岗卫娟，景向红

（中国中医科学院针灸研究所，北京 100700）

摘要：近年来，越来越多的多囊卵巢综合征（PCOS）患者寻求针刺治疗。而2017年6月27日在JAMA杂志发表的“针刺联用克罗米芬治疗中国妇女多囊卵巢综合征”一文的研究结果为不支持针刺治疗此类患者不孕。本文从针刺治疗方案、研究设计、结局指标和研究结果的解读等方面进行分析，研究发现存在以下5方面问题。1）该研究所采用的激痛点治疗方案与传统针刺治疗方案不同：激痛点治疗方案依据西方针灸的神经阶段支配理论来制定，与传统针刺的辨证治疗方案不同，并且没有证据显示该治疗方案对活产率的效果。因此，该治疗方案值得探讨。2）主要结局指标活产率的设定不能完全反映多囊卵巢综合征的治疗情况：活产率确是PCOS不孕患者的终点指标，而不是反映卵巢功能的直接指标。该研究在未明确所采用治疗方案对直接指标疗效的情况下，而选用终点指标作为主要结局指标值得考虑。3）4个月的针刺治疗时间太短不足以反映针刺治疗效应：以往研究显示4个月的电针治疗降低PCOS患者睾酮水平，可能对高雄激素征和月经稀发/闭经有效。针刺治疗存在剂量-效应关系，4个月的电针治疗能降低睾酮水平，未必能凸显活产率的提高。因此，从睾酮降低到活产率提高，可能需要更长治疗时间。4）针刺组与对照针刺组差异无统计学意义不能得出针刺无效的结论：针刺组加克罗米芬组和对照针刺加克罗米芬组的疗效虽无统计学差异，但二者均优于单独克罗米芬的疗效；以往研究显示浅刺型安慰针刺并非完全无效，也未见证据显示该安慰针刺方案对PCOS患者不孕无效。5）研究方案及统计方法偏离既定方案：该研究设计是验证3种假设，样本量计算及既定统计分析方法均是基于该3种假设。该研究报告显示研究结果统计方法及研究目的均与既定方案不同。因此，该研究结论值得商榷。该研究结果只能说明对于PCOS患者的活产率结局，研究所选针刺治疗方案与所选对照针刺方案之间无差异，而不能说明其他针刺治疗方案（包括选穴、针刺手法、频次和治疗时间等）对此类患者无效。研究结论应基于研究结果而定，宜谨慎不宜将其泛化。就该研究而言，其研究结论应为“该针刺方案和对照针刺方案均能提高PCOS患者活产率，但二者之间差异无统计学意义。”

关键词：针灸；针刺疗法；多囊卵巢综合征；临床研究；治疗方案

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