By Denise Grady 
NEW YORK TIMES NEWS SERVICE 
April 18, 2002 

A new report by a panel of international experts casts doubt on
long-standing claims that hormone replacement in
postmenopausal women can prevent or treat a variety of ills,
including heart disease, Alzheimer's disease, major depression, urinary incontinence and broken bones due to osteoporosis.

While hormone therapy is the most effective way to relieve
menopausal symptoms such as hot flashes and night sweats,
scientific evidence is insufficient to support its use for the other
problems, according to the report, which is to be published in June.

And the hormones have well-documented drawbacks, including an increased risk of blood clots and gallbladder disease and, with prolonged use, breast cancer.

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 for women who
reach menopause early because of surgery to remove their ovaries.

Hormone replacement usually consists of estrogen plus 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 in deciding whether she really needs it.

Drugs to lower cholesterol and blood pressure are better for
reducing the risk of heart disease for many women, and other
nonhormonal drugs work better in preventing fractures.

That advice departs from decades of medical practice: 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, 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 Giovanni Loren Zini Medical Science Foundation of Italy.

The full report, which is book-length, is to be issued by the
National Heart, Lung and Blood Institute, but the chapter on
hormone replacement and other treatments was published early
and distributed at a symposium at the National Institutes of Health.

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

 Dr. Vivian Pinn, director of the NIH Office of Research on Women's
 Health and a co-editor of the report, said many people, including
 doctors, had believed that hormone replacement would prevent
 heart disease and strokes and help women live longer.

 But, she 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. Nanette Wenger, chief of cardiology at Grady Memorial
 Hospital in Atlanta and editor of the report, said that until fairly
 recently many doctors simply told women: " 'Take this. You'll look
 better. You'll feel better.' People acquiesced. There was no
 questioning."

 "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,"
 Wenger said. "And in many areas there have been enormous surprises."

 For instance, Wenger said, three recent controlled trials have
 found that, rather than protecting women from heart attacks and
 strokes, hormone replacement increases their risk.

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

Hormone replacement can prevent bone loss from osteoporosis,
and some studies have suggested it reduces the risk of fractures.
But bone loss resumes after a woman stops taking hormones.
Moreover, no large randomized controlled trials have determined
whether the treatment reduces fractures.

The Food and Drug Administration has approved hormone
 therapy to prevent osteoporosis, but not to treat it.

 Wenger said 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.

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

 Dr. Deborah Grady, a professor of epidemiology and medicine at
 the University of California San Francisco, said, "A decade ago I
 thought preventive hormone therapy should probably be prescribed to most    postmenopausal women, except those at high risk for breast cancer."

 As lead author of the 1992 guidelines on hormone replacement for
 the American College of Physicians, she incorporated that view
 into the guidelines.

 But now, she says, "there have been major changes in the way we
 use hormone therapy."

 Today, 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 go
  away entirely for four to five years. So she tries to taper
  women off the drugs and stop every year or two to see if they
  can get by without them. Then, for women who have not had
  fractures or other serious risk factors for osteoporosis, she
  recommends a bone density test at age 65. Those at risk for
  fractures can then take medication, she said. 

  "So I spend a lot of my life now trying to figure out how to help
  women taper off estrogen," she said. Many can do it gradually,
  though a few have severe problems with hot flashes and
  decide to keep taking the drugs, she said. 
 

CLEVELAND (April 22, 2002) – A recent article published in the New York Times (Thursday, April 18, 2002) that previews an unpublished report by an international panel has generated widespread media attention for its conclusions questioning the effectiveness of hormone therapy in postmenopausal women for preventing heart disease, Alzheimer’s disease, osteoporotic fractures, depression, and urinary incontinence. To address the concerns expressed by women and healthcare providers, The North American Menopause Society (NAMS) is issuing this response. 

“NAMS has not yet had an opportunity to review the final report, which will be published in June by the National Heart, Lung, and Blood institute,” said Wulf H. Utian, MD, PhD, Executive Director and Honorary Founding President of NAMS. “However, it should be emphasized that this report is a compilation of previously published research mostly in elderly women with established disease, and it will present no new research in itself.”

The report, called the International Position Paper on Women’s Health and Menopause, was developed by 28 physicians and researchers from the United States, Australia, and several European countries. One chapter of the report was distributed at a symposium last month at the National Institutes of Health.

“The major issue for perimenopausal and early postmenopausal women considering hormone replacement therapy is whether such therapy will actually reduce the likelihood of development of cardiovascular disease, stroke, or Alzheimer’s disease,” said Dr. Utian. “At present, definitive answers are not available. Fortunately, several major clinical trials are underway that are attempting to provide answers to these questions. The most significant trial is the Women’s Health Initiative, being conducted under the auspices of the National Institutes of Health.” 

“At this time, NAMS does not recommend making any changes from its current recommendations, as have been reported in various NAMS publications.” 

NAMS is North America’s leading nonprofit organization dedicated to promoting women’s health through menopause and beyond through an understanding of menopause. The Society’s unique multidisciplinary membership includes 2,000-plus experts from medicine, nursing, sociology, psychology, anthropology, epidemiology, nutrition, education, and basic science — helping NAMS to be the preeminent resource on all aspects of menopause to healthcare providers and the public.

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