# Patient-Reported Epigastric Symptom Dynamics During Trimebutine Maleate Treatment: A Post-Marketing Study

## TL;DR

This study shows that trimebutine maleate effectively reduces gastrointestinal symptoms in patients with functional disorders, as reported by patients themselves.

## Contribution

The study provides real-world evidence of trimebutine's efficacy and tolerability in treating functional gastrointestinal disorders.

## Key findings

- Symptom severity, including epigastric pain and dyspepsia, significantly decreased within two weeks of treatment.
- Mean pain scores dropped from 2.65 to 0.46, showing a statistically significant improvement (p < 0.001).
- Trimebutine was found to be well-tolerated and effective in real-world clinical settings.

## Abstract

Background and Objectives: This prospective, non-interventional, multicenter study aims to assess the therapeutic effectiveness of trimebutine maleate in patients with functional gastrointestinal disorders (FGIDs) by patient-reported outcomes. Materials and Methods: The study encompassed 2501 patients from 50 clinical sites diagnosed with irritable bowel syndrome, functional dyspepsia, or other functional gastrointestinal diseases. A validated questionnaire, an adapted version of the Izumo scale, was employed for self-assessment of symptoms and quality of life related to gastrointestinal issues. Results: The findings indicate a significant decrease in symptom severity, encompassing epigastric pain, dyspeptic symptoms, and defecation difficulties, as early as the second visit, with mean pain scores declining from 2.65 to 0.46 (p < 0.001). Conclusions: The data validate trimebutine’s profile as a well-tolerated and efficacious therapy for patients with IBS in real-world clinical practice in Bulgaria. The findings endorse the prospective inclusion of trimebutine as a treatment option in forthcoming clinical guidelines.