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Open Access Study protocol

Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial

Ying Li1, Hui Zheng1, Qianhua Zheng1, Ling Zhao1, Erqi Qin1, Yu Wang12, Qian Zeng3, Huabin Zheng3, Yu Zhao4, Wei Sun1, Xiaoxia Zhang1, Zhishun Liu5 and Baoyan Liu5*

Author Affiliations

1 Chengdu University of Traditional Chinese Medicine, 37 Shi’er Qiao Road, Jinniu District, Chengdu, Sichuan 610075, PR China

2 General Hospital of Chengdu Military Region of the Chinese People’s Liberation Army, 270 Tianhui Road, Rongdu Avenue, Chengdu, Sichuan 610083, PR China

3 First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, 39 Shi’er Qiao Road, Jinniu District, Chengdu, Sichuan 610072, PR China

4 Chengdu Integrated TCM & Western Medicine Hospital, 18 North Wanxiang Road, Gaoxin District, Chengdu, Sichuan 610016, PR China

5 Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No. 5 BeiXianGe Street, XiCheng District, Beijing 100053, PR China

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Trials 2014, 15:198  doi:10.1186/1745-6215-15-198

Published: 30 May 2014

Abstract

Background

Whether acupuncture is effective for relieving perimenopausal syndrome has been controversial recently. In this article, we report the protocol of a randomized controlled trial using acupuncture to treat perimenopausal syndrome, aiming to answer this controversy.

Design

A multicenter randomized controlled trial with two parallel arms is underway in China. Two hundred and six women with perimenopausal syndrome will be randomly assigned to a treatment group using acupuncture plus auricular acupressure (AA group) and a control group using Climen® (Bayer Healthcare Company Limited, Guangzhou, China), a 28-day sequential hormone replacement therapy, in a 1:1 ratio. Participants in the AA group will receive three acupuncture sessions per week in the first 4 weeks and two sessions per week in the following 8 weeks, for a total of 28 sessions over 12 weeks. Auricular points will be plastered by Semen Vaccariae twice per week for a consecutive 12 weeks, with both ears used alternately. The Climen® control group is prescribed a tablet containing estradiol valerate 2 mg/day for the first 11 days, and a tablet containing estradiol valerate 2 mg/day plus cyroterone acetate 1 mg/day for the following 10 days. The total treatment period of the control group is three cycles. The post-treatment follow-up period will last 24 weeks. The primary outcome is the Menopause Rating Scale (MRS) assessed at baseline and 4, 12, 16, 24 and 36 weeks after randomization. The secondary outcomes are Menopause-Specific Quality of Life, average hot flash score during 24 hours, serum estradiol, follicle-stimulating hormone and luteinizing hormone level. The first two secondary outcomes are measured at the same point as the MRS. Other secondary outcomes are measured at baseline and 12, 24 weeks after randomization.

Discussion

The results of this trial, which will be available in 2015, will clarify whether acupuncture is effective to relieve perimenopausal syndrome.

Trial registration

ClinicalTrials.gov NCT01933204 (registered 9 August 2013)

Keywords:
acupuncture; randomized controlled trial; perimenopausal syndrome; study protocol