HEALTHDoctors work to ease anxiety over hormone replacement therapyNew studies have left patients on HRT reeling and physicians reevaluating risk factors before deciding where to go from here.By Susan J. Landers, amednews staff. Aug. 5, 2002. - Clarification Washington -- Physicians' telephones began ringing shortly after the news broke July 9 that a large federal study on hormone replacement therapy had been halted because researchers determined that participants taking a combination of estrogen and progestin had a higher risk of breast cancer and coronary heart disease. In the weeks since, both doctors and patients have been rethinking this therapy -- once considered an almost silver-bullet solution to the variety of problems women face as they age. "We've had many, many phone calls and patient visits from women either already on hormones or contemplating taking them," said Andrea Kielich, MD, an internist in a Portland, Ore., multispecialty clinic. On the East Coast, the story was the same. Kathleen Fitzgerald, MD, a gynecologist in Providence, R.I., and a clinical assistant professor at Brown University, said her phone was still ringing constantly more than a week after the findings had been played prominently in news reports. "Women are panicked, which is understandable given the tenor of the media reporting," Dr. Fitzgerald said. In addition to phone calls, patients of Dan Van Durme, MD, a family physician in Tampa, Fla., have been reaching him via fax and e-mail. But he may have prepared his patients for the headlines. "Medicine changes all the time," he has warned them over the years.
6 million U.S. women take estrogen plus progestin as hormone replacement therapy.
The reason driving the amount of anxiety is clear. About 6 million women in the United States take estrogen in combination with progestin for the short-term relief of hot flashes, sleeplessness and vaginal dryness that often accompany menopause as well as for the long-term prevention of osteoporosis and heart disease. Now the fear that the risks uncovered by this arm of the Women's Health Initiative outweigh the benefits of HRT has left patients wondering about their options and physicians scrambling to respond to their questions. Patient by patientThere have been many inquiries from patients as well as a lot of confusion and frustration over how the results of the study apply to them, said Michael Fleming, MD, a family physician in Shreveport, La. "Patients had heard and read, just as I have on the medical side, that [HRT] was the best treatment for prevention of osteoporosis as well as having long-term potential to limit heart disease. Now we have had that turned upside down," Dr. Fleming said. Specifically, the WHI study, published in the July 17 issue of the Journal of the American Medical Association, concluded that if 10,000 women took the drugs for a year and 10,000 did not, women in the first group would have eight more cases of invasive breast cancer, seven more heart attacks, eight more strokes and 18 more episodes of blood clots, including eight with blood clots in the lungs. On the plus side, they would have six fewer colorectal cancers and five fewer hip fractures.
Smoking puts women at higher risk for heart attacks, stroke and breast cancer than does estrogen plus progestin.
"This is a relatively small annual increase in risk for an individual woman," noted Jacques Rossouw, MD, WHI acting director. "However," he said, "even small individual risks over time, and on a populationwide basis, add up to tens of thousands of these serious adverse health events." In light of the findings, doctors are reassessing the advice they provide to patients. But they have to provide that advice one patient at a time, and that means talking to a lot of patients. For example, Dr. Kielich's group practice has about 4,000 patients, and 95% of them are women. About 2,000 are of an age to be on HRT. "Considering that internists see about 4,000 patients a year, you can see where the dilemma lies," she said. To reach patients as quickly as possible, Sandra Ann Carson, MD, a professor of obstetrics and gynecology at Baylor College of Medicine in Houston, is distributing a handout urging patients not to panic and emphasizing the low individual risk disclosed by the study. Rebecca Jaffe, MD, a family physician in Wilmington, Del., is also bringing patients in to discuss their fears and update them on the current state of medical research on the hormone issue. She is recommending that patients not stop taking their hormones just yet. She would rather they discuss all their options during an office visit before deciding what to do. Dr. Jaffe also believes that her patients need to know that the risks of taking HRT might not be as high as news reports indicated. "Your risk from smoking two cigarettes a day is higher for heart attacks, stroke and breast cancer than is taking [estrogen and progestin]," she said. Dr. Fleming has told patients who call that they can stop their hormone use or stay on them, but they should schedule a time to come into the office and talk about their decision. In general, he said, he would recommend that patients continue to use hormones for the short-term relief of menopausal symptoms but to refrain from using them if there is a family history of heart disease or breast cancer. "And we don't need to lose osteoporosis from the equation," he warned. HRT was a standard treatment for osteoporosis, he noted, and he now fears that patients will stop using hormones and fail to replace them with an alternative therapy, thus placing them at risk of bone loss over the long term. A closer lookPhysicians likely haven't heard the final word on the findings. More in-depth analysis of the study is already in the works at the American College of Obstetricians and Gynecologists. ACOG had assembled a task force in June to examine recent studies on the effect of combined estrogen and progestin therapy, and now the new study will be included. Until the task force's recommendations are available, ACOG is advising physicians to discuss alternatives to HRT for women who have taken the hormones for several years already. For those patients using hormones for the short-term relief of menopausal symptoms, ACOG advises that the benefits are likely to outweigh the risks, as the study did not seem to uncover a worrisome increase in risks until a woman had been taking the hormones for five years. Although the study was intended to provide some definitive answers to the long-running controversy over the risks posed by hormone therapy, it also served to raise several more questions. Dr. Fleming's patients who have had hysterectomies and are taking only estrogen are wondering what they should do. The benefits and risks of estrogen alone are being studied in an arm of the trial that is ongoing. Dr. Van Durme wonders if there was something in the specific conjugated equine estrogen that was used in the study and the specific progestin that caused the risk increase. "If we used other forms of estrogen and progestin would we have different answers?" he asks. Dr. Jaffe questions the wisdom of shutting down the 16,000-woman study when so little individual risk was evidenced. She wonders if HRT might have been shown to improve cardiovascular health, for example, over the long term. "It could be that once you were on it for x number of years, it actually statistically made a difference. But they aren't going to watch it long enough to be able to make those comments," she said. Because the study was halted early -- after 5.2 years rather than the planned eight, Dr. Carson and others would have appreciated a little advance notice. "I do wish that the journals would allow physicians to read the articles first. It's so hard to answer patients' questions when you don't have the original research. All we had was the newspaper," she said. ADDITIONAL INFORMATION:Weighing choicesPhysicians now will have to discuss a range of options and alternatives with affected female patients in the wake of the abrupt halt of the 16,000-subject Women's Health Initiative combination hormone replacement therapy study. These include:
WeblinkWomen's Health Initiative HRT trial update from the National Heart, Lung and Blood Institute (http://www.nhlbi.nih.gov/whi/hrtupd/) Article, "Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women," JAMA, July 17 (http://jama.ama-assn.org/issues/v288n3/ffull/joc21036.html) Alternatives to HRT suggestions from North American Menopause Society (http://www.menopause.org/alternatives_hrt.html) ClarificationThis story noted that JAMA reported the halt of the Women's Health Initiative study in its July 17 issue. In rare instances such as this one, JAMA publishes an article on its Web site ahead of print publication. The article was made available, without registration, at the same time the media embargo was lifted, which gave physicians and everyone else access to the information at the same time. In all other cases, distribution of the print edition of JAMA precedes the media embargo date by several days. Copyright 2002 American Medical Association. All rights reserved.
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