Melatonin in IBS
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
46.0% male
N = 136
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
41.2%
70.6%
70.6 %
52.9 %
35.3 %
17.6 %
0.0 %
Melatonin
Placebo
Significant
decrease ▼
NNT = 3
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