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.
From the 1Massachusetts General Hospital, Boston, MA; 2MsFLASH Data Coordinating Center, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA; 3VA Medical Center, University of Minnesota, Minneapolis, MN; 4School of Nursing, Indiana University, Indianapolis, IN; 5Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN; 6Group Health Research Institute, Group Health Cooperative, Seattle, WA; 7Departments of Obstetrics/Gynecology and Epidemiology, University of Washington School of Medicine, Seattle, WA; 8Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA; 9Division of Research, Kaiser Permanente Medical Program of Northern California, Oakland, CA; 10Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA; and 11School of Nursing, University of Washington, Seattle, WA.
Received April 9, 2013; revised and accepted May 29, 2013.
Parts of this manuscript were presented at the annual meeting of The North American Menopause Society on October 7, 2012, in Orlando, FL.
Funding/support: This study was funded by the National Institutes of Health (as a cooperative agreement issued by the National Institute on Aging), Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Center for Complementary and Alternative Medicine, Office of Research on Women’s Health, and National Institute on Aging (grants U01 AG032656, U01AG032659, U01AG032669, U01AG032682, U01AG032699, and U01AG032700). At Indiana University, the project was partly funded by the Indiana Clinical and Translational Sciences Institute, National Institutes of Health grant UL1RR02571, National Center for Research Resources, and Clinical and Translational Sciences Award. The omega-3 study supplement (ω-3, n − 3, or polyunsaturated fatty acids) was manufactured as ethyl eicosapentaenoic acid and donated, with matching placebo, by Nordic Naturals.
Clinical trial registration: NCT01178892 (ClinicalTrials.gov).
Financial disclosure/conflicts of interest: L.S.C. has received research support from Astra-Zeneca Pharmaceuticals, Bristol-Myers Squibb, Cephalon Inc, National Institute on Aging, Ortho-McNeil Janssen, and Sunovion Pharmaceuticals Inc, and has served on the advisory board for and as consultant to Noven Pharmaceuticals. H.J. has received grant support from Cephalon/Teva, is on the advisory board for Noven, and has performed consulting for Sunovion. K.E.E. is a consultant to the Data Monitoring Committee for Merck, Sharp, and Dohme. M.F. has received research funding from GlaxoSmithKline, Forest Laboratories Inc, and Lilly, has performed consulting for PamLab, is on the advisory board for Takeda/Lundbeck and Otsuka, and has received stipends for medical editing from DSM Nutritionals. L.A.L. is a consultant to the Data Monitoring Committee for Ariosa Diagnostics. K.M.N. has received research support from Otsuka Pharmaceutical Co Ltd and Integrated Diagnostics Inc. E.W.F. has received research support from Forest Laboratories Inc and Bionovo Inc. All other authors have no direct conflicts of interest or financial disclosures relevant to this manuscript.
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Address correspondence to: Lee S. Cohen, MD, Massachusetts General Hospital, 185 Cambridge Street, Boston, MA 02114. E-mail: email@example.com