Menopausal Hormone Therapy: Summary of a Scientific Workshop

Although the primary reason for hormone therapy (HT) is to relieve the vasomotor symptoms of menopause, several observational studies have suggested that long-term HT protects against coronary heart disease and osteoporotic fractures. Thus, in the early 1990s, the National Institutes of Health implemented a large prevention study, the Women's Health Initiative (WHI), to determine whether long-term HT could prevent coronary heart disease (CHD) in postmenopausal women and to assess the overall benefits and risks of long-term HT. In studies of women 50 to 79 years of age, those who still had a uterus were randomly assigned to receive daily combination HT (0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone [E + P] as Prempro, from Wyeth-Ayerst) or placebo; those who had had a hysterectomy received estrogen alone ([E-alone] as Premarin, also from Wyeth-Ayerst) or placebo. The combination HT trial was stopped in July 2002 after 5.2 years because the risks of E + P (increases in breast cancer, coronary heart disease, stroke, and pulmonary embolism) were considered to outweigh the benefits (reduction in hip fracture and colorectal cancer). The companion E-alone trial continues, with close monitoring by the data and safety monitoring board (DSMB). Participants in the E-alone trial were informed that risk for breast cancer had not increased at 5.2 years. Like participants in the E + P trial, participants receiving only E had been notified in 2000 and 2001 of increased risks for heart attack, stroke, and blood clots during the early years of the trial.

On 23 and 24 October 2002, the National Institutes of Health (NIH) convened a Scientific Workshop on Menopausal Hormone Therapy. Dr. Ruth Kirschstein, Deputy Director, NIH, and Dr. Vivian Pinn, Director of the Office of Research on Women's Health, NIH, opened the conference, stating that the purposes of this …