Many women quit hormone therapy after critical study

Thursday, October 24th 2002, 12:00 am

By: News On 6

BETHESDA, Md. (AP) _ Women have quit hormone therapy in droves since a major study in July declared the pills far riskier than once thought _ but federal scientists seeking to ease confusion over just who should ever take post-menopausal hormones acknowledge they have lots of questions still to answer.

One clear recommendation, scientists told a meeting at the National Institutes of Health on Wednesday, is that women shouldn't start hormone therapy in hopes of preventing age-related diseases _ one big reason that estrogen-progestin pills were prescribed to some 6 million U.S. women.

``We can't take a pill for the rest of our life to make us young again. Disappointing but true,'' said Dr. Susan Hendrix of Wayne State University, a co-investigator in the NIH's Women's Health Initiative, the biggest study ever done of hormone therapy.

Still, hormones are the mainstay treatment for hot flashes and other menopause symptoms _ and there lie the biggest quandaries: Which women are at such high risk from the pills' side effects that they shouldn't use them even to briefly ease menopause symptoms? And for women who do try the pills to ease hot flashes, how long are they safe to use?

Nobody yet knows. But Hendrix offered herself as an example, saying her own hot flashes aren't bad enough for her to risk taking hormones, but that she might reconsider if they were especially severe.

``There's still a place for this product,'' said Dr. Ginger Constantine of Wyeth Pharmaceuticals, maker of the best-selling hormone brands. She noted that lower doses than were used in the Women's Health Initiative study can bring menopause relief _ although there's no proof they'll also bring fewer side effects.

The study that set off the controversy found women who take the estrogen-and-progestin combination are at significantly higher risk of heart disease and cancer than previously thought. For every 10,000 women taking the pills, every year 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 if they hadn't taken the pills, the study found.

For an individual, those are small risks _ although with millions of users they add up. But the study concluded they far outweigh the pills' few benefits _ preventing five hip fractures and six cases of colorectal cancer a year for every 10,000 users _ especially as there are other ways to fight bone loss and colon cancer.

That's only half the story: Researchers are continuing to study whether using estrogen alone _ only possible for women who have had hysterectomies _ is safe.

The news has prompted many women to abandon hormones.

Sales of Preempro, the brand used in the study, are down 40 percent, Wyeth says. Also, 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.

Estrogen-only sales are down 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 in 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.

NIH researchers are working to tease out of the Women's Health Initiative 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.