Two new treatment regimens for Helicobacter pylori eradication:: a randomised study

Background Several studies have found a fairly low Helicobacter pylori eradication rate using a standard 7-day triple therapy in Italy. Recently, two new therapeutic schedules have been proposed with an eradication rate higher than 90%. This study compared the efficacy of these two treatment regimens. Patients and Methods. A total of 131 patients with Helicobacter pylori infection and either non-ulcer dyspepsia (73 patients) or peptic ulcer [58 patients] were enrolled. Helicobacter pylori infection was assessed by rapid urease test and histology on gastric biopsies. Patients were randomised to receive either a 5-day course of ranitidine bismuth citrate 400 mg bid, clarithromycin 500 bid, and tinidazole 500 bid, or a 10-day course of omeprazole 20 mg bid plus amoxycilin Ig bid for the first 5 days, and omeprazole 20 mg bid, clarithromycin 500 mg bid and tinidazole 500 mg bid for the remaining 5 days. Eradication: was assessed by endoscopy 4-6 weeks after therapy. Results. Overall, 4 patients (2 fop each treatment group) were lost to follow-up. Helicobacter pylori eradication rates were 67.2% (95% confidence interval: 55.7-78.7) and 65.2% (95% confidence interval. 53.7-76.6) at per protocol and intention-to-treat analyses, respectively, after the 5-day regimen, and 96.8% (95% confidence interval. 92.9-100) and 93.8% (95% confidence interval: BB-99.7) after the 10-day regimen (p <0.05). Both treatments were well tolerated, and no major side-effects were reported. Conclusions. The 5-day regimen gave disappointing results, while the eradication rate after the 10-day regimen was very high.