Although the primary endpoint resulted in null findings, researchers presented data from the National Institute on Aging, NIH-funded randomized clinical trial, Menopause Strategies: Finding Lasting Answers for Symptoms and Health, or MsFLASH here.
Andrea Z. LaCroix, PhD, professor of epidemiology in the division of public health sciences and co-principal investigator of the MsFLASH Data Coordinating Center at the Fred Hutchinson Cancer Research Center in Seattle, told Endocrine Today that some statistically significant findings were evident for secondary endpoints such as depressive symptoms and sleep problems.
The 3-by-2 factorial design, 12-week trial evaluated interventions including yoga, aerobic exercise and omega-3 fish oil supplementation.
LaCroix and colleagues sent requests for participation and 7,377 women responded. Of the responses, 355 (4.8%) women with 2 or more hot flashes daily and not already exercising, practicing yoga or taking omega-3 supplements, (mean age, 54.7 years) were randomly assigned to yoga (30%), exercise (30%) and usual activity (40%).
“One of the hardest things about this recruitment was we had to find women who weren’t already doing yoga or aerobic exercise, or taking omega-3 supplements and had hot flashes,” LaCroix told Endocrine Today.
The yoga intervention included a class series, “Yoga for Mid-Life Women,” with poses, breathing exercises and meditation. The women attended a weekly class and continued to practice at home daily.
Women in the exercise group attended aerobic exercise training classes using [on] a treadmill, stationary bicycle or elliptical trainer three times per week in a local fitness facility, LaCroix said.
Lastly, the omega-3 supplement or a matching placebo was administered to all patients in 615 mg gel capsules daily.
“None of the three interventions reduced hot flashes. For that indication, we have very clear null results,” LaCroix said.
“What we did find was that the secondary endpoints (ie, sleep problems, depressive symptoms [on] and anxiety symptoms) showed improvement with yoga or exercise. For sleep and depression, there were significant benefits of doing aerobic exercise and not any difference in adverse effects. Sleep and depression improved with exercise. We also had this result from yoga,” she said.
Regarding insomnia, sleep quality and depression for all three outcomes, LaCroix said there was a benefit of doing yoga compared with the usual activity group.
“These are things that bother women quite a lot in menopause. For omega-3, it’s simple. We saw absolutely nothing. The hot flashes were completely null; there were no differences in the secondary endpoints, and no differences in menopause-related quality of life. It didn’t hurt anybody, but it turns out, in this trial, the omega-3 was an excellent placebo,” LaCroix said.
The yoga intervention may have provided an array of beneficial effects related to stress reduction similar to mindfulness-based approaches and other interventions that reduce sympathetic nervous system arousal [stress reduction and more], she said.
“This was not an intervention that would improve fitness level at all, so it’s very different from exercise. However, it may have decreased sympathetic nervous system response tone and increased parasympathetic response tone every single day,” LaCroix said. “This intervention was actually a big success. If you can help with insomnia, sleep problems and depression, you’re doing midlife women a lot of good.”
For more information:
LaCroix AZ. MsFLASH Research Network. Presented at: the North American Menopause Society’s 23rd Annual Meeting; Oct. 3-6, 2012; Orlando, Fla.
Disclosure: LaCroix has no relevant financial disclosures.