Canceled HRT Trial Makes Women Anxious
Safety of Most Types of Hormone Replacement Therapy Unknown
Oct. 24, 2002 -- The hormone replacement trial halted in July by the National Institutes of Health raised alarms among women and their doctors, prompting some women to take themselves off of hormone treatments for fear of an increased risk of breast cancer, blood clots, and perhaps heart disease. But experts say the risk may have been overstated.
The original reports may have exaggerated the risks, says Susan Dentzer, who is a health reporter for PBS's News Hour with Jim Lehrer.
The absolute risks are actually quite small. For example, the study projects that in 10,000 women, 38 would get invasive breast cancer when taking hormones, while 30 would get it if they were not taking HRT.
But the impact on women's health could be more severe. Researchers who helped run the study hasten to point out that it only weighed the ability of combination estrogen and progestin therapy to prevent specific conditions: heart disease and hip fractures. And the conclusion -- that hormone replacement therapy should not be used as a preventive measure - applies to just that.
As a treatment for the symptoms of menopause, HRT is unmatched, and some women will undoubtedly choose to continue taking the therapy in spite of the risks.
The study also applied only to Prempro, a mixture of estrogen and a progestin. However, there are other forms of HRT that are approved for the treatment of menopause symptoms and/or the prevention of osteoporosis. Researchers agreed that the risks demonstrated in the halted trial cannot be extrapolated to these other therapies.
In response to the study's findings, many women on hormones have stopped taking them. In fact, HRT manufacturers are reporting a sharp decline in sales since July. Sales of Prempro itself have fallen 40%. Sales of the estrogen-only sister drug, Premarin, have fallen 15%.
However, stopping HRT can produce side effects similar to menopause itself, such as hot flashes and night sweats, according to Susan L. Hendrix, DO, of the Wayne State University School of Medicine and one of the researchers on the hormone replacement trial. "Women are scared to come off the hormones because they don't know what to expect. We need to help determine optimal ways for women to come off" to help avoid or minimize such symptoms, she tells WebMD.
And even if the side effects are severe, it does not mean women should jump right back onto the hormones. "You might be able to give them something for hot flashes and something to help them sleep, and that may be safer" than a return to hormones, she says.
Another concern expressed by doctors is that a sudden stoppage of estrogen therapy could cause an increase in osteoporosis if women and their physicians are not careful to monitor their bone mineral density. Estrogen therapy is not the only means to prevent osteoporosis and not necessarily even the best, but "it is the least expensive and being used by the largest population of women," Barbara Yawn, MD, MSc, of the American Academy of Family Physicians, tells WebMD.
If a large number of women suddenly stops because of this news, it could have important health effects. "Bone health might get lost in all of this. Most people think about breast cancer and [heart] disease. ... Physicians are not screening [for bone density] in their offices. They haven't had to think about it because so many women were taking hormones," says Yawn. -->