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Effects of estradiol and venlafaxine on insomnia symptoms and sleep quality in women with hot flashes.
- Source :
-
Sleep [Sleep] 2015 Jan 01; Vol. 38 (1), pp. 97-108. Date of Electronic Publication: 2015 Jan 01. - Publication Year :
- 2015
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Abstract
- Study Objectives: Determine effects of low-dose estradiol and low-dose venlafaxine on self-reported sleep measures in menopausal women with hot flashes.<br />Design: 3-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.<br />Setting: Academic research centers.<br />Participants: 339 community-dwelling perimenopausal and postmenopausal women with ≥2 bothersome hot flashes per day.<br />Measurements and Results: Insomnia 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).<br />Conclusions: Among 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.<br />Clinical Trial Registration: NCT01418209 at www.clinicaltrials.gov.<br /> (© 2014 Associated Professional Sleep Societies, LLC.)
- Subjects :
- Cyclohexanols administration & dosage
Cyclohexanols therapeutic use
Double-Blind Method
Estradiol administration & dosage
Estradiol therapeutic use
Estrogens administration & dosage
Estrogens pharmacology
Estrogens therapeutic use
Female
Hot Flashes physiopathology
Humans
Menopause drug effects
Menopause physiology
Middle Aged
Perimenopause drug effects
Perimenopause physiology
Sleep Initiation and Maintenance Disorders complications
Venlafaxine Hydrochloride
Cyclohexanols pharmacology
Estradiol pharmacology
Hot Flashes complications
Sleep drug effects
Sleep physiology
Sleep Initiation and Maintenance Disorders drug therapy
Sleep Initiation and Maintenance Disorders physiopathology
Subjects
Details
- Language :
- English
- ISSN :
- 1550-9109
- Volume :
- 38
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Sleep
- Publication Type :
- Academic Journal
- Accession number :
- 25325454
- Full Text :
- https://doi.org/10.5665/sleep.4332