Health-related quality of life in women with or without hot flashes: a randomized placebo-controlled trial with hormone therapy

Objective: We assessed the impact of hot flashes and various forms of hormone therapy on health-related quality of life and sexual well-being in recently postmenopausal women. Methods: We prospectively interviewed 150 healthy women about hot flashes and health-related quality of life (using the Women's Health Questionnaire and the McCoy Female Sexuality Questionnaire), menopause-related symptoms, and general health. The women were classified into those with (n = 72) and without (n = 78) hot flashes and treated for 6 months with transdermal estradiol (1 mg/d), oral estradiol (2 mg/d) with or without medroxyprogesterone acetate (5 mg/d), or placebo. Results: At baseline, hot flashes contributed most strongly to poor sleep (correlation coefficient r = -0.525, P < 0.0001), somatic symptoms such as muscle pains (r = -0.348, P < 0.0001), menstrual cycle-resembling complaints (r = -0.304, P < 0.0001), anxiety and fears (r = -0.283, P < 0.0001), decreased memory and concentration (r = -0.279, P = 0.001), and sexual behavior (r = -0.174, P = 0.035). The different hormone therapy regimens alleviated hot flashes equally effectively and were therefore combined into a single group for further analysis. In women with baseline flashes, hormone therapy use significantly improved the scores for sleep (0.787 [0.243] vs 0.557 [0.249], hormone therapy vs placebo, P = 0.001, at 6 mo), memory and concentration capacity (0.849 [0.228] vs 0.454 [0.301], P < 0.0001, at 6 mo), and anxiety and fears (0.942 [0.133] vs 0.826 [0.193], P = 0.005, at 6 mo). Hormone therapy use showed no significant impact on these variables in women without baseline flashes. Conclusions: Hot flashes contribute differently to various variables affecting health-related quality of life shortly after menopause. Estradiol or an estradiol-medroxyprogesterone acetate combination similarly alleviates hot flashes and improves health-related quality of life in relation to elimination of hot flashes. Hormone therapy use does not confer any detectable quality-of-life benefit over placebo in women without disturbing baseline flashes.