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Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial.
JAMA. 2017 06 27; 317(24):2502-2514.JAMA

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.

Links

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Authors+Show Affiliations

Wu XK
Committee of Reproductive Medicine, World Federation of Chinese Medicine Societies, Beijing, China2Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.
Stener-Victorin E
Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China3Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
Kuang HY
Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.
Ma HL
Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.
Gao JS
Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.
Xie LZ
Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.
Hou LH
Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China.
Hu ZX
Outpatient Department, Xuzhou Maternal and Children's Hospital, Xuzhou, China.
Shao XG
Centre for Reproductive Medicine, Dalian Maternal and Children's Centre, Dalian, China.
Ge J
Department of Infertility, Tanggu District Maternal and Children's Hospital, Tianjin, China.
Zhang JF
Department of Obstetrics and Gynecology, Shanxi Province Hospital of Chinese Medicine, Taiyuan, China.
Xue HY
Centre for Reproductive Medicine, Huaian Maternal and Children's Hospital, Huaian, China.
Xu XF
Department of Gynecology, Suzhou City Hospital of Chinese Medicine, Suzhou, China.
Liang RN
Department of Gynecology, Second Hospital, Jiangxi University of Chinese Medicine, Nanchang, China.
Ma HX
Department of Chinese Medicine, First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.
Yang HW
Department of Infertility, Liwan District Hospital of Chinese Medicine, Guangzhou, China.
Li WL
Department of Obstetrics and Gynecology, Affiliated Hospital, Anhui University of Chinese Medicine, Hefei, China.
Huang DM
Institute of Integrated Traditional and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Sun Y
Department of Gynecology, Wenzhou City Hospital of Chinese Medicine, Wenzhou, China.
Hao CF
Centre for Reproductive Medicine, Yuhuangding Hospital, Yantai, China.
Du SM
Department of Obstetrics and Gynecology, Daqing Longnan Hospital, Daqing, China.
Yang ZW
Department of Obstetrics and Gynecology, First Affiliated Hospital, Hunan University of Chinese Medicine, Changsha, China.
Wang X
Department of Obstetrics and Gynecology, First Affiliated Hospital, Liaoning University of Chinese Medicine, Shenyang, China.
Yan Y
Department of Gynecology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Chen XH
Department of Traditional Technology, Guangdong Province Hospital of Chinese Medicine, Guangzhou, China.
Fu P
Department of Gynecology, Hangzhou City Hospital of Chinese Medicine, Hangzhou, China.
Ding CF
Centre for Reproductive Medicine, Zhejiang Province Hospital of Integrative Medicine, Hangzhou, China.
Gao YQ
Centre for Reproductive Medicine, Daqing Oilfield General Hospital, Daqing, China.
Zhou ZM
Department of Obstetrics and Gynecology, Hubei Province Hospital of Chinese Medicine, Wuhan, China.
Wang CC
Department of Obstetrics and Gynecology, The Chinese University of Hong Kong, Hong Kong, China27Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Hong Kong, China28School of Biomedical Sciences, The Chinese University of Hong Kong, Hong Kong, China.
Wu TX
Chinese Clinical Trial Registry, Shenzhen, China.
Liu JP
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
Ng EHY
Department of Obstetrics and Gynecology, The University of Hong Kong, Hong Kong, China.
Legro RS
Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang University of Chinese Medicine, Harbin, China32Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey.
Zhang H
Department of Biostatistics, Yale University School of Public Health, New Haven, Connecticut.
PCOSAct Study Group
No affiliation info available

MeSH

Acupuncture TherapyAdultBody Mass IndexClomipheneCombined Modality TherapyContusionsDiarrheaDouble-Blind MethodDrug Administration ScheduleFemaleFertility Agents, FemaleHumansInfertility, FemaleLive BirthPolycystic Ovary SyndromePregnancySingle-Blind MethodTime Factors

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

28655015

Clinical Trial Links

Clinical trial which this article describes [1]
Clinical trial which this article describes [2]
A Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth in Women With PCOS
Treat of Functional Ovarian Cysts by Compare Between Cocs and Progesterone Only Pills

Citation

Wu, Xiao-Ke, et al. "Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: a Randomized Clinical Trial." JAMA, vol. 317, no. 24, 2017, pp. 2502-2514.
Wu XK, Stener-Victorin E, Kuang HY, et al. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA. 2017;317(24):2502-2514.
Wu, X. K., Stener-Victorin, E., Kuang, H. Y., Ma, H. L., Gao, J. S., Xie, L. Z., Hou, L. H., Hu, Z. X., Shao, X. G., Ge, J., Zhang, J. F., Xue, H. Y., Xu, X. F., Liang, R. N., Ma, H. X., Yang, H. W., Li, W. L., Huang, D. M., Sun, Y., ... Zhang, H. (2017). Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA, 317(24), 2502-2514. https://doi.org/10.1001/jama.2017.7217
Wu XK, et al. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: a Randomized Clinical Trial. JAMA. 2017 06 27;317(24):2502-2514. PubMed PMID: 28655015.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. AU - Wu,Xiao-Ke, AU - Stener-Victorin,Elisabet, AU - Kuang,Hong-Ying, AU - Ma,Hong-Li, AU - Gao,Jing-Shu, AU - Xie,Liang-Zhen, AU - Hou,Li-Hui, AU - Hu,Zhen-Xing, AU - Shao,Xiao-Guang, AU - Ge,Jun, AU - Zhang,Jin-Feng, AU - Xue,Hui-Ying, AU - Xu,Xiao-Feng, AU - Liang,Rui-Ning, AU - Ma,Hong-Xia, AU - Yang,Hong-Wei, AU - Li,Wei-Li, AU - Huang,Dong-Mei, AU - Sun,Yun, AU - Hao,Cui-Fang, AU - Du,Shao-Min, AU - Yang,Zheng-Wang, AU - Wang,Xin, AU - Yan,Ying, AU - Chen,Xiu-Hua, AU - Fu,Ping, AU - Ding,Cai-Fei, AU - Gao,Ya-Qin, AU - Zhou,Zhong-Ming, AU - Wang,Chi Chiu, AU - Wu,Tai-Xiang, AU - Liu,Jian-Ping, AU - Ng,Ernest H Y, AU - Legro,Richard S, AU - Zhang,Heping, AU - ,, PY - 2017/6/28/entrez PY - 2017/6/28/pubmed PY - 2017/7/14/medline SP - 2502 EP - 2514 JF - JAMA JO - JAMA VL - 317 IS - 24 N2 - 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/28655015/Effect_of_Acupuncture_and_Clomiphene_in_Chinese_Women_With_Polycystic_Ovary_Syndrome:_A_Randomized_Clinical_Trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2017.7217 DB - PRIME DP - Unbound Medicine ER -