BACKGROUND: The eradication of Helicobacter pylori has been always a concern. In the present study, we aimed to compare two novel treatments in Iran. METHOD:Four hundred and twenty patients with peptic ulcer and naïve H. pylori infection were randomized in the study. Two hundred and ten patients receivedhybrid therapy: pantoprazole 40 mg/b.i.d. and amoxicillin 1 g/b.i.d. for 14 days plus 500 mg clarithromycin and 500 mg tinidazole, both twice daily for the last 7 days. The other 210 patients receivedsequential therapy: 40 mg pantoprazole/b.i.d. for 10 days and 1 g amoxicillin/b.i.d. for the first 5 days, followed by 500 mg clarithromycin/b.i.d. and 500 mg tinidazole/b.i.d. for the last 5 days. C¹⁴-urea breath test was performed 8 weeks after the treatment. RESULTS:Three hundred and ninety-six patients (197 patients in the hybrid group and 199 patients in the sequential group) completed the study. The compliance rates were 96.7 and 98.6% for the two groups, respectively. The intention-to-treat eradication rate was 89.5% (95% CI = 85.4-93.6) for the hybrid group and 76.7% (95% CI = 71-82.4) for the sequential group (p = .001), and the per-protocol eradication rates were 92.9% (95% CI = 89.2-96.5) and 79.9% (95% CI = 74.1-85.4) for the hybrid and sequential groups (p = .001), respectively. Severe adverse effects were observed in 2.4% of patients in the hybrid group and 3.8% of those in the sequential group. CONCLUSION: According to our results, sequential regimen does not seem to be an appropriate therapy for H. pylori eradication in the Iranian population, whereas hybrid therapy showed to be more effective. However, considering the high cost of clarithromycin in Iran, we recommend further studies to compare hybrid therapy with bismuth-containing regimens or to assess the effects of hybrid therapies with periods shorter than 14 days.
RCT Entities:
BACKGROUND: The eradication of Helicobacter pylori has been always a concern. In the present study, we aimed to compare two novel treatments in Iran. METHOD: Four hundred and twenty patients with peptic ulcer and naïve H. pyloriinfection were randomized in the study. Two hundred and ten patients received hybrid therapy: pantoprazole 40 mg/b.i.d. and amoxicillin 1 g/b.i.d. for 14 days plus 500 mg clarithromycin and 500 mg tinidazole, both twice daily for the last 7 days. The other 210 patients received sequential therapy: 40 mg pantoprazole/b.i.d. for 10 days and 1 g amoxicillin/b.i.d. for the first 5 days, followed by 500 mg clarithromycin/b.i.d. and 500 mg tinidazole/b.i.d. for the last 5 days. C¹⁴-urea breath test was performed 8 weeks after the treatment. RESULTS: Three hundred and ninety-six patients (197 patients in the hybrid group and 199 patients in the sequential group) completed the study. The compliance rates were 96.7 and 98.6% for the two groups, respectively. The intention-to-treat eradication rate was 89.5% (95% CI = 85.4-93.6) for the hybrid group and 76.7% (95% CI = 71-82.4) for the sequential group (p = .001), and the per-protocol eradication rates were 92.9% (95% CI = 89.2-96.5) and 79.9% (95% CI = 74.1-85.4) for the hybrid and sequential groups (p = .001), respectively. Severe adverse effects were observed in 2.4% of patients in the hybrid group and 3.8% of those in the sequential group. CONCLUSION: According to our results, sequential regimen does not seem to be an appropriate therapy for H. pylori eradication in the Iranian population, whereas hybrid therapy showed to be more effective. However, considering the high cost of clarithromycin in Iran, we recommend further studies to compare hybrid therapy with bismuth-containing regimens or to assess the effects of hybrid therapies with periods shorter than 14 days.