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Randomised controlled trial
Trial suggests yoga and exercise lead to modest improvements in menopause-related quality of life: longer term studies are needed
  1. Nancy Fugate Woods
  1. Department of Biobehavioral Nursing and Health Systems, University of Washington, Seattle, Washington, USA
  1. Correspondence to : Dr Nancy Fugate Woods, Department of Biobehavioral Nursing and Health Systems, University of Washington, Box 357266, Seattle, WA 98195, USA; nfwoods{at}uw.edu

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Context

Since publication of the Women's Health Initiative Study, the potential benefits of non-pharmacological therapies for menopause-related symptoms have gained increased interest among midlife women, clinicians and researchers.1 Interventions requiring behavioural change have yielded mixed outcomes, owing to small sample sizes, a variety of outcome measures, lack of control groups and limited follow-up.2–4

Methods

To assess the effects of exercise, yoga and ω-3 therapy on menopause-specific quality of life, MS-FLASH investigators conducted a multisite factorial design (3×2), randomised controlled trial in which women were randomised to 12 weeks of exercise, yoga or usual activity and simultaneously randomised to receive ω-3 supplements or a placebo.

The yoga intervention emphasised cooling breathing exercises (Asthana) and relaxation (Nidra) in 12 weekly 90 min classes and 20 min home-practice sessions on days with no class. The exercise intervention included three individual cardiovascular training sessions per week for 12 weeks, with targeted training heart rates of 50–60% of heart rate reserve for the first month and 60–70% for the remainder of the intervention.

Women exercised for 40–60 min per session to achieve a goal of 1000–1500 kcal expenditure per week. The ω-3 supplement contained 425 mg ethyl eicosapentaenoic acid, 100 mg docosahexaenoic acid and 90 mg of other ω-3 substances.

The efficient study design reflected typical health-promoting activities of many women by including multiple treatments, such as exercise and supplement use.

Investigators used the Menopausal Quality of Life Questionnaire (MENQOL) to assess primary outcomes at baseline and 12 weeks later. Additional validated measures included vasomotor symptoms recorded in daily diaries, the Insomnia Severity Index, Pittsburgh Sleep Quality Index, Patient Health Questionnaire measure of depression, Generalised Anxiety Disorder Scale, Hot Flash-Related Daily Interference Scale, Perceived Stress Scale, Pain Intensity, Interference with Enjoyment of Life, and Interference with General Activity Scale, and Female Sexual Function Index. Outcomes were compared across multiple measures and approximated clinically important differences. Intent-to-treat analyses examined primary outcomes using the MENQOL and its four subscales (vasomotor symptoms, physical, psychosocial and sexual functioning) adjusted for baseline measures, treatment centre and concurrent treatment with ω-3 or placebo. Analyses were also adjusted for symptom thresholds (eg, anxiety, depressive symptoms, sleep quality and insomnia) at baseline. Seventy-eight to eighty-three per cent of women were adherent to the various treatments.

Findings

Yoga resulted in a significantly greater improvement in MENQOL total, vasomotor and sexual domain scores at 12 weeks, compared with usual activity. Neither exercise nor ω-3 compared with usual activity or placebo resulted in significantly greater improvement in MENQOL total scores, but exercise resulted in significantly greater improvement in physical domain scores. Careful analyses of treatment effects on validated measures of symptoms revealed significant effects of yoga versus usual activity on the Hot Flash Daily Interference Scale scores.

Commentary

Effects of yoga and exercise on menopause-related quality of life were modest, although women using the yoga treatment did experience improvement in vasomotor symptoms and sexual domain scores on the MENQOL and on the Hot Flash Daily Interference Scale. Results of the yoga trial, in combination with positive findings from earlier trials and consideration of other health benefits of yoga, support its further testing and use for hot flashes for women who are able to tolerate the postures and have no contraindications. Exercise benefits for physical symptoms, cardiovascular health and maintenance of weight may support its adoption as a lifestyle change, although the efficacy for hot flashes is not supported by the MS-FLASH trial.

Adopting either yoga or an exercise programme involves a lifestyle change and one wonders whether the 12-week duration of these trials is sufficient to allow treatment effects to occur. A recent behavioural change trial for weight loss, including 200 min of exercise per week, revealed reduced frequency and severity of hot flashes after 24 weeks of treatment for women who lost weight.5 Evaluation of complex interventions such as yoga and exercise programmes may require an extended treatment period exceeding those that are typically used in the evaluation of pharmaceuticals.

References

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Footnotes

  • Competing interests None.

  • Provenance and peer review Commissioned; internally peer reviewed.