What is the effectiveness and safety of acupuncture treatment for treatment of ovulation disorders in women with polycystic ovarian syndrome (PCOS)?
PCOS is where women have small cysts on their ovaries (organs that produce eggs) and is characterised by the clinical signs of infrequent or very light menstruation (periods), failure to conceive (become pregnant) and excessive hair growth. The current standard western medical treatments for women with PCOS are prescription medicines, surgery and lifestyle changes. There has been evidence suggesting acupuncture may influence ovulation (release of the egg) by affecting levels of various hormones. Acupuncture is a Chinese therapy where fine needles are inserted into the skin in certain places. Various non-randomised studies (an experimental study in which people are allocated to different treatments using methods that are not random) of acupuncture in PCOS suggested that there were low rates of side effects, no increased risk of multiple pregnancy (e.g. twins) and that it was comparatively inexpensive to administer. However, it should be emphasised that these conclusions were made based on the findings of non-randomised controlled studies alone and, therefore, may not reliably support the effectiveness and use of acupuncture in this area.
We searched medical databases for randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) of acupuncture treatment for women with PCOS who were infrequently or never ovulating. Acupuncture was compared with pretend acupuncture (sham), no treatment, lifestyle changes (e.g. relaxation) and conventional treatment (e.g. clomiphene, which causes ovulation).
We included five studies with 413 women in this review. The studies compared true acupuncture versus sham acupuncture (two RCTs), clomiphene (one RCT), relaxation (one RCT) and electroacupuncture (where small electrical currents are passed through the acupuncture needles) versus physical exercise (one RCT). Four of the studies were at high risk of bias (there may be an overestimate of the true effect) in at least one of the areas we assessed. The results were current to October 2015.
Our main interests (outcomes) were live birth rate and ovulation. Our secondary outcomes included clinical pregnancy and side effects. None of the included studies reported live birth rate. Three small studies reported ovulation. One study did not fully report ovulation rate. One study of 84 women found no evidence of a difference in ovulation rate between true and sham acupuncture. However, one study of 28 women reported very low quality evidence suggesting that true acupuncture might be associated with higher ovulation frequency than relaxation. Two other studies reported that acupuncture or electroacupuncture may be associated with higher restored menstruation frequency.
There was no evidence of a difference in pregnancy rate between true and sham acupuncture. There was no evidence of a difference in side effect rates between any of the groups compared, but there were far too few data to reach a firm conclusion. The evidence was very low quality, the main limitations being failure to report important clinical outcomes, and imprecision because of the wide range of effects and low numbers of events. There was also poor reporting of study methods. There is currently insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS.
Quality of the evidence
The evidence was low quality, the main limitations being failure to report important clinical outcomes and very serious imprecision.
Thus far, only a limited number of RCTs have been reported. At present, there is insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS.
Polycystic ovarian syndrome (PCOS) is characterised by the clinical signs of oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Beta-endorphin presents in the follicular fluid of both normal and polycystic ovaries. It was demonstrated that the beta-endorphin levels in ovarian follicular fluid of otherwise healthy women who were undergoing ovulation were much higher than the levels measured in plasma. Given that acupuncture has an impact on beta-endorphin production, which may affect gonadotropin-releasing hormone (GnRH) secretion, it is postulated that acupuncture may have a role in ovulation induction and fertility.
To assess the effectiveness and safety of acupuncture treatment of oligo/anovulatory women with polycystic ovarian syndrome (PCOS).
We identified relevant studies from databases including the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, EMBASE, PsycINFO, CNKI and trial registries. The data are current to 19 October 2015.
We included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs. Primary outcomes were live birth and ovulation (primary outcomes), and secondary outcomes were clinical pregnancy, restoration of menstruation, multiple pregnancy, miscarriage and adverse events. We assessed the quality of the evidence using GRADE methods.
Two review authors independently selected the studies, extracted data and assessed risk of bias. We calculated Mantel-Haenszel odds ratios (ORs) and mean difference (MD) and 95% confidence intervals (CIs).
We included five RCTs with 413 women. They compared true acupuncture versus sham acupuncture (two RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT) and electroacupuncture versus physical exercise (one RCT). Four of the studies were at high risk of bias in at least one domain.
No study reported live birth rate. Two studies reported clinical pregnancy and found no evidence of a difference between true acupuncture and sham acupuncture (OR 2.72, 95% CI 0.69 to 10.77, two RCTs, 191 women, very low quality evidence).
Three studies reported ovulation. One RCT reported number of women who had three ovulations during three months of treatment but not ovulation rate. One RCT found no evidence of a difference in mean ovulation rate between true and sham acupuncture (MD -0.03, 95% CI -0.14 to 0.08, one RCT, 84 women, very low quality evidence). However, one other RCT reported very low quality evidence to suggest that true acupuncture might be associated with higher ovulation frequency than relaxation (MD 0.35, 95% CI 0.14 to 0.56, one RCT, 28 women).
Two studies reported menstrual frequency. One RCT reported true acupuncture reduced days between menstruation more than sham acupuncture (MD 220.35, 95% CI 252.85 to 187.85, 146 women). One RCT reported electroacupuncture increased menstrual frequency more than no intervention (0.37, 95% CI 0.21 to 0.53, 31 women).
There was no evidence of a difference between the groups in adverse events. Evidence was very low quality with very wide CIs and very low event rates.
Overall evidence was low or very low quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.