BACKGROUND: The object of the study was to study the efficacy and safetyof furazolidone and tetracycline compared to metronidazole and amoxicillin in an omeprazole based tripletherapy in a prospective randomized-blind-clinical trial. MATERIAL/METHODS: Patients with endoscopicallyverified active duodenal ulcer disease in the presence of Helicobacter pylori infection were eligibleto 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 takenfrom the antrum and corpus. H. pylori eradication was defined as absence in histology of the biopsy specimensat the second endoscopy. Ulcer healing was considered as decrease in ulcer size to less than 20% of itsprimary size. Patients were randomly assigned to receive omeprazole 20 mg, amoxicillin 1000 mg and metronidazole500 mg (OAM group) or omeprazole 20 mg, tetracycline 500 mg and furazolidone 200 mg (OTF group). Allmedications 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. OAMregimen 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 recommendit to be used especially in developing countries.

Keywords: Amoxicillin, Anti-Bacterial Agents, Anti-Infective Agents, Local, Antibiotics, Combined, Duodenal Ulcer, furazolidone, Helicobacter pylori, metronidazole, Tetracycline