This study aims to evaluate the effects of low-dose estradiol (E 2) or venlafaxine on menopause-related quality of life and associated symptoms in healthy perimenopausal and postmenopausal women with hot flashes. Methods A double-blind, placebo-controlled, randomized trial of low-dose oral 17β-E 2 0.5 mg/day and venlafaxine XR 75 mg/day, versus identical placebo, was conducted among 339 women (aged 40-62 y) experiencing two or more vasomotor symptoms (VMS) per day (mean [SD], 8.07 [5.29]) who were recruited at three clinical sites from November 2011 to October 2012. The primary trial outcome, as reported previously, was frequency of VMS at 8 weeks. Here, we report on secondary endpoints of total and domain scores from the Menopause-Specific Quality of Life Questionnaire (MENQOL) and from measures of pain (Pain, Enjoyment in life, and General activity scale), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder Questionnaire-7), and perceived stress (Perceived Stress Scale). Results Treatment with both E 2 and venlafaxine resulted in significantly greater improvement in quality of life, as measured by total MENQOL scores, compared with placebo (E 2: mean difference at 8 wk,-0.4; 95% CI,-0.7 to-0.2; P < 0.001; venlafaxine: mean difference at 8 wk,-0.2; 95% CI,-0.5 to 0.0; P = 0.04). Quality-of-life domain analyses revealed that E 2 had beneficial treatment effects on all domains of the MENQOL except for the psychosocial domain, whereas venlafaxine benefits were observed only in the psychosocial domain. Neither E 2 nor venlafaxine improved pain, anxiety, or depressive symptoms, although baseline symptom levels were low. Modest benefits were observed for perceived stress with venlafaxine. Conclusions Both low-dose E 2 and venlafaxine are effective pharmacologic agents for improving menopause-related quality of life in healthy women with VMS.
Bibliographical notePublisher Copyright:
© 2014 by The North American Menopause Society.
- Quality of life