Concomitant, sequential, and hybrid therapy for H.pylori eradication: A pilot study

摘要

Background and objective: Since the efficacy of the standard triple therapies for Helicobacter pylori eradication has decreased, novel antibiotic regimens have been introduced, including concomitant, sequential, and hybrid therapies. We aimed to compare the cure rates achieved by these new therapy regimens. Methods: This was a multicenter, open-label, pilot study enrolling consecutive non-ulcer dyspepsia patients with H.pylori infection never previously treated for the infection. Patients were randomized to receive one of the following treatments: (a) concomitant therapy: omeprazole 20mg, amoxicillin 1g, clarithromycin 500mg, and tinidazole 500mg for 5days; (b) sequential therapy: omeprazole 20mg and amoxicillin 1g for 5days followed by omeprazole 20mg, clarithromycin 500mg, and tinidazole 500mg for 5days; (c) hybrid therapy: omeprazole 20mg, and amoxicillin 1g for 7days followed by omeprazole 20mg, amoxicillin 1g, clarithromycin 500mg, and tinidazole 500mg, for 7days. All drugs were administered twice daily. Bacterial eradication was checked 6weeks after treatment by using a 13C-urea breath test. A 10-day, second-line therapy with omeprazole 20mg, levofloxacin 250mg, and amoxicillin 1g, all given twice daily, was offered to the eradication failure patients. Results: Overall, 270 patients were enrolled, but 13 patients early interrupted treatment due to side effects. At intention-to-treat (ITT) and per-protocol analysis (PP), the eradication rates were 85.5% and 91.6% with the concomitant regimen, 91.1% and 92.1% with the sequential therapy, and 80% and 85.7% with the hybrid regimen. Differences were not statistically significant. H.pylori infection was cured in 10 (55.6%) patients with the second-line regimen. Conclusion: In our study, both concomitant and sequential therapy, but not hybrid therapy, reached high eradication rates. The success rate of second-line levofloxacin-based triple therapy is decreasing.