comparison between moderate- and high-dose furazolidone in triple regimens for Helicobacter pylori eradication in Iran

ABSTRACT

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. Two hundred and ten patients with peptic ulcer disease who were naive 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. 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]. 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