Last year, a large study found that the widely used estrogen and progestin combinations are bad for women's physical health. Now, data from the same study suggest they do nothing for their memory, sleeping or mental outlook, either.
"There is no place for this treatment in women who are not having hot flashes. That simplifies matters a lot," said Dr. Deborah Grady of the University of California, San Francisco, who was not involved in the study.
Though many women well past the hot flash stage believe the pills make them feel better, the new research concludes this is probably nothing more than a placebo effect.
"The average woman will not experience an improvement in her quality of life by taking this pill," said Jennifer Hays of Baylor College of Medicine, a psychologist who directed the analysis.
The results released Monday are another impressive reversal for what, until recently, was one of the most universally accepted treatments in medicine. Women typically begin taking combinations of estrogen and progestin to ease hot flashes and other miseries of menopause. But many keep taking them, often into their 60s and 70s, believing the drugs are good for their health and well-being.
Last year, however, data from the same study found the pills do more physical harm than good. While hormone replacement decreases hip fractures and colon cancer, it slightly increases the chance of heart attacks, strokes and breast cancer.
Despite those findings, many women vowed to stick with hormone replacement because they felt it helped their memory and mood and made them think and feel better. But the new report says hormone replacement does not have such effects.
"There is a myth that hormone therapy improves quality of life, even in women without menopausal symptoms. This study dispels the myth," said Dr. JoAnn Manson of Harvard's Brigham and Women's Hospital in Boston.
Experts now say the hormones' only acceptable use is for the short-term relief of severe menopausal symptoms. For otherwise healthy women in their early 50s, the risks of this treatment are small and the benefits worthwhile. Last week, the Food and Drug Administration approved a new low-dose variety but urged that it be taken only for the shortest possible duration.
The latest data are from the Women's Health Initiative, a federally sponsored study of 16,608 postmenopausal women ages 50 to 79. They were randomly given Prempro or dummy pills, and researchers followed them for an average of five years.
The results will be published in the May 8 issue of the New England Journal of Medicine. Because of their importance, the journal posted them Monday on its Internet site.
The study found no meaningful effects of the pills on women's physical or emotional health, pain, energy levels, memory, sleeping or sexual satisfaction, among other things.
"It's a reassuring message," Hays said. "If women stopped taking hormones because they heard about the health risks, they are not missing anything. The differences we found were so small that they would not be noticed by the average woman."
Most of the women in the study were well past the age of hot flashes, but for those still having menopausal symptoms, the study confirmed that estrogen is effective. So were dummy pills, however.
After a year of treatment, three-quarters of those younger women on Prempro had fewer hot flashes, as did half of the ones on placebos. However, the researchers cautioned that women with the most severe symptoms probably did not volunteer for the study and risk being put on sugar pills.
Hays said many women in the study, convinced they were receiving estrogen and benefiting from it, were upset when the study ended earlier than planned. However, when doctors broke the codes and sorted out who was taking what, they found that these women often were on placebos.
"The mind is very powerful," she said. "They were taking a sugar pill and feeling great."
Hays acknowledged, however, that hormones may still have benefits that some women find important, such as a sense that the drugs improve the appearance of their skin or hair.
By Daniel Q. Haney