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Menopause Study Terminated As Health Risks Come to Light

By Ridgely Ochs
NEWSDAY -- WASHINGTON

Healthy menopausal women who take a combination of estrogen and progestin appear to increase their risk of breast cancer, heart attacks, strokes and blood clots, prompting government-funded researchers to halt a study of almost 17,000 women three years early. They pronounced that the risks of such combination hormone therapy outweigh the benefits.

The results, the first major clinical trial to look at healthy post-menopausal women, are sure to have an impact on the 6 million women who take combination hormone therapy and on the millions more who are approaching menopause. Another 8 million women who have had a hysterectomy take estrogen alone; a section of the trial examining its effect on women’s health is continuing.

Tuesday’s announcement is seen as a landmark.

“My prediction is that this will indeed change (medical) practice,” said Dr. Jacques Rossouw, acting director of the Women’s Health Initiative, in a news conference Tuesday. If women “do decide to take the therapy, they should do so for a short time” to relieve menopausal symptoms, not to prevent chronic disease such as osteoporosis or heart disease. However, he conceded, “there’s no really safe period.”

Tuesday’s announcement concerned one branch of an ongoing federally funded trial called the Women’s Health Initiative, which involves more than 160,000 post-menopausal women at 40 clinical sites across the country. The estrogen-progestin section of the study has followed 16,608 women, ages 50 to 79, who were given either the combination hormone therapy or a placebo.

The trial was to continue for 8.5 years, until 2005. But the study’s independent data monitoring safety board decided to halt it after only 5.2 years when interim results showed that the rates of heart disease, stroke, blood clots and breast cancer outweighed any benefits.

Women in the study have been informed they should stop their pills, researchers said.

A parallel trial examining estrogen alone in women who have had a hysterectomy is continuing because “the balance of risk and benefits is still uncertain,” according to a statement from the National Heart, Lung, and Blood Institute, part of the National Institutes of Health and the lead agency for the study.

Specifically, the estrogen-progestin study, released a week early by the Journal of the American Medical Association, found the following:

A 22 percent increase in total cardiovascular disease, with a 29 percent increase in heart attacks and a 41 percent increase in strokes. For heart attacks, the increased risk began in the first year and went up in the second. It persisted throughout the study.