Quality-of-life and depressive symptoms in postmenopausal women after receiving hormone therapy: results from the Heart and Estrogen/Progestin Replacement Study (HERS) trial.
BACKGROUND
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.


METHODS
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.


METHODS
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.


METHODS
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.


CONCLUSIONS
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.
Hlatky
Mark A
MA
Stanford University School of Medicine, HRP Redwood Bldg, Room 150, Stanford, CA 94305-5405, USA. hlatky@stanford.edu
Boothroyd
Derek
D
Vittinghoff
Eric
E
Sharp
Penny
P
Whooley
Mary A
MA
D000368:Aged; D003324:Coronary Artery Disease / Q000517:prevention & control; D003863:Depression / Q000453:epidemiology*; D004311:Double-Blind Method; D015914:Estrogen Replacement Therapy / Q000009:adverse effects; D004966:Estrogens, Conjugated (USP) / Q000494:pharmacology; D005221:Fatigue / Q000453:epidemiology*; D005260:Female; D019584:Hot Flashes; D006801:Humans; D016014:Linear Models; D017258:Medroxyprogesterone Acetate / Q000494:pharmacology; D008603:Mental Health; D015999:Multivariate Analysis; D005082:Physical Exertion; D017698:Postmenopause; D045167:Progesterone Congeners / Q000494:pharmacology; D019057:Quality-Adjusted Life Years
D004966:Estrogens, Conjugated (USP); D045167:Progesterone Congeners; D017258:Medroxyprogesterone Acetate