflammatories ies on placebo analgesia and expectancy-based pain
[NSAIDS], steroids, opioids, and anesthetics) include modulation revealed that placebo effects and expecta-
liver failure, GI bleed, renal failure, cardiotoxicity, seda- tions can stimulate regions of the brain that control pain
tion, addiction, and respiratory depression. The side ef- pathways and also affect the regions of the brain that
fects of EA seem mild in comparison. Six out of 10 affect mood [25].
RCTs recorded adverse events, consisting of local pain
at the site of the acupuncture needle, dizziness, and Given the effectiveness of placebo analgesia, as well as
nausea. The other four studies did not mention adverse the positive physiological effects of the needling of any
events. Usichenkos 2005 pilot and 2006 study reported body points for pain reduction [24,25], the present au-
transitory circulatory complications. It should be noted thors conclude that while EA cannot be stated to be
that these studies authors were hesitant to explain bra- clinically superior to comparators, if EA is at least as ef-
dycardia as a possible result of ear needling, at least in fective as the comparators used in the studies, which
the patients from the comparator group, as this group include sham acupuncture, pain medications, and dis-
only got needled in the helix of the ear, which is not in- traction, EA may be considered for pain reduction.
nervated by the vagus nerve [17]. The limited data avail-
able in our review do not suggest that EA results in
more serious or more frequent adverse events than the Cost of Supplies and Ease of Administration
various comparators. The adverse effects noted in the
six RCTs have been well documented previously. A EA can be a low-cost modality compared with other
2013 systematic literature review noted adverse events pain interventions and medications. It is also easy to
for EA, which include short-term local pain, skin irrita- perform. For example, a feasibility study in the military
tion, minor bleeding, and dizziness [27]. There are also showed that nonphysicians and nonacupuncturists can
case reports that include the following adverse events: effortlessly learn the battlefield acupuncture protocol
slight fever, dry mouth, upper limb numbness [28], peri- [39], a five-point EA pain protocol for which the military
chondritis [2935], and basal cell carcinoma [36]. To has now created a short certification course for nonacu-
note, although EA manuals warn about abortion as a puncturist providers. The protocol can be easily admin-
possible side effect, the current authors found no cases istered in less than five minutes, with experienced
of abortion documented in the English-language litera- providers doing this in less than one minute. Using
ture. To the contrary, the NADA (nada, Spanish for stainless steel ASP needles, completing a five-point BFA
nothing) protocol, an EA protocol for drug addiction, ear protocol uses roughly $2.00 in supplies. State regu-
has been studied in an RCT to show that it can actually lations determine whether or not a medical provider has
be safely used on pregnant women with chemical de- to be licensed or certified to perform acupuncture (i.e.,
pendence [37]. an acupuncturist may not need to be added to staff).

562
Ear Acupuncture for Pain: Systematic Review

Conclusions 7 Clarke Tea. Trends in the Use of Complementary Health


Approaches Among Adults: United States, 20022012;
This systematic literature review and meta-analysis of February 10, 2015. Report No., Contract No. 79.
RCTs shows that EA may be effective for immediate relief
of pain. Taking into consideration that EA 1) is at least as 8 Nogier R. How did Paul Nogier establish the map of
effective as analgesic comparators, 2) has fewer side ef- the ear? Med Acupunct 2014;26(2):7683.
fects than current pain treatment regimens, and 3) is
quick, affordable, and easy to perform, it can be con- 9 Walter J, York A, Thati S, Niemtzow R, Burns S.
cluded that EA may be a reasonable and promising mo- The feasibility of integrating ear acupuncture into the
dality for health care providers to consider using in the aeromedical evacuation system from Ramstein Air
outpatient, intra-operative, and ED setting for pain reduc- Base (Germany) to Andrews Air Force Base (US).
tion. Our recommendation would be made with more en- BMC Complement Altern Med 2012;12:114
thusiasm if further research were to show a greater, that
is, a clinically significant, reduction in pain intensity. 10 Usichenko TI, Lehmann C, Ernst E. Auricular acu-
puncture for postoperative pain control: A system-
atic review of randomised clinical trials. Anaesthesia
Acknowledgments 2008;63(12):13438.

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