Effect of acupuncture on menopausal hot flashes:Study protocol for a randomized controlled clinical trial  

针刺对围绝经期潮热的影响:一项随机对照临床试验研究方案

作　　者：Kun XU Anna Bogachko(Sweden) Shan-shan LI Xuan YIN Hong-yu YUE Tian LI Li-xing LAO Shi-fen XU 胥琨;Anna Bogachko(Sweden);李珊珊;殷萱;岳虹妤;李甜;劳力行;徐世芬(上海中医药大学附属上海市中医医院,中国上海200071;东方医学弗吉尼亚结合大学,美国弗吉尼亚州22031)

机构地区：[1]Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China [2]Virginia University of Integrative Medicine,Fairfax,Virginia 22031,United Stares

出　　处：《World Journal of Acupuncture-Moxibustion》2021年第4期324-329,共6页世界针灸杂志（英文版）

基　　金：Supported by grants from Shanghai Municipal Commission of Health and Family Planning:ZY(2018-2020)-ZYJS-03。

摘　　要：Background:Hot flashes are one of the most common symptoms in menopause and significantly affect the quality of life of 67% of menopausal women.Acupuncture is found to be a low risk treatment in treating hot flashes but the evidence for its effectiveness is inconclusive.We developed an optimized acupuncture treatment protocol and designed a randomized controlled trial(RCT) to assess the efficacy of acupuncture for reducing hot flashes in menopausal women.Methods:This is a single-site,single-blind,randomized sham-controlled trial with two parallel arms.A total of 60 eligible patients will be recruited and randomly assigned to either the acupuncture group(n=30) or the sham acupuncture group(n=30).Treatment will be given twice a week,for 30 min,for six consecutive weeks.The primary outcome is the hot flashes scores,assessed using the validated hot flashes diary at baseline,week 3,week 6 and week 10.The secondary outcome will be measured by menopause-specific quality of life(MENQOL) at baseline,week 6,and week 10.Meanwhile,any adverse events will be recorded.Discussion:If the outcome of this study confirms acupuncture to be an effective therapy to reduce hot flashes in menopausal women,we expect this study to inspire further investigations and provide useful information in forming an optimal acupuncture treatment protocol for clinic.Trial registration:Chinese Clinical Trial Registry identifier:ChiCTR1800018638,Date of registration:30 th September 2018.URL:http://www.chictr.org.cn/showproj.aspx?proj=31462.Background:Hot flashes are one of the most common symptoms in menopause and significantly affect the quality of life of 67% of menopausal women.Acupuncture is found to be a low risk treatment in treating hot flashes but the evidence for its effectiveness is inconclusive.We developed an optimized acupuncture treatment protocol and designed a randomized controlled trial(RCT) to assess the efficacy of acupuncture for reducing hot flashes in menopausal women.Methods:This is a single-site,single-blind,randomized sham-controlled trial with two parallel arms.A total of 60 eligible patients will be recruited and randomly assigned to either the acupuncture group(n=30) or the sham acupuncture group(n=30).Treatment will be given twice a week,for 30 min,for six consecutive weeks.The primary outcome is the hot flashes scores,assessed using the validated hot flashes diary at baseline,week 3,week 6 and week 10.The secondary outcome will be measured by menopause-specific quality of life(MENQOL) at baseline,week 6,and week 10.Meanwhile,any adverse events will be recorded.Discussion:If the outcome of this study confirms acupuncture to be an effective therapy to reduce hot flashes in menopausal women,we expect this study to inspire further investigations and provide useful information in forming an optimal acupuncture treatment protocol for clinic.Trial registration:Chinese Clinical Trial Registry identifier:ChiCTR1800018638,Date of registration:30 th September 2018.URL:http://www.chictr.org.cn/showproj.aspx?proj=31462.

关 键 词：Hot flashes MENOPAUSE ACUPUNCTURE Randamized controlled trial(RCT) 

分 类 号：R246.3[医药卫生—针灸推拿学]