Jewish World Review May 29, 2003 / 27 Iyar, 5763

Hormone therapy raises risk of mental decline for some women | (KRT) In the latest blow to hormone therapy, a large federal study has found that long-term use doubles the risk of dementia in postmenopausal women, dimming hopes that hormones might ward off Alzheimer's disease.

A companion analysis found that taking the sex hormones estrogen and progestin for five years does not enhance mental functioning, and may even result in mental decline for some postmenopausal women.

"This study just looked at women aged 65 to 79, so it doesn't say that if you're a 50-year-old woman taking hormones for menopausal symptoms, you're putting yourself at risk of dementia," said co-author Jennifer Hays, a developmental psychologist at Baylor College of Medicine. "It does say, certainly, this is not a good thing for older women."

The latest findings, published in Wednesday's Journal of the American Medical Association, are from the Women's Health Initiative, the decade-long clinical trial that has become a continuing fount of surprisingly bad news for makers and takers of hormone therapy.

The government halted the estrogen-progestin part of the study last July because after following 16,600 women for only five years, those taking the hormones had slightly more breast cancer, heart attacks, lung blood clots and strokes compared to women taking dummy pills. (Today's JAMA also updates the stroke data, confirming a 31 percent increase in risk.) These risks outweighed the reduction in colon cancer and hip fractures.

Two months ago, more data from the Women's Health Initiative rebutted the popular belief that hormones improve such intangibles as mood, vitality, insomnia and sexual satisfaction.

The landmark study has shattered so many of the medical community's convictions about long-term estrogen-progestin therapy that the latest findings regarding the brain "provoke a strong sense of deja vu," wrote Kristine Yaffe, a psychiatrist at the University of California, San Francisco, in an editorial in JAMA.

No one knows why the Women's Health Initiative results fly in the face of previous circumstantial but persuasive evidence that hormones protect the heart, blood vessels and brain. Yaffe and the authors of the latest articles hypothesize that estrogen-progestin promote clotting or inflammation in blood vessels, leading to tiny, undetected strokes in the brain.

The latest news comes with the same caveats and questions as earlier findings: On an individual basis, increased risk is very small. The risks of different hormone brands and types (pill vs. patch), and the risks of taking estrogen alone, are not known. (The estrogen-only part of the study is continuing.) Also unknown is how the timing and duration of hormone use affects the risks and benefits.

Wyeth Pharmaceuticals, of Collegeville, Pa., which supplied the estrogen-progestin for the study, stressed the limitations of the latest findings. The average age of the 4,500 women who were tested for mental function and dementia over a four-year period was 71, while the average age of current hormone users is around 51.

"The applicability of the finding to the typical current user - a younger woman taking hormone therapy to relieve menopausal symptoms such as hot flashes, night sweats and vaginal dryness - is unclear," Wyeth said in a release.

That typical user reflects the sea change that has occurred since July. Because the Women's Health Initiative is the most definitive research to date - controlling women's hormone use rather than simply observing women who choose to take the drugs - it prompted experts to abandon the idea that most women benefit from long-term use. Estrogen-progestin should be prescribed only for relief of temporary menopausal symptoms, and in some situations, for osteoporosis, experts now agree.

Wyeth, which makes the country's most popular hormone therapy brands - Premarin and Prempro, has seen total sales plummet from 9 million to less than 4 million.

Summing up the new thinking, Wyeth medical director Victoria Kusiak said, "Hormone therapy should be prescribed at the lowest dose for the shortest duration consistent with treatment goals and risks for the individual woman."

The tests for dementia found that of the 4,500 women, only 61 had clear-cut signs of such severe mental impairment over four years, but 40 of them were taking hormones, compared to 21 taking placebo - indicating hormones doubled the risk. That means that for every 10,000 postmenopausal women like those in the study, 45 hormone users would develop dementia after a year, compared to 22 women not on hormones.

The same tests were used to assess such thinking functions as sentence writing, abstract reasoning, and immediate and delayed recall. On average, the two groups of women both improved. However, when researchers looked at women whose scores substantially declined, a disproportionate number were hormone users.

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© 2003, Distributed by Knight Ridder/Tribune Information Services