Pilot study: miscellaneous therapy is highly successful for Helicobacter pylori eradication
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 118 participants or records.
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