Sequential metronidazole-furazolidone or clarithromycin-furazolidone compared to clarithromycin-based quadruple regimens for the eradication of Helicobacter pylori in peptic ulcer disease: a double-blind randomized controlled trial

Background: Furazolidone is a much cheaper drug with a very low resistance against Helicobacter pylori compared to clarithromycin. We aim to evaluate safety and efficacy of a sequential furazolidone‐based regimen versus clarithromycin‐based therapy in H. pylori eradication for ulcer disease. Materials: Patients with proven peptic ulcer or duodenitis were randomized into three groups: OAB‐M‐F; metronidazole (M) (500 mg bid) for the first 5 days, followed by furazolidone (F) (200 mg bid) for the second 5 days; OAC‐P; clarithromycin (C) (500 mg bid) for 10 days; and OAB‐C‐F; clarithromycin (500 mg bid) for the first 5 days and furazolidone (200 mg bid) for the second 5 days. All groups received omeprazole (O) (20 mg bid) and amoxicillin (A) (1 g bid). Groups OAB‐M‐F and OAB‐C‐F were also given bismuth subcitrate (B) (240 mg bid), whereas a placebo (P) was given to group OAC‐P. Adverse events were scored and recorded. Two months after treatment, a C¹³‐urea breath test was performed. Results: Three hundred and ten patients were enrolled and 92 (OAB‐M‐F), 95 (OAC‐P), and 98 (OAB‐C‐F) completed the study. The intention‐to‐treat eradication rates were 78.5% (95% CI = 69–85), 81.1% (95% CI = 73–88), and 82% (95% CI = 74–89), and per‐protocol eradication rates were 91.3% (95% CI = 83–96), 90.4% (95% CI = 82–95), and 88.7% (95% CI = 81–94), for group OAB‐M‐F, OAC‐P, and OAB‐C‐F, respectively. Eradication rate differences did not reach statistical significance. The most common adverse event, bad taste, occurred in all groups, but more frequently in groups OAC‐P (34%) and OAB‐C‐F (32%), than OAB‐M‐F (14%) (p < .05). Adverse symptoms score were 0.88 ± 2.05 in group OAB‐M‐F, 1.15 ± 1.40 in group OAC‐P, and 1.87 ± 1.62 in group OAB‐C‐F. Conclusion: Furazolidone can replace clarithromycin in H. pylori eradication regimens because of lack of development of resistance and very low cost.