So, Should I Stay on Hormones?
A month after major study is halted, still no simple answers
FRIDAY, Aug. 9, 2002 (HealthDayNews) -- As the news was breaking that a large federal study on hormone therapy was being halted because the drugs' risks outweigh the benefits, the phone began ringing at the California office of Dr. William Parker.
The first caller, a woman on her cell phone, posed the question millions of other women would echo to their doctors and themselves in the coming weeks: What do I do now?
Today marks one month since the research was released in the Journal of the American Medical Association, and the study was halted because the therapy raised the risk of breast cancer and cardiovascular trouble. Still, there seem to be more questions than answers.
There's no consensus among doctors, except that the decision must be tailored to specific women based on medical history, risks and menopausal symptoms. Among women, who've been urged not to panic by the American College of Obstetricians and Gynecologists, the reaction ranges from fear to a wait-and-see approach to outright defiance. As Parker, a gynecologist with Santa Monica-UCLA Medical Center, was discussing the study with colleagues in the hospital cafeteria, a woman walked up and said, only half-jokingly, "No one's taking away my hormones."
For years, doctors have wished more women would have thought that way. The party line for post-menopausal women has been to take hormone replacement therapy (HRT) to stay healthy, feel better and reduce risks of osteoporosis, heart disease, perhaps Alzheimer's disease, and colon cancer.
Last month's announcement changed all that.
The study, called the Women's Health Initiative, evaluated more than 16,000 healthy women -- half taking a combination of equine estrogens and medroxyprogesterone acetate and half taking a placebo. The trial was halted after 5.2 years of a planned eight-year study. The trial on estrogen alone continues, since no increased risk for breast cancer was found in the estrogen-only group.
Here's how the other risks play out if 10,000 women take the hormones for one year, as compared to women on placebo: Eight more of the hormone-treated women will develop breast cancer, seven more will have a heart attack or other coronary problem, eight more will have a stroke, and 18 more will have blood clots. However, there would be six fewer cancers of the colon and five fewer hip fractures. The results do not necessarily apply to other formulas, lower doses, or to hormones administered through skin patches rather than orally.
"This study caught us all off guard," Parker says.
And doctors' reactions to it are varied. "We're taking this study very seriously," Parker says. If patients have been on hormone therapy less than five years, he advises, "let the dust settle."
In the coming months, he believes experts will analyze and re-analyze the study, and more information will come out.
"Women who don't have a uterus, who are on estrogen only, can stay on it for now," he says.
For women who have been on the combination therapy for more than five years, he suggests they taper down over the next few months and then stop. "Then we deal with individual problems such as a risk for osteoporosis, by trying other options," such as bone-building drugs, he says. In his practice, about eight in 10 women he's seen are deciding to stop the therapy.
For women who don't want to quit, Parker has other strategies, including prescribing oral estrogen and inserting the Mirena Intrauterine device, which secretes low levels of a progesterone, thought to protect the lining of the uterus. That treatment is not approved by the U.S. Food and Drug Administration for this purpose, Parker emphasizes. Taking estrogen alone increases uterine cancer risk, and isn't advised for women who still have a uterus.
The problem is clearly the medroxyprogesterone used in the study, says Dr. Alan M. Altman, an assistant clinical professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School. For more than seven years, he has prescribed a less potent, more natural progesterone than medroxyprogesterone, such as Prometrium.
"The more potent the progesterone, the more you are going to negate the beneficial effects of the estrogen," Altman says.
Deciding whether to stay on hormone therapy doesn't just depend on disease risks, but quality-of-life issues, says Dr. Nieca Goldberg, a cardiologist and chief of the Women's Heart Program at Lenox Hill Hospital in New York City.
"Not all women are going to come off HRT," she says. "It makes some more comfortable. Some don't have vaginal dryness." Like Altman, she says the more natural the progesterone, the better if a woman decides to stay on hormones.
As doctors debate which approach is best, women do the same.
"I'm staying on for the moment," says Alice Appel, 59, of Arroyo Grande, Calif., who's been on hormone therapy for eight years. "I'm seeing a new doctor soon and will discuss it. I have no risk factors for coronary disease or breast cancer, but I am concerned about osteoporosis."
Her mother has lost about three inches, her grandmother had osteoporosis, and Appel herself is a petite 5-foot-3 and a half inches tall.
Other women are balancing the pros and cons of hormone therapy against existing medical problems, and trying to keep their sense of humor at the same time.
"I am playing off one set of calculated risks against another," says Laurie Nadel, a 54-year-old New York journalist who is on hormone therapy. She's at high risk for osteoporosis, but also has asthma, and there is conflicting information on HRT and asthma.
"I decided to wean myself off Premarin and Provera slowly," she says, then see if any menopausal symptoms resurface. "The first sign of dementia or early Alzheimer's, and I'm back on them," she jokes.
If deciding whether to take hormones for a lifetime is too overwhelming a decision, consider Altman's reassuring approach. "When women say, 'Do I stay on this for the rest of my life,' I say it's a year-to-year decision." At each annual physical, Altman reviews a woman's history, symptoms and risk factors, and gives her the current status of the risk and benefit of hormone therapy for her.
What To Do
For a copy of the study report, see Journal of the American Medical Association. To see the statement released by another leading group, visit the American College of Obstetricians and Gynecologists.