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Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial.

ABSTRACT: Whether acupuncture is effective for relieving perimenopausal syndrome has been controversial recently. In this article, we report the protocol of a randomized controlled trial using acupuncture to treat perimenopausal syndrome, aiming to answer this controversy.A multicenter randomized controlled trial with two parallel arms is underway in China. Two hundred and six women with perimenopausal syndrome will be randomly assigned to a treatment group using acupuncture plus auricular acupressure (AA group) and a control group using Climen (Bayer Healthcare Company Limited, Guangzhou, China), a 28-day sequential hormone replacement therapy, in a 1:1 ratio. Participants in the AA group will receive three acupuncture sessions per week in the first 4 weeks and two sessions per week in the following 8 weeks, for a total of 28 sessions over 12 weeks. Auricular points will be plastered by Semen Vaccariae twice per week for a consecutive 12 weeks, with both ears used alternately. The Climen control group is prescribed a tablet containing estradiol valerate 2 mg/day for the first 11 days, and a tablet containing estradiol valerate 2 mg/day plus cyroterone acetate 1 mg/day for the following 10 days. The total treatment period of the control group is three cycles. The post-treatment follow-up period will last 24 weeks. The primary outcome is the Menopause Rating Scale (MRS) assessed at baseline and 4, 12, 16, 24 and 36 weeks after randomization. The secondary outcomes are Menopause-Specific Quality of Life, average hot flash score during 24 hours, serum estradiol, follicle-stimulating hormone and luteinizing hormone level. The first two secondary outcomes are measured at the same point as the MRS. Other secondary outcomes are measured at baseline and 12, 24 weeks after randomization.The results of this trial, which will be available in 2015, will clarify whether acupuncture is effective to relieve perimenopausal syndrome.ClinicalTrials.gov NCT01933204 (registered 9 August 2013).

SUBMITTER: Li Y

PROVIDER: S-EPMC4055374 | biostudies-literature | 2014 May

REPOSITORIES: biostudies-literature

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Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial.

Li Ying Y Zheng Hui H Zheng Qianhua Q Zhao Ling L Qin Erqi E Wang Yu Y Zeng Qian Q Zheng Huabin H Zhao Yu Y Sun Wei W Zhang Xiaoxia X Liu Zhishun Z Liu Baoyan B

Trials 20140530

<h4>Background</h4>Whether acupuncture is effective for relieving perimenopausal syndrome has been controversial recently. In this article, we report the protocol of a randomized controlled trial using acupuncture to treat perimenopausal syndrome, aiming to answer this controversy.<h4>Design</h4>A multicenter randomized controlled trial with two parallel arms is underway in China. Two hundred and six women with perimenopausal syndrome will be randomly assigned to a treatment group using acupunct ...[more]

PMID: 24886348

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Project description:Hwa-byung (HB) is an anger syndrome caused by an inadequate release of accumulated anger that leads to somatic and psychiatric symptoms. As HB results from long-term inadequately treated negative emotions, its symptoms are complex, intractable and concomitant with other psychiatric disorders. Therefore, studies aiming to develop effective and safe treatment options for HB are needed. We plan to conduct a pilot study for a future, full-scale, randomized controlled trial (RCT) of an optimal acupuncture procedure using semi-individualized acupuncture points that consider participants' personal disposition and type of emotional stress.This randomized, sham-controlled, participant- and assessor-blinded pilot trial aims to determine the study feasibility of acupuncture for HB and to explore its clinical effects and safety. This clinical trial will be conducted with two groups: one treated with real acupuncture and the other with sham acupuncture for 10 sessions over 4 weeks. The experimental group (EG) will receive semi-individualized acupuncture, whereas the control group (CG) will receive sham acupuncture, namely minimal acupuncture on non-acupuncture points. The recruitment, compliance, and completion rate and clinical evaluations, including a Visual Analogue Scale (VAS), the Korean version of the Beck Depression Inventory (BDI), the short form of the Stress Response Inventory (SRI-short form) and the Instrument of the Oriental Medical Evaluation for HB (IOME-HB), will be assessed to evaluate feasibility and possible effects and safety. Four weeks after completing treatment, follow-up assessments will be performed.As this is a pilot study mainly aiming to investigate trial feasibility, the results of this study will be analyzed descriptively and interpreted for the study purposes. Cohen's d will be reported to determine the effect of acupuncture for HB and to enable comparisons with other treatment methods. This protocol is significant in that it provides optimal semi-individualized acupuncture treatment. We expect this study to offer information about the feasibility of this treatment and data about the possible effects and safety.Clinical Research Information Service (CRIS), Republic of Korea: KCT0001732 . Registered on 14 December 2015.

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Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial.

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Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial.

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