|
Help for Hot
Flashes
WASHINGTON (By Barbara Kantrowitz and Pat
Wingert, Newsweek) January 18. 2006 — Gynecologists still shudder when they
remember July 9, 2002. That morning, the National Institutes of Health (NIH)
halted a major clinical trial of estrogen and progestin therapy after
preliminary results showed that women in the study who were taking the
combined hormone regimen had an increased risk of breast cancer, heart
attacks, stroke and blood clots. In doctors’ offices around the country,
phones rang incessantly as confused and frightened women demanded answers.
Millions of women had been taking hormones to stave off heart disease; now
they were learning that the medicine that was supposed to help them could
actually hurt them. The study, called the Women’s Health Initiative (WHI),
made headlines around the world. Two years later, another arm of the study
that looked at women on estrogen alone was also stopped early because of
increased risk of stroke. As a result of the WHI’s hormone studies, leading
medical organizations and the Food and Drug Administration revised their
policies for estrogen therapy. It’s now recommended only on a short-term
basis to treat symptoms like hot flashes and vaginal dryness—not as
long-term prevention against heart disease.
When it began 15 years ago under the administration of then-NIH director Bernadine Healy, the WHI was the first comprehensive study of diseases affecting older women in the United States. A major goal was to see whether hormone therapy really protected women against heart disease—a conclusion reached by a number of earlier observational studies. At that time, women were getting the message that they were somehow negligent if they didn’t take hormones at menopause. As a clinical trial, with one group of women on hormones and the other on a placebo, the WHI could conclusively establish or debunk those earlier results. The results were not just a bombshell for the medical community; they also rewrote the script for how women interact with their doctors. Instead of just accepting their doctors’ word that hormone therapy is a good idea, women are finding that they have to ask a lot of questions to reach a decision on an issue that turns out to be much more complex than most realized. It has also made many women think more carefully about other health care decisions. But for all its contributions, the WHI still leaves some nagging questions. One of the biggest dilemmas is how to apply the WHI’s results to women around the age of menopause who are looking for relief from hot flashes, not protection from heart disease. Because the average age of the women in the study was 63 (generally more than a decade past menopause), many doctors think the results frightened off younger women who might benefit from hormones for a year or two when their hot flashes are most severe. Estrogen is still the most effective treatment for that common menopausal symptom and a younger, healthy woman is less likely to have a stroke or heart attack than an older woman. Many doctors consider the risk to younger women acceptable, especially if night sweats are ruining sleep. But age is not the only factor to consider. The FDA says women should not take estrogens and progestins if they think they are pregnant or have had any of these conditions: unusual vaginal bleeding, estrogen-sensitive cancers, blood clots, liver disease, or a stroke or a heart attack in the past year. A woman thinking about hormone therapy has to understand her overall health picture, says Marcia Stefanick, a professor of medicine at Stanford and chair of the WHI’s steering committee. A 50-year-old woman who is only slightly overweight and relatively inactive, with borderline but normal risk for coronary heart disease, could raise her chance of a stroke or heart disease to that of a 60-year-old or possibly even a lean, active 70-year-old who is not on hormone therapy, Stefanick says. That kind of comparison might persuade some women to try alternate measures—like exercising or wearing layered clothing—and just riding out the rough times. Other women might really want the relief immediately, no matter what the risk. In the last few years, the WHI has spurred pharmaceutical companies to develop new products that limit a woman’s exposure to estrogen. Women whose only complaint is vaginal dryness can choose local therapy (like creams, tablets and vaginal rings). Women who are close to menopause but still menstruating can take low-dose oral contraceptives to even out fluctuating hormones. Many women are also exploring alternative ways to manage menopausal symptoms through deep breathing, stress-reducing exercise or meditation.
The WHI didn’t answer all of our questions about the risks and benefits of hormone therapy for women. But thanks to these studies, women have much more knowledge and some real choices. "Medicine is an art form," says Dr. Elizabeth Nabel, director of the Heart, Lung, and Blood Institute, which administers the WHI. Research adds information that doctors and patients use to decide what might be best for the individual. The study continues to make news—and not just about hormone therapy. Earlier this month, WHI investigators published a report in the Journal of the American Medical Association showing that a low-fat, increased carbohydrate diet doesn’t lead to weight gain in postmenopausal women. More data from the WHI’s diet studies will come in February, when researchers will publish results from two clinical trials—one looking at the impact of a low-fat diet on the prevention of breast and colorectal cancer and heart disease and the other on whether calcium and vitamin D supplements can prevent colorectal cancer and fractures related to osteoporosis. With many of the original 161,000 postmenopausal women in the study still volunteering to stay on, follow-up research will continue until 2010, says Nabel. Ongoing studies will examine what happens years later to women who have been on hormone therapy. “What was extraordinary was the level of enthusiasm of the participants,” Nabel says. Some of the women have even created quilts with patchwork to represent their reasons for joining. In a quilt displayed on the WHI participant website (www.whi.org), one square shows appliquéd yellow footprints on a white background. The woman who made it, identified as ED, calls it “Footprints to Follow,” explaining: “I volunteered for WHI'S research study program for the healthy and happier lives of one daughter-in-law, three granddaughters, three great granddaughters, their families and all other women and families.” Even more research is on the horizon, says Nabel. Biotech companies have started using sophisticated gene sequencing with WHI samples to figure out what makes some women more vulnerable to certain diseases. “When WHI was first proposed” in the early 1990s, says Nabel, a cardiologist, “this technology was just a twinkle in people’s eyes.” This year, the NHLBI is also opening up the study’s database to scientists as a kind of research library for exploring issues in women’s health. Hopefully, quiltmaker ED's granddaughters and great granddaughters will indeed reap the benefits. |
|
|
