JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

[What scientific and clinical findings will result from the controlled trial "Women's Health Initiative"?]

U Gaspard
Bulletin et Mémoires de L'Académie Royale de Médecine de Belgique 2003, 158 (1): 133-41; discussion 141-5
12852099
The Women's Health Initiative Study is the first large randomized controlled trial for primary prevention, comparing the beneficial or adverse effects of an oral continuous-combined regimen of conjugated estrogens + medroxyprogesterone acetate, vs placebo in late postmenopausal women. This study brings evidence for an absence of preventive cardiovascular effects of hormone replacement therapy (HRT), shows for the first time a small increase in risk for coronary disease, and confirms a small increased risk for invasive breast cancer from four-five years of treatment on, a reduction of risk of colorectal cancer and osteoporotic fractures, and a moderate increase in other already known cardiovascular risks during HRT, such as venous thromboembolism and stroke. Although this study has inherent limitations and may be criticised, and the observed risks are restricted, it forces the physician to better respect known contra-indications (a.o. vascular) to HRT, to carefully weigh the benefit/risk balance of the patients, shorten HRT administration (4-5 years?), use minimal effective hormone dosages, preferably by non-oral route, and change for new compounds with more selective estrogenic action, which are under development.

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