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Keywords:

  • Acupuncture;
  • premenstrual syndrome;
  • systematic review

Abstract

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information

Please cite this paper as: Kim S-Y, Park H-J, Lee H, Lee H. Acupuncture for premenstrual syndrome: a systematic review and meta-analysis of randomised controlled trials. BJOG 2011;118:899–915.

Background  Although acupuncture is widely applied in obstetrics and gynaecology, evidence for its efficacy in treating premenstrual syndrome (PMS) is equivocal.

Objective  To summarise and evaluate the current evidence for acupuncture as a treatment for PMS.

Search strategy  Ten databases were searched electronically, and relevant reviews were searched by hand through June 2009.

Selection criteria  Our review included randomised controlled trials (RCTs) of women with PMS; these RCTs compared acupuncture with sham acupuncture, medication, or no treatment.

Data collection and analysis  Study outcomes were presented as mean differences (for continuous data) or risk ratios (RRs) (for dichotomous data) with a 95% confidence interval (95% CI). The risk of bias was assessed using the assessment tool from the Cochrane Handbook.

Main results  Ten RCTs were included in our review. The pooled results demonstrated that acupuncture is superior to all controls (eight trials, pooled RR 1.55, 95% CI 1.33–1.80, P < 0.00001). A meta-analysis comparing the effects of acupuncture with different doses of progestin and/or anxiolytics supported the use of acupuncture (four trials, RR 1.49, 95% CI 1.27–1.74, P < 0.00001). In addition, acupuncture significantly improved symptoms when compared with sham acupuncture (two trials, RR 5.99, 95% CI 2.84–12.66, P < 0.00001). No evidence of harm resulting from acupuncture emerged. Most of the included studies demonstrated a high risk of bias in terms of random sequence generation, allocation concealment, and blinding.

Author’s conclusions  Although acupuncture seems promising for symptom improvement in women with PMS, important methodological flaws in the included studies weaken the evidence. Considering the potential of acupuncture, further rigorous studies are needed.


Introduction

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information

Premenstrual syndrome (PMS) is a condition that presents with distressing physical, behavioural, and psychological symptoms, in the absence of organic or underlying psychiatric disease, which regularly recurs during the luteal phase of each menstrual cycle, and which disappears or significantly regresses by the end of menstruation.1 Although mild symptoms occur in approximately 75% of women of reproductive age,2 20–30% of women are reported to suffer from clinically significant PMS.3 A recent evaluation of published reports suggests that 13–18% of women of reproductive age exhibit PMS symptoms severe enough to warrant treatment.4 Women with PMS usually complain of somatic symptoms, such as food cravings, mastalgia, bloating, headache, lack of energy, abdominal discomfort and pain, and weight gain. Frequently reported affective changes include depression, angry outbursts, crying spells, anxiety, irritability, and feelings of being unable to cope. When diagnosing and evaluating the effect of treatment for PMS, the Daily Record of Severity of Problems (DRSP) form is now accepted.1

The aetiology and pathogenesis of PMS have yet to be established; therefore, a broad range of treatment options is suggested.5 Before starting treatment, lifestyle changes, exercise or cognitive behavioural therapy are encouraged as a first-line option. For women who have moderate to severe PMS, or for those in whom simple lifestyle adjustments have failed, evidence-based pharmacological treatment options include combined new contraceptive pills (cyclically or continuously), continuous or luteal phase low-dose selective serotonin reuptake inhibitors (SSRIs), and percutaneous estradiol with cyclical progestogen.1

As an integrated approach is beneficial, many women with PMS seek complementary and alternative medicine (CAM) treatments such as herbal preparations, manipulative therapy, homoeopathy, and acupuncture.6,7 Although acupuncture is widely applied in obstetrics and gynaecology,8,9 evidence of its effectiveness for PMS is equivocal. Moreover, acupuncture is not mentioned in the recent Royal College of Obstetricians and Gynaecologists (RCOG) guidelines for PMS management, whereas many other CAM modalities with limited effectiveness have been listed. In this context, we conducted a systematic review and a meta-analysis to summarise and critically evaluate the current evidence for, or against, the use of acupuncture for PMS.

Methods

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information

Data sources and searches

This systematic review was performed according to the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement.10 The following electronic databases were searched from their inception to June 2009, without language restrictions: PUBMED, EMBASE, The Cochrane Library, AMED, SocINDEX, CINAHL, Academic Search Premier, China National Knowledge Infrastructure (CNKI), Korean Studies Information Service System (KISS), and the National Digital Science Library of Korea databases. The search terms used were ‘acupuncture’ and ‘premenstrual’, ‘premenstrual syndrome’, or ‘PMS’. The references in all located studies and reviews were manually searched for further relevant articles. Publication types, e.g. conference proceedings, abstract only, or theses, were not limited, as long as they met the following inclusion criteria.

Study selection

Studies meeting the following criteria were included: (1) the study was an RCT; (2) the study participants were women who met the diagnostic criteria for PMS or premenstrual tension syndrome; (3) the study compared needle acupuncture for one or more menstrual cycles with sham acupuncture, usual care, waiting list or no treatment; (4) if any concomitant treatment other than acupuncture was given, this was given to both acupuncture and control groups; and (5) the study reported changes or improvements in PMS symptoms as outcome measures. Studies looking only at specific symptoms of PMS (e.g. menstrual migraine), comparing two different forms of acupuncture, or comparing acupuncture with a herbal medicine, the efficacy of which cannot be determined at present, were excluded. Trials of acupuncture-related techniques (e.g. auricular seed, laser, acupuncture point embedding or injection, acupressure, magnetic devices, and moxibustion) were excluded. No language restrictions were imposed.

Data extraction and risk of bias assessment

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information

The study selection, data extraction and risk of bias assessment were performed independently by two of the authors (S-Y Kim and H Lee). Hard copies of all articles included were obtained and read in full. Data from the articles were validated and extracted using a predefined data extraction form. We contacted study authors via e-mail or telephone to collect further information when necessary. The details of acupuncture and control interventions were tabulated separately based on the recently revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) recommendations.11

Quality assessment was also independently performed by the two reviewers (S-Y Kim and H Lee) using the tool for the assessment of risk of bias from the Cochrane Handbook for Systematic Reviews of Interventions.12 The following items were assessed;

  • 1
     Was the allocation sequence adequately generated?
  • 2
     Was allocation adequately concealed?
  • 3
     Was knowledge of the allocated interventions adequately prevented during the study?
  • 4
     Were incomplete outcome data adequately addressed?
  • 5
     Are reports of the study free of suggestion of selective outcome reporting?
  • 6
     Was the study free of other problems that could put it at a risk of bias? The answer ‘yes’ indicated a low risk of bias (Y), ‘unclear’ indicated that the risk of bias was uncertain (U), and ‘no’ indicated a high risk of bias (N). The blinding to the allocated interventions was assessed separately for participants and outcome assessors. Disagreements were resolved by discussions between all authors.

Data synthesis and analysis

All analyses were conducted using review manager v5.0.21 for windows (The Nordic Cochrane Centre, Copenhagen, Denmark). Studies were classified and combined in the analysis according to the type of control used.

We used the mean difference (MD) with a 95% confidence interval (95% CI) for continuous data. For dichotomous data (e.g. the number of women reporting clinical improvement), the results were presented as a risk ratio (RR) with a 95% CI. As most Chinese trials report outcomes based on a categorical assessment (e.g. ‘markedly improved’, ‘improved’, ‘slightly better’ or ‘no effect’),13 we performed a sensitivity analysis by re-analysing the dichotomous outcomes. In other words, we compared the ‘all improved versus no effect’ scenario (as reported) with the ‘improved or more versus slightly better or no effect’ scenario to ascertain any discrepancies.

Although both fixed-effects and random-effects models were computed, only random-effects results were presented if there were no significant differences between the two methods. Heterogeneity was examined with the I2 test, where I2 values of 50% or more indicated a substantial level of heterogeneity.14

Results

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information

Study characteristics

Figure 1 summarises the results of the literature searches. From a total of 306 titles, 199 records were screened, and 50 studies were deemed to be potentially relevant. These 50 full-text articles were read to confirm their eligibility. Ten studies met our inclusion criteria (Table 1),15–24 after the exclusion of two duplicates.25,26

image

Figure 1.  Flow chart of the studies included.

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Table 1.   Summary of the included RCTs (n = 10)
Author (year)DesignDiagnosis (mean age)/menstrual cyclesAcupuncture (no of analysed/randomised patients)Control (no of analysed/randomised patients)Main outcome measuresMain results*AE
  1. *Data were re-analysed when statistics were missing or should be clarified.

  2. AE, adverse events; EA, electroacupuncture; ICD, International Classification of Diseases; MMSL, Menstrual Symptom Severity List; NR, not reported; NS, not significantly different between groups; OB/GYN, obstetrics and gynaecology; PMS, premenstrual syndrome; RCT, randomised controlled trial; yrs, years.

Acupuncture vs Medication
Xu (2006a)22Parallel, three armsChinese standards for diagnosis and treatment, Chinese guideline for new Chinese medicine research for PMS, and OB/GYN textbook (32.2 yrs)/3(A) Back shu point acupuncture (20/20) (B) Standard acupuncture (20/20)Medication (20/20)(1) Symptom score after three cycles(A) better than control (< 0.05) (B) vs control: NS (A) better than (B) (< 0.05)NR
(2) Clinical improvement rate after three cycles(A) better than control (< 0.05) (B) vs control: NS (A) better than (B) (< 0.05)
Xu (2006b)23Parallel, two armsChinese guideline for new Chinese medicine research for PMS and OB/GYN textbook (31.1 yrs)/3Point-through-point acupuncture at the back (30/30)Medication (30/30)Clinical improvement rate after three cyclesAcupuncture better than control (< 0.05)NR
Guo (2004a)16Parallel, two armsPhysical, psychological and behavioral symptoms of PMS (30.9 yrs)/3Acupuncture (35/35)Medication (31/31)Clinical improvement rate after three cyclesAcupuncture better than control (< 0.05)NR
Hong (2002)18Parallel, two armsOB/GYN textbook (NR, range 20-41 yrs)/3Scalp EA (35/35)Medication (31/31)Clinical improvement rate after three cyclesAcupuncture better than control (< 0.05)NR
Acupuncture vs sham acupuncture
Yu (2006)24Parallel, two armsDSM-IV (31.6 yrs)/3Acupuncture (30/33)Sham acupuncture (30/32)(1) Changes in discomforts after three cycles(1) Acupuncture better than control (P < 0.05)Two cases of hypomenorrhea during 2nd cycle, recovered at 3rd cycle in acupuncture group
(2) Changes in days with discomforts after three cycles(2) Acupuncture better than control (P < 0.05)
(3) Clinical improvement rate after three cycles(3) Acupuncture better than control (P < 0.0001)
Kim (2005)19Parallel, two armsICD-10 criteria for PMS and DSM-IV for PMDD (28.9 yrs)/1Acupuncture (10/10)Sham acupuncture (3/10)MSSL score change between two cyclesNSNR
Habek (2002)17Parallel, two armsSymptoms of PMS, diagnostic criteria NR (30.2 yrs)/1Acupuncture (18/18)Sham acupuncture (17/17)Clinical improvement rate, measurement time-point unclearAcupuncture better than control (P = 0.008)One subcutaneous abdominal haematoma in acupuncture group
Acupuncture vs no treatment
Shin (2009)21Parallel, three armsICD-10 criteria (27 yrs)/1Korean Hand acupuncture (7/10) Korean Hand moxibustion (8/10)No treatment (7/10)MSSL score at 4 weeks(A) better than control (< 0.001) (B) better than control (< 0.001)No serious AE observed
Acupuncture plus medication vs medication
Guo (2004b)15Parallel, two armsChinese standards for diagnosis and treatment, & OB/GYN textbook (30.9 yrs)/3Acupuncture plus medication (20/20)Medication (22/22)(1) Symptom score after three cycles(1) Acupuncture better than control (< 0.01)NR
(2) Clinical improvement rate after three cycles(2) Acupuncture better than control (< 0.05)
Acupuncture plus herbal medicine vs herbal medicine
Peng (2009)20Parallel, two armsChinese guideline for new Chinese medicine research for PMS and OB/GYN textbook (31.1 yrs)/3Acupuncture + Chinese herbal medicine (30/30)Chinese herbal medicine (30/30)Clinical improvement rate after three cyclesAcupuncture better than control (< 0.05)No serious AE observed

Seven studies were conducted in China,15,16,18,20,22–24 two were conducted in Korea,19,21 and one was conducted in Croatia.17 Except for two articles in English17,21 and one in Korean,19 the studies were all reported in Chinese.15,16,18,20,22–24

Participants and settings

The trials were relatively small, with an average of 47 women per trial. Patients were diagnosed as having PMS according to the International Statistical Classification of Diseases and Related Health Problems, tenth revision (ICD-10),19,21 the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV),19,24 national guidelines,15,20,22,23 textbooks,15,18,20,22,23 or other criteria.16,17

Acupuncture interventions

A range of acupuncture techniques were adopted in the studies included. Details of the reporting of interventions are listed in Table 2, in accordance with the STRICTA recommendations.11 Most (70%) of the studies tested traditional Chinese medicine (TCM)-style acupuncture, as most studies originated from China. Two of the TCM studies employed specific points on the back alone.22,23 The three non-TCM studies used scalp electroacupuncture,18 traditional Korean acupuncture,19 and Korean hand acupuncture.21 The acupuncture techniques varied greatly in terms of acupuncture style, treatment variation (i.e. fixed or individual), acupuncture point selection, and manipulation method. The participants received 21.2 sessions of acupuncture, on average (median 25.5 sessions; SD 10.5 sessions) for between one and three menstrual cycles (mean 2.4 cycles; SD 1.0 cycles; median 3.0 cycles). The frequently used acupuncture points were as follows (Table S1): LR3 (n = 6); SP6 (n = 5); PC6 (n = 4); GV20 (n = 4); CV4 (n = 5); CV6 (n = 4); CV17 (n = 3) except acupuncture points at the back such as BL17 (n = 3); BL18 and BL20 (n = 4, each); and BL23 (n = 6). Many of these points are commonly used in other obstetric and gynaecological conditions, and additional points were used based on symptoms. Most studies employed forms of manual stimulation, such as twirling or lifting/thrusting the needle to elicit the de qi sensation (i.e. the patient’s feeling of soreness, numbness, distension, heaviness, or a sensation like an electric shock around the point, together with the practitioner’s feeling of tenseness around the needle).27 In only three studies were specific characteristics or the educational background of the practitioner described: a Korean medicine doctor;19 an obstetrics/gynaecology specialist;17 and a Korean hand acupuncture therapist.21

Table 2.    Acupuncture interventions in the included studies based on the STRICTA recommendations (n = 10)
First author (year)Acupuncture rationaleDetails of needlingTreatment regimenOther components of treatmentPractitioner backgroundControl intervention
Style of acupunctureTreatment rationaleAcupuncture treatment variationNumber of needles per session Acupuncture points used (uni/bilateral/NR) Insertion depth Response sought Stimulation method Retention time Needle typeNumber of sessions/frequency and duration of sessionsOther interventions given to the acupuncture groupSetting and context of treatmentRationale for the controlDescription of the control
  1. De-qi means acupuncture-evoked specific sensations, such as soreness, numbness, heaviness, and distention at the site of needle placement, and these sensations may spread to other parts of the body; acupuncture point ST36 refers to the 36th point of the stomach meridian. Some extra points have Chinese names.

  2. EA, electroacupuncture; min, minutes; NA, not applicable; NR, not reported; STRICTA, standards for reporting interventions in controlled trials of acupuncture; TCM, traditional Chinese medicine; TKM, traditional Korean medicine.

Acupuncture vs medication
Xu (2006a)22(A) Back shu point acupunctureHistorical context and literature sourcesFixedNR BL15, 17, 18, 20, 21, 23 (NR) 1 cun De-qi response Manual, manipulation at every 5 min 30 min 0.25 × 40 mm30 sessions Once daily 14 days before menstruation for three cycles, rest during periodNRHospitalNRNRMedroxyprogesterone, 6 mg daily, from 16th day of menstrual cycle for 10 days
(B) Standard acupunctureNRFixedNR GV20, CV4, 6, Ex-CA1 (Zigong), SP6, ST36 (NR) NR De-qi response Manual, manipulation at every 5 min 30 min 0.25 × 40 mm30 sessions Once daily 14 days before menstruation for three cycles, rest during period
Xu (2006b)23Point-through-point acupuncture at the backHistorical context and literature sourcesFixedNR From GV8 to 7, 6 to 5, 4 to 3/BL18 to 19, 20 to 21, 22 to 23/BL47 to 48, 49 to 50, 51 to 52 NR De-qi response Manual, point-through-point acupuncture method 30 min 0.38 × 40 mm30 sessions Once daily 14 days before menstruation for three cycles, rest during periodNRHospitalNRNRMedroxyprogesterone, 6 mg daily, from 16th day of menstrual cycle for 10 days
Guo (2004a)16TCM acupunctureHistorical context and literature sourcesFixedNR BL17, 18, 20, 23 followed by GV20, CV17, CV4, SP6, PC6, LR3 0.5–1 cun De-qi response Manual, manipulation at every 5 min 0–30 min 0.35 × 40 mm30 sessions Once daily from 14 days before menstruation for three cycles, rest during periodNRHospitalNRNRMedroxyprogesterone, 4 mg daily and diazepam 2.5 mg twice daily
Hong (2002)18Scalp EAHistorical context and literature sourcesSemi-standardisedNR Basic points: MS1, 5; additional points based on symptoms: MS2/MS3/MS4 Beneath the epicranial aponeurosis Electrical intensity was adjusted for patients to feel comfortable Electrical, 1.3–1.7 Hz60 min 0.65 × 25 mmApproximately 30 sessions Three times/week for three cycles, rest for 5 days during periodNRNRNRNRMedroxyprogesterone (4 mg daily and diazepam 2.5 mg twice daily, starting from 14 days before menstruation, stopping at the end of menstruation
Acupuncture vs sham acupuncture
Yu (2006)24TCM acupunctureHistorical context and literature sourcesSemi-standardisedNR Basic points: GV20, Ex-HN3, 5, SP6, 10; additional points based on symptoms: LR3, CV17, LR14/Ex-CA1 (Zigong), CV4, SP9/ST36, CV6/PC6, HT7/BL23, GV4, KI3 bilaterally Different depths for different acupuncture points De-qi response Manual, manipulation at every 10 min 30 min 0.30 × 25 mm, 0.30 × 40 mmNine sessions Three sessions, from 7 days before menstruation, for three cyclesNRHospitalNRPilot test for sham acupuncture control on 12 healthy volunteersSuperficial acupuncture at non-acupuncture points 1 cm away from basic acupuncture points at 0.2–0.3 cun depth, induction of de-qi response unclear
Kim (2005)19TCM acupunctureHistorical context and literature sourcesSemi-standardised-NR Basic points: SP6, CV6; additional points based on symptoms: LR2, 3, SP10, LI4/ST36 (NR) NR De-qi response Manual NR 0.30 × 30 mm (DongBang, Korea)18–20 sessions, from 14 days before menstruation twice weekly, for 8 weeksNRHospitalKorean medicine doctorsHistorical context and literature sourcesAcupuncture at SI5 and ST40 considered ineffective to PMS, de-qi elicited
Habek (2002)17TCM acupuncture + ear acupunctureHistorical context and literature sourcesFixedNR Standard acupuncture point: GV20, CV3, 4, 6, LI4, LR3, PC6, GB34, BL23 (bilateral)/Ear acupuncture: Shenmen NR De-qi response Manual NR NRMean 2.6 sessions (range 2–4) Once every other day for 7 days, during the 3rd luteal phase of the cycle 30 min/sessionProgestin (n = 3), and fluoxetine (n = 1)Health centrePhysician (OB/GYN)NRSuperficial acupuncture at non-acupuncture points without de-qi
Acupuncture vs no treatment
Shin (2009)21(A) Korean Hand acupunctureTextbooksFixedNR A5, 6, 8, 12, 16, 18, N18, F6 (bilateral) <1 mm NR Manual NR NRTen sessions Once per 3 days for 4 weeksNRLaboratory within a hospitalKorean hand acupuncture therapistNRNo treatment
(B) Korean Hand moxibustionTextbooksFixedNA A5, 6, 8, 12, 16, 18, N18, F6 (bilateral) NA NA Moxibustion, three times per sessions 30 min NA
Acupuncture plus medication vs medication
Guo (2004b)15TCM acupunctureHistorical context and literature sourcesFixedNR BL17, 18, 20, 23 followed by GV20, CV17, CV4, SP6, PC6, LR3 0.5–1 cun De-qi response Manual, manipulation at every 5 min 0–30 min 0.25 × 40 mm30 sessions Once daily from 14 days before menstruation for three cycles, rest during periodIdentical medication as in the control groupHospitalNRNRMedroxyprogesterone, 6 mg daily, for 10 days, from 16 days before menstruation
Acupuncture plus herbal medicine vs herbal medicine
Peng (2009)20TCM acupuncture + Chinese herbal medicineHistorical context and literature sourcesFixedNR LR3, CV4, 6, SP6, GV24 (NR) NR De-qi response Manual, manipulation at every 5 min 30 min 0.30–35 × 25–40 mmApproximately 21 sessions Once every other day for 7 days from 14 days before menstruation, rest during period, for three cyclesJiaweixiaoyao powder, once daily, from 14 days before menstruation, for 14 daysHospitalNRNRJiaweixiaoyao powder, once daily, from 14 days before menstruation, for 14 days
Types of control groups

Four out of ten trials compared acupuncture with medication.16,18,22,23 There were three sham-controlled trials, including two with superficial needling at non-acupuncture points,17,24 and one with identical needling at real but irrelevant acupuncture points.19 One Korean study compared Korean hand acupuncture with no treatment at all.21 In one Chinese trial, a herbal medicine widely used for PMS was given to both acupuncture and control groups.20Table 2 lists the details of control group interventions. In several studies, acupuncture was compared with progestin administered alone (medroxyprogesterone, 6 mg daily)22,23 or in combination with diazepam (medroxyprogesterone, 4 mg daily, and diazepam, 2.5 mg twice daily) starting on the 14th or 16th day of the menstrual cycle, and continuing for 10–14 days.15,16,18 Although most studies did not describe the rationale for their selection of a control group, two sham-controlled trials reported the use of pilot testing or literature sources in their selection of a control group.19,24

Outcome measures

The Menstrual Symptom Severity List (MSSL) was used to measure the treatment outcome in two studies.19,21 Eight out of ten studies reported clinical improvement based on a four-point Likert-type scale, with possible outcomes of ‘markedly improved’, ‘improved’, ‘slightly better’, and ‘no effect’. The definitions of clinical improvement or treatment effectiveness varied across trials, and most studies compared all improvements to no effect. In our statistical pooling of the numbers of women with or without an improvement as a dichotomous outcome, two scenarios were analysed and compared: one was an ‘as reported’ scenario comparing ‘all improvements’ with ‘no effect’, and the other was a ‘re-calculated’ scenario comparing ‘improved or more’ with ‘slightly better or no effect’.

Risk of bias assessment

Adequate sequence generation

One study used a computer-generated random number sequence to allocate patients to the treatment and control groups (Table 3).24 Nine studies did not clearly report how their random numbers were generated.15–23

Table 3.    Risk of bias assessment in the included studies (n = 10)
First author (year), locationRisk of bias assessment
(1) Adequate sequence generation?(2) Allocation concealment?(3) Blinding?(4) Incomplete outcome data adequately addressed?(5) Free of selective outcome reporting?(6) Free of other bias?
ParticipantOutcome assessor
  1. (1) Was the allocation sequence adequately generated? (2) Was the allocation adequately concealed? (3) Was knowledge of the allocated interventions adequately prevented during the study? (4) Were incomplete outcome data adequately addressed? (5) Are reports of the study free of suggestion of selective outcome reporting? (6) Was the study apparently free of other problems that could put it at a risk of bias?

  2. N, no (high risk of bias)12 ; U, unclear; Y, yes (low risk of bias).

Xu (2006a), China22UUNUYYY
Xu (2006b), China23UUNUYYY
Guo (2004a), China16UUNUYYN
Hong (2002), China18NUNUYYY
Yu (2006), China24YYUUYYY
Kim (2005), Korea9UUUUNYN
Habek (2002), Croatia17UUUUYNN
Shin (2009), Korea21UUNNUYN
Guo (2004b), China15UUNUYYY
Peng (2009), China20UUNUYYY
Allocation concealment

Only one study adequately concealed group assignments by adopting central randomisation.24 It was not clear whether group allocation was adequately concealed in the remaining nine trials.

Blinding

Blinding was evaluated separately for patients and outcome assessors. We could not judge whether the patients were blinded for the three sham-controlled trials because of insufficient information.17,19,24 For outcome assessor blinding, all studies received ratings of ‘unclear’ or ‘no’ because of poor reporting or the self-reporting nature of the outcome measures used.

Incomplete outcome data reporting

Two studies had a high attrition rate.19,21 The numbers of dropouts in these two studies were highly imbalanced between the treatment and control groups: this probably affected the outcomes.19 Statistical analysis was performed only on the patients who completed the protocol,19,21 introducing a substantial bias into these studies. The other eight studies were rated as having a low risk of bias.

Selective outcome reporting

Although most of the studies were evaluated as having a low risk of bias, the risk of bias was deemed high in one study where the outcome measurement was not clearly pre-specified or reported.17

Other sources of bias

Four out of ten studies were rated as having a high risk of bias for reasons not listed above: two trials did not report definitive diagnostic criteria,16,17 and two other studies involved either vulnerable subjects, i.e. nurses working in the study hospital,19,21 or patients with an extreme baseline imbalance.19

Main outcomes

Acupuncture versus all controls (eight trials, 429 women analysed)

When pooled, the results from eight RCTs showed a significant benefit of acupuncture on improving the symptoms of PMS (Figure 2A; n = 429, pooled RR 1.55, 95% CI 1.33–1.80, P < 0.00001, I2 = 28%).15–18,20,22–24 Our re-analysis of these data using the ‘improved or more’ versus the ‘slightly better or no effect’ criterion confirmed a significant improvement in symptoms achieved by acupuncture (pooled RR 2.35, 95% CI 1.73–3.19, P < 0.00001, I2 = 29%). Excluding one outlier did not significantly change the overall benefit of acupuncture over controls (seven trials, n = 394, pooled RR 1.52, 95% CI 1.34–1.72, P < 0.00001, I2 = 0%).17

image

Figure 2.  Forest plots of acupuncture for premenstrual syndrome (PMS). The vertical line shows the ‘no effect’ point. An event indicates a patient with clinical improvement in the symptoms of PMS: A, acupuncture versus all controls; B, acupuncture versus medication; C, acupuncture versus sham acupuncture. Sham acupuncture indicates superficial needling on non-acupuncture points. AT, acupuncture therapy; CI, confidence interval.

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Acupuncture versus medication (four trials, 232 women analysed)

Four studies compared approximately 30 sessions of acupuncture over three menstrual cycles with different doses of progestin (4–6 mg daily), with or without anxiolytics.16,18,22,23 Overall, women receiving acupuncture were approximately 1.5 times more likely to experience symptom improvement than those on hormonal preparations with or without anxiolytics (Figure 2B; four trials, n = 232, pooled RR 1.49, 95% CI 1.27–1.74, P < 0.00001, I2 = 0%). The result remained significant when the ‘all improvements’ versus ‘no effect’ data were re-analysed as ‘improved or more’ versus ‘slightly better or no effect’ (pooled RR 2.19, 95% CI 1.57–3.05, P < 0.00001, I2 = 0%).

Acupuncture versus sham acupuncture (three trials, 108 women analysed)

Three studies compared acupuncture with sham acupuncture: for sham control, one study adopted identical needling on real acupuncture points that are considered ineffective in PMS,19 and the other two studies used superficial needling at non-acupuncture points.17,24 The pooled results from the two trials reporting clinical improvement rates demonstrated a non-significant impact of acupuncture on symptom improvement, with significant heterogeneity (two trials, n = 95, pooled RR 4.31, 95% CI 0.44–42.29, = 0.21, I2 = 82%).17,24 The result was changed, however, when the ‘all improvements’ versus ‘no effect’ data were re-analysed as ‘improved or more’ versus ‘slightly better or no effect’ (Figure 2C; pooled RR 5.99, 95% CI 2.84–12.66, P < 0.00001, I2 = 0%). The other sham-controlled trial produced non-significant MSSL score changes from data collected over the course of two menstrual cycles (one trial, n = 13, MD 3.43, 95% CI 0.04–6.82, P = 0.05).19

Acupuncture versus no treatment (one trial, 14 women analysed)

Compared with no treatment, the MSSL score significantly improved after ten sessions of Korean hand acupuncture (one trial, n = 14, MD −13.60, 95% CI −15.70 to −11.50, P < 0.00001).

Acupuncture and medication versus medication alone (one trial, 42 women analysed)

Guo investigated whether acupuncture treatment coupled with progestin (6 mg daily) alleviated the symptoms of PMS more than progestin alone.15 Acupuncture was significantly associated with improved symptoms (RR 1.52, 95% CI 1.04–2.22, P = 0.03), and this statistical difference was maintained in a ‘improved or more’ versus ‘slightly better or no effect’ analysis (RR 1.93, 95% CI 1.03–3.59, P = 0.04).

Acupuncture and herbal medicine versus herbal medicine alone (one trial, 60 women analysed)

Peng compared acupuncture combined with herbal medicine against herbal medicine alone.20 The result as originally reported (‘all improvements’ versus ‘no effect’ analysis) indicated that acupuncture was better than the control (RR 1.37, 95% CI 1.01–1.86, P = 0.04); however, when the data were analysed as ‘improved or more’ versus ‘slightly better or no effect’, we found no significant difference between acupuncture and the control (RR 1.56, 95% CI 0.80–3.03, P = 0.19).

Safety

Adverse events were reported in four studies.17,20,21,24 No serious adverse events were reported during treatment.20,21 Minor adverse events, which were resolved by the end of treatment, included a small subcutaneous haematoma following acupuncture,17 hypomenorrhoea, and a shortened menstrual cycle.24

Discussion and conclusion

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information

Summary of main findings

Our systematic review and meta-analysis have found a favourable effect of acupuncture over various controls (n = 429, pooled RR 1.55, 95% CI 1.33–1.80, P < 0.00001). We analysed four trials that compared acupuncture for 3 months against progestin treatment with or without anxiolytics. The pooled results showed acupuncture to be superior to the control treatments in reducing the symptoms of PMS (n = 232, pooled RR 1.49, 95% CI 1.27–1.74, P < 0.00001). When compared with sham acupuncture, acupuncture significantly impacted symptom improvement (n = 95, RR 5.99, 95% CI 2.84–12.66, P < 0.00001). No evidence emerged for any significant harm caused by acupuncture. These results appear promising, but it should be stressed at the same time that they are based on a small number of small trials with a high risk of bias. Therefore, before rushing into a positive conclusion, a careful interpretation is necessary to provide doctors and patients with unbiased evidence.

Applicability of evidence

The trials we reviewed differed in the types of acupuncture interventions used, control procedures, and outcome measures. Such differences are common in studies of both acupuncture and PMS.28,29

It is not easy to evaluate whether the tested acupuncture treatment was appropriate or optimal for the relief of PMS symptoms. Because the active components of acupuncture treatment have not been identified, various factors could have an impact on outcomes, including pattern diagnosis, acupuncture points selected, intensity, duration, frequency of stimulation, total number of sessions, and treatment period. Although acupuncture interventions vary greatly, it is notable that most of the studies included involved more than 20 sessions of acupuncture treatment over three menstrual cycles. The acupuncture points applied in each study were also the commonly used ones in general acupuncture practice for obstetrics/gynaecology conditions.

The pooling of eight RCTs produced positive outcomes for acupuncture. However, as the definitions and categorical classifications of symptom improvement are heterogeneous, the pooled results should be interpreted with caution. Given that the empirical evidence indicates that some countries produce only positive results in acupuncture studies,30 our review may not be free from publication bias.

There was poor reporting of adverse events in the studies included, which makes a benefit/harm analysis difficult. Although acupuncture has been reported to be relatively safe,31,32 the thorough reporting of adverse events in groups receiving acupuncture is nevertheless necessary to analyse its benefit/harm profile.

Risk of bias in the studies included

In our ‘risk of bias’ assessment, we tried to fully report how each trial was rated for six critical domains.

All of the included studies were found to have a high risk of bias: RCTs without adequate allocation concealment, for instance, tend to overestimate the benefit of interventions. Therefore, meta-analyses of such trials also favour interventions.33 Most of the trials in our review lacked adequate reporting of their randomisation and allocation concealment methods. Only one trial adequately generated random numbers and concealed group assignments.24 Therefore, the positive outcomes in these studies might be too optimistic. As clinical studies of PMS have shown that there is a substantial placebo effect,34 and because outcome measures of PMS rely heavily on self-reporting, blinding is crucial for a rigorous study design. Nevertheless, none of the eligible studies were rated as having a low risk of bias for patient and assessor blinding; thus, their positive outcomes are likely to be overestimated. Previous acupuncture studies have usually concluded that acupuncture is better than no treatment, but is not superior to sham acupuncture; this indicates that acupuncture is merely a placebo.35 In this context, it is noteworthy that in our analysis, sham-controlled trials demonstrated greater benefits than did the acupuncture versus medication studies. This encouraging result appears to derive from the low responder rate (12.8%) in the sham group compared with the responder rate (83.3%) in the treatment group (Figure 2C). It is not clear whether acupuncture definitely outperforms sham acupuncture or produces effects similar to those produced by medication, as the studies included were confounded by methodological flaws.

Other problems that could threaten the validity of the trials should be noted. Although the menstrual cycle is an important factor in PMS research, the small sample sizes and short study durations of the trials included can be problematic. Regarding the control issue, a lack of a true placebo control for acupuncture has been an inevitable obstacle, and the specific effects of acupuncture for PMS have not been illuminated. Used as a control in some of the studies included, medroxyprogesterone can be controversial, as it has been reported as ineffective or may even produce PMS symptoms.1

Limitations and strengths of this review

Although our literature searches included English, Chinese, and Korean databases, and included searching by hand for relevant articles, we cannot be absolutely certain that all relevant RCTs were found.

Bias can be introduced in many ways in the process of locating and selecting studies for inclusion in a meta-analysis;36 our systematic review may not be an exception. As 90% of the eligible studies support acupuncture for PMS, a possible publication bias should have been explored. However, the number of studies included in our meta-analysis (eight) may be too small to test for funnel plot asymmetry in order to distinguish chance from real asymmetry.37 Because of poor reporting in the studies, this review cannot determine whether the positive outcomes exclusively reflect the effect of acupuncture in women with PMS. Only three included trials reported on the intensity and improvement of different symptoms, thus we don’t have a clear picture of which aspects of the symptoms were helped by acupuncture.

A recently published review examines the same topic as the present article.38 It included two trials comparing acupuncture with herbal medicines of unproven efficacy,39,40 and another two trials testing the embedding of catgut in acupuncture points,41 or acupuncture combined with injections of herbal medicines,42 which were all excluded in our review. The interpretation of the data from such trials can be less generalisable, and thus less clinically applicable. Exclusion of such trials serves the aim of our review well: i.e. restricts our evaluation to just the evidence on acupuncture for PMS. In addition, without any convincing reason, Cho et al. failed to locate several important studies that were included and analysed in our review.15,16,24 Different inclusion criteria could only partly explain this discrepancy. Compared with the previous systematic review, we believe that the more comprehensive search and more rigorous inclusion/exclusion criteria of our review strengthen the validity and generalisability of the current evidence from our review.

Implications for practice and research

Although acupuncture appears to relieve symptoms associated with PMS, and no serious harm resulting from acupuncture was reported, we rightly acknowledge at the same time that our review is based on a small number of studies of low methodological quality. Therefore, the choice of acupuncture for women with PMS who do not respond to other therapeutic interventions cannot be offered at present. Considering the potential of acupuncture demonstrated in the trials included, however, additional, large clinical studies of high methodological quality will be necessary to firmly determine the value of acupuncture in the management of PMS. These studies should implement adequate diagnostic criteria, optimal interventions, validated outcome measures, and a detailed reporting of how diagnoses (both in western and in traditional Chinese medicine) were made. Acupuncture researchers should follow the STRICTA recommendations and adopt the CONSORT statement to improve the quality of their reporting.11,43 As it is unclear whether acupuncture alleviates the somatic symptoms of PMS, the emotional symptoms, or both, outcomes should be carefully collected. Given that PMS is closely related to quality of life (QoL), the assessment of which depends on self-reported symptoms,44 the measurement of QoL should also be an interesting addition to future studies. In addition, women’s experience of the impact of PMS on their lives may vary across cultures or countries,45–47 and familiarity with or expectations of acupuncture treatment may also be different.48 As these are likely to result in different outcomes, future studies should take account of which aspects of PMS acupuncture may help with, what characteristics responders to acupuncture may have, and to which direction different cultures under different healthcare settings may affect the outcome. Although there has been no economic evaluation of the use of acupuncture for PMS, it is interesting that some recent European studies reported that in the treatment of other conditions acupuncture is more cost-effective for women than for men.49,50 Future economic analyses will help determine the true potential of acupuncture for women with PMS.

In conclusion, although acupuncture seems promising for symptom improvement in women with PMS, important methodological limitations in the studies included undermine the evidence. Considering the potential of acupuncture in the trials included, further rigorous studies are needed.

Contribution to authorship

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information

S-YK and H-JP formulated the idea for conducting a systematic review; S-YK and HL performed literature searches, study selection, data extraction, risk of bias assessment, meta-analysis, and wrote the initial draft; all of the authors dissolved disagreements regarding study selection and risk of bias assessment, and critically revised the article.

Funding

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information

This research was supported by the Basic Science Research Programme through the National Research Foundation (NRF) funded by the Korean Ministry of Education, Science and Technology (R11-2005-014).

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information
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    Higgins JPT, Altman DG. Chapter 8: Assessing risk of bias in included studies. In: HigginsJPT, GreenS, (editors). Cochrane Handbook for Systematic Reviews of Interventions. Chichester, UK: The Cochrane Collaboration, John Wiley & Sons, 2008, pp. 187242.
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    Guo S. Clinical study on the treatment of premenstrual syndrome by the Back-Shu and Front-Mu and network points acupuncture. Harbin: Heilongjiang University of Chinese Medicine, 2004.
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    Habek D, Habek JC, Barbir A. Using acupuncture to treat premenstrual syndrome. Arch Gynecol Obstet 2002;267:236.
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Journal club

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information

Discussion points

  • 1
     Background: List and evaluate the available medical, surgical, complementary, and alternative medicine options for the treatment of premenstrual syndrome,1 in addition to acupuncture.
    Are you aware of any further management options?
  • 2
     Methods: Compare this paper with a previous systematic review on the topic.2 Pay particular attention to the inclusion and exclusion criteria, the intervention(s) being compared, and the outcome measures used.
    Describe the Cochrane Collaboration’s tool for assessment of bias in studies included.3
    Using examples from this paper, describe the type(s) of bias addressed by each item in the tool.
    Comment on the quality of the studies included, with reference to the tool.
    Discuss the options for meta-analysing studies when they are very heterogeneous, statistically and/or clinically.
  • 3
     Results and implications: The Cochrane Handbook states: ‘Studies with limited follow-up or infrequent monitoring may not reliably detect adverse effects; the absence of information must not be interpreted as indicating the intervention is safe’.3 Discuss with reference to this paper.
    Discuss the availability and cost of complementary and alternative medicine (CAM) therapies in your area, and your legal and moral responsibilities when referring patients with PMS to services that offer CAM therapies. Are these responsibilities clearly defined by law or national guidance? (Data S1) ▮

D Siassakos University of Bristol & Southmead Hospital, Bristol, UK Email jsiasakos@gmail.com

References

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information
  • 1
    RCOG. Management of Premenstrual Syndrome. Green-top Guideline No. 48. London: RCOG Press, 2007.
  • 2
    Cho SH, Kim J. Efficacy of acupuncture in management of premenstrual syndrome: a systematic review. Complement Ther Med 2010;18:10411.
  • 3
    HigginsJPT, GreenS (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2 [updated September 2009]. The Cochrane Collaboration, 2008 [www.cochrane-handbook.org].

Supporting Information

  1. Top of page
  2. Abstract
  3. Introduction
  4. Methods
  5. Data extraction and risk of bias assessment
  6. Results
  7. Discussion and conclusion
  8. Disclosure of interests
  9. Contribution to authorship
  10. Details of ethics approval
  11. Funding
  12. Acknowledgements
  13. References
  14. Journal club
  15. Supporting Information

Data S1. Powerpoint slides summarising the study.

Table S1. Locations of frequently used acupuncture points in the included studies.

FilenameFormatSizeDescription
BJO_2994_sm_DataS1.ppt547KSupporting info item
BJO_2994_sm_TableS1.pdf10KSupporting info item

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