Evaluation of safety and efficacy of the combination of mebeverine and sulpiride in treatment of patients with functional gastrointestinal disorders: A prospective cohort
Abstract
ObjectiveIn this study, we aimed to evaluate the safety and efficacy of a combination of 100 mg mebeverine and 25 mg sulpiride (Colona®) in patients with functional gastrointestinal disorders.MethodsThis multicenter, cohort study was conducted in Egypt, comprising 253 patients diagnosed with functional gastrointestinal disorders. The treatment duration was 2 weeks. The primary endpoint was the percentage of relative change in the tailored gastrointestinal symptoms rating scale.ResultsThe baseline tailored gastrointestinal symptoms rating scale mean (±SD) score was 11.42 ± 4.10. However, after 2 weeks (±1 week) of combination therapy, the score significantly decreased to 3.11 ± 2.48 (p < 0.01), demonstrating a mean (±SD) improvement of 71.84% ±20.56%. Among 253 patients, 227 patients (89.72%, 95% confidence interval: 85.96%-93.49%) demonstrated ≥50% improvement in the tailored gastrointestinal symptoms rating scale total score, whereas 26 (10.28%) did not report any improvement. In terms of safety, 2 (0.79%) patients reported diarrhea, 1 (0.4%) had mild dyspepsia, and 1 (0.4%) had galactorrhea.ConclusionOur results suggest that the combination of mebeverine and sulpiride may represent a safe and effective treatment option for patients with functional gastrointestinal disorders.
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 253 participants or records.
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