Healthy Skepticism Library item: 1757

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Publication type: news

Grady D.
Scientists Question Hormone Therapies for Menopause Ills
New York Times 2002 Apr 19
http://www.nytimes.com/2002/04/18/us/scientists-question-hormone-therapies-for-menopause-ills.html?pagewanted=1

Full text:

A new report by a panel of international experts casts doubt on longstanding claims that hormone replacement can prevent or treat a variety of ills in postmenopausal women, including heart disease, Alzheimer’s disease, severe depression, urinary incontinence and broken bones caused by osteoporosis.

While hormone therapy is the most effective way to relieve menopausal symptoms like hot flashes and night sweats, there is not enough scientific evidence to support its use for the other problems, says the report, which is to be published in June. The hormone treatments have well-documented drawbacks, including an increased risk of blood clots and gall bladder disease and breast cancer with prolonged use.

More than 40 million American women are 50 or older, and 20 million more will reach menopause within the next decade. About 20 percent of women who reach menopause naturally use hormone replacement at least temporarily, according to the North American Menopause Society. The figure is higher among women who reach menopause early because their ovaries have been surgically removed.

Hormone replacement usually consists of estrogen with another hormone, progestin, or – for women who have had hysterectomies – estrogen alone.

Given the known risks and limited benefits of hormone treatments, the report says, each woman and her doctor should weigh her medical history carefully when deciding whether she really needs it. Drugs to lower cholesterol and blood pressure are a better way to cut the risk of heart disease for many women, and other nonhormonal drugs may be a better way to prevent fractures.

That advice is a departure from decades of medical practice in which many women and their doctors assumed that taking estrogen at menopause was a way to preserve youth and health. American women spent $2.75 billion on hormone replacement in 2001, according to IMS Health, a company that tracks drug sales. Premarin, a form of estrogen replacement therapy sold by Wyeth, was the third most commonly prescribed drug in the United States last year, with more than 45 million prescriptions dispensed.

The new report, called the International Position Paper on Women’s Health and Menopause, was financed by the National Institutes of Health and the private Giovanni Loren Zini Medical Science Foundation of Italy. It reviews existing studies and was compiled by 28 doctors and scientists from the United States, Italy, Sweden, Switzerland and Australia.

Dr. Nanette K. Wenger, chief of cardiology at Grady Memorial Hospital in Atlanta, who was an editor of the report and chairwoman of the panel that prepared it, said the report tried to put up-to-date information into one publication that doctors all over the world could use.

The report’s cautious approach to hormones is based on the findings of recent studies and on its authors’ decision to emphasize “evidence-based medicine” – that is, treatments tested in randomized controlled trials.

Such trials, in which patients are assigned at random to either a treatment or a placebo, are considered the gold standard in medical research. By contrast, observational studies, in which patients themselves decide whether to take a drug, are considered less reliable.

Observational studies have suggested many health benefits from hormone replacement, but more recent controlled trials have disagreed. Researchers say the observational studies may have painted a falsely rosy picture of hormone replacement because women who opt for the treatments are healthier and have better habits to begin with than women who do not.

The full report is to be issued in June by the National Heart, Lung and Blood Institute, but a chapter on hormone replacement and other treatments was distributed at a symposium last month at the National Institutes of Health.

Researchers who worked on the report said some of its findings might shock doctors and patients.

Dr. Vivian W. Pinn, director of the institutes’ office of research on women’s health and another editor of the report, said that many people, including physicians, had believed that hormone replacement would prevent heart disease and strokes and help women live longer.

But, Dr. Pinn said, “as we’re learning more from long-term studies and better defined studies over the past few years, all these things we’ve thought about the wonders of hormone replacement may not be holding up under scrutiny.”

Dr. Wenger added: “Given the fact that hormone replacement has been around for half a century, it’s really only in the last decade that we’ve begun to get stringent scientific evidence, from randomized controlled trials. In many areas there have been enormous surprises.”

For instance, Dr. Wenger said, three recent controlled trials have found that, rather than protecting women from heart attacks and strokes, hormone replacement increased their risk. One trial in women who already had heart disease showed no benefit from four years of hormone treatment and a 50 percent increase in the risk of heart attack in the first year of treatment.

Another study, which includes more than 27,000 women, most without heart disease at the start of the trial, found a slight increase after three years in heart attacks, strokes and blood clots in the lungs in women taking hormones. That study will not be completed until 2006.

A third study found no benefit to hormone treatment after 2.8 years, and a more than doubling of the risk of stroke in the first six months.

Last year, the American Heart Association warned that women should not regard hormone replacement as a means of treating or preventing heart disease. Even though hormones can help lower LDL cholesterol – the “bad” kind of cholesterol – and raise HDL cholesterol – the “good” kind – the group said that statin drugs were a far better way to do so.

Hormone replacement can prevent bone loss from osteoporosis, and observational studies have suggested that it reduces the risk of fractures. But bone loss resumes once a woman stops taking hormones. Moreover, no large
randomized controlled trials have been conducted to determine whether the treatment reduces fractures. The Food
and Drug Administration has approved hormone therapy to prevent osteoporosis, but not to treat it.

Another group of drugs called bisphosphonates prevent bone loss about as well as estrogen, and have been proved to cut the risk of fractures by 40 percent to 50 percent in women with osteoporosis.

Dr. Wenger said that doctors had long assumed that hormone replacement would help older women who suffered from urinary incontinence. “But now two trials show no improvement, and there may be a worsening,” she said.

The reports notes that many doctors thought estrogen would prevent memory loss and slow the progression of Alzheimer’s disease. But clinical trials have shown no benefit in early Alzheimer’s disease. Studies on memory loss are still being done.

Similarly, there is no evidence that hormones can treat severe depression in postmenopausal women. But the report notes that hormones may improve “mood and well-being” in women who suffer from hot flashes and night sweats that disturb their sleep.

“So many of the earlier presumptions, as they come to trial, do not show evidence of benefit,” Dr. Wenger said.

Dr. Deborah Grady, a professor of epidemiology and medicine at the University of California at San Francisco, was lead author of the 1992 guidelines on hormone replacement for the American College of Physicians.

At that time, she said, “I thought preventive hormone therapy should probably be prescribed to most postmenopausal women, except those at high risk for breast cancer,” and incorporated that view into the guidelines.

Today, Dr. Grady said, “rather than prescribing it for most postmenopausal women, I prescribe it for symptoms, for which it is far and away the best treatment.”

In many women, she said, hot flashes diminish after three to six months even without treatment, though they may not end for four to five years.

“I spend a lot of my life now trying to figure out how to help women taper off estrogen,” Dr. Grady said.

Dr. Wenger said that, in contrast to the year 1900, when few women survived much past menopause, women today in developed countries live a third of their lives after menopause.

“We must require that medical management be based on the same stringent scientific evidence that we’ve always required for the treatment of men,” she said.