Data Increase Doubts About Hormone Therapy
Hormone Pills Don't Help Memory, Sleep, Study Shows

By David Armstrong

Older women taking hormone-replacement pills experience little improvement in their emotional states, sex lives or mental capacities, according to a new study that further questions the effectiveness of the therapy.

The latest findings from the federally funded Women's Health Initiative come less than a year after the same research group warned that women taking a combination of estrogen and progestin had an increased risk of heart attack, breast cancer and stroke. Those findings prompted the National Institutes of Health to halt the study three years early because of danger to the subjects.

Taken together, the findings paint a harsh picture of increased risk and low benefit for what had become a widely prescribed treatment for preventing heart disease and bone fractures in postmenopausal women, as well as improving sleep patterns and overall health.

In the latest study, authors said hormone replacement provided a small, clinically insignificant, benefit in terms of sleep disturbance, pain and physical functioning after one year of the therapy. After three years, however, even those small improvements vanished.

"Does this mean there is no place for prescription hormones? Our data doesn't answer that question," said Jennifer Hays, the study's author and the director of the Center for Women's Health at Baylor College of Medicine, Houston. What the findings do indicate, she said, is that "a lot of women might be OK without it."

Dr. Hays said hormones have been known to help women suffering from hot flashes and that taking hormones in lower dosages and for less time may be safer. She added that more research was needed on alternatives, such as taking hormones through a patch or cream or using hormones produced from plants rather than animals.

The results of the latest study will be published in the May 8 edition of the New England Journal of Medicine. The results were released early on the journal's Web site3 because of "potential therapeutic implications."

The most recent findings may further cut into sales of Prempro, the combination estrogen/progestin pill made by Wyeth. After the study last year warning of health risks, U.S. sales of the pill fell 47% to $510 million from the year before, said Douglas Petkus, a Wyeth spokesman.

Mr. Petkus said the company takes issue with the methodology in the most recent study. He said the women in the study group tested within the normal range for the quality-of-life indicators at the beginning of the study, making any improvement less obvious and more difficult to obtain.

The study's authors measured the quality of life for 16,608 postmenopausal women aged 50 to 79. About half the women took a hormone pill while the other half received a placebo.