BACKGROUND:Furazolidone has been effective against Helicobacter pylori in Iran, with no resistance, but with intolerable side effects in the second week. One-week regimens have not been useful here. We compared the efficacy and side effect profiles of three anti-H. pylori regimens. METHODS:Patients with peptic ulcer disease and positive H. pylori infection were randomly allocated into three groups. The patients in group A received omeprazole 20 mg + amoxicillin 1g + metronidazole 500 mg, and bismuth subcitrate 240 mg twice daily each, for two weeks; the patients in group B received the same regimen but metronidazole was replaced by furazolidone 200 mg twice daily; and the patients in group C received regimen B for the first week and regimen A for the second week. H. pylori eradication was verified with 13C-urea breath test at the tenth week. RESULTS:Three hundred and fourteen patients were enrolled; 107, 104, and 103 patients in groups A-C, respectively but 278 patients completed the study. Seven, three, and six patients discontinued their medication in groups A-C, respectively. Fever, dizziness, and weakness were more common in group B than group C (P < 0.05). Vomiting, pruritus, and rash were more common in group C than group A (P < 0.05). Per-protocol eradication rates were 83.1%, 95.2%, and 95.3% in groups A-C, respectively (P = 0.005, groups A and C). Intention to treat eradication rates were 74.5%, 87.0%, and 86.6% in groups A-C, respectively (P = 0.02, groups A and C). CONCLUSION: One-week furazolidone followed by one-week metronidazole regimen is as efficient as two-week furazolidone regimen but with fewer side effects. Furazolidone-based regimens are superior to metronidazole-based ones for H. pylori eradication in Iran.
RCT Entities:
BACKGROUND:Furazolidone has been effective against Helicobacter pylori in Iran, with no resistance, but with intolerable side effects in the second week. One-week regimens have not been useful here. We compared the efficacy and side effect profiles of three anti-H. pylori regimens. METHODS:Patients with peptic ulcer disease and positive H. pyloriinfection were randomly allocated into three groups. The patients in group A received omeprazole 20 mg + amoxicillin 1g + metronidazole 500 mg, and bismuth subcitrate 240 mg twice daily each, for two weeks; the patients in group B received the same regimen but metronidazole was replaced by furazolidone 200 mg twice daily; and the patients in group C received regimen B for the first week and regimen A for the second week. H. pylori eradication was verified with 13C-urea breath test at the tenth week. RESULTS: Three hundred and fourteen patients were enrolled; 107, 104, and 103 patients in groups A-C, respectively but 278 patients completed the study. Seven, three, and six patients discontinued their medication in groups A-C, respectively. Fever, dizziness, and weakness were more common in group B than group C (P < 0.05). Vomiting, pruritus, and rash were more common in group C than group A (P < 0.05). Per-protocol eradication rates were 83.1%, 95.2%, and 95.3% in groups A-C, respectively (P = 0.005, groups A and C). Intention to treat eradication rates were 74.5%, 87.0%, and 86.6% in groups A-C, respectively (P = 0.02, groups A and C). CONCLUSION: One-week furazolidone followed by one-week metronidazole regimen is as efficient as two-week furazolidone regimen but with fewer side effects. Furazolidone-based regimens are superior to metronidazole-based ones for H. pylori eradication in Iran.