Levofloxacin based vs clarithromycin based sequential therapy in helicobacter pylori eradication; a randomized clinical trial.

Aim: This study was aimed to evaluating the efficacy of levofloxacin based sequential therapy vs clarithromycin based sequential therapy in h.pylori (HP) eradication.

Background: Several therapeutic regimen were investigated to treat HP infection. Sequential therapy is an alternative to classic triple therapy.

Methods: In this randomized clinical trial, 200 HP infected patients randomly divided into two therapeutic groups .1-Levofloxacin based sequential regimen (group A); omeprazole and amoxicillin for 7days followed by omeprazole, amoxicillin and levofloxacin for 7days. 2-clarithromycin based sequential regimen (group B): omeprazole and amoxicillin for 7days followed by omeprazole, amoxicillin and clarithromycin for 7days. HP eradication was evaluated with urea breath test with carbon 13 (UBT) 6 weeks after the end of treatment.

Results: Per protocol eradication rates of group A and B were 87.6% and 76% respectively. By intention to treat analysis, eradication rate of group A and B groups were 85.1% and 73% respectively. Levofloxacin based sequential regimen was more effective than clarithromycin based sequential regimen (Pv=0.028). Adverse events were seen in 19.6% and 15.6% in group A and B respectively. Drug compliance was 97% in group A and 96% in group B. There was no significant difference between two groups in term of adverse events (p=0.470) and compliance (p=0.651).

Conclusion: Levofluxacin based sequential therapy was more effective than Clarithromycin based sequential therapy in HP eradication. The suggested Levofluxacin based sequential therapy could be an alternative therapy in area with high clarithromycin resistance. Further studies are needed to confirm these findings.