Pilot study: miscellaneous therapy is highly successful for Helicobacter pylori eradication

Summary Background Success in H. pylori eradication with conventional therapies has decreased to unacceptable levels (≤80%). New schemes of combined treatment are currently needed. Aim To test a miscellaneous therapy for H. pylori eradication. Methods/patients Open‐label, pilot, single‐centre and prospective study. Patients received a 15‐day treatment scheme that consisted of 5 initial days of lansoprazole 30 mg b.d., amoxicillin 1 g b.d., and metronidazole 500 mg t.d.s.; days 6 to 10: lansoprazole 30 mg q.d.s. and metronidazole 500 mg t.d.s.; days 11 to 15: lansoprazole 30 mg b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg t.d.s. Each patient underwent an upper endoscopy before treatment and a second follow‐up endoscopy at least 4 weeks after therapy. Success was defined on the basis of an eradication rate following a per‐protocol analysis ≥95%. Biopsies before and after therapy were obtained for histological evaluation and rapid urease test. Results One hundred and twenty‐two patients were enrolled and 118 patients completed the study. The eradication rate for H. pylori with miscellaneous therapy was 94% (confidence Interval (CI) 95%, 90–98.3%) in the per‐protocol analysis (PP) and 91% (95% CI, 86–96%) in the intention‐to‐treat (ITT) analysis. Adherence to treatment was 96% (113 patients). Among patients who completed treatment, 55% presented adverse events, mainly nausea and abdominal pain. Conclusion A miscellaneous therapy, based on the combination of multiple medications in high doses for 2 weeks, and with gastric pH elevation, is a highly effective treatment as a first‐line therapy for the eradication of H. pylori.