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Combination HRT Continues to Come Up Empty

Most combination-HRT recipients had no substantial long-term improvements in quality of life.

Combination hormone replacement therapy (HRT; estrogen plus progestin) has repeatedly been proven ineffective for cardiovascular-disease prevention. In the randomized, placebo-controlled Women's Health Initiative (WHI), combination HRT was associated with increased cardiovascular risk, and the combination-therapy arm of the trial was consequently halted (Journal Watch Cardiology Aug 23 2002). (The estrogen-only arm is still ongoing.)

Some continue to argue that combination HRT can improve quality of life (QOL), so the WHI researchers have analyzed the health-related QOL effects of combination HRT versus placebo in the 16,608 postmenopausal WHI subjects (age range, 50-79). At baseline, 12% had moderate-to-severe vasomotor symptoms.

By year 1, combination HRT was associated with very small QOL improvements (i.e., a statistically significant improvement in bodily pain and marginally significant improvements in physical functioning and sleep disturbance) but with no improvements in general health, vitality, mental health, depressive symptoms, cognition, and sexual satisfaction. Most combination-HRT recipients had no substantial 1-year improvements on any measure. By year 3, the few 1-year improvements that had been found were gone.

Comment: Looking at all the WHI trial data, one sees that the participants gained essentially nothing but risk from combination HRT. An editorialist urges that combination HRT be used only to treat symptoms in women who have weighed the treatment's clear risks against the benefits of symptom relief. She highlights a need to identify new treatments that are effective and safe.

— Harlan M. Krumholz, MD, SM

Published in Journal Watch Cardiology July 11, 2003

Citation(s):

Hays J et al. for the Women's Health Initiative Investigators. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med 2003 May 8; 348:1839-54.

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• Medline abstract (Free)

Grady D. Postmenopausal hormones -- Therapy for symptoms only. N Engl J Med 2003 May 8; 348:1835-7.

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• Medline abstract (Free)