ABSTRACT
Background and study aims: The success rate of Helicobacter pylori [H. pylori] eradication with the classical triple therapy is gradually declining. In this study, we aimed to compare and assess the efficacies of six different eradication regimens including sequential protocols
Patients and methods: Endoscopically confirmed nonulcer dyspepsia patients were enrolled. H. pylori presence was determined either histologically or by a rapid urease test. Treatment-naive patients were randomly assigned to an either one of three 10-day [OAC, OTMB, and OACB] or one of three sequential protocols [OA + OCM, OA + OCMB, and OA + OMDB] [O = omeprazole, A = amoxicillin, C = clarithromycin, T = tetracycline, M = metronidazole, B = bismuth, D = doxycycline]. The eradication was assessed 6-8 weeks after the completion of the treatment by a 14C-urea breath test
Results: In total, 301 patients were included. Fifty-two percent of the participants [n = 157] were female, and the mean age was 44.9 years [range = 18-70]. The intention to treat [ITT] and per protocol [PP] eradication rate for each regimen is as follows: OAC [ITT = 61.2%, PP = 75%], OTMB [83.3%, 87%], OACB [76.5%, 79.6%], OA + OCM [72.3%, 73.9%], OA + OCMB [82.7%, 89.6%], and OA + OMDB [59.3%, 65.3%]. Smoking significantly affected the eradication rate [P = 0.04]
Conclusion: In this study, OTMB and OA + OCMB were significantly superior to the triple therapy and succeeded to reach the eradication rate proposed by the Maastricht consensus [over 80%]. These two bismuth-containing regimens could be considered for first-line therapy in the regions with high clarithromycin resistance