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	Full Text PDF PDA Full Text Perspective by Grady, D. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background The Women's Health Initiative (WHI) and other clinical trials indicate that significant health risks are associated with combination hormone use. Less is known about the effect of hormone therapy on health-related quality of life.

Methods The WHI randomly assigned 16,608 postmenopausal women 50 to 79 years of age (mean, 63) with an intact uterus at base line to estrogen plus progestin (0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate, in 8506 women) or placebo (in 8102 women). Quality-of-life measures were collected at base line and at one year in all women and at three years in a subgroup of 1511 women.

Results Randomization to estrogen plus progestin resulted in no significant effects on general health, vitality, mental health, depressive symptoms, or sexual satisfaction. The use of estrogen plus progestin was associated with a statistically significant but small and not clinically meaningful benefit in terms of sleep disturbance, physical functioning, and bodily pain after one year (the mean benefit in terms of sleep disturbance was 0.4 point on a 20-point scale, in terms of physical functioning 0.8 point on a 100-point scale, and in terms of pain 1.9 points on a 100-point scale). At three years, there were no significant benefits in terms of any quality-of-life outcomes. Among women 50 to 54 years of age with moderate-to-severe vasomotor symptoms at base line, estrogen and progestin improved vasomotor symptoms and resulted in a small benefit in terms of sleep disturbance but no benefit in terms of the other quality-of-life outcomes.

Conclusions In this trial in postmenopausal women, estrogen plus progestin did not have a clinically meaningful effect on health-related quality of life.

Source Information

From the Department of Medicine, Baylor College of Medicine, Houston (J.H.); the Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester (J.K.O.); the Women's Health Center, University of Nevada School of Medicine, Reno (R.L.B.); the Division of Epidemiology, Medical College of Wisconsin, Milwaukee (J.M.K.); the Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston (J.E.M.); the Fred Hutchinson Cancer Research Center, Seattle (R.E.P., A.K.A., A.Z.L.); the Department of Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, N.C. (S.A.S.); the Department of Obstetrics and Gynecology, University of Texas Health Science Center, San Antonio (R.G.B.); the Department of Preventive Medicine, State University of New York at Stony Brook, Stony Brook (I.A.G.); and the Epidemiology and Disease Prevention Program, Kaiser Permanente Center for Health Research, Portland, Oreg. (B.G.V.).

This article was published at www.nejm.org on March 17, 2003.

Address reprint requests to Dr. Hays at the Center for Women's Health, Department of Medicine, Baylor College of Medicine, 6535 Fannin St., M.S. A701, Houston, TX 77025, or at jhays{at}bcm.tmc.edu.

Full Text of this Article

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Effects of Estrogen plus Progestin on Health-Related Quality of Life
Lopes A. A., Latado A., Lopes G. B., Watts N. B.
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N Engl J Med 2004; 350:622, Feb 5, 2004. Correspondence

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