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ORLANDO, Fla. - Older women who use a popular form of hormone-replacement therapy double their risk of developing dementia, according to a new study that shatters a widely held belief the hormones help keep their minds sharp.
The study, published in Wednesday's Journal of the American Medical Association, is the latest research unmasking hidden dangers in a therapy used by millions of women to treat the symptoms of menopause.
The research focuses on the drug Prempro, the most widely used estrogen-progestin supplement, which already had been linked last year to an increased risk of heart attacks, stroke, blood clots and breast cancer. Those findings triggered widespread confusion and concern among the millions of women taking hormones to get through the symptoms of menopause and beyond.
Doctors said Tuesday that the latest research is another warning bell against the long-term use of hormone replacement therapy.
"It's just another piece of evidence that there are more risks than benefits associated with taking this drug long term," said Jennifer Hays, a psychologist and director of the Center for Women's Health at the Baylor College of Medicine in Texas.
But doctors cautioned that the study, by researchers at Wake Forest University, involved women age 65 and older who took Prempro for at least four years. Its findings may not apply to younger women, or those who take other formulations of estrogen and progestin.
"There's still a lot of unknowns here," said Dr. Arnold Lazar, an obstetrician/gynecologist and vice chief of staff for Orlando Regional Healthcare. "It's an evolving type of situation. I think hormone replacement therapy can be very helpful to women in certain situations. But again, it has to be done on an individual basis with the woman deciding what she's comfortable with."
Doctors started changing their approach to hormone replacement therapy last July, when data linking Prempro to heart disease and other risks caused the National Institutes of Health to halt a large trial involving the drug.
Before then, the medications routinely were prescribed to women in their 50s, who were told the drugs could do everything from reduce wrinkles and control mood swings to prevent heart disease and keep their minds nimble.
But the NIH study - the Women's Health Initiative - challenged those assumptions and suggested the risks of long-term use outweighed the benefits. The unnerving results frightened many women away from the drugs.
About 6 million women were taking some form of hormone therapy this time last year; today an estimated 2.7 million women use the supplements. Prempro remains the most widely used form of hormone therapy: down from about 3.4 million last summer to 1.2 million users currently, according to Wyeth Pharmaceuticals, the drug's manufacturer.
Dee Schwartz of Winter Park, Fla., followed last summer's developments closely and decided to continue taking Prempro as the best way to ward off mood swings and other symptoms. She plans to reevalute the drug again but, like many women, she is reluctant to go without them.
"I think it's worked well for what I wanted it for," said Schwartz, 54. "I'm leery to go off of it because I don't like the mood swings."
The dementia study is based on 4,532 women who were enrolled in the Women's Health Initiative study on Prempro. Researchers at Wake Forest found that 61 of those women developed dementia. Of those, 40 were taking Prempro and 21 were taking a sugar pill.
Overall, researchers said that translates into about 23 additional cases of dementia for every 10,000 women taking Prempro each year.
"These findings, coupled with previously reported Women's Health Initiative data, support the conclusion that the risk of estrogen plus progestin outweigh the benefits," the study reports.
The drug's manufacturer said the data are sobering and a clear signal that women should not be going on hormone therapy strictly as a way to prevent a decline in mental function.
"I think there's no doubt that you shouldn't be using hormone therapy for the prevention or treatment of dementia or mild cognitive impairment," said Dr. Victoria Kusiak, North American medical director for Wyeth Pharmaceuticals, which is based in the Philadelphia suburbs.
Some interpret the findings broadly to cover all forms of estrogen and progestin therapies. Others caution strongly that the findings can't be extrapolated broadly.
Research has shown that estrogen by itself has a positive effect on the brain, stimulating the formation of new connections called synapses, said Dr. Philip Sarrel, emeritus professor of obstetrics, gynecology and psychiatry at Yale University.
But the other hormone - progesterone - tends to counteract these effects, Sarrel said. Prempro uses a particularly potent form of synthetic progesterone and therefore is in a unique situation, he said.
Sarrel said there are other formulations of estrogen and progestin that would not carry the same risks as Prempro. He would advise women to ask their doctors about alternatives.
And he stressed that women who take estrogen alone do not have to be concerned at this point. A separate portion of the Women's Health Initiative involving estrogen use alone continues. He said women who take estrogen by itself are being needlessly frightened.
"We have something of an emergency situation in this country," Sarrel said. "A lot of women heard this last summer and panicked and stopped everything. I think Prempro has distorted the picture a lot."
However, other doctors say the findings cast doubt on the safety of all hormone therapies. They say even more studies are needed before women can be confident than other forms are safe. In the meantime, they recommend women become educated about what they're using so they can make an informed decision.
The Food and Drug Administration already has added a warning label to hormone therapies that caution women to use the lowest dose possible, for the shortest amount of time possible.
"If women don't need it for severe menopausal symptoms, there aren't a lot of reasons to continue taking hormones long-term," said Dr. Marian Limacher, a professor of cardiovascular medicine at the University of Florida, which is one of 40 sites nationwide participating in the Women's Health Initiative.
Dr. John Guarneri, a Florida Hospital gynecologist and obstetrician, said he is steering clear of Prempro for most of his patients, opting to prescribe other brands.
But he said some women find it works best for their symptoms. Overall, he said, women need to use the new findings as a sign that they must continually evaluate their use of hormones.
"It's one of those evolutions in medicine," said Guarneri. "We thought there was very strong documented research saying one thing and then we find out that doesn't seem to be the case."
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(c) 2003, The Orlando Sentinel (Fla.). Distributed by Knight Ridder/Tribune News Service.
