N Vakil1, F Lanza, H Schwartz, J Barth. 1. University of Wisconsin Medical School, Milwaukee, WI 53233, USA. nvakil@wisc.edu
Abstract
BACKGROUND: The ideal duration of Helicobacter pylori treatment in the United States and whether eradication therapy is as successful in nonulcer dyspepsia as in peptic ulcer disease are controversial topics. AIM: This study compared the efficacy of 3-, 7- and 10-day triple therapies with rabeprazole to a 10-day omeprazole control triple therapy for the eradication of Helicobacter pylori in patients with and without peptic ulcer disease in the United States. METHODS: This was a multicentre, double-blind, randomized, parallel-group trial. A total of 803 patients with H. pylori infection (determined by [13C]urea breath test and rapid urease test or culture) received either rabeprazole 20 mg b.d., amoxicillin 1000 mg b.d., and clarithromycin 500 mg b.d. for 3, 7, or 10 days, or 10 days of omeprazole 20 mg b.d. with the same antibiotic regimen (control). H. pylori status was assessed by [13C]urea breath test > or =6 weeks after completing treatment. RESULTS: In intent-to-treat patients, the eradication percentages achieved for the rabeprazole-based treatments were: 3-day, 27% (95% confidence interval: 21%-34%); 7-day, 77% (95% confidence interval: 71%-83%); and 10-day, 78% (95% confidence interval: 72%-84%). The eradication percentage with the 10-day omeprazole-based treatment was 73% (95% confidence interval: 67%-79%). There was no statistically significant difference between the 7-day rabeprazole-based regimen and the 10-day rabeprazole- and omeprazole-based regimens. CONCLUSIONS: Seven-day therapy with rabeprazole, clarithromycin, and amoxicillin is similar in efficacy to 10-day therapies and had similar efficacy in patients with and without ulcer disease.
RCT Entities:
BACKGROUND: The ideal duration of Helicobacter pylori treatment in the United States and whether eradication therapy is as successful in nonulcer dyspepsia as in peptic ulcer disease are controversial topics. AIM: This study compared the efficacy of 3-, 7- and 10-day triple therapies with rabeprazole to a 10-day omeprazole control triple therapy for the eradication of Helicobacter pylori in patients with and without peptic ulcer disease in the United States. METHODS: This was a multicentre, double-blind, randomized, parallel-group trial. A total of 803 patients with H. pylori infection (determined by [13C]urea breath test and rapid urease test or culture) received either rabeprazole 20 mg b.d., amoxicillin 1000 mg b.d., and clarithromycin 500 mg b.d. for 3, 7, or 10 days, or 10 days of omeprazole 20 mg b.d. with the same antibiotic regimen (control). H. pylori status was assessed by [13C]urea breath test > or =6 weeks after completing treatment. RESULTS: In intent-to-treat patients, the eradication percentages achieved for the rabeprazole-based treatments were: 3-day, 27% (95% confidence interval: 21%-34%); 7-day, 77% (95% confidence interval: 71%-83%); and 10-day, 78% (95% confidence interval: 72%-84%). The eradication percentage with the 10-day omeprazole-based treatment was 73% (95% confidence interval: 67%-79%). There was no statistically significant difference between the 7-day rabeprazole-based regimen and the 10-day rabeprazole- and omeprazole-based regimens. CONCLUSIONS: Seven-day therapy with rabeprazole, clarithromycin, and amoxicillin is similar in efficacy to 10-day therapies and had similar efficacy in patients with and without ulcer disease.