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Long term oestrogen plus progestin increased venous thromboembolism and biliary tract surgery in postmenopausal women
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 QUESTION: In postmenopausal women with established coronary heart disease (CHD), what is the effect of oestrogen plus progestin on the risks of common non cardiovascular disease outcomes after 6.8 years of follow up?

Design

Randomised (allocation concealed*), placebo controlled trial. The study was blinded (patients, investigators, and outcome assessors)* for the initial mean 4.1 years of follow up and unblinded* for the subsequent mean 2.7 years of follow up (the latter 2.7 years was the HERS II study).

Setting

20 US outpatient and community centres.

Patients

2763 postmenopausal women <80 years of age (mean age 67 y) with established CHD who had not had a hysterectomy. Exclusion criteria included deep venous thrombosis, pulmonary embolism, breast cancer, endometrial hyperplasia or cancer, abnormal Papanicolaou result, hormone use in the previous 3 months, and life threatening disease. Of those alive at 4.1 years, (n=2510), follow up was 84% at …

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