The current Cochrane review of acupuncture for polycystic ovary syndrome (PCOS) included 5 RCTs and concluded that 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.
A new study was aimed at assessing whether active acupuncture, either alone or combined with clomiphene, increases the likelihood of live births among women with PCOS. A double-blind (clomiphene vs placebo), single-blind (active vs control acupuncture) factorial trial was conducted at 27 hospitals in mainland China between July 6, 2012, and November 18, 2014, with 10 months of pregnancy follow-up until October 7, 2015. Chinese women with polycystic ovary syndrome were randomized in a 1:1:1:1 ratio to 4 groups. Active or control acupuncture administered twice a week for 30 minutes per treatment and clomiphene or placebo administered for 5 days per cycle, for up to 4 cycles. The active acupuncture group received deep needle insertion with combined manual and low-frequency electrical stimulation; the control acupuncture group received superficial needle insertion, no manual stimulation, and mock electricity. The primary outcome was live birth.
Among the 1000 randomized women, 250 were randomized to each group, and 926 women completed the trial. Live births occurred in
- 69 of 235 women (29.4%) in the active acupuncture plus clomiphene group,
- 66 of 236 (28.0%) in the control acupuncture plus clomiphene group,
- 31 of 223 (13.9%) in the active acupuncture plus placebo group,
- 39 of 232 (16.8%) in the control acupuncture plus placebo group.
There was no significant interaction between active acupuncture and clomiphene, so main effects were evaluated. The live birth rate was significantly higher in the women treated with clomiphene than with placebo and not significantly different between women treated with active vs control acupuncture.
The authors concluded that among Chinese women with polycystic ovary syndrome, the use of acupuncture with or without clomiphene, compared with control acupuncture and placebo, did not increase live births. This finding does not support acupuncture as an infertility treatment in such women.
There is much evidence to show that nearly 100% of all acupuncture trials originating from China report positive findings regardless of the condition treated. This led to the assumption by myself and several other experts that such studies are best ignored.
This study is from China and does not report positive results. What is more, it is well-designed and well-reported. This trial therefore is a most laudable exception, and I applaud the authors for their courage and good science.
Does this mean that in future we can trust all Chinese acupuncture trials?
One swallow does not make a summer. And I will remain very sceptical. But perhaps this new study is a sign indicating that things are beginning to change. Perhaps Chinese acupuncture researchers are starting to join the 21st century?