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)

Dahima Cintron, Brian D. Lahr, Kent R Bailey, Nanette Santoro, Robin Lloyd, Joann E. Manson, Genevieve Neal-Perry, Lubna Pal, Hugh S. Taylor, Whitney Wharton, Fredrick Naftolin, S. Mitchell Harman, Virginia M Miller

Research output: Contribution to journalArticle

10 Citations (Scopus)

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 (rs = 0.170, P < 0.001 for hot flashes; rs = 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.

Original languageEnglish (US)
Pages (from-to)145-153
Number of pages9
JournalMenopause
Volume25
Issue number2
DOIs
StatePublished - Feb 1 2018

Fingerprint

Sleep
Estrogens
Hormones
Therapeutics
Hot Flashes
Conjugated (USP) Estrogens
Sweat
Progesterone
Estradiol
Placebos

Keywords

  • Conjugated equine estrogens
  • Estradiol
  • Hot flashes
  • Night sweats
  • Pittsburgh Sleep Quality Index
  • Vasomotor symptoms

ASJC Scopus subject areas

  • Obstetrics and Gynecology

Cite this

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). / Cintron, Dahima; Lahr, Brian D.; Bailey, Kent R; Santoro, Nanette; Lloyd, Robin; Manson, Joann E.; Neal-Perry, Genevieve; Pal, Lubna; Taylor, Hugh S.; Wharton, Whitney; Naftolin, Fredrick; Harman, S. Mitchell; Miller, Virginia M.

In: Menopause, Vol. 25, No. 2, 01.02.2018, p. 145-153.

Research output: Contribution to journalArticle

Cintron, Dahima ; Lahr, Brian D. ; Bailey, Kent R ; Santoro, Nanette ; Lloyd, Robin ; Manson, Joann E. ; Neal-Perry, Genevieve ; Pal, Lubna ; Taylor, Hugh S. ; Wharton, Whitney ; Naftolin, Fredrick ; Harman, S. Mitchell ; Miller, Virginia M. / 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). In: Menopause. 2018 ; Vol. 25, No. 2. pp. 145-153.
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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 (rs = 0.170, P < 0.001 for hot flashes; rs = 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.",
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AU - Cintron, Dahima

AU - Lahr, Brian D.

AU - Bailey, Kent R

AU - Santoro, Nanette

AU - Lloyd, Robin

AU - Manson, Joann E.

AU - Neal-Perry, Genevieve

AU - Pal, Lubna

AU - Taylor, Hugh S.

AU - Wharton, Whitney

AU - Naftolin, Fredrick

AU - Harman, S. Mitchell

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KW - Estradiol

KW - Hot flashes

KW - Night sweats

KW - Pittsburgh Sleep Quality Index

KW - Vasomotor symptoms

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