Effectiveness of Integral Yoga on Objective and Subjective Menopausal Hot Flashes

描述(申请人提供)：血管运动症状-潮热和盗汗-是与更年期有关的最常见和最令人担忧的症状。对于许多女性来说，这些症状可能会频繁和严重到足以使人虚弱并干扰日常活动。它们通常发生在晚上，将女性从睡眠中唤醒，导致白天易怒或疲劳。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，治疗血管运动症状的金标准是雌激素疗法。然而，羟色胺与许多风险有关，通常是乳腺癌高危女性和患有乳腺癌的女性的禁忌。考虑到与高血压相关的风险和副作用，许多女性寻求治疗潮热的替代疗法。不幸的是，这些治疗中的许多都有很高的副作用发生率，或者没有被证明是有效的。行为干预包括放松和缓慢的深腹呼吸，已经被发现对减少轻度到中等强度的潮热是有用的。这些呼吸技巧构成了任何瑜伽练习中最不可或缺的核心。瑜伽练习包括身体姿势(体式)、呼吸(调息)和深度放松(体式)。瑜伽可能有益于缓解更年期潮热。我们选择了整体式瑜伽作为一种特别适合潮热女性的瑜伽，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有关积分瑜伽减少更年期潮热的疗效的初步数据。次要目标是确定瑜伽对客观潮热和其他结果的影响，并研究其可行性。我们的主要假设是，与两个对照组相比，瑜伽组的主观潮热频率和严重程度的下降幅度更大。次要结果将包括客观潮热频率的更大减少；热潮热干扰的更大减少；瑜伽组在睡眠、其他症状、情绪和总体生活质量方面的更大改善。共有60名围绝经期或新近绝经后的女性每天至少有7次潮热，他们将被招募并随机分配到每周一次的瑜伽课程中，为期10周，作为教育对照组或等待名单对照组。瑜伽干预组将鼓励女性在家练习瑜伽。在此期间，所有女性都将监测她们的主观潮热。女性将在试验期开始、中期和结束时佩戴为期3天的动态潮热监测仪。10周后，等待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个月进行随访。在这笔试点拨款之后，我们计划寻求R01资金，以进行一项关于瑜伽有效性的全功率随机试验。

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.