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PMID- 28655015
OWN - NLM
STAT- MEDLINE
DA  - 20170627
DCOM- 20170711
LR  - 20170713
IS  - 1538-3598 (Electronic)
IS  - 0098-7484 (Linking)
VI  - 317
IP  - 24
DP  - 2017 Jun 27
TI  - Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary
      Syndrome: A Randomized Clinical Trial.
PG  - 2502-2514
LID - 10.1001/jama.2017.7217 [doi]
AB  - 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.
FAU - Wu, Xiao-Ke
AU  - Wu XK
AD  - 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.
FAU - Stener-Victorin, Elisabet
AU  - Stener-Victorin E
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang 
      University of Chinese Medicine, Harbin, China3Department of Physiology and
      Pharmacology, Karolinska Institutet, Stockholm, Sweden.
FAU - Kuang, Hong-Ying
AU  - Kuang HY
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang 
      University of Chinese Medicine, Harbin, China.
FAU - Ma, Hong-Li
AU  - Ma HL
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang 
      University of Chinese Medicine, Harbin, China.
FAU - Gao, Jing-Shu
AU  - Gao JS
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang 
      University of Chinese Medicine, Harbin, China.
FAU - Xie, Liang-Zhen
AU  - Xie LZ
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang 
      University of Chinese Medicine, Harbin, China.
FAU - Hou, Li-Hui
AU  - Hou LH
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang 
      University of Chinese Medicine, Harbin, China.
FAU - Hu, Zhen-Xing
AU  - Hu ZX
AD  - Outpatient Department, Xuzhou Maternal and Children's Hospital, Xuzhou, China.
FAU - Shao, Xiao-Guang
AU  - Shao XG
AD  - Centre for Reproductive Medicine, Dalian Maternal and Children's Centre, Dalian, 
      China.
FAU - Ge, Jun
AU  - Ge J
AD  - Department of Infertility, Tanggu District Maternal and Children's Hospital,
      Tianjin, China.
FAU - Zhang, Jin-Feng
AU  - Zhang JF
AD  - Department of Obstetrics and Gynecology, Shanxi Province Hospital of Chinese
      Medicine, Taiyuan, China.
FAU - Xue, Hui-Ying
AU  - Xue HY
AD  - Centre for Reproductive Medicine, Huaian Maternal and Children's Hospital,
      Huaian, China.
FAU - Xu, Xiao-Feng
AU  - Xu XF
AD  - Department of Gynecology, Suzhou City Hospital of Chinese Medicine, Suzhou,
      China.
FAU - Liang, Rui-Ning
AU  - Liang RN
AD  - Department of Gynecology, Second Hospital, Jiangxi University of Chinese
      Medicine, Nanchang, China.
FAU - Ma, Hong-Xia
AU  - Ma HX
AD  - Department of Chinese Medicine, First Affiliated Hospital, Guangzhou Medical
      University, Guangzhou, China.
FAU - Yang, Hong-Wei
AU  - Yang HW
AD  - Department of Infertility, Liwan District Hospital of Chinese Medicine,
      Guangzhou, China.
FAU - Li, Wei-Li
AU  - Li WL
AD  - Department of Obstetrics and Gynecology, Affiliated Hospital, Anhui University of
      Chinese Medicine, Hefei, China.
FAU - Huang, Dong-Mei
AU  - Huang DM
AD  - Institute of Integrated Traditional and Western Medicine, Tongji Hospital, Tongji
      Medical College, Huazhong University of Science and Technology, Wuhan, China.
FAU - Sun, Yun
AU  - Sun Y
AD  - Department of Gynecology, Wenzhou City Hospital of Chinese Medicine, Wenzhou,
      China.
FAU - Hao, Cui-Fang
AU  - Hao CF
AD  - Centre for Reproductive Medicine, Yuhuangding Hospital, Yantai, China.
FAU - Du, Shao-Min
AU  - Du SM
AD  - Department of Obstetrics and Gynecology, Daqing Longnan Hospital, Daqing, China.
FAU - Yang, Zheng-Wang
AU  - Yang ZW
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Hunan
      University of Chinese Medicine, Changsha, China.
FAU - Wang, Xin
AU  - Wang X
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Liaoning
      University of Chinese Medicine, Shenyang, China.
FAU - Yan, Ying
AU  - Yan Y
AD  - Department of Gynecology, First Teaching Hospital of Tianjin University of
      Traditional Chinese Medicine, Tianjin, China.
FAU - Chen, Xiu-Hua
AU  - Chen XH
AD  - Department of Traditional Technology, Guangdong Province Hospital of Chinese
      Medicine, Guangzhou, China.
FAU - Fu, Ping
AU  - Fu P
AD  - Department of Gynecology, Hangzhou City Hospital of Chinese Medicine, Hangzhou,
      China.
FAU - Ding, Cai-Fei
AU  - Ding CF
AD  - Centre for Reproductive Medicine, Zhejiang Province Hospital of Integrative
      Medicine, Hangzhou, China.
FAU - Gao, Ya-Qin
AU  - Gao YQ
AD  - Centre for Reproductive Medicine, Daqing Oilfield General Hospital, Daqing,
      China.
FAU - Zhou, Zhong-Ming
AU  - Zhou ZM
AD  - Department of Obstetrics and Gynecology, Hubei Province Hospital of Chinese
      Medicine, Wuhan, China.
FAU - Wang, Chi Chiu
AU  - Wang CC
AD  - 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.
FAU - Wu, Tai-Xiang
AU  - Wu TX
AD  - Chinese Clinical Trial Registry, Shenzhen, China.
FAU - Liu, Jian-Ping
AU  - Liu JP
AD  - Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese
      Medicine, Beijing, China.
FAU - Ng, Ernest H Y
AU  - Ng EHY
AD  - Department of Obstetrics and Gynecology, The University of Hong Kong, Hong Kong, 
      China.
FAU - Legro, Richard S
AU  - Legro RS
AD  - Department of Obstetrics and Gynecology, First Affiliated Hospital, Heilongjiang 
      University of Chinese Medicine, Harbin, China32Department of Obstetrics and
      Gynecology, Pennsylvania State University, Hershey.
FAU - Zhang, Heping
AU  - Zhang H
AD  - Department of Biostatistics, Yale University School of Public Health, New Haven, 
      Connecticut.
CN  - PCOSAct Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT01573858
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - JAMA
JT  - JAMA
JID - 7501160
RN  - 0 (Fertility Agents, Female)
RN  - 1HRS458QU2 (Clomiphene)
SB  - AIM
SB  - IM
CIN - JAMA. 2017 Jun 27;317(24):2489-2490. PMID: 28654992
MH  - *Acupuncture Therapy/adverse effects/statistics & numerical data
MH  - Adult
MH  - Body Mass Index
MH  - Clomiphene/adverse effects/*therapeutic use
MH  - Combined Modality Therapy/methods
MH  - Contusions/etiology
MH  - Diarrhea/etiology
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Fertility Agents, Female/adverse effects/*therapeutic use
MH  - Humans
MH  - Infertility, Female/drug therapy/etiology/*therapy
MH  - Live Birth/*epidemiology
MH  - Polycystic Ovary Syndrome/complications/drug therapy/*therapy
MH  - Pregnancy
MH  - Single-Blind Method
MH  - Time Factors
EDAT- 2017/06/28 06:00
MHDA- 2017/07/14 06:00
CRDT- 2017/06/28 06:00
AID - 2633915 [pii]
AID - 10.1001/jama.2017.7217 [doi]
PST - ppublish
SO  - JAMA. 2017 Jun 27;317(24):2502-2514. doi: 10.1001/jama.2017.7217.