Effect of acupuncture on menopausal hot flashes: Study protocol for a randomized controlled clinical trial

Background: Hot 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. Methods: This 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. Discussion: If 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. (C) 2021 Published by Elsevier B.V. on behalf of World Journal of Acupuncture Moxibustion House.