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Hormone Replacement Therapy Reconsidered

By Sean Henahan, Access Excellence

Chicago (7/17/02)- Once considered a boon to women during and after menopause, the risks of hormone supplementation now appear to outweigh the putative benefits, at least in some patients, according to the results of a huge clinical trial.

Federal health authorities stopped the trial, part of the Women's Health Initiative (WHI), when it became clear that post-menopausal women who were taking a common combination of estrogen and progestin had an increased risk for developing breast cancer and cardiovascular disease. The study involved 16,608 women across the United States. It is the first randomized trial to study the effects of long-term treatment with the hormone combination on these risks.

"We have long sought the answer to the question: Does postmenopausal hormone therapy prevent heart disease and, if it does, what are the risks? The bottom-line answer from WHI is that this combined form of hormone therapy is unlikely to benefit the heart. The cardiovascular and cancer risks of estrogen plus progestin outweigh any benefits--and a 26 percent increase in breast cancer risk is too high a price to pay, even if there were a heart benefit. Similarly, the risks outweigh the benefits of fewer hip fractures," said NHLBI Director Claude Lenfant, M.D

In brief, the study revealed that when compared with placebo, women taking the hormone combination had:

    • A 41% increase in strokes
    • A 29 % increase in heart attacks
    • A doubling of rates of venous thromboembolism (blood clots)
    • A 22 % increase in total cardiovascular disease
    • A 26% increase in breast cancer

The study also showed some apparent benefits associated with hormone use. These included:

  • A 37 % reduction in cases of colorectal cancer
  • A one-third reduction in hip fracture rates
  • A 24 % reduction in total fractures

In editorial accompanying the publication in JAMA, Suzanne W. Fletcher, MD, M. Sc., and Graham A. Colditz, MD Dr.P.H., of the Harvard Medical School, suggest that the time may have come to stop prescribing estrogen/progestin for preventive purposes.

"The whole purpose of healthy women taking long-term estrogen/progestin therapy is to preserve health and prevent disease. The results of this study provide strong evidence that the opposite is happening for important aspects of women's health, even if the absolute risk is low. Given these results, we recommend that clinicians stop prescribing this combination for long-term use."

Ovarian Cancer Risk

In a related report in the same issue of the journal JAMA that announced the results, researchers from the National Cancer Institute reported an increased risk of ovarian cancer among women receiving estrogen replacement therapy. In a study that tracked the health of 44,241 women for approximately 20 years, the researchers found women taking estrogen had a 60% increased risk of ovarian cancer compared to those who were not. The risk increased with length of estrogen use.

"The main finding of our study was that postmenopausal women who used estrogen replacement therapy for 10 or more years were at significantly higher risk of developing ovarian cancer than women who never used hormone replacement therapy," said James V. Lacey, Jr., Ph.D., lead author of the study from National Cancer Institute's Division of Cancer Epidemiology and Genetics.

The NCI study primarily looked at the long-term effects of estrogen use alone. The study did not report an increased risk for ovarian cancer among women who used combination hormone replacement therapy. However, Dr. Lacey cautioned that the study had not followed enough women for a long enough period to say whether taking the combined therapy has any effect on ovarian cancer.

Caveats and Limitations

It is important to keep the WHI study in perspective. The study looked at the effect of one combination of hormones taking for a long period of time. The findings may not apply to women who take hormone replacement therapy for only a short-period to ease the symptoms of the menopausal transition. The WHI investigators stress that the current results do not necessarily apply to lower dosages of these drugs, to other formulations of oral estrogens and progestins, or to estrogens and progestins administered through the transdermal route. Indeed, they say it is still possible that transdermal estradiol with progesterone, may provide a different risk-benefit profile.

A parallel WHI trial of estrogen only in women who have had a hysterectomy will continue. The trial is scheduled to end in March 2005, by which time the average follow-up with be about 8.5 years.

During the time in which the WHI trial has been conducted, many new treatments have been found that offer an alternative to hormone replacement for reducing fracture risk associated with osteoporosis. In addition, there has been a growing awareness of the need to inform women of strategies to reduce the risk for cardiovascular disease.

"Menopausal women who might have been candidates for estrogen plus progestin should now focus on well-proven treatments to reduce the risk of cardiovascular disease, including measures to prevent and control high blood pressure, high blood cholesterol, and obesity. This effort could not be more important: heart disease remains the number one killer of American women," stressed Dr. Lenfant.

The research appears in the July 17, 2002 issue of JAMA.


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