Low‐dose melatonin for sleep disturbances in early‐stage cirrhosis: A randomized, placebo‐controlled, cross‐over trial

Background and aim Melatonin 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. Methods In a single‐center, randomized, double‐blind, placebo‐controlled, cross‐over clinical trial, patien...

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Published in:JGH open 2020-08, Vol.4 (4), p.749-756
Main Authors: De Silva, Arjuna P, Niriella, Madunil A, Ediriweera, Dileepa S, De Alwis, Jerome P, Liyanage, Isurujith K, Ettickan, Ushanthani, Liyanapathirana, Kasun V, Undugodage, Chandimani, Silva, H. Asita, Silva, H. Janaka
Format: Article
Language:English
Subjects:
cirrhosis
clinical trial
Drug dosages
Intervention
Liver cirrhosis
Males
Melatonin
Original
Outpatient care facilities
Patients
Quality
Sleep
sleep disturbances
treatment
Variables
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Summary:Background and aim Melatonin 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. Methods In 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. Results Seventy 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 (P 
ISSN:2397-9070
2397-9070
DOI:10.1002/jgh3.12356