Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial

• Published in: JAMA : the journal of the American Medical Association 2017-06, Vol.317 (24), p.2502-2514
• Main Authors: Wu, Xiao-Ke, Stener-Victorin, Elisabet, Kuang, Hong-Ying, Ma, Hong-Li, Gao, Jing-Shu, Xie, Liang-Zhen, Hou, Li-Hui, Hu, Zhen-Xing, Shao, Xiao-Guang, Ge, Jun, Zhang, Jin-Feng, Xue, Hui-Ying, Xu, Xiao-Feng, Liang, Rui-Ning, Ma, Hong-Xia, Yang, Hong-Wei, Li, Wei-Li, Huang, Dong-Mei, Sun, Yun, Hao, Cui-Fang, Du, Shao-Min, Yang, Zheng-Wang, Wang, Xin, Yan, Ying, Chen, Xiu-Hua, Fu, Ping, Ding, Cai-Fei, Gao, Ya-Qin, Zhou, Zhong-Ming, Wang, Chi Chiu, Wu, Tai-Xiang, Liu, Jian-Ping, Ng, Ernest H. Y, Legro, Richard S, Zhang, Heping
• Format: Article
• Language: English
• Subjects: Active control; Acupuncture; Acupuncture Therapy - adverse effects; Acupuncture Therapy - statistics & numerical data; Adult; Body mass; Body Mass Index; Bruising; Clinical trials; Clomiphene; Clomiphene - adverse effects; Clomiphene - therapeutic use; Combined Modality Therapy - methods; Contusions - etiology; Diarrhea; Diarrhea - etiology; Double-Blind Method; Drug Administration Schedule; Electrical stimuli; Female; Fertility Agents, Female - adverse effects; Fertility Agents, Female - therapeutic use; Humans; Infertility; Infertility, Female - drug therapy; Infertility, Female - etiology; Infertility, Female - therapy; Insertion; Live Birth - epidemiology; Medical treatment; Medicin och hälsovetenskap; Original Investigation; Ovulation; Polycystic ovary syndrome; Polycystic Ovary Syndrome - complications; Polycystic Ovary Syndrome - drug therapy; Polycystic Ovary Syndrome - therapy; Pregnancy; Single-Blind Method; Stimulation; Time Factors; Womens health
• ISSN: 0098-7484; 1538-3598; 1538-3598
• DOI: 10.1001/jama.2017.7217

IMPORTANCE: Acupuncture is used to induce ovulation in some women with polycystic ovary syndrome, without supporting clinical evidence. OBJECTIVE: To assess whether active acupuncture, either alone or combined with clomiphene, increases the likelihood of live births among women with polycystic ovary syndrome. DESIGN, SETTING, AND PARTICIPANTS: A double-blind (clomiphene vs placebo), single-blind (active vs control acupuncture) factorial trial was conducted at 21 sites (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. INTERVENTIONS: 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. MAIN OUTCOMES AND MEASURES: The primary outcome was live birth. Secondary outcomes included adverse events. RESULTS: Among the 1000 randomized women (mean [SD] age, 27.9 [3.3] years; mean [SD] body mass index, 24.2 [4.3]), 250 were randomized to each group; a total of 926 women (92.6%) 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, and 39 of 232 (16.8%) in the control acupuncture plus placebo group. There was no significant interaction between active acupuncture and clomiphene (P = .39), so main effects were evaluated. The live birth rate was significantly higher in the women treated with clomiphene than with placebo (135 of 471 [28.7%] vs 70 of 455 [15.4%], respectively; difference, 13.3%; 95% CI, 8.0% to 18.5%) and not significantly different between women treated with active vs control acupuncture (100 of 458 [21.8%] vs 105 of 468 [22.4%], respectively; difference, −0.6%; 95% CI, −5.9% to 4.7%). Diarrhea and bruising were more common in patients receiving active acupuncture than control acupuncture (diarrhea: 25 of 500 [5.0%] vs 8 of 500 [1.6%], respectively; difference, 3.4%; 95% CI, 1.2% to 5.6%; bruising: 37 of 500 [7.4%] vs 9 of 500 [1.8%], respecti