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Associated Press

Many Women Quit Hormone Therapy
October 23, 2002

BETHESDA, Md. (AP) -- Women have quit hormone therapy in droves since a major study in July declared the pills riskier for their hearts and breasts than once thought.

Seeking to ease confusion over just who should take hormones and for how long, federal scientists opened a long-awaited meeting Wednesday to detail the pros and cons -- only to acknowledge they have lots of questions still to research.

"'What should I do?' is the most common question you hear from patients," said Dr. Elias Zerhouni, director of the National Institutes of Health.

There's no easy answer. But the main message from the latest research is that women shouldn't start hormone therapy in hopes of stopping age-related diseases -- one big reason that estrogen-and-progestin pills were prescribed to some 6 million U.S. women, said the scientists who conducted NIH's Women's Health Initiative, the biggest hormone study ever done.

"We can't take a pill for the rest of our life to make us young again. Disappointing but true," said co-investigator Dr. Susan Hendrix of Wayne State University.

The WHI study that set off the controversy found that for every 10,000 women who swallow estrogen-and-progestin pills, there will be eight more breast cancers, seven more heart attacks, eight more strokes, and eight more life-threatening blood clots in the lungs than women not taking the pills would suffer. The heart risks occurred in the first year of treatment; other risks increased with time.

For an individual, those are small risks. But for every 10,000 users, the pills would prevent only five hip fractures and six cases of colorectal cancer -- benefits the researchers declared too few to warrant long-term use, especially as there are other ways to fight bone loss and colon cancer.

But that doesn't tell hormones' whole story:

-Researchers are continuing to study if using estrogen alone -- only possible for women who have had hysterectomies, as estrogen alone causes uterine cancer -- is safe, and whether hormones prevent Alzheimer's disease.

-No one knows if stopping estrogen-and-progestin pills makes their risk go away. However, a recent NIH study compared hundreds of women who use hormones now, never used them or quit using them -- and found only current users of estrogen-and-progestin pills appeared at increased risk of getting breast cancer, said Dr. Robert Spirtas, NIH's reproductive health chief.

-Many physicians' main complaint is the July study didn't consider that hormones are the undisputed best treatment for hot flashes and other symptoms of menopause. Consequently, no one can yet say who are the best candidates to use hormones for that reason, or how long it's safe to do so.

Doctors who "deal with patients from the vagina up, not the heart down -- you have created a terrible problem for us," one physician told the NIH meeting Wednesday.

Menopause symptoms mean "there's still a place for this product," said Dr. Ginger Constantine of Wyeth Pharmaceuticals, maker of the Preempro estrogen-and-progestin pills used in the WHI study. She said lower doses than those used in that study can effectively treat menopause symptoms and prevent bone loss, although there's no way to know if lower doses mean lower heart and breast risks.

Still, many women have abandoned hormones. Sales of Preempro are down 40 percent, Wyeth says, and 632,000 fewer prescriptions for all estrogen-progestin brands were filled the month after the study was announced than the 2.2 million filled the month before the bad headlines, according to IMS Health, a company that tracks drug sales. (Researchers insist there's no reason one brand would be riskier than another.)

Estrogen-only sales are down, too, by 15 percent for the top brand, Premarin, Wyeth said. For all estrogen brands, 426,000 fewer prescriptions were filled in August than the 5.5 million filled in June, says IMS Health.

There are no good alternatives to estrogen for menopause symptoms, said Dr. Lorraine Anne Fitzpatrick of the Mayo Clinic. The most promising are antidepressants in the Prozac family, called SSRIs, but they need more study and pose their own side effects, she said.

The often-touted herbs soy and evening primrose have failed menopause studies. But for women who refuse any drugs, Fitzpatrick called black cohosh promising, noting that the German government, which regulates herbs more rigorously than other nations, has approved its use for hot flashes.

What's next? NIH researchers are working to tease out of the WHI data whether certain characteristics make women more prone to hormone dangers and how the therapy affected their quality of life, points that may ultimately help women decide whether to try it.

Copyright 2002 The Associated Press. All rights reserved.

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