Efficacy of trimebutine maleate as treatment for patients with functional gastrointestinal disorders: a multicenter prospective trial

Trimebutine, a selective antispasmodic and gastrointestinal motility modulator, was evaluated for symptom control in functional dyspepsia and overlapping functional gastrointestinal disorders. A multicenter, prospective observational study was conducted in four centers in Sofia, Bulgaria, enrolling 161 patients aged 24–75 years diagnosed according to the Rome IV criteria. All patients received trimebutine maleate 300 mg once daily for four weeks, with symptom severity assessed on a 0–5 self-reported scale. At study completion, more than 90% of patients demonstrated symptomatic improvement across upper and lower gastrointestinal symptoms. No statistically significant difference was observed between trimebutine monotherapy and combined proton pump inhibitor therapy in alleviating upper gastrointestinal symptoms at week four. The findings suggest that trimebutine at a 300 mg daily dose is effective in reducing functional gastrointestinal symptoms over a four-week period. These results support further investigation through randomized controlled trials to confirm efficacy and optimize combination strategies.