Complementary Therapies in Medicine (2010) 18, 104111

available at www.sciencedirect.com

journal homepage: www.elsevierhealth.com/journals/ctim

Efcacy of acupuncture in management of

premenstrual syndrome: A systematic review
Seung-Hun Cho a,, Jongwoo Kim b

a
Hospital of Korean Medicine, Kyung Hee University Medical Center, Kyung Hee University, #1 Hoegi-Dong, Dongdaemun-Gu,
Seoul 130-701, Republic of Korea
b
Stress Clinic, Kyung Hee University East-West Neo Medical Center, Kyung Hee University, Seoul, Republic of Korea
Available online 17 March 2010

KEYWORDS Summary
Background: The effectiveness of acupuncture in the case of premenstrual syndrome (PMS) is
Acupuncture;
not fully understood.
Premenstrual
Objectives: To assess the effectiveness and adverse effects of acupuncture for the symptomatic
syndrome;
treatment of PMS from randomised controlled trials (RCTs).
Systematic review;
Search strategy: Electronic databases, including English, Korean, Japanese and Chinese, were
Randomised
systematically searched up to January 2009 with no language restrictions.
controlled trials
Selection criteria: RCTs comparing acupuncture with control investigating acupuncture for PMS
were considered.
Data collection and analysis: Study collection and quality assessment were performed by two
reviewers using the criteria described in the Cochrane Handbook.
Main results: Nine studies were systematically reviewed. Only two of the nine trials reported
details regarding sequence generation and allocation concealment. Four studies reported a
signicant difference in reduction of PMS symptoms for acupuncture treatment compared
with pharmacological treatment. Two studies reported the improvements in primary symptoms
within the acupuncture and herbal medications groups compared with baseline. Only two RCTs
reported information regarding acupuncture-related adverse events, which included one case
of a small subcutaneous haematoma.
Conclusions: Although the included trials showed that acupuncture may be benecial to patients
with PMS, there is insufcient evidence to support this conclusion due to methodological aws
in the studies, including unknowns in sequence generation, concealment of allocation, blinding
and outcome measures.
2009 Elsevier Ltd. All rights reserved.

Abbreviations: PMS, premenstrual syndrome; RCT, randomised controlled trial; PMDD, premenstrual dysphoric disorder; SMD, stan-
dard mean differences; OR, odds ratios; CI, 95% condence intervals; AT, acupuncture; AA, auricular acupuncture; ACE, acupoint catgut
embedding; AI, acupoint injection.
Corresponding author. Tel.: +82 2 958 9498; fax: +82 2 958 9187.

E-mail address: chosh@khu.ac.kr (S.-H. Cho).

0965-2299/$ see front matter 2009 Elsevier Ltd. All rights reserved.
doi:10.1016/j.ctim.2009.12.001
Acupuncture for PMS 105
Contents

Materials and methods ................................................................................................... 105

Data sources ........................................................................................................ 105
Study selection...................................................................................................... 106
Types of studies .............................................................................................. 106
Types of participants ......................................................................................... 106
Types of interventions ........................................................................................ 106
Types of outcome measures................................................................................... 106
Data collection and quality assessment.............................................................................. 106
Data analysis ........................................................................................................ 106
Results ................................................................................................................... 107
Study description.................................................................................................... 107
Methodological quality .............................................................................................. 107
Sequence generation ......................................................................................... 107
Allocation concealment....................................................................................... 107
Blinding ...................................................................................................... 107
Incomplete outcome data .................................................................................... 107
Selective outcome reporting.................................................................................. 107
Other sources of bias ......................................................................................... 109
Data analysis ........................................................................................................ 109
Acupuncture versus sham acupuncture (n = 2)................................................................. 109
Acupuncture versus wait-list control (n = 1) ................................................................... 109
Acupuncture versus pharmacologic treatment (n = 4) ......................................................... 109
Acupuncture versus herbal medication (n = 2) ................................................................. 109
Adverse events ............................................................................................... 109
Discussion ................................................................................................................ 109
Conict of interest ....................................................................................................... 110
References ............................................................................................................... 110

Premenstrual syndrome (PMS) is a condition charac- oral contraceptives.7 Complementary/alternative therapies

terised by a number of behavioural, psychological and
physical symptoms recurring cyclically during the luteal
phase of the menstrual cycle. These symptoms disappear
within a few days of the onset of menstruation.1 Over 150
symptoms have been attributed to PMS. Common symp-
toms include breast tenderness, headache, backache, lack
of energy, clumsiness, tension, anxiety, irritability, depres-
sion, food cravings, bloating and changes in sexual drive.
Although surveys have suggested that over 80% of women
report premenstrual symptoms, when strict diagnostic cri-
teria are applied, the prevalence of severe PMS is estimated
to be about 26% in women of reproductive age.2 In the
United Kingdom, it is estimated that up to 1.5 million women
experience signicant and disruptive symptoms.3 Premen-
strual symptoms are common, affecting up to 75% of women
with regular menstrual cycles. However, clinically signi-
cant PMS occurs in 2030% of women.4 The 5% of women
with the severest premenstrual symptoms and impairment of
social and role functioning often meet the diagnostic crite-
ria for premenstrual dysphoric disorder (PMDD),5 an addition
to the diagnostic classication of the severe and mainly
psychological form of premenstrual syndrome in the fourth
edition of the Diagnostic and Statistical Manual of Mental
Disorders (DSM-IV-TR).5 The terminology can be confusing,
as researchers also use the broader term PMS to describe
severe symptoms.6
The uncertainty in the pathogenesis of PMS has led
to many treatments being suggested as possible thera-
pies. Pharmacologic treatments have included serotonin
re-uptake inhibitors, hormonal interventions and combined
are sometimes recommended for alleviating symptoms of
PMS.8 A study undertaken in the United Kingdom indicated
that the majority of long-term sufferers attending a special-
ist clinic had used complementary or alternative medicine
(CAM).9
Acupuncture is one of the least frequently used interven-
tions and its effectiveness on PMS is not fully understood.
To date, there has not been a systematic review of ran-
domised controlled trials (RCTs) of acupuncture without
language and database restrictions, even though a Cochrane
protocol is available.10 The aim of this review was to deter-
mine whether the use of acupuncture for PMS is supported
by assessing the effectiveness and adverse events from
RCTs.
Materials and methods
Data sources
The following sources were searched until January 2009:
The Cochrane Library, including the Cochrane Central Regis-
ter of Controlled Trials (CENTRAL, 2008), MEDLINE, EMBASE,
SCOPUS, Korean medical databases (which included the
National Assembly Library, KoreaMed, Korean Studies Infor-
mation Service System, DBpia and the Korea Institute of
Science Technology Information and Research Information
Service System), a Japanese database (Japan Science and
Technology Information Aggregator Electronic) and Chinese
databases (which included the China Academic Journal,
106
Century Journal Project, China Doctor/Master Dissertation
Full Text DB and China Proceedings Conference Full Text DB).
We also searched the databases of clinical trials such as Cur-
rent Controlled Trials (http://www.controlled-trials.com),
the National Centre for Complementary and Alternative
Medicine (NCCAM) at the National Institutes of Health
(NIH) (http://nccam.nih.gov/) and the Complementary and
Alternative Medicine Specialist Library at the NHS National
Library for Health (http://www.library.nhs.uk/cam/). The
reference lists of articles were checked for further relevant
publications and experts in complementary medicine. Man-
ufacturers of acupuncture equipment were asked for any
additional trials. We conducted an additional manual search
of relevant journals, symposia, conference proceedings
and retrieved relevant trials; all identied publications
were cross-referenced. If necessary, personal contact was
made with the authors of the published studies to request
additional data.
Keywords used to search for RCTs included (acupunc-
ture OR electroacupuncture OR scalp acupuncture OR
catgut embedding OR auricular acupuncture OR merid-
ian OR acupoint) AND (premenstrual syndrome OR
premenstrual tensions OR PMS OR premenstrual dys-
phoric disorder OR PMDD OR premenstrual). As all
of the various databases used in this study possessed
their own subject headings, each database was searched
independently.
Study selection
Types of studies
This review was restricted to RCTs that compared acupunc-
ture with a control group, which included no treatment,
placebo treatment, pharmacologic treatment or non-
pharmacologic treatments for the alleviation of PMS
symptoms. No restriction was imposed on studies with
respect to language, publication type, blinding or the type
of design such as parallel or cross-over designs. This review
excluded quasi-randomised trials.
Types of participants
This study included women of any age who met the medi-
cally dened diagnostic criteria for PMS or PMDD. This study
excluded women with cyclical mastalgia alone, as opposed
to part of PMS. Trials on menstrual disorders distinct from
PMS (e.g., dysmenorrhoea) or on only one symptom of PMS
(e.g., mastalgia) were excluded.
Types of interventions
Clinical trials evaluating all forms of acupuncture tech-
niques, specically classical acupuncture, electroacupunc-
ture, laser acupuncture and acupoint injection, were
included. Both traditional acupuncture (classical merid-
ian points) and contemporary acupuncture (non-meridian
or trigger points) were included if the points of stimula-
tion were acupuncture related (e.g., hand, needle, seed,
laser, electrical or injection stimulation excluding mox-
ibustion). Studies that assessed the combined effect of
acupuncture with other therapies (e.g., acupuncture plus
psychotherapy and acupuncture plus herbal medication)
were excluded because the purpose of our review was to
S.-H. Cho, J. Kim
assess the effects of acupuncture alone on PMS symptoms.
Trials that compared different forms of acupuncture to
each other were also excluded. Trials that compared dif-
ferent acupoints to each other were excluded. Types of
control interventions considered in this review included
no acupuncture treatment (wait-listed or treatment as
usual), placebo-controlled (sham acupuncture, minimal
acupuncture or non-invasively controlled), pharmacologic
treatment (such as progesterone, antidepressants or pyri-
doxine) or non-conventional interventions (such as herbal
medication).
Types of outcome measures
The primary outcomes for this review were any scales for
overall symptoms or particular symptoms of PMS, and the
improvement of overall symptoms (as a dichotomous mea-
sure). Secondary outcomes included adverse events.
Data collection and quality assessment
Each study identied by the search strategy was assessed
against the inclusion criteria by one of the reviewers.
Where there was uncertainty regarding eligibility, a second
reviewer also assessed the study and a decision was reached
through discussion. Both reviewers independently assessed
whether the studies met the inclusion criteria and disagree-
ments were resolved by discussion. Further information was
sought from the authors where articles contained insuf-
cient information to make a decision regarding eligibility.
Study collection and quality assessment were performed
by two reviewers who followed the detailed descriptions
of these tasks provided in the Cochrane Handbook for
Systematic Reviews of Interventions.11 The following char-
acteristics were assessed: (a) Was the allocation sequence
adequately generated? (b) Was allocation adequately con-
cealed? (c) Was knowledge of the allocated interventions
adequately prevented during the study? (d) Were incom-
plete outcome data adequately addressed? (e) Were reports
of the study free of any suggestion of selective outcome
reporting? (f) Was the study apparently free of other prob-
lems that could put it at a risk of bias? The judgements
made by the review authors involved answering these spe-
cic questions. The answer Yes indicated a low risk of
bias (Y), the answer Unclear indicated an uncertain risk
of bias (U) and the answer No indicated a high risk of
bias (N).
Data analysis
Standard mean differences (SMDs) were calculated for
changes in PMS symptom scores for continuous data. Odds
ratios (ORs) were calculated for changes in the responder
rate with improved PMS symptoms or successful treatment
for dichotomous data. Both of these parameters, along
with 95% condence intervals (CIs), were calculated using
Review Manager (RevMan) software (version 5.8 for Win-
dows; The Nordic Cochrane Centre, Copenhagen, Denmark).
An assessment of pooled data and publication bias and a sub-
group/sensitivity analysis could not be performed due to a
limited number of trials.
Acupuncture for PMS
Results
Study description
An initial search identied 34 potentially relevant articles.
Twenty articles were initially excluded because they did not
meet our inclusion criteria. Among them, two studies12,13
included subjects without PMS in the inclusion criteria and
two studies14,15 were duplicated articles. The remaining 14
studies were further evaluated regarding randomisation:
two trials16,17 were found to be non-randomised trials and
three trials1820 were found to be quasi-randomised trials.
The remaining nine studies, involving 545 subjects, met our
inclusion criteria and were systematically reviewed. Fig. 1
summarises the search results based on the quality of report-
ing of meta-analyses (QUOROM) ow diagram.21
The key data are summarised in Table 1. The intervention
varied considerably across the trials. Various acupoints for
acupuncture treatments were used in the included RCTs; the
SP6 acupoint was commonly selected in six trials. The peri-
ods of treatment ranged from 14 days to three menstrual
cycles. The trialists attempted to begin the intervention at
various time points: in the third luteal phase, on the rst
day of symptoms or 10, 14 or 15 days before the next men-
strual period. Six trials2227 originated in China, two28,29 in
Korea and one30 in Croatia. For Fang et al.22 and Wang and
Wu,24 the lead authors were involved in both trials. The lead
authors in Shin et al.29 were involved in Kim et al.28 The lead
author in Xu25 was also involved in Xu and Sun.26
Methodological quality
Sequence generation
Four studies referred to a random number table for sequence
generation.2224,27 The other ve studies did not describe the
sequence generation process.
Figure 1 Flow diagram showing the number of studies included and excluded from the systematic review. RCT, randomized
controlled trial.
107
Allocation concealment
Two studies22,24 ensured that allocations were concealed by
using envelopes. Seven studies provided no information on
the methods used for allocation concealment.
Blinding
One study30 used sham acupuncture (supercial acupunc-
ture) without de gi effect at points on the thighs and arms
that are not on classically described meridians. Another
study28 reported blinding of acupuncturists and participants
by using sham acupuncture at points unrelated to the treat-
ment of PMS; however, the authors discussed an inability to
ensure blinding of the acupuncturists. Seven studies did not
blind participants or acupuncturists or outcome assessment;
the outcome measurements were likely to be inuenced by
this lack of blinding.
Incomplete outcome data
In one study,30 the missing outcome data were unlikely to be
related to true outcomes because of survival data. In three
studies,22,24,29 the proportion of the missing outcome data
compared with observed event risk was not enough to have
a clinically relevant impact on the interventions estimated
effect. However, in one study, there were enough missing
outcomes data to allow clinically relevant bias.28 The risk
of bias in the other included trials was unclear because the
numbers randomised into each intervention group were not
clearly reported.
Selective outcome reporting
Five studies2224,26,27 analysed continuous outcomes as
a dichotomous variable, with the further possibility of
selecting from multiple cut-points. The pre-specied pri-
mary outcome measurement of one study30 was not
reported.
 108
Table 1 Characteristics of RCTs of acupuncture for premenstrual syndrome.
Study Subjects (mean age) Intervention type, Type of control group Main Outcomes/Result Quality
treatment frequency assessment*
(treatment period);
treated acupoints
Fang et al., 200822 90 women with physical, AT, daily 14 d before Herbal medication Improved primary symptoms within all Y-Y-N-Y-N-N
psychological and behavior menstruation (3 menstrual (Xiaoyao Pills) 8pills 3 groups from baseline (95.5%, 88.1%,
symptoms of PMS (24.8 y) cycles); GV24, LI4, LR3, times daily 14 d before p < 0.05); between-group differences not
SP6 menstruation reported
Habek et al., 200230 35 women with PMS in the AT plus AA, 7 sessions. Sham AT (at thighs and Reduced PMS symptoms with AT vs sham U-U-Y-Y-N-Y
Department of Gynecology (third luteal phase); arms described (p < 0.001 vs p > 0.05), success rate of
and Obstetrics (30.6 y) GV20,LI4, LR3, CV3,4,6, non-meridians) treatment AT vs sham (77.8% vs 5.6%)
PC6, GB34, BL23, and
Shenmen
Kim et al., 200528 20 women with PMS or AT, twice per week (2 Sham AT (at SI5, ST40) Reduced Menstrual Symptom Severity U-U-Y-N-Y-N
PMDD DSM-IV criteria menstrual cycles); SP6, List scores from baseline within AT group
(28.9 y) CV9, and adjunctive points (49.8%, p < 0.05)
Liu and Han, 200623 88 women with PMS or ACE, once on 15 d before Fluoxetine 20 mg per d Signicant difference in responder rates Y-U-N-Y-N-Y
PMDD DSM-IV criteria (28 y) menstruation, (3 menstrual with reduced premenstrual dysphoric
cycles); PC6, SP6, CV4,17, disorder symptom scores in ACE vs
LR3, and adjunctive points control (93.2% vs 72.7%, p<0.005)
Shin et al., 30 women with PMS Hand AT, 10 sessions. (a) Wait-list control Reduced Menstrual Symptom U-U-N-Y-Y-Y
200829 ICD-10 criteria (27 y) (4 wks); A5,6,8,12,16,18, (b) Hand moxibustion; A5, Severity scores in Hand AT vs control
N18, F6 6,8,12,16, 18, N18, F6 (p < 0.001)
Wang and Wu, 200724 60 women with physical, AT, daily 14 d before Herbal medication Improved primary symptoms within all Y-Y-N-Y-N-N
psychological and behavior menstruation (3 menstrual (Xiaoyao Pills) 8 pills 3 groups from baseline (96.8% 64.3%,
symptoms of PMS (26 y) cycles); GV24, LI4, LR3, times daily 14 d before p < 0.05); between-group differences not
SP6 menstruation reported
Xu, 200527 102 women with physical, AT plus AI, once every Diazepam 5 mg once per d, Signicant difference in responder rates Y-U-N-Y-N-N
psychological and behavior three d from 10 d before oryzanol 10 mg three times of reduced Menstrual Symptom scores
symptoms of PMS (28.4 y) menstruation (3 menstrual per d with AT plus AI vs control (92.6% vs
cycles); LI4, LR3, CV4,6, 75.0%, p < 0.05)
GB20, EX-HN5, ST36, SP6
Xu, 200625 60 women with (a) AT, daily 14 d before Medroxyprogesterone Reduced PMS symptom scores with U-U-N-Y-Y-N
physical, menstruation (3 menstrual 6 mg daily from 16th AT(a) vs control (12.3 vs 7.2
psychological and cycles); d to 25th d of points, p < .005); no between-group
behavior symptoms BL15,17,18,20,21,23 menstrual cycle differences in AT(b) vs control
of PMS (32.4 y) (b) classical AT; GV20, (p > 0.005)
CV4,6,19, SP6, ST36
Xu and Sun, 200626 60 women with physical, AT, daily 14 d before Medroxyprogesterone 6 mg Signicant difference in responder rates U-U-N-Y-N-N
psychological and behavior menstruation (3 menstrual daily from 16th d to 25th d with reduced PMS symptom scores in AT
symptoms of PMS (31 y) cycles); GV3,4,5,6,7,8, of menstrual cycle vs control (90.0% vs 60.0%, p < 0.005)

S.-H. Cho, J. Kim

BL18,19,20,21,22,23,47,48,49,50,51,52
Abbreviations: AT, acupuncture; AA, auricular acupuncture; ACE, acupoint catgut embedding; AI, acupoint injection; PMS, premenstrual syndrome.
* (a) Was the allocation sequence adequately generated? (b) Was allocation adequately concealed? (c) Was knowledge of the allocated interventions adequately prevented during the

study? (d) Were incomplete outcome data adequately addressed? (e) Were the results of the study free of suggestion of selective outcome reporting? (f) Was the study apparently free of
other problems that could put it at a risk of bias?
Key: (Y) Yes; (U) Unclear; (N) No.
Acupuncture for PMS
Other sources of bias
One study28 demonstrated extreme imbalance in baseline
Menstrual Symptom Severity List scores. Five studies22,2427
used retrospective checklists for symptoms. Retrospective
checklists can themselves bias reporting.3133
Data analysis
The reduction in PMS symptom scores for continuous data
was measured using SMD in three studies.25,28,29 The respon-
der rates with improved primary symptoms or successful
treatment for dichotomous data were measured by OR in
six studies.2224,26,27,30
Acupuncture versus sham acupuncture (n = 2)
Two studies reported conicting outcomes for PMS by com-
paring acupuncture treatments with sham acupuncture.
While one trial with acupuncture plus auricular acupunc-
ture provided a statistically insignicant OR of 56.0 (95%
CI = 5.58561.75),30 the other trial with acupuncture alone
produced a marginally insignicant SMD of 1.17 (95%
CI = 0.042.39).28
Acupuncture versus wait-list control (n = 1)
One study29 compared hand acupuncture versus wait-
list and exhibited statistically signicant differences
between the treatment and control groups (SMD = 1.50, 95%
CI = 0.262.74).
Acupuncture versus pharmacologic treatment (n = 4)
Four studies reported a signicant difference in reduc-
tion of PMS symptoms for acupuncture treatment compared
with pharmacologic treatment. Signicant differences were
found in two trials that used acupuncture at acupoints
on the bladder meridian (SMD = 1.09, 95% CI = 0.421.76),25
(OR = 6.00, 95% CI = 1.4824.30).26 However, no signi-
cant difference was observed among additional subjects
who received acupuncture treatment at classical acupoints
(SMD = 0.06, 95% CI = 0.68 to 0.56).25 The other two stud-
ies also reported a signicant improvement in the treatment
group using acupuncture plus acupoint injection or acu-
point catgut embedding (OR = 4.17, 95% CI = 1.2413.97),27
(OR = 5.13, 95% CI = 1.3319.71),23 respectively.
Acupuncture versus herbal medication (n = 2)
Two studies reported an improvement in primary symp-
toms from baseline within both groups (p < 0.05). When
comparing the groups, both studies provided statistically
insignicant ORs of 2.84 (95% CI = 0.5215.51)22 and 3.60
(95% CI = 0.3536.80),24 respectively.
Adverse events
Of the studies that reported adverse events, one RCT30
reported minimal adverse events and one RCT29 reported
no serious adverse events. Habek et al.30 reported no major
adverse events; however, one subject developed a small sub-
cutaneous haematoma following acupuncture at acupoint
CV6.
109
Discussion
In this comprehensive review, we specically focussed
on RCTs that investigated the efcacy of acupuncture in
the treatment of PMS symptoms. Our review followed the
standard guidelines of the QUOROM recommendations with
no restrictions on language or the number of literature
databases.
The results of this review are limited because the num-
ber of trials is small and they contain some methodological
aws and thus should be interpreted with caution. The tri-
als included in this review provided insufcient evidence to
assess the efcacy and safety of acupuncture in PMS for a
number of reasons. First, the evidence from critical analysis
of RCTs is limited due to their methodological deciencies.
Only two of the studies demonstrated evidence of accept-
able sequence generation and allocation concealment. Some
methodological aws were found in all of the trials. Method-
ological weaknesses in the studies might have exaggerated
the treatment effects of acupuncture.34,35 Second, the num-
ber of trials that used sham or placebo control was too
small; therefore, the specic effect of acupuncture, with-
out placebo effect, could not be assessed. PMS is generally
believed to demonstrate a signicant placebo effect. Trials
of other treatments for PMS have also reported more appar-
ent effects from placebos than from the active treatment32
and that the benet from a placebo outlasts the benet from
the active intervention.36 Third, in this review, the interpre-
tation of results was limited by the different instruments
used across trials. While the types of symptoms assessed
overlapped, the number and structure of items differed,
as did the analysis and reporting. Furthermore, ve stud-
ies used retrospective checklists of symptoms. The wording
of questionnaires and checklists can themselves bias the
reporting.31 Retrospective accounts by participants of their
PMS symptoms have been shown to be unreliable.32,33 How-
ever, ve studies that used the checklists made assessments
of outcomes only a day before/after treatment and appar-
ently did not depend on participants recall of the severity
of symptoms on every day. No tests of internal consistency or
reliability were conducted for the checklists. Fourth, six of
the nine included trials reported superior results of acupunc-
ture therapies compared with control treatments. As such,
the evidence from this review is not free of publication bias.
Six of the nine included studies originated from China. A pre-
vious analysis found that Medline-indexed published clinical
trials conducted in China almost never report an experi-
mental treatment to be equal or inferior to control.37 With
this in mind, the results should be interpreted with caution.
Fifth, it is generally recognised that RCTs have major limita-
tions as sources of adverse events data, and only two RCTs
reported adverse events in the acupuncture-treated group.
They may not be generalisable having excluded patients at
high or even medium risk of experiencing certain adverse
effects, or may have only short-term follow-up and rela-
tive small sample sizes.38,39 While acupuncture seems to be
relatively safe, it is not risk free.40,41 Apart from the com-
monly seen benign adverse events of acupuncture (e.g.,
needling pain, haematoma formation, bleeding and ortho-
static problems), potentially serious adverse effects are
also known and practitioners should be aware of them
(e.g., pneumothorax, spinal lesion and infection).40,4245
110
Adverse events in clinical trials of acupuncture should be
described.
Given all of this, it is not possible to conclude that
acupuncture is an effective treatment for PMS; however, in
some cases, the ndings are sufciently promising to war-
rant further research. There is clearly a need for rigorous
research on the subject of acupuncture for PMS. To improve
the trial design quality, level of performance and the
degree of reporting of clinical trials on acupuncture, future
research should follow not only the basic guidelines for
reporting clinical trials, such as the CONSORT statement,46
but also the STRICTA recommendations, which provide spe-
cic guidelines for the reporting of acupuncture trials.47
Because PMS is highly susceptible to the placebo response,48
appropriate placebo control groups and (wherever possible)
adequate blinding procedures are of paramount importance.
Future research on PMS should use outcomes that allow
researchers to distinguish between women who benet from
the intervention from those who do not. Outcomes need
only be divided into symptoms relieved and symptoms
not relieved; rating scales should be designed with this in
mind. An electronic method for recording symptom severity
based on visual analogue scales has been designed.3 Copies
of charts or diaries used in the trial should be published
together with the instructions given to the participants. As is
suggested for analyses of statistical reports in medical jour-
nals, all raw data even that not used in the nal analysis
should be preserved electronically.49
In addition, this systematic review has several limi-
tations. The trials satisfying the inclusion criteria were
clinically, as well as methodologically, heterogeneous with
respect to different acupoints, type of acupuncture tech-
niques and control groups used. To fully assess the efcacy
of any acupuncture techniques for these conditions, stud-
ies need to address and report on a range of aspects of
the therapy. The types of acupuncture techniques used in
the trials included body acupuncture, auricular acupunc-
ture, acupoint injection, hand acupuncture and acupoint
catgut embedding. Styles of acupuncture techniques could
not be explored with pre-specied subgroup analysis due to
the small number of trials.
In conclusion, although the included trials showed that
acupuncture may be benecial to patients with PMS,
the authors of this systematic review note that there is
insufcient evidence to support this conclusion due to
methodological aws in the studies, including unknowns in
sequence generation, concealment of allocation, blinding
and outcome measures. We suggest that large, well-
designed, placebo-controlled RCTs with rigorous methods of
randomisation, blinding and adequately concealed alloca-
tion, as well as validated outcome measures, are needed.
Information on adverse effects should also be provided in
future trials.
Conict of interest
No competing nancial interests exist.
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