Acupuncture for dysmenorrhoea

Background Primary dysmenorrhoea is the most common form of period pain and affects up to three‐quarters of women at some stage of their reproductive life. Primary dysmenorrhoea is pain in the absence of any organic cause and is characterised by cramping pain in the lower abdomen, starting within the first eight to 72 hours of menstruation.This review examines the currently available evidence supporting the use of acupuncture (stimulation of points on the body using needles) and acupressure (stimulation of points on the body using pressure) to treat primary dysmenorrhoea.

To determine the effectiveness and safety of acupuncture and acupressure in the treatment of primary dysmenorrhoea when compared with a placebo, no treatment, or conventional medical treatment. Search methods We searched the following databases: the Cochrane Menstrual Disorders and Subfertility Group Trials Register (to September 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE, EMBASE, PsycINFO, CINAHL and Chinese databases including Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), VIP database and registers of ongoing trials. Selection criteria We included all published and unpublished randomised controlled trials (RCTs) comparing acupuncture with sham acupuncture or placebo control, usual care, pharmacological treatment or no treatment. We included the following modes of treatment: acupuncture, electro‐acupuncture, and acupressure. Participants were women of reproductive age with primary dysmenorrhoea during the majority of the menstrual cycles or for three consecutive menstrual cycles, and moderate to severe symptoms. Data collection and analysis We calculated odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) or standardised mean differences (SMDs) for continuous outcomes, with 95% confidence intervals (CIs). We pooled the data where appropriate. Our primary outcomes was pain. Secondary outcomes included menstrual symptoms, quality of life, and adverse effects. Main results We included 42 RCTs (4640 women). Acupuncture or acupressure was compared with a sham/placebo group, medication, no treatment or other treatment. Many of the continuous data were not suitable for calculation of means, mainly due to evidence of skew. 1. Acupuncture studies Acupuncture versus sham or placebo control (6 RCTs) Findings were inconsistent and inconclusive. However, the only study in the review that was at low risk of bias in all domains found no evidence of a difference between the groups at three, six or 12 months. The overall quality of the evidence was low. No studies reported adverse events. Acupuncture versus NSAIDs Seven studies reported visual analogue scale (VAS) pain scores, but were unsuitable for pooling due to extreme heterogeneity (I² = 94%). In all studies the scores were lower in the acupuncture group, with the mean difference varying across studies from 0.64 to 4 points on a VAS 0 ‐ 10 scale (low‐quality evidence). Four RCTs reported rates of pain relief, and found a benefit for the acupuncture group (OR 4.99, 95% CI 2.82 to 8.82, 352 women, I² = 0%, low‐quality evidence). Adverse events were less common in the acupuncture group (OR 0.10, 95% CI 0.02 to 0.44, 4 RCTs, 239 women, 4 trials, I² = 15%, low‐quality evidence). Acupuncture versus no treatment Data were unsuitable for analysis, but pain scores were lower in the acupuncture group in all six studies reporting this outcome. The quality of the evidence was low. No studies reported adverse events. 2. Acupressure studies No studies of acupressure reported adverse events. Acupressure versus sham or placebo control Data were unsuitable for pooling, but two studies reported a mean benefit of one to three points on a 0 ‐ 10 VAS pain scale. Another four studies reported data unsuitable for analysis: all found that pain scores were lower in the acupuncture group. No studies reported adverse events. The quality of the evidence was low. Acupressure versus NSAIDs One study reported this outcome, using a 0 ‐ 3 pain scale. The score was higher (indicating more pain) in the acupressure group (MD 0.39 points, 95% CI 0.21 to 0.57, 136 women, very low‐quality evidence). Acupressure versus no treatment There was no clear evidence of a difference between the groups on a VAS 0 ‐ 10 pain scale (MD ‐0.96 points, 95% CI ‐2.54 to 0.62, 2 trials, 140 women, I² = 83%, very low‐quality evidence). Authors' conclusions There is insufficient evidence to demonstrate whether or not acupuncture or acupressure are effective in treating primary dysmenorrhoea, and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias. Plain language summary Acupuncture for period pain Review question Cochrane researchers reviewed the evidence about the effect of acupuncture and acupressure versus a control to reduce menstrual pain and symptoms in all women of reproductive age with primary dysmenorrhoea. Primary dysmenorrhoea is defined as pain without any underlying cause.

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

Description of the condition Dysmenorrhoea (period pain) can be described as painful uterine cramps of menstrual origin (Proctor 2006) and is classified as primary or secondary dysmenorrhoea. The focus of this review is on primary dysmenorrhoea, the most common form of period pain in young women (French 2008), and the most frequently underreported cause of period pain (Jamieson 1996). Primary dysmenorrhoea is defined as pain in the absence of any organic cause and is most common in women under the age of 25, with pain starting within three years of menarche (Coco 1999). Primary dysmenorrhoea’s characteristic symptom is crampy, colicky spasms of pain in the suprapubic area, occurring within eight to 72 hours of menstruation and peaking within the first few days as menstrual flow increases (Proctor 2006). In addition to painful cramps, many women with primary dysmenorrhoea experience other menstrual‐related symptoms, including back and thigh pain, headaches, diarrhoea, nausea and vomiting (Proctor 2006). Studies describing the prevalence of primary dysmenorrhoea report wide ranges of rates. A recent review of high‐quality studies found prevalence rates to range from 16.8% to 81% (Latthe 2006). In a review of women under 20 years of age, higher prevalence rates of 43% to 91% were found (Zahradnik 2010).These wide‐ranging rates are most likely explained by the varying criteria used to assess dysmenorrhoea between surveys, and the descriptions used to classify the severity of pain (Jamieson 1996). The largest contributing physiological factor in primary dysmenorrhoea is increased amounts of prostaglandins present in the menstrual fluid (Dawood 2006). These prostaglandins are released when the endometrial lining breaks down during menses. Prostaglandins, especially PGF₂α, stimulate myometrial contractions, reducing uterine blood flow and causing uterine hypoxia. This is responsible for the painful cramping that characterises primary dysmenorrhoea (Dawood 2006). Secondary symptoms associated with primary dysmenorrhoea, such as headache, nausea and vomiting, are due to prostaglandins and their metabolites entering general circulation (Howard 2000), and are similar to side effects seen in women who have induction of labour via prostaglandin gel (Dawood 2006). Description of the intervention Acupuncture is a component of traditional East Asian medicine, with various forms of acupuncture present historically in Japan, China and Korea (White 2004). Acupuncture is the insertion of fine needles into the body at specific acupuncture points, while acupressure is the stimulation of acupuncture points by means of pressure, usually applied by fingers or thumbs (Beal 1999). Acupuncture, in common with many other non‐pharmacological therapies, is a complex intervention (MacPherson 2007). Inherent in the idea of complex interventions is the concept that a mixture of specific and non‐specific mechanisms contribute to the action of the therapy. Acupuncture can take place within a number of different theoretical frameworks, with the following being most common: Traditional Chinese, Five Element, Japanese or Biomedical (sometimes called “Western”) (Bovey 2005; Hopton 2012; Robinson 2012). These frameworks dictate many facets of the treatment, including diagnosis, point location, point selection, co‐interventions such as moxibustion, needling style, retention time for needles, and stimulation style. A traditional Chinese medicine (TCM) acupuncture consultation typically includes but is not limited to: history taking, self‐care and lifestyle advice, TCM diagnosis and explanation, palpation of the pulse and other parts of the body, observation of the tongue, insertion and manipulation of needles, as well as common co‐modalities, such as moxibustion and cupping (Langevin 2011). Western or biomedical acupuncture more commonly uses a neurophysiological approach to point selection and often includes lifestyle advice based on biomedical considerations (Hopton 2012). Ear acupuncture, or auriculotherapy, is a relatively modern therapy and is based on the idea that there is a reflex connection between the ear and the rest of the body, allowing conditions to be treated by stimulation of certain parts of the ear (Andersson 2007). Serious adverse events from acupuncture are rare; minor side effects may include tiredness, pain at the site of needling, and headache (MacPerson 2004). How the intervention might work The exact mechanism of acupuncture to treat period pain is unclear. However, there has been extensive research into the mechanisms by which acupuncture may exert its pain‐relieving effects, with current evidence suggesting that endogenous opioids, modulation of neurotransmitters (such as dopamine), and anti‐inflammatory effects mediated via the hypothalamus–pituitary–adrenal (HPA) axis may all play a role (Napadow 2008). Because of the quick onset of the pain‐relieving effect of acupuncture observed in some studies, it is likely that the immediate analgesic effects observed are modulated, at least in part, by endogenous opioid release (Wang 2008). Overall, current experimental data support three possible non‐exclusive mechanisms for the observed long‐term effects of acupuncture on primary dysmenorrhoea: Descending pain modulation An increase in uterine blood flow via ovarian sympathetic nerve reflex A change in prostaglandin levels. Smith 2010 proposes a descending pain modulation hypothesis, where pain relief in primary dysmenorrhoea occurs via stimulation of common acupuncture points, including REN4, SP6 and SP8, that transmit signals via afferent pathways to the midbrain. This information is integrated and changes women’s perception of pain. This alteration in descending pain modulation changes the perceived pain intensity. Animal models suggest that needling regulates neuro‐endocrine activities including levels of progesterone (Liu 2009) and needling point SP6 has been shown to increase ovarian blood flow via a reflex response in rats (Stener‐Victorin 2006). A similar reflex response increasing uterine blood flow via SP6 has been found in humans (Stener‐Victorin 1996) and appears to be related to some of the analgesic benefits of acupuncture in primary dysmenorrhoea. Lin 2008 found that after three months of acupuncture treatment there was a reduction in PGF₂α levels. A recent meta‐analysis, including Chinese‐language research, has shown that the effect of acupuncture on prostaglandins is still unclear due to poor trial methodology and small sample sizes (Xu 2014b). It is likely that acupressure exerts its benefits via mechanisms similar to acupuncture, with pressure rather than needle stimulation activating the pain‐relieving mechanism(s). The appropriateness of using sham acupuncture as a control is currently debated in the literature (Langevin 2011). Sham acupuncture devices deliver significant non‐specific effects, greater than that of placebo pills, so it is likely that these compromise at least some of the therapeutic benefit that acupuncture may deliver (Kaptchuk 2006). Why it is important to do this review Menstrual pain remains an important women's health issue and has medical, social, and economic consequences (Dawood 1990). Many young women do not seek help for their period pain or are undertreated (O'Connell 2006). In one study, 98% of adolescents used non‐pharmacological methods such as heat, rest, or distraction, with a perceived effectiveness of 40% or less (Campbell 1999). Conventional treatments have focused on the use of non‐steroidal anti‐inflammatory drugs (NSAIDs) and the oral contraceptive pill (OCP). NSAIDs work as prostaglandin synthetase inhibitors, as do OCPs, where the progestogen component of the OCP has a direct effect on uterine smooth muscle to reduce myometrial activity. The efficacy of these conventional treatments is high, although 20% to 25% of women have inadequate pain relief (Dawood 1985; Henzl 1985). NSAIDs appear to be a very effective treatment for dysmenorrhoea, although women using them need to be aware of the substantial risk of adverse effects (Marjoribanks 2015). There is some evidence in favour of oral contraceptives for pain management (Wong 2009). These two drug groups are now considered standard treatments for primary dysmenorrhoea (Dawood 1988; Dawood 1990). Other evidence‐based approaches to effectively managing symptoms of dysmenorrhoea are therefore needed. A number of clinical trials have been performed to study the efficacy of acupuncture for period pain, although it remains uncertain whether the existing evidence is rigorous enough to reach a definitive conclusion.

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

Criteria for considering studies for this review Types of studies All randomised controlled trials (RCTs) were eligible for inclusion. We included cross‐over trials if they had pre‐cross‐over data. We excluded quasi‐randomised trials and trials where we were unable to ascertain if the trial was truly randomised. Types of participants Inclusion criteria Women needed to meet the following criteria to be included in the review: of reproductive age (15 to 49 years); primary dysmenorrhoea, i.e. no identifiable pelvic pathology as indicated by pelvic examination, ultrasound scans, or laparoscopy; primary dysmenorrhoea (self‐reported pain) during the majority of the menstrual cycles or for three consecutive menstrual cycles; moderate to severe primary dysmenorrhoea (pain that does not respond well to analgesics, affects daily activities, or has a high baseline score on a validated pain scale). Exclusion criteria If participants in the trial met any of the following exclusion criteria, we excluded the trial from the review: diagnosed secondary dysmenorrhoea (e.g. fibroids, endometriosis); dysmenorrhoea resulting from use of an intra‐uterine device (IUD); mild or infrequent dysmenorrhoea. Types of interventions Any RCT involving acupuncture (manual insertion of needles to points located on the body, and to the ear) and electro‐acupuncture as treatment for primary dysmenorrhoea. We made an amendment to the protocol to include trials of acupressure; this covers pressure applied using blunt studs or seeds. We also included application of minimal moxibustion on a small number of points, but we excluded trials of moxibustion alone, due to a different mode of application and action. Interventions were compared to placebo control (including invasive and non‐invasive placebo controls), no treatment, pharmacological management, other types of control groups (for example, wait list controls, where the control group will receive the intervention after a waiting period), or other conventional treatments. Types of outcome measures We required reporting of at least one of the following primary outcomes for a trial to be included. We recorded data for each of the following outcomes, where available: Primary outcomes 1. Pain score, as a continuous variable measured preferably by the visual analogue scale (VAS) or other validated scales. Pain relief, measured as dichotomous outcomes (i.e. pain relief: yes or no). Secondary outcomes 1. Overall improvement in generic menstrual symptoms (e.g. nausea, tiredness) measured by changes in overall dysmenorrhoeic symptoms that were either self‐reported or investigator‐observed, or any other similar measures. 2. Reported use of additional medication, measured as the proportion of women requiring analgesics. 3. Restriction of daily life activities, measured as the proportion of women who reported activity restrictions. 4. Absence from work or school, measured as the proportion of women reporting absences from work or school, and also as hours and days of absence as a more selective measure. 5. Quality of life, measured by a validated scale, for example the Short Form (SF) 36. 6. Adverse effects from treatment, measured as incidence of side effects and types of side effects. Search methods for identification of studies We sought all published and unpublished RCTs of acupuncture and acupressure versus control, using the following search strategy, without language restrictions and in consultation with the Menstrual Disorders and Subfertility Group (MDSG) Trials Search Co‐ordinator. Electronic searches We searched the Cochrane Menstrual Disorders and Subfertility Group Trials Register (to September 2015), Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE, EMBASE, PsycINFO, CINAHL, and Chinese databases including Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI) and VIP database. The search terms are presented in the appendices (Appendix 1; Appendix 2; Appendix 3; Appendix 4; Appendix 5; Appendix 6; Appendix 7; Appendix 8). Searching other resources We searched for additional studies in the reference lists of the relevant trials identified. We also searched ProQuest Dissertations and Theses, Web of Knowledge, AMED (the Allied and Complementary Medicine Database), OpenGrey, LILACS, Acubase, Google Scholar and PubMed. We searched the following clinical trial registries for ongoing trials: Australian and New Zealand Clinical Registry (www.anzctr.org.au/), Chinese Clinical Trial Register (www.chictr.org); Current Controlled Trials (controlled‐trials.com); Clinical trials.gov (clinicaltrials.gov); ISRCTN (www.isrctn.org/); and WHO International Clinical Trial Registration Platform search portal (www.who.int/trialsearch/). Data collection and analysis Selection of studies Two review authors (CS and MA) screened the titles and abstracts of articles found in the search, and discarded trials that were clearly not eligible. One review author (XL) searched for and selected the trials from the Chinese databases. Two out of the three review authors (CS, MA, XL) undertook trial selection. Three review authors (XZ, XL, ZL) translated Chinese papers. CS, MA, and XL independently assessed whether trials met the inclusion criteria, with disagreements resolved by discussion. If articles contained insufficient information to make a decision about eligibility, CS attempted to contact authors of the original reports to obtain further details. If details of randomisation were unclear in the reporting, we contacted all trial authors to ascertain if the study was truly randomised. We made a first contact and then sent a reminder. We translated letters and email into Chinese. Data extraction and management Following an assessment for inclusion, CS, MA, XZ, XL, ZL and JS independently extracted data. Author XZ and colleague JM reviewed the trial published by review author CS. We resolved discrepancies by discussion. For each included trial we extracted data regarding the location of the trial, the methods of the trial (as per assessment of risk of bias), the participants (age range, eligibility criteria), the nature of the interventions, and data relating to the outcomes specified above. We collected information on reported benefits and adverse effects. We extracted data and entered them onto a form (Appendix 9) sourced from the Cochrane Handbook for Systematic Reviews of Interventions (Cochrane Handbook; Higgins 2011). Two review authors (CS and MA) checked and entered data into Review Manager 5 (New Reference). Assessment of risk of bias in included studies Two review authors independently assessed risks of bias, using the criteria described in the Cochrane Handbook (Higgins 2011) ( Appendix 10). The tool consists of six items, with three potential responses: 'yes', 'no', and 'unclear'. In all cases a judgement of ‘yes’ indicates a low risk of bias and a judgement of ‘no’ indicates a high risk of bias. If insufficient detail was reported our judgement was usually ‘unclear’. We also made a judgement of 'unclear' if we knew what happened in the study but the risk of bias was unknown to us, or if an entry was not relevant to the study at hand (particularly for assessing blinding and incomplete outcome data, or when the outcome being assessed by the entry had not been measured in the study). We assessed the following characteristics: sequence generation, allocation concealment, blinding (or masking), incomplete data assessment, selective outcome reporting, and other sources of bias. We resolved disagreements that arose at any stage by discussion between the review authors or with a third party, when necessary. We generated a 'Risk of bias' assessment table for each study. We assessed other aspects of trial quality including the extent of blinding (if appropriate), whether groups were comparable at baseline, the extent of losses to follow‐up, non‐compliance, whether the outcome assessment was standardised, and whether an intention‐to‐treat analysis was undertaken, according to the Cochrane Handbook (Higgins 2011). This information is presented in the Characteristics of included studies. Measures of treatment effect We performed statistical analysis in accordance with the Cochrane Handbook (Higgins 2011). We performed statistical analysis using Review Manager 5 software (RevMan 2014). For dichotomous data, we expressed results for each study as odds ratios (ORs) with corresponding 95% confidence intervals (CIs), using the Mantel‐Haenszel method. We expressed continuous data as mean differences (MDs) with 95% CIs, or as standardised mean differences (SMDs) if outcomes were conceptually the same but measured in different ways in the different trials. A standard rule of thumb for interpreting effect sizes is that 0.2 represents a small effect, 0.5 a moderate effect and 0.8 a large effect. Unit of analysis issues The primary analysis was per woman randomised. We included trials with multiple arms and describe them in the Characteristics of included studies, for example acupuncture compared with placebo acupuncture and with no acupuncture. If there were two acupuncture groups, we combined data from both treatment arms into one group. For studies with a placebo control and no treatment control group, we divided the shared intervention evenly between groups as described in the Cochrane Handbook (Higgins 2011). Where outcomes were repeated measures, we undertook analysis of outcomes at the end of the intervention. Dealing with missing data We analysed data on an intention‐to‐treat basis, as far as possible. We did not impute missing data but we did report the proportion lost to follow‐up and analysed only the available data. Assessment of heterogeneity We identified and measured heterogeneity by visually inspecting the overlaps of the CIs for the results of individual studies. If there was poor overlap, this was suggestive of statistical heterogeneity and we included a more formal Chi² test. A low P value (or a large Chi² statistic relative to its degrees of freedom) provided evidence of heterogeneity of intervention effects (variation in effect estimates beyond chance). We measured inconsistency across trials in the meta‐analysis using the I² statistic. This describes the percentage of total variation across studies that is due to heterogeneity rather than chance (Higgins 2003; Higgins 2011). The interpretation of the I² statistic is as follows: 10% to 40% might not be important; 30% to 60% may represent moderate heterogeneity; 50% to 90% may represent substantial heterogeneity; 75% to 100% considerable heterogeneity. Assessment of reporting biases We planned to investigate potential biases of publication using the funnel plot or other analytical methods (Egger 1997). If there were 10 or more studies in the meta‐analysis we would have investigated reporting biases (such as publication bias) using funnel plots. If visual assessment had suggested asymmetry, we would have explored possible reasons. Data synthesis We combined the data using a fixed effect model in the following comparisons: 1. Acupuncture versus control. 2. Acupressure versus control. Subgroup analysis and investigation of heterogeneity We planned to undertake a subgroup analysis based on different types of acupuncture therapies: manual acupuncture versus electro‐acupuncture. Sensitivity analysis In the presence of substantial heterogeneity (an I² statistic greater than 50%) we aimed to examine the causes by prespecified subgroup using a sensitivity analysis. Where subgroup analysis failed to explain the heterogeneity, we analysed data using a random‐effects model. A priori, we had planned to perform sensitivity analyses on results to look at the possible contribution of: (1) differences in methodological quality, with trials of high quality (low risk of bias) compared to all trials; and (2) publication bias by country. Overall quality of the body of evidence: Summary of findings table We prepared 'Summary of findings' tables using GRADEPRO software. These tables evaluate the overall quality of the body of evidence for the main review outcomes (pain and adverse effects), using GRADE criteria (study limitations, consistency of effect, imprecision, indirectness and publication bias). We justified, documented and incorporated judgements about evidence quality (high, moderate, low) into the results for each outcome.

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

of the search The updated search to September 2015 identified 73 potentially eligible studies of which we included 34: (Aghamiri 2005; Bazarganipour 2010; Bu 2011; Cao 2011; Charandabi 2011; Darabi 2010; Han 2012; Hu 2005; Kashefi 2010; Lee 2007; Li 2012b; Ma 2010; Ma 2013; Mirbagher‐Ajorpaz 2011; Peng 2012; Qiao 2013; Ruan 2011; Shi 2011; Song 2013; Sriprasert 2015; Sun 2011; Wang 2005b; Wang 2013b; Wang 2014a; Wong 2010; Xu 2013; Xu 2014; Yeh 2013a; Youn 2008; Yu 2014; Zafari 2011; Zhang 2012; Zhang 2013a; Zhang 2013b), and excluded 39 trials. Two RCTs previously included in the review (Jiang 2007; Wu 2007) we now exclude from this update. We now have 42 included and 65 excluded trials. see Figure 1. Included studies Study design and setting The review includes 42 studies. Forty studies were parallel design and two studies were cluster‐randomised trials. Twenty‐eight trials had two study groups. Eight trials had three groups and six trials had four arms. Study location and sources of women Twenty‐two studies were undertaken in China. Eight studies were undertaken in Iran, four studies in Taiwan, two studies in Korea, and one each in Australia, Germany, Hong Kong, Thailand, Turkey, and the USA. Participants The studies included 4640 women with primary dysmenorrhoea. Twenty studies recruited participants from gynaecology hospital clinics. Fifteen trials recruited college or high school students, and five trials recruited from the community. Details were not reported in two trials. Women with secondary dysmenorrhoea were excluded, although this diagnosis was not clearly reported. One study used cancer or carbohydrate antigen 125 (CA 125) to eliminate a diagnosis of endometriosis (Wang 2009a). Evidence of a physical assessment confirming the diagnosis of primary dysmenorrhoea was reported in six trials, confirmed by ultrasound and physical examination. In all other 36 trials no clear, specific details were reported on how pelvic pathology was eliminated. Interventions Ten trials used acupressure and 32 trials provided stimulation using acupuncture (including manual and electro‐acupuncture). Three of these acupuncture trials also reported using moxa (warming needle). Acupuncture and acupressure varied in point selection, frequency of treatment, and number of treatments. A summary of the characteristics of the acupuncture and acupressure interventions is described in Appendix 11. Comparative and control groups varied between studies. Nine trials used placebo controls. Placebo techniques varied between invasive and non‐invasive techniques. It is possible that the 11 control groups that used invasive pressure or needle stimulation may have had some physiological action. Comparisons with medication using NSAIDs and oral contraceptives were used in 15 trials. Eight trials used a no‐treatment control. One trial used Chinese herbal medicine. Two studies reported unspecified "usual care". One trial used rest. One trial used visits or social support. Three trials used a mixture of no treatment and active sham points. One trial used two groups comprising sham and medication. Outcomes All studies assessed the primary outcome of pain. VAS scales were widely used. Nine studies used a subjective assessment of pain and other menstrual symptoms. Six studies reported adverse events in a form that could be entered into meta‐analysis (Cao 2011; Peng 2012; Ruan 2011; Sriprasert 2015; Witt 2008; Zhang 2013a). Excluded studies We excluded 64 trials. Seventeen trials did not meet the inclusion criteria for the intervention; for example, the use of point injection acupuncture, use of moxibustion alone, or laser acupuncture. Nine trials did not meet the inclusion criteria for the control group; for example, comparisons between acupuncture versus acupuncture at another point. We exclude 35 trials due to insufficient reporting of randomisation; we were unable to ascertain the true randomisation status from the author, or trials were quasi‐randomised. No clinically relevant outcomes were reported in three trials. One trial did not meet the age criteria for participants. We present further background information on these trials in the table Characteristics of excluded studies. Risk of bias in included studies See Figure 2 and Figure 3 for a graphical summary of the 'Risk of bias' assessments of the included studies made by the review authors, based on the six 'Risk of bias' domains. Overall we judged one trial to be at a low risk of bias on all domains, 32 trials at high risk of bias in at least one domain and 12 trials rated as at an unclear risk of bias in one or more domains (but with no domains rated as at high risk). Allocation Using the Cochrane criteria, which rate the adequacy of randomisation allocation and concealment, we rated most trials (36) at a low risk of bias with adequate generation of randomisation sequence. In 11 trials the sequence was computer‐generated (Han 2012; Ma 2010; Ma 2013; Ruan 2011; Shi 2011; Smith 2010; Song 2013; Sriprasert 2015; Wang 2009a; Witt 2008; Zhi 2007). The sequence was drawn by lot in three trials (Chen 2004; Chen 2010; Zhang 2013a) and from random‐number tables in 20 trials (Bazarganipour 2010; Cao 2011; Helms 1987; Hu 2005; Kashefi 2010; Li 2008; Li 2012b; Lee 2007; Mirbagher‐Ajorpaz 2011; Qiao 2013; Sun 2011; Wang 2005b; Wang 2013b; Wang 2014a; Youn 2008; Xu 2013; Xu 2014; Yu 2014; Zhang 2012; Zhang 2013b), and coin toss in one trial (Yeh 2013a). The risk was unclear in six trials. We rated allocation concealment at low risk of bias in 12 trials (27%). Central randomisation was undertaken in seven trials (Han 2012; Ma 2010; Ma 2013; Ruan 2011; Smith 2010; Song 2013; Witt 2008) and using sealed envelopes in five trials (Chen 2004; Chen 2010; Sun 2011; Sriprasert 2015; Wang 2009a). We assessed all other studies (30) to be at an unclear risk of bias due to insufficient reporting. Blinding We rated blinding at low risk of bias in three trials (Ma 2010; Smith 2010; Wang 2009a). All these trials were assessed as double‐blind with blinding of analyst and participants. Twenty‐eight trials were at high risk of bias, and the risk of bias was unclear in 11 trials. Incomplete outcome data We assessed incomplete outcome reporting to be at a low risk of bias in 30 trials (Bu 2011; Cao 2011; Charandabi 2011; Han 2012; Helms 1987; Li 2008; Li 2012b; Ma 2010; Mirbagher‐Ajorpaz 2011; Peng 2012; Qiao 2013; Ruan 2011; Shi 2011; Smith 2010; Song 2013; Sun 2011; Wang 2005b; Wang 2009a; Wang 2013b; Wang 2014a; Witt 2008; Wong 2010; Xu 2013; Yu 2014; Zafari 2011; Zhang 2012; Zhang 2013a; Zhang 2013b; Zhi 2007; Xu 2014). Nine trials were at high risk of bias, of which Chen 2004 had a 50% dropout rate (Aghamiri 2005; Bazarganipour 2010; Chen 2004; Chen 2010; Lee 2007; Ma 2013; Sriprasert 2015; Yeh 2013a; Youn 2008). We rated three trials as unclear, due to incomplete reporting (Darabi 2010; Hu 2005; Kashefi 2010). Selective reporting We rated the risk of selective reporting as low risk in one trial for which we were able to obtain the protocol published on a clinical trial registry (Smith 2010). We judged six other trials to be at low risk, due to receipt of entire theses. One study we rated at high risk because not all their secondary outcomes were reported. We assessed 34 trials to be unclear risk of bias. Other potential sources of bias We rated the risk of bias from other sources as low in five trials (Qiao 2013; Smith 2010; Song 2013; Wang 2013b; Witt 2008). We found one trial to be at high risk due to imbalances at baseline (Han 2012). We rated all other 36 trials as being at unclear risk of bias. There were imbalances at randomisation in two trials. Smith 2010 reported imbalances in body mass index, smoking, and socio‐economic indices, and these were adjusted for in the primary analyses. Witt 2008 reported imbalances at randomisation for physical functioning, bodily pain, and physical component score of the SF36. For the majority of studies these data were not reported. Five trials conducted and reported an intention‐to‐treat analysis (Ma 2013; Ruan 2011; Smith 2010; Wang 2014a; Witt 2008). Four trials reported the source of funding. Three trials received government research funding (Chen 2004; Chen 2010; Smith 2010) and one trial received funding from health insurance organisations (Witt 2008). Effects of interventions Summary of findings for the main comparison. Summary of findings: acupuncture for primary dysmenorrhoea. | Acupuncture compared with placebo, no treatment or active controls for primary dysmenorrhoea | |||||| | Population: women with primary dysmenorrhoea Settings: outpatient, community Intervention: acupuncture Comparison: placebo , no treatment or active controls | |||||| | Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | | | Assumed risk | Corresponding risk | ||||| | Control | Acupuncture | ||||| | Pain: Acupuncture versus sham or placebo control Follow up: 1‐12 months | Findings were inconsistent and inconclusive:1 study at low risk of bias in all domains found no evidence of a difference in pain scores at 3, 6 or 12 months 2 studies found no evidence of a difference in pain scores at 1 to 3 months 2 studies reported lower pain scores in the intervention group at 3 months 1 study reported higher rates of pain relief in the acupuncture group at 3 months | 477 (6 RCTs) | ⊕⊕⊝⊝ low1,2 | Data unsuitable for calculation of means | || | Adverse events: Acupuncture versus sham or placebo control | No studies reported this outcome | ||||| | Pain: Acupuncture versus NSAIDs Follow‐up: 1 ‐ 4 months | Pain scores were lower in the acupuncture group in six of seven studies (n = 389/449) that reported VAS scores, with the mean difference varying across studies from 0.64 to 4 points on a VAS 0 ‐ 10 scale [In 4 studies (n = 352) reporting rates of pain relief, rates were higher in women having acupuncture than in women having NSAIDs] | [OR 4.99 (2.82 to 8.82)] | 611 (10 RCTs) | ⊕⊕⊝⊝ low1,3 | Continuous data unsuitable for pooling, I² = 94%. Consistent direction of effect | | | Adverse events: Acupuncture versus NSAIDs Follow‐up: 3 months | 83 per 1000 | 9 per 1000 (2 to 38) | OR 0.10 (0.02 to 0.44) | 239 (4 RCTs) | ⊕⊕⊝⊝ low1,4 | | | Pain: Acupuncture versus no treatment Follow‐up: 1 ‐ 6 months | Six studies reported this outcome, using a VAS scale. The findings were consistent but unsuitable for pooling, in most cases because data were skewed. | 384 (6 RCTs) | ⊕⊕⊝⊝ low1, 4 | Data unsuitable for calculation of means | || | Adverse events: Acupuncture versus no treatment | No studies reported this outcome | ||||| | *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio | |||||| | GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | 1Downgraded one level for serious risk of bias: all or most studies at high or unclear risk of bias in one or more domains assessed. 2Downgraded one level for serious inconsistency. 3Downgraded one level for serious risk of publication bias, evident on funnel plot. 4Downgraded one level for serious imprecision: low overall event rate and/or small overall sample size. Summary of findings 2. Summary of findings: acupressure for primary dysmenorrhoea. | Acupressure compared with placebo, no treatment or active controls for primary dysmenorrhoea | |||||| | Population: women with primary dysmenorrhoea Settings: outpatient, community Intervention: acupressure Comparison: placebo, no treatment or active controls | |||||| | Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | | | Assumed risk | Corresponding risk | ||||| | Control | Acupressure | ||||| | Pain: Acupressure versus sham or placebo control Follow‐up: 2 days to 3 months | All studies reported a benefit in the acupressure group. Two studies reported a mean benefit of 1 ‐ 3 points on a 0 ‐ 10 VAS scale | 538 (5 RCTs) | ⊕⊕⊝⊝ low1,2 | Data were unsuitable for pooling. I² = 98% when the 2 studies with data suitable for analysis were pooled | || | Pain: Acupressure versus NSAIDs Follow‐up: 3 months | 1 study used a 0 ‐ 3 pain scale and reported a higher score (indicating more pain) in the acupressure group (MD 0.39 points, 0.21 to 0.57 higher). | 136 (1 RCT) | ⊕⊝⊝⊝ very low3,4 | ||| | Pain score: Acupressure versus no treatment Follow‐up: 1 ‐ 3 months | There was no conclusive evidence of a difference between the groups on a VAS 0 ‐ 10 scale. MD 0.96 points lower in the acupressure group (‐2.54 lower to 0.62 higher) | 140 (2 RCTs) | ⊕⊝⊝⊝ very low1, 2,4 | Lower scores indicate less pain, I² = 83% | || | Adverse effects: Acupressure versus placebo , no treatment or active controls | No studies reported this outcome | ||||| | *The basis for the assumed risk is the median control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: mean difference | |||||| | GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. | 1Downgraded one level for serious risk of bias: all or most studies at high or unclear risk of bias in one or more domains assessed. 2Downgraded one level for serious inconsistency in findings. 3Downgraded two levels for very serious risk of bias: rated as at high risk in two of the six domains assessed. 4Downgraded one level for serious imprecision, small sample size We present results separately for acupuncture and acupressure, and by type of control group. Data were excluded from Charandabi 2011 due to data presented within subcategories of dysmenorrhoea. We could not obtain raw data for Helms 1987; Lee 2007; Ma 2010; Wang 2013b; Youn 2008, and present a narrative reports of their results. 1) Acupuncture versus sham/placebo control Data were presented for pain outcomes reported after the intervention and at one to three months. 1.1 Primary outcome: Pain 1.1.1 Outcome: pain score Five studies reported this outcome (Darabi 2010; Lee 2007; Smith 2010; Song 2013; Youn 2008). Data were unsuitable for pooling, in most cases because standard deviations (SDs) were not reported or data were skewed. One study reported no evidence of a difference between the groups (Lee 2007) at one month. Two studies reported evidence of a benefit in the intervention group at three months (Darabi 2010; Song 2013), but two (Smith 2010; Youn 2008) found no evidence of a benefit at this time point. The single study with longer follow‐up reported no evidence of a difference between the groups at six or 12 months (Smith 2010). Details of findings and rationale for not pooling are presented in Table 3. 1. Acupuncture versus sham/placebo control: pain score. | Study | Measure | Follow‐up | Acupuncture group Mean score | Control group Mean score | P < 0.05 | Comment | | Darabi 2010 | VAS (0 ‐ 10) | 3 months | 2.12, SD 1, n = 50 | 4.24, SD 0.91, n = 50 | Yes | This study reported implausibly low SDs. We assumed that these might be standard errors, but recalculation based on this assumption resulted in skewed data | | Lee 2007 | Measure of Menstrual Pain Questionnaire (scale unclear) | 1 month | 4.46 | 4.58 | No | Total n = 63. No SDs reported | | Smith 2010 | McGill Questionnaire Pain scale (0 ‐ 5) (Melzack 1975) | 3 months | 2, SD 2.5, n = 46 | 2.6, SD 2.7, n = 46 | No P = 0.32 | Data skewed | | 6 months | 2.2, SD 3 | 2.8, SD 2.7 | No P = 0.11 | Data skewed | || | 12 months | 2.6, SD 2.7 | 2.8, SD 2.7 | No P = 0.60 | Data skewed | || | Song 2013 | VAS (0 ‐ 10) | 3 months | 4.2, SD 7.28, n = 25 | 8.77, SD 16.3, n = 96 | Yes | Data skewed | | Youn 2008 | Measure of Menstrual Pain Questionnaire (scale unclear) | 3 months | MD 0.54, 95% CI 0.12 to 1.19 | No | Total n = 80. No primary data reported | SD: standard deviation 1.1.2 Outcome: pain relief One study (Helms 1987) reported this outcome. After treatment for three cycles the rate of post‐treatment pain relief was higher in the acupuncture group (OR 17.5, 95% CI 1.6 to 191.9; 22 women). Secondary outcomes 1.2 Outcome: overall improvement in menstrual symptoms One trial (Smith 2010) compared acupuncture with a sham acupuncture control and found no evidence of a difference between the groups in the number of women reporting an improvement in menstrual symptoms at three months (OR 1.57, 95% 0.61 to 4.04, 92 women), six months (OR 1.47, 95% CI 0.62 to 3.48, 92 women) or at 12 months (OR 2.35, 95% CI 0.80 to 6.94) Analysis 1.2. At three months women in this study reported fewer mood changes in the acupuncture group (53%) compared with the control group (72%) (OR 0.72, 95% CI 0.53 to 1.00; P = 0.05). Lee 2007 found a reduction in the severity of menstrual symptoms using the Menstrual Severity Symptom list, with the acupuncture scores reduced from 60.09 to 32.48, and the control scores declining from 62.40 to 39.65. Data were unsuitable for analysis as no standard deviations were reported. 1.3 Outcome: use of additional medication Three trials reported on this outcome (Darabi 2010; Helms 1987; Smith 2010). Smith 2010 found no evidence of a difference between the groups in the rate of additional medication use at three months (OR 0.91, 95% CI 0.40 to 2.09, 92 women) (Analysis 1.3) or at 12 months (OR 1.51, 95% CI 0.62 to 1.3.7). A reduction in medication use was found at six months for women in the acupuncture group (OR 0.34, 95% CI 0.14 to 0.79). Helms 1987 reported that mean daily strength of analgesic medication (calculated using a study‐defined measure) dropped 41% in the intervention group after treatment, but increased among controls (48 women) (data not reported in meta‐analysis). Darabi 2010 reported less use of medication in the acupuncture group compared with the control at three months (data not shown). 1.4 Outcome: restriction of daily living activities There was no evidence of a difference between the groups at the end of the trial (OR 0.72, 95% CI 0.29 to 1.81, 92 women, 1 trial) (Analysis 1.4). 1.5 Outcome: absence from school or work No trials reported on this outcome. 1.6 Outcome: quality of life There was no evidence of a difference between groups on any quality of life domain, measured using the SF36 (92 women, 1 trial, high‐quality evidence) (Analysis 1.5, Analysis 1.6; Analysis 1.7; Analysis 1.8; Analysis 1.9; Analysis 1.10; Analysis 1.11). 1.7 Adverse events No trial reported on this outcome. 2) Acupuncture versus medication Data were presented for pain outcomes at one to three months. 2.1 Primary outcome: pain 2.1.1 Outcome: pain score Acupuncture versus NSAIDS Seven studies reported this outcome using a VAS 0 ‐ 10 scale, but data were unsuitable for pooling due to extreme heterogeneity (I² = 94%) for which there was no obvious explanation. In six of seven studies (389 women) acupuncture was associated with reduced pain scores compared to NSAIDs, with the mean differences varying across studies from 0.64 to 4 points (Analysis 2.1; Figure 4). The overall quality of the evidence was very low. One trial (Han 2012) used an unspecified scale and was not included in the analysis; this trial found acupuncture was associated with reduced pain scores (MD ‐3.70, 95% CI ‐4.68 to ‐2.80, 120 women). Acupuncture versus combined oral contraceptives (COC) Combined oral contraceptives were found to be more effective than acupuncture in reducing pain scores as measured by a 0 ‐ 10 numeric rating scale (NRS) in one small trial (MD 2.0, 95% CI 0.59 to 3.41, 52 women; Analysis 2.1). 2.1.2 Outcome: pain relief Acupuncture versus NSAIDS Women having acupuncture were more likely to report pain relief than women having NSAIDs (OR 4.99, 95% CI 2.82 to 8.82, 4 trials, 352 womenI² = 0%, low‐quality evidence (Analysis 2.2). Acupuncture versus combined oral contraceptives There was no evidence of a difference between acupuncture and combined oral contraceptives in the number of women reporting pain relief (OR 0.39, 95% CI 0.12 to 1.21, 42 women). Secondary outcomes 2.2 Outcome: menstrual symptoms 2.2.1 Acupuncture versus NSAIDS Women having acupuncture reported a lower score for menstrual symptoms than women having NSAIDs (MD ‐2.25 points, 95% CI ‐3.33 to ‐1.17, 6 trials, 440 women, I² = 89%, Analysis 2.3.1). Statistical heterogeneity was high but the direction of effect was consistent. These studies used the self‐report Clinical Principle of New Chinese Drug Clinical Research (scale unknown). Three studies used other instruments and all reported reduced menstrual symptoms in the acupuncture group; however the scales of the measures used were unclear: Cao 2011 (MD ‐2.16, 95% CI ‐3.57 to ‐0.75, 53 women), Xu 2013 (MD ‐6.32, 95% CI ‐7.15 to ‐5.49, 45 women), and Zhi 2007 (MD ‐2.83, 95% CI ‐4.25 to ‐1.68, 64 women) 2.2.2 Acupuncture versus juyuansuan tamoxifen Women having acupuncture reported a lower score for menstrual symptoms than women having juyuansuan tamoxifen (MD ‐4.22, 95% CI ‐5.12 to ‐3.32, one RCT, 80 women, Analysis 2.3.2). 2.3 Outcome: use of additional medication 2.3.1 Acupuncture versus combined oral contraceptives One trial of acupuncture compared with COC found no evidence of a difference between the groups in the reduction from baseline in rescue medication used at three months (MD 0.56 tablets, 95% CI ‐1.03 to 2.15, 42 women, Analysis 2.4). 2.4 Outcome: quality of life 2.4.1 Acupuncture versus combined oral contraceptives One trial of acupuncture compared with COC found no evidence of a difference between the groups in the quality of life at three months, measured using the SF‐36 (MD ‐9.14, 95% CI ‐19.23 to 0.95, one trial, 42 women; Analysis 2.5). 2.5 Outcome: adverse events 2.5.1 Acupuncture versus NSAIDs The adverse event rate was lower in the acupuncture group than in the NSAIDs group (OR 0.10, 95% CI 0.02 to 0.44, 239 women, 4 trials, I² = 15%, low‐quality evidence) (Analysis 2.6.1). 2.5.1 Acupuncture versus combined oral contraceptives There was no evidence of a difference in adverse events between COCs and acupuncture (OR 1.12, 95% 0.34 to 3.63, 1 trial, 52 women, Analysis 2.6). Outcome: restriction of daily living activities No trials reported on this outcome. Outcome: absence from work or school No trials reported on this outcome. 3) Acupuncture versus Chinese herbs 3.1 Primary outcome: Pain 3.1.1 Pain score Acupuncture was associated with a lower pain score (on an unspecified scale) than Chinese herbs (MD ‐4.58, 95% CI ‐5.79 to ‐3.37, 1 RCT, 120 women, low‐quality evidence, Analysis 3.1). Secondary outcomes 3.2 Outcome: menstrual symptom improvement Women having acupuncture were more likely to report improvement in menstrual symptoms than those using Chinese herbs (OR 7.00, 95% CI 2.22 to 22.06, 120 women, 1 RCT, low‐quality evidence, Analysis 3.2). 3.3 Outcome: use of additional medication No trials reported on this outcome. 3.4 Outcome: restriction of daily living activities No trials reported on this outcome. 3.5 Outcome: absence from work or school No trials reported on this outcome. 3.6 Outcome: quality of life No trials reported on this outcome. 3.7 Outcome: adverse events No trials reported on this outcome. 4) Acupuncture versus no treatment 4.1 Primary Outcome: Pain 4.1.1 Outcome: pain score Six studies reported this outcome, using a VAS scale, after a single session of acupuncture (Shi 2011), three months (Song 2013; Xu 2014), four months (Sun 2011), and six months (Xu 2013; Zhang 2013b). Data were unsuitable for pooling, in most cases because data were skewed. All studies reported a benefit in the acupuncture group. Details of findings at up to three months and rationale for not pooling are reported in Table 4. 2. Acupuncture versus no treatment: pain score. | Study | Measure | Follow‐up | Acupuncture group Mean score | Control group Mean score | P < 0.05 | Comment | | Shi 2011 | VAS | Post‐treatment | 30.05, SD 25.62 n = 20 | 48.2, SD 7.25, n = 10 | Yes | Data skewed | | Song 2013 | VAS | 3 months | 4.1, SD 7.8, n = 25 | 25.23, SD 24.43, n = 48 | Yes | Data skewed | | Sun 2011 | VAS | 3 months | 42.62, SD 8.14, n = 28 | 62.77, SD 12.15, n = 28 | Yes | | | Xu 2013 | VAS | 3 months | 2.96, SD 0.31, n = 25 | 7.7, SD 0.3, n = 20 | Yes | This study reported implausibly low SDs | | Xu 2014 | VAS | 3 months | 3, SD 0.19, n = 48 | 8.13, SD 0.21, n = 48 | Yes | This study reported implausibly low SDs | | Zhang 2013b | VAS | 3 months | 3.37, SD 1.64, n = 55 | 5.03, SD 2.37, n = 29 | Yes | SD: standard deviation Secondary outcomes 4.2 Outcome: menstrual symptoms Five studies reported this outcome, using various measures, after a single session of acupuncture (Shi 2011), three months (Song 2013; Xu 2014), four months (Sun 2011), and six months (Xu 2013, Zhang 2013b). Two of the studies reported data suitable for pooling, using the Retrospective Symptom Scale (RSS) (Sun 2011) or the CMSS (Bu 2011). When data were pooled using the SMD, the results suggested a moderate to large benefit in the acupuncture group (SMD ‐0.81, 95% CI ‐1.17 to ‐0.45, two RCTs, 132 women, I² = 0%). The other three studies reported data that were unsuitable for analysis. All three studies reported a benefit in the acupuncture group. Details of the findings of these studies at up to three months and the rationale for not pooling are reported in Table 5 3. Acupuncture versus no treatment: menstrual symptom severity. | Study | Measure | Follow‐up | Acupuncture group Mean score | Control group Mean score | P < 0.05 | Comment | | Ma 2013 | CMSS | 3 months | 1.56, SD 0.87, n = 382 | 2.4, SD 0.81, n = 40 | Yes | This study reported implausibly low SDs | | Xu 2014 | RSS | 3 months | 11.56, SD 0.25, n = 48 | 36.76, SD 2.35, n = 48 | Yes | This study reported implausibly low SDs | | Yu 2014 | VAS | 3 months | 2.81, SD 0.16 n = 48 | 4.85, SD 0.19, n = 48 | Yes | This study reported implausibly low SDs. | SD: standard deviation 4.3 Outcome: use of additional medication No trials reported on this outcome. 4.4 Outcome: restriction of daily living activities No trials reported on this outcome. 4.5 Outcome: absence from work or school No trials reported on this outcome. 4.6 Outcome: quality of life No trials reported on this outcome. 4.7 Outcome: adverse events No trials reported on this outcome. 5) Acupuncture versus usual care One study made this comparison (Witt 2008). The 'usual care' group was a wait list control, but women could use any additional conventional treatments they chose. 5.1 Primary Outcome: Pain 5.1.1 Outcome: pain score Acupuncture was associated with a lower pain score than usual care, measured with a 0 ‐ 10 numerical rating scale (MD ‐2.09, 95% CI ‐2.99 to ‐1.19, 117 women, 1 RCT, high‐quality evidence) (Analysis 5.1). Secondary outcomes 5.2 Outcome: menstrual symptoms No trial reported on this outcome 5.3 Outcome: use of additional medication No trial reported on this outcome. 5.4 Outcome: restriction of daily living activities No trial reported on this outcome. 5.5 Outcome: absence from work or school There was no evidence of a difference between groups in days of absence from school or work, measured by a self‐reported questionnaire (continuous) (MD 0.06, 95% CI ‐0.54 to 0.66, 117 women, 1 trial) (Analysis 5.2). 5.6 Outcome: quality of life 5.6.1 Outcome: quality of life: physical health Acupuncture was associated with improved physical function compared with usual care, measured using the SF36 (MD 5.57, 95% CI 2.68 to 8.46; 117 women, 1 trial) (Analysis 5.3). 5.6.2.Outcome: quality of life: mental health There was evidence that acupuncture improved mental health compared with usual care, measured using the SF36 (MD 10.49, 95% CI 3.63 to 17.35; 117 women, 1 trial) (Analysis 5.4). 5.6.3 Outcome: quality of life: bodily pain There was evidence that acupuncture reduced bodily pain compared with usual care, measured using the SF36 (MD 20.10, 95% CI 9.90 to 30.30; 117 women, 1 trial) (Analysis 5.5). 5.6.4 Outcome: quality of life: general health There was no evidence of a difference in general health compared with usual care, measured using the SF36 (MD 6.38, 95% CI ‐0.26 to 13.02, 117 women, 1 trial) (Analysis 5.6). 5.6.5 Outcome: quality of life: vitality Acupuncture was associated with improved vitality compared with usual care, measured using the SF36 (MD 18.12, 95% CI 11.52 to 24.72; 117 women, 1 trial) (Analysis 5.7). 5.6.7 Outcome: quality of life: social function There was evidence that acupuncture improved social function compared with usual care, measured using the SF36 (MD 20.27, 95% CI 11.52 to 29.02; 117 women, 1 trial) (Analysis 5.8). 5.6.8 Outcome: quality of life: emotional role There was evidence that acupuncture improved emotional role compared with usual care, measured using the SF36 (MD 14.16, 95% CI 1.29 to 27.03; 117 women, 1 trial) (Analysis 5.9). 5.7 Outcome: adverse events There was no evidence of a difference in self‐reported side effects in the acupuncture group compared with the usual care group (OR 0.27, 95% CI 0.05 to 1.34; 117 women, 1 trial) (Analysis 5.10). 6) Acupressure versus sham/placebo control 6.1 Primary outcome: pain 6.1.1 Outcome: pain score Five studies reported this outcome at two days (Yeh 2013a), one month (Mirbagher‐Ajorpaz 2011), two months (Aghamiri 2005; Kashefi 2010) and three months (Bazarganipour 2010). Two of the studies reported data suitable for analysis. We did not pool them because of high heterogeneity (I² = 98%). Both found that acupressure was associated with lower pain scores, measured on a VAS 0 ‐ 10 scale (MD ‐3.50 points, 95% CI ‐4.10 to ‐2.90, 1 trial, 100 women (Aghamiri 2005); MD ‐1.37 points, 95% CI ‐2.07 to ‐0.67, 1 trial, 81 women (Kashefi 2010); Analysis 6.1). The other three studies reported data that were unsuitable for analysis. Two found a benefit in the acupressure group. Details of the findings of these studies are reported in Table 6. The third trial (Bazarganipour 2010) reported pain severity as categorical data; pain severity was lower in the acupressure group than in the control group (P < 0.001). 4. Acupressure versus no treatment: menstrual symptom severity. | Study | Measure | Follow‐up | Acupuncture group Mean score | Control group Mean score | P < 0.05 | Comment | | Mirbagher‐Ajorpaz 2011 | VAS 0 ‐ 10 | 1 month | 1.66, SD 1.98, n = 15 | 4.9, SD 1.37, n = 40 | Yes | Skewed data | | Yeh 2013a | VAS 0 ‐ 10 | 2 days | 2.03, SD 2.02, n = 50 | 3.36, SD 2.65, n = 50 | Yes | Skewed data | SD: standard deviation Secondary outcomes 6.2 Outcome: severity of menstrual symptoms There was no evidence that acupressure improved menstrual symptoms using the Menstrual Distress Questionnaire compared with the placebo control (MD ‐1.84, 95% CI ‐3.71 to 0.03; 171 women, 2 RCTs, I² = 74%, low‐quality evidence, inconsistent direction of treatment effect) (Analysis 6.2). 6.3 Outcome: use of additional medication No trial reported on this outcome. 6.4 Outcome: restriction of daily living activities No trial reported on this outcome. 6.5 Outcome: absence from work or school No trial reported on this outcome. 6.6 Outcome: quality of life No trial reported on this outcome. 6.7 Outcome: adverse events No trial reported on this outcome. 7) Acupressure versus medication Primary outcome: pain 7.1.1 Outcome: pain score Acupressure versus NSAIDs One study reported this outcome (Zafari 2011). One study reported a higher pain score at two months in women having acupressure than in those using ibuprofen, measured using a 0 ‐ 3 scale (MD 0.39, 95% CI 0.21 to 0.57, 136 women, 1 RCT) (Analysis 7.1). Secondary outcomes 7.2 Outcome: severity of menstrual symptoms No trial reported on this outcome. 7.3 Outcome: use of additional medication No trial reported on this outcome. 7.4 Outcome: restriction of daily living activities No trial reported on this outcome. 7.5 Outcome: absence from work or school No trial reported on this outcome. 7.6 Outcome: quality of life No trial reported on this outcome. 7.7 Outcome: adverse events No trial reported on this outcome 8) Acupressure versus no treatment 8.1 Primary outcome: Pain 8.1.1 Outcome: Pain score Two studies reported this outcome, at one month (Chen 2004) and three months (Chen 2010). There was no evidence of a difference between the acupressure and the no‐treatment groups in pain scores measured on a 0 ‐ 10 VAS scale (MD ‐0.96, 95% CI ‐2.54 to 0.62, 2 trials, 140 women, I² = 83%) (Analysis 8.1; Figure 5). Statistical heterogeneity was very high, with no obvious explanation, and findings should be regarded with caution. Secondary outcomes 8.2 Outcome: menstrual symptoms Three studies reported this outcome (Chen 2004; Chen 2010; Wong 2010). There was no evidence of a difference between the groups in menstrual symptom scores, measured using the Menstrual Distress Questionnaire (MD ‐1.90, 95% CI ‐5.57 to 1.77, 160 women, 3 RCTs, I² = 81%). Statistical heterogeneity was very high and the direction of effect was inconsistent, so findings should be regarded with caution. 8.3 Outcome: use of additional medication No trial reported on this outcome. 8.4 Outcome: restriction of daily living activities No trial reported on this outcome. 8.5 Outcome: absence from work or school No trial reported on this outcome. 8.6 Outcome: quality of life No trial reported on this outcome. 8.7 Outcome: adverse events No trial reported on this outcome. Sensitivity analysis We had planned, a priori, to undertake sensitivity analyses on the results to look at the possible contribution of differences in methodological quality, with trials of high quality (low risk of bias) compared to all trials. We did not pursue this, since only one was at an overall low risk of bias. Subgroup analysis We did not undertake any subgroup analysis, as there was little diversity by mode of stimulation of the included trials (five trials of manual acupuncture and one trial of electro‐acupuncture). Reporting bias There were insufficient studies to explore publication bias by visual scanning of a funnel plot.

Summary of main results We include 42 trials and data from 4640 women in this updated review. Pain For our primary outcome (pain), there was no consistent evidence of a difference between women receiving acupuncture and those receiving a sham control. The only study in the review that was at low risk of bias in all domains found no evidence of a difference between the groups at three, six or 12 months. However there was limited evidence to suggest a benefit for women receiving acupuncture compared with NSAIDs, juyuansuan tamoxifen, Chinese herbs, no treatment, or usual care. Comparisons of the effectiveness of acupuncture versus combined oral contraceptives were inconsistent. There was very limited evidence to suggest a benefit for acupressure compared with a sham control, but other findings for acupressure were inconsistent. Secondary review outcomes For our secondary review outcomes (which include menstrual symptoms, use of additional medication, restriction in activities, quality of life and adverse events), there was no consistent evidence of a benefit from acupuncture compared with a sham control. None of these studies reported adverse events. Acupuncture versus other comparators offered very limited evidence to suggest that it was more effective than NSAIDs, juyuansuan tamoxifen or Chinese herbs for treating menstrual symptoms, was more effective than usual care for improving quality of life, and was less likely than NSAIDs to cause adverse events. There was no evidence of a difference between acupuncture and other comparators for other secondary review outcomes. Acupressure versus other comparators found no evidence of a difference between the groups for any secondary review outcomes. Overall completeness and applicability of evidence Most of the trials did not report on outcomes other than pain, very few reported on adverse events or quality of life, and for many comparisons there were few data. There were also few trials with follow‐up of outcomes in the medium and long term, as most had follow‐up of three months or less. There were variations in the eligibility criteria between trials, with the majority lacking detail in the reporting, or excluding some criteria for primary dysmenorrhoea. However, the majority of women in the community seeking acupuncture or acupuncture support are unlikely to have investigative procedures to exclude secondary dysmenorrhoea. Distinguishing between primary and secondary dysmenorrhoea was not well reported or undertaken in some trials. This may have impacted on the homogeneity of women included in the trials and the severity of symptoms, and could have potentially influenced the responsiveness to acupuncture. Trials recruited women from settings similar to those where women would access acupuncture or acupressure. Studies were conducted in different countries, and consequently reflects the different styles of acupuncture administered in the studies. Twenty‐five of the trials were conducted in China and the applicability of their findings to women in other settings is unclear. The characteristics of acupuncture treatment, including variations in the duration, mode of stimulation, frequency, and selection of acupuncture points, may influence the quality of acupuncture and treatment effect. How acupuncture is practised varies significantly between countries, for example daily treatment is common in China while very rare in other countries. This is reflected in the differing treatment frequency of the included trials. It is possible that acupuncture may not have been therapeutically effective, and in some cases may not represent best clinical practice. In contemporary clinical practice, for example, the duration of treatment would generally be longer than one month or one menstrual cycle. Among acupuncturists trained in TCM, standardised prescriptions would not be used and treatment would be individualised based on the diagnosis, with acupuncture treatment varying between sessions. For those trials involving comparisons with medication, no data were reported on compliance, so it is unclear if these study groups could have been affected by suboptimal doses of medication. Placebo controls remain controversial, due to afferent activity arising from these applications. Quality of the evidence There remain almost no high‐quality trials of acupuncture and acupressure for the management of primary dysmenorrhoea, and only one study was assessed at a low risk of bias on all domains. The quality of reporting was poor in 70% of the trials. Many trials were at a high risk of bias in relation to randomisation. Rates of follow‐up were high in the majority of trials, with only a small number of trials reporting a small loss of participants. For many studies blinding of participants and the practitioner was not possible, and reporting indicated that the outcomes could have been influenced by a lack of blinding, and consequently were rated at a high risk of bias. (Figure 2; Figure 3). Continuous measures of effectiveness varied and were not always interpretable, and in many cases the data were skewed or unreliable, which precluded pooling them. Where pooling was possible, we found substantial unexplained heterogeneity for some outcomes. We were unable to explore the effect of study quality using a sensitivity analysis, due to the lack of studies at low risk of bias. We were also unable to undertake any subgroup analyses. However there was clear variation in study characteristics and delivery of the intervention that may contribute to this heterogeneity. The quality of evidence using GRADE was low for the two outcomes of pain relief and menstrual symptoms (Table 1). We downgraded the outcomes because of high statistical heterogeneity, imprecision and the risk of bias. Potential biases in the review process We attempted to minimise publication bias. Although our search was comprehensive and we included studies identified in languages other than English, we cannot rule out the possibility that we may have missed some studies. Agreements and disagreements with other studies or reviews There are three other reviews of acupuncture to treat primary dysmenorrhoea. Cho 2010 included nine trials out of 27 trials identified, Xu 2014b included two out of 20 trials identified and Yang 2008b identified 30 trials. Cho 2010, Yang 2008b and Xu 2014b included other modalities of TCM, which we excluded from our review, and included trials for which we were unable to ascertain the randomisation details or that we excluded because they did not meet the eligibility criteria. All three reviews found promising evidence for the use of acupuncture to treat primary dysmenorrhoea compared with pharmacological medicine or Chinese herbal medicine. The findings from the Yang 2008b review were more cautious, due to conflicting results, in part due to a greater number of trials included which added to the heterogeneity of the findings. The findings from all three reviews were influenced by the methodological flaws of the trials. Authors' conclusions Implications for practice. There is insufficient evidence to demonstrate whether or not acupuncture or acupressure is effective in treating primary dysmenorrhoea, and for most comparisons no data were available on adverse events. The quality of the evidence was low or very low for all comparisons. The main limitations were risk of bias, poor reporting, inconsistency and risk of publication bias. Implications for research. Further randomised controlled trials are required to evaluate the effectiveness, efficacy and safety of acupuncture and acupressure in the treatment of primary dysmenorrhoea. All future randomised trials should be adequately powered and should consider other outcome measures as described in this review. Greater attention should be given to methodological design and the design of the treatment rationale, and the context of the treatment used in a research setting. There is also a need to improve the quality of reporting of future trials. Future studies may need to consider the use of both comparative effectiveness designs using medication, for example NSAIDs or other forms of standard care, and efficacy designs using placebo controls. Future studies should also give consideration to including a long‐term evaluation of effectiveness and the adverse effects of acupuncture. What's new | Date | Event | Description | |---|---|---| | 16 February 2016 | New search has been performed | Updated search: 34 new trials included and 2 previously included trials excluded. The Results and Discussion have been updated, and 'Summary of findings' tables added. | | 16 February 2016 | New citation required but conclusions have not changed | The inclusion of new trials did not change the conclusions. | History Protocol first published: Issue 3, 2009 Review first published: Issue 1, 2011 | Date | Event | Description | |---|---|---| | 11 January 2012 | Amended | Correction made to data relating to outcome pain relief. Data replaced with outcome pain intensity. Inclusion of outcome to the results and additional statements made to discussion. | | 17 May 2010 | Amended | Inclusion of acupressure trials. | | 23 December 2009 | Amended | Changes to the protocol. Unit of analysis: trials with multiple arms were included for example acupuncture compared with sham acupuncture and no acupuncture. If there were two acupuncture groups data from both treatment arms were combined into one group. For studies with a sham control and no treatment control group, the shared intervention was divided evenly between groups. Where outcomes were repeated measures, analysis of outcomes was undertaken at the end of the intervention. Elaboration of the objectives and comparisons. | | 19 November 2008 | Amended | The published review: Proctor ML, Smith CA, Farquhar CM, Stones RW. Transcutaneous electrical nerve stimulation and acupuncture for primary dysmenorrhoea. Cochrane Database of Systematic Reviews 2002, Issue 1 (Proctor 2002), has now been divided into two reviews. These are: 'Transcutaneous electrical nerve stimulation for primary dysmenorrhoea' and 'Acupuncture for primary dysmenorrhoea'. |

The review authors would like to acknowledge the Cochrane Menstrual Disorders and Subfertility Group for their assistance with the preparation of the review, including the Trials Search Co‐ordinator for assistance in developing the search strategy, the editors, co‐editors and other staff within the team. We also acknowledge the Chinese‐to‐English translation assistance from Kelly Ho, Wai Sun Lam (Malaysia), Rana Taghipouran (Auckland University) and Song Mei Wu. We thank Julie Marker (JM) for her assistance with review and data extraction of English‐language trials, and Karen Cheer for assisting with implementing the search strategy. We wish to thank Lin He for his contribution to previous published versions of the review. We acknowledge the correspondence from Claudia Witt identifying the error in data relating to pain outcomes. Appendices Appendix 1. Gynaecology and Fertility Group Menstrual disorders and subfertility database search

CONTAINS "dysmenorrhea" or "Dysmenorrhea‐Symptoms" or "dysmenorrhoea" or "pain‐dysmenorrhea" or "pain‐pelvic" or "pelvic pain" or "menstrual cramps" or "menstrual pain" or "primary dysmenorrhea" or "*Dysmenorrhea"or "menstrual distress"or "*menstrual pain"or "primary dysmenorrheal" or Title CONTAINS "dysmenorrhea" or "Dysmenorrhea‐Symptoms" or "dysmenorrhoea" or "pain‐dysmenorrhea" or "pain‐pelvic" or "pelvic pain" or "menstrual cramps" or "menstrual pain" or "primary dysmenorrhea" or "*Dysmenorrhea"or "menstrual distress"or "*menstrual pain" AND

CONTAINS "acupoint" or "acupressure" or "acupressure‐acupuncture therapy" or "acupuncture" or "electro‐acupuncture" or "electro‐magnetic" or "electroacupuncture" or "electrical stimulation" or "moxibustion" or "*acupuncture"or "auricular acupressure"or "auricular pressure"or "needle insertion" or Title CONTAINS "acupoint" or "acupressure" or "acupressure‐acupuncture therapy" or "acupuncture" or "electro‐acupuncture" or "electro‐magnetic" or "electroacupuncture" or "electrical stimulation" or "moxibustion"or "*acupuncture"or "auricular acupressure"or "auricular pressure"or "needle insertion" Appendix 2. CENTRAL Database: EBM Reviews ‐ Cochrane Central Register of Controlled Trials Search Strategy: 1 exp Dysmenorrhea/ (329) 2 pain$ period$.tw. (69) 3 menstrua$ cramp$.tw. (17) 4 pelvi$ pain$.tw. (449) 5 (period$ adj3 cramp$).tw. (7) 6 (menstrua$ adj3 pain$).tw. (176) 7 Dysmenorr$.tw. (724) 8 or/1‐7 (1257) 9 exp Acupuncture Therapy/ or exp Acupuncture, Ear/ or exp Acupuncture Points/ or exp Acupuncture Analgesia/ or exp Acupuncture/ (2489) 10 exp Acupressure/ (174) 11 exp Electroacupuncture/ (411) 12 exp Meridians/ (943) 13 exp Moxibustion/ (177) 14 Acupuncture.tw. (5332) 15 acupressure$.tw. (327) 16 (electroacupuncture or electro acupuncture or electro‐acupuncture).tw. (825) 17 meridian$.tw. (403) 18 mox$.tw. (1317) 19 needling.tw. (673) 20 (acu‐point$ or acu point$).tw. (7) 21 acupoint$.tw. (1133) 22 shu.tw. (127) 23 (shiatsu or tui na).tw. (5) 24 or/9‐23 (8207) 25 8 and 24 (97) 26 limit 25 to yr="2010 ‐Current" (38) Appendix 3. MEDLINE Database: Ovid MEDLINE(R) In‐Process & Other Non‐Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R) Search Strategy: 1 exp Dysmenorrhea/ (3064) 2 pain$ period$.tw. (135) 3 menstrua$ cramp$.tw. (101) 4 pelvi$ pain$.tw. (5812) 5 (period$ adj3 cramp$).tw. (22) 6 (menstrua$ adj3 pain$).tw. (865) 7 Dysmenorr$.tw. (4076) 8 or/1‐7 (10786) 9 exp Acupuncture Therapy/ or exp Acupuncture, Ear/ or exp Acupuncture Points/ or exp Acupuncture Analgesia/ or exp Acupuncture/ (17070) 10 exp Acupressure/ (454) 11 exp Electroacupuncture/ (2456) 12 exp Meridians/ (4121) 13 exp Moxibustion/ (1082) 14 Acupuncture.tw. (14440) 15 acupressure$.tw. (576) 16 (electroacupuncture or electro acupuncture or electro‐acupuncture).tw. (3061) 17 meridian$.tw. (3921) 18 mox$.tw. (7407) 19 needling.tw. (1571) 20 (acu‐point$ or acu point$).tw. (22) 21 acupoint$.tw. (2808) 22 shu.tw. (526) 23 (shiatsu or tui na).tw. (77) 24 or/9‐23 (30594) 25 8 and 24 (223) 26 randomized controlled trial.pt. (370764) 27 controlled clinical trial.pt. (88164) 28 randomized.ab. (290727) 29 randomised.ab. (58340) 30 placebo.tw. (157152) 31 clinical trials as topic.sh. (169371) 32 randomly.ab. (210819) 33 trial.ti. (124986) 34 (crossover or cross‐over or cross over).tw. (60283) 35 or/26‐34 (936480) 36 exp animals/ not humans.sh. (3923552) 37 35 not 36 (863648) 38 25 and 37 (124) 39 (2010$ or 2011$ or 2012$ or 2013$ or 2014$).ed. (4247951) 40 (2010$ or 2011$ or 2012$ or 2013$ or 2014$).dp. (3920946) 41 39 or 40 (4758325) 42 38 and 41 (72) Appendix 4. EMBASE Search Strategy: 1 exp dysmenorrhea/ (8599) 2 pain$ period$.tw. (220) 3 Dysmenorr$.tw. (5707) 4 menstrua$ cramp$.tw. (140) 5 pelvi$ pain$.tw. (9860) 6 (period$ adj3 cramp$).tw. (33) 7 (menstrua$ adj3 pain$).tw. (1266) 8 or/1‐7 (19020) 9 exp acupuncture analgesia/ or exp acupuncture/ or exp acupuncture needle/ (35286) 10 exp electroacupuncture/ (4599) 11 exp moxibustion/ (1885) 12 Acupuncture.tw. (22898) 13 acupressure$.tw. (893) 14 (electroacupuncture or electro acupuncture or electro‐acupuncture).tw. (4335) 15 meridian$.tw. (4846) 16 mox$.tw. (11173) 17 needling.tw. (2381) 18 (acu‐point$ or acu point$).tw. (37) 19 acupoint$.tw. (4258) 20 shu.tw. (1381) 21 (shiatsu or tui na).tw. (131) 22 or/9‐21 (51415) 23 8 and 22 (552) 24 Clinical Trial/ (849581) 25 Randomized Controlled Trial/ (381395) 26 exp randomization/ (67715) 27 Single Blind Procedure/ (20861) 28 Double Blind Procedure/ (122971) 29 Crossover Procedure/ (44106) 30 Placebo/ (261711) 31 Randomi?ed controlled trial$.tw. (122193) 32 Rct.tw. (17954) 33 random allocation.tw. (1445) 34 randomly allocated.tw. (23077) 35 allocated randomly.tw. (2051) 36 (allocated adj2 random).tw. (734) 37 Single blind$.tw. (16246) 38 Double blind$.tw. (153721) 39 ((treble or triple) adj blind$).tw. (476) 40 placebo$.tw. (219097) 41 prospective study/ (304195) 42 or/24‐41 (1495041) 43 case study/ (33432) 44 case report.tw. (289086) 45 abstract report/ or letter/ (935451) 46 or/43‐45 (1251520) 47 42 not 46 (1455346) 48 23 and 47 (264) 49 2014$.em. or 2014$.dp. (1618058) 50 48 and 49 (35) Appendix 5. PsycINFO Search Strategy: 1 exp Dysmenorrhea/ (185) 2 pain$ period$.tw. (33) 3 Dysmenorr$.tw. (345) 4 menstrua$ cramp$.tw. (17) 5 pelvi$ pain$.tw. (444) 6 (period$ adj3 cramp$).tw. (2) 7 (menstrua$ adj3 pain$).tw. (183) 8 or/1‐7 (946) 9 exp Acupuncture/ (1200) 10 Acupuncture.tw. (1621) 11 acupressure$.tw. (128) 12 (electroacupuncture or electro acupuncture or electro‐acupuncture).tw. (277) 13 meridian$.tw. (724) 14 mox$.tw. (154) 15 needling.tw. (107) 16 (acu‐point$ or acu point$).tw. (1) 17 acupoint$.tw. (210) 18 shu.tw. (164) 19 (shiatsu or tui na).tw. (18) 20 or/9‐19 (2854) 21 8 and 20 (13) 22 limit 21 to yr="2014" (1) Appendix 6. CINAHL CINAHL search strategy for CS1680 (EBSCO platform) | # | Query | Results | | S40 | S25 AND S39 | 122 | | S39 | S26 OR S27 or S28 or S29 OR S30 OR S31 OR S32 OR S33 OR S34 OR S35 OR S36 OR S37 OR S38 | 883,698 | | S38 | TX allocat* random* | 3,869 | | S37 | (MH "Quantitative Studies") | 11,815 | | S36 | (MH "Placebos") | 8,705 | | S35 | TX placebo* | 31,362 | | S34 | TX random* allocat* | 3,869 | | S33 | (MH "Random Assignment") | 37,008 | | S32 | TX randomi* control* trial* | 71,278 | | S31 | TX ( (singl* n1 blind*) or (singl* n1 mask*) ) or TX ( (doubl* n1 blind*) or (doubl* n1 mask*) ) or TX ( (tripl* n1 blind*) or (tripl* n1 mask*) ) or TX ( (trebl* n1 blind*) or (trebl* n1 mask*) ) | 710,419 | | S30 | TX ( (trebl* n1 blind*) or (trebl* n1 mask*) ) | 104 | | S29 | TX ( (trebl* n1 blind*) or (trebl* n1 mask*) ) | 0 | | S28 | TX clinic* n1 trial* | 162,337 | | S27 | PT Clinical trial | 75,742 | | S26 | (MH "Clinical Trials+") | 173,495 | | S25 | S8 AND S24 | 227 | | S24 | S9 OR S10 OR S11 OR S12 OR S13 OR S14 OR S15 OR S16 OR S17 OR S18 OR S19 OR S20 OR S21 OR S22 OR S23 | 34,744 | | S23 | TX (shiatsu or tui na) | 225 | | S22 | TX shu* | 20,087 | | S21 | TX acupoint* | 535 | | S20 | TX (acu‐point* or acu point*) | 10 | | S19 | TX needling | 499 | | S18 | TX mox* | 1,497 | | S17 | TX meridian* | 1,336 | | S16 | TX (electroacupuncture or electro acupuncture or electro‐acupuncture) | 1,135 | | S15 | TX acupressure | 897 | | S14 | TX Acupuncture | 12,372 | | S13 | (MM "Moxibustion") | 164 | | S12 | (MM "Meridians+") | 647 | | S11 | (MM "Electroacupuncture") | 519 | | S10 | (MM "Acupressure+") | 532 | | S9 | (MM "Acupuncture+") OR (MM "Acupuncture, Ear") OR (MM "Acupuncture Points") OR (MM "Acupuncture Anesthesia") OR (MM "Acupuncture Analgesia") | 6,739 | | S8 | S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7 | 4,376 | | S7 | TX (menstrua* N3 pain*) | 256 | | S6 | TX (period* N3 cramp*) | 6 | | S5 | TX (pelvi* pain*) | 2,139 | | S4 | TX (menstrua* N3 cramp*) | 60 | | S3 | TX (pain* period*) | 1,232 | | S2 | TX Dysmenorr* | 1,081 | | S1 | (MM "Dysmenorrhea") | 476 | Appendix 7. AMED Database : AMED (Allied and Complementary Medicine) Search Strategy: 1 exp Dysmenorrhea/ (113) 2 pain$ period$.tw. (14) 3 menstrua$ cramp$.tw. (11) 4 pelvi$ pain$.tw. (119) 5 (period$ adj3 cramp$).tw. (2) 6 (menstrua$ adj3 pain$).tw. (38) 7 Dysmenorr$.tw. (178) 8 or/1‐7 (323) 9 exp Acupuncture Therapy/ or exp Acupuncture, Ear/ or exp Acupuncture Points/ or exp Acupuncture Analgesia/ or exp Acupuncture/ (9753) 10 exp Acupressure/ (287) 11 exp Electroacupuncture/ (807) 12 exp Meridians/ (449) 13 exp Moxibustion/ (505) 14 Acupuncture.tw. (9286) 15 acupressure$.tw. (369) 16 (electroacupuncture or electro acupuncture or electro‐acupuncture).tw. (990) 17 meridian$.tw. (633) 18 mox$.tw. (618) 19 needling.tw. (805) 20 (acu‐point$ or acu point$).tw. (10) 21 acupoint$.tw. (1855) 22 shu.tw. (84) 23 (shiatsu or tui na).tw. (332) 24 or/9‐23 (10671) 25 8 and 24 (78) 26 randomized controlled trial.pt. (3283) 27 controlled clinical trial.pt. (70) 28 randomized.ab. (6712) 29 randomised.ab. (1577) 30 placebo.tw. (2598) 31 clinical trials as topic.sh. (0) 32 randomly.ab. (4825) 33 trial.ti. (3873) 34 (crossover or cross‐over or cross over).tw. (917) 35 or/26‐34 (15029) 36 exp animals/ not humans.sh. (8306) 37 35 not 36 (14633) 38 25 and 37 (22) 39 limit 38 to yr="1887 ‐ 2014" (22) Appendix 8. Chinese databases Chinese databases update: Searching: 148+323+481=952 Scanning: 101+449=550 Full paper: 95+15=110 Searching terms: #1 痛经 (dysmenorrhea) #2 月经 (period) #3 痛 (pain) #4 #2 AND #3 #5 #1 OR #3 #6原发性 (primary) #7 #5 AND #6 #8 针灸 (acupuncture) #9 针刺 (needling) #10 电针 (electronic acupuncture) #11 手针 (manual acupuncture) #12 针 (needle) #13 指压 (finger press) #14 艾灸 (moxibustion) #15 OR （#7 to #14） #16 #7 AND #15 Appendix 9. Checklist of items to consider in data collection or data extraction Source Study ID (created by review author) Report ID (created by review author) Review author ID (created by review author) Citation and contact details Eligibility Confirm eligibility for review Reason for exclusion Methods Study design Total study duration Sequence generation Allocation sequence concealment Blinding Other concerns about bias Participants Total number Setting Diagnostic criteria Age Sex Country Co‐morbidity Socio‐demographics Ethnicity Date of study Interventions Total number of intervention groups For each intervention and comparison group of interest: Specific intervention; Intervention details (sufficient for replication, if feasible); Integrity of intervention; Outcomes Outcomes and time points (i) collected; (ii) reported; For each outcome of interest: Outcome definition (with diagnostic criteria if relevant); Unit of measurement (if relevant); For scales: upper and lower limits, and whether high or low score is good Results Number of participants allocated to each intervention group For each outcome of interest: Sample size; Missing participants; Summary data for each intervention group (e.g. 2 X 2 table for dichotomous data; means and SDs for continuous data); Estimate of effect with confidence interval; P value; Subgroup analyses. Miscellaneous Key conclusions of the study authors Appendix 10. Risk of bias assessment tool Criteria for judging risk of bias in the Risk of bias assessment tool SEQUENCE GENERATION Was the allocation sequence adequately generated? Criteria for a judgment of ‘YES’ (i.e. low risk of bias) The investigators describe a random component in the sequence generation process such as: referring to a random number table; using a computer random number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots. *Minimization may be implemented without a random element, and this is considered to be equivalent to being random. Criteria for the judgment of ‘NO’ (i.e. high risk of bias) The investigators describe a non‐random component in the sequence generation process. Usually, the description would involve some systematic, non random approach, for example: sequence generated by odd or even date of birth; sequence generated by some rule based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number. Other non‐random approaches happen much less frequently than the systematic approaches mentioned above and tend to be obvious. They usually involve judgement or some method of non‐random categorization of participants, for example: allocation by judgment of the clinician; allocation by preference of the participant; allocation based on the results of a laboratory or a series of tests; allocation by availability of the intervention. Criteria for the judgement of 'UNCLEAR' (uncertain risk of bias) Insufficient information about the sequence generation process to permit judgement 'Yes' or 'No'. ALLOCATION CONCEALMENT Was allocation adequately concealed? (Short form: Allocation concealment?). Criteria for a judgment of ‘YES’ (i.e. low risk of bias) Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: Central allocation (including telephone, web‐based, and pharmacy controlled randomisation; Sequentially numbered drug containers of identical appearance; Sequentially numbered, opaque, sealed envelopes. Criteria for the judgment of ‘NO’ (i.e. high risk of bias) Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: Using an open random allocation schedule (e.g. a list of random numbers); Assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non‐opaque or not sequentially numbered); Alternation or rotation; Date of birth; Case record number; Any other explicitly unconcealed procedure. Criteria for the judgment of 'UNCLEAR' (uncertain risk of bias) Insufficient information about the sequence generation process to permit judgement 'Yes' or 'No'. This is usually the case if the method of concealment is not described or not described in sufficient detail to allow a definitive judgement, for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were \sequentially numbered, opaque and sealed. BLINDING OF PARTICIPANTS, PERSONNEL AND OUTCOME ASSESSORS Was knowledge of the allocated interventions adequately prevented during the study? (Short form: Blinding). Criteria for a judgement of ‘YES’ (i.e. low risk of bias) Anyone of the following: No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be influenced by lack of blinding; Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken; Either participants and key study personnel were not blinded, but outcome assessment was blinded and the non‐blinding of others unlikely to introduce bias. Criteria for the judgment of ‘NO’ (i.e. high risk of bias) Any one of the following: No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding; Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken; Either participants or some key study personnel were not blinded, and the non blinding or others likely to introduce bias. Criteria for the judgment of 'UNCLEAR' (uncertain risk of bias) Any one of the following: Insufficient information to permit judgment of 'Yes' or 'No'; The study did not address this outcome. INCOMPLETE OUTCOME DATA Were incomplete outcome data adequately addressed? (Short form: Incomplete outcome data addressed?). Criteria for a judgment of ‘YES’ (i.e. low risk of bias) Anyone of the following: No missing data; Reasons for missing outcome data unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias); Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups; For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk not enough to have clinically relevant impact on the intervention effect estimate; For continuous outcome data, plausible effect size (difference in means or standardized difference in means) among missing outcomes not enough to have a clinically relevant impact on observed effect size; Missing data have been imputed using appropriate methods. Criteria for the judgment of ‘NO’ (i.e. high risk of bias) Any one of the following: Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups; For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk enough to induce clinically relevant bias in the intervention effect estimate; For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes enough to have a clinically relevant impact on observed effect size; "As treated" analysis done with substantial departure of the intervention received from that assigned at randomisation; Potentially inappropriate application of simple imputation. Criteria for the judgment of 'UNCLEAR' (uncertain risk of bias) Any one of the following: Insufficient reporting of attrition/exclusions to permit judgement of 'Yes' or 'No' (e.g. number randomised not stated, no reasons for missing data provided); The study did not address this outcome. SELECTIVE OUTCOME REPORTING Are reports of the study free of suggestion of selective outcome reporting? (Short form: Free of selective reporting?) Criteria for a judgment of ‘YES’ (i.e. low risk of bias) Anyone of the following: The study protocol is available and all the study's pre‐specifies (primary and secondary) outcomes that are of interest in the review have been reported in the pre‐specified way; The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre‐specified (convincing test of this nature may be uncommon); Criteria for the judgment of ‘NO’ (i.e. high risk of bias) Any one of the following: Not all of the study's pre‐specified primary outcomes have been reported; One or more primary outcomes is reported using measurements, analysis methods or subsets of the data (subscales) that were not pre‐specified; One or more reported primary outcomes were not pre‐specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); One or more outcomes of interest in the review are reported incompletely so that they cannot be entered be entered in a meta‐analysis; The study report fails to include results for a key outcome that would be expected to have been reported for such a study. Criteria for the judgment of 'UNCLEAR' (uncertain risk of bias) Insufficient information to permit judgment of 'Yes' or 'No'. It is likely that the majority of studies will fall into this category. OTHER POTENTIAL THREATS TO VALIDITY Was the study apparently free of other problems that could put it at a risk of bias? (Short form: Free of other bias?) Criteria for a judgment of ‘YES’ (i.e. low risk of bias) The study appears free of other sources of bias. Criteria for the judgment of ‘NO’ (i.e. high risk of bias) There is at least one important risk of bias. For example, the study: Had a potential source of bias related to the specific design used; or Stopped early due to some data‐dependent process (including a formal‐stopping rule); or Had extreme baseline imbalance; or Has been claimed to have been fraudulent; or Had some other problem. Criteria for the judgment of "UNCLEAR" (uncertain risk of bias) There maybe a risk of bias, but there is either: Insufficient information to assess whether an important risk of bias exists; or Insufficent rationale or evidence that an identified problem will introduce bias. Appendix 11. Results: characteristics of the interventions Acupuncture points used: A fixed set of acupuncture points only were administered in 21 trials (Bu 2011; Cao 2011; Darabi 2010; Han 2012; Helms 1987; Hu 2005; Lee 2007; Li 2012b; Ma 2010; Ma 2013; Peng 2012; Qiao 2013; Shi 2011; Song 2013; Sriprasert 2015; Wang 2013b; Wang 2014a; Xu 2014; Youn 2008; Zhang 2013b; Zhi 2007). Individualised treatment was administered in nine trials (Li 2008; Ruan 2011; Smith 2010; Sun 2011; Wang 2005b; Witt 2008; Xu 2013; Zhang 2012; Zhang 2013a). This frequently involved some fixed points used to treat pain with additional points administered based on the diagnosis made. The combined acupuncture and moxibustion trials used fixed points (Han 2012; Hu 2005). Four trials used electro‐acupuncture. Fixed sets of acupressure points were used in 12 trials, mostly 1 ‐ 2 points (Aghamiri 2005; Bazarganipour 2010; Charandabi 2011; Chen 2004; Chen 2010; Kashefi 2010; Mirbagher‐Ajorpaz 2011; Wang 2009a; Wong 2010; Yeh 2013a; Zafari 2011). See Characteristics of included studies. Treatment duration Seven studies were undertaken over one menstrual cycle (Chen 2004; Lee 2007; Ma 2010; Mirbagher‐Ajorpaz 2011; Shi 2011; Wang 2009a; Yeh 2013a). Three studies were each administered over two cycles (Aghamiri 2005; Charandabi 2011; Kashefi 2010;). Thirty one studies were undertaken over three menstrual cycles (Bazarganipour 2010; Bu 2011; Cao 2011; Chen 2010; Darabi 2010; Han 2012; Helms 1987; Hu 2005; Li 2008; Li 2012b; Ma 2013; Peng 2012; Qiao 2013; Ruan 2011; Smith 2010; Song 2013; Sriprasert 2015; Wang 2005b; Wang 2013b; Wang 2014a; Witt 2008; Wong 2010; Xu 2013; Yu 2014; Youn 2008; Xu 2014; Zhang 2012; Zafari 2011; Zhang 2013a; Zhang 2013b; Zhi 2007). One trial was administered over four menstrual cycles (Sun 2011). Number of sessions Acupressure Eight acupressure trials involved teaching participants to self administer (Bazarganipour 2010; Charandabi 2011; Chen 2004; Chen 2010; Wang 2009a; Wong 2010; Yeh 2013a; Zafari 2011). Bazarganipour 2010 included self application before the period was due (3 ‐ 7 days). Charandabi 2011 instructed women to self administer for spasmodic cases during the first two days of menstruation and for congestive group during the two days before menstruation. Chen 2010, and Wong 2010 instructed self administration for three days during menstruation. Researchers administered acupressure for one session per menstrual cycle (Kashefi 2010). In two trials it was unclear, due to reporting of the process of administration (Aghamiri 2005; Cao 2011). Acupuncture The frequency of treatment was more varied for the acupuncture trials One session was applied only in the Shi 2011 trial. Three sessions were given in two trials (Ma 2010; Ma 2013), five sessions in two trials (Lee 2007; Ma 2013), and seven sessions in three trials (Qiao 2013; Ruan 2011; Zhi 2007). Some studies administered treatments weekly except for the week of menses for three menstrual cycles, and other studies administered higher frequencies due to daily treatments. Nine sessions were administered in six studies (Darabi 2010; Helms 1987; Hu 2005; Smith 2010; Song 2013; Zhang 2012), More than 10 and up to 30 sessions were administered in 14 trials (Li 2008; Li 2012b; Sun 2011; Sriprasert 2015; Wang 2013b; Witt 2008; Wang 2005b; Wang 2014a; Xu 2013; Xu 2014; Zhang 2013b; Youn 2008; Han 2012; Zhang 2013a). Frequency of treatment Acupressure Charandabi 2011 and Yeh 2013a applied pressure for 10 minutes or less. Aghamiri 2005 applied pressure twice for 15 minutes, and 20 minutes of pressure was applied in five trials (Bazarganipour 2010; Chen 2004; Chen 2010; Mirbagher‐Ajorpaz 2011; Zafari 2011). Pressure was applied for 30 minutes in one trial (Kashefi 2010). Acupuncture Daily treatment was administered in 17 trials (Bu 2011; Cao 2011; Han 2012; Hu 2005; Li 2008; Li 2012b; Ma 2013; Peng 2012; Qiao 2013; Ruan 2011; Wang 2005b; Wang 2013b; Wang 2014a; Xu 2013; Zhang 2012; Zhang 2013b; Zhi 2007). Treatment was applied (i) prior to menstruation and (ii) during menstruation in 13 trials (Bu 2011; Han 2012; Hu 2005Li 2008; Li 2012b; Qiao 2013; Ruan 2011; Sun 2011; Wang 2005b; Wang 2013b; Wang 2014a; Zhang 2013a; Zhang 2013b).Treatment was given once 1 ‐ 4 days before menstruation and then at weekly intervals over four weeks in one trial (Lee 2007). In Ma 2013 Groups A and C were treated once a day for about five days before menstruation until menstrual onset. Treatment was administered once menstrual pain started in six trials (Peng 2012; Ma 2013; Song 2013; Zhang 2012; Zhi 2007; Zhang 2013b). Treatment was given prior to menstruation: every second day in the week before menstruation (Darabi 2010), and at least once a week in the three weeks before menses (Helms 1987; Smith 2010; Sriprasert 2015). Daily treatment was administered for seven days in the week before menstruation in two trials (Xu 2013; Xu 2014). Details of timing were unclear in five trials (Ma 2010; Shi 2011; Wang 2009a; Witt 2008; Youn 2008). Data and analyses Comparison 1. Acupuncture versus sham/placebo acupuncture. | Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | |---|---|---|---|---| | 1 Pain score | 3 | Mean Difference (IV, Fixed, 95% CI) | Subtotals only | | | 2 Improvement in menstrual symptoms | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Subtotals only | | | 2.1 At three months | 1 | 92 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.58 [0.61, 4.04] | | 2.2 At six months | 1 | 92 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.47 [0.62, 3.48] | | 2.3 At 12 months | 1 | 92 | Odds Ratio (M‐H, Fixed, 95% CI) | 2.35 [0.80, 6.94] | | 3 Use of additional medication | 1 | Odds Ratio (M‐H, Fixed, 95% CI) | Subtotals only | | | 3.1 At three months | 1 | 92 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.91 [0.40, 2.09] | | 3.2 At six months | 1 | 92 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.34 [0.14, 0.79] | | 3.3 At 12 months | 1 | 92 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.51 [0.62, 3.70] | | 4 Restriction of daily living activities | 1 | 92 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.72 [0.29, 1.81] | | 5 Quality of life: physical health | 1 | 92 | Mean Difference (IV, Fixed, 95% CI) | ‐2.90 [‐6.33, 0.53] | | 6 Quality of life: mental health | 1 | 92 | Mean Difference (IV, Fixed, 95% CI) | 4.40 [‐3.59, 12.39] | | 7 Quality of life: bodily pain | 1 | 92 | Mean Difference (IV, Fixed, 95% CI) | ‐7.5 [‐16.71, 1.71] | | 8 Quality of life: general health | 1 | 92 | Mean Difference (IV, Fixed, 95% CI) | 2.30 [‐6.98, 11.58] | | 9 Quality of life: vitality | 1 | 92 | Mean Difference (IV, Fixed, 95% CI) | 2.20 [‐6.98, 11.38] | | 10 Quality of life: social function | 1 | 92 | Mean Difference (IV, Fixed, 95% CI) | ‐0.5 [‐9.53, 8.53] | | 11 Quality of life: role emotional | 1 | 92 | Mean Difference (IV, Fixed, 95% CI) | 0.0 [‐14.11, 14.11] | Comparison 2. Acupuncture versus medication. | Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | |---|---|---|---|---| | 1 Pain score | 8 | Mean Difference (IV, Random, 95% CI) | Totals not selected | | | 1.1 NSAIDs (VAS 0 ‐ 10 scale) | 7 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | | | 1.2 Combined oral contraceptive (NRS 0 ‐ 10 scale) | 1 | Mean Difference (IV, Random, 95% CI) | 0.0 [0.0, 0.0] | | | 2 Pain relief | 5 | Odds Ratio (M‐H, Fixed, 95% CI) | Subtotals only | | | 2.1 NSAIDs | 4 | 352 | Odds Ratio (M‐H, Fixed, 95% CI) | 4.99 [2.82, 8.82] | | 2.2 COC | 1 | 52 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.39 [0.12, 1.21] | | 3 Menstrual symptom score | 7 | Mean Difference (IV, Random, 95% CI) | Subtotals only | | | 3.1 NSAIDS | 6 | 440 | Mean Difference (IV, Random, 95% CI) | ‐2.25 [‐3.33, ‐1.17] | | 3.2 Juyuansuan tamoxifen | 1 | 80 | Mean Difference (IV, Random, 95% CI) | ‐4.22 [‐5.12, ‐3.32] | | 4 Use of additional medication | 1 | 42 | Mean Difference (IV, Fixed, 95% CI) | 0.56 [‐1.03, 2.15] | | 5 Quality of life | 1 | 42 | Mean Difference (IV, Fixed, 95% CI) | ‐9.14 [‐19.23, 0.95] | | 6 Adverse events | 5 | Odds Ratio (M‐H, Fixed, 95% CI) | Subtotals only | | | 6.1 NSAIDs | 4 | 239 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.10 [0.02, 0.44] | | 6.2 COC | 1 | 52 | Odds Ratio (M‐H, Fixed, 95% CI) | 1.12 [0.34, 3.63] | Comparison 3. Acupuncture versus Chinese herbs. | Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | |---|---|---|---|---| | 1 Pain score | 1 | 120 | Mean Difference (IV, Fixed, 95% CI) | ‐4.58 [‐5.79, ‐3.37] | | 2 Menstrual symptom improvement | 1 | 120 | Odds Ratio (M‐H, Fixed, 95% CI) | 7.00 [2.22, 22.06] | Comparison 4. Acupuncture versus no treatment. | Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | |---|---|---|---|---| | 1 Pain score | 6 | Std. Mean Difference (IV, Random, 95% CI) | Subtotals only | | | 2 Severity of menstrual symptoms | 2 | 132 | Std. Mean Difference (IV, Fixed, 95% CI) | ‐0.81 [‐1.17, ‐0.45] | Comparison 5. Acupuncture versus usual care. | Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | |---|---|---|---|---| | 1 Pain score | 1 | 117 | Mean Difference (IV, Fixed, 95% CI) | ‐2.09 [‐2.99, ‐1.19] | | 2 Absence from work or school | 1 | 117 | Mean Difference (IV, Fixed, 95% CI) | 0.06 [‐0.54, 0.66] | | 3 Quality of life physical health | 1 | 117 | Mean Difference (IV, Fixed, 95% CI) | 5.57 [2.68, 8.46] | | 4 Quality of life: mental health | 1 | 117 | Mean Difference (IV, Fixed, 95% CI) | 10.49 [3.63, 17.35] | | 5 Quality of life: bodily pain | 1 | 117 | Mean Difference (IV, Fixed, 95% CI) | 20.10 [9.90, 30.30] | | 6 Quality of life: general health | 1 | 117 | Mean Difference (IV, Fixed, 95% CI) | 6.38 [‐0.26, 13.02] | | 7 Quality of life: vitality | 1 | 117 | Mean Difference (IV, Fixed, 95% CI) | 18.12 [11.52, 24.72] | | 8 Quality of life: social function | 1 | 117 | Mean Difference (IV, Fixed, 95% CI) | 20.27 [11.52, 29.02] | | 9 Qualit of life: role emotional | 1 | 117 | Mean Difference (IV, Fixed, 95% CI) | 14.16 [1.29, 27.03] | | 10 Adverse events | 1 | 117 | Odds Ratio (M‐H, Fixed, 95% CI) | 0.27 [0.05, 1.34] | Comparison 6. Acupressure versus sham/placebo. | Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | |---|---|---|---|---| | 1 Pain score (VAS 0 ‐ 10) | 2 | Mean Difference (IV, Random, 95% CI) | Subtotals only | | | 2 Severity of menstrual symptoms | 2 | 171 | Mean Difference (IV, Fixed, 95% CI) | ‐1.84 [‐3.71, 0.03] | Comparison 7. Acupressure versus medication (NSAIDs). | Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | |---|---|---|---|---| | 1 Pain score | 1 | Mean Difference (IV, Random, 95% CI) | Subtotals only | Comparison 8. Acupressure versus no treatment. | Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size | |---|---|---|---|---| | 1 Pain score (VAS 0 ‐ 10) | 2 | 140 | Mean Difference (IV, Random, 95% CI) | ‐0.96 [‐2.54, 0.62] | | 2 Menstrual symptoms (MDQ) | 3 | 160 | Mean Difference (IV, Random, 95% CI) | ‐1.90 [‐5.57, 1.77] | Characteristics of studies Characteristics of included studies [ordered by study ID] Aghamiri 2005. | Methods | RCT; parallel design of acupressure versus sham acupressure | | | Participants | 100 medical students from Sari University, 50 in each group. Diagnosis not confirmed | | | Interventions | Conducted over 2 menstrual cycles Acupressure points 23 & 24 at the waist; points 3 & 4 in abdomen; points 3 & 4 in leg included Shenmen (points not specified from translation). Pressure applied for 15 minutes, then rested for 15 minutes and applied for a further 15 minutes. Sham acupressure applied off points. Treatment administration the same as for acupressure. | | | Outcomes | Pain assessed using the VAS 30 ‐ 180 minutes following treatment. Outcome recorded at 3 hours post‐treatment. | | | Notes | Country: Iran Language: Farsi Conducted in 2002 ITT not mentioned, and not stated if undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Described as simple randomisation manner | | Allocation concealment (selection bias) | Unclear risk | Insufficient reporting | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants blinded, personnel not blind, assessor unclear | | Incomplete outcome data (attrition bias) All outcomes | High risk | Insufficient reporting, no details reported on the numbers analysed | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting | Bazarganipour 2010. | Methods | RCT of acupressure versus placebo acupressure, 95 allocated to acupuncture and 102 to control. | | | Participants | 253 female students assessed, 197 randomised, recruited from Nasibe Tarbiat Moallem University, Tehran, Iran. Participants were aged 18 ‐ 21 years, with menstrual pain, no gynaecological disease, no other pain during menstrual cycle and not taking analgesics 4 hours before treatment. | | | Interventions | Intervention group: Acupressure to Taichong (LIV3) point applied for 20 minutes. Mild pain generated with clockwise movement for 1 minute, and counter clockwise for 1 minute. After 2 minutes massage to point was applied. Pressure applied so that nail colour changed. Alternation continued for 20 minutes. Participants instructed to apply protocol 3 ‐ 7 days before the period for next 2 menstrual cycles. Placebo point applied on the dorsal surface of the point. Investigator trained in acupressure. | | | Outcomes | Pain severity assessed using Andersch and Milsom scale. | | | Notes | Baseline characteristics: assessed no imbalance Loss to follow‐up: 2 intervention group, 5 placebo group due to irregular menstruation ITT not reported and undertaken Duration: March – Dec 2008 (1 baseline cycle, 3 treatment cycles) | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Generated from a table of random numbers | | Allocation concealment (selection bias) | Unclear risk | Not reported in text | | Blinding (performance bias and detection bias) All outcomes | High risk | Participants blinded, practitioner not blind and one of the investigators also undertook data analysis; no blinding reported. | | Incomplete outcome data (attrition bias) All outcomes | High risk | Intervention group: 1 dropout due to fear of side effects, 4 did not start treatment due to personal reasons. Control group: 3 did not undergo treatment due to personal reasons, 10 dropped out due to fear of adverse events, believed treatment would be ineffective, sought medical advice. | | Selective reporting (reporting bias) | Unclear risk | Insufficent reporting to assess | | Other bias | Unclear risk | Insufficient reporting to assess | Bu 2011. | Methods | RCT of 3 groups, acupuncture before menstruation, acupuncture during menstruation or untreated control group. Participants randomly assigned on the ratio of 1:1:2 into three groups | | | Participants | 80 women randomised to the study with primary dysmenorrhoea, women with secondary dysmenorrhoea excluded by gynaecological examination. Participants were Chinese college students. 40 women in each of the two groups | | | Interventions | Acupuncture points SP6, BL32, SP8, BL17 were administered to the 2 acupuncture groups. Before‐menstruation group received acupuncture 3 ‐ 7 days before the start of menstruation. Treatment was performed daily. Needles were administered for 30 minutes. DeQi was applied every 10 minutes. The second acupuncture group received treatment once menstruation started, with the points, treatment duration the same as the pre‐menstruation group. No‐treatment group could take aspirin if their VAS score was > 80. | | | Outcomes | The CMSS scale was used to assess the severity of pain at the end of each of 3 consecutive cycles and monthly over a 3‐month period.The Cox scale includes 17 symptoms commonly associated with menstrual distress. For each symptom, the scale measures both intensity and duration, with a range from 0 (not perceivable) to 4 (extremely upsetting). | | | Notes | Country: China. Baseline characteristics not assessed Loss to follow‐up due to students returning home, 2 dropped out from acupuncture administered before menstruation, and 1 dropped out from the group receiving treatment during the cycle. Compliance: not reported. ITT not reported and not undertaken. Duration: 3 menstrual cycles Assessment of blinding: participant blinding not appropriate. Data from the 2 acupuncture groups were combined for the analysis. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Unclear risk | Not reported. Participants were assigned randomly on a ratio of 1:1:2 into 3 groups | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | Participants were not blind to their group allocation, Outcomes were self reported and not blinded, no details on the status of the analyst.. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | Four subjects (10%) from the acupuncture group described as a post randomisation exclusion | | Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgment of "yes" or "No". | | Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. | Cao 2011. | Methods | Parallel RCT, manual acupuncture compared with medication | | | Participants | 60 women randomised to the study, 30 to each group. Diagnosis based on Western and Chinese medicine diagnosis guidelines. | | | Interventions | 3‐month intervention. Manual acupuncture: Shiqizhui (EX‐B8), perpendicular with 0.5‐1 cun needle insertion depth. Ciliao, perpendicular with 1‐1.5 Cun, Diji, perpendicular with 1‐1.5 Cun Daily treatment for 30 minutes with manipulation every 10 minutes started 1 day before menstrual cycle and finished after end of the cycle. 3 consecutive treatments were performed in total. Control: Oral intake 1.2 ‐ 0.4 g ibuprofen daily was prescribed during menstrual cycle and continued for 3 cycles. | | | Outcomes | Pain measured by VAS, overall improvement in symptoms (unspecified scale) at the end of the intervention. | | | Notes | Country: China Language: Chinese Setting: Hospital in Helongiang province ITT not mentioned and not undertaken. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number table | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants not blinded, insufficient reporting regarding other study personnel. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 post‐randomisation exclusion in acupuncture group, reason not stated. | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting | Charandabi 2011. | Methods | Cluster‐randomised controlled trial of acupressure versus no treatment. Randomisation was made at the level of 4 dormitories. | | | Participants | 228 women assessed, 72 randomised, 36 allocated to treatment and 36 to the control group. Women were aged 18 ‐ 22 years from Tabriz University and Tabriz University of Medical Sciences, Iran. Regular menstruation, score of > 5 on the VAS, no evidence of pelvic disease. | | | Interventions | Both groups could take ibuprofen (400 mg) every 6 hours if needed. Acupressure applied to SP6 point with the thumb for 5 minutes (6‐second pressure and 2 seconds rest) to an intensity where pain was tolerable. The participants were told that at the time of pain and menstrual symptoms (for spasmodic cases during the 2 first days of menstruation and for congestive group during the 2 days before menstruation) the point should be pressed. This procedure should then be repeated for the other foot. The whole routine was repeated on both feet for another 10 minutes (each foot for 2 x 5‐minutes). Control group was no acupressure. | | | Outcomes | Menstrual symptoms questionnaire, symptom severity scale | | | Notes | Data were not presented in a form. No imbalance in characteristics at baseline. Loss to follow‐up: no loss Compliance: not reported Duration: 2 cycles. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Unclear risk | Cluster‐randomisation stated but not specified. | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | Participants were not blind to group allocation, outcome assessment was subjective and no details on analyst status were reported. . | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up | | Selective reporting (reporting bias) | Unclear risk | Not reported | | Other bias | Unclear risk | Not reported | Chen 2004. | Methods | RCT, 2 groups acupressure on SP6 (41 women), compared with rest (40 women) | | | Participants | 81 female students participated in the study. Inclusion criteria: age < 20 years, pain greater than 5 on VAS scale, no pain medication taken 4 hours prior to the start of the intervention. Participants were recruited with ‘no prior history of gynaecological disease or secondary dysmenorrhoea', although it was not reported how this was established. | | | Interventions | The intervention was manual acupressure, applied by researcher at the initial treatment, then self‐administered at subsequent treatments. Acupressure applied to SP6 on alternate legs, 2 complete 5‐minute cycles of pressure performed on each leg for a total of 20 minutes. The force applied initially 1.21 kg, (method of assessment of the force not reported) increasing to 3.53 kg. Acupressure applied for 6 seconds, released for 2 seconds without pressure. This was continued for 5 minutes on each leg, and repeated 4 times. When cramping occurred in the initial session acupressure was applied. The intervention was applied over 1 cycle. When cramping occurred participants were asked to rest in the school health centre for 20 minutes. | | | Outcomes | VAS 0 ‐ 10 cm scale measures the intensity of pain, Menstrual Distress Questionnaire, VAS to measure anxiety: end‐score. | | | Notes | Country: Taiwan Setting: Technical high school Loss to follow‐up: 12% loss acupressure, 35% control. Compliance: not reported. No certainty or evidence that intervention was self‐administered at all. ITT: not reported Duration: December 2000 ‐ August 2001 Funding: Government grant | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Drawn by lot | | Allocation concealment (selection bias) | Low risk | Sealed envelopes | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding of participants, or of the care provider but outcomes said to be recorded by ‘a research assistant unaware of the group assignment’ and ‘administered all the instruments in the health centre’. | | Incomplete outcome data (attrition bias) All outcomes | High risk | 50% dropout in control group | | Selective reporting (reporting bias) | Unclear risk | Study protocol was not available, therefore cannot rule out selective reporting. No clear statement of primary or secondary outcomes. | | Other bias | Unclear risk | Baseline characteristics assessed were said to be statistically similar, but number of participants in the groups does not add up for 'analgesic usage' and 'absent from class'. There may be imbalances at baseline. | Chen 2010. | Methods | RCT, 4 groups, acupressure on group 1) ST 36; group 2) LI4; group 3) LI4 plus SP6; versus 4) no treatment.50 women allocated to each group. | | | Participants | 134 adolescents (aged 4 on the VAS, no gynaecological disease, or secondary diagnosis (details of diagnosis confirmation not reported). Exclusion criteria included skin infection, haemorrhage or phlebitis.The mean age was 16 plus years, although the standard deviation indicates some women may have been 15 years. | | | Interventions | The 3 experimental groups were given a detailed acupressure protocol. The researcher applied acupressure during the first menstrual period. When the VAS pain score was > 4, participants were asked to attend the health care office for acupressure. Acupressure was applied alternating between each leg. The force was initially 1 kg (method of assessment of force applied not reported), increasing to 4 kg at the end of the therapy. Pressure was applied for 6 seconds, then a rotating movement was made for 2 ‐ 3 seconds alternating without pressure. The process was applied 4 times over 20 minutes, over 3 days for 3 cycles. Participants in the control group had 20 minutes of bed rest. Participants in the experimental group were taught how to apply pressure in the next menstrual cycle. | | | Outcomes | VAS pain (0 ‐ 10) measures the intensity of pain, Menstrual Distress Questionnaire, VAS to measure anxiety. Assessed at 1,3 and 6 months. Data reported at 1 month. | | | Notes | Country: Taiwan Setting: Medical Technology University Groups comparable at baseline. Loss to follow‐up: 40% dropout similar between groups ITT: not reported Compliance: not ascertained Duration: January ‐ August 2003 Funding: Government grant | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Drawn by lot | | Allocation concealment (selection bias) | Low risk | Sealed envelopes | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding of participants, the practitioner was not blind, and blinding of the analyst was not reported. | | Incomplete outcome data (attrition bias) All outcomes | High risk | High dropout rates of up to 40% but similar number and reason across all groups. Attempts made to increase return rate of questionnaires by trained assistants. | | Selective reporting (reporting bias) | Unclear risk | Study protocol was not available, therefore cannot rule out selective reporting. No clear statement of prospective primary or secondary outcomes. | | Other bias | Unclear risk | Unclear from reporting | Darabi 2010. | Methods | RCT, parallel design. Manual acupuncture versus sham acupuncture | | | Participants | 100 participants, 50 in each group. Diagnosis was not clinically confirmed. Age of participants eligible: 15 ‐ 30 Exclusion criteria: wound in the area where acupuncture would be applied. | | | Interventions | Intervention administered over 3 cycles. Acupuncture: CV3, St29, CV12, CV4, Bl23 applied. 3 sessions every second day in the week before period. A total of 9 treatments. Control: sham acupuncture with points applied away from real points. Timing as per experimental group. | | | Outcomes | Pain measured using the VAS, with scores reported at the end of the intervention at 3 months. | | | Notes | Country: Iran Language: Farsi Setting: Hospital clinic Study conducted 2007 ‐ 2008 ITT not mentioned and not stated if undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Unclear risk | Stated as randomisation but method not reported | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants were blinded, study personnel were not blinded; no details provided on the outcome assessor. | | Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting | Han 2012. | Methods | RCT of acupuncture plus moxibustion and ibuprofen | | | Participants | 120 women recruited, aged < 45 years. Diagnosis of primary dysmenorrhoea made by Western and Chinese methods. 40 women in the control arm and 80 women in the treatment group. | | | Interventions | Daily treatment was performed 4 days prior to period, continued for 7 days and 3 cycles. Points were Ciliao, Zhongwan, Guanyuan, Zusanli, Sanyinjiao, Taichong and Diji. The points were manually stimulated for 10 seconds after DeQi. The needles were then retained for another 10 ‐ 15 minutes. Moxibustion with self‐made herbal‐based materials which contained Honghua, Huoxiang, Zisuye. The herbs were ground into powder and mixed with yellow rice wine. The shape of the object was 3 cm in diameter and 0.8 cm in thickness. Moxibustion was performed on Guanyuan, Zusanli, Sanyinjiao and Taichong points. Participants took ibuprofen. 0.3 g taken each time and twice daily. Treatment started from 4 days before menstrual cycle and continued for 7 days. 3 consecutive treatments were conducted. | | | Outcomes | Pain relief, overall improvement in symptoms using unspecified scale at end of the intervention. | | | Notes | Country: China Setting: 3 hospitals in Wuhan Funding: not stated | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated | | Allocation concealment (selection bias) | Low risk | Central | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | Insufficient reporting to determine | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting to make a judgement | | Other bias | High risk | Extreme imbalance at randomisation | Helms 1987. | Methods | RCT, 4 groups: 1) acupuncture (11 women); 2) placebo acupuncture (11 women); 3) standard control initial visit only (11 women; and 4) visit control (10 women). | | | Participants | 48 women were recruited. Women had recurrent pain that started within 2 years of regular menstruation, and in the absence of any pelvic pathology. No other details on inclusion and exclusion criteria were stated. | | | Interventions | 1. Acupuncture group: real acupuncture with needles inserted into the skin along meridian points; 2. Placebo acupuncture with needles inserted in the same manner at points close to ’real’ acupuncture points, but areas that were verified as having no electrical activity; 3. Standard control involved an initial meeting but then participants continued on whatever method they used prior to the study; 4. Visit control was the same as the standard control with the addition of extra visits to the physician during the study. 1. Acupuncture points: SP4, K3, ST36, ST30, CV2, CV4, CV6, (points located on feet, below the knee and lower abdomen). Duration: needles in place for 30 ‐ 40 minutes, once a week for 3 weeks a month, for 3 months. 2. Placebo acupuncture needles of the same types of needles at points off acupuncture channel (meridian) and verified as not having electrical activity. 12 needles were used per treatment, retained for 30 minutes. 3) Standard control group had no contact with the physician‐investigator after initial interview. 4) Visit control visited the physician once a month after their first 3 periods and reviewed their symptom evaluation form with him. For the subsequent 9 months forms were completed with no special attention. | | | Outcomes | Pain duration, pain intensity, pain scores pre‐, during, post‐treatment, and a menstrual questionnaire. Improvement was arbitrarily defined as being an average post‐treatment score of less than half that of the pretreatment score. | | | Notes | Country: USA Setting: Gynecological clinic Groups comparable at baseline: yes. Loss to follow‐up: 11%, 2 from visit and 1 respectively from each group Compliance: not reported. ITT: not stated Duration: not stated Funding: not reported | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Table of random numbers | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | The women in 2 groups were blinded to their acupuncture group (blinding not assessed), but participants aware of allocation to acupuncture or control group. The outcome analyst was blinded, the therapist was not blinded. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 women (10%) discontinued treatment. 2 pregnancies, 2 job relocations, 1 lack of interest. Missing outcome data balanced across groups. | | Selective reporting (reporting bias) | Unclear risk | Study protocol not available and primary outcomes were not prespecified. | | Other bias | Unclear risk | The study appears free of other biases. | Hu 2005. | Methods | RCT parallel design of manual acupuncture plus moxibustion compared with pharmacological treatment. 80 women randomised, 40 to each group. | | | Participants | Diagnosis was based on Western and Chinese medical diagnoses. No further details provided. | | | Interventions | Manual acupuncture on Guan Yuan (CV4), San Yin Jiao (SP6), Tai Chong (LIV 3), and placed 2 cm * 2 of moxa bar on the needle after DeQi. Once each day. Starting from 3 days before each cycle, for 3 days, 3 circles as 1 treatment course. Control: Juyuansuan tamoxifen, 10 mg, x 2/day for 3 days; 3 circle as 1 treatment course | | | Outcomes | Unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research assessed at the end of the intervention. | | | Notes | Country: China Language: Chinese Setting: Xin Gang Central Hospital of Jianxi Province Duration: 3 months ITT: not reported or undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number tables | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding. | | Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting | | Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were prespecified. | | Other bias | Unclear risk | Insufficient reporting | Kashefi 2010. | Methods | RCT: Acupressure versus sham acupressure | | | Participants | 100 University medical students with no knowledge of acupuncture or acupressure were screened, and 86 were randomised, 43 to each group. A clinical diagnosis was not confirmed. Needed to have a regular cycle, with severe pain in recent cycles, and pain coinciding with onset of bleeding (score 2/3 on non‐specified scale). | | | Interventions | Treatment administered over 2 menstrual cycles Experiment: manual acupressure. Point: SP6, 6 seconds with pressure applied in circular clockwise motion applying 1.2 kg pressure, administered over 1 treatment per cycle. Total 30 minutes of stimulation Control: sham acupressure at non‐channel points. All other aspects were the same. | | | Outcomes | Pain was measured using the VAS scale at 30 min, 1, 2 and 3 hours post‐treatment. Score at 3 hours after end of intervention assessed. | | | Notes | Country: Iran Language: Farsi Duration: 2007 ‐ 2008 ITT not reported and not stated if undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number chart | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | Women were blinded, other personnel were not blinded, and no details reported re the outcome assessors. | | Incomplete outcome data (attrition bias) All outcomes | Unclear risk | In the acupressure group 3 discontinued intervention because of treatment ineffectiveness, 2 in the first month and 1 in second month. In the control group 2 discontinued the intervention because of adverse effects, 1 each in the first and second months. | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting to allow an assessment | Lee 2007. | Methods | RCT of manual acupuncture versus minimal acupuncture | | | Participants | 63 women screened, primary dysmenorrhoea not confirmed by examination. 23 allocated to treatment 26 allocated to control. | | | Interventions | Manual acupuncture: versus minimal acupuncture Acupuncture: GB41, SI3, BL66, SI2, SP6. Duration of needle stimulation 15 minutes, 1 mm depth of insertion. 5 treatments administered. Treatment 1 1 ‐ 4 days before period. Treatments 2 ‐ 5 at 5 ‐ 8‐day intervals. Minimal acupuncture: LU10, ST40, PC5, GB40.Duration of needle stimulation 15 minutes, 1 mm depth of insertion. 5 treatments administered. Treatment 1 1 ‐ 4 days before period. Treatments 2 ‐ 5 at 5 ‐ 8‐day intervals. Duration: 1 month | | | Outcomes | Measure of Menstrual Pain questionnaire was used to assess menstrual pain and the MSSL for menstrual symptoms at the end of the intervention. | | | Notes | Country: Korea Setting: Hospital ITT not mentioned or undertaken. Per protocol analysis. Groups comparable at baseline: not reported, but see 'Other bias' below. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Randon number table | | Allocation concealment (selection bias) | Unclear risk | Not stated | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | Insufficient information to permit judgement. Participants were blinded, personnel and outcome assessors were not. | | Incomplete outcome data (attrition bias) All outcomes | High risk | Insufficient reporting. 14 women excluded from analysis and not reported by group. 1 irregular period, 7 dropped out, 3 did not meet the pain criteria, 2 had another disease, 1 took pain killers during the study. Data on 49 women analysed. | | Selective reporting (reporting bias) | Unclear risk | Insufficient information reported | | Other bias | Unclear risk | The experimental‐group women had shorter periods. | Li 2008. | Methods | RCT, 3 groups: 1) acupuncture using the 4 gates; 2) traditional acupuncture points; 3) patented Chinese herbal medicine, 60 women in each group. | | | Participants | 180 women aged 12 ‐ 27 were recruited. Pathology was eliminated although not specified. No other details were reported. However no women aged less than 17 years was recruited to the study. | | | Interventions | The active acupuncture group used points LI4, LIV3. Additional points allowed. For qi stagnation with blood stasis points CV6 and PC6 were added. For cold stagnation with blood stasis CV4, CV3 were added, for severe pain BL32 and SP8 were added. Hawato brand needles were used (0.35 x 40 mm). For LI4, LIV 3 needles were inserted and manipulated using twirling reinforcing reducing method until DeQi obtained. Needles were retained at an angle 45° towards the area of pain. CV6, PC6, BL32, SP8 were manipulated using twirling and reinforcing reducing method, CV3 and CV4 were manipulated using reinforcing method. Needles manipulated for 2 minutes and retained for 30 minutes. LI4 and LIV3 were manipulated every 10 minutes. Mild moxibustion applied to CV3 and CV4 for 10 minutes. Treatment applied once a day starting 3 ‐ 5 days before the start of period, and continued until the last day of bleeding. 2 control groups were used. Firstly, routine acupuncture which did not meet our criteria for comparison for a control group. Secondly, the use of a Chinese patent herbal medicine Yueyueshu. Yueyueshu granules (manufactured by Henan Wanxi Pharmaceutical company) were administered orally. Once sachet of 10 g was dissolved in hot water and 10 at morning and night starting 1 week prior to the onset of the menstrual cycle, until the third day of bleeding. | | | Outcomes | Basal body temperature, improvement in dysmenorrhoea symptoms, plasma levels of PGF₂α. Assessment at the end of the intervention. | | | Notes | Country: China Setting: Henan Luohe High Medical Training School Third Affiliated Hospital and Luohe Municipal Hospital of TCM's gynaecological department Groups comparable at baseline: not reported Loss to follow‐up: no dropouts Compliance: not reported Duration: 3‐month intervention ITT: not stated Funding: not reported | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number tables used | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding, and outcome measurement may be influenced by lack of blinding, no other details reported. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Unclear risk | Insufficient information to judge | | Other bias | Unclear risk | Insufficient information to judge | Li 2012b. | Methods | Parallel RCT, manual acupuncture versus medication | | | Participants | 60 women randomised to the study from a hospital outpatients clinic, 30 in each group. | | | Interventions | Acupunture: administered daily on Guanyuan (CV4), Qihai (CV6), Sanyinjiao (SP6), Zhongji (CV3) points 3 days before cycle and finished 3 days after cycle. After manipulation moxibustion was performed on Guanyuan, Qihai and Zhongji points. Needles were retained in the points for 30 minutes. Control: prescribed with ibuprofen 0.3 g when the period pain appeared. Maximum daily dosage was controlled under 0.6 g until the syndrome disappeared. | | | Outcomes | Pain measured by the VAS at 3 months | | | Notes | Country: China Language: Chinese Setting: Hospital in Guangzhou Duration: 5 months (3 months experiment plus 2 months follow‐up) ITT: no mention and not undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number table | | Allocation concealment (selection bias) | Unclear risk | Not stated | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding, and outcome measurement may be influenced by lack of blinding, no other details reported. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting | Ma 2010. | Methods | RCT: electro‐acupuncture at SP6 913 women), GB39 (14 women), an adjacent non meridian point (12 women), and wait list control (13 women). 52 randomised, | | | Participants | 52 women with primary dysmenorrhoea from 4 universities in Jinan, Shandong Province of China and Affiliated Hospital of Shandong University of Traditional Chinese Medicine were recruited. Women needed to be aged 15 ‐ 30 years, normal menstrual cycle and a score > 4 on the VAS, no use of analgesics 24 hours before the trial. Women with secondary dysmenorrhoea were excluded. | | | Interventions | 3 treatment sessions administered, with 10 minutes in first session, then 30 minutes in the next 2 days, and once a day for 3 days. All 3 groups were administered by the same acupuncturist. There was no variation in the acupuncture technique. 40 x 0.25 mm disposable needles were administered to the 3 groups, with a basic lifting and thrusting and twirling technique for 1 minute to produce the DeQi sensation. Electro‐acupuncture then applied with 2/100 Hz for 10 minutes to women in all 3 treatment groups. Treatment over 1 menstrual cycle. | | | Outcomes | VAS for pain severity, VRS the influence of pain on daily work, general symptoms and use of analgesics | | | Notes | Due to the active stimulation administered to the 2 acupuncture control groups a comparison was made with the no‐treatment group only. Wrote to authors for data to be presented in a form for the meta‐analysis, but no response was received. Duration: November 30, 2007 to July 15, 2008 Losses to follow‐up: 1 dropped out in no treatment, SP6 1 dropped out due to inability to attend for treatment ITT analysis not reported and not undertaken Baseline characteristics: no differences reported | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated sequence | | Allocation concealment (selection bias) | Low risk | Central randomisation | | Blinding (performance bias and detection bias) All outcomes | Low risk | "Participants were blinded to treatment, as those who had history of acupuncture treatment and knew the effects of acupoints were excluded. The acupuncturist maintained neutral communications with all participants and avoided providing cues that might reveal whether she was performing acupuncture with real or sham acupoints. In the process of trial, only the acupuncturist knew the treatment allocation and was separated from the imaging technician. Moreover, the punctured area was covered during the needle retention time, thus blinding the imaging technician to treatment allocation. The assessor who recorded the results of clinical scale assessments after treatment was also blinded to treatment allocation". | | Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 post‐randomisation exclusions, 1 from the treated and 1 from the control group. Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups. | | Selective reporting (reporting bias) | Unclear risk | Not reported | | Other bias | Unclear risk | Not reported | Ma 2013. | Methods | 600 women with primary dysmenorrhoea were randomly assigned to the single point group (n = 200) including group A (treating before the menstruation, n = 100) and group B (immediately treating as soon as pain occurrence, n = 100), the multipoints group (n = 200) including group C (treating before the menstruation, n = 100) and group D (immediately treating as soon as pain occurrence, n = 100), or the control group, group E (n = 200, no treatment). | | | Participants | Women were aged 16 ‐ 35 years, meeting the criteria of primary dysmenorrhoea, and symptoms experienced between 6 months and 15 years. | | | Interventions | Treatment was administered over 3 menstrual cycles. Group A and B group single‐point received point Shiqizhui (EX‐B8). The needle was inserted to a depth 0.5 to 1 cm for 30 minutes. Lift, thrust and twirling was applied every 30 seconds for 10 minutes. Groups C and D (multipoints) received points SP6, SP8, BL32 and EXB8. Points were inserted to a depth of 1 ‐ 1.5 cm, with the same mode of stimulation applied. The control group received no intervention. Groups A and C were treated before menstruation, Group B and D as soon as pain occurred. Treatment frequencies varied between groups. | | | Outcomes | Cox menstrual symptom scale measured at the end of the intervention (3 months) and follow‐up at months 4,5, and 6. VAS measured at 5, 10, 20, and 30 minutes mean upon acupuncture; 30, 60, and 120 minutes mean after needle withdrawal. Also adverse events | | | Notes | Country: China Setting: University‐affiliated hospitals. Five centres: Shandong University of Traditional Chinese Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Zhejiang University of Traditional Chinese Medicine Institute of Acupuncture and Massage, Affiliated Hospital of Shandong Provincial Research Academy of Traditional Chinese Medicine Duration: March 2008 ‐ January 2010 ITT undertaken but per protocol reported in paper. 4 treatment groups were combined into 1 acupuncture group. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated | | Allocation concealment (selection bias) | Low risk | Central randomisation | | Blinding (performance bias and detection bias) All outcomes | High risk | Some participants were not blinded to group allocation and this is likely to have introduced bias. Statistican was blinded to group allocation. | | Incomplete outcome data (attrition bias) All outcomes | High risk | Low rates of completion were reported in the 4 intervention groups. 4 acupuncture groups combined (72% completed), 38 discontinued, 13 non‐compliant, 13 lost to follow‐up, 11 other, 1 side effects. Control group (93% completed), 13 discontinued, 3 were non‐compliant, 6 lost to follow‐up, 2 side effects, 2 other reasons. | | Selective reporting (reporting bias) | Unclear risk | No protocol available | | Other bias | Unclear risk | Sample size calculation reported | Mirbagher‐Ajorpaz 2011. | Methods | RCT of acupressure versus light touch, 30 randomised, 15 in each group. | | | Participants | The study was conducted with 30 college students residing at the dormitories of Kashan University of Medical Sciences, Kashan, Iran. Women were aged 18 ‐ 30 years, regular menstruation with moderate to severe pain (score > 3 on VAS scale). Exclusion criteria included use of the IUD, and a diagnosis of secondary dysmenorrhoea (not specified). | | | Interventions | In the intervention group the researcher placed both thumbs on the SP6 acupoint of both legs simultaneously and applied strong vertical pressure for 10 second‐cycles (8 seconds of acupressure and 2 seconds of rest), 120 times in a total of 20 minutes (SP6 acupressure). In the control group, the researcher’s thumb was lightly placed on the SP6 sites for 20 minutes without applying any pressure for 8 seconds and 2 second‐cycles of rest (placebo; SP6 touch). | | | Outcomes | Pain intensity assessed using VAS at 1, 2, 3 hours after treatment following 1 cycle | | | Notes | Duration: 6 months during 2008 Compliance not reported. No difference in baseline characteristics. No loss to follow‐up. ITT not reported but undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number tables | | Allocation concealment (selection bias) | Unclear risk | Not reported. | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants were blinded, but blinding status of others unclear. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient rationale or evidence that an identified problem will introduce bias. | Peng 2012. | Methods | RCT of manual acupuncture compared to pharmacological treatment | | | Participants | 60 women, 30 in each group. No details reported on how primary dysmenorrhoea was diagnosed. | | | Interventions | Acupuncture: Points used Diji SP8, Zhongdu GB32, Shuiquan KI5, bilaterally. Perpendicular insertion of needles. DeQi obtained. Needles retained for 20 ‐ 30 minutes. Treatment daily once pain started. Pharmacological treatment: ibuprofen 300 mg x 2/day. Pain relief started in first cycle with onset of menstrual pain until the last day of menses. During 2nd and 3rd cycle pain medication began on day 1 and continued until last day of menses. | | | Outcomes | Pain relief measured using VAS scale, and overall improvement in generic menstrual pain using unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research assessed at the end of the intervention. | | | Notes | Country: China. Setting: Guang Zhou City Hospital outpatients and inpatients Obstetric and Gynaecological department Duration of study: 3 menstrual cycles ITT not reported but undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Unclear risk | Stated as randomised but no details reported. | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | Participants and some key study staff were not blinded, and lack of blinding likely to introduce bias. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Low risk | Study protocol not available but thesis indicates all outcomes were reported. | | Other bias | Unclear risk | Insufficient reporting | Qiao 2013. | Methods | RCT of 4 groups, acupuncture versus medication, | | | Participants | 80 women randomised. Experiment n=20 body; Experiment n=20 wrist ankle needle; Experiment n=20 auricular acupressure; Control n=20 anti‐inflammatories. | | | Interventions | 1. Body acupuncture: Guanyuan (CV4), Sanyinjiao (SP6), Diji (SP8), Shiqizhui (Extra point) stimulated. Needles retained for 30 minutes, and manipulated every 10 minutes. Daily treatment started 5 days before menstrual cycle. Treatment stopped on second day of cycle. 2. Wrist ankle needle group: needles inserted to hypodermal level, at an angle 30° obliquely, retained for 30 minutes, manipulated every 10 minutes. Daily treatment started 5 days before menstrual cycle. Treatment stopped on second day of cycle. 3. Auricular plaster therapy, herbal paste made and applied to reproductive, endocrine, subcortical, Shenmen, Liver, Kidney ear points. Instructed to press points every 3 hours. Daily treatment started 5 days before menstrual cycle. Treatment stopped on second day of cycle. 4.Pharmacological treatment: indomethacin 25 mg x 2/day. Groups 1 and 3 combined. | | | Outcomes | Pain relief as measured by VAS. Overall general improvement in menstrual pain, using an unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research assessed at the end of the intervention. | | | Notes | Country: China Setting: students recruited from a TCM school Study duration: 3 menstrual cycles Study period: October 2011 ‐ October 2012 ITT undertaken but not reported | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number table | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | Study participants not blinded, and non‐blinding likely to introduce bias. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Low risk | Reporting as per methods in Masters thesis appears complete. | | Other bias | Low risk | No apparent risk of additional bias. | Ruan 2011. | Methods | Parallel RCT, manual acupuncture versus medication | | | Participants | 60 participants randomised to the study, 30 to each group. | | | Interventions | 3‐month intervention, with 2‐month follow‐up Acupuncture: Daily treatment started 5 days before menstrual cycle and ceased on 2nd day of period arrival. Each treatment lasted for 30 minutes. Guanyuan, Guilai, Sanyinjiao were the major points for the acupuncture treatment. The following additional points were used based on TCM pattern differentiation. *Cold and damp stagnation ‐ Acupuncture: YinlingQuan; moxibustion: Pishu, Mingmen. Even reinforcing‐reducing method was used for acupuncture treatment. Each treatment continued for 30 minutes. Moxibustion was performed 2 cm above the points and continued for 10 minutes. *Qi stagnation and blood stasis ‐ Taichong, Hegu, Xuehai. Even reinforcing‐reducing method was used for acupuncture. Each treatment continued for 30 minutes. Moxibustion was performed 2 cm above the points and continued for 10 minutes. *Qi and blood deficiency ‐ Moxibustion: Zusanli, Pishu, Weishu. Moxibustion was performed 2 cm above the points and continued for 10 minutes. Medication: prescribed ibuprofen. 0.3 g was taken each time and twice daily when period pain occurred. The treatment ceased when the pain disappeared. During the treatment, alcohol and drinks with caffeine were not allowed for participants in control group. | | | Outcomes | Pain VAS scale and overall symptoms using an unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research assessed at the end of the intervention. No data reported at 3‐month follow‐up. | | | Notes | Country: China Language: Chinese Setting: Gynaecological clinic of TCM college in Fujian Province Duration: 8‐month study ITT reported and undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated | | Allocation concealment (selection bias) | Low risk | Central randomisation | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data; all completed the trial and assessments. | | Selective reporting (reporting bias) | Low risk | Full thesis available and it is clear that the published reports include all expected outcomes, including those that were prespecified. | | Other bias | Unclear risk | Insufficient reporting addressed in the thesis. | Shi 2011. | Methods | RCT of electro‐acupuncture (EA) to SP6, EA to active point not used for period pain, and EA to sham acupuncture and no treatment. | | | Participants | 40 women aged 15 ‐ 30 years, recruited from Tianjin, China. A history of regular menstruation (28‐day cycle ± 7 days). Participants experienced menstrual cramping pain of moderate or severe intensity, varying from 40 to 100 on the VAS, and lasting at least 6 months. Participants agreed to refrain from the use of any analgesics 24 hours before the trials. Women with underlying conditions leading to secondary dysmenorrhoea, such as endometriosis, uterine myoma, ovarian cyst, or intrauterine synechia, intrauterine devices, were excluded from the study. 10 women allocated to each group. | | | Interventions | EA to SP6, or GB 39, or a non‐acupuncture point. DeQi obtained for all points and EA of 2/100 HZ stimulation applied for 30 minutes. No pain medication used in the 24 hours prior to the study beginning. | | | Outcomes | VAS scale for pain severity, and PGE2 at the end of the intervention | | | Notes | Country: China Setting: not reported No differences in age and dysmenorrhoea at baseline Loss to follow‐up: none Compliance: single session only Duration: November 2007 ‐ July 2008 ITT analysis not reported but undertaken Due to the stimulation of EA and application of de qi to both control points, these were viewed as being active to some degree and we used a comparison between acupuncture and no treatment only. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Unclear risk | Not reported | | Other bias | Unclear risk | Not reported | Smith 2010. | Methods | RCT, 2 groups, acupuncture compared with placebo control using placebo needle, 46 women in each group. | | | Participants | 92 women aged 14 ‐ 25 years recruited. A diagnosis of primary dysmenorrhoea was based on self‐reported severe incapacitating pain for at least 1 day of menses in 2 menstrual cycles classified by a predefined pain score of > 6 on the McGill questionnaire. Secondary dysmenorrhoea was excluded by clinical evidence confirming diagnosis of primary dysmenorrhoea. Other exclusion criteria included: pelvic pathology, pain associated with IUD. | | | Interventions | All participants received the intervention for 30 ‐ 40 minutes, weekly for 3 weeks, followed by a week of no treatment during the week of expected menses. Treatment was administered over 3 months. TCM acupuncture protocol based on expert opinion, review of literature and experience of practitioners. 9 diagnostic patterns with standardised treatment: ·Qi and blood stagnation: Taichong LR3, Sanyinjiao SP6, Hegu LI4, Zhongji Ren‐3, Ciliao UB32, Xuehai SP10, Qihai Ren‐6, Diji SP8, GongSun SP4. ·Qi and blood Deficiency: Zusanli ST36, Sanyinjiao SP6, Guanyuan Ren ‐34, Qihai Ren‐6, Geshu BL17, Diji SP8, Pishu UB20, Ciliao UB32. ·Stagnation of cold: Shenshu UB23, Zhongji Ren‐3, Qihai Ren‐6, Sanyinjiao SP6, Guanyuan Ren‐4, Mingmen Du‐4, Lie Que LU7, Zhaohai KD6, Zusanli ST36. ·Accumulation of damp heat: Yanglingquan GB34, Quchi LI11, Xingjian LR2, Guilai ST29, Ciliao UB32, Fenglong ST40, Yinlingquan SP9, Shuidao ST28, Sanyinjiao SP6, Sanjiaoshu UB22. ·Kidney and liver deficiency: Zusanli ST36, Sanyinjiao SP6, Guanyuan Ren‐4, Qihai Ren‐6, Geshu UB17, Ganshu UB18, Shenshu UB23, Taixi KD3. Seirin 0.2 x 30 mm acupuncture needles were inserted bilaterally to a depth of not greater than 2 cm, and the needles were retained for 30 minutes. All participants received the DeQi sensation following initial insertion of needles and half way through the treatment session. Reinforcing or reducing stimulation was given according to the TCM diagnoses, and standardised to the individual. The placebo control group received placebo acupuncture, with the timing and duration of the control intervention the same as the active acupuncture group. The placebo needle was inserted away from classical acupuncture points and meridians on the sacral area, lower back, lower abdomen, foot, lower leg and forearm. These locations ranged from 2 to 4 cm away from an acupuncture point or meridian. Placebo acupuncture needles (0.30 x 30 mm) were used. | | | Outcomes | Primary and secondary endpoints were measured at 3, 6, and 12 months after trial entry. The primary outcome measures were end‐of‐treatment scores for menstrual pain intensity and duration, measured by the McGill questionnaire. The overall improvement in dysmenorrhoea (measured by change in dysmenorrhoea symptoms, for example, nausea, vomiting, and mood changes), and the proportion of women requiring additional analgesia for pain relief were gathered by a self‐report questionnaire. Subjects completed a self report questionnaire to collect data on secondary endpoints including restriction of daily living activities, and the Short Form 36 (SF36). | | | Notes | Country: South Australia Setting: from the community through their general practitioner, gynaecologist or by self referral Funding: Government National Health and Medical Research Council Groups comparable at baseline: comparable for most baseline characteristics. > 5% difference in BMI, smoking and socio‐economic status (adjusted for in analysis). Loss to follow‐up: 12 months: acupuncture 0%, control 4% Compliance: median number of treatments: acupuncture = 9, control n = 9. Duration: February 2003 ‐ August 2005 ITT analysis undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated using variable block size, stratified by previous use or non‐use of acupuncture, generated by independent statistician | | Allocation concealment (selection bias) | Low risk | Central telephone randomisation procedure | | Blinding (performance bias and detection bias) All outcomes | Low risk | Participants were blinded to treatment allocation (blinding assessed), the acupuncturists were not blinded, the statistician was blinded to group allocation.Assessment of blinding: undertaken at the end of the trial. 41% of women receiving acupuncture believed they received acupuncture, 22% of women in control thought they were receiving true acupuncture (P = 0.07), | | Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing outcome data: 5 from the treatment group and 2 from the control, similar between both groups. | | Selective reporting (reporting bias) | Low risk | The study protocol is available and all primary and secondary endpoints were prespecified as on the Australian and New Zealand Clinical Trial Registry. | | Other bias | Low risk | There was high compliance with the treatment schedule, attempts were made to encourage completion of follow‐up questionnaires, the treatment protocol was representative of ‘usual practice’ in terms of points, frequency, duration and time of needle stimulation, intervention and control participant reports (“Assessment of blinding”) suggest they were genuinely ‘blinded’ to treatment allocation, and control participants had similar contact time and psychosocial experience to intervention group. | Song 2013. | Methods | RCT of electro‐acupuncture SP36, group GB39, sham and no treatment | | | Participants | 200 women were recruited from 4 hospitals in Beijing and Tianjing, 50 women allocated to each group. | | | Interventions | 3 treatment groups were allocated. 3 days of treatment were performed for each month if the VAS ≥ 40. The total course of treatment lasted for 3 months. 1. Sanyinjiao (SP6) group: The needle was inserted perpendicularly about 25 ‐ 30 mm deep in Sanyinjiao. After DeQi feeling was achieved, the second needle was inserted about 2.5 mm in depth 2 ‐ 5 mm away from the first one. EA device was used to connect both needles to enhance the stimulation. Frequency 2 Hz/100/Hz, current 0.5 ‐ 1.6 mA. The treatment lasted for 30 minutes. 2. Unrelated Xuanzhong (GB 39) group: The needle was inserted perpendicularly about 15 ‐ 25 mm deep in Xuanzhong. After DeQi feeling was achieved, the second needle was inserted about 2.5 mm in depth 2 ‐ 5 mm away from the first one. EA device was used to connect both needles to enhance the stimulation. Frequency 2 Hz/100/Hz, current 0.5 ‐ 1.6 mA. The treatment lasted for 30 minutes. 3. Non‐acupoint group. The needle was inserted perpendicularly about 15 ‐ 25 mm deep in non‐acupoint level withXuanzhong(GB39) in between stomach and gallbladder channels. DeQi was not required if it could not be achieved. The second needle was inserted about 2.5 mm in depth 2 ‐ 5 mm away from the first one. EA device was used to connect both needles to enhance the stimulation. Frequency 2 Hz/100/Hz, current 0.5 ‐ 1.6 mA. The treatment lasted for 30 minutes. 4. Control group: no treatment was given for 2 consecutive periods. EA treatment was performed for control group once the 2 periods finished. All participants, 0.5 g of aspirin was given if VAS ≥ 80. | | | Outcomes | VAS, RSS COX 2 measured at the end of the intervention. | | | Notes | Country: China Setting: Hospital. Data from the 2 acupuncture control groups were combined for the analysis. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated | | Allocation concealment (selection bias) | Low risk | Central randomisation | | Blinding (performance bias and detection bias) All outcomes | High risk | Blinding adequate for outcome assessors, but no blinding was performed of participants and personnel | | Incomplete outcome data (attrition bias) All outcomes | Low risk | 6 post‐randomisation exclusions, 1 treatment and 5 across the 3 control groups. Reasons for missing outcome data unlikely to be related to true outcome | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Low risk | Study appears free of other sources of bias. | Sriprasert 2015. | Methods | RCT, acupuncture vs combined oral contraceptives (COC). 52 women allocated, 27 to acupuncture, 25 to CoC. | | | Participants | Participants aged 18 ‐ 35 years. Inclusion criteria: a history of dysmenorrhoea within the previous 3 consecutive months with a NRS of 5 or more, a VMSS of grade 2 or more, and the use of rescue analgesic drug for dysmenorrhoea (at least 1 tablet during the run‐in period). Exclusion criteria were contraindications to COC or acupuncture and underlying gynaecologic conditions associated with dysmenorrhoea. Transabdominal ultrasonography was performed by a gynaecologist to rule out abnormal gynaecologic conditions such as uterine myoma, endometrioma, and ovarian tumour. A run‐in period of 1 month during which they discontinued all treatment for dysmenorrhoea with the exception of rescue analgesics. | | | Interventions | All participants received a supply of rescue NSAIDs, mefenamic acid (250 mg per tablet), prescribed at 1 tablet as needed for dysmenorrhoea to be taken based on the perception of pain by participants themselves and to be repeated every 4 to 6 hours in case of no significant dysmenorrhoea pain relief. 1. The acupuncture protocol used consisted of 6 acupuncture points per session. Needles were inserted in the following order: Qi Hai (Ren 6), Zhong Ji (Ren 3), and both sides of Di Ji (SP 8) and San Yin Jiao (SP 6). 6 sterile acupuncture needles (size 0.25 × 40 mm) were inserted into each point to the appropriate depth to achieve DeQi, and the needles were retained for 20 minutes without any needle stimulation. The acupuncture treatment was initiated on the 10th day after the first day of the LMP of each menstrual cycle and was repeated for 3 consecutive cycles. During each cycle, the participants were treated 3 times a week for 2 weeks to ensure that 6 sessions of acupuncture treatment were accomplished before the initiation of the next menstrual period.18 acupuncture sessions were scheduled during the 3 menstrual cycles. Acupuncture treatment was performed by a certified acupuncturist who was experienced in gynaecological diseases. 2. The COC group participants were treated with a daily monophasic COC containing 20 mg ethinyl estradiol and 150 mg desogestrel. They were instructed to take the first pill within 5 days after the first day of their LMP and continue taking 1 pill every day for 3 cycles. A pill count was conducted at every follow‐up visit to assess compliance. | | | Outcomes | Assessments by: 10‐point VRS to assess pain, 0 no pain, 10 maximal pain. Number of days experiencing dysmenorrhoea. Use of rescue medication. QoL SF36 multidimensional scoring system to assess ability to work, systemic symptoms and use of analgesics. Grade 0, menstruation not painful and daily life activity unaffected; Grade 1, menstruation painful but seldom inhibiting normal activity, analgesics seldom required, and mild pain; Grade 2, daily activity affected, analgesics required and giving sufficient relief so that absence from school is unusual, and moderate pain; Grade 3, activity clearly inhibited, poor effect of analgesics, vegetative symptoms such as headache, fatigue, vomiting, and diarrhoea, and severe pain. Menstrual symptoms, and use of additional medication measured as a change from baseline to end of intervention at 3 months. Pain scores measured at the end of the intervention; 3‐month data supplied by researcher. SF36 scores reported at the end of treatment at 3 months | | | Notes | Country: Thailand. Setting: Community Study duration: January 2014 ‐ February 2014. ITT mentioned and undertaken Power analysis:undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated | | Allocation concealment (selection bias) | Low risk | Sealed envelope | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding of participants and blinding status of analyst not reported. The outcome or outcome measurement is likely to be influenced by lack of blinding. | | Incomplete outcome data (attrition bias) All outcomes | High risk | Reason for missing outcome data likely to be related to true outcome, with an imbalance in reasons for missing data across intervention groups; acupuncture: 6 personal reasons, 3 lost to follow‐up. CoC 1 due to ineffectiveness | | Selective reporting (reporting bias) | Unclear risk | Protocol not available | | Other bias | Unclear risk | No other sources of bias identified. | Sun 2011. | Methods | Parallel RCT of acupuncture, a warming needle with moxibustion and no treatment. | | | Participants | 90 women randomised to the trial, 30 in each group. Diagnosis made by pelvic examination. | | | Interventions | Duration 4 menstrual cycles. Treatment frequency: 1st cycle: start treatment on first day of dysmenorrhoea when VAS ≥ 40 mm to observe the timeliness of the analgesic effect of acupuncture. 2nd, 3rd and 4th cycles: start treatment 3 days before menses, once per day for 3 days until day of menses. Acupuncture: main point SP6, BL26, with additional points based on TCM diagnosis 1. Stasis = Ciliao BL32, Xuehai SP10. 2. Alpine stagnate dysmenorrhoea = Yinglingquan SP9, Diji SP8. 3. Qi deficiency = Zusanli ST36, Qihai CV6. 4. Liver and kidney loss syndrome = Ganshu BL18, Shenshu BL23 Between 3 ‐ 11 points selected at each treatment. Needle stimulation 30 minutes. DeQi obtained after a further 10 minutes following needles insertion. Acupuncture needle with moxibustion. Main points: Shenque CV8, Guanyuan BL26, Sanyinjiao SP6. Additional points for participants with: 1. Stasis = Ciliao BL32, Xuehai SP10. 2. Alpine stagnate dysmenorrhoea = Yinglingquan SP9, Diji SP8.3. Qi deficiency = Zusanli ST36, Qihai CV6. 4. Liver and kidney loss syndrome = Ganshu BL18, Shenshu BL23 3 ‐ 11 points selected. Needle duration 30 minutes. Frequency of treatment: For Shenque CV8, 10 minutes after each time needle inserted (for 30 minutes) until skin flushes. For the remaining acupuncture points, 10 minutes after each time needle inserted (for 30 minutes) until there is significant soreness at site of needle insertion. Control: No treatment | | | Outcomes | Pain relief measured by VAS measured during acupuncture treatment, also includes overall improvement in menstrual pain. RSS: evaluated on total frequency (in terms of duration) of symptoms of dysmenorrhoea, on severity (in terms of effect on daily life) of symptoms of dysmenorrhoea. . Evaluation criteria for total frequency of symptoms of dysmenorrhoea: 0 points: none 1 point: for < 3 hours 2 points: for 3 ‐ 7 hours 3 points: for a whole day 4 points: for a few days Evaluation criteria for severity of symptoms of dysmenorrhoea: 0 points: no feeling 1 point: mild (mild symptom, does not quite affect normal lifestyle) 2 points: moderate (appreciable/obvious symptoms, affects normal lifestyle) 3 points: severe (symptom more severe, severely affects lifestyle) | | | Notes | Country: China Language: Chinese ITT not reported | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Randomised on case number | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding and the outcome or outcome measurement is likely to be influenced by lack of blinding. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for missing outcome data unlikely to be related to true outcome. 4 from intervention group, 2 from acupuncture group, 2 from control group dropped out mainly due to personal reasons and loss to follow‐up. | | Selective reporting (reporting bias) | Low risk | The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were prespecified in the thesis. | | Other bias | Low risk | The study appears free of other sources of bias. | Wang 2013b. | Methods | RCT of manual acupuncture compared with NSAIDs | | | Participants | 90 undergraduate women with period pain, 30 women in each group. | | | Interventions | 2 treatment groups: Wrist ankle acupuncture of Xia 1 (lower 1) and Xia 2 (lower 2) This is for another acupuncture point system known as wrist and ankle acupuncture, totally 6 in wrist (Shang 1(upper 1) ‐ Shang 6 (upper 6), and another 6 in ankle (Xia1(lower1) ‐ Xia 6 (lower6)), and (2) stimulation of SP6 and CV4. Treatment began 3 days before menstruation, once a day until pain was relieved. Treatment was administered over 3 months. Control group: ibuprofen (no further details given). | | | Outcomes | Pain severity assessed by a VAS at the end of the intervention. | | | Notes | Location China Setting: Hospital in Beijing ITT not reported. The 2 acupuncture groups were combined for the analysis. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number tables | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding, and the outcome measurement could have been influenced by a lack of blinding. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | Atrition for 5 women, 3 from the 2 acupuncture groups, and 2 from the control. Reasons not specified | | Selective reporting (reporting bias) | Low risk | The study protocol was not available but the report includes the expected outcomes. | | Other bias | Low risk | No apparent sources of bias | Wang 2005b. | Methods | Parallel RCT of manual acupuncture versus medication. | | | Participants | 58 women randomised to the trial; participants were student from University clinic. 30 women in the acupuncture group and 28 in the medication group. No details reported on diagnosis. | | | Interventions | Acupuncture: Ear manual acupuncture: internal reproductive, endocrine, liver and kidney correspondent sections on the ear were chosen. If TCM pattern was Qi and blood stasis, plus Erzhong correspondent section on the ear; If TCM pattern was cold and damp stagnation, plus spleen and Sanjiao correspondent sections on the ear; If TCM pattern was damp heat stagnation, plus Erjian and adrenal gland correspondent sections on the ear; If TCM pattern was Qi and blood deficiency, plus spleen and stomach correspondent sections on the ear; If TCM pattern was liver and kidney deficiency, plus subcortex correspondent section on the ear; If the pain was getting worse, plus Shenmen, sympathetic nervous correspondent sections on the ear; If the participants had low back pain, plus lumbar sacral correspondent sections on the ear. Ear acupuncture was done daily and started from 3 days before menstrual cycle. The treatment ceased 3 days after the cycle. The needles were retained for 20 minutes and applied with medium‐level manipulation every 10 minutes. During non‐period time, herbal sticker (made of herb Wang Bu Liu Xin) was applied to internal reproductive, endocrine, liver and kidney correspondent sections on the ear. Each sticker was kept for 3 days on 1 side alternately. The course of treatment lasted for 3 months. Control: Oral intake 0.25 indomethacin 3 times daily was prescribed. It started when the period pain occurred and ceased after the pain disappeared. The course of treatment lasted for 3 months. | | | Outcomes | Pain reported only as a dichotomous variable: pain relief yes/no. | | | Notes | Country: China Language: Chinese Setting: Guangzhou TCM University ITT not reported and unclear if undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number tables | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding to participant and doctor, not information provided to outcome assessors and statisticians. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting. | Wang 2009a. | Methods | RCT, 2 groups, auricular acupressure compared with placebo adhesive patch. | | | Participants | 74 women aged 18 ‐ 28 years were recruited, 37 randomised to each group. Women had no secondary dysmenorrhoea or other pathology, a serum CA125 level of < 35 mg/dL, onset of primary dysmenorrhoea within 6 months of menses, menstrual pain on 3 occasions within the past 6 months, no history of smoking, not taking over‐the‐counter analgesics, able to speak Chinese or Taiwanese. | | | Interventions | Intervention: 3 auricular acupressure points were used Liver C012, Kidney CO10 and Endocrine CO18. Acupressure was performed using acupressure seeds named Semen vaccariae. Seeds were kept in place by opaque adhesive patch. Control group: plain adhesive patch placed on same point with no seed. Both groups had acupressure. All participants were instructed to massage each point 15 times, 3 times a day for 20 days. Patches were replaced every 5 days. | | | Outcomes | Short form Menstrual Distress Questionnaire, and serum nitrous oxide 20 days post‐baseline.Participants were asked to rate the presence of menstrual symptoms experienced during their most recent menstrual period on a 4‐ point Likert‐type scale, ranging from 1 (no experience of the symptom) to 4 (severe or partially disabling symptoms), assessed 3 hours after completing the intervention. | | | Notes | Country: Taiwan Setting: College Groups comparable at baseline: no differences between groups Loss to follow‐up: 3, 1 treatment, 2 control groups Compliance: not reported ITT: not reported Duration: not reported Funding: not reported | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated | | Allocation concealment (selection bias) | Low risk | Concealed envelopes | | Blinding (performance bias and detection bias) All outcomes | Low risk | Blinding of participants was attempted, with both groups receiving patches. The practitioner was not blind to group allocation, outcome was self report and analysis was undertaken by independent researcher. Double‐blind. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | Data missing on 3 participants. Similar reasons due to time management across groups. | | Selective reporting (reporting bias) | Unclear risk | Study protocol not available. | | Other bias | Unclear risk | Insufficient reporting to judge. | Wang 2014a. | Methods | RCT of acupuncture versus moxibustion versus medication | | | Participants | 93 University students randomised to the study, acupuncture n = 31, moxibustion n = 30, medication n = 32 | | | Interventions | Treatment administered over 3 menstrual cycles. 1. Manual acupuncture: Guanyuan and Sanyinjiao (both sides) were chosen for manual acupuncture. The needles were retained for 30 minutes after DeQi feeling. During the treatment, even reducing and reinforcing acupuncture technique were used. Daily treatment was performed 3 days before menstrual cycle and ceased after the pain disappeared. The course of treatment lasted for 3 menstrual cycles. 2. Moxibustion: Guanyuan and Sanyinjiao (both sides) were chosen for direct manual moxibustion. 10 minutes per point was allocated. Daily treatment was performed 3 days before menstrual cycle and ceased after the pain disappeared. The course of treatment lasted for 3 menstrual cycles. 3. Medication: 0.3 g ibuprofen daily was prescribed. It started from 3 days before menstrual cycle and ceased after the pain disappeared. | | | Outcomes | VAS and an unspecified scale: the Clinical Principle of New Chinese Drug Clinical Research assessed at the end of the intervention. | | | Notes | Country: China Setting: Hebei United University, Herbei Province ITT reported and undertaken. Data from the acupuncture group versus medication were included in the analysis. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number tables | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported | | Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for missing outcome data unlikely to be related to the outcome. 3 post‐randomisation exclusions, 1 acupuncture, 2 medication. | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting | Witt 2008. | Methods | Pragmatic RCT, 2 groups, acupuncture or usual care | | | Participants | 201 women were randomised to the study, 117 of them with primary dysmenorrhoea. Inclusion criteria: aged > 18 years, primary dysmenorrhoea from the onset of menarche, and at least for 12 months. Exclusion criteria: pain caused by inflammatory or malignant disease. It was not stated how secondary dysmenorrhoea was excluded, although data were presented for primary dysmenorrhoea.100 allocated to acupuncture, 101 to usual care. | | | Interventions | Acupuncture was administered over 3 months; participants received a maximum of 15 acupuncture sessions. The trial was undertaken in primary healthcare setting with acupuncture performed by physicians. The trial consisted of a 3‐month treatment intervention, with a 3‐month follow‐up. All women could use any co‐interventions. Each participant received a maximum of 15 acupuncture treatments. Points and numbers of needles selected by physician. The control group was a wait‐list control (but all participants allowed to use any additional conventional treatments they chose). | | | Outcomes | Primary endpoint was average pain intensity measured along numerical rating scale (0 ‐ 10). Responder defined as a reduction of 33%. Secondary outcomes: worst pain intensity, QoL using the SF36, and side effects. Outcomes were measured at 3 months. | | | Notes | Country: Germany Setting: Health insurance fund Funding: social health insurance companies Groups comparable at baseline: imbalance SF36 scores physical functioning, bodily pain and physical component. Loss to follow‐up. Data available at 3 months, 88%, similar for both groups. Compliance: acupuncture mean 10.5 treatments, 15 treatments offered, 27% received more than 10. Duration: January 2001 ‐ August 2001 ITT analysis undertaken | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation sequence | | Allocation concealment (selection bias) | Low risk | Central telephone randomisation procedure | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding and the outcome measure was self‐reported and may be influenced by lack of blinding. No other details reported. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | For the primary outcome of pain after 3 months, the missing data were similar for the intervention and control groups. More control participants did not complete the 6‐month outcome questionnaires. No explanation or reason for dropouts was given at 3 or 6 months. | | Selective reporting (reporting bias) | Unclear risk | Study protocol not available | | Other bias | Low risk | High follow‐up rates, conservative methods to deal with missing data. | Wong 2010. | Methods | Cluster‐RCT of acupressure or no acupressure, 19 allocated to treatment and 21 to control. | | | Participants | Participants: 40 women randomised from 1 class to the intervention, and in another class the control. The criteria for choosing the participants include the following: female students aged 5 on the pain VAS for at least 2 months in the past half year; and have not had any prior history of gynaecological disease, gynaecological surgery, or secondary dysmenorrhoea. Participants who were pregnant, who have used contraceptive pills 6 months prior to the study, and who have used pain medication and other relief measures 6 hours before and during the study period were excluded. | | | Interventions | 3‐month intervention, participants taught to perform the technique twice a day from the first to third days of their menstrual cycle. Pressure applied to SP6 for 20 minutes by the researcher, alternating between each leg at the SP6 acupoint. The SP6 acupoint was pressed using the thumb, and gently and vertically applied to 1 leg for 15 seconds each time and then allowed to rest for 15 seconds. This was repeated 10 times to satisfy a 5‐minute intervention. It was then repeated on the other leg and pressed for another 5 minutes. This completed a 10‐minute cycle, and was repeated twice on both legs until the 20‐minute period of intervention was completed. After the intervention, the Acupressure Teaching Booklet was given to the participants in the acupressure group and they were taught to practice SP6 acupressure at home in order for them to use the technique themselves. A TCM practitioner examined the content validity of the Teaching Booklet. The pressure‐sensing device was also used to train the participants in the acupressure group. It recorded the interface pressure between the participants’ SP6 acupoint and the thumb that pressed on it. The pressure and time can be observed visually on a computer screen. The participants in the acupressure group were required to press successively for at least 15 seconds each time, but the pressure readings could not be seen by the participants until they achieved the correct pressing force 10 times. Participants in the acupressure group were required to perform SP6 acupressure for 20 minutes upon waking and at bedtime during their first 3 days (average duration of menstrual pain) of their next 3 menstrual cycles. Control group: were allowed to rest for 20 minutes accompanied by the researcher in the room with no acupressure intervention. During the first 3 days of their next 3 menstrual cycles, they were required to rest for 20 minutes upon waking and at bedtime. | | | Outcomes | Pain VAS, Short Form McGill Pain Questionnaire, Short Form Menstrual Distress Questionnaire. Undertaken following the intervention, and at 1,2, 3 months follow up. | | | Notes | Country: Hong Kong Setting: University Baseline characteristics: no significant differences between groups. Compliance: not reported Duration: Not reported ITT analysis not undertaken. Correction made in the analysis for a cluster trial. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Unclear risk | Randomisation stated but not reported | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding of participants, outcomes self assessed and no details of blinding status of the analyst. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | 3 post‐randomisation exclusions in the control due to use of other interventions, and 3 in the intervention due to dropout or use of medication. Missing outcome data balanced in numbers across intervention groups, with similar reasons for missing data across groups. | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting to assess | | Other bias | Unclear risk | Insufficient reporting to assess | Xu 2013. | Methods | RCT, 2 groups, acupuncture versus NSAIDs | | | Participants | 45 women, 25 in the acupuncture group and 20 in the NSAIDs group. | | | Interventions | Acupuncture: points SP6, CV4, CV7, CV3, KD12, BL32. Plus LIV3 if Qi and blood stagnation. Point if cold damp stagnation SP8, SP9. Daily treatment starting 7 days before start of period, with no treatment following onset of menstruation. Needles retained for 30 minutes following sensation of DeQi. Control group: no treatment unless VAS pain score was > 8, then 0.3 g ibuprofen prescribed; maximum daily dose was 0.6 g. | | | Outcomes | Pain severity (VAS) over 3 cycles, and follow‐up at the fourth and sixth cycles. Overall improvement in menstrual symptoms using the RSS assessed at the end of the intervention. | | | Notes | Country: China Setting: Beijing Hospital Groups at baseline unclear Compliance: not reported Duration: 3‐month intervention and 3‐month follow‐up ITT not reported Funding not reported | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number tables | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | Insufficient data to make a judgement | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Unclear risk | Insufficient data reported | | Other bias | Unclear risk | Insufficient data reported | Xu 2014. | Methods | RCT of manual acupuncture versus no treatment | | | Participants | 96 women participated in the study, 48 in each group. | | | Interventions | Manual acupuncture: Yinjiao, Guanyuan, Zhongji, Dahe, Ciliao (both sides), Sanyinjiao (both sides) were chosen for manual acupuncture. The needles were inserted perpendicularly and retained for 30 minutes after DeQi feeling. During the treatment, even reducing and reinforcing acupuncture technique were used. Daily treatment was performed 7 days prior to menstrual cycle and ceased on the first day of period. The course of treatment lasted for 3 menstrual cycles. No treatment provided for the 6 months. 0.3 g ibuprofen was prescribed if pain not bearable, or VAS ≥ 8. Maximum daily dosage was controlled under 0.6 g. | | | Outcomes | Pain measured by VAS, and overall improvement in symptoms monthly during intervention, and 4 ‐ 6 months of follow‐up. Data reported at 3 months. | | | Notes | Country: China Language: Chinese Setting: TCM hospital in Ping Gu District, Beijing | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number table | | Allocation concealment (selection bias) | Unclear risk | Insufficient reporting | | Blinding (performance bias and detection bias) All outcomes | High risk | Participants and clinicians were not blinded. No details reported regarding outcome assessment and analyst. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting | Yeh 2013a. | Methods | Single‐blind RCT of auricular acupressure versus sham acupressure | | | Participants | Community study of 113 adolescent girls from Taiwan, 59 acupuncture, 54 control. | | | Interventions | The experimental group received auricular acupressure applied to 6 true acupoints (shenmen, Kidney, Liver, Internal Genitals, Central Rim, and Endocrine). The control group received 6 sham acupoints without effects on dysmenorrhoea. All participants were instructed to press each acupoint for 1 minute, 4 times a day for 2 days. Adhesive plasters were used to stick seeds to the ear. Seeds were removed after 48 hours. | | | Outcomes | Pain severity measured along the VAS, Short Form McGill Pain Questionnaire, menstrual Distress questionnaire assessed at the end of the 2‐day intervention | | | Notes | Country: Taiwan Setting: High School Groups: comparable at baseline. Compliance: not stated ITT not reported. Duration: not reported. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Coin tossing | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | 1 researcher knew the code but it was unclear who. Assessment of blinding: single‐blind but unclear of integrity of blinding of women, and who in the research team was unblinded. | | Incomplete outcome data (attrition bias) All outcomes | High risk | 13 failed to complete the post‐intervention evaluation process (9 in the experimental and 4 in the control group). Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups; over double the dropouts in experimental vs control group. Attrition rate 11%. No reasons were given. | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting | Youn 2008. | Methods | RCT of acupuncture versus minimal acupuncture | | | Participants | 80 women with dysmenorrhoea but no details of how diagnosis was confirmed.80 randomised, details of allocation to groups unclear. | | | Interventions | Duration of intervention: administered over 3 menstrual cycles Acupuncture: 6 set points, GB41, SI3, SI2, SP6, REN6, and either ST36 or LI2 depending on symptoms, needles inserted for 20 minutes, to a depth of 3 mm. 8 treatments given 7 ‐ 10 days apart. Minimal acupuncture: 5 non‐acupuncture points given having no relation to effects on dysmenorrhoea, treatment frequency and duration the same as treatment group. | | | Outcomes | Pain measurement using MMP, a continuous scale. Overall symptom improvement measured by MSSL, a continuous scale. | | | Notes | Country: Korea Setting: Hospital ITT analysis not mentioned and not undertaken. 25 available for analysis in treatment and 22 in control groups. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐numbers table | | Allocation concealment (selection bias) | Unclear risk | No information reported | | Blinding (performance bias and detection bias) All outcomes | High risk | Only the participants were reported as being blinded. | | Incomplete outcome data (attrition bias) All outcomes | High risk | 30 excluded from analysis. 10 dropped out, 8 with disease, 15 no reason stated. Not reported by group. | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting | Yu 2014. | Methods | RCT of acupuncture versus wait list, 96 randomised, 48 to each group. | | | Participants | Women were recruited from an obstetrics and gynaecological clinic, with a mean age of 23 (SD 1). | | | Interventions | Acupuncture: Manual acupuncture administered 7 days before the period, once each day, until deqi obtained. Acupoints were Yinjiao, Guanyuan, Zhong ji, Dahe, Ciliao (both sides), Sanyin jiao (both sides); For qi stagnation and blood stasis, added Taichong, Xue hai; Cold‐damp added Diji, Yinlingquan. Needle: 0.25 mm 30 ˜ 40 mm. retention for 30 minutes after needling Treatment stopped when period started. Treatment over 3 menstrual cycles. When the pain was strong, or VAS ≥ 8, prescribed ibuprofen, 1 tablet each time, maximum 2 tablets each day. Control: wait list for 6 months, from month 7 ‐ 9 received the same acupuncture as intervention group. When the pain was strong, or VAS ≥ 8, prescribed ibuprofen, 1 tablet each time, maximum 2 tablets each day. | | | Outcomes | VRS of the impact of pain on daily living. RSS describing menstrual symptoms. | | | Notes | Country: China Setting: Hospital, Beijing Duration : 6 months ITT: not reported. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number table | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding or incomplete blinding, and the outcome or outcome measurement is likely to be influenced by lack of blinding; participants were not blinded and the researchers only mentioned that they would avoid telling participants about the allocation. No other details reported. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses | | Selective reporting (reporting bias) | Unclear risk | The study protocol is not available | | Other bias | Low risk | The study appears free of bias | Zafari 2011. | Methods | RCT, parallel design of fish oils versus acupressure (n = 60) versus ibuprofen (n = 76) | | | Participants | 196 Iranian college students from the University of Mazandaran aged 18 ‐ 22 years, with regular menstruation, menstrual pain in the majority of cycles in the last 6 months, and described as severe or moderate pain. | | | Interventions | Treatment was administered over 3 menstrual cycles. The first cycle was monitoring only. The first group received the daily dosage of 1 g of fish oil. This capsule is gelatin form and yellow colour. It contains polyunsaturated fat (1 g), saturated fat (1 g), EPA (180 mg) and DHA (120 mg) over 2 months. A second group received 400 mg of ibuprofen to be taken as soon as the pain started, and repeated 8 hours later if the pain persisted. The third group received acupressure using point SP6. Students were trained to apply pressure to SP6 for 6 seconds, release the pressure for 2 seconds and then reapply. This continued for 5 minutes after which they applied pressure to the other leg for the same pattern of stimulation. Pressure was applied for a total of 20 minutes. | | | Outcomes | Severity and duration of pain, participant satisfaction, and use of sedatives at the end of the intervention. No instruments reported. | | | Notes | Country: Iran Setting: College Groups comparable at baseline: no differences in demographics and pain reported. Compliance: The student was interviewed once a week to check on correct administration of the treatments. ITT: not stated Duration: not reported A pairwise analysis was undertaken with the inclusion of the 2 control groups. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Unclear risk | Not reported | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | No participants were blind to their group allocation. No other details were reported on blinding. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | High risk | Some secondary outcomes were not fully reported | | Other bias | Unclear risk | Not reported | Zhang 2012. | Methods | Parallel RCT of manual acupuncture compared with pharmacological treatment | | | Participants | 90 women randomised to the study, 45 in each group. Age range 11 ‐ 27 years was specified as the inclusion criterion. | | | Interventions | The treatment started when period pain occurred and continued for 3 days. The needles were manipulated every 5 minutes and retained for 30 minutes. TCM pattern: Qi and blood stasis, Xuehai, Taichong, Hegu, Sanyinjiao, Ashi points were chosen. The needles were inserted perpendicularly about 1 cun. Strong reducing acupuncture technique was applied once DeQi had arrived. If TCM pattern was cold and damp stagnation, Guanyuan, Diji, Sanyinjiao, Ashi points were chosen. The needles were inserted perpendicularly about 1 cun. Strong reducing acupuncture technique was applied to Diji, Sanyinjiao and Ashi points once DeQi had arrived. Guanyuan was applied with strong reinforcing technique once Deqi happened. If TCM pattern was damp heat in the liver, Hegu, Taichong, Sanyinjiao, Ashi points were chosen. Strong reducing acupuncture technique was applied once DeQi had arrived. If TCM pattern was Qi and blood deficiency, Qihai, Xuehai, Zusanli, Xuanzhong, Ashi points were chosen. Strong reinforcing acupuncture technique was applied once DeQi had arrived. If TCM pattern was liver and kidney deficiency, Ganshu, Shenshu, Taixi, Taichong, Ashi points were chosen. Strong reinforcing acupuncture technique was applied once DeQi had arrived. Control group: indomethacin was prescribed 3 times a day for 3 days. Each time dosage was 25 mg. | | | Outcomes | Pain reported as dichotomous variable, relating to improvement or no improvement. | | | Notes | Country: China Setting: Hospital clinic Duration: 3‐month intervention Baseline comparability: not reported Funding: not reported | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number table | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants were not blinded to group allocation. No other details reported. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Unclear risk | Insufficient data reported to allow judgement to be made | | Other bias | Unclear risk | Insufficient reporting | Zhang 2013a. | Methods | RCT, parallel design of acupuncture versus diclofenac | | | Participants | 60 women aged 16 ‐ 47 years recruited from a community clinic, 30 in each group. Exclusion history of PID. Women presented with patterns of Qi and blood stagnation, Qi and blood deficiency, retention of heat and dampness, Kidney and Liver deficiency, retention of cold and dampness. | | | Interventions | Acupuncture: core points SP10, SP8, LIV8, KID3, SP15, SP14, KID 14, SP6. SP9. Additional points: stagnation of Qi and Blood LIV 3. Qi and Blood deficiency: LIV13. Retention of heat and dampness: LIV2. Liver/Kidney deficiency:KD6. Needles inserted to a depth 0.5 cun. duration of needling 30 minutes, moxa was administered for 5 minutes for cold patterns. Treatment began 3 days prior to expected menstruation. Treatment duration up to 10 days. Control group: oral administration of diclofenac with the onset of period pain, 0.1 mg daily. | | | Outcomes | Pain score and dichotomous measures of treatment effect measured at the end of the intervention | | | Notes | Country: China. Possibility of effects from treatments administered prior to trial may not have washed out Groups comparable at baseline: not reported. Compliance: not reported ITT not stated Durations: 3 cycles, with 3‐month follow‐up | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Lot drawing | | Allocation concealment (selection bias) | Unclear risk | Not reported | | Blinding (performance bias and detection bias) All outcomes | High risk | No blinding and the outcome is likely to be influenced by a lack of blinding. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data | | Selective reporting (reporting bias) | Unclear risk | Study protocol not available | | Other bias | Unclear risk | Insufficient information reported to allow assessment | Zhang 2013b. | Methods | RCT, manual acupuncture versus no treatment. 2 groups of acupuncture: 1 administered acupuncture before period arrived and the second group administered treatment once period arrived. 90 randomised, 30 women in each group. | | | Participants | 90 women recruited from the hospital TCM clinic | | | Interventions | Treatment group 1: Daily acupuncture on Shiqizhui (EX‐B8) started 3 ‐ 7 days before menstrual cycle. Treatment ceased on the day of period arrival. Total of 3 consecutive treatments were performed. Treatment group 2: Daily acupuncture on Shiqizhui (EX‐B8) started on the day when period pain occurred. Treatment ceased when the pain disappeared. Total of 3 consecutive treatments were performed. Method: Performing reducing acupuncture technique in Shiqizhui (EX‐B8) after DeQ i feeling. Needles were manipulated 30 seconds for every 10 minutes. The needles were retained in the point for 30 minutes. Control: no treatment | | | Outcomes | VAS to measure pain and continuous scales to measure overall improvement, Outcome assessed at 1, 2, 3 months (end of intervention), and follow‐up at 4, 5, 6 months. | | | Notes | Country: China Language: Chinese Setting: Hospital in Shangdong province Study duration: Total study duration 3months plus 2 months follow‐up on treatment groups. ITT mentioned and undertaken For the analysis we combined treatment groups 1 and 2. | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Random‐number table | | Allocation concealment (selection bias) | Unclear risk | Insufficient reporting | | Blinding (performance bias and detection bias) All outcomes | Unclear risk | No blinding was performed in participants and doctors. Not mentioned for outcome assessors and statisticians. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | Post‐randomisation exclusions group 1 = 2, group 2 = 3, group 3 = 1.Reasons for missing outcome data unlikely to be related to true outcome. | | Selective reporting (reporting bias) | Unclear risk | Insufficient reporting | | Other bias | Unclear risk | Insufficient reporting | Zhi 2007. | Methods | RCT, parallel design, 3 groups: 1) electro‐acupuncture; 2) superficial acupuncture; 3) control medication ibuprofen. | | | Participants | 171 women were recruited, 57 to each group. Women were required to meet a TCM diagnosis of blood stasis, or Qi stagnation. Women were required to have a diagnosis of primary dysmenorrhoea, with pain occurring in 3 consecutive menstrual cycles, affecting women's work or lifestyle and requiring treatment. Women were excluded if they had a current psychotic condition, liver or kidney function impairments, circulation conditions, infectious diseases, currently taking other medications that interact with the trial medications, or in the last 2 weeks having taken other medications such as anti‐inflammatories. | | | Interventions | Women received the first treatment on the first day of the cycle, thereafter treatment began 3 days before the start of the cycle. This was continued for 3 menstrual cycles. Women who received superficial acupuncture (SA) received acupuncture bilateral stimulation to point SP6 only. Needles 0.60 mm x 32 mm were used. Needles were positioned at 15 ‐ 25° and inserted at a rapid speed, the needles are inserted to the needle length of 30 mm, and the manipulating left and right in a 15° fan shape for 3 ‐ 6 times. The needle was removed leaving a soft cover subdermal with the base exposed. The point of insertion was then covered and secured with a sterilised bandage. For women receiving electrostimulation the position, point location, insertion method, manipulation method were identical to SA group. The needle was then pulled out 3 ‐ 4 mm, and connected to electro‐stimulation machines model G 6805‐2 A type (manufactured by Shanghai Medical Electrical Equipment Company), using alternating frequency (long frequency rate 60Hz, 2.5 sec, continuous frequency 60 Hz, 5 sec), voltage at 2 ‐ 3 V (or until participant can feel it), the machine was turned on for 30 minutes. Needles were then removed, leaving the soft cover subdermal, with a sterilised bandage used to cover the exposed needle base. Control group: women allocated to the medication group took oral 0.3 mg ibuprofen sustained‐release capsule (manufactured by Tianjin Pharmaceutical), twice a day for 3 days; then 3 days before the subsequent cycle (based on basal body temperature increase for 12 days), and for 2 days into cycle, continue for the third month. | | | Outcomes | Self‐report assessment of the severity of pain and menstrual‐related symptoms. Abdominal pain was assessed before, during and after the menstrual cycles. Other assessments made of fainting, pale complexion, cold sweats, cold extremities, requiring bed rest, affects work/study, effect of usual pain relief, back ache, nausea. These items were then assessed as recently cured, marked effect, or no effect. Measured at the end of the intervention. | | | Notes | Country: China Setting: Gynaecology hospital department, Jiaozuo Groups comparable at baseline: no differences in small number of variables reported. Loss to follow‐up: 1 woman from superficial acupuncture dropped out and 3 from the medication group. Compliance: not stated ITT not reported Duration: September 2004 ‐ May 2006 Funding: not reported | | | Risk of bias | || | Bias | Authors' judgement | Support for judgement | | Random sequence generation (selection bias) | Low risk | Computer‐generated list | | Allocation concealment (selection bias) | Unclear risk | No details reported | | Blinding (performance bias and detection bias) All outcomes | High risk | Participants were not blinded to their group allocation. No other details were reported. | | Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 woman from the electro group, 2 from superficial acupuncture, 1 from medication failed to follow up. The risk was not enough to have clinically relevant impact on the intervention effect estimate. | | Selective reporting (reporting bias) | Unclear risk | Insufficient information to permit judgement | | Other bias | Unclear risk | Insufficient information to assess | EA: electro‐acupuncture ITT: intention‐to‐treat IUD: intra‐uterine device LMP: last menstrual period MMP: measure of menstrual pain MSSL: menstrual symptoms severity list NRS: numeric rating scale NSAID: non‐steroidal anti‐inflammatory drug PGF₂α: prostaglandin F2alpha PID: pelvic inflammatory disease QoL: quality of life RCT: randomised controlled trial RSS: retrospective symptom scale TCM: traditional Chinese medicine VAS: visual analogue scale VMSS: verbal multidimensional scoring system VRS: verbal rating scale Characteristics of excluded studies [ordered by study ID] | Study | Reason for exclusion | |---|---| | Bing 2011 | Quasi‐randomised controlled trial | | Chao 2012 | The trial uses point injection which did not meet our inclusion criteria. | | Chao 2014 | The trial uses point injection which did not meet our inclusion criteria. | | Chen 2008 | We were unable to confirm any details of randomisation. | | Chen 2011 | The trial evaluated single stimulation of acupuncture compared with a group receiving multi‐stimulation from several acupuncture points. | | Chen 2014 | We were unable to confirm any details of randomisation. | | Gao 2014a | We were unable to confirm any details on randomisation. | | Gao 2014b | We were unable to confirm any details of randomisation. | | Geng 2008 | The study evaluated the use of acupuncture plus Chinese herbs and did not meet our inclusion criteria. | | Gharloghi 2012 | The trial included an active control of acupressure. | | Guo 2008 | The trial evaluated acupuncture plus Tui Na compared with acupuncture alone as an alternate treatment. | | Habek 2003 | We were unable to confirm any details of randomisation. | | He 2005 | This trial evaluated acupuncture plus moxibustion and did not meet our inclusion criteria. | | Hu 2011 | Women less than 15 years were included in the trial, and therefore met our exclusion criteria. | | Hu 2014 | We were unable to confirm any details of randomisation. | | Huang 2013 | The trial compared acupuncture to an alternative acupuncture treatment group and was non‐randomised. | | Huyou‐Ping 2013 | The trial compared acupuncture to an alternative acupuncture treatment group and did not meet our inclusion criteria. | | Jiang 2007 | Quasi‐randomised | | Jun 2007 | The trial used quasi‐randomisation and did not meet our inclusion criteria. | | Jun 2004 | The trial used quasi‐randomisation and did not meet our inclusion criteria. | | Kempf 2009 | The trial evaluated the use of laser acupuncture and did not meet the eligibility criteria. | | Kim 2011 | The trial reported no clinically relevant outcomes. | | Kiran 2013 | Quasi‐randomised | | Li 2006 | The trial evaluated the effect of moxibustion as the sole active intervention on acupuncture points and did not meet the inclusion criteria. | | Li 2007 | The trial evaluated acupuncture plus a herbal plaster and did not meet our inclusion criteria. | | Li 2011 | The trial evaluated single stimulation of acupuncture compared with a group receiving multi‐stimulation from several acupuncture points. | | Li 2012a | The trial compared acupuncture and moxibustion combined with cupping and did not meet our inclusion criteria. | | Lin 2008 | The study was non‐randomised. | | Liu 2005 | The trial injected vitamin K3 into the acupuncture point, which did not meet the inclusion criteria. | | Liu 2014a | The control group did not meet our criteria, with comparison with active points or active acupuncture stimulation. | | Liu 2014b | We were unable to confirm any details of randomisation. | | Lui 1999 | The control group did not meet our criteria for the control group. | | Luo 2014 | We were unable to confirm any details of randomisation. | | Mahoney 1993 | The study was non‐randomised. | | Miao 2014 | The trial examined electro‐acupuncture plus herbal medicine and did not meet the inclusion criteria. | | Pouresmail 2002 | We were unable to confirm details of randomisation from the author. | | Pu 2011 | We attempted to contact the author to establish if the study was randomised. Contact was not successful. We were unable to confirm the study was randomised. | | Reyes‐Campos 2013 | The trial was not randomised. | | Ro 2013 | The study was excluded because it was a pre‐test post‐test design. | | She 2008 | We were unable to confirm details of randomisation from the author. | | Shi 1994 | We were unable to obtain details from the author on the methods of concealment and allocation of randomisation. | | Song 1992 | We were unable to obtain details from the author on the methods of concealment and allocation of randomisation. | | Sun 2004 | This trial examined moxibustion to the acupuncture point. | | Sun 2008 | This trial examined moxibustion to the acupuncture point. | | Wang 2002 | Data reporting was incomplete and we were unable to obtain details from the author regarding randomisation. | | Wang 2005a | This examined the effect of moxibustion to the acupuncture point. | | Wang 2009b | Following translation, we found this study to be an intervention evaluating moxibustion, not acupuncture. | | Wang 2013a | The study was non‐randomised. | | Wang 2014b | We were unable to confirm any details of randomisation. | | Wu 2007 | Quasi‐randomised | | Xie 2003 | The trial compared acupuncture to an alternative acupuncture treatment group. | | Xiong 2012 | The trial evaluated single stimulation of acupuncture compared with a group receiving multi‐stimulation from several acupuncture points. | | Yang 2008a | This trial evaluated moxibustion and did not meet our inclusion criteria. | | Yang 2014 | We were unable to confirm any details of randomisation. | | Yeh 2013 | The study was non‐randomised. | | Yi 2005 | The trial evaluated acupuncture plus massage and did not meet our inclusion criteria. | | Yu 2010 | No clinically relevant outcomes reported, and the control group used an active acupuncture intervention. | | Yuk 2005 | Non‐randomised study. | | Zhang 2004 | The study did not meet our inclusion criteria. | | Zhang 2014 | We were unable to confirm any details of randomisation. | | Zheng 2006 | We were unable to obtain details from the author on the methods of concealment and allocation of randomisation. | | Zheng 2014 | We were unable to confirm any details of randomisation. | | Zhou 2003 | We were unable to obtain details from the author on the methods of concealment and allocation of randomisation. | | Zhou 2014 | We were unable to confirm any details of randomisation. | Characteristics of studies awaiting assessment [ordered by study ID] Han 2015. | Methods | Paper requiring translation | | Participants | | | Interventions | | | Outcomes | | | Notes | Zhang 2003. | Methods | No further details available | | Participants | | | Interventions | | | Outcomes | | | Notes | Characteristics of ongoing studies [ordered by study ID] Armour 2013. | Trial name or title | Acupuncture primary dysmenorrhoea: examining the role of frequency of treatment and mode of stimulation on clinical outcomes | | Methods | Randomised controlled trial | | Participants | 74 women. Age 18 ‐ 45 years. Women with confirmed primary dysmenorrhoea, pain > 3 on a pain scale, regular menstrual cycles. | | Interventions | Manual acupuncture provided by manual stimulation administered once a week starting the week after menses and then once in the first days of the menstrual cycle for 3 cycles versus manual acupuncture delivered 3 times in the week prior to menses, and then once in the first 2 days of menstruation, versus electro‐acupuncture once a week after menses and then for the first 2 days of menses, versus electro‐acupuncture 3 times in the week prior to menses and then in the first 2 days of the period. | | Outcomes | Pain intensity, duration of pain, quality of life, pain relief, participant satisfaction | | Starting date | May 2013 | | Contact information | Mike Armour: [email protected] | | Notes | Recruitment complete | Huang 2010. | Trial name or title | Randomised controlled trial of acupuncture for dysmenorrhoea | | Methods | Randomised controlled trial | | Participants | Sample size: 22 women aged > 13 years who are not pregnant and meet either of the following 2 criteria: 1. Suffering from dysmenorrhoea in recent 3 menstrual periods; 2. Dysmenorrhoea with poor response to non‐steroid anti‐inflammation drugs | | Interventions | Acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed up for another 2 months versus usual care with medication and behaviour therapy for 2 months, followed by acupuncture for additional 2 months. | | Outcomes | Pain score, quality of life, use of medication, impact on daily living activities, safety | | Starting date | May 2010 | | Contact information | Chien‐Hsun Huan, National Taiwan University Hospital Yun‐Lin Branch, Yun‐Lin, Taiwan, 640 | | Notes | The study is complete | Witt 2012. | Trial name or title | Effectiveness of additional self‐care acupressure for women with menstrual pain compared to usual care | | Methods | Randomised controlled trial | | Participants | 220 women. Age 18 ‐ 25 years. Women with menstrual pain every cycle, no history of gynaecological disease that could be a reason for dysmenorrhoea. Moderate to severe pain | | Interventions | Self‐care acupressure at 3 predefined points starting 5 days before menstruation, applying 1 minute for each point, once to twice daily, when pain is present 2 to 5 times daily. | | Outcomes | Mean pain intensity, worst pain intensity, duration of pain, responder rate defined as 50% pain reduction, sick leave, adverse events, self efficacy | | Starting date | December 2012 | | Contact information | Claudia Witt: [email protected] | | Notes | Recruiting | Contributions of authors Caroline Smith conceptualised and wrote the protocol and systematic review: she reviewed the trials, performed data extraction and wrote the review. Caroline Smith is the guarantor of the review. Mike Armour undertook the search, performed data extraction, contributed to writing of the review. Xiaoshu Zhu undertook review of the trials, performed data extraction, and commented on the review. Xun Li undertook a search of the Chinese databases, retrieved papers, undertook translations from Chinese to English, performed data extraction and commented on the review. Zhi Lu undertook translations from Chinese to English, performed data extraction and commented on the review. Jing Song commented on the protocol and review, undertook data extraction and contributed to data interpretation. Sources of support Internal sources - Caroline Smith, Australia. National Institute of Complementary Medicine, Western Sydney University - Xiao Zhu, Australia. National Institute of Complementary Medicine Western Sydney University - Jing Song, Australia. Campbelltown and Camden Hospitals External sources No sources of support supplied Declarations of interest CS recently completed a randomised controlled trial of acupuncture to treat primary dysmenorrhoea. MA recently completed a randomised controlled trial of acupuncture to treat primary dysmenorrhoea. XZ, XL, ZL and JS have no conflicts of interest.. New search for studies and content updated (no change to conclusions)

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