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The Women's Health Initiative Memory Study: A Randomized Controlled Trial

Sally A. Shumaker, PhD; Claudine Legault, PhD; Stephen R. Rapp, PhD; Leon Thal, MD; Robert B. Wallace, MD; Judith K. Ockene, PhD, MEd; Susan L. Hendrix, DO; Beverly N. Jones III, MD; Annlouise R. Assaf, PhD; Rebecca D. Jackson, MD; Jane Morley Kotchen, MD, MPH; Sylvia Wassertheil-Smoller, PhD; Jean Wactawski-Wende, PhD; for the WHIMS Investigators

JAMA. 2003;289:2651-2662.

Context  Postmenopausal women have a greater risk than men of developing Alzheimer disease, but studies of the effects of estrogen therapy on Alzheimer disease have been inconsistent. On July 8, 2002, the study drugs, estrogen plus progestin, in the Women's Health Initiative (WHI) trial were discontinued because of certain increased health risks in women receiving combined hormone therapy.

Objective  To evaluate the effect of estrogen plus progestin on the incidence of dementia and mild cognitive impairment compared with placebo.

Design, Setting, and Participants  The Women's Health Initiative Memory Study (WHIMS), a randomized, double-blind, placebo-controlled clinical trial, began enrolling participants from the Women's Health Initiative (WHI) estrogen plus progestin trial in May 1996. Of the 4894 eligible participants of the WHI study, 4532 (92.6%) postmenopausal women free of probable dementia, aged 65 years or older, and recruited from 39 of 40 WHI clinical centers were enrolled in the WHIMS.

Intervention  Participants received either 1 daily tablet of 0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate (n = 2229), or a matching placebo (n = 2303).

Main Outcome Measures  Incidence of probable dementia (primary outcome) and mild cognitive impairment (secondary outcome) were identified through a structured clinical assessment.

Results  The mean (SD) time between the date of randomization into WHI and the last Modified Mini-Mental State Examination (3MSE) for all WHIMS participants was 4.05 (1.19) years. Overall, 61 women were diagnosed with probable dementia, 40 (66%) in the estrogen plus progestin group compared with 21 (34%) in the placebo group. The hazard ratio (HR) for probable dementia was 2.05 (95% confidence interval [CI], 1.21-3.48; 45 vs 22 per 10 000 person-years; P = .01). This increased risk would result in an additional 23 cases of dementia per 10 000 women per year. Alzheimer disease was the most common classification of dementia in both study groups. Treatment effects on mild cognitive impairment did not differ between groups (HR, 1.07; 95% CI, 0.74-1.55; 63 vs 59 cases per 10 000 person-years; P = .72).

Conclusions  Estrogen plus progestin therapy increased the risk for probable dementia in postmenopausal women aged 65 years or older. In addition, estrogen plus progestin therapy did not prevent mild cognitive impairment in these women. These findings, coupled with previously reported WHI data, support the conclusion that the risks of estrogen plus progestin outweigh the benefits.

Author Affiliations: Department of Public Health Sciences (Drs Shumaker and Legault) and Department of Psychiatry and Behavioral Medicine (Drs Rapp and Jones), Wake Forest University Health Sciences, Winston-Salem, NC; Department of Neurosciences, University of California at San Diego (Dr Thal); Department of Epidemiology, University of Iowa, Iowa City/Davenport (Dr Wallace); Division of Preventive and Behavioral Medicine, University of Massachusetts, Worcester (Dr Ockene); Department of Obstetrics and Gynecology, Wayne State University School of Medicine/Hutzel Hospital, Detroit, Mich (Dr Hendrix); Center for Primary Care and Division, Brown University, Providence, RI (Dr Assaf); Department of Internal Medicine, The Ohio State University, Columbus (Dr Jackson); Department of Epidemiology and Medicine, Medical College of Wisconsin, Milwaukee (Dr Kotchen); Department of Epidemioliogy and Population Health, Albert Einstein College of Medicine, Bronx, NY (Dr Wassertheil-Smoller); and Department of Social and Preventive Medicine, University of Buffalo, State University of New York, Buffalo (Dr Wactawski-Wende).

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