Background/aims: Bismuth-containing quadruple therapy given four times a day is effective in the first-line treatment of Helicobacter pylori. We aimed to investigate whether twice daily posology could eradicate H. pylori at a comparable rate in an area with a high prevalence of antibiotic resistance.
Materials and methods: The study group consisted of 90 patients with treatment naïve H. pylori. Patients were randomized to BOMT1 group (Bismuth citrate 2 x 600 mg, omeprazole 2 x 20 mg, metronidazole 2 x 500 mg, tetracycline 2 x 500 mg; for 14 days) and BOMT2 group (Bismuth citrate 2 x 600 mg, omeprazole 2 x 20 mg, metronidazole 3 x 500 mg, tetracycline 4 x 500 mg; for 14 days). H. pylori eradication was assessed by both C14-urea breath test and stool antigen test at least 8 weeks after treatment.
Results: Demographic characteristics and endoscopy findings of the groups were similar. Eighty-two patients completed the study (BOMT1= 38 and BOMT2 = 44) including H. pylori eradication assessment. The eradication rates determined by PP and ITT analyses were 86.8% and 733% for BOMT1 group, 90.1% and 88.9% for BOMT2 group, respectively. BOMT1 was found to be non-inferior to BOMT2 treatment. Patients in BOMT2 group had a significantly higher rate of drug associated adverse events than BOMT1 (34.1% vs 9.3%; p = 0.008).
Conclusions: Twice a day quadruple therapy is as effective as four times a day quadruple therapy in the first line treatment of H. pylori in a country with high resistance to metronidazole and clarithromycin and is more tolerable.