Efficacy of Manual Acupuncture Versus Placebo Acupuncture for Generalized Anxiety Disorder (Gad) in Perimenopause Women : Study Protocol for a Randomized Controlled Trial

Abstract BackgroundGeneralized anxiety disorder (GAD) is common among perimenopause women. Drug treatment and cognitive behavioral therapy have their pros and cons. Acupuncture may be an effective treatment for GAD, but evidence is limited. The pathogenesis of GAD is not yet clear, but it is related to hypothalamic-pituitary-adrenal axis and its excretion, cortisol (CORT) and adrenocorticotropic hormone (ACTH). The object of this study is to assess the efficacy of manual acupuncture (MA) versus placebo acupuncture (PA) for perimenopause women with GAD. MethodsThis study is a single center, randomized, double blind clinical trial that will be conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 112 eligible GAD patients will be randomly assigned (1:1) to receive MA (n=56) or PA (n=56) three times per week for four weeks. The primary outcome measure will be the score of GAD-7. The secondary outcome measures will be the score of HAMA and PSQI, and the level of CORT and ACTH. The evaluation will execute at baseline, 2 weeks, the end of the treatment and a follow-up period. All main analyses will be carried out based on the intention-to-treat (ITT) principle. DiscussionThis study intends to conduct to compare the efficacy between MA and PA in the treatment of perimenopause woman with GAD, and to further study the mechanisms of effect. Trial registrationChinese Clinical Trial Registry, ID: ChiCTR2100046604. Registered on 22 May 2021. URL: http://www.chictr.org.cn.