Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome: A randomized clinical trial

PCOSAct Study Group

Research output: Contribution to journalArticle

44 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)2502-2514
Number of pages13
JournalJAMA - Journal of the American Medical Association
Volume317
Issue number24
DOIs
StatePublished - Jun 27 2017

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Clomiphene
Polycystic Ovary Syndrome
Acupuncture
Randomized Controlled Trials
Live Birth
Placebos
Needles
Diarrhea
Electricity
Birth Rate

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

@article{f6dd5abaf6a8471c87fdc3eb3ec48416,
title = "Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome: A randomized clinical trial",
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.",
author = "{PCOSAct Study Group} and Wu, {Xiao Ke} and Elisabet Stener-Victorin and Kuang, {Hong Ying} and Ma, {Hong Li} and Gao, {Jing Shu} and Xie, {Liang Zhen} and Hou, {Li Hui} and Hu, {Zhen Xing} and Shao, {Xiao Guang} and Jun Ge and Zhang, {Jin Feng} and Xue, {Hui Ying} and Xu, {Xiao Feng} and Liang, {Rui Ning} and Ma, {Hong Xia} and Yang, {Hong Wei} and Li, {Wei Li} and Huang, {Dong Mei} and Yun Sun and Hao, {Cui Fang} and Du, {Shao Min} and Yang, {Zheng Wang} and Xin Wang and Ying Yan and Chen, {Xiu Hua} and Ping Fu and Ding, {Cai Fei} and Gao, {Ya Qin} and Zhou, {Zhong Ming} and Wang, {Chi Chiu} and Wu, {Tai Xiang} and Liu, {Jian Ping} and Ng, {Ernest H.Y.} and Legro, {Richard S.} and Heping Zhang",
year = "2017",
month = "6",
day = "27",
doi = "10.1001/jama.2017.7217",
language = "English (US)",
volume = "317",
pages = "2502--2514",
journal = "JAMA - Journal of the American Medical Association",
issn = "0002-9955",
publisher = "American Medical Association",
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}

Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome : A randomized clinical trial. / PCOSAct Study Group.

In: JAMA - Journal of the American Medical Association, Vol. 317, No. 24, 27.06.2017, p. 2502-2514.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome

T2 - A randomized clinical trial

AU - PCOSAct Study Group

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

PY - 2017/6/27

Y1 - 2017/6/27

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.

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.

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U2 - 10.1001/jama.2017.7217

DO - 10.1001/jama.2017.7217

M3 - Article

C2 - 28655015

AN - SCOPUS:85021289863

VL - 317

SP - 2502

EP - 2514

JO - JAMA - Journal of the American Medical Association

JF - JAMA - Journal of the American Medical Association

SN - 0002-9955

IS - 24

ER -