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Estrogen on Trial

Large-scale studies are pending, but current data on the risks and benefits of hormone replacement therapy for post-menopausal women remain inconclusive.


Susan Sullivan doesn't know whether her health would be helped or harmed by hormone replacement therapy.

But the 55-year-old Topanga Canyon artist is counting on one thing: By the time her 20-year-old daughter reaches menopause, there will finally be some solid, trustworthy medical information about who should be on hormones and why.

Like most U.S. women over age 45, Sullivan has watched with apprehension as studies made public during the last few months have presented disturbing and contradictory findings, leaving many women confused about the risks and benefits of using hormones.

Sullivan is doing her small part to bring some clarity to the confusion. She visits UCLA Medical Center several times a year to participate in the largest study to date of the medical impact of hormone therapy in women.

"When I arrived at menopause, I found there wasn't any good information out there," Sullivan says. "But I have a daughter, and I thought her generation deserves better."

Known as the Women's Health Initiative, the federally funded study involves 161,000 women between the ages of 50 and 79, as well as researchers at more than 40 sites. The 15-year, $700-million study (which looks at other women's health issues besides hormone therapy) is considered a crown jewel in current women's health research.

"The Women's Health Initiative is the only [scientifically rigorous] trial that actually looks at the effect of estrogen on bones, brain, heart and other issues, including types of cancers," says Michele Blackwood, a breast surgeon in Stamford, Conn.

Other recent studies have greatly complicated the question of who should take hormones. Among the findings:

* Two epidemiological studies found that the risk of breast cancer increases the longer women take hormones.

* A small, short-term study of women with Alzheimer's disease showed that, after 16 weeks, there was no apparent benefit from hormones in reducing symptoms of the disease. Earlier studies, however, have indicated that estrogen may be helpful for Alzheimer's.

* A major, long-term study of post-menopausal women with heart disease, called the Estrogen Replacement and Atherosclerosis (ERA) study, showed that hormone use did not slow the course of the disease.

If those results weren't disappointing enough, another study published this month found that soy, a popular alternative to estrogen for relieving hot flashes related to menopause, was ineffective.

The spate of discouraging news has so upset some women participating in the Women's Health Initiative, researchers say, that a small number have dropped out of the study to avoid taking hormones.

Most doctors acknowledge that women will not be able to make well-informed decisions on hormone therapy until the completion of the Women's Health Initiative. Researchers have said they expect the trial's first major results to be released sometime in 2005.

"I feel we're at the tip of the iceberg in trying to figure out what will make a woman's [menopausal] symptoms go away in addition to making her life better," Blackwood says.

Adds Dr. Howard L. Judd, the principal investigator of the WHI study site at UCLA Medical Center, "We're feeling enormous pressure."

Many major questions remain about the effects of hormone replacement therapy. Estrogen is often recommended to women at menopause to alleviate some of its symptoms, such as hot flashes, vaginal dryness and mood swings.

It is also recommended for women at risk of osteoporosis because replacing the estrogen lost at menopause helps maintain strong bones.

"What I tell women is if you have symptoms [of menopause], there is no reason not to take hormones," Judd says. "And, if you are at risk for osteoporosis, take hormones."

Estrogen is also known to increase good cholesterol (high-density lipoprotein, or HDL) and reduce the bad kind (LDL) and maintain the elasticity of arterial walls. These findings have raised hopes that hormones can be used long-term to prevent heart disease.

And some small studies have hinted that estrogen may help prevent the dementia associated with Alzheimer's.

But, so far, there is no clear, convincing evidence that estrogen prevents heart disease or Alzheimer's disease, experts say.

Two large, randomized, controlled clinical studies--the recent ERA study and a 1998 study called the Heart and Estrogen-Progestin Replacement Study (HERS)--produced disappointing results.

"The two best sources of data [on heart disease and estrogen] are the HERS and ERA studies, and both show the same thing: no benefit," says Dr. David Herrington, a cardiologist at Wake Forest University who presented the ERA study two weeks ago at the annual meeting of the American College of Cardiology in Anaheim. "It's possible that estrogen could be relatively helpful in preventing heart disease while being ineffective once disease has been established."

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