Estrogen, Venlafaxine, and Menopause-Related Quality of Life
Objective. This study aims to evaluate the effects of low-dose estradiol (E2) 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-E2 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 E2 and venlafaxine resulted in significantly greater improvement in quality of life, as measured by total MENQOL scores, compared with placebo (E2: 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 E2 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 E2 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 E2 and venlafaxine are effective pharmacologic agents for improving menopause-related quality of life in healthy women with VMS.
More than 38 million US women aged 45 to 64 years (88%) experience daytime hot flashes or night sweats during the midlife transition. Vasomotor symptoms (VMS) have been shown to affect multiple role functions, including work, social activity, leisure activity, and sexual activity. In addition, many women with VMS report that the symptoms affect, or are accompanied by, problems with sleep, mood, pain, concentration, and energy levels, resulting in a significant negative impact on women's quality of life. Sixty percent of midlife women seek medical care or advice for these symptoms at least once. Clearly, there is a compelling need for effective treatments to relieve VMS in midlife women, and evaluation of such treatments should include the impact on commonly affected quality-of-life domains. Because use of estradiol (E2; at low doses), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for VMS is increasing, we need evidence on the magnitude of the treatment effects of low-dose estrogen and serotonergic agents versus placebo on quality-of-life outcomes so that women can be properly informed and counseled about their options.
The Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) network recently completed a three-arm double-blind trial of low-dose oral 17β-E2, low-dose venlafaxine (serotonergic agent), and placebo for 8 weeks to examine the efficacy of both E2 and venlafaxine, relative to placebo, in reducing the number of VMS that women experience. We have previously described that both E2 and venlafaxine were superior to placebo in reducing the frequency of VMS. The purpose of this report is to examine the impact of both low-dose estrogen and the nonhormonal SNRI alternative venlafaxine, compared with placebo, on menopause-related quality of life, pain, anxiety, depressive symptoms, and perceived stress. The consistency of these interventions on overall quality of life across subgroups of women defined by race/ethnicity, menopause stage, pretreatment VMS frequency or severity, and other baseline characteristics was also evaluated.
Abstract and Introduction
Abstract
Objective. This study aims to evaluate the effects of low-dose estradiol (E2) 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-E2 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 E2 and venlafaxine resulted in significantly greater improvement in quality of life, as measured by total MENQOL scores, compared with placebo (E2: 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 E2 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 E2 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 E2 and venlafaxine are effective pharmacologic agents for improving menopause-related quality of life in healthy women with VMS.
Introduction
More than 38 million US women aged 45 to 64 years (88%) experience daytime hot flashes or night sweats during the midlife transition. Vasomotor symptoms (VMS) have been shown to affect multiple role functions, including work, social activity, leisure activity, and sexual activity. In addition, many women with VMS report that the symptoms affect, or are accompanied by, problems with sleep, mood, pain, concentration, and energy levels, resulting in a significant negative impact on women's quality of life. Sixty percent of midlife women seek medical care or advice for these symptoms at least once. Clearly, there is a compelling need for effective treatments to relieve VMS in midlife women, and evaluation of such treatments should include the impact on commonly affected quality-of-life domains. Because use of estradiol (E2; at low doses), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for VMS is increasing, we need evidence on the magnitude of the treatment effects of low-dose estrogen and serotonergic agents versus placebo on quality-of-life outcomes so that women can be properly informed and counseled about their options.
The Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) network recently completed a three-arm double-blind trial of low-dose oral 17β-E2, low-dose venlafaxine (serotonergic agent), and placebo for 8 weeks to examine the efficacy of both E2 and venlafaxine, relative to placebo, in reducing the number of VMS that women experience. We have previously described that both E2 and venlafaxine were superior to placebo in reducing the frequency of VMS. The purpose of this report is to examine the impact of both low-dose estrogen and the nonhormonal SNRI alternative venlafaxine, compared with placebo, on menopause-related quality of life, pain, anxiety, depressive symptoms, and perceived stress. The consistency of these interventions on overall quality of life across subgroups of women defined by race/ethnicity, menopause stage, pretreatment VMS frequency or severity, and other baseline characteristics was also evaluated.
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