Estudio aleatorizado comparando una primera línea de terapia estándar contra Helicobacter pylori con claritromicina versus levofloxacina por 10 días 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 levofloxacin, amoxicillin, and a proton pump inhibitor is effective and well tolerated. This scheme has been suggested as an alternative for standard first-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 levofloxacin, 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 significant statistical differences in effectiveness between the two treatment groups, but there were no significant differences in toleration and adverse effects between the two groups. Conclusions: Treatment of H. pylori infections with triple therapy based on levofloxacin was a better alternative than clarithromycin-based triple therapy in this study .