Randomized study comparing standard first line 10 day therapy against Helicobacter pylori including clarithromycin versus standard first line therapy with levofloxacin

Background: Evidence is mounting that the standard triple therapy against H. pylori infections has been losing clinical effectiveness, but triple therapy with levofl oxacin, amoxicillin, and a proton pump inhibitor is effective and well tolerated. This scheme has been suggested as an alternative for standard fi rst-line therapy. The purpose of this randomized, multicenter, controlled study is to compare rates of successful eradication of standard triple therapy using clarithromycin, amoxicillin and omeprazole (CAO) and triple therapy using levofl oxacin, amoxicillin and omeprazole (LAO). Materials and Methods: A total of 317 patients who had been diagnosed with H. pylori infections through biopsies were randomized into two groups. One group of 160 patients was assigned a 10 day CAO treatment regimen and the other group of 157 patients was assigned a 10 day LAO treatment regimen. Eradication was assessed by optimized breath test. Adverse effects and toleration were also assessed. Results: Intention to treat analysis gave the following results: CAO, 68.8% (110/160) and LAO, 84.1% (132/157) with p = 0.0021. The CAO eradication rates was 71.9% (105/146) and the LAO eradication rate was 89.3% (125/140) with p = 0.0004. There were signifi cant statistical differences in effectiveness between the two treatment groups, but there were no signifi cant differences in toleration and adverse effects between the two groups. Conclusions: Treatment of H. pylori infections with triple therapy based on levofl oxacin was a better alternative than clarithromycin-based triple therapy in this study.