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

<i>Background and Objectives:</i> 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. <i>Materials and Methods:</i> 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. <i>Results:</i> 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 (<i>p</i> < 0.001). <i>Conclusions:</i> 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.