TUESDAY, March 2, 2004 (HealthDayNews) -- The halting of yet another hormone therapy trial, this one the estrogen-only segment of the Women's Health Initiative (WHI), has women once again stopping and wondering where to go from here.
By all accounts, the news, though disturbing, is no reason for alarm.
"It's important for women, especially women who've been on hormones, not to panic because, in truth, there's a slight increase of stroke but it's not a huge increase," says Dr. Elizabeth Garner, a gynecologic oncologist at Brigham and Women's Hospital and Dana Farber Harvard Cancer Center, both in Boston. "Just because you took hormones for a couple of years doesn't mean you're going to have a stroke."
Nor should women who are on birth control pills panic. "These findings are not relevant to women on birth control pills," says Dr. Susan Lobel, associate director of reproductive endocrinology at Maimonides Medical Center in New York City. "Women on birth control pills are in a different age range."
And despite the recent spate of stopped trials, most experts predict hormone therapy will retain its place as the only effective treatment for menopausal symptoms such as hot flashes and disturbed sleep.
The estrogen-only phase of the WHI was designed to look at the effects of hormone therapy on heart disease. It was halted not only because it appeared to have no effect on heart disease risk but also because it elevated the risk of stroke, albeit only by about eight in 10,000 women. At the same time, there were no changes in breast cancer risk and a decreased risk of hip fracture.
In 2002, the government halted the combination therapy (estrogen plus progestin) arm of the WHI because of an increased risk of breast cancer, stroke, heart disease and blood clots. Last year, the memory portion of the WHI was stopped because there was an increased risk of dementia in women over 65. A British study was also halted in 2002 because of elevated risks of breast cancer, while a Swedish study was stopped last month because of an elevated risk of breast cancer recurrence.
The fallout from this litany will depend, in large part, on why someone is being treated, Lobel says.
"Clearly, women shouldn't think that hormone therapy alone can prevent diseases such as heart disease and dementia," says Dr. Nieca Goldberg, chief of women's cardiac care at Lenox Hill Hospital and author of the book Women Are Not Small Men.
The American Heart Association joined this chorus, issuing a statement reiterating that "the association reinforces its recommendation that hormone therapy not be used for cardiovascular prevention."
Menopausal symptoms, however, are a whole different story.
"It is important to put this study into context," reads a statement from the Society for Women's Health Research. "It was designed to assess the effect of long-term hormone therapy in healthy postmenopausal women in the prevention of heart disease and hip fractures and any related changes in the risk for breast cancer. The study did not evaluate the short-term risks and benefits of hormone therapy for the treatment of moderate or severe menopausal symptoms, such as hot flashes or vulvar and vaginal atrophy."
"There are definitely still some clear benefits in alleviating menopausal symptoms," Garner adds.
"For all the women who are quitting [hormone therapy], there's definitely a huge number who aren't quitting. I don't think we're hearing that voice as much, but it's definitely out there," she says. "In terms of symptom relief, I think it's going to be at the lowest dose possible and the shortest time."
But when prescribing, doctors and patients need to clearly weigh the risks and benefits, which is what should happen whenever a drug prescription is written. "With any drug there are potential risky side effects, even with cholesterol-lowering drugs," Garner says.
"If a woman comes to me who's 51 and going through miserable hot flashes, the most effective way to treat that is with hormones," Garner adds. "I would be hard-pressed to say there's a potential that after five years your risk of breast cancer might be slightly increased. I don't think that's a reasonable response."
It's also important to keep in mind that the study just halted looked at women who were a decade or so beyond menopause. "This doesn't really address what to do when someone going through menopause is going through hot flashes," Lobel says.
"Right now, the main purpose of prescribing hormone therapy is for a woman having menopausal symptoms," Goldberg adds. "This study did not look at that. The WHI women were started on therapy on average 10 to 15 years after menopause, so comparing them to a 50-year-old or a woman in her late 40s who's actually going through menopause is like apples and oranges."
That is not to say the role of hormone replacement therapy is not due for a change. "Until a couple of years ago, we envisioned women being on replacement therapy for 20 or 30 years, and that certainly has changed," Lobel says.
More information
The American Heart Association has more on women and cardiovascular disease. The U.S. Food and Drug Administration has more on menopause and hormones. Learn more about the Women's Health Initiative.
