NIH Halts Hormone Replacement Study

The largest study of hormone replacement therapy in post-menopausal women was stopped abruptly by the government because of a slight increase in the risk of invasive breast cancer. Concluding that the risks of taking hormones outweigh the benefits for women who have not had hysterectomies, researchers at the National Institutes of Health decided on May 31 to close the study three years early. NIH then sent out letters to the 16,000 women involved in the study to tell them to stop taking the drugs – which they should begin to receive in the mail today. They are also advising the estimated 6 million women nationwide who take a combination of estrogen and progestin to replace the hormones lost at menopause to consult their doctors. “For the longer term, particularly beyond the four-year point, we would advise that it has to be an individualized risk-benefit analysis,” said Dr. Victoria Kusiak, vice president of clinical affairs at Wyeth, the largest producer of the drugs.

The study, sponsored by NIH’s Women’s Health Initiative, is the largest to compare the effects of hormones with a placebo – many hoped that findings would conclude that the drugs not only relieve symptoms due to menopause but also improve women’s overall health. However, data indicates that in one year, for every 10,000 women who take the estrogen-progestin combination there will be eight more breast cancers, eight more strokes and seven more heart attacks – and six fewer colon cancers and five fewer hip fractures – compared with 10,000 women who didn’t take the drugs, according to the Associated Press.

In addition, a study published last week concluded that hormone replacement therapy does not protect against heart attacks or strokes in older women with heart disease, and actually increases the risk of blood clots and gall bladder disease. “If you’re using it for heart disease, “forget about it,'” Dr. Jacques Rossouw, acting director of the Women’s Health Initiative told the Associated Press. “For osteoporosis, in some women there may be a place. For promoting overall health, our data suggests it’s not a good idea.”


Associated Press 7/9/02; USA Today 7/9/02; New York Times 7/9/02

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