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Effects of Conjugated Equine Estrogen on Health-Related Quality of Life in Postmenopausal Women With Hysterectomy
Results From the Women’s Health Initiative Randomized Clinical Trial
Robert L. Brunner, PhD;
Margery Gass, MD;
Aaron Aragaki, MS;
Jennifer Hays, PhD;
Iris Granek, MD;
Nancy Woods, PhD, RN;
Ellen Mason, MD;
Robert Brzyski, MD, PhD;
Judith Ockene, PhD;
Annlouise Assaf, PhD;
Andrea LaCroix, MPH, PhD;
Karen Matthews, PhD;
Robert Wallace, MD; for the Women’s Health Initiative Investigators
Arch Intern Med. 2005;165:1976-1986.
Background The Women’s Health Initiative (WHI) clinical trial of conjugated equine estrogens (CEEs), involving 10 739 postmenopausal women with hysterectomy, aged 50 to 79 years, was stopped early owing to lack of overall health benefit and increased risk of stroke. Because CEE is still prescribed for treatment of menopausal symptoms and prevention of osteoporosis, it is important to understand the overall impact of this therapy on health-related quality of life (HRQOL).
Methods All participants completed 6 specific measures of quality of life at baseline and 1 year, and a subsample (n = 1189) also completed the questions 3 years after randomization. Changes in scores were analyzed for treatment effect.
Results Randomization to CEE was associated with a statistically significant but small reduction in sleep disturbance at year 1 compared with baseline (mean benefit, 0.4 points on a 20-point scale) and a statistically significant but small negative effect on social functioning (mean effect, –1.3 points on a 100-point scale). There were no significant improvements due to CEE in the areas of general health, physical functioning, pain, vitality, role functioning, mental health, depressive symptoms, cognitive function, or sexual satisfaction at year 1. A subgroup examined 3 years after baseline had no significant benefits for any HRQOL outcomes. Among women aged 50 to 54 years with moderate to severe vasomotor symptoms at baseline, CEE did not improve any of the HRQOL variables at year 1.
Conclusion In this trial of postmenopausal women with prior hysterectomy, oral CEE did not have a clinically meaningful effect on HRQOL.
Author Affiliations: Department of Family and Community Medicine, University of Nevada School of Medicine, Reno (Dr Brunner); Department of Obstetrics/Gynecology, University of Cincinnati, Cincinnati, Ohio (Dr Gass); Clinical Coordinating Center, Fred Hutchinson Cancer Research Center (Mr Aragaki and Dr LaCroix), and University of Washington School of Nursing, Center for Women’s Health Research (Dr Woods), Seattle; Women’s Health Center, Department of Medicine, Baylor College of Medicine, Houston, Tex (Dr Hays); Department of Preventive Medicine, State University of New York at Stony Brook (Dr Granek); Department of Obstetrics and Gynecology, John H. Stroger Jr Hospital of Cook County, Chicago, Ill (Dr Mason); Department Obstetrics and Gynecology, University of Texas Health Science Center, San Antonio (Dr Brzyski); Division of Preventive and Behavioral Medicine, University of Massachusetts Medical School, Worcester (Dr Ockene); Department of Community Health, Brown University, Providence, RI (Dr Assaf); Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pa (Dr Matthews); and Department of Epidemiology, University of Iowa, Iowa City (Dr Wallace).
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