The Women’s Health Initiative: The Road to Scientific Clarity?

Abstract

The U.S. National Institutes of Health (NIH) has recently embarked on its most ambitious and expensive trial ever, the Women’s Health Initiative (WHI). The primary component of this project involves a randomized factorial trial to evaluate the effectiveness of three interventions for the prevention of cancer, cardiovascular disease, and osteoporotic fractures. The interventions to be tested are hormone replacement therapy, low-fat dietary pattern, and calcium plus vitamin D supplementation. A 10-year period of intervention is planned. A second goal is to evaluate strategies to achieve healthful behaviors that have established value, including smoking prevention and cessation, improved dietary pattern, achievement and maintenance of optimal weight, increased physical activity, and early cancer detection.