Health-Related Quality of Life After Combined Hormone-Replacement Therapy: Randomized Controlled Trial: Women’s International Study of Long Duration Estrogen After the Menopause

Abstract

Previous trials evaluating possible improvements in health-related quality of life (QOL) with combined hormone-replacement therapy (HRT) used generic instruments that did not contain specific items on postmenopausal symptoms, and may have underestimated improvements for a particular outcome or condition. This placebo-controlled, double-blind, randomized trial—part of the Women’s International Study of Long Duration Estrogen after the Menopause (WISDOM)—evaluated the effects of HRT on health-related QOL using condition-specific instruments. A total of 3271 postmenopausal women aged 50 to 69 with a uterus were randomized to receive either combined estrogen/progestin (n = 1862) or placebo (n = 1859). The study subjects were recruited from primary care practices in the United Kingdom, Australia, and New Zealand between 1999 and 2002. At follow-up time of 1 year, data were available for 1043 women who had received combined HRT and 1087 given the placebo. Combined HRT contained conjugated equine estrogen 0.625 mg plus oral medroxyprogesterone acetate 2.5/5.0 mg self-administered daily for 1 year. The condition-specific instruments used were several validated women’s health questionnaires measuring health-related QOL, psychological well-being, and changes in emotional and physical menopausal symptoms. Compared with the placebo, combined HRT produced small but significant improvements at 1 year in vasomotor symptoms, sleep problems, and sexual functioning (all comparisons, P < 0.001). Fewer women in the combined HRT group reported hot flushes, night sweats, insomnia, aching joints and muscles, and vaginal dryness, but more had breast tenderness or vaginal discharge (all comparisons, P < 0.001). There was more than a 2-fold reduction in hot flushes at 1 year in the HRT group compared with the placebo group (9% vs. 25%, respectively). At 1 year, there were no significant differences between the 2 groups in other symptoms of menopause, overall QOL, or depression. The investigators believe that inclusion of mainly asymptomatic women well past the menopause in this study and other similar controlled trials may underestimate the positive effects of combined HRT on health-related QOL for women with symptoms.