Hormone Replacement Therapy (HRT) went from medical acceptance to medical uncertainty in a heartbeat this year when government researchers reported that it increases the risk of breast cancer, heart attacks, strokes, and blood clots. They immediately cautioned healthy women against continuing or starting long-term use of HRT to prevent heart disease.

But despite the alarm, women should still consider the researchers' complete recommendations (below) and talk with their own doctors before deciding whether HRT is friend or foe. It may still be a useful option for short-term use to treat the symptoms of menopause. The increased risks for an individual woman are still quite small.

"Decisions to take hormone replacement therapy, particularly estrogen plus progestin, which is widely prescribed, will be more difficult now," said Harmon Eyre, MD, chief medical officer for the American Cancer Society.

The findings about HRT came from the Women's Health Initiative (WHI) a long-term study of more than 16,000 healthy, postmenopausal women, funded by the National Institutes of Health. The results were published in the July 17, 2002 Journal of the American Medical Association (Vol. 288:321-333, 366-368). The women began taking either a combination estrogen/progesterone pill or a placebo each day, starting in the mid-1990's.

After 5.2 years, directors stopped the study early because the risks of HRT outweighed and outnumbered the benefits. This long-term use of oral estrogen/progestin therapy led to the following health problems -- and some benefits:

• a 26% increase in breast cancer, but no increase in breast cancer deaths.
• a 41% increase in strokes
• a 29% increase in heart attacks
• Doubled rates of blood clots in legs and lungs
• 37% decrease in colorectal cancer
• 34% fewer hip fractures and 24% fewer total fractures

Women should not be alarmed by the statistics above. A 26% increase to a tiny risk for breast cancer is still a very small risk. "Each woman in the study who took the estrogen plus progestin therapy had an increased risk of breast cancer of less than a tenth of one percent per year," according to a statement from the Women's Health Initiative.

In the U.S., 38% of menopausal women take some form of HRT -- for several different reasons. Women find it especially useful to treat hot flashes, sleeplessness, moodiness, and other disruptive symptoms of menopause. It is also useful in preventing osteoporosis. And until now, HRT has been touted as a way to help prevent heart disease well after menopause.

WHI researchers made the following specific recommendations on what to do now:

• "First, the therapy should not be continued or started to prevent heart disease. Women should consult their doctor about other methods of prevention, such as lifestyle changes, and cholesterol- and blood pressure-lowering drugs"
  
  
• "Second, for osteoporosis prevention, women should consult their doctor and weigh the benefits against their personal risks for heart attack, stroke, blood clots, and breast cancer."
  
  
• "Alternate treatments also are available to prevent osteoporosis and fractures."
  
  
• "Third, women should keep up with their regular schedule of mammograms and breast self-examinations."
  
  
• "Finally, while short-term use was not studied, women taking the therapy for relief of menopausal symptoms may reap more benefits than risks. Women should talk with their doctor about their personal risks and benefits."

Drugs that are used for many years must meet high standards for safety, especially when they're taken by healthy people to keep them that way. Two independent experts, Suzanne Fletcher, MD, MSc, and Graham Colditz, MD, MPH, of Harvard Medical School emphasized this point in an editorial about the WHI study.

“Given these results, we recommend that clinicians stop prescribing this combination for long term use. 'Primum non nocere' [First, do no harm] applies especially to preventive health care,” the editorial authors wrote.

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Sources: Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women, Journal of the American Medical 288:321-333, 366-368)
Failure of Estrogen Plus Progestin Therapy for Prevention, Journal of the American Medical Association (Vol. 288:321-333, 366-368)
New Facts About: ESTROGEN/PROGESTIN HORMONE THERAPY, The Women's Health Initiative, National Heart, Lung and Blood Institute website.

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Published 09/27/02