L'etude clinique du mois. Balance benefice/risque du traitement oestroprogestatif postmenopausique en peril dans l'etude Women's Health Initiative: attitude pratique du clinicien

The Women's Health Initiative (WHI) is sponsored by the NIH. The study focuses on risk and benefits of strategies that could potentially reduce the incidence of heart disease, breast and colon cancer, and fractures in postmenopausal women. One arm of the study, a double-blind, placebo-controlled trial, looking at the effects of continuous combined estrogen-progestin regimen was stopped prematurely based on health risks which exceeded health benefits. The main reason for this decision was the increase in risk of invasive breast cancer, as well as a slight increase in the rate of myocardial infarction and stroke. In this paper, we inform our colleagues of the detailed results of the study. We comment on its limitation and discuss the new original observations. Finally, we integrate the others to previous world literature data that are confirmed by the WHI study. It is important for the individual prescribing practitioner to issue practical conclusions and therapeutic recommendations. The department of Obstetrics and Gynaecologic of the University of Liege, in agreement with the European Menopause Society and the International Menopause Society, is convinced that there is no alternative to the hormone replacement therapy for menopausal symptoms. We should stick to the traditional indications for hormones, namely vasomotor symptoms and osteoporosis. We should continue to recommend hormones for symptomatic women. One should realize that the risk for breast cancer appears only after several years of use, and the risk for cardiovascular events below age 60 is very small (the age of the patients was 63 at inclusion in the WHI study). We should encourage women to take the necessary measures for routine, periodic breast examinations (both manual, echographic and radiographic). Women who use HRT for more than 5 years should discuss the latest data of the WHI study with their physician, in order to consider their individual benefit-risk equation. Those who feel good on hormones and are fully satisfied with this treatment should learn of possible harm after long-term use. It is important to take into account the importance of quality of life. We should leave to the patient the final decision whether or not to continue the treatment. It is presently impossible to decide whether other estroprogestin associations, other administration routes and other molecules such as estradiol, natural progesterone or other progestins, SERMS and Tibolone could have an impact very different from that of the estroprogestin combination used in the WHI study. It is the duty of every physician to decide, from the complex epidemiological data obtained in the aged women (63-68 years) with a high cardiovascular risk in the WHI study, if it is possible or not in each individual case to recommend the initiation or pursue of an hormone replacement therapy.