Hard Look at Risks of Hormones
Alicia Goldstein has been on hormone replacement therapy for a year and half now--and loves the way her daily regimen deftly dealt with her severe night sweats, hot flashes and insomnia.
But now the 54-year-old Oakland resident is scared. Could the same hormones that have steadied her life now do her harm?
“Right now,” she said, “I just don’t know what to do.”
Women and their doctors are reeling after Tuesday’s stunning announcement that a major federal study of hormone replacement therapy was halted early because the treatment conferred more harm, not less, to post-menopausal women. Now, they face difficult decisions: Should women stop taking drugs that, in some cases, have drastically improved their quality of life? How great are the health risks--and are the risks worth taking?
Doctors’ phones have been ringing off the hook with calls from worried, confused and frightened women.
“Patients are scared. There’s an uneasiness because they don’t know what to do,” said Dr. Edward Yosowitz, a Houston obstetrician-gynecologist.
The study, part of a major research effort called the Women’s Health Initiative, found that women who took the hormones estrogen and progestin after menopause were at increased risk for breast cancer, blood clots, strokes and heart attacks compared to those who took an identical placebo.
Risks for hip fractures and colorectal cancer were lowered by the hormones, but the study’s safety committee terminated the study three years short of its scheduled duration because the risks outweighed the benefits.
The increases in risk detected in the study were significant but slight. But that is no comfort to women who in many cases took hormones because they thought the drugs would help them stay healthier into old age.
The decisions women will make will be very personal, said Dr. Nananda Col, professor of medicine at Harvard Medical School and an internist at Brigham and Women’s Hospital. They may have to reconsider why they were taking the hormones in the first place.
“The advice I’m giving to women who are on particularly the preparations in the study is that we should probably be thinking about tapering them off,” she said. “We need to go back and figure out why they were taking it to begin with.”
One of the primary reasons that women have taken hormone therapy over the long term is that many studies have suggested the drugs protect against heart disease. The new data throw cold water on this theory. They reveal that, in contrast, taking estrogen and progestin had a negative effect on cardiovascular health.
Heart disease risks, doctors point out, can be better addressed through lifestyle changes such as exercise, weight loss, dietary changes and drugs such as aspirin, statins and beta blockers.
Even those who are taking the hormones for protection of their bones--a benefit supported by the study--may be better off taking some other medication, said Dr. Clifford Rosen, an osteoporosis expert at the University of Maine who has patients who take hormones to protect their bones. The earlier-than-expected breast cancer risk is “making us rethink what our long-term strategy will be,” he said.
This presents a serious dilemma to some of his younger patients with skeletal problems. Other bone-protecting medicines, such as the bisphosphonates, are more expensive and have side effects, Rosen said. Another drug, raloxifene (Evista), is an artificial form of estrogen that does not appear to harm the breast. But it aggravates hot flashes.
Doctors said they have known hormone replacement therapy confers slightly increased risks for blood clots and breast cancer, and have urged patients to factor those risks into their decision. But some doctors were surprised at how quickly the heightened breast cancer risk appeared--after just three years--and said that they might recommend shorter time on the hormone for women seeking relief of menopausal symptoms.
Wanda Critchfield, a 62-year-old public health nurse in Sebastopol, Calif., who has been taking hormones for 17 years, said she “isn’t buying into” the latest uproar. During menopause, she was plagued with hot flashes, vaginal dryness, sleeplessness and intermittent bleeding. Even though there is a history of heart disease in her family, she believes the benefits of hormone replacement therapy outweigh the risks.
“I’ve thoroughly researched the issue,” she said, “and I’m going to stay with it.”
But Harvard’s Col said she is reluctant to even recommend short-term use of hormones because some of the heart risk showed up early in the study. There are alternatives for menopause treatment, she said, including antidepressants and high blood pressure medication to help with hot flashes, and moisturizers and estrogen creams to help with vaginal dryness and atrophy.
Some women, she added, are likely to want to remain on hormones because the drugs are believed to help a woman’s skin stay youthful. Others simply feel better on hormones or hope that the therapy will help ward off memory loss and Alzheimer’s disease, as some studies have suggested.
Quality-of-life issues need to be addressed in considering hormone replacement therapy, said Dr. Dan Mishell, chairman of the department of obstetrics and gynecology at USC’s Keck School of Medicine. The study “didn’t address Alzheimer’s disease; it didn’t address hot flashes; it didn’t address genitourinary problems,” he said.
The study also tested just one formulation of the hormones estrogen and progestin, Mishell said. For instance, it may turn out that women may do better taking just estrogen alone, he said.
The risks and benefits associated with taking only estrogen are not yet known. Another large study that is part of the Women’s Health Initiative is exploring that question and is expected to have results in 2005. The fact that this study was not halted at the same time as the study testing estrogen and progestin in combination is encouraging, Mishell said.
Among doctors, there is likely to be a wide variety of responses. “Even in our group [of seven doctors], there are questions about which way to go,” Yosowitz said. Some, he said, are keeping their patients on hormones, while others are stopping the therapy.
Douglas Lord, a gynecologist in Silver Spring, Md., has administered hormone treatments to his patients for more than 25 years. He said that while the study is “mildly surprising,” it is not “an emergency situation.”
He said he spent much of Tuesday reassuring patients, many of whom are not on the treatment, that they were not in grave danger.
Unlike the subjects of the study, only 15% of his patients continue hormone therapy for more than five years, he said.
In the end, hormone therapy will likely still play a role in treatment for women after menopause. But doctors and patients will probably be more cautious in starting the regimen and especially in recommending long-term treatment.
“Right now everyone is swinging over as if we never ought to use hormones for anyone,” said Dr. Isaac Schiff, chief of obstetrics and gynecology at Massachusetts General Hospital in Boston. “I think there is a place for estrogen replacement therapy--that it will get its rightful place for symptom relief.”
Times staff writers Lianne Hart in Houston and Lisa Fackler in Washington, and researcher Anna M. Virtue in Miami contributed to this report.
