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.
Highlights
In recently menopausal women, the overall sleep quality was improved by both hormone therapy (HT) regimens compared with PBO, with the transdermal estrogen formulation performing modestly better than the oral formulation
Efficiency, and daytime dysfunction were not affected by the HT regimes used in this study
Alleviation of vasomotor symptom (VMS) was associated with improvements in overall sleep quality
Summary
Participants completed the Pittsburgh Sleep Quality Index at baseline and during the intervention at 6, 18, 36, and 48 months. Participants The KEEPS (NCT00154180)—a randomized, doubleblind, PBO-controlled multisite trial—enrolled women from the communities surrounding each recruitment site who were between the ages of 42 and 58 years, between 6 and 36 months since their last menses, and had serum follicle-stimulating hormone level !35 mIU/mL and/or estradiol level 50 Agatston Units, history of cardiovascular disease, body mass index (BMI) >35 kg/m2, uncontrolled hypertension (systolic blood pressure >150 mm Hg and/or diastolic blood pressure >95 mm Hg), low-density lipoprotein cholesterol (LDL) >190 mg/dL, triglycerides (Tg) >400 mg/dL, fasting blood glucose >126 mg/dL (or history of diabetes), current or recent (6 months) use of cholesterol-lowering medications (statins, fibrate, or >500 mg/d niacin), if they reported smoking more than 10 cigarettes per day, or had a diagnosis of clinical depression. The study was approved by Institutional Review Boards at each participating institution. The study design and methods have been described in detail elsewhere.[21]
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