G Heiss

Dr G Heiss, University of North Carolina School of Public Health, Chapel Hill, NC, USA; gerardo_heiss@unc.edu

STUDY DESIGN

Design:

randomised placebo-controlled trial (Women’s Health Initiative [WHI] trial).

Allocation concealment:

{concealed}*.†

Blinding:

blinded (participants, clinicians, {data collectors, outcome assessors, and safety committee}*).†

STUDY QUESTION

Setting:

40 clinical centres in the USA.

Patients:

16 608 postmenopausal women 50–79 years of age with an intact uterus. 15 730 women (mean age 63 y) were included in the postintervention phase.

Intervention:

Conjugated equine oestrogen (CEO), 0.625 mg/day, plus medroxyprogesterone acetate (MPA), 2.5 mg/day (n = 8052), or placebo (n = 7678).

Outcomes:

included all-cause mortality; cardiovascular (CV) events (coronary heart disease [CHD], revascularisation, stroke, and thromboembolism); cancer (invasive breast, endometrial, colorectal, and all); fractures; …