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Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial.
Trials. 2016 05 21; 17(1):256.T

Abstract

BACKGROUND

Whether electroacupuncture is effective for patients with polycystic ovary syndrome is still inconclusive. Therefore, this study aims to evaluate the add-on effects of electroacupuncture to conventional drugs for the treatment of polycystic ovary syndrome.

METHODS/DESIGN

This study is a two-center, open-labeled, randomized, controlled trial. A total of 116 eligible patients with polycystic ovary syndrome will be randomly allocated in a 1:1 ratio to the electroacupuncture plus clomiphene citrate group or to the clomiphene citrate group. Participants in the electroacupuncture plus clomiphene citrate group will receive electroacupuncture treatment in addition to clomiphene citrate capsules, whereas participants in the clomiphene citrate group will be prescribed clomiphene citrate capsules only. Electroacupuncture treatment will be performed from the fifth day of menstruation or withdrawal bleeding until the next menstruation, in three sessions per week for three menstrual cycles. The primary outcome is the ovulation rate. The secondary outcomes include the dominant follicle rate, mean number of dominant follicles, endometrial thickness, time point of ovulation, follicular size before ovulation, luteinizing hormone, estradiol level, and pregnancy rate. The measuring points for outcomes will be baseline and the completion of treatment. Any adverse events occurring during the trial process will be recorded. In addition, a quality-monitoring group independent from the research team will be set up to control the quality of the trial.

DISCUSSION

The design and methodological rigor of this trial will allow for the collection of valuable data to evaluate the effectiveness of electroacupuncture for treating polycystic ovary syndrome. Therefore, this trial will contribute reliable evidence for use in clinical decision-making in acupuncture therapy of polycystic ovary syndrome as well as to future research in acupuncture for polycystic ovary syndrome.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, ChiCTR-IOR-15007358 , registered on 26 October 2015.

Links

Authors+Show Affiliations

Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.

Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.

Maternal and Child Health Hospital of Sichuan Province, Chengdu, Sichuan, China.

Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.

Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.

Sichuan Orthopedic Hospital, Chengdu, Sichuan, China.

Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.

Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China. jenny_yang_jie@126.com.

Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China. acuresearch@126.com.

MeSH

AdultClinical ProtocolsClomipheneElectroacupunctureFemaleHumansPolycystic Ovary SyndromeResearch DesignYoung Adult

Pub Type(s)

Journal Article

Randomized Controlled Trial

Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27206612

Citation

Chen, Jiao, et al. "Effectiveness of Electroacupuncture for Polycystic Ovary Syndrome: Study Protocol for a Randomized Controlled Trial." Trials, vol. 17, no. 1, 2016, p. 256.

Chen J, Feng S, Zeng J, et al. Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial. Trials. 2016;17(1):256.

Chen, J., Feng, S., Zeng, J., Wu, X., Yang, M., Tang, H., Fan, H., Yang, J., & Liang, F. (2016). Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial. Trials, 17(1), 256. https://doi.org/10.1186/s13063-016-1375-4

Chen J, et al. Effectiveness of Electroacupuncture for Polycystic Ovary Syndrome: Study Protocol for a Randomized Controlled Trial. Trials. 2016 05 21;17(1):256. PubMed PMID: 27206612.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Effectiveness of electroacupuncture for polycystic ovary syndrome: study protocol for a randomized controlled trial. AU - Chen,Jiao, AU - Feng,Shuwei, AU - Zeng,Jiuzhi, AU - Wu,Xi, AU - Yang,Mingxiao, AU - Tang,Hongzhi, AU - Fan,Huaying, AU - Yang,Jie, AU - Liang,Fanrong, Y1 - 2016/05/21/ PY - 2015/12/10/received PY - 2016/04/15/accepted PY - 2016/5/22/entrez PY - 2016/5/22/pubmed PY - 2018/1/9/medline KW - Effectiveness KW - Electroacupuncture KW - Polycystic ovary syndrome KW - RCT KW - Study protocol SP - 256 EP - 256 JF - Trials JO - Trials VL - 17 IS - 1 N2 - BACKGROUND: Whether electroacupuncture is effective for patients with polycystic ovary syndrome is still inconclusive. Therefore, this study aims to evaluate the add-on effects of electroacupuncture to conventional drugs for the treatment of polycystic ovary syndrome. METHODS/DESIGN: This study is a two-center, open-labeled, randomized, controlled trial. A total of 116 eligible patients with polycystic ovary syndrome will be randomly allocated in a 1:1 ratio to the electroacupuncture plus clomiphene citrate group or to the clomiphene citrate group. Participants in the electroacupuncture plus clomiphene citrate group will receive electroacupuncture treatment in addition to clomiphene citrate capsules, whereas participants in the clomiphene citrate group will be prescribed clomiphene citrate capsules only. Electroacupuncture treatment will be performed from the fifth day of menstruation or withdrawal bleeding until the next menstruation, in three sessions per week for three menstrual cycles. The primary outcome is the ovulation rate. The secondary outcomes include the dominant follicle rate, mean number of dominant follicles, endometrial thickness, time point of ovulation, follicular size before ovulation, luteinizing hormone, estradiol level, and pregnancy rate. The measuring points for outcomes will be baseline and the completion of treatment. Any adverse events occurring during the trial process will be recorded. In addition, a quality-monitoring group independent from the research team will be set up to control the quality of the trial. DISCUSSION: The design and methodological rigor of this trial will allow for the collection of valuable data to evaluate the effectiveness of electroacupuncture for treating polycystic ovary syndrome. Therefore, this trial will contribute reliable evidence for use in clinical decision-making in acupuncture therapy of polycystic ovary syndrome as well as to future research in acupuncture for polycystic ovary syndrome. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IOR-15007358 , registered on 26 October 2015. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/27206612/Effectiveness_of_electroacupuncture_for_polycystic_ovary_syndrome:_study_protocol_for_a_randomized_controlled_trial_ DB - PRIME DP - Unbound Medicine ER -