Liu Zhishun, Wang Yang, Xu Huanfang, Wu Jiani, He Liyun, Jiang John Yi, Yan Shiyan, Du Ruosang, Liu Baoyan
Guang'anmen Hospital, China Academy of Chinese Medical Sciences, No,5, Beixiange Street, 100053 Beijing, Xicheng District, China.
Trials. 2014 Jun 21;15:242. doi: 10.1186/1745-6215-15-242.
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.
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.
ClinicalTrials.gov Identifier: NCT01849172 (Date of registration: 05/05/2013).
既往研究表明，针刺可缓解潮热等绝经后症状，但很少有研究评估围绝经期（MT）症状。因此，针刺对MT症状的影响尚不清楚。我们设计了一项大规模试验，旨在评估电针与假电针对MT症状的疗效，并观察电针的安全性。
方法/设计：在这项多中心随机对照试验中，360名女性将被随机分为电针组或假电针组。在为期8周的治疗期间，观察更年期评定量表、平均24小时潮热评分、更年期特异性生活质量问卷评分和女性激素水平。将在第20周和第32周进行随访。
虽然不存在完全惰性的安慰剂针刺，且针刺试验中难以实现盲法，但本研究仍可部分排除电针的安慰剂效应。对于安慰剂对照，我们使用非穴位和特制的假针。这种针与通常用于假针刺的伸缩针不同。本试验中的针构造更简单，中国人更容易接受。我们期望评估电针治疗MT症状的疗效，并阐明其对这些症状的影响。
ClinicalTrials.gov标识符：NCT01849172（注册日期：2013年5月5日）。
