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.

Public Health Relevance

For many women, hot flashes and/or night sweats can be troubling symptoms associated with menopause. The only currently effective treatment for hot flashes is hormone therapy, which many women are reluctant to take because of potential risks and adverse side effects. This projects seeks to determine if yoga can be an effective method to reduce the frequency and/or severity of hot flashes.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21AT004234-02
Application #
7809451
Study Section
Special Emphasis Panel (ZAT1-JH (28))
Program Officer
Alekel, D Lee
Project Start
2009-05-01
Project End
2012-04-30
Budget Start
2010-05-01
Budget End
2011-04-30
Support Year
2
Fiscal Year
2010
Total Cost
$183,150
Indirect Cost
Name
Wake Forest University Health Sciences
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
937727907
City
Winston-Salem
State
NC
Country
United States
Zip Code
27157
Avis, Nancy E; Legault, Claudine; Russell, Gregory et al. (2014) Pilot study of integral yoga for menopausal hot flashes. Menopause 21:846-54