Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial
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- 作者：Zhishun Liu (6)
Yang Wang (6)
Huanfang Xu (6)
Jiani Wu (6)
Liyun He (7)
John Yi Jiang (8)
Shiyan Yan (7)
Ruosang Du (6)
Baoyan Liu (6)
6. Guang鈥檃nmen Hospital ; China Academy of Chinese Medical Sciences ; No.5 ; Beixiange Street ; 100053 ; Beijing ; Xicheng District ; China
7. China Academy of Chinese Medical Sciences ; No. 16 ; Nanxiaojie ; Dongzhimen Nei ; 100700 ; Beijing ; Dongcheng District ; China
8. Acucentre Ltd. ; 965 Colombo St ; Christchurch ; New Zealand - 关键词：Electroacupuncture ; Menopausal transition ; Multicenter randomized controlled trial ; Safety
- 刊名：Trials
- 出版年：2014
- 出版时间：December 2014
- 年：2014
- 卷：15
- 期：1
- 全文大小：403 KB
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- 出版者：BioMed Central
- ISSN：1745-6215
文摘
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).