A Comparison between Moderate- and High-dose Furazolidone in Triple Regimens for Helicobacter pylori Eradication in Iran

BACKGROUND: Furazolidone has been used as an alternative for clarithromycin or metronidazole in Helicobacterpylori (H. pylori) eradication regimens. In Iran, 14-day Furazolidone-containing quadruple regimens have shown promising eradication rates, but short-course, low dose therapies are always attractive. Therefore, we designed a study to compare the efficacy of two 10-day triple regimens containing moderate and high dose furazolidone for H. pylori eradication. METHOD: Two hundred and ten patients with peptic ulcer disease who were naïve to H. pylori treatment were included. They were randomized into 2 groups: 105 patients received omeprazole 20mg, amoxicillin 1000mg, and furazolidone 200mg(OAF-400), all twice a day for ten days.And the remaining 105 patients received omeprazole 20mg twice a day, amoxicillin 1000mg twice a day and furazolidone 200mg three times a day for ten days(OAF-600). Urease breath test was performed 8 weeks after the treatment to confirm H. pylori eradication. RESULTS: The intention-to-treat eradication rate was 76.19% in group OAF-400 and 80.95% in group OAF-600 (p=0.38). Per protocol eradication rates were 81.63% and 89.47%, respectively (p= 0.11).Severe adverse effects were reported by 8.6% of the patients in group OAF-400 and 5.7% of the patient in group OAF-600 (p=0.1). However, the total side effects (including mild, moderate, and severe ones) were significantly more prevalent in the OAF-600 group (p=0.001). CONCLUSION: None of our triple furazolidone-based regimens (moderate- and high-dose) could achieve the standard eradication rate, and therefore, cannot be considered as a suitable option for first-line treatment.