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Women's Health Study at UM Sheds Light on Risks of Hormone-Replacement

Posted on: Tuesday, 15 February 2005, 18:00 CST

Feb. 15--Before the Women's Health Initiative, the largest health study conducted in this country, most medical investigations involved only men.

"Maybe they thought we were all the same," said Joanne Dinga, 68, of West Palm Beach. "Ain't true."

Dinga was one of 161,000 female volunteers in the 12-year, $725 million project that forever changed the medical establishment's treatment of women. The findings of the initiative's researchers, who are in the final stages of their work, were a surprise to the women, doctors and the researchers.

Before the study, when women reached a certain age they routinely got prescriptions for hormones from their doctors, who told them it would be good for them. The prevailing theory was that replacing the hormones lost at menopause would prevent heart disease and other vagaries of aging.

As the women, including more than 3,000 from South Florida, go for their final clinical visits as the study winds down, they know they helped to prove that theory wrong.

The studies showed that taking hormone-replacement therapy after menopause increased -- rather than decreased -- the risk of heart disease by 81 percent in the first year.

The hormones also increased the risk of stroke, blood clots, invasive breast cancer and dementia. They helped women stave off bone loss and colorectal cancer, but researchers say the bad effects outweigh the good, and they do not recommend that women take the hormones long-term. Women who suffer hot flushes and night sweats severe enough to disrupt their daily living might still want to take hormone replacement on a short-term basis.

Results from two other arms of the studies -- one on possible benefits of a low-fat diet, and another on whether vitamin D and calcium will prevent bone loss -- are being analyzed and will be published in October. The hormone studies were published in major journals JAMA and the New England Journal of Medicine in 2002, 2003 and 2004.

Dr. Mary Jo O'Sullivan, who led the South Florida arm of the study at the University of Miami's Miller School of Medicine, said she and other doctors thought hormone replacement was a good idea.

"It made perfect sense because women have less cardiovascular disease than men until 10 years after menopause, so it appeared that hormones were being protective," O'Sullivan said. "It was all thought to be estrogen-progesterone-related."

Dinga, who volunteered for the low-fat diet arm of the trial, said she didn't want to be in the hormone trial because of an earlier experience with the pills.

"My doctor had insisted that I be on it, but I didn't feel good when I was taking it and I quit," Dinga said. "Now I feel vindicated."

Donna Shalala, president of the University of Miami, praised the volunteers for their dedication over a long period of time.

She credited the women's movement in the 1970s and '80s, Ms. Magazine and books such as Our Bodies, Ourselves by the Boston Women's Health Collective for first calling attention to the "men-only" preference of medical researchers.

Shalala said the first research on breast cancer involved men, not women.

"A major initiative on women's health didn't happen until the women's movement pushed," said Shalala, who was involved in the planning for the Women's Health Initiative before she became secretary of Health and Human Services during the Clinton administration.

Pat Hamilton, 75, of Pembroke Pines, was one of 93,000 women in the "observational" arm of the initiative. She did not have to take any pills, but just live her normal life and record a lot of information on her diet and lifestyle over the course of her participation.

"I've answered quite detailed questions, and they have all of my medical records. When I was in for my final appointment last week, there was this big notebook about 7 inches thick, and I said, 'Is that all about me?' When you fill out the questionnaires, it's quite detailed -- how many times a week do you do certain kinds of exercise, eat certain kinds of food. They ask you personal questions about sex but primarily questions on your lifestyle."

She volunteered because she thought it was important and because she liked the idea of having her health carefully monitored during the study, she said.

"I'm a person who over the last few years has become kind of suspicious of the motivation of pharmaceutical companies. I see all these commercials on TV, and it really makes me uneasy. It's made me scrutinize are we taking too many medications and for the wrong reasons," said Hamilton, a retired teacher.

Data from the observational study will create a future resource to identify biological indicators of disease, especially substances and factors found in blood, and to advance knowledge about risk factors for disease.

Dr. Jacques Rossouw, national director of the Women's Health Initiative at the National Institutes of Health, said women are being asked at their final clinical visits at the 40 participating centers around the country whether they will volunteer for a follow-up study. Those who agree will be asked to fill out health questionnaires once a year and continue to share their medical records with the researchers for five more years, he said.

Rossouw said the NIH will fund the follow-up studies that may expand the knowledge about best treatments.

"When you stop hormones, you lose bone. We did advise them to speak to their physicians about preventing bone loss, so we'll want to know what they are using," Rossouw said. "And we're advising them to go for an annual mammogram and provide us with a report if they were on the combination hormone."

Rossouw said while no increase in breast cancer was found in women taking estrogen alone, those women will be followed as well to see whether that holds up.

"Cancers can take a long time, and we want to follow up," he said.

O'Sullivan said the women are also being asked permission to allow the blood samples they have given to be used for future research.

She said the blood is being studied for markers of diseases such as diabetes and other biomarkers to help predict cardiovascular disease.

"Some analyses have already been done, and we're looking for people interested in genes and proteomics [the study of proteins produced by genes] who might be able to tell us even more," O'Sullivan said. "Thousands of these samples are stashed away for these studies."

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Source: South Florida Sun-Sentinel

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