Non-inferiority of reverse hybrid regimen versus standard concomitant regimen for H. pylori eradication in a randomized-controlled trial.

Abstract

Helicobacter pylori (H. pylori) infection is strongly related to peptic ulcer disease, chronic gastritis, and gastric malignancies. Therefore, H. pylori eradication is necessary in these cases. This study was aimed to compare the efficacy of 14-day reverse hybrid therapy with standard 14-day concomitant regimen for H. pylori eradication in Iran. Of the 317 patients with dyspepsia and H. pylori infection enrolled in the study, 153 and 164 patients were randomly assigned to reverse hybrid and concomitant groups, respectively. The reverse hybrid regimen containing pantoprazole, amoxicillin, clarithromycin, and metronidazole was taken every 12 hours in the first 7 days, however, Clarithromycin and Metronidazole were discontinued within the next 7 days. Patients in the concomitant group also received the same drugs for 14-day. Eradication confirmation tests were used 8 weeks after the end of treatments. A crowd of 281 patients continuedthetrialuntil the end. H. pylori eradication rates based on intention to treat analysis were 71.2% (109/153) and 83.5% (137/164) in reverse hybrid and concomitant groups, respectively (P = 0.007). By the per-protocol analysis, rates of eradication were 85.8% (109/127) and 89% (137/154), respectively (P = 0.428). Severe side effects were few in both groups. More side effects were observed in concomitant group (p < 0.001), however, the severity of side effects was not statistically different between the two regimens (P = 0.314). Reverse hybrid regimen was better tolerated (98% vs. 91.5%, P = 0.009). Both 14-day reverse hybrid and concomitant regimens have a fair response rate in Iran.