For years hormone replacement therapy has been a common treatment for menopausal women, and long-term observational studies have been interpreted as showing a 40 to 50 percent reduction in risk of heart disease in women on the therapy. Now, results from several randomized clinical trials are throwing into question those earlier findings.

    One of those studies is the Women's Health Initiative (WHI) Hormone Program, a clinical trial in which UMDNJ is participating. The study recently informed participants nationwide that preliminary data compiled after two years of follow-up indicate a "small increase" in the number of heart attacks, strokes, and blood clots in the lungs of women who were taking estrogen or estrogens combined with progestins.

    The WHI hormone trial includes 27,348 women and is part of a larger WHI study of 161,861 women - sponsored by NIH - investigating the leading causes of illness and death among women ages 50 to 79. It is examining the relationship between lifestyle and disease and conducting controlled clinical trials on the effects of a low-fat diet, calcium/vitamin D supplementation, and hormone replacement. The women in the study are receiving either Premarin (.625 mg a day), Premarin plus the equivalent of Provera (2.5 mg a day) or a placebo. UMDNJ is one of 40 clinical research centers participating nationwide.

    Although the data are preliminary, the WHI Data and Safety Monitoring Board (DSMB) - an independent monitoring body - advised WHI to notify participants of a potential risk not thought possible when they signed their original consent form. It also recommended that the study continue, since these early results did not indicate a major safety threat to participants. In fact, the trend appeared to be disappearing.

    "Fewer than 1 percent of WHI women had any problems, regardless of whether it was the estrogen, estrogen plus progestin, or a placebo that they took," says Norman Lasser, MD, PhD, professor of medicine at UMDNJ-New Jersey Medical School and UMDNJ's principal investigator for the study. This was lower than expected in this group of women. Although the preliminary hormone replacement therapy findings were unexpected, Lasser said the study will continue. He emphasized that the findings are only preliminary, and that it is important to continue the study so that the long-term benefits of hormone replacement therapy can be assessed.