Effect of acupuncture on menopausal vasomotor symptoms (VMS): A study protocol for a randomized controlled clinical trial

Abstract Background During menopause, many women are troubled by vasomotor symptoms (VMS) when hot flashes, night sweats, or both, interfere with normal daily life. Both hormone therapy (HT) and taking antidepressants are common ways to reduce VMS but they have associated health risks such as breast cancer and thromboembolic events. Acupuncture is found to be a safe treatment option to reduce VMS and recent studies have demonstrated positive results applying personalized selections of acupuncture points. Hence, we hypothesize acupuncture, according to Chinese Medicine's basic principle of pattern differentiation, can reduce both frequency and severity of VMS in menopausal women. We designed a randomized controlled trial to test the hypothesis using a wait-list group as a control group and pattern differentiation to find an optimal therapeutic treatment. Method/Design The study is a single-center, pragmatic, randomized control trial with two parallel arms, to assess the effectiveness of acupuncture in 60 women in the Shanghai international and Chinese community with peri- and postmenopausal VMS. Eligible participants will be randomly assigned into two groups on a ratio 1:1. An acupuncture group of 30 women will twice weekly receive totally 12 acupuncture treatments and we will follow their treatment response through their VMS self-rating journal entries recorded at baseline, during intervention and twice post intervention as primary outcome. A waitlisted control group will record the same self-ratings of their VMS for purposes of comparison. After the six-week wait period is over, they will receive the same 12 sessions acupuncture treatment. As a second outcome, menopause-specific quality of life indicators will be assessed at baseline and twice post intervention by all participants. Discussion If the outcome of this study confirms acupuncture to be an effective and safe management method to reduce VMS in menopausal women, we expect further investigations and trials to clinically find optimal acupuncture treating strategies.