Hormone replacement therapy study halted
Increased risk of breast cancer a factor, government says
WASHINGTON (CNN) -- In a move that may affect millions of women, U.S. government scientists Tuesday stopped a major study of hormone replacement therapy on the risks and benefits of combined estrogen and progestin in healthy menopausal women, citing an increased risk of invasive breast cancer.
Researchers from the National Heart, Lung and Blood Institute of the National Institutes of Health also found increases in coronary heart disease, stroke and pulmonary embolism.
The study further clouds an issue that already was confusing for many women. Contradicting research about the risks and benefits of hormone replacement therapy has been periodically released for years. The only consensus among experts is that the decision is an individual one since every woman's lifestyle issues and risk profile is different.
"Women with a uterus who are currently taking estrogen plus progestin should have a serious talk with their doctor to see if they should continue it," said Jacques Rossouw in a statement. Rossouw is acting director of the Women's Health Initiative, which sponsored the study.
"If they are taking this hormone combination for short-term relief of symptoms, it may be reasonable to continue since the benefits are likely to outweigh the risks," Rossouw continued. "Longer term use or use for disease prevention must be re-evaluated."
A statement from the institute noted the benefits of estrogen combined with progestin, "including fewer cases of hip fractures and colon cancer, but on balance the harm was greater than the benefit."
About 6 million women in the United States are taking estrogen and progestin for various reasons, including relief of menopausal symptoms and long-term use for the prevention of heart disease and brittle bones.
The estrogen and progestin trial study involved 16,608 women ages 50 to 79 with an intact uterus.
A major objective of the trial study was to explore the effect of estrogen and progestin on the prevention of heart disease and hip fractures and any associated change in risk for breast and colon cancer.
"We have long sought the answer to the question: Does postmenopausal hormone therapy prevent heart disease and, if it does, what are the risks? The bottom-line answer from [the Women's Health Initiative] is that this combined form of hormone therapy is unlikely to benefit the heart," said Dr. Claude Lenfant, director of the heart, lung and blood institute, in a statement.
"The cardiovascular and cancer risks of estrogen plus progestin outweigh any benefits -- and a 26 percent increase in breast cancer risk is too high a price to pay, even if there were a heart benefit. Similarly, the risks outweigh the benefits of fewer hip fractures.
"Menopausal women who might have been candidates for estrogen plus progestin should now focus on well-proven treatments to reduce the risk of cardiovascular disease, including measures to prevent and control high blood pressure, high blood cholesterol and obesity," Lenfant continued.
In a statement, Garnet Anderson, a biostatistician who led the analysis at the Fred Hutchinson Cancer Research Center in Seattle, Washington, said, "The trial was stopped at the first clear indication of increased risk."
Anderson also said that, at that point, there was no indication of increased risk for breast cancer in the estrogen-only group.
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