Cohen Lee S, Joffe Hadine, Guthrie Katherine A, Ensrud Kristine E, Freeman Marlene, Carpenter Janet S, Learman Lee A, Newton Katherine M, Reed Susan D, Manson Joann E, Sternfeld Barbara, Caan Bette, Freeman Ellen W, LaCroix Andrea Z, Tinker Lesley F, Booth-Laforce Cathryn, Larson Joseph C, Anderson Garnet L
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.
Menopause. 2014 Apr;21(4):347-54. doi: 10.1097/GME.0b013e31829e40b8.
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.
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).
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).
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.
本研究旨在确定ω-3脂肪酸在降低围绝经期和绝经后女性血管舒缩症状（VMS）频率及困扰方面的疗效和耐受性。
本研究为一项为期12周的三因素二水平析因随机对照试验。符合条件的女性被随机分为接受ω-3胶囊（n = 177）或安慰剂胶囊（n = 178）的双盲比较组，同时被分为瑜伽组（n = 107）、有氧运动组（n = 106）或其日常体育活动组（n = 142）。参与者每天服用1.8克ω-3，持续12周。每粒胶囊含有二十碳五烯酸乙酯（425毫克）、二十二碳六烯酸（100毫克）和其他ω-3脂肪酸（90毫克）。主要结局为VMS频率和困扰。次要结局包括睡眠质量（匹兹堡睡眠质量指数）、失眠症状（失眠严重程度指数）、抑郁症状（医生健康问卷-8）和焦虑（广泛性焦虑障碍-7）。
VMS的日均基线频率为7.6（95%可信区间，7.0至8.2）。12周后，ω-3组VMS频率的降低幅度（-2.5；95%可信区间，-3.0至-1.9）与安慰剂组（-2.7；95%可信区间，-3.3至-2.2）无显著差异，每天潮热次数的相对差异为少0.3次（95%可信区间，-0.5至1.0；P = 0.28）。12周时两组VMS困扰的变化也相似，在四分制量表上无相对差异（95%可信区间，-0.1至0.2；P = 0.36）。与安慰剂相比，ω-3脂肪酸在自我报告的睡眠或情绪方面未显示出改善（所有比较P > 0.09）。
在健康、久坐的围绝经期和绝经后女性中，与安慰剂相比，12周的ω-3脂肪酸治疗在改善VMS频率、VMS困扰、睡眠或情绪方面并无效果。
