Effects of oral versus transdermal menopausal hormone treatments on self-reported sleep domains and their association with vasomotor symptoms in recently menopausal women enrolled in the Kronos Early Estrogen Prevention Study (KEEPS)

• Type of Material: Article
• Authors: Dahima Cintron, Mayo Clinic; Brian D. Lahr, Mayo Clinic; Kent R. Bailey, Mayo Clinic; Nanette Santoro, University of Colorado Denver; Robin Lloyd, Mayo Clinic; JoAnn E. Manson, Harvard Medical School; Genevieve Neal-Perry, University of Washington; Lubna Pal, Yale University; Hugh S. Taylor, Yale University; Whitney Wharton, Emory University; Fredrick Naftolin, New York University; S. Mitchell Harman, Kronos Longevity Research Institute; Virginia M. Miller, Mayo Clinic
• Language: English
• Date: 2018-02-01
• Publisher: Lippincott, Williams & Wilkins
• Publication Version: Final Published Version
• Copyright Statement: © 2017 The Author(s).
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): https://journals.lww.com/menopausejournal/fulltext/2018/02000/Effects_of_oral_versus_transdermal_menopausal.6.aspx
• Title of Journal or Parent Work: MENOPAUSE-THE JOURNAL OF THE NORTH AMERICAN MENOPAUSE SOCIETY
• Volume: 25
• Issue: 2
• Start Page: 145
• End Page: 153
• Grant/Funding Information: KEEPS would not have been possible without funding by grants from the Aurora Foundation to the Kronos Longevity Research Institute, NIH HL90639 to VMM, NIH P50 AG 44170 to VMM, 1 UL1 RR024150∗, TL1 TR000137 to the Mayo Foundation, Brigham and Women's Hospital/Harvard Medical School CTSA, CTSA UL1 RR024139 and UCSF CTSA UL1 RR024131, the Mayo Clinic Office of Health Disparities Research, and the Mayo Foundation; Pfizer: for the limited goal of measurement of estrogens in already collected blood samples.
• Keywords: THERAPY; FLASHES; Night sweats; DESIGN; Conjugated equine estrogens; Hot flashes; Pittsburgh Sleep Quality Index; DISTURBANCE; Vasomotor symptoms; HEALTH; Estradiol; QUALITY INDEX; Science & Technology; Obstetrics & Gynecology; Life Sciences & Biomedicine; TRIAL; METAANALYSIS
• Research Categories: Health Sciences, Obstetrics and Gynecology

Abstract

Objective: This study determined whether two different formulations of hormone therapy (HT): oral conjugated equine estrogens (o-CEE; 0.45 mg/d, n = 209), transdermal 17β-estradiol (t-E2; 50 μg/d, n = 201) plus cyclic progesterone (Prometrium, 200 mg) or placebo (PBO, n = 243) affected sleep domains in participants of the Kronos Early Estrogen Prevention Study. Methods: Participants completed the Pittsburgh Sleep Quality Index at baseline and during the intervention at 6, 18, 36, and 48 months. Global sleep quality and individual sleep domain scores were compared between treatments using analysis of covariance, and correlated with vasomotor symptom (VMS) scores using Spearman correlation coefficients. Results: Global Pittsburgh Sleep Quality Index scores (mean 6.3; 24% with score > 8) were similar across groups at baseline and were reduced (improved sleep quality) by both HT (average change -1.27 [o-CEE] and -1.32 [t-E2] ) when compared with PBO (-0.60; P = 0.001 [o-CEE vs PBO] and P = 0.002 [t-E2 vs PBO] ). Domain scores for sleep satisfaction and latency improved with both HT. The domain score for sleep disturbances improved more with t-E2 than o-CEE or PBO. Global sleep scores significantly correlated with VMS severity (r s = 0.170, P < 0.001 for hot flashes; r s = 0.177, P < 0.001 for night sweats). Change in scores for all domains except sleep latency and sleep efficiency correlated with change in severity of VMS. Conclusions: Poor sleep quality is common in recently menopausal women. Sleep quality improved with both HT formulations. The relationship of VMS with domains of sleep suggests that assessing severity of symptoms and domains of sleep may help direct therapy to improve sleep for postmenopausal women.