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QUESTION: In postmenopausal women with established coronary heart disease (CHD), does oestrogen plus progestin reduce the risks of CHD events 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. Of those alive at 4.1 years (n=2510), follow up was 84% at 6.8 years.
Intervention
Women were allocated to conjugated oestrogen, 0.625 mg/day, plus medroxyprogesterone acetate, 2.5 mg/day (n=1380), or placebo (n=1383) for 4.1 years. In the subsequent 2.7 years (during HERS II), 1156 women in the oestrogen plus progestin group and 1165 women in the placebo group continued follow …