作者：孙梦晓 来源：本站原创 点击：152次 更新：2018-08-08
Is acupuncture actually not effective for PCOS?
——Analysis of the trial published in JAMA
GANG Weijuan, JING Xianghong
(Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing China 100700)
Abstract: In recent years, acupuncture has been applied to treat more and more patients suffering from polycystic ovary syndrome. On June 27, 2017 a paper titled “Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome: a randomized clinical trial” was published in Journal of the American Medical Association (JAMA). The results did not support acupuncture as an effective therapy for improving the live births in PCOS. The aim of this study was to analyze the therapeutic regimen and design of the clinical trial. The primary outcome and the conclusion of the results of the paper were discussed as well. There are 5 doubts in the paper. 1) The therapeutic regimen decided by trigger points in the paper was different from that of the traditional Chinese acupuncture. The theory of trigger points is based on segmental distribution of nerve innervation. TCM's characteristic primarily lies in its holism and treatment based on syndrome/pattern differentiation. And some specific effective acupoints for PCOS were not adminstrated in the trial. Therefore, the regimen in the trial is not optimal.2) The live birth as the primary outcome was limited during the PCOS recovery. The live birth was the primary outcome in the trial and indeed the endpoint of infertility of PCOS. It reflects ovarian function but it is affected by many factors. From ovulation to live birth, it needs a long time to keep a series of procedures such as fertilization, implantation, conception, pregnancy and delivery. Therefore any dysfunction during these procedures may lead to failure of live birth. That is why the live births may not be increased even though menstruation, hormone levels and ovulation rate have been improved after treatment of PCOS.3) In addition the period of the treatment was too short to reflect the therapeutic effect. The duration of treatment was 4 menstrual cycles in the trial, which was determined from Jedel’s study. The results from Jedel indicated that testosterone concentration was significantly reduced by electro-acupuncture (EA) and EA may be effective in hyperandrogenism and oligo/amenorrhea. Because of the dose-response effect of acupuncture for PCOS, the testosterone concentration decreased after 4-month acupuncture. But 4-month acupuncture is too short to increase live births as the endpoint index. 4) Although there was no significant difference between active acupuncture and control acupuncture, the conclusion that acupuncture was not effective for PCOS was not confirmed because the control acupuncture plus clomiphene was also more effective than that of clomiphene alone. 5) The proposal and the statistics were not in accordance with the one planned before. The purpose of the trial was to demonstrate 3 hypotheses based on live birth rate as a primary outcome of PCOS in the protocol published before. The sample size calculation and the prespecified statistical analysis approaches were based on the 3 hypotheses. However, the statistical analysis approach and the aim of the trial was deviated from the prespecified plan. The results of the trial only indicated that the live birth rate was not significantly improvement between the active acupuncture and the control. The results did not indicate that other acupuncture regimens including different acupoints, manipulation, duration, frequency of treatments were not effective in PCOS women. The proper conclusion should be drawn rigorously from the results and it should not be widen that acupuncture was not effective to PCOS. The conclusion should be that both active acupuncture and control acupuncture can increase the live birth rate of PCOS women, but there is no significant difference between the two groups.
Key words：Acupuncture and moxibustion, acupuncture therapy, polycystic ovary syndrome (PCOS), clinical tria, regimen