Abstract
BackgroundGeneralized anxiety disorder (GAD) is common among perimenopausal women. 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 the hypothalamic-pituitary-adrenal axis and its excretion, cortisol (CORT), and adrenocorticotropic hormone (ACTH). The object of this study is to evaluate the efficacy of manual acupuncture (MA) versus placebo acupuncture (PA) for perimenopausal women with GAD.MethodsThis study is a single-center, randomized, single-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 4 weeks. The primary outcome measure will be the HAMA score. The secondary outcome measures will be the GAD-7 and PSQI scores and the levels of CORT and ACTH. The evaluation will be executed at baseline, 2 weeks, the end of the treatment, and a follow-up 3-month period. All main analyses will be carried out based on the intention-to-treat (ITT) principle.DiscussionThis study intends to compare the efficacy between MA and PA in the treatment of perimenopausal women with GAD and to further study the mechanisms underlying the effect.Trial registrationChinese Clinical Trial Registry ChiCTR2100046604. Registered on 22 May 2021.
Highlights
Generalized anxiety disorder (GAD) is common among perimenopausal women
The secondary outcome measures are the changes in scores on the Generalized Anxiety Disorder Scale (GAD-7) and Pittsburgh Sleep Quality Index (PQSI), and laboratory indicators related to the current possible pathogenesis of GAD, mainly including CORT and adrenocorticotropic hormone (ACTH)
This protocol aims to explore the efficacy of manual acupuncture (MA) in GAD patients who would not prefer drug or cognitive behavioral therapy (CBT) therapies
Summary
Study design This is a randomized controlled and patient-andassessor-blind trial. A total of 112 participants will be enrolled from the outpatient Acupuncture and Moxibustion Department of the First Affiliated Hospital of Guangzhou University of Chinese Medicine. Eligible patients who meet the inclusion criteria and exclusion criteria will be enrolled in the outpatient department of the First Affiliated Hospital of Guangzhou University of Chinese Medicine. An enzyme-linked immunosorbent assay (ELISA) will be used to measure CORT and ACTH These related tests will be carried out by the clinical laboratory of the First Affiliated Hospital of Guangzhou University of Chinese Medicine. Follow-up After the completion of 12 sessions of acupuncture, we will follow patients via telephone or WeChat to score the HAMA, GAD-7, and PSQI scores in the first month and the third month to determine whether the efficacy can be maintained. The HAMA, GAD-7, and PSQI scores assessed in each group will be subjected to normality tests. The repeatedly assessed HAMA, GAD-7, and PSQI scores in the MA or PA group will be subjected to a normality test. Quality inspectors will check the CRFs randomly to ensure that there are no recorded errors
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
