Researchers who want to reopen the question of whether hormone replacement can stave off heart disease in middle-aged women say they have secured $12 million to fund a pilot study that will begin next year. The study design differs from the protocol used by the Women's Health Initiative (WHI), the 16,000-subject clinical trial of postmenopausal hormone replacement therapy (HRT) that the National Institutes of Health (NIH) shut down in July 2002, 3 years early.
The WHI data monitoring committee had concluded that small increases in breast cancer, coronary heart disease, stroke, and pulmonary embolism were showing up in the treatment group. Researchers mounting the new 5-year study hope its results will be quite different. They say that animal work, observational human studies, and even some data from the WHI itself suggest that other approaches to HRT might yield cardiovascular benefits.
The group's aim is to persuade the NIH to fund ...
