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QUESTIONS: (1) In postmenopausal women 50–79 years of age, does hormone replacement therapy (HRT) increase the risk of stroke? (2) In postmenopausal women ≥65 years of age, does HRT increase the risk of probable dementia or protect global cognitive function?
Design
The Women’s Health Initiative (WHI) hormone therapy study of oestrogen plus progestin was a randomised (allocation concealed*), blinded (clinicians, participants, data collectors, outcome assessors, and monitoring committee),* placebo controlled trial with a mean follow up period of 5.6 years. The Women’s Health Initiative Memory Study (WHIMS) was an ancillary study to the larger WHI hormone trial with a mean follow up of 4.2 years.
Setting
39 of 40 WHI US clinical centres also participated in WHIMS.
Participants
16 608 community dwelling postmenopausal women 50–79 years of age (mean age 63 y) who had an intact uterus participated in the WHI trial of oestrogen plus progestin. Exclusion criteria included participation in other trials, predicted survival <3 years, alcoholism, drug dependence, diagnosed mental illness, and dementia. WHI follow up was 100%. 4532 women enrolled in WHI who were ≥65 years of age and free of probable dementia were recruited to participate in WHIMS. WHIMS follow up was 97%.
Intervention
Women were allocated to HRT consisting of conjugated equine oestrogen, 0.625 mg, plus medroxyprogesterone acetate, 2.5 mg daily (n=8506 and 2229 for WHI and WHIMS, respectively) or placebo (n=8102 and 2303 for WHI and WHIMS, respectively).
Main outcome measures
WHI: incidence of overall stroke and …