Effectiveness of Integral Yoga on Objective and Subjective Menopausal Hot Flashes

描述（由申请人提供）：血管舒缩症状-潮热和盗汗-是与更年期相关的最常见和最令人不安的症状。对许多女性来说，这些症状可能频繁而严重，足以使人虚弱并干扰日常活动。它们通常发生在晚上，使女性从睡眠中醒来，导致白天烦躁或疲劳。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，治疗血管舒缩症状的金标准是雌激素治疗。然而，HT与许多风险相关，并且通常是乳腺癌高风险妇女和乳腺癌患者的禁忌症。考虑到与高温疗法相关的风险和副作用，许多女性寻求替代疗法来治疗潮热。不幸的是，这些治疗方法中有很多副作用的发生率很高，或者没有被证明是有效的。包括放松和缓慢的深腹式呼吸在内的行为干预被发现对减少轻度到中度的潮热很有用。这些呼吸技巧构成了任何瑜伽练习中最完整的核心。瑜伽练习包括身体姿势（体式）、呼吸（调息）和深度放松（savasana）的组合。瑜伽可能有助于缓解更年期潮热。我们选择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试点拨款的主要目标是获得关于整体瑜伽减少更年期潮热功效的初步数据。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，与两个对照组相比，瑜伽组在主观潮热频率和严重程度上有更大的降低。次要结果将包括客观热闪频率的更大减少；更大程度地减少热闪干扰；瑜伽组在睡眠、其他症状、情绪和整体生活质量方面有更大的改善。共有60名绝经前后或刚绝经的女性每天至少经历7次潮热，将被招募并随机分配参加为期10周的每周瑜伽课程，一个教育对照组，或一个等候名单对照组。瑜伽干预组的女性将被鼓励在家练习瑜伽。在此期间，所有女性都将监测她们的主观潮热。女性将在试验开始、中期和结束时佩戴一个动态热闪监测器3天。10周后，等候名单上的女性将被随机分配参加瑜伽或教育课程。干预后2个月将进行随访。在这项试点资助之后，我们计划寻求R01资金来进行一项关于瑜伽有效性的全动力随机试验。

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.