USING ACUPUNCTURE TO RELIEVE PERIMENOPAUSAL SYNDROME:STUDY PROTOCOL OF A MULTICENTER RANDOMIZED CLINICAL TRIAL

【Author】

Ying Li;Hui Zheng;Qian-hua Zheng;Ling Zhao;Er-qi Qin;Yu Wang;Qian Zeng;Hua-bin Zheng;Yu Zhao;Wei Sun;Xiao-xia Zhang;Zhi-shun Liu;Bao-yan Liu;Chengdu University of Traditional Chinese Medicine;General Hospital of Chengdu Military Region of the Chinese People's Liberation Army,Chengdu University of Traditional Chinese Medicine;First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine;Chengdu Integrated,TCM & Western Medicine Hospital;Guang'anmen Hospital,China Academy of Chinese Medical Sciences;

【Institution】

Chengdu University of Traditional Chinese Medicine;General Hospital of Chengdu Military Region of the Chinese People's Liberation Army;First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine;Chengdu Integrated,TCM & Western Medicine Hospital;Guang'anmen Hospital,China Academy of Chinese Medical Sciences;

【Abstract】

Objective: In this article, we report the protocol of a randomized controlled trial of using acupuncture to treat perimenopausal syndrome, aiming to answer the question whether acupuncture is effective for relieving perimenopausal syndrome.Methods: A multicenter randomized controlled trial with two parallel arms is undergoing in China.Two hundred and six women with perimenopausal syndrome will be randomly assigned to a treatment group using acupuncture plus auricular acupressure(AA) and a control group using Climen? in a 1:1 ratio.Participants in the AA treatment group will receive acupuncture 3 times per week in the first 4 weeks and 2 times per week in the following 8 weeks, for a total 28 sessions over 12 weeks.Auricular points will be plastered by Semen Vaccariae 2 times per week for 12 weeks.The Climen? control group, a 28-day sequential hormone replacement therapy, is prescribing a tablet containing estradiol valerate(E2V) 2 mg per day for the first 11 d, and a tablet containing E2 V 2 mgplus cyproterone acetate(CPA) 1 mg per day for the following 10 d.The total treatment period of control group is three cycles.Post-treatment follow-up period will last 24 weeks.The primary outcome is Menopause Rating Scale(MRS) that assessed at baseline and 4, 8, 16, 24 and 36 weeks after randomization.The secondary outcomes are Menopause-Specific Quality of Life(MENQOL), average hot flash score during 24 h, and the serum estradiol(E2), follicle-stimulating hormone(FSH) and luteinizing hormone(LH) level.The first two secondary outcomes are measured at as the same point as MRS.And other second outcomes are measured at baseline and 12, and 24 weeks after randomization.Discussion: The result of this trial, which will be available in 2015, will clarify whether acupuncture is effective to relieve perimenopausal syndrome.

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