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Is HRT Safe?

A national research study of hormone replacement therapy (HRT) that involved 16,000 postmenopausal women was halted in July 2002 when findings showed a rise in the risk of breast cancer, heart disease, blood clots, and stroke. The risks were judged to be slight, but significant. The study, entitled the Women's Health Initiative (WHI), focused on estrogen and progestin, currently taken by an estimated six million American women.

The federally funded WHI study was unique because, unlike other HRT studies that evaluated indicators of disease, such as cholesterol levels, it directly measured incidence of heart disease, breast cancer, and other disorders. Data showed that in the short term, the HRT regimen was safe, but that after five years, "the breast cancer risk exceeded the predefined boundary for safety," said Jacques E. Rossouw, the acting director of the study.

Freya R. Schnabel, MD, FACS
Freya R. Schnabel, MD, FACS
Chief, Breast Surgery Section

"This was a large, prospective, randomized, well-designed study that quantified risk for the first time," says Freya Schnabel, MD, Chief, Breast Service at CUMC. "From my perspective, this study documents issues we have suspected for a long time."

Since it was first prescribed in the 1960s, almost mythical benefits have been attributed to HRT, Dr. Schnabel says. In addition to being prescribed as a treatment for hot flashes and night sweats and a preventative against osteoporosis, HRT has been touted as protection against heart disease and as an all-purpose way to delay the aging process.

"Patients have asked me, 'Do you believe in HRT?' I tell them that HRT is not something to be believed in," Dr. Schnabel says. "HRT is a medication, and as with any medication, there are risks and benefits that must be considered before it is prescribed. That is the message of this study. We need to apply the same scientific standards to HRT that we apply in analyzing all medications. We need to consider indications for treatment and duration of treatment.

"We also need to remember that menopause is a natural process, and not a disease that automatically requires medication. Some women have life-altering menopausal symptoms, such as severe hot flashes and night sweats that keep them from sleeping. These are not trivial, and HRT can be useful as a short-term therapy to help them through this process. But this study challenges assumptions we have made about HRT as a life-long therapy."


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