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- Title
Effect of Estrogen Plus Progestin on Global Cognitive Function in Postmenopausal Women: The Women's Health Initiative Memory Study: A Randomized Controlled Trial.
- Authors
Rapp, Stephen R.; Espeland, Mark A.; Shumaker, Sally A.; Henderson, Victor W.; Brunner, Robert L.; Manson, JoAnn E.; Gass, Margery L. S.; Stefanick, Marcia L.; Lane, Dorothy S.; Hays, Jennifer; Johnson, Karen C.; Coker, Laura H.; Dailey, Maggie; Bowen, Deborah
- Abstract
Context: Observational studies have suggested that postmenopausal hormone treatment may improve cognitive function, but data from randomized clinical trials have been sparse and inconclusive. The Women's Health Initiative Memory Study (WHIMS) is an ancillary study of the Women's Health Initiative (WHI) hormone therapy trials. On July 8, 2002, the estrogen plus progestin therapy in the WHI trial was discontinued because of certain increased health risks for women. Objective: To determine whether estrogen plus progestin therapy protects global cognitive function in older postmenopausal women. Design, Setting, and Participants: A randomized, double-blind, placebo-controlled clinical trial, WHIMS is an ancillary study of geographically diverse, community-dwelling women aged 65 years or older from 39 of 40 clinical centers within the WHI estrogen plus progestin trial that started in June 1995. Of 4894 eligible postmenopausal women aged 65 years or older and free of probable dementia at baseline, 4532 (92.6%) were enrolled in the estrogen plus progestin component of WHIMS. A total of 4381 participants (96.7%) provided at least 1 valid cognitive function score between June 1995 and July 8, 2002. Interventions: Participants received either 1 daily tablet containing 0.625 mg of conjugated equine estrogen with 2.5 mg of medroxyprogesterone acetate (n = 2145) or matching placebo (n = 2236). Main Outcome Measure: Global cognitive function measured annually with the Modified Mini-Mental State Examination. Results: The Modified Mini-Mental State Examination mean total scores in both groups increased slightly over time (mean follow-up of 4.2 years). Women in the estrogen plus progestin group had smaller average increases in total scores compared with women receiving placebo (P = .03), but these differences were not clinically important. Removing women by censoring them after adjudicated dementia, mild cognitive impairment, or stroke, and nonadherence to study protocol, did...
- Subjects
MENOPAUSE; HORMONE therapy; ESTROGEN; CLINICAL medicine
- Publication
JAMA: Journal of the American Medical Association, 2003, Vol 289, Issue 20, p2663
- ISSN
0098-7484
- Publication type
Article
- DOI
10.1001/jama.289.20.2663