Sequential therapy versus standard triple-drug therapy for Helicobacter pylori eradication: result of the HPFEZ randomised study.

ABSTRACT

OBJECTIVE: The aim of this study was to assess and compare the efficacy and safety of sequential treatment with standard triple therapies in a located population in Morocco. METHODS: Consecutive H. pylori-positive patients with endoscopy-proven ulcer or non ulcer dyspepsia were prospectively randomized in the trial into one of three groups AM and AC group were administered a tri-therapy for 7 days including PPI + amoxicillin + metronidazole (AM group)/clarithromycin (AC group) and SQ group was administered a sequential regimen consisting of PPI + amoxicillin for 5 days followed by PPI + clarithromycin + metronidazole for the remaining 5 days. Eradication was confirmed by 13C-urea breath test 3 months after the end of the treatment. RESULTS: Groups AM, AC and SQ included respectively 104, 115 and 104 patients. They were comparable in terms of age, sex, clinical and endoscopic presentation. The rate of H. pylori eradication with sequential therapy was found at 94.2% (n=98) in ITT and 96% (n=98) in PP. It was higher than those found in the AM group 70% (n=73) in ITT and 70.8% (n=73) in PP and the AC group 78.2% (n=90) in ITT and 79.6% (n=90) in PP (0.001). The prevalence of side effects following the sequential treatment was 9.6% (n=10) versus 22% (n=22) and 27.8% (n=32) in the AM and AC groups, respectively, (P=0.006). CONCLUSIONS: Sequential treatment was better tolerated and achieved a significantly higher eradication rate of H. pylori compared with standard triple therapies in this population.