ArticleJGH open : an open access journal of gastroenterology and hepatology2020
Low-dose melatonin for sleep disturbances in early-stage cirrhosis: A randomized, placebo-controlled, cross-over trial.
Article in JGH open : an open access journal of gastroenterology and hepatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07046429 (Effect of Supplemental Nightly Melatonin On REM and Cognition in Hepatic Encephalopathy), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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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.
Effect of Supplemental Nightly Melatonin On REM and Cognition in Hepatic Encephalopathy (SNORE-HE) Trial
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.
- Effect of melatonin supplementation on sleep quality: a systematic review and meta-analysis of randomized controlled trials.Journal of neurology · 2022Pooled it
- Sleep disturbance in patients with cirrhosis and transjugular intrahepatic portosystemic shunt.BMC gastroenterology · 2024Trial
- Sleep irregularity is associated with reduced wellbeing in patients with cirrhosis.JHEP reports : innovation in hepatology · 2026Article
- Unrecognised sleep disturbances in patients with cirrhosis diagnosed with a portable electroencephalogram device.BMJ health & care informatics · 2026Article
- Therapeutic and chemopreventive potential of melatonin in liver diseases: targeting oxidative stress and inflammatory signaling.Frontiers in pharmacology · 2026Review
- The Beauty Sleep to Keep a Healthy Liver.International journal of molecular sciences · 2025Review
- Outpatient management after hospitalisation for acute decompensation of cirrhosis: A practical guide.World journal of hepatology · 2024Review
- Association between serum trace elements and sleep disturbance in patients with decompensated cirrhosis.Therapeutic advances in chronic disease · 2023Article
- AASLD Practice Guidance: Palliative care and symptom-based management in decompensated cirrhosis.Hepatology (Baltimore, Md.) · 2022Article
- Review article: current and emerging therapies for the management of cirrhosis and its complications.Alimentary pharmacology & therapeutics · 2022Review
- Melatonin prevents oxidative stress, inflammatory activity, and DNA damage in cirrhotic rats.World journal of gastroenterology · 2022Article
- Benefits and Risks of Melatonin in Hepatic and Pancreatic Disorders; A Review of Clinical Evidences.Iranian journal of pharmaceutical research : IJPR · 2021Review
- Management of fatigue and sleep disorders in patients with chronic liver disease.Clinical liver diseaseArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
aimMelatonin is used to treat sleep disturbances (SDs). The aim of this study was to investigate the safety and efficacy of low-dose melatonin for SDs in early-stage cirrhosis.
methodsIn a single-center, randomized, double-blind, placebo-controlled, cross-over clinical trial, patients with early-stage (Child-Turcotte-Pugh [CTP] class A or B) cirrhosis with SDs, without hepatic encephalopathy, were randomized to placebo or 3 mg of melatonin for 2 weeks. After 2 weeks, the patients were given a washout period of 1 week and crossed over to melatonin or placebo for a further 2 weeks. The Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) were used to measure sleep quality and daytime sleepiness, respectively. Analysis of results was based on intention to treat, and linear mixed-effect models were used to evaluate the effect of melatonin. Analysis was conducted using R-programming language 3.5.1.
resultsSeventy one patients were recruited (mean age: 61.9 ± 8.7 years, males: 46 [64.8%], and CTP Class A = 52 [73.2%] and Class B = 19 [26.8%]). Sixty patients completed the study (mean age: 61.7 ± 8.8 years, males: 40 [66.6%], and CTP Class A = 45 [75.0%] and Class-B = 15 [25.0%]). Two patients dropped out due to adverse events. Nine patients were lost to follow up. Patients given melatonin had a significantly lower PSQI and ESS compared to both pretreatment (
conclusionMelatonin seems safe and effective for use in patients with SDs in early-stage cirrhosis in the short term. However, larger and longer-term studies to assess efficacy and safety are required before its clinical use can be recommended.
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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.