Comparison of bismuth and concomitant therapy for H. pylori eradication: a prospective, randomized clinical trial.

Abstract

Background: In Tunisia, concomitant quadruple therapy (QTC) has been the standard first-line treatment for Helicobacter pylori (H. pylori) infection. However, increasing resistance to clarithromycin (28%) has raised concerns about its long-term efficacy. Bismuth-based quadruple therapy (QTB) offers an alternative, yet its higher cost and safety profile remain debated. This study aimed to compare the efficacy, safety, and cost of both regimens.

Methods: We conducted a prospective, randomized, open-label study enrolling 200 patients naïve to any anti-HP treatment. Patients were randomized to either 10 days of bismuth therapy (QTB: potassium bismuth subcitrate, metronidazole, and tetracycline hydrochloride, omeprazole) or 14 days of concomitant quadruple therapy (QTC: amoxicillin, clarithromycin, metronidazole, esomeprazole). H. pylori eradication as defined by a negative urea breath test 4-6 weeks after treatment.

Results: Among 200 patients, the intention-to-treat eradication rate was 82% for QTC and 87% for QTB (p = 0.29); per-protocol rates were 84.53% and 89.58%, respectively (p = 0.39). Compliance was high (97% in QTC vs 96% in QTB; p = 0.32). Adverse events were similar between groups (61.85% for QTB vs 69% for QTC; p = 0.29).

Conclusion: Bismuth and concomitant quadruple therapies were comparable in terms of efficacy and safety but didn't achieve the accepted minimum eradication rate (90%).