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

Reprinted with permission of the www.womenshealthresearch.org

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 a major clinical trial on one specific dose and formulation. Last week, a large and well-designed study on the therapy 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, Women's Health Initiative researchers decided, were overshadowed by the risks.

To HRT or Not to HRT?
So should women abandon HRT altogether? "Hardly," say specialists like Steven R. Goldstein, MD, professor of obsterics 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 hard-fast 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 out once a patient's personal health risks are compared with 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 physicians had high hopes that HRT would reduce the risk of heart disease, last week's 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, 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 has been shown to be effective in preventing and treating osteoporosis and may even reduce the risk of breast cancer. Bisphosphonates have also been shown to maintain bone mineral density. The drawback of these medications, according to Dr. Goldstein, is that neither will relieve the discomfort of menopause.

What about Estrogen-Only Therapy?
Millions of other menopausal women who have had their uteruses removed have been taking estrogen-alone for the relief of menopausal symptoms, prevention or treatment of osteoporosis and in hopes of preserving heart health. How do the latest findings affect them? Unfortunately the relative risks and benefits of this type of therapy remain to be seen.

Leaders of the Women's Health Initiative study did not halt the part of the trial comparing estrogen alone with placebo in women with hysterectomies. When results of that study are revealed in 2005, researchers will have a better idea of the relative benefits of estrogen and progestin. 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 a hysterectomy.

Many Unanswered Questions Remain
While the latest 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.

July 19, 2002

Sophia Cariati
Society for Women's Health Research

Sophia Cariati is a medical and science writer with a bachelor's of science degree in biology and a master's degree in scientific and environmental reporting.