Effect of acupuncture on insomnia in menopausal women: A Study protocol for a Randomized Controlled Trial
Abstract Background China today has high occurrences of insomnia in women experiencing menopausal transition. Some studies have shown that acupuncture might be effective in treating primary insomnia and insomnia related to depression and stroke. Although there are some programs supporting insomnia during the menopausal transition, there are few randomized controlled trials to provide evidence regarding their effectiveness. We design a randomized controlled trial of suitable sample size to verify the effectiveness of acupuncture in patients with insomnia during the menopausal transition and to form an optimized acupuncture treatment protocol. Method/Design In this randomized, single-site, single-blind, placebo-controlled trial, 84 eligible patients will be recruited and randomly assigned to either the acupuncture group (n = 42) or the sham control group (n = 42) in 1:1 ratio. Participants will receive 18 sessions of treatment in total for eight consecutive weeks. Treatments will be given three times per week in the first four weeks and then twice a week for the next two weeks followed by once a week treatment for the final two weeks. Treatment will utilize eight main acupoints (GV20, GV24, GV29, RN6, RN4, SP6, HT7, EX-HN22), and extra two acupoints based on syndrome differentiation. The primary outcome will be assessed using the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes will be measured by sleep parameters recorded in the Actigraphy (SE, TST, SA), Insomnia Severity Index (ISI), Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) and Menopause Quality of Life (Men-QOL). The primary outcomes will be assessed at baseline, four-week, eight-week, and first and the third month after the end of treatment. Discussion If the results confirm that acupuncture is effective and safe for the treatment on insomnia in menopausal women, they could provide evidence for clinical application.