Sleep disturbances are common in patients with inflammatory bowel disease (IBD) and are associated with increased disease activity and reduced quality of life. Melatonin, a hormone regulating circadian rhythms, has shown potential anti-inflammatory and sleep-promoting effects in preliminary studies. This study aimed to evaluate the efficacy of melatonin supplementation on sleep quality in IBD patients in clinical remission.
IBD patients with clinical remission Crohn's disease: HBI < 5 Ulcerative colitis: Partial Mayo score 0-1 w/o bloody stool
Age > 18 years
PSQI score > 5
No medical adjustment for 2 months and use corticosteroids not more than Prednisolone equivalent 5 mg/day
Current alcohol or substance abuse
High risk for OSA (STOP-BANG score > 5)
Psychiatric problem: PHQ-9 score > 20 or GAD-7 score > 20
Hypnotic drug use and unable to hold for 1week before trial
Parallel
Melatonin ("Circadin")
Drug2 mg of prolonged release melatonin was prescribed at a dose of one tablet daily, taken one hour before the participant's usual bedtime.
Placebo
Drugplacebo were manufactured to be identical in appearance
PSQI (Pittsburgh Sleep Quality Index) score at 12th week of study
Comparison of sleep quality between the melatonin and placebo groups in patients with IBD in clinical remission
PSQI (Pittsburgh Sleep Quality Index) score at 6th week of study
Sleep quality at 6th week of study
Component of PSQI score
The PSQI comprises seven components: (1) subjective sleep quality, (2) sleep latency, (3) sleep duration, (4) habitual sleep efficiency, (5) sleep disturbances, (6) use of sleep medication, and (7) daytime dysfunction.
Inflammatory Bowel Disease Questionnaire (IBDQ) score
Inflammatory Bowel Disease Questionnaire (IBDQ) score
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