Effectiveness of Integral Yoga on Objective and Subjective Menopausal Hot Flashes

描述（由申请人提供）：血管症状-潮热和盗汗-是与更年期有关的最常见和最令人不安的症状。对于许多女性来说，这些症状可能是频繁和严重的，足以使人衰弱并干扰日常活动。它们通常发生在夜间，将妇女从睡眠中惊醒，导致白天烦躁不安或疲劳。缓解潮热和盗汗已被证明是女性开始激素治疗（HT）的主要原因。目前，治疗血管痉挛症状的金标准是雌激素治疗。然而，HT与许多风险相关，并且通常禁忌于乳腺癌高危女性和患有乳腺癌的女性。考虑到与HT相关的风险和副作用，许多女性已经寻求潮热的替代治疗。不幸的是，这些治疗中的许多具有高副作用发生率或尚未显示出有效性。已经发现，包括放松和缓慢的深腹式呼吸在内的行为干预对于减少轻度至中度的潮热是有用的。这些呼吸技巧是任何瑜伽练习中最重要的核心。瑜伽练习包括身体姿势（体式），呼吸（调息）和深度放松（萨瓦萨纳）的组合。瑜伽可能有助于缓解更年期潮热。我们选择了整体瑜伽作为一种特别适合经历潮热的女性的瑜伽，因为它主要强调减压-深度放松，呼吸和冥想。这项R21试点补助金的主要目标是获得关于整体瑜伽减少更年期潮热疗效的初步数据。次要目的是确定瑜伽对客观潮热和其他结果的影响以及研究的可行性。我们的主要假设是，瑜伽组的主观潮热频率和严重程度比两个对照组有更大的降低。次要结果将包括客观潮热频率的更大减少;潮热干扰的更大减少;瑜伽组的睡眠，其他症状，情绪和整体生活质量的更大改善。将招募总共60名每天至少经历7次潮热的绝经期或新绝经后妇女，并随机分配参加为期10周的每周瑜伽课程，教育对照组或候补对照组。瑜伽干预组的妇女将被鼓励在家里练习瑜伽。在此期间，所有女性都将监测其主观潮热。女性将在试验期开始、中间和结束时佩戴动态潮热监测仪3天。10周后，候补名单上的妇女将被随机分配参加瑜伽或教育课程。将在干预后2个月进行随访。在这项试点拨款之后，我们计划寻求R 01资金，对瑜伽的有效性进行完全随机试验。

DESCRIPTION (provided by applicant): Vasomotor symptoms - hot flashes and night sweats - are the most common and troubling symptoms associated with menopause. For many women, these symptoms can be frequent and severe enough to become debilitating and interfere with daily activity. They often occur at night, waking women from sleep and leading to daytime irritability or fatigue. Relief from hot flashes and night sweats has been shown to be the primary reason that women initiate hormone therapy (HT). Currently, the gold standard for treatment of vasomotor symptoms is estrogen therapy. HT, however, is associated with a number of risks and is often contraindicated for women at high risk for breast cancer and those who have had breast cancer. Given the risks and side effects associated with HT, many women have sought alternative treatments for hot flashes. Unfortunately, many of these treatments have a high incidence of side effects or have not been shown to be effective. Behavioral interventions involving relaxation and slow deep, abdominal breathing have been found to be useful for reducing mild- to moderate-intensity hot flashes. These breathing techniques form the most integral core of any yoga practice. Yoga practice involves the combination of physical postures (asanas), breathing (pranayama), and deep relaxation (savasana). Yoga may be beneficial for relief of menopausal hot flashes. We have chosen Integral yoga as a type particularly well-suited to women experiencing hot flashes because of the major emphasis on stress reduction - deep relaxation, breathing, and meditation. The primary goal of this R21 pilot grant is to obtain preliminary data on the efficacy of Integral Yoga for reducing menopausal hot flashes. Secondary aims are to determine the impact of yoga on objective hot flashes and other outcomes and study feasibility. Our primary hypothesis is a greater reduction in subjective hot flash frequency and severity in the yoga group than two control groups. Secondary outcomes will include a greater reduction in objective hot flash frequency; a greater decrease in hot flash interference; greater improvement in sleep, other symptoms, mood, and overall quality of life in the yoga group. A total of 60 peri- or newly postmenopausal women experiencing at least 7 hot flashes per day will be recruited and randomly assigned to participate in weekly yoga sessions for 10 weeks, an educational control group, or a waitlist control group. Yoga Intervention group women will be encouraged to practice yoga at home. During this time, all women will monitor their subjective hot flashes. Women will wear an ambulatory hot flash monitor for 3 days at the beginning, middle, and end of the trial period. After 10 weeks, waitlist women will be randomly assigned to participate in yoga or educational sessions. A follow-up will be conducted 2 months post-intervention. Following this pilot grant, we plan to seek R01 funding to conduct a fully powered randomized trial on the effectiveness of yoga.