Effect of Yoga on Objective and Subjective Menopausal Hot Flashes
Condition: Vasomotor Symptoms
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      The purpose of this research study is to compare yoga and health and wellness classes for
      helping perimenopausal or newly postmenopausal women who are experiencing hot flashes. The
      investigators want to learn about the effects of yoga and health and wellness classes on
      symptoms and other quality of life issues. The results of this study may provide important
      knowledge to women and clinicians who counsel women with menopausal hot flashes.
    

Detailed description: 
      Hot flashes and/or night sweats are the most common and troubling symptoms associated with
      menopause. It is estimated that 64% to 87% of women report experiencing hot flashes for an
      average of about 4 years. For many women, these symptoms are frequent and severe enough to
      become debilitating and interfere with daily activities. They often occur at night,
      disturbing sleep and leading to daytime irritability, fatigue and depressed mood. About
      30-40% of menopausal women seek medical help for hot flashes. Relief from hot flashes has
      been shown to be the primary reason that women initiate hormone therapy (HT).

      HT is currently the gold standard for treatment of vasomotor symptoms. A Cochrane Database
      systematic review showed a 75% reduction in hot flash frequency with hormone therapy compared
      to placebo.1 However, recent findings from the Women's Health Initiative (WHI) trial indicate
      that benefits of HT are outweighed by risks, such as coronary heart disease, stroke,
      pulmonary embolism, breast cancer, and probable dementia. The wide publicity of the WHI
      results has heightened women's concerns about taking HT and many women have sought
      alternative treatments for hot flashes. These alternatives include other pharmaceutical
      agents, herbal or dietary remedies, and behavioral therapies. Unfortunately, many of these
      agents have a high incidence of side effects or have not been shown to be effective. A recent
      NIH conference has called for more research on alternative treatments for hot flashes.

      Behavioral interventions involving relaxation and slow deep, abdominal breathing have been
      found to be useful for reducing mild- to moderate-intensity hot flashes. Although the
      physiological mechanisms for the effectiveness of these interventions are not completely
      understood, there is some suggestion that they may help reduce sympathetic activity which is
      related to the narrowing of the thermoneutral zone. It is currently thought that hot flashes
      are linked to a disruption in thermoregulation and that elevated levels of brain
      norepinephrine may be the primary mechanism for altered thermoregulation. Breathing
      techniques form the most integral core of any yoga practice which involves the combination of
      physical postures (asanas), breathing (pranayama), and deep relaxation (savasana). Despite
      suggestions that yoga may be beneficial for the relief of hot flashes, these potential
      benefits have not been well-studied.

      To date, treatment efficacy for hot flashes has been limited to self-reported, subjective
      symptoms. While subjective hot flashes are important from a woman's perspective in her
      decision-making with respect to treatment, research has shown that they can be influenced by
      mood and reporting biases. Objective measures are not subject to these biases and have the
      advantage of providing insight as to whether an intervention has a physiological effect.
      However, until recently, reliable objective measures that could be used in an ambulatory
      setting were not available. NCCAM has recently funded the development of new technologies to
      monitor objective hot flashes in an ambulatory setting, as measured by skin conductance. This
      technology greatly enhances our ability to fully evaluate the impact of treatment on both
      subjective and objective hot flashes.

      The primary goal of this R21 pilot grant is to obtain preliminary data on the efficacy of
      Integral Yoga for reducing self-reported 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 will be a greater reduction in subjective hot flash
      frequency and severity in the yoga group than in two control groups. Secondary outcomes will
      include a greater reduction in objective hot flash frequency; a greater decrease in hot flash
      interference; and greater improvement in sleep, other symptoms, mood, perceived stress, and
      overall quality of life in the yoga group.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention description(s): Integral Yoga class (90 minutes per class), Once weekly for 10 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Menopause; Hot Flashes; Vasomotor symptoms; Yoga