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Clinical Trial
. 2003 Dec;55(6):511-7.

No effect of HRT on health-related quality of life in postmenopausal women with heart disease

A M Sherman  1 , S A Shumaker, P Sharp, D M Reboussin, C Kancler, M Walkup, D M Herrington
Affiliations
  • PMID: 14676740
Clinical Trial

No effect of HRT on health-related quality of life in postmenopausal women with heart disease

A M Sherman et al. Minerva Ginecol. 2003 Dec.

Abstract

Aim: Previous clinical studies suggest hormone replacement therapy (HRT) alleviates menopausal symptoms and may improve health-related quality of life (HRQL). Most studies on HRT and HRQL were limited in duration (12 months or less) and scope (few and non-standard HRQL measures). The aim of this paper is to assess HRQL in the Estrogen Replacement and Atherosclerosis (ERA) trial.

Methods: A subset of women within a randomized, blinded, placebo-controlled secondary prevention trial has been studied in outpatient and community settings at 5 US sites. A total of 246 postmenopausal women with angiographically documented heart disease (mean age 66 years, 83% Caucasian) were enrolled in the ERA trial. Participants received either 0.625 mg/day conjugated equine estrogen only, estrogen plus 2.5 mg/day medroxyprogesterone acetate, or placebo. HRQL was assessed using validated questionnaire instruments at baseline and follow-up (mean 3.2 years of trial). Physical and mental functioning, life satisfaction, depressive symptoms, urinary incontinence, sleep disturbance, and frequency and intensity of physical symptoms were evaluated.

Results: In this group of women with established coronary disease, active therapy was not significantly associated with more favorable outcomes for any HRQL. The estrogen-only group reported more urinary incontinence than the placebo group (p<0.05). Analyses restricted to adherent women (those who took > or = 80% of pills) showed a similar pattern of results, showing that the estrogen only group reported significantly higher urinary incontinence compared to placebo (p<0.01).

Conclusion: The hormone replacement regimens in the ERA trial did not improve HRQL of postmenopausal women with heart disease.

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