Clinical studyEffect of postmenopausal hormone therapy on cognitive function: the Heart and Estrogen/progestin Replacement Study☆
Section snippets
Subjects and methods
The design, methods, baseline findings, and main outcomes of the trial have been published 9, 10. Briefly, participants were postmenopausal women younger than 80 years old with established coronary disease and an intact uterus. Participants were assigned randomly to daily oral conjugated estrogen (0.625 mg) and medroxyprogesterone acetate (2.5 mg) in one tablet (Prempro, Wyeth-Ayerst, Radnor, Pennsylvania) or identical placebo. Randomization was stratified by clinical center. Participants,
Results
Between January 1993 and September 1994, the 10 HERS centers that participated in this ancillary study enrolled 1328 women; 662 were assigned randomly to estrogen plus progestin therapy and 666 to placebo. All participants were fluent in English. By the end of the trial, 61 women in the hormone group and 58 women in the placebo group had died. Twenty-eight women in the hormone group and 22 in the placebo group were willing but unable to complete cognitive testing because of physical problems
Discussion
Compared with placebo, 4 years of treatment with oral estrogen plus progestin did not result in better cognitive function in elderly women. Rather, the age-adjusted mean score on one of the six cognitive tests was statistically significantly worse among women assigned to hormones compared with those assigned to placebo. However, the absolute difference in scores between the groups was small and not likely to be clinically important. Similar proportions of the hormone and placebo groups were
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This research was funded by Wyeth-Ayerst Research, Radnor, Pennsylvania. Dr. Yaffe is supported by grant K23-AG00888 from the National Institute on Aging and a Paul Beeson Faculty Scholars Award.