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Therapeutics
Oestrogen plus progestin increased risk of stroke and probable dementia in postmenopausal women
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https://doi.org/10.1136/ebm.8.6.170

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    (2003) JAMA 289, 2673; Wassertheil-Smoller S, Hendrix SL, Limacher M, et al.. Effect of estrogen plus progestin on stroke in postmenopausal women: the Women’s Health Initiative: a randomized trial.. ;. :. –84.
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    (2003) JAMA 289, 2651; Shumaker SA, Legault C, Rapp SR, et al.. Estrogen plus progestin and the incidence of dementia and mild cognitive impairment in postmenopausal women: the Women’s Health Initiative Memory Study: a randomized controlled trial.. ;. :. –62.
    OpenUrlCrossRefPubMedWeb of Science

    
 


    (2003) JAMA 289, 2663. Rapp SR, Espeland MA, Shumaker SA, et al.. Effect of estrogen plus progestin on global cognitive function in postmenopausal women: the Women’s Health Initiative Memory Study: a randomized controlled trial.. ;. :. –72.
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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 …

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