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Original Investigation
June 27, 2017

Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary SyndromeA Randomized Clinical Trial

Author Affiliations
  • 1Committee of Reproductive Medicine, World Federation of Chinese Medicine Societies, Beijing, China
  • 2Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China
  • 3Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden
  • 4Outpatient Department, Xuzhou Maternal and Children’s Hospital, Xuzhou, China
  • 5Centre for Reproductive Medicine, Dalian Maternal and Children’s Centre, Dalian, China
  • 6Department of Infertility, Tanggu District Maternal and Children’s Hospital, Tianjin, China
  • 7Department of Obstetrics and Gynecology, Shanxi Province Hospital of Chinese Medicine, Taiyuan, China
  • 8Centre for Reproductive Medicine, Huaian Maternal and Children’s Hospital, Huaian, China
  • 9Department of Gynecology, Suzhou City Hospital of Chinese Medicine, Suzhou, China
  • 10Department of Gynecology, Second Hospital, Jiangxi University of Chinese Medicine, Nanchang, China
  • 11Department of Chinese Medicine, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China
  • 12Department of Infertility, Liwan District Hospital of Chinese Medicine, Guangzhou, China
  • 13Department of Obstetrics and Gynecology, Affiliated Hospital, Anhui University of Chinese Medicine, Hefei, China
  • 14Institute of Integrated Traditional and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
  • 15Department of Gynecology, Wenzhou City Hospital of Chinese Medicine, Wenzhou, China
  • 16Centre for Reproductive Medicine, Yuhuangding Hospital, Yantai, China
  • 17Department of Obstetrics and Gynecology, Daqing Longnan Hospital, Daqing, China
  • 18Department of Obstetrics and Gynecology, First Affiliated Hospital, Hunan University of Chinese Medicine, Changsha, China
  • 19Department of Obstetrics and Gynecology, First Affiliated Hospital, Liaoning University of Chinese Medicine, Shenyang, China
  • 20Department of Gynecology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China
  • 21Department of Traditional Technology, Guangdong Province Hospital of Chinese Medicine, Guangzhou, China
  • 22Department of Gynecology, Hangzhou City Hospital of Chinese Medicine, Hangzhou, China
  • 23Centre for Reproductive Medicine, Zhejiang Province Hospital of Integrative Medicine, Hangzhou, China
  • 24Centre for Reproductive Medicine, Daqing Oilfield General Hospital, Daqing, China
  • 25Department of Obstetrics and Gynecology, Hubei Province Hospital of Chinese Medicine, Wuhan, China
  • 26Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Hong Kong, China
  • 27Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Hong Kong, China
  • 28School of Biomedical Sciences, The Chinese University of Hong Kong, Hong Kong, China
  • 29Chinese Clinical Trial Registry, Shenzhen, China
  • 30Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China
  • 31Department of Obstetrics and Gynecology, The University of Hong Kong, Hong Kong, China
  • 32Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey
  • 33Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut
JAMA. 2017;317(24):2502-2514. doi:10.1001/jama.2017.7217
Key Points

Question  Does acupuncture alone or combined with clomiphene increase the likelihood of live births among women with polycystic ovary syndrome?

Findings  In this randomized clinical trial that recruited 1000 Chinese women with polycystic ovary syndrome, the live birth rate was significantly higher in the group of women who received clomiphene compared with placebo (28.7% vs 15.4%, respectively). However, it was not significantly different between the groups who received active vs control acupuncture (21.8% vs 22.4%, respectively), and there was no significant interaction between active acupuncture and clomiphene.

Meaning  Acupuncture, alone or with clomiphene, was not effective as an infertility treatment in women with polycystic ovary syndrome.

Abstract

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%], respectively; difference, 5.6%; 95% CI, 3.0% to 8.2%).

Conclusions and Relevance  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.

Trial Registration  clinicaltrials.gov Identifier: NCT01573858

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