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Oestrogen plus progestogen increased risk of breast cancer in postmenopausal women
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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 …

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