comparison of the melatonin effect on gastrointestinal symptoms and quality of life in irritable bowel syndrome patients with and without sleep disorders
Abstract
Irritable bowel syndrome (IBS) is a disease of common concern worldwide. Current treatments are not effective enough to relieve all symptoms of this disease. Determining the effect of melatonin on gastrointestinal symptoms and quality of life in irritable bowel syndrome patients with and without sleep disorders
Materials and methods: In this randomized double-blind clinical trial with a control group, 136 patients diagnosed with IBS with ROME-4 criteria participated in 2 groups of 68 people with or without sleep disorder. Both groups were randomly assigned to 2 subgroups of melatonin (3 mg every 12 hours) or placebo. Patients were followed for 2 months later in terms of changes in gastrointestinal symptoms, quality of life, and sleep parameters.
Results: In both groups with and without sleep disorders, the intensity of abdominal pain, the intensity of abdominal bloating, the number of days with abdominal pain, and the number of defecations in the melatonin subgroups were significantly reduced compared to the placebo group; Stool form was normalized in significantly more patients of melatonin subgroups; and the improvement of the quality of life compared to before the intervention was significantly higher in melatonin subgroups (P<0.05). Compared to placebo, melatonin led to a significant improvement of sleep parameters in the fields of mental quality, sleep delay, sleep duration, sleep efficiency, and daily performance in the group with sleep disorder (P<0.05).