TY - JOUR
T1 - Effects of estrogen and venlafaxine on menopause-related quality of life in healthy postmenopausal women with hot flashes
T2 - A placebo-controlled randomized trial
AU - Caan, Bette
AU - Lacroix, Andrea Z.
AU - Joffe, Hadine
AU - Guthrie, Katherine A.
AU - Larson, Joseph C.
AU - Carpenter, Janet S.
AU - Cohen, Lee S.
AU - Freeman, Ellen W.
AU - Manson, Joann E.
AU - Newton, Katherine
AU - Reed, Susan
AU - Rexrode, Kathy
AU - Shifren, Jan
AU - Sternfeld, Barbara
AU - Ensrud, Kris
N1 - Publisher Copyright:
© 2014 by The North American Menopause Society.
PY - 2015/6/6
Y1 - 2015/6/6
N2 - 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.
AB - 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.
KW - Estrogen
KW - Menopause
KW - Pain
KW - Quality of life
KW - Stress
KW - Venlafaxine
UR - http://www.scopus.com/inward/record.url?scp=84930457319&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84930457319&partnerID=8YFLogxK
U2 - 10.1097/GME.0000000000000364
DO - 10.1097/GME.0000000000000364
M3 - Article
C2 - 25405571
AN - SCOPUS:84930457319
SN - 1072-3714
VL - 22
SP - 607
EP - 615
JO - Menopause
JF - Menopause
IS - 6
ER -