Prospective trial in Saudi Arabia comparing the 14-day standard triple therapy with the 10-day sequential therapy for treatment of Helicobacter pylori infection

摘要

Background/Aims: Treatment success for Helicobacter pylori infection in Saudi Arabia is relatively unexplored. This prospective study compared the efficacy of sequential versus standard triple therapy in curing H. pylori infections. Patients and Methods: Eligible patients underwent upper endoscopy at a single center in Saudi Arabia from October 2011 to February 2014. Patients who tested positive for H. pylori infection were randomly assigned to sequential therapy or standard triple therapy. Sequential treatment: Esomeprazole (20 mg bid for 10 days), amoxicillin (1000 mg for 5 days), then clarithromycin 500 mg and tinidazole 500 mg; both bid for 5 days. Standard triple treatment: Esomeprazole 20 mg, clarithromycin 500 mg, and amoxicillin 1000 mg each bid for 14 days. After 6 weeks of treatment, patients were tested for cure using a validated urea breath test. Application of the E-test determined susceptibility of H. pylori to different antibiotics. Results: Of the 115 patients who received sequential therapy, 93 completed treatment. In the triple-therapy arm, 103 of 117 patients completed treatment. The eradication rate was 58/93 (62.3%) with sequential therapy and 69/102 (67.6%) with standard triple therapy, P = 0.44. Risk ratio was 0.92 (95% CI; 0.75–1.13), and number needed to treat was 19. Overall primary resistance: Metronidazole (48.5%), clarithromycin (23.3%), amoxicillin (14.8%), levofloxacin (11.1%), and tetracycline (2.3%). Mild adverse events occurred in 35 and 17 patients in the sequential and standard therapy groups, respectively. Conclusion: Sequential and standard triple therapies were similarly effective at eradicating H. pylori in two-thirds of Saudi patients. Metronidazole and clarithromycin resistance to H. pylori strains was common.