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Abstract

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Conducted a double-blind (clomiphene vs placebo), single-blind (active vs control acupuncture) factorial trial To assess whether active acupuncture, either alone or combined with clomiphene, increases the likelihood of live births among women with polycystic ovary syndrome.

Background

Acupuncture is used to induce ovulation in some women with polycystic ovary syndrome, without supporting clinical evidence.

Methodology

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%). Diarrhoea and bruising were more common in patients receiving active acupuncture than control acupuncture (diarrhoea: 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%).

Conclusion

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.

References

Wu XK1, Stener-Victorin E2, Kuang HY3, Ma HL3, Gao JS3, Xie LZ3, Hou LH3, Hu ZX4, Shao XG5, Ge J6, Zhang JF7, Xue HY8, Xu XF9, Liang RN10, Ma HX11, Yang HW12, Li WL13, Huang DM14, Sun Y15, Hao CF16, Du SM17, Yang ZW18, Wang X19, Yan Y20, Chen XH21, Fu P22, Ding CF23, Gao YQ24, Zhou ZM25, Wang CC26, Wu TX27, Liu JP28, Ng EHY29, Legro RS30, Zhang H31; PCOSAct Study Group. Effect of Acupuncture and Clomiphene in Chinese Women With Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA. 317(24):2502-2514. doi: 10.1001/jama.2017.7217. Jun 27 2017.Comment in

    Acupuncture for Infertility in Polycystic Ovary Syndrome. [JAMA. 2017]
    Acupuncture for Infertility in Polycystic Ovary Syndrome. [JAMA. 2017]
    Acupuncture and the Complex Connections Between the Mind and the Body. [JAMA. 2017]
    Acupuncture is not as effective as infertility treatment in women with PCOS. [Evid Based Med. 2017]