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QUESTION: In postmenopausal women, does oestrogen plus progestogen hormone therapy (HT) increase the risk of abnormal mammographic results and diagnoses of breast cancer?
Design
Randomised (allocation concealed*), blinded (clinicians, participants, data collectors, outcome assessors, and monitoring committee),* placebo controlled trial with a mean 5.6 year follow up (Women’s Health Initiative [WHI]).
Setting
40 US clinical centres.
Participants
16 608 postmenopausal women who were 50–79 years of age (mean age 63.3 y). Exclusion criteria were previous hysterectomy, breast cancer, or probable survival <3 years. Follow up data were available for 15 931 women (95.9%).
Intervention
Women were allocated to 1 daily tablet of conjugated equine oestrogen, 0.625 mg, and medroxyprogesterone acetate, 2.5 mg (n=8506), or placebo (n=8102).
Main outcome measures
Incidence of breast cancer (total, invasive, and in situ) and abnormal mammogram results.
Main results
Analysis was by intention to treat. Women …
Footnotes
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Sources of funding: National Heart, Lung and Blood Institute and Wyeth-Ayerst Research Laboratories.
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For correspondence: Dr R T Chlebowski, Harbor-UCLA Research and Education Institute, Torrance, CA, USA. rchlebowski{at}rei.edu
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Abstract and commentary also appear in ACP Journal Club.