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Investigators stop part of drug-taking in Women's Health Initiative

stigators stressed that only a tiny fraction of the women taking estrogen plus progestin -- about 2.5 percent -- had any problems. "These results tell us that during one year, for every 10,000 women taking estrogen plus progestin, we would expect seven more women would have heart attacks (than in the placebo group), eight more women with strokes, eight more women with breast cancer, and 18 more women with blood clots," but six fewer cases of colorectal cancer, five fewer hip factures.

Bonds said the decision to stop the estrogen-progestin arm of the study also is being rapidly disseminated to physicians through the Journal of the American Medical Association, which will publish the results in the July 17 issue.

Gregory L. Burke, M.D., professor and chairman of the Department of Public Health Sciences, now heads the Wake Forest portion of the study, which began in 1993 and ultimately enrolled about 3,500 women in the Piedmont Triad, especially Winton-Salem and Greensboro.

In addition, 2,200 women in the Triad who were not eligible for the clinical trial were enrolled in an observational study, which essentially monitored their health over the years.

Wake Forest was a Vanguard Center, one of 16 university sites chosen to launch the massive study. Ultimately, the initiative enrolled 157,000 women between 50 and 79 years old at 45 clinical centers across the United States, making it the largest clinical trial ever undertaken in the United States.

The estrogen-only group, which is continuing, was open to women who had had a hysterectomy. Other groups test the effect of a low fat diet -- less than 20 percent of calories from fat -- on breast and colon cancer and heart disease, and the effect of calcium and vitamin D supplements on fractures, osteoporosis and colorectal cancer, and those are also unchanged.


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Contact: Robert Conn
rconn@wfubmc.edu
336-716-4587
Wake Forest University Baptist Medical Center
9-Jul-2002


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