In addition, all outcomes were downgraded in the imprecision domain, due to small sample size that was far from optimal information size. The objective of this review was to summarize and evaluate acupuncture treatment to improve ovulation and menstruation rates and other hormonal changes, in women with PCOS. We found a low level of evidence that acupuncture is more likely to improve ovulation and menstruation rates compared to not receiving acupuncture.
When compared with metformin, acupuncture improves menstruation rates but the level of evidence is also low. To date the evidence on acupuncture for PCOS remains largely inconclusive as the studies we reviewed tested different acupuncture protocols against various control types and the reported outcomes varied greatly.
Acupuncture seems to be associated with few adverse events. Reported adverse events, such as needling pain, were mild and transient; there were no serious adverse events leading to withdrawals from the study. The included studies poorly addressed ovulation and menstruation rates, the primary outcomes in our review. We found that acupuncture significantly improved monthly menstrual rates in comparison with no treatment or medication only, while ovulation rates were significantly improved by acupuncture only when it was compared with no treatment, but not with sham acupuncture.
There may be 2 different interpretations for this. Acupuncture works mainly via a placebo effect [ 46 ] ; or the adopted sham acupuncture control may not be completely inert. The optimal acupuncture treatment is a complex issue involving a range of contributing factors, [ 48 ] for example, number of sessions, acupoint specificity and selection, stimulation methods, and the practitioner's expertise.
In the study comparing acupuncture with a sham control where no difference was detected in ovulation rates, [ 44 ] women received 12 acupuncture sessions over 8 weeks and the needle placement and stimulation was identical in both true and sham acupuncture groups. In another study, [ 10 ] where needles were placed similarly as in the previous study, [ 44 ] women received acupuncture twice weekly during the study period, thus an increased dose of acupuncture treatment was tested.
Women allocated to the acupuncture group had a higher ovulation frequency compared with the no treatment group, indicating a dose—response effect as well as an augmented acupuncture effect. This suggests that different acupuncture doses exert different treatment effects, and therefore, exploring the optimal acupuncture treatment intervention for PCOS should be preconditions of any future trials.
Neuroendocrinological mechanisms of acupuncture have been extensively studied not only in pain research [ 49 , 50 ] but also in reproductive medicine.
The pooled data showed that acupuncture significantly increased pregnancy rates when added to medication compared to medication alone. However, as the definition of pregnancy ie, clinical pregnancy determined by ultrasound was not uniform across studies, this finding needs to be confirmed in future trials with clearly defined outcome measures. Regarding safety, 11 of 27 studies reported adverse events such as mild bleeding and pain at the site of needling, fatigue, dizziness, and short-term nausea; however, it appears that these occur less frequently when compared with the medication groups.
Additionally, 2 trials reported that when acupuncture was added, it reduced adverse events associated with CC [ 22 ] or metformin. We acknowledge that there are recently published systematic reviews and meta-analyses. The reasons for these discrepancies may arise from the different search strategies, data extraction, and analysis method.
Consistent with other systematic reviews on acupuncture, a big limitation of this report lies in the clinical and methodological diversity of the included studies. PCOS itself is also heterogeneous by nature in terms of clinical and biochemical features. The PCOS phenotypic variability among participating women may have created a variety of clinical manifestations. All these clinical as well as methodological diversities and complexities of PCOS may have yielded considerable heterogeneity in our meta-analyses, making generalizability more complicated.
On the other hand, only 3 trials reported a formal sample size calculation, and it is of note that most of the included trials are not entirely free from type II error due to small sample sizes.
To confirm the ovarian activity, assessments should be conducted more rigorously in future trials. More studies with long-term follow-up are needed to examine the effectiveness of acupuncture for improving live births and to assess the sustainability of effect. This systematic review and meta-analysis suggests that the evidence base for the use of acupuncture for improving ovulation and menstruation rates and other hormonal changes in women with PCOS is weak.
Given the poor reporting and methodological flaws of existing studies, large-scale, long-term RCTs with rigorous methodological input are needed to clarify the role of acupuncture in this population. JJ and YJL contributed equally to this work.
Details of ethics approval: No ethical approval was required for this systematic review and meta-analysis. The authors have no conflicts of interest to disclose. Supplemental Digital Content is available for this article. National Center for Biotechnology Information , U. Journal List Medicine Baltimore v. Medicine Baltimore.
Published online Jun 8. Find articles by Hyangsook Lee. Author information Article notes Copyright and License information Disclaimer. Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the Creative Commons Attribution License 4.
This article has been cited by other articles in PMC. Supplemental Digital Content. Abstract Background: This systematic review aimed at summarizing and evaluating the evidence from randomized controlled trials RCTs using acupuncture to treat polycystic ovarian syndrome PCOS , specifically focusing on ovulation rate, menstrual rate, and related hormones.
Methods: Fifteen databases were searched electronically through February Results: We found a low level of evidence that acupuncture is more likely to improve ovulation rate MD 0. Conclusion: There is limited evidence to judge the efficacy and safety of acupuncture on key reproductive outcomes in women with PCOS. Keywords: acupuncture, menstrual cycle, meta-analysis, ovulation, polycystic ovarian syndrome, randomized controlled trial.
Introduction Polycystic ovarian syndrome PCOS is diagnosed on the basis of oligo-ovulation or anovulation, hyperandrogenism, and the presence of polycystic ovaries. Materials and methods The protocol for this systematic review was registered CRD and the review was conducted and reported as outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.
Search strategies We searched databases for relevant studies published through February , comprising 4 international, 3 Chinese, 6 Korean, and 2 Japanese databases. Risk of bias assessment We evaluated the risk of bias among the included studies using the risk of bias assessment tool by the Cochrane Collaboration.
Data synthesis Statistical analyses were performed with the Review Manager program Version 5. Dealing with missing data As much as possible, data were analyzed using an intention-to-treat basis, and attempts were made to obtain missing data from the original investigators. Results Our initial search identified records, of which articles were screened.
Open in a separate window. Figure 1. Characteristics of the included studies 3. Study design Of 27 studies, 23 originated from China and were all published in Chinese [ 20 — 41 ] except 1 trial that was published in English. Participants A total of participants were enrolled in the 27 studies with sample sizes ranging from 25 to Interventions Twelve trials tested the effectiveness of acupuncture alone [ 10 , 20 , 24 , 29 — 31 , 37 , 42 — 45 ] and the others used acupuncture as an adjunct to CC, [ 21 , 22 , 28 , 33 , 35 , 36 , 38 ] Chinese herbal medicine CHM , [ 26 , 27 , 40 ] metformin, [ 20 , 32 ] Diane, or combinations of these.
Table 1 Characteristics of the included studies. Outcomes For primary outcomes, 2 studies reported ovulation rate [ 10 , 44 ] and another 2 studies reported menstruation rate. Risk of bias in the included studies A summary of the risks of bias is provided in Fig. Figure 2. Table 2 Meta-analysis of outcomes and level of evidence. Acupuncture versus sham acupuncture 4 studies Outcomes: There were no studies that reported menstruation rate.
Acupuncture versus medication 6 studies Outcomes: There were no studies that reported ovulation rate. Acupuncture with medication versus sham acupuncture with medication 4 studies Outcomes: There were no studies that reported ovulation rates and monthly menstruation rates per woman.
Acupuncture with medication versus medication alone 12 studies Outcomes: There were no studies that reported ovulation rates and monthly menstruation rates per woman. Discussion 4. Summary of main findings The objective of this review was to summarize and evaluate acupuncture treatment to improve ovulation and menstruation rates and other hormonal changes, in women with PCOS.
Applicability of the current evidence The included studies poorly addressed ovulation and menstruation rates, the primary outcomes in our review. Strengths and limitations of this review We acknowledge that there are recently published systematic reviews and meta-analyses. Implications for further studies To confirm the ovarian activity, assessments should be conducted more rigorously in future trials. Conclusion This systematic review and meta-analysis suggests that the evidence base for the use of acupuncture for improving ovulation and menstruation rates and other hormonal changes in women with PCOS is weak.
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