Studying the effect of melatonin on biochemical markers and sleep improvement in patients with inflammatory bowel disease: a randomized, double-blind clinical trial study
Gastroenterology and Hepatology from Bed to Bench,
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2 March 2026
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Page 1-8 (e18)
https://doi.org/10.22037/ghfbb.v19i01.3279
Abstract
Aim: The present study was conducted to investigate the effect of melatonin on biochemical markers and improving sleep quality in patients with inflammatory bowel disease.
Background: Inflammatory bowel disease (IBD) is a long-term inflammatory disease of the gastrointestinal tract. The antioxidant and anti-inflammatory properties of melatonin, along with evidence of a relationship between sleep disorders and IBD, have led to melatonin receiving attention in recent years.
Methods: In this double-blind randomized clinical trial, patients aged 20 or older with a confirmed diagnosis of IBD by colonoscopy and histology were classified as mild, moderate, or severe based on disease severity. Eligible patients were randomly assigned to receive one melatonin tablet (3 mg/day) or one placebo tablet in a 1:1 ratio for three months. The Pittsburgh Sleep Quality Questionnaire was used in this study. At baseline and after 3 months, the biomarkers CRP, ESR, and FC, as well as a sleep quality questionnaire, were evaluated.
Results: After examining the effect of melatonin on the studied indicators, a significant decrease in ESR was reported (P<0.001). The change in CRP level also decreased significantly, from 20.27 ± 9.82 to 4.21 ± 4.60 (P<0.001). Melatonin caused a significant and noticeable decrease in calprotectin level from 80.315 ± 210 to 100.36 ± 60 (P<0.001). The sleep quality score also improved significantly after the intervention, decreasing from 10.29 ± 3.33 to 60.7 ± 3.67 (P<0.001). Melatonin significantly improved the inflammatory indices ESR, CRP, and calprotectin, as well as sleep quality (PSQI), compared with pre-intervention values. These changes were statistically significant in all variables (P<0.001).
Conclusion: Based on our findings, melatonin significantly improved the inflammatory indices ESR, CRP, and Calprotectin, as well as sleep quality (PSQI), compared to pre-intervention values.
- Inflammatory bowel disease, sleep quality, melatonin.
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