BACKGROUND/AIMS: Furazolidone has been introduced as an effective drug against Helicobacter pylori infection in Iran, but intolerable side effects may limit its use. The aim of this study was to compare quadruple and triple furazolidone-based regimens to achieve an economically affordable regimen with acceptable success rate and fewer side effects. METHODS:Patients with Helicobacter pylori positive peptic ulcer disease were randomly allocated into two groups: amoxicillin 1 g b.i.d., furazolidone 200 mg b.i.d. and omeprazole 20 mg b.i.d. with or without bismuth subcitrate 240 mg b.i.d. for two weeks (amoxicillin, furazolidone, omeprazole, bismuth and amoxicillin, furazolidone, omeprazole regimens, respectively). Helicobacter pylori eradication was confirmed by 13C-urea breath test 12 weeks after the end of therapy. RESULTS:Eighty-six patients were enrolled, but 16 patients discontinued their therapy or follow-up. The eradication rates with amoxicillin, furazolidone, omeprazole, bismuth and amoxicillin, furazolidone, omeprazole were 85.3% and 61.1% by per-protocol analysis, respectively (p=0.02) and 67.4% and 51.2% by intention-to-treat analysis, respectively (p<0.05). The most frequent adverse effects in the two study groups were weakness, nausea, anorexia, and dizziness, and no significant differences between the groups were shown. CONCLUSIONS: Based on the results in this study, furazolidone-based triple therapy (without bismuth) is not recommended for Helicobacter pylori eradication because of the lower eradication rate and unchanged frequency of adverse effects. Thus, we recommend furazolidone, amoxicillin and omeprazole in combination with bismuth for treatment of Helicobacter pylori.
RCT Entities:
BACKGROUND/AIMS: Furazolidone has been introduced as an effective drug against Helicobacter pyloriinfection in Iran, but intolerable side effects may limit its use. The aim of this study was to compare quadruple and triple furazolidone-based regimens to achieve an economically affordable regimen with acceptable success rate and fewer side effects. METHODS:Patients with Helicobacter pylori positive peptic ulcer disease were randomly allocated into two groups: amoxicillin 1 g b.i.d., furazolidone 200 mg b.i.d. and omeprazole 20 mg b.i.d. with or without bismuth subcitrate 240 mg b.i.d. for two weeks (amoxicillin, furazolidone, omeprazole, bismuth and amoxicillin, furazolidone, omeprazole regimens, respectively). Helicobacter pylori eradication was confirmed by 13C-urea breath test 12 weeks after the end of therapy. RESULTS: Eighty-six patients were enrolled, but 16 patients discontinued their therapy or follow-up. The eradication rates with amoxicillin, furazolidone, omeprazole, bismuth and amoxicillin, furazolidone, omeprazole were 85.3% and 61.1% by per-protocol analysis, respectively (p=0.02) and 67.4% and 51.2% by intention-to-treat analysis, respectively (p<0.05). The most frequent adverse effects in the two study groups were weakness, nausea, anorexia, and dizziness, and no significant differences between the groups were shown. CONCLUSIONS: Based on the results in this study, furazolidone-based triple therapy (without bismuth) is not recommended for Helicobacter pylori eradication because of the lower eradication rate and unchanged frequency of adverse effects. Thus, we recommend furazolidone, amoxicillin and omeprazole in combination with bismuth for treatment of Helicobacter pylori.