Background: The object of the study was to study the efficacy and safety of furazolidone and tetracycline compared to metronidazole and amoxicillin in an omeprazole based triple therapy in a prospective randomized-blind-clinical trial.
Material/methods: Patients with endoscopically verified active duodenal ulcer disease in the presence of Helicobacter pylori infection were eligible to enter the study. Endoscopy was performed a day before and 6-8 weeks after the cessation of treatment. H. pylori status was assessed by histologic examination (Giemsa stain) of biopsy specimens were taken from the antrum and corpus. H. pylori eradication was defined as absence in histology of the biopsy specimens at the second endoscopy. Ulcer healing was considered as decrease in ulcer size to less than 20% of its primary size. Patients were randomly assigned to receive omeprazole 20 mg, amoxicillin 1000 mg and metronidazole 500 mg (OAM group) or omeprazole 20 mg, tetracycline 500 mg and furazolidone 200 mg (OTF group). All medications were taken twice daily, for 2 weeks.
Results: Out of 111 patients enrolled in the study, 108 completed a course of treatment and underwent a follow-up endoscopy, with 54 patients in each group. H. pylori eradication was achieved in 52 patients (96.3% - 95% CI: 91.27-100) in OTF group and 45 patients (83.3% - 95% CI: 73.35-93.25) in OAM group (P=0.015). Our study showed the superiority of OTF vs. OAM regimen with a 13% increment in eradication rate, with only occasional severe side effect.
Conclusions: In conclusion OTF regimen is a safe, cheaper and effective alternative for OTF regimen and we recommend it to be used especially in developing countries.