Estrogen plus progestin did not improve health-related quality of life in postmenopausal women 50 to 79 years of age

Abstract

Question: In postmenopausal women 50 to 79 years of age, is estrogen plus progestin (EPP) more effective than placebo for improving health-related quality of life (HRQL)?

Design: Randomized (allocation concealed), blinded (clinicians, participants, data collectors, outcome assessors, and monitoring committee), placebo-controlled trial with 1-year follow-up (Women’s Health Initiative).

Setting: 40 U.S. clinical centers.

Patients: 16 608 community-dwelling postmenopausal women who were 50 to 79 years of age (mean age 63 y) and had an intact uterus. Exclusion criteria included a last menstrual period that occurred < 6 months before enrollment in the study (< 12 mo for women 50 to 54 years of age), predicted survival < 3 years, history of breast cancer, low hematocrit or platelet count, alcoholism, and dementia. Follow-up was 100%.

Intervention: Women were allocated to EPP therapy (conjugated equine estrogen, 0.625 mg, plus medroxyprogesterone acetate, 2.5 mg once/d) (n = 8506), or placebo (n = 8102).

Main outcome measures: HRQL and functional status (RAND 36-Item Health Survey), depressive symptoms (Center for Epidemiologic Studies Depression Scale and the National Institute of Mental Health Diagnostic Interview Schedule), sleep disturbance (5-item Women’s Health Initiative Insomnia Rating Scale), sexual functioning, cognitive functioning (Modified Mini-Mental State Examination), and menopausal symptoms.

Main results: Analysis was by intention to treat. Improvement from baseline in physical functioning, bodily pain, and sleep disturbance was greater in the EPP group than in the placebo group (Table). However, the improvements were small and not clinically meaningful (effect sizes were less than a threshold of 0.2 standard deviation units). The groups did not differ for all other outcomes.

Conclusion: In postmenopausal women 50 to 79 years of age, estrogen plus progestin was not more effective than placebo for improving health-related quality of life.