RESUMO
Background and study aims: Untreated Helicobacter pylori infection causes increased risk of gastric cancer, GI morbidity and mortality. Standard treatment for eradication of Helicobacter pylori infection, is the triple therapy which consists of a proton pump inhibitor; together with two antibiotics [amoxicillin 1000 mg with clarithromycin 500 mg or metronidazole 400 mg] given twice daily for 7-14 days. Recent evidence revealed, that cure rates of Helicobacter pylori infection with triple therapy had fallen below satisfactory targets. Sequential therapy consisting of a twice daily dose of a PPI for ten days with Amoxicillin given at 1000 mg twice daily in the first 5 days followed by clarithromycin 500 mg and Metronidazole 400 mg given twice daily in the subsequent 5 days, was recommended to improve eradication rates. We performed a randomised open label study to compare the efficacy of sequential against triple therapy in Helicobacter pylori naive and retreat patients
Patients and methods: In a randomised open label observational study 485 patients fulfilling inclusion and exclusion criteria were randomly assigned to be treated with triple therapy [n = 231] or sequential therapy [n = 254]. Eradication of Helicobacter pylori was documented with [14]C Urea breath test [UBT] performed 6 weeks after the treatment
Results: The intention-to-treat eradication rate was better in sequential therapy group 84.6% than triple therapy 68% [p < 0.001]. Eradication rates were significantly higher for treatment naive than retreat patients in triple therapy group [70.5% and 58.3%, respectively, p < 0.01]. A trend of a better response was observed in eradication rate for treatment naive 88.55% versus retreat 74.6% in sequential therapy group but was not statistically significant [p = 0.76]. Compliance was similar in the two groups, however side effects were less and the clinical response was better in the sequential therapy group