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Open Access Study protocol

Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial

Zhishun Liu1, Yang Wang1, Huanfang Xu1, Jiani Wu1, Liyun He2, John Yi Jiang3, Shiyan Yan2, Ruosang Du1 and Baoyan Liu1*

Author Affiliations

1 Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No.5, Beixiange Street, 100053 Beijing, Xicheng District, China

2 China Academy of Chinese Medical Sciences, No. 16, Nanxiaojie, Dongzhimen Nei, 100700 Beijing, Dongcheng District, China

3 Acucentre Ltd., 965 Colombo St, Christchurch, New Zealand

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Trials 2014, 15:242  doi:10.1186/1745-6215-15-242

Published: 21 June 2014

Abstract

Background

Previous studies have shown that acupuncture can alleviate postmenopausal symptoms, such as hot flashes, but few studies have assessed symptoms during the menopausal transition (MT) period. Thus, the effect of acupuncture upon MT symptoms is unclear. We designed a large-scale trial aimed at evaluating the efficacy of electroacupuncture for MT symptoms compared with sham electroacupuncture and at observing the safety of electroacupuncture.

Methods/design

In this multicenter randomized controlled trial, 360 women will be randomized to either an electroacupuncture group or a sham electroacupuncture group. During the 8-week-long treatment, a menopause rating scale, average 24-hour hot flash score, Menopause-Specific Quality of Life Questionnaire score, and level of female hormones will be observed. Follow-ups at the 20th and 32nd week will be made.

Discussion

Though there is no completely inert placebo acupuncture and blinding is difficult in acupuncture trials, the placebo effect of EA can still be partially excluded in this study. For the placebo control, we use non-points and a tailor-made sham needle. This needle is different from a retractable needle, which is usually used for sham acupuncture. The needle in this trial is more simply constructed and more acceptable to Chinese people. We expect to evaluate the efficacy of electroacupuncture for MT symptoms and clarify its effect on these symptoms.

Trial registration

ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).

Keywords:
Electroacupuncture; Menopausal transition; Multicenter randomized controlled trial; Safety