BACKGROUND:Bismuth-containing quadruple therapy given twice a day for 14 days has been shown to be an excellent first-line H. pylori eradication therapy. AIM: To compare the efficacy and tolerability of twice-a-day bismuth-containing quadruple H. pylori eradication therapy for 10 versus 14 days in a noninferiority trial. METHODS:Dyspeptic patients with H. pylori infection and naïve to H. pylori treatment were randomly assigned to: pantoprazole 20 mg, tetracycline 500 mg, metronidazole 500 mg, and bismuth subcitrate caplets 240 mg given b.i.d. (with the midday and evening meals) for 10 or 14 days. Eradication was defined by negative UBT and/or histology 4-6 weeks posttherapy. Efficacy and side effects were determined. RESULTS: A total of 417 patients were randomized (153 men, 264 women; median age 52). Per protocol (PP) treatment success with 14 and 10 days was essentially identical [i.e., 96% (95% CI: 92-98) vs 95% (95% CI: 91-98) for 14 days versus 10 days, respectively. Results with intention-to-treat (ITT) analysis were also similar (92% (95% CI, 87-95) vs 92% (95% CI, 88-96)) for 14 and 10 days, respectively. Compliance was excellent in both groups. Side effects were generally mild and similar between groups. Fatigue, discomfort, and vomiting were more common in those in the 14-day group. The 10-day regimen costs € 17.65 (ie, approximately 25%) less than the 14-day regimen. CONCLUSIONS:Bismuth-containing quadruple therapy remained highly effective (i.e., ≥95% PP and >90% ITT) despite reducing the duration from 14 to 10 days.
RCT Entities:
BACKGROUND:Bismuth-containing quadruple therapy given twice a day for 14 days has been shown to be an excellent first-line H. pylori eradication therapy. AIM: To compare the efficacy and tolerability of twice-a-day bismuth-containing quadruple H. pylori eradication therapy for 10 versus 14 days in a noninferiority trial. METHODS: Dyspeptic patients with H. pyloriinfection and naïve to H. pylori treatment were randomly assigned to: pantoprazole 20 mg, tetracycline 500 mg, metronidazole 500 mg, and bismuth subcitrate caplets 240 mg given b.i.d. (with the midday and evening meals) for 10 or 14 days. Eradication was defined by negative UBT and/or histology 4-6 weeks posttherapy. Efficacy and side effects were determined. RESULTS: A total of 417 patients were randomized (153 men, 264 women; median age 52). Per protocol (PP) treatment success with 14 and 10 days was essentially identical [i.e., 96% (95% CI: 92-98) vs 95% (95% CI: 91-98) for 14 days versus 10 days, respectively. Results with intention-to-treat (ITT) analysis were also similar (92% (95% CI, 87-95) vs 92% (95% CI, 88-96)) for 14 and 10 days, respectively. Compliance was excellent in both groups. Side effects were generally mild and similar between groups. Fatigue, discomfort, and vomiting were more common in those in the 14-day group. The 10-day regimen costs € 17.65 (ie, approximately 25%) less than the 14-day regimen. CONCLUSIONS:Bismuth-containing quadruple therapy remained highly effective (i.e., ≥95% PP and >90% ITT) despite reducing the duration from 14 to 10 days.