SEATTLE, Feb 13, 2004 (United Press International via COMTEX) -- Women and physicians remain confused and frightened by the surprising negative results of a study on the long-term effects of hormone replacement therapy, researchers said Friday.
Estrogen combined with the hormone progestin, usually used to treat symptoms of menopause, also was used to prevent such problems as heart disease and stroke in post-menopausal women -- until the landmark Women's Health Initiative study found the HRT actually caused a small increase in the risk of disease.
"The risks were teeny but the benefits were teenier," said University of Iowa Professor Susan Johnson, one of the medical researchers involved in the study, which was stopped prematurely in 2002 for safety reasons. Johnson and colleagues presented their findings at the annual meeting of the American Association for the Advancement of Science.
When the study was stopped early it sowed confusion and fear among women using the hormones and also raised some tough questions about how the public can be assured the practice of medicine is based on science and not guesswork, other researchers said.
"The public is left wondering what other areas of treatment choices are informed by less than solid data," said lawyer Debra Lappin, president of Princeton Partners in Denver, a science policy consulting firm.
Combined estrogen and progestin therapy was approved in 1945 to treat menopausal symptoms such as hot flashes, mood swings, irritability and fatigue. In the 1980s, data began to accumulate that seemed to show long-term use of the two hormones might help prevent heart disease and other health problems in older women.
The Women's Health Initiative study -- which comprises more than 16,000 women -- was designed to settle the question and researchers, guided by a "whole universe of data that all pointed in the same direction," expected it would show "estrogen did all sorts of good things," Johnson said.
For reasons researchers still do not understand, however, the study did not confirm the earlier data. Instead, it indicated an increased risk of heart disease, as well as breast cancer and stroke, she said.
One result has been U.S. prescriptions for HRT dropped from about 90 million a year in 2002 to about 50 million in 2003, and Johnson said the drop probably means some women who should be on the hormones are walking away from them.
"For a small number of women, (menopausal symptoms) can be really quite severe," she said, and for those women the risk-benefit balance tips in favor of using the combined hormones.
For women who were taking the hormones just to prevent heart disease, the lesson is simple, she said: This treatment does not work.
The lesson has not seemed so simple, however, to women and their doctors, said bio-statistician Garnet Anderson of Seattle's Fred Hutchinson Cancer Research Center.
"I see the confusion in the medical literature," she told United Press International, "and there's been a lot of criticism that hasn't been all that well-founded, because they don't seem to understand the study."
One major stumbling block for many physicians, she said, is the result that showed a swift increase in the risk of breast cancer -- the reason the study was stopped.
"They don't believe it can happen that quickly but our data are quite compelling," Anderson said.
The Canadian Cancer Society last month urged women to avoid HRT, except for those who have severe menopausal symptoms, mainly because of the breast cancer results. Canadian gynecologists reacted angrily that the cancer society was frightening women.
Anderson said the Canadian conflict is typical of the polarization of the debate in the United States.
"I have plenty of e-mail and faxes and even some phone calls from practicing clinicians saying, 'What am I going to do with my patients?'" she said.
Anderson said the study should be a "wake-up call" for women and their doctors to think carefully about whether to use the combined hormone therapy. "The risks are small, but they exist," she added.
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