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Effects of estradiol and venlafaxine on insomnia symptoms and sleep quality in women with hot flashes.
- Author(s): Ensrud, Kristine E
- Guthrie, Katherine A
- Hohensee, Chancellor
- Caan, Bette
- Carpenter, Janet S
- Freeman, Ellen W
- LaCroix, Andrea Z
- Landis, Carol A
- Manson, JoAnn
- Newton, Katherine M
- Otte, Julie
- Reed, Susan D
- Shifren, Jan L
- Sternfeld, Barbara
- Woods, Nancy F
- Joffe, Hadine
- et al.
Published Web Locationhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4262961/
No data is associated with this publication.
Study objectivesDetermine effects of low-dose estradiol and low-dose venlafaxine on self-reported sleep measures in menopausal women with hot flashes.
Design3-arm double-blind randomized trial. Participants assigned in a 2:2:3 ratio to 17β estradiol 0.5 mg/day (n = 97), venlafaxine XR 75 mg/day (n = 96), or placebo (n = 146) for 8 weeks.
SettingAcademic research centers.
Participants339 community-dwelling perimenopausal and postmenopausal women with ≥2 bothersome hot flashes per day.
Measurements and resultsInsomnia symptoms (Insomnia Severity Index [ISI]) and sleep quality (Pittsburgh Sleep Quality Index [PSQI]) at baseline, week 4 and 8; 325 women (96%) provided ISI data and 312 women (92%) provided PSQI data at baseline and follow-up. At baseline, mean (SD) hot flash frequency was 8.1/day (5.3), mean ISI was 11.1 (6.0), and mean PSQI was 7.5 (3.4). Mean (95% CI) change from baseline in ISI at week 8 was -4.1 points (-5.3 to -3.0) with estradiol, -5.0 points (-6.1 to -3.9) with venlafaxine, and -3.0 points (-3.8 to -2.3) with placebo (P overall treatment effect vs. placebo 0.09 for estradiol and 0.007 for venlafaxine). Mean (95% CI) change from baseline in PSQI at week 8 was -2.2 points (-2.8 to -1.6) with estradiol, -2.3 points (-2.9 to -1.6) with venlafaxine, and -1.2 points (-1.7 to -0.8) with placebo (P overall treatment effect vs. placebo 0.04 for estradiol and 0.06 for venlafaxine).
ConclusionsAmong perimenopausal and postmenopausal women with hot flashes, both low dose oral estradiol and low-dose venlafaxine compared with placebo modestly reduced insomnia symptoms and improved subjective sleep quality.
Clinical trial registrationNCT01418209 at www.clinicaltrials.gov.
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