New HRT Findings Tell Old Story:
Therapy is Not One-Size-Fits-All
by Sophia Cariati

(Washington DC, 7/19/02):  Reports of recent studies revealing hormone replacement therapy (HRT) is associated with health risks have left women scared and confused about how to stay comfortable and healthy during menopause.

After decades of seemingly conflicting information on the pros and cons of HRT, there are finally data from the Women's Health Initiative (WHI) a major clinical trial being conducted by the National Institutes of Health (NIH) National Heart, Lung, and Blood Institute (NHLBI) on one specific dose and formulation of combination HRT. Last week (7/02), this portion of the WHI was halted prematurely when researchers concluded that post-menopausal women taking a combination of estrogen and progestin were at a small but significantly increased risk of heart disease, stroke, blood clots and breast cancer compared with women taking a sugar pill (placebo). The benefits of therapy, including relief of menopausal symptoms, reduced risk of hip fractures, and a lower incidence of colon cancer, were overshadowed by the risks, WHI researchers decided.

To HRT or Not to HRT?
So should women abandon HRT altogether? "Hardly," say specialists like Steven R. Goldstein, MD, professor of obstetrics and gynecology at the New York Medical Center in Manhattan. Instead, "every woman should reevaluate exactly why she is on HRT to see whether the benefits still outweigh the risks," says Dr. Goldstein. Thus, while medical research has finally provided some answers, even the results of a landmark study can not offer women a one-size-fits-all answer to the question of whether or not to take HRT.

The right decision hinges on how the scales balance once a patient's personal health risks are weighed against the potential for HRT to improve quality of life, according to Dr. Goldstein. For most women, menopause brings a barrage of uncomfortable symptoms as the body produces less of the hormone estrogen. Hot flashes, sleeplessness, and vaginal dryness prevent some women from carrying on day-to-day functions. Others pass more peacefully through this period. "We need to make decisions about HRT one patient at a time," says Dr. Goldstein.

Understanding the Risks
In medical research, risk is averaged out over a large number of study participants and is presented as a fixed number. Last week's findings were summarized as follows: over a one year period, among 10,000 postmenopausal women taking estrogen plus progestin, seven more will have a heart attack, eight more will suffer a stroke, eight more will develop breast cancer, and 18 additional will have blood clots compared with a group of 10,000 women not taking HRT.

In real life, however, health risks vary depending upon the individual's lifestyle and family medical history. Thus, the actual risk of cardiovascular problems and breast cancer associated with HRT will vary from woman to woman. "Patients are not statistics, they are individuals," says Dr. Goldstein.

Consider the case of a 56-year old menopausal woman who goes to her doctor complaining of hot flashes. "If she is overweight, a smoker, and doesn't exercise, I might suggest she invest in a personal fan," said Dr. Goldstein half-jokingly. In contrast, the same patient with fewer cardiovascular disease risk factors might be a better candidate for HRT. After all, experts remind women that the health risks faced by individual study participants were relatively small. Hence, the benefits of using HRT for the short-term relief of hot flashes and vaginal dryness will outweigh the risks for many women.

Women who began HRT solely to promote heart health should reconsider their decision.  While this was never an approved indication for the use of HRT, many physicians had high hopes that HRT would reduce the risk of heart disease; the WHI results prove otherwise. Instead of HRT, women concerned with heart health should talk to their doctors about other methods of reducing the risk of cardiovascular disease including aspirin, prescription drugs (e.g. statins), diet and exercise.

HRT Still the Best Relief for Hot Flashes and Vaginal Dryness
Last week's landmark report failed to factor in issues of quality of life, points out Dr. Goldstein. Some patients are desperate for relief when they visit their doctors. A woman who can't sleep, is sweating profusely, and can't perform professionally is exactly the kind of person who should continue on HRT until she is no longer symptomatic, according to Dr. Goldstein. "How can we give women a blanket response until we've walked a mile in each of their shoes?" asks Dr. Goldstein.

Other women, who began HRT a number of years ago for menopausal symptoms, might want to consider weaning themselves off the hormones. Hot flashes and the like generally subside a few years after a woman enters menopause. "If a patient tapers her dose of HRT over a few months and she feels okay, I would recommend going off it," says Dr. Goldstein, "If, on the other hand, she doesn't like the way she feels, she can have her HRT back."

Bone Benefits of HRT
What about women with osteoporosis or those at high-risk? Luckily, there are alternatives to HRT. Raloxifene (Evista) has been shown to be effective in preventing and treating osteoporosis and may even reduce the risk of breast cancer. Bisphosphonates (e.g. Actonel and Fosamax) have also been shown to maintain bone mineral density. Calcitonin is another option.  The drawback of these medications, according to Dr. Goldstein, is that neither will relieve the discomfort of menopause.

What about Estrogen-Only Therapy?
What should a woman think if she is one of the millions of menopausal women who have had her uterus removed and has been taking estrogen alone for the relief of menopausal symptoms, prevention or treatment of osteoporosis and in hopes of preserving heart health?  How do these WHI findings affect them?  While the relative risks and benefits of this type of therapy remain to be seen, the WHI safety board study did not halt the part of the trial comparing estrogen alone with placebo in women who had had hysterectomies. When results of that study are revealed in 2005, researchers will have a better idea of the relative benefits of estrogen alone.  In the meantime, experts do know that estrogen alone increases the risk of uterine cancer, which explains why it is generally prescribed only to women who have had their uterus removed.

Many Unanswered Questions Remain
While the WHI findings provide valuable information, experts caution that more research into treatments for menopausal symptoms and the prevention of disease in post-menopausal women is needed. Preliminary evidence has some experts hoping that so-called "designer estrogens" or selective estrogen receptor modulators (SERMs) may turn out to extend long-term health in post-menopausal women much like HRT was expected to do. Yet only large-scale, well-designed trials on the safety and effectiveness of these and other drugs in use by postmenopausal women will determine if these are educated guesses or scientifically sound answers.

The Society for Women's Health Research is the nation's only not-for-profit organization whose sole mission is to improve the health of women through research. Founded in 1990, the Society brought to national attention the need for the appropriate inclusion of women in major medical research studies and the resulting need for more information about conditions affecting women. The Society advocates increased funding for research on women's health, encourages the study of sex differences that may affect the prevention, diagnosis and treatment of disease, and promotes the inclusion of women in medical research studies. Dr. Donnica Moore has been a member of the Society since 1990 and is a past member of its Board of Directors.

For more information on hormone replacement therapy, click here.

Created: 7/30/2002  -  Donnica Moore, M.D.
Reviewed: 1/23/2003  -  Donnica Moore, M.D.