Trial reportMenopause (New York, N.Y.)2018
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).
Trial report in Menopause (New York, N.Y.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 60 citations in OpenAlex.
- Efficacy of hormone therapy and phytoestrogens on the psychological symptoms of menopausal women: a systematic review, meta-analysis, and trial sequential analysis.Frontiers in medicine · 2026Pooled it
- Is endometriosis associated with poor sleep quality? A meta-analysis.Women's health (London, England)Pooled it
- Lessons from KEEPS: the Kronos Early Estrogen Prevention Study.Climacteric : the journal of the International Menopause Society · 2021Trial
- Sleep quality and cortical amyloid-β deposition in postmenopausal women of the Kronos early estrogen prevention study.Neuroreport · 2021Trial
- Effects of perimenopausal transdermal estradiol on self-reported sleep, independent of its effect on vasomotor symptom bother and depressive symptoms.Menopause (New York, N.Y.) · 2019Trial
- Improvement in sleep outcomes with a 17β-estradiol-progesterone oral capsule (TX-001HR) for postmenopausal women.Menopause (New York, N.Y.) · 2018Trial
- SLCO1B1 genetic variation and hormone therapy in menopausal women.Menopause (New York, N.Y.) · 2018Trial
- Progestins - a review of clinical application in gynecology.Annals of medicine · 2025Review
- Sleep duration and the risk of epithelial ovarian cancer.Cancer causes & control : CCC · 2025Article
- Sex Differences in Atherosclerotic Cardiovascular Disease Risk in Obstructive Sleep Apnea.Current atherosclerosis reports · 2025Review
- Sleep Disturbance and Perimenopause: A Narrative Review.Journal of clinical medicine · 2025Review
- Conceptualizing Sleep Satisfaction: A Rapid Review.Behavioral sciences (Basel, Switzerland) · 2024Review
- Summary of the 2023 Thai Menopause Society Clinical Practice Guideline on Menopausal Hormone Therapy.Journal of menopausal medicine · 2024Review
- Examining the Health-Related Needs of Females during Menopause: A Systematic Review Study.Journal of menopausal medicine · 2023Review
- Sleep Disturbances Across a Woman's Lifespan: What Is the Role of Reproductive Hormones?Journal of the Endocrine Society · 2023Review
- Sex Hormones, Sleep, and Memory: Interrelationships Across the Adult Female Lifespan.Frontiers in aging neuroscience · 2022Review
- The Effect ofJournal of clinical medicine · 2020Article
- The Kronos Early Estrogen Prevention Study (KEEPS): what have we learned?Menopause (New York, N.Y.) · 2019Review
- Sex hormones and stroke: Beyond estrogens.Hormones and behavior · 2019Review
- A heartfelt message, estrogen replacement therapy: use it or lose it.American journal of physiology. Heart and circulatory physiology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 9 institutions in 1 country.
Funding
Abstract
objectiveThis 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.
methodsParticipants 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.
resultsGlobal 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.
conclusionsPoor 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.