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

Trials, May 2014

Background 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. Design 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. Discussion The results of this trial, which will be available in 2015, will clarify whether acupuncture is effective to relieve perimenopausal syndrome. Trial registration ClinicalTrials.gov NCT01933204 (registered 9 August 2013)

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

Ying Li 3 Hui Zheng 3 Qianhua Zheng 3 Ling Zhao 3 Erqi Qin 3 Yu Wang 2 3 Qian Zeng 1 Huabin Zheng 1 Yu Zhao 5 Wei Sun 3 Xiaoxia Zhang 3 Zhishun Liu 0 4 Baoyan Liu 0 4 0 Guang'anmen Hospital, China Academy of Chinese Medical Sciences , No. 5 BeiXianGe Street, XiCheng District, Beijing 100053 , PR China 1 First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine , 39 Shi'er Qiao Road, Jinniu District, Chengdu, Sichuan 610072 , PR China 2 General Hospital of Chengdu Military Region of the Chinese People's Liberation Army , 270 Tianhui Road, Rongdu Avenue, Chengdu, Sichuan 610083 , PR China 3 Chengdu University of Traditional Chinese Medicine , 37 Shi'er Qiao Road, Jinniu District, Chengdu, Sichuan 610075 , PR China 4 Guang'anmen Hospital, China Academy of Chinese Medical Sciences , No. 5 BeiXianGe Street, XiCheng District, Beijing 100053 , PR China 5 Chengdu Integrated TCM & Western Medicine Hospital , 18 North Wanxiang Road, Gaoxin District, Chengdu, Sichuan 610016 , PR China Background: 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. Design: 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. Discussion: The results of this trial, which will be available in 2015, will clarify whether acupuncture is effective to relieve perimenopausal syndrome. Trial registration: ClinicalTrials.gov NCT01933204 (registered 9 August 2013) 2014 Li et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. - Background Perimenopause is defined as a period during 2 to 8 years preceding menopause and 1 year after final menstruation [1]. During this period, the changes in serum hormone levels especially estrogen cause perimenopausal syndrome, manifested as menstrual irregularities, hot flashes, sweats, insomnia, emotional disorders, vaginal dryness, sexual dysfunction, and so forth. The syndrome significantly reduces the womens healthrelated quality of life [2,3]. Hormone replacement therapy (HRT) is an effective method to relieve these symptoms [4]. According to recent studies, however, HRT may increase the risk of coronary heart disease [5], stroke [6], breast cancer [7], and endometrial cancer [8]. The benefits of estrogen plus progestin are unable to counterbalance the risks, indicated by the Womens Health Initiative [9]. More and more women therefore seek alternative therapies rather than HRT, because of the life-threatening side effects [10,11]. As one of the complementary and alternative therapies without serious side effects [12,13], acupuncture is used frequently to treat a wide range of health problems [14], including hot flashes, which is one of the most common symptoms and the reason why women in the stage of menopausal transition seek medical care [15]. However, several randomized controlled trials (RCTs) indicated that acupuncture is not superior to sham acupuncture in relieving perimenopausa (...truncated)


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Ying Li, Hui Zheng, Qianhua Zheng, Ling Zhao, Erqi Qin, Yu Wang, Qian Zeng, Huabin Zheng, Yu Zhao, Wei Sun, Xiaoxia Zhang, Zhishun Liu, Baoyan Liu. Use acupuncture to relieve perimenopausal syndrome: study protocol of a randomized controlled trial, Trials, 2014, pp. 198, 15, DOI: 10.1186/1745-6215-15-198