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No Benefits Seen From Hormone Therapy

Medicine: Hearts aren't protected and the regimen could be risky for women, study finds.


Hormone replacement therapy does nothing to protect the hearts of women with heart disease and confers some risk, according to a pair of reports on a new study that tracked several thousand post-menopausal women for nearly seven years.

The reports in today's Journal of the American Medical Assn. found no reduction in heart attacks or overall risk of dying when the women were given the hormones estrogen and progestin. They found no reduction, either, in other signs that disease had progressed, such as the need for bypass surgery.

In contrast, the risk of forming blood clots was doubled, and the rate of gallbladder surgery increased by 50%, in the group that took the hormones compared to those who swallowed placebo pills.

"I think this study lays to rest the notion that hormone replacement therapy prevents heart attacks or other cardiac events in women with preexisting coronary disease, " said Diana Petitti, director of research for Kaiser Permanente Southern California, who wrote a commentary accompanying the two papers.

But the study does not rule out the possibility that hormone treatment might help prevent heart disease in post-menopausal women who have not yet developed the disease, experts said.

Nor does it negate other reasons for taking the hormones, such as relief for hot flashes and other symptoms of menopause, and protection against fractures in women who have osteoporosis.

The study--known as the Heart and Estrogen/progestin Replacement Study, or HERS--was undertaken because much evidence seems to link estrogen to protection against heart disease. For instance, epidemiological studies suggest that women who opt to take estrogen have a lower risk for heart disease than those who don't.

But there is always the chance that women taking hormones differ from those who do not: For instance, they may be richer or more apt to go to the doctor or look after their health. These factors, not the hormones, might be the real reason for the differences in risk.

In the trial, 2,763 U.S. women with heart disease--age 67 on average at the start of the study--were randomly assigned to receive either estrogen and progestin or a placebo. Nobody knew who was getting hormones.

Results from the trial after four years, published in 1998, were not encouraging. Overall, there was no observed difference in risk. For the first year of the study, the risk of heart attacks was even higher in the group taking hormones. Then, that risk declined.

That decline led scientists at the 20 centers involved in the UC San Francisco study to continue monitoring the women. They hoped that the decline would continue, leading to a protective effect from the hormone. After nearly three years, it did not.

Instead, "it seems likely that there are no benefits and there are some harms," said Dr. Stephen Hulley, coauthor on both studies and professor and chairman of the department of epidemiology and biostatistics at UC San Francisco.

Women with heart disease would be better off using proven therapies such as low-dose aspirin, blood pressure medications and cholesterol-lowering drugs, doctors said. Diet and exercise are also important.

And because there are many reasons why women opt to take hormones, the decision for each is personal, they said, to be reached after discussion with a doctor.

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