Efficacy of omega-3 for vasomotor symptoms treatment: a randomized controlled trial
Lee S Cohen, Hadine Joffe, Katherine A Guthrie, Kristine E Ensrud, Marlene Freeman, Janet S Carpenter, Lee A Learman, Katherine M Newton, Susan D Reed, Joann E Manson, Barbara Sternfeld, Bette Caan, Ellen W Freeman, Andrea Z LaCroix, Lesley F Tinker, Cathryn Booth-Laforce, Joseph C Larson, Garnet L Anderson, Lee S Cohen, Hadine Joffe, Katherine A Guthrie, Kristine E Ensrud, Marlene Freeman, Janet S Carpenter, Lee A Learman, Katherine M Newton, Susan D Reed, Joann E Manson, Barbara Sternfeld, Bette Caan, Ellen W Freeman, Andrea Z LaCroix, Lesley F Tinker, Cathryn Booth-Laforce, Joseph C Larson, Garnet L Anderson
Abstract
Objective: This study aims to determine the efficacy and tolerability of omega-3 fatty acids in reducing vasomotor symptoms (VMS) frequency and bother in perimenopausal and postmenopausal women.
Methods: This study was a 12-week, three-by-two factorial, randomized controlled trial. Eligible women were randomized to a double-blind comparison of omega-3 (n = 177) or placebo (n = 178) capsules, and simultaneously to yoga (n = 107), aerobic exercise (n = 106), or their usual physical activity (n = 142). Participants received 1.8 g of omega-3 daily for 12 weeks. Each capsule contained ethyl eicosapentaenoic acid (425 mg), docosahexaenoic acid (100 mg), and other omega-3s (90 mg). Primary outcomes were VMS frequency and bother. Secondary outcomes included sleep quality (Pittsburgh Sleep Quality Index), insomnia symptoms (Insomnia Severity Index), depressive symptoms (Physician's Health Questionnaire-8), and anxiety (Generalized Anxiety Disorder-7).
Results: The mean baseline frequency of VMS per day was 7.6 (95% CI, 7.0 to 8.2). After 12 weeks, the reduction in VMS frequency with omega-3 (-2.5; 95% CI, -3.0 to -1.9) did not differ significantly from that with placebo (-2.7; 95% CI, -3.3 to -2.2), with a relative difference of 0.3 fewer hot flashes per day (95% CI, -0.5 to 1.0; P = 0.28). Changes in VMS bother at 12 weeks were also similar between groups, with no relative difference on a four-point scale (95% CI, -0.1 to 0.2; P = 0.36). Omega-3s compared with placebo showed no improvement in self-reported sleep or mood (P > 0.09 for all comparisons).
Conclusions: Among healthy, sedentary perimenopausal and postmenopausal women, a 12-week treatment with omega-3 does not improve VMS frequency, VMS bother, sleep, or mood compared with placebo.
Trial registration: ClinicalTrials.gov NCT01178892.
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Source: PubMed