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

Trials

Baoyan Liu³  Ruosang Du³  Shiyan Yan²  John Yi Jiang¹  Liyun He²  Jiani Wu³  Huanfang Xu³  Yang Wang³  Zhishun Liu³ 

[1] Acucentre Ltd., 965 Colombo St, Christchurch, New Zealand;China Academy of Chinese Medical Sciences, No. 16, Nanxiaojie, Dongzhimen Nei, 100700 Beijing, Dongcheng District, China;Guang’anmen Hospital, China Academy of Chinese Medical Sciences, No.5, Beixiange Street, 100053 Beijing, Xicheng District, China

关键词: Safety;    Multicenter randomized controlled trial;    Menopausal transition;    Electroacupuncture;   

Others  :  812494
DOI  :  10.1186/1745-6215-15-242

 received in 2014-01-09, accepted in 2014-06-12,  发布年份 2014

【 摘 要 】

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).

【 授权许可】

   
2014 Liu et al.; licensee BioMed Central Ltd.

【 图 表 】

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