Early hormone use may be beneficial


For the second time in a week, researchers say they have new findings on hormone therapy that might reassure women who take the medications in the early years of menopause.

The new study, published Tuesday in the British medical journal BMJ, found some evidence that the hearts of women who take estrogen, with or without progestin, stay at least as healthy as the hearts of women who don't take hormones in the decade right after menstruation ends. When the researchers looked at heart attacks, cases of heart failure and deaths among 1,000 evenly divided women, they found those events, when combined, were less likely in the hormone users. Yet critics said the study was too small and too flawed to prove that case or to show other differences in bad outcomes.

The new study comes from Denmark, and, like a study of U.S. women presented at a meeting a few days ago, it focuses on women starting at around age 50 -- the time when they are most likely to seek the relief that hormones can bring from symptoms such as hot flashes and vaginal dryness.

Women have been much less likely to use hormones since 2002, when the much larger Women's Health Initiative (WHI) found increases in heart problems and breast cancer among hormone users. But that study enrolled women at an average age of 64, so questions have remained about how relevant the findings are for more typical, youthful users -- especially given earlier observational studies that suggested the hormones actually were good for the heart.

The sharp drop in use "is a shame, because hormone therapy seems to have a very positive impact on quality of life" for many women, says Louise Lind Schierbeck, lead researcher on the new study, which followed women for 16 years, including 10 years of therapy. During the therapy years, the researchers found:

Sixteen deaths, heart attacks and cases of heart failure combined in the users, vs. 33 in the non-users. That difference was statistically significant. But the number of deaths, heart attacks and heart failures were too small to create meaningful statistics on their own.

No statistically significant differences in breast cancers or cancers combined, or in strokes and blood clots, though, again, actual numbers were small: For instance, there were just 11 strokes in treated women and 14 in untreated women.

"We cannot make definite statements, but everything was headed in the right direction," says Schierbeck, a researcher at Hvidovre Hospital in Kettegrd.

But the numbers "are just far too small" to say much of anything about disease risk, says JoAnn Manson, chief of preventive medicine at Brigham and Women's Hospital in Boston. Manson was a researcher in the WHI and in the study presented last week. That study included slightly more than 700 women and showed that hormones reduced hot flashes and improved moods and sexual health without raising blood pressure or harming arteries -- but it also was too small to show any disease differences, such as differing cancer or heart attack rates, Manson says.

The Danish study has another major flaw: Women knew whether or not they were getting hormones, and no one got a placebo.

That can skew results, because it can bias patients and providers -- and because it eliminates the sometimes-powerful effect of placebos, says Jacques Rossouw, who leads ongoing WHI activities at the National Heart, Lung and Blood Institute in Bethesda, Md.

Rossouw agrees that the numbers were too small. A trial that would answer all questions about the effects of early-starting hormone use on disease risk would need 30,000 women followed for a decade or more, he says. "The problem is that it's going to cost so much money that it's just not doable."

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