Group recommends against hormone therapy
(CNN) — The task force that sparked controversy with its breast cancer screening recommendations a few years ago — and PSA prostate-cancer screening pronouncements last week — is weighing in on hormone replacement therapy. But this time the U.S. Preventive Services Task Force recommendations are remarkable for their lack of controversy.
The group says menopausal women should not use hormone therapy — estrogen either alone or combined with progestin — primarily to prevent chronic disease.
“In the face of pretty good evidence, the balance of potential benefits and potential harms leads us not to recommend the use of these therapies,” said Dr. Kirsten Bibbins-Domingo, a task force member.
The proposed recommendations do not apply to women younger than 50 who have undergone surgical menopause or who are taking hormone therapy to manage menopausal symptoms such as hot flashes, according to the panel.
“No shock there,” said Dr. Carolyn Crandall, a professor of medicine at the David Geffen School of Medicine at UCLA. “I don’t think the recommendations are surprising at all.”
The question used to shape the draft recommendations, which were posted online Tuesday, is whether hormone therapy should be used by menopausal women to prevent a hypothetical future health event such as heart disease or cognitive decline, Bibbins-Domingo said.
“These are women who don’t have disease, who don’t have menopause symptoms, who are using the therapies only to prevent something that might happen in the future,” said Bibbins-Domingo, an associate professor of medicine, epidemiology and biostatistics at the University of California, San Francisco. “There is no evidence that the therapies would prevent those conditions.”
Years ago, in addition to providing relief for menopause symptoms, hormone therapy was thought to offer protection against cardiovascular problems, osteoporosis and dementia, so doctors routinely prescribed it to otherwise healthy women. That practice fell out of favor about 10 years ago when a large clinical trial — the Women’s Health Initiative — designed to confirm these hypotheses was halted early.
Women involved in that trial were actually at higher risk for many of the problems that hormone therapy was supposed to prevent.
Data from the Women’s Health Initiative and other large-scale trials suggest estrogen plus progestin therapy moderately reduces risk for fractures but increases the chance of developing strokes, dementia, deep vein thrombosis, urinary incontinence and gallbladder disease.
For patients taking estrogen only, the picture is similar. As with combination therapy, the risk of fractures is lower, but there is an increased risk of stroke, gallbladder disease, deep vein thrombosis and urinary incontinence.
“Another apparently paradoxical finding is that estrogen and progestin impart a small increase in the risks for developing and dying from breast cancer, whereas estrogen alone appears to slightly reduce these risks,” according to the U.S. Preventive Services Task Force document outlining the draft recommendations.
Researchers detected the lower risk of breast cancer after 11 years of follow-up; those findings and other data were enough to trigger a new look at hormone therapy research, Bibbins-Domingo said.
“It’s not that the findings are new,” said Crandall, who is not part of the task force. “But they give a practical sense about how to counsel someone about the rare but serious harms of taking hormone therapy.”
The new recommendations are based on a review of data, published Monday in the Annals of Internal Medicine, covering nine clinical trials over the last decade.
The standard of care shifted for many doctors after the Women’s Health Initiative trial was halted, but updated recommendations from the task force are important because many patients still have questions, and many doctors are reluctant to let go of old prescribing habits, Crandall said.
As with any set of sweeping recommendations, there are people for whom the weight of risks versus benefits is more complicated.
One of those groups is younger women with menopause symptoms, whose risks may be different.
“We use menopausal hormone therapy for women with moderate to severe hot flashes interfering with their lives,” Crandall said. “It’s a subjective thing. Only women can say how disturbing is this to me.”
Youth — or a person’s specific risk factors for disease — may also affect their risk for developing heart disease and dementia.
“The balance of benefits or harms may be different with young women, so you can’t say this absolutely applies to younger women making hormone therapy decisions,” Crandall said.
The panel acknowledges research gaps when it comes to taking hormone therapy for chronic illness, particularly as it relates to this younger group of women. The average age of women participating in the Women’s Health Initiative was 64 years, well past the age that menopause usually begins.
The task force recommendations “are aimed at older women, who are generally healthy asking, ‘If I take a pill a day, will I prevent a heart attack?’ ” Crandall said.
Many doctors have already greatly limited how they apply the treatment, and the risks of hormone therapy are well-known among professional organizations.
On its website, the American Congress of Obstetrics and Gynecologists warns against hormone therapy for preventing cardiovascular disease. The North American Menopause Society website stresses the same cardiovascular risks and advises that a woman’s personal risk factors should play a role in deciding whether to take hormone therapy.
“The bottom line is clinicians must take all clinical parameters into account for the patient and prescribe the lowest dose for the shortest duration of time,” said Dr. Joseph Sanfilippo, vice chairman of reproductive sciences at Magee-Women’s Hospital in Pittsburgh, in an e-mail to CNN.
The task force is inviting public comment about its latest recommendations until June 26. Then it will decide whether to make the draft recommendations final.