Effect of acupuncture on menopausal hot flashes: Study protocol for a randomized controlled clinical trial: 针刺对围绝经期潮热的影响:一项随机对照临床试验研究方案

Abstract

BackgroundHot flashes are one of the most common symptoms in menopause and significantly affect the quality of life of 67% of menopausal women. Acupuncture is found to be a low risk treatment in treating hot flashes but the evidence for its effectiveness is inconclusive. We developed an optimized acupuncture treatment protocol and designed a randomized controlled trial (RCT) to assess the efficacy of acupuncture for reducing hot flashes in menopausal women. MethodsThis is a single-site, single-blind, randomized sham-controlled trial with two parallel arms. A total of 60 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 30) or the sham acupuncture group (n = 30). Treatment will be given twice a week, for 30 min, for six consecutive weeks. The primary outcome is the hot flashes scores, assessed using the validated hot flashes diary at baseline, week 3, week 6 and week 10. The secondary outcome will be measured by menopause-specific quality of life (MENQOL) at baseline, week 6, and week 10. Meanwhile, any adverse events will be recorded. DiscussionIf the outcome of this study confirms acupuncture to be an effective therapy to reduce hot flashes in menopausal women, we expect this study to inspire further investigations and provide useful information in forming an optimal acupuncture treatment protocol for clinic. Trial registrationChinese Clinical Trial Registry identifier: ChiCTR1800018638, Date of registration: 30th September 2018.URL: http://www.chictr.org.cn/showproj.aspx?proj=31462