Add-on trimebutine-maleate does not improve tolerability or eradication in bismuth quadruple therapy for Helicobacter pylori

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BACKGROUND Bismuth quadruple therapy (BQT) remains an important first-line regimen forHelicobacter pylori (H.pylori) eradication in regions with high clarithromycin resistance, but tolerability is limited by a heavy pill burden and a high frequency of gastrointestinal adverse events.Trimebutine maleate, a peripherally acting opioid receptor agonist that modulates gastrointestinal motility and visceral sensitivity, has been hypothesized to attenuate these symptoms. AIMTo evaluated whether add-on trimebutine reduces adverse events and improves medication adherence and eradication rates in patients receiving 14-day BQT. METHODSThis open-label, single-center, randomized controlled trial enrolled adults with newly diagnosed H. pylori infection at a tertiary hospital in Korea between July 2020 and October 2022.Participants were randomly assigned to receive 14-day BQT alone or with add-on trimebutine maleate 100 mg three times daily.Co-primary outcomes were the incidence of treatment-emergent adverse events and medication adherence.The secondary outcome was microbiological eradication assessed by 13 C-Urea breath test 4-6 weeks after treatment completion. RESULTSA total of 132 patients were randomized (66 per arm).Baseline characteristics were balanced.Any adverse event occurred in 34/66 control patients (51.5%) and 33/66 trimebutine patients (50.0%) [absolute difference +1.5%, 95% confidence interval (CI):-15.5% to 18.6%; P > 0.999].Treatment discontinuation due to adverse events was identical [7/66 (10.6%) in each arm].Mean adherence was 85.0% and 81.6%, respectively (P = 0.764).Eradication rates did not differ: Intention-to-treat 75.8% versus 74.2% (P > 0.999); Per-protocol 87.7% vs 89.1% (P > 0.999).The study had 80% 3 / 32 power to detect an absolute reduction of ≥ 24 percentage points in any-adverse-event rates; the 95%CI excluded reductions larger than 15 percentage points. CONCLUSIONAdd-on trimebutine neither reduced adverse events nor improved adherence or eradication in Korean patients receiving 14-day BQT for H. pylori infection.This study did not demonstrate sufficient evidence of benefit to support the routine coprescription of trimebutine with BQT, and suggests that future efforts may be better directed toward mucosal-and microbiota-directed adjuncts.

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