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With hormone risk, doctors change menopause view

THE BALTIMORE SUN

In the few months since a study of a widely used hormone regimen found that its risks outweighed its benefits, the prevailing view of menopause has undergone a momentous shift.

For decades, women have been told that the symptoms of menopause - hot flashes and night sweats, as well as vaginal dryness that could make sex a painful ordeal and libido a distant memory - were burdens they should not have to bear.

With hormone replacement therapy, they would feel as if the clock were turned back. At the same time, they could protect themselves against osteoporosis and probably even reduce their risk of heart attack and stroke.

When the study, known as the Women's Health Initiative, was halted in July, many doctors changed their message. Try to live with your symptoms, these doctors now say. Or find other ways to deal with them. And forget about using hormones solely to protect yourself from diseases; there are other, better ways.

In interviews, gynecologists and internists say some patients have stopped taking hormones, only to resume when they find symptoms intolerable.

Others say most women who stop taking the pills have little or no trouble. They note that even before the study was halted last summer, more than half of the women who started hormone therapy stopped it on their own within a few years.

Still other doctors are devising methods of weaning women from the drugs - suggesting they wear estrogen patches and gradually trim them down to nothing or increase the interval between pills. In this, however, the doctors are acting on their own. There are no practice guidelines, no rigorous studies on what works best.

Eventually, the Women's Health Initiative will have data on how its participants fared when they were advised to stop taking their hormone pills.

The only current data come from drug company sales figures, which show that many women taking Prempro, the hormone combination made by Wyeth that was tested in the study, have stopped, their number falling from 2.7 million to 1.5 million.

But in Wyeth's loss, other companies see an opportunity. For example, sales of Evista, made by Eli Lilly & Co., rose by 24 percent in September. Evista, which can actually elicit hot flashes but protects bone, has some estrogen-like properties, but the company emphasizes that it is not a hormone.

"There's this whole open market," said Valerie Layne, a nurse practitioner at Hightstown Medical Associates, a private practice in New Jersey where she says the Eli Lilly sales representative is now a frequent visitor.

"They know our alternative now is their drug," Layne said. "Even though hormone therapy may be OK, everyone is too afraid to continue."

The study that caused this uproar, the Women's Health Initiative, involved 16,000 women who were randomly assigned to take either Prempro, which is a popular combination of estrogens and progestin, or a placebo.

The researchers halted the study prematurely when the accumulating data indicated that even though hormone therapy can reduce cholesterol levels, women who took Prempro had slightly more heart attacks, strokes and blood clots. They also had slightly more incidences of breast cancer.

These risks exceeded the regimen's benefits, of slightly less colon cancer and slightly fewer fractures.

Women who were taking Prempro were advised to stop taking the pills immediately, and the scientists said there was no reason to believe that the findings applied only to Prempro.

Until evidence proved otherwise, they said, women and their doctors should assume that all hormone replacement therapy that involved estrogen and progestin bears the same risks.

The study did not test other hormone regimens, but many researchers say it cannot be assumed that they are any safer.

At first, many doctors - gynecologists in particular - reacted with anger and denial.

Dr. Isaac Schiff, chairman of obstetrics and gynecology at Massachusetts General Hospital in Boston, said it was his impression that many gynecologists were upset because their clinical experience had told them that the drugs were a boon to women.

Internists, he added, who had been prescribing hormone therapy to prevent conditions such as heart disease and osteoporosis, tended to be more accepting of the study's findings.

Schiff explained: "As a gynecologist, you have a patient who comes into your office who is troubled with hot flashes, or she has severe vaginal atrophy, and she says sex is not pleasurable. You prescribe hormone therapy, and she comes back four months later and says, 'Oh, doctor, I feel so much better.'

"An internist does not have someone come back and say, 'Thank you, doctor, my heart feels better.'"

Yet many gynecologists, even those who say they think hormone therapy has been demonized, say they have changed their message.

"In the old days, I used to say, 'Look, there's no evidence that this is going to hurt you,'" said Dr. Andrew Good, a gynecologist at the Cleveland Clinic. "Now I can't say that with the same enthusiasm."

Dr. Jan L. Herr, a gynecologist at Kaiser Permanente Medical Group in San Rafael, Calif., said the new message means women have had to change their expectations of what life will be like in their middle years.

"They are having to deal with their symptoms," she said. "They are having to ask themselves just how bad it is."

She asks women who find their symptoms of menopause unbearable to try the lowest possible dose of hormone therapy, which might not completely rid them of their symptoms.

"They have to be satisfied with feeling better, but not perfect," Herr said. "They had always wanted to feel perfect," with no hot flashes, no night sweats, no vaginal dryness. "They had always said, 'Why should I feel like I'm 55? I want to feel like I'm 30.'" Now, she said, women have to get used to feeling as if they are 55.

Some doctors wonder, however, whether there might be critical periods when estrogen protects against heart disease, osteoporosis or, most troublesome, Alzheimer's disease. While there are drugs to protect against heart disease and osteoporosis, there is nothing yet to prevent Alzheimer's.

While some laboratory and animal studies indicate that hormone therapy might protect brain cells, it is not clear what would be required to prevent Alzheimer's. In some studies, including one published last week, women who were taking hormones had less Alzheimer's disease; in others they did not.

Copyright © 2021, The Baltimore Sun, a Baltimore Sun Media Group publication | Place an Ad

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