Benefits of hormone drug therapy debunked

Published Apr 14, 2004

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By Michael Conlon

Chicago - Two major studies of hormone replacement therapy, both halted because of adverse results, show the drugs have no role in preventing heart disease and other chronic conditions, health experts said on Tuesday.

But they said the therapy does appear to be relatively safe and useful at low doses for short periods of time for treating menopausal symptoms such as hot flashes and night sweats.

"Hormone therapy is not the panacea" once thought, said Marian Limacher, a cardiologist and professor of medicine at the University of Florida in Gainesville who was involved in the studies.

Women who have taken hormones for years because they felt good and thought they were protecting themselves against heart disease should seek alternatives, said Barbara Alving, director of the National Heart, Lung and Blood Institute.

The researchers spoke during a teleconference coinciding with the publication in the Journal of the American Medical Association of their study, the bulk of which was made public on March 2 after it was halted.

The research found that estrogen replacement pills failed to reduce women's risk of heart disease and increased their chances of having a stroke. It also found no significant effect on the risk of breast or colorectal cancer, but there was a reduction in the risk of hip and other fractures.

The study was the second large trial of hormone replacement therapy stopped in two years. In July 2002, women taking estrogen and progestin N a combination most often sold as Wyeth's Prempro N were told to stop because of the risk of heart attack, stroke and some forms of cancer.

Stephen Hulley and Deborah Grady, physicians at the University of California in San Francisco, made similar comments in an editorial in the same journal this week.

Hulley and Grady said it can be concluded now that "hormone therapy is effective for treating menopausal symptoms" such as hot flashes and vaginal dryness.

"In the absence of evidence for an overall net benefit of post-menopausal treatment with estrogen alone, and with the evidence that estrogen plus progestin is harmful, neither therapy should be used for preventing disease," the editorial concluded.

Hormone replacement therapy grew rapidly in popularity amid beliefs that it might protect against cardiovascular disease, some cancers and brittle bones. But prescriptions declined markedly after a series of alarming studies.

The US Food and Drug Administration now recommends that post-menopausal women preferring hormone therapy for hot flashes or vaginal dryness take the lowest possible dose for the shortest possible time.

The study published on Tuesday involved women over 50 who had hysterectomies and were taking Wyeth's Premarin, made from the urine of pregnant mares.

Tuesday's study did find a reduced, but statistically insignificant, risk of breast cancer among women taking estrogen compared to those given an inert placebo.

Gary Stiles, chief medical officer for Wyeth, said the breast cancer result was "perhaps the most striking finding."

"Coupled with the significant decrease in osteoporotic fractures and no overall increase in cardiovascular risk, these findings reinforce the use of estrogen therapy for its approved indications," he said.

As of July 2003, about 10-million American women were taking some form of hormone therapy, the study said. It is estimated that about 6,7-million of those take estrogen alone and 3,3-million take estrogen plus progestin.

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