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Results From the Heart and Estrogen/Progestin Replacement Study (HERS) Trial

Mark A. Hlatky, MD; Derek Boothroyd, PhD; Eric Vittinghoff, PhD; Penny Sharp, EdD; Mary A. Whooley, MD; for the HERS Research Group

JAMA. 2002;287:591-597.

Context  Postmenopausal hormone therapy is commonly used by women for disease prevention, but its effects on quality of life have not been well documented.

Objective  To determine the effect on quality of life of estrogen plus progestin therapy used as secondary prevention in women with coronary artery disease.

Design, Setting, and Participants  A total of 2763 postmenopausal women with documented coronary artery disease (mean age, 67 years) in the Heart and Estrogen/Progestin Replacement Study, a randomized, placebo-controlled, double-blind trial conducted from January 1993 to July 1998 at outpatient and community settings at 20 US clinical centers.

Intervention  Participants were randomly assigned to receive either 0.625 mg/d of conjugated equine estrogen plus 2.5 mg/d of medroxyprogesterone acetate (n = 1380) or placebo (n = 1383) for 36 months.

Main Outcome Measures  Physical activity, measured by the Duke Activity Status Index; energy/fatigue and mental health, measured by RAND scales; and depressive symptoms, measured on the Burnam screening scale, at 3 years of follow-up.

Results  In all patients, scores declined significantly over 3 years for physical function (-3.8; P<.001), mental health (-0.6; P = .05), and energy/fatigue (-3.8; P<.001), but depressive symptoms were not significantly changed (P = .20). The effect of hormone therapy on these measures depended on the presence (n = 434) or absence (n = 2325) of flushing at study entry. Women with flushing who were assigned to hormone therapy had improved mental health (+2.6 vs - 0.5; P = .04) and fewer depressive symptoms (-0.5 vs + 0.007; P = .01) over follow-up compared with those assigned to placebo. Women without flushing who were assigned to hormone therapy had greater declines in physical function (-4.2 vs -3.3; P = .04) and energy/fatigue (-4.6 vs -3.1; P = .03) over follow-up. Quality-of-life scores were significantly lower among patients with older age, diabetes, hypertension, chest pain, or heart failure. These differences in quality of life among women classified by clinical characteristics were much greater than the effects of hormone therapy.

Conclusion  Hormone therapy has mixed effects on quality of life among older women. The effects of hormone therapy depend on the presence of menopausal symptoms; women without flushing had greater declines in physical measures, while women with flushing had improvements in emotional measures of quality of life.

Author Affiliations: Stanford University School of Medicine, Stanford, Calif (Drs Hlatky and Boothroyd); School of Medicine, University of California, San Francisco (Drs Vittinghoff and Whooley); Wake Forest University School of Medicine, Winston-Salem, NC (Dr Sharp); and Department of Veterans Affairs Medical Center, San Francisco, Calif (Dr Whooley).

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