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Tuesday, March 18, 2003

By Anita Srikameswaran, Post-Gazette Staff Writer

Once again a study has shown that hormone replacement therapy does not measure up to expectations.

Many menopausal women have taken estrogen and progesterone for years in the belief that the hormones could help them feel better. But researchers have found that the hormone combination has no more impact than a placebo on depression symptoms, sexual functioning, sense of well-being and other quality of life factors.

The findings are the latest to emerge from the large clinical trial called the Women's Health Initiative. Last year, a study based on the same trial raised major questions about hormone replacement therapy, showing that it slightly increased chances of heart attack, breast cancer, stroke and blood clots, outweighing its benefits in preventing osteoporotic fractures and reducing risk of colorectal cancer.

"Our data shows that even if you do suffer somewhat from hot flashes, a year later your quality of life is indistinguishable from someone who is not taking hormones," said Jennifer Hays, the study's lead author and director of the Center for Women's Health at Baylor College of Medicine. "It doesn't warrant taking the health risks for most women."

An early online version of the study was posted yesterday on the New England Journal of Medicine's Web site, www.nejm.org, and will be published in the journal's May 8 issue.

Still, a short course of hormone treatment may alleviate severe symptoms in some women, the experts said.

"I don't want people to think that if you are having terrible hot flashes and you're very depressed and you're feeling awful at the time of menopause that estrogen and progesterone is not going to help you," said Dr. Lewis Kuller, an epidemiologist at the University of Pittsburgh Graduate School of Public Health.

Women need to differentiate the short-term relief of these symptoms from the long-term benefits that the study tried to measure. About 20 percent of women seek medical attention for menopause symptoms.

"What this [study] says is if you're feeling pretty good at the time of menopause or after, the likelihood that [the hormones are] going to make you feel a lot better is zero," Kuller added.

For the trial, more than 16,500 menopausal women ages 50 to 79, including many from the Pittsburgh area, were randomly assigned to take either the hormone treatment or a placebo. They completed a variety of questionnaires about their mood, mental abilities, sexual function and menopausal symptoms when they entered the trial and again one year later.

Compared to the placebo takers, the hormone treatment group had almost imperceptible benefits in sleep, pain relief and general physical functioning. For example, the group scored less than a half-point better on a 20-point sleep scale, less than one point better on a 100-point physical functioning scale and less than two points better on a 100-point pain scale.

Those differences "would not translate into anything that a woman would notice in her everyday life," Hays said.

After three years, the researchers reassessed a subset of about 1,500 women who had moderate to severe symptoms, such as hot flashes, difficulty concentrating and mood swings, when the study began. No benefit from hormone therapy was found.

Hays pointed out that the study participants hadn't had a menstrual period for at least a year. Seventy-five percent of women suffer hot flashes in the first year of menopause, so short-term hormone replacement may still be helpful at that time.

Kuller, who was the principal investigator of the Pittsburgh arm of the Women's Health Initiative, said the study would have had trouble measuring long-term benefits if the women with the greatest need for hormone replacement refused to participate.

Women already convinced of their need for the hormones, he explained, probably wouldn't join the study for fear of being randomized to the placebo group.

Analyses of specific menopause symptoms and of the impact of hormone replacement on memory are underway, Hays said.

Also, there are ongoing studies of the long-term use of estrogen, without progesterone, in menopausal women who have had hysterectomies.