Standard triple therapy versus sequential therapy for eradication of Helicobacter pylori in treatment naïve and retreat patients.

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 1000mg with clarithromycin 500mg or metronidazole 400mg) given twice daily for 7-14days. 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 1000mg twice daily in the first 5days followed by clarithromycin 500mg and Metronidazole 400mg given twice daily in the subsequent 5days, 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 14C Urea breath test (UBT) performed 6weeks 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.

RCT Entities:   Population Interventions Outcomes