MSI FLASH: An RCT of Yoga and Ultra Low-Dose Estrogen Gel for Vasomotor Symptoms

MSI FLASH：瑜伽和超低剂量雌激素凝胶治疗血管舒缩症状的随机对照试验

• 批准号: 7923833
• 负责人: Katherine M. Newton
• 金额: $ 35.5万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-15 至 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7923833
• 关键词: Age; Alternative Therapies; Behavioral; Boston; Breathing; Breathing Exercises; Clinical; Coagulation Process; Controlled Study; Data Coordinating Center; Development; Dose; Estradiol; Estrogen Therapy; Estrogens; Event; Frequencies; Gel; Goals; Hepatic; Home environment; Hormonal; Hot flushes; Inflammation; Intervention; Lateral; Measures; Meditation; Menopausal Symptom; Menopause; Mind-Body Intervention; Monitor; Moods; NCI Center for Cancer Research; Outcome; Philadelphia; Placebos; Posture; Progestins; Publications; Randomized; Randomized Controlled Trials; Recruitment Activity; Research Design; Research Personnel; Risk; Safety; Site; Sleep; Sweat; Sweating; Symptoms; Testing; Training; Vasomotor; Woman; Women' s Health; Work; Yoga; arm; body-mind; clinical research site; design; experience; hormone therapy; instructor; interest; intervention effect; multidisciplinary; programs; response; secondary outcome

DESCRIPTION (provided by applicant): This application describes one of five proposals being submitted in conjunction with the network application entitled, "The Menopausal Symptoms Initiative -Finding Lasting Answers to Sweats and Hot Flashes (MSI- FLASH)". Our network and data coordinating center (DCC) will be jointly led by two Co-PIs of the Women's Health Initiative, Clinical Coordinating Center (Seattle) who have worked together for over a decade (LaCroix, Anderson, PIs). The MSI-FLASH network has five clinical sites: Boston, MA (Cohen, Joffe, PIs); Indianapolis, IN (Carpenter, PI); Oakland, CA (Sternfeld, Caan, PIs); Philadelphia, PA (Freeman, PI); and Seattle, WA (Newton, Reed, PIs). This multidisciplinary investigator group proposes five randomized controlled trials testing a range of behavioral, mind-body, hormonal and pharmacologic interventions. Our overall goal is to fulfill the main objective of the RFA, "New Interventions for Menopausal Symptoms (U01)", to accelerate the identification of effective remedies for vasomotor symptoms (VMS). In this site application we propose a multicenter, factorial design, RCT of yoga, ultra low-dose estradiol (E2) gel and placebo gel to be conducted in Seattle, Indianapolis and Boston. The primary aims are to: 1. Evaluate the effects of yoga vs. no yoga on: a) subjective VMS frequency; and b) VMS bothersomeness; and 2. Evaluate the effects of ultra-low dose estrogen (E2) gel vs. placebo gel on: a) subjective VMS frequency; and b) bothersomeness. Our hypotheses are that 1. The effect of yoga will be greater than no yoga on: a) subjective VMS frequency and b) VMS bothersomeness; and 2. The effect of ultra-low dose E2 gel will be greater than no E2 gel on: a) subjective VMS frequency; and b) bothersomeness. Our secondary aims are: 1. To evaluate the effects of yoga and ultra-low dose E2 gel on other common menopause outcomes including: a) objective VMS frequency (Bahr monitor); b) sleep (PSQI, Actigraph"); and c) mood (CESD, HADS); and 2. To examine whether the combined effect of yoga and ultra low-dose E2 on our primary and secondary outcomes is greater than the effect of either alone. To accomplish our specific aims we will: 1) recruit and randomize 400 women to one of 4 treatment arms for 12 weeks (placebo gel; yoga + placebo gel; ultra low-dose E2 gel; yoga + ultra low-dose E2 gel); 2) measure primary and secondary outcomes at baseline and 12 weeks; and 3) compare changes in outcomes in yoga and ultra low-dose E2 gel groups to placebo; and 4) compare changes in primary and secondary outcomes for yoga + ultra low-dose E2 gel to the effects of either intervention alone (if yoga alone is efficacious).

描述（由申请人提供）：该申请描述了与网络申请一起提交的五个提案中的一个，题为“更年期症状倡议-寻找出汗和潮热的持久答案（MSI- FLASH）”。我们的网络和数据协调中心（DCC）将由妇女健康倡议临床协调中心（西雅图）的两个共同pi共同领导，他们已经在一起工作了十多年（LaCroix, Anderson, pi）。MSI-FLASH网络有五个临床站点：马萨诸塞州波士顿（Cohen, Joffe, pi）；印第安纳州印第安纳波利斯（卡彭特，PI）；奥克兰，CA（斯特恩菲尔德，凯恩，PIs）；费城，PA（弗里曼，PI）；和西雅图，WA（牛顿，里德，pi）。这个多学科研究小组提出了五项随机对照试验，测试一系列行为、身心、激素和药物干预。我们的总体目标是实现RFA的主要目标，“更年期症状的新干预措施（U01）”，加速血管舒缩症状（VMS）的有效补救措施的识别。在此现场申请中，我们建议在西雅图、印第安纳波利斯和波士顿进行多中心、因子设计、瑜伽、超低剂量雌二醇（E2）凝胶和安慰剂凝胶的随机对照试验。主要目标是：1。评估瑜伽与不瑜伽对以下方面的影响：a)主观VMS频率；和b) VMS的麻烦；和2。评估超低剂量雌激素（E2）凝胶与安慰剂凝胶对：a)主观VMS频率的影响；b)麻烦。假设是1。瑜伽的影响将大于不瑜伽：a)主观VMS频率和b) VMS烦人；和2。超低剂量E2凝胶对：(a)主观VMS频率的影响大于未使用E2凝胶；b)麻烦。我们的次要目标是：1。评估瑜伽和超低剂量E2凝胶对其他常见绝经结局的影响，包括：a)客观VMS频率（Bahr监测仪）；b)睡眠（PSQI, Actigraph”）；c)心境（CESD， HADS）；和2。为了检查瑜伽和超低剂量E2对我们的主要和次要结果的联合影响是否大于单独使用任何一种的影响。为了实现我们的具体目标，我们将：1)招募并随机分配400名女性到4个治疗组之一，为期12周（安慰剂凝胶、瑜伽+安慰剂凝胶、超低剂量E2凝胶、瑜伽+超低剂量E2凝胶）；2)测量基线和12周时的主要和次要结局；3)比较瑜伽组和超低剂量E2凝胶组与安慰剂组的结局变化；4)比较瑜伽+超低剂量E2凝胶与单独干预（如果单独瑜伽有效）的主要和次要结果的变化。