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Raloxifene and Estrogen Effects on Quality of Life in Healthy Postmenopausal Women: A Placebo-Controlled Randomized Trial

From the Department of Obstetrics and Gynecology, Henry Ford Hospital, Detroit, Michigan; the Department of Obstetrics and Gynecology, Virginia Commonwealth University, Richmond, Virginia; Barnes Jewish Hospital, St. Louis, Missouri; and Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.

Address reprint requests to: Sheryl L. Silfen, MD Lilly Research Laboratories Eli Lilly and Company Indianapolis, IN 46285

Objective: To assess the effects of raloxifene, estrogen, and placebo on quality of life in healthy, asymptomatic, postmenopausal women.

Methods: In a multicenter, double-blind, 12-month study, 398 women were assigned randomly to one of four groups: raloxifene HCl, 60 (n = 97) or 150 mg/day (n = 100); conjugated equine estrogens, 0.625 mg/day (n = 96); or placebo (n = 105). The Women’s Health Questionnaire, a validated quality-of-life instrument for perimenopausal and postmenopausal women, was administered at baseline and 3-month intervals.

Results: Overall, quality of life from baseline to end point was preserved equally in all treatment groups. Six domains (depressed mood, somatic symptoms, memory/ concentration, sexual behavior, sleep problems, and perceived attractiveness) were unchanged in all groups. Three domains (menstrual symptoms, vasomotor symptoms, and anxiety/fears) were statistically significantly different among groups. Mean scores for menstrual symptoms significantly worsened and vasomotor symptoms significantly improved from baseline to end point in the estrogen group. Mean scores for vasomotor symptoms did not worsen at any point in the raloxifene 60 mg/day group. Mean anxiety/fears scores improved significantly during raloxifene 60 mg/day administration throughout treatment (P < .05), irrespective of previous hormone replacement therapy, baseline estradiol (E2) levels, or years postmenopause.

Conclusion: Most quality-of-life domains were not affected by treatment with estrogen or raloxifene. Estrogen provided relief from vasomotor symptoms but caused menstrual symptoms. Raloxifene 60 mg/day improved anxiety levels in postmenopausal women.

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