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.