6/28/23, 11:19 PM Melatonin in IBS Pathway Feedback Search Clinical Topics Home Studies Melatonin in IBS Melatonin in IBS Disease Irritable bowel syndrome Trial question What is the effect of melatonin on IBS patients with and without sleep disorders? Study design Single center Double blinded RCT Population Characteristics of study participants 54.0% female N = 136 46.0% male 136 patients (74 female, 62 male) Inclusion criteria: patients with a diagnosis of IBS based on Rome IV criteria Key exclusion criteria: allergies; side effects or compromised adherence to the treatment Interventions N=68 melatonin (at a dose of 3 mg BID for 2 months) N=68 placebo (matching placebo for 2 months) Primary outcome Moderate-to-severe irritable bowel syndrome in patients with sleep disorders 70.6 % 70.6 https://web.pathway.md/studies/recXNEQH19wjWQVrD 1/2 6/28/23, 11:19 PM Melatonin in IBS Pathway 52.9 % 41.2 35.3 % Significant decrease 17.6 % NNT = 3 0.0 % Melatonin Placebo Significant decrease in moderate-to-severe IBS in patients with sleep disorders (41.2% vs. 70.6%; RR 0.58, 95% CI 0.08 to 1.08) Secondary outcomes Significant decrease in moderate-to-severe IBS in patients without sleep disorders (41.2% vs. 76.5%; RR 0.54, 95% CI 0.07 to 1.01) Significant decrease in quite severe-to-severe abdominal pain in patients with sleep disorders (20.6% vs. 32.3%; RR 0.64, 95% CI 0.05 to 1.23) Conclusion In patients with a diagnosis of IBS based on Rome IV criteria, melatonin was superior to placebo with respect to a moderate-to-severe IBS in patients with sleep disorders. Reference Masood Faghih Dinevari, Farzaneh Jafarzadeh, Amirreza Jabbaripour Sarmadian et al. The effect of melatonin on irritable bowel syndrome patients with and without sleep disorders: a randomized double-blinded placebo-controlled trial study. BMC Gastroenterol. 2023 Apr 25;23(1):135. Open reference URL https://web.pathway.md/studies/recXNEQH19wjWQVrD 2/2