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


CONCLUSIONS
The hormone replacement regimens in the ERA trial did not improve HRQL of postmenopausal women with heart disease.
Sherman
A M
AM
Department of Psychology, Brandeis University, Waltman, MA, USA.
Shumaker
S A
SA
Sharp
P
P
Reboussin
D M
DM
Kancler
C
C
Walkup
M
M
Herrington
D M
DM
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy / Q000523:psychology*; D005260:Female; D006801:Humans; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires