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National study halted since health risks exceed benefits in postmenopausal women on estrogen

(Embargoed) CHAPEL HILL Researchers nationwide have halted the part of a 40-center study that involved trying to determine the risks versus the benefits of healthy postmenopausal women taking the hormones estrogen and progestin.

That's because after five years of data collection, the study clearly showed the risks outweighed the benefits, scientists said. Taking the combination appears to boost the chance of developing breast cancer somewhat and does not lead to the anticipated benefits in preventing heart attacks and strokes.

The National Heart, Lung and Blood Institute sponsors the continuing, larger project, which is known as the Women's Health Initiative. Institute officials were scheduled to hold a news conference at the National Press Club in Washington, D.C. Tuesday (July 9) to announce their action. A paper describing the findings in detail will appear online in JAMA-Express also on July 9 and in the July 17 issue of the Journal of the American Medical Association.

"This was a randomized, placebo-controlled trial of estrogen plus progestin in more than 16,000 women with a uterus," said Dr. Gerardo Heiss, professor of epidemiology at the University of North Carolina at Chapel Hill School of Public Health. "The estrogen plus progestin trial was stopped early -- after 5.2 years -- because of a 26 percent increased risk for breast cancer and also a lack of overall benefit. As soon as the increased risk for breast cancer was established, the independent data and safety monitoring board halted the study."

A second trial of estrogen alone in 11,000 women who have had hysterectomies continues unchanged, said Heiss, a member of the Women's Health Initiative steering committee. "We wish to express our appreciation and thanks to the 16,608 women who participated in this WHI study. They are true pioneers and have made an important contribution in answering a very important question for millions of women.

"Because of them, we now k
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Contact: David Williamson
david_williamson@unc.edu
919-962-8596
University of North Carolina at Chapel Hill
9-Jul-2002


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