ABSTRACT
Background: Considering the importance of Helicobacter pylori [H. pylori] eradication, this clinical trial was designed to prospectively evaluate the efficacy of levofloxacin-based, sequential therapy in comparison with quadruple therapy for eradicating H. pylori
Methods: Overall 156 patients with dyspepsia and H. pylori infection were included in this study and were randomly allocated to either 10-day sequential therapy group [group A] to receive pantoprazole [40 mg twice daily], amoxicillin [1 gr twice daily], levofloxacin [500 mg twice daily], and tinidazole [500 mg twice daily] [PALT] or 14-day quadruple therapy group [group B] to receive pantoprazole, clarithromycin, bismuth subcitrate, and amoxicillin [PABC]. At the end of the study the eradication rate in each group was assessed by urea breath test [UBT]
Results: Age range of the participants was 18-65 years [average 36.9 years] and 50% of them [78 patients] were men. 78 patients were allocated to group A and 78 patients to groupe B. After antibiotic therapy, all the patients received acid suppression therapy with Proton Pump Inhibitor [PPI] for 4 weeks and then the eradication rate was confirmed by UBT [Heli FAN plus 13C, Germany]. Before performing UBT, all the participants were requested to halt consumption of PPI for at least 1 week. During the treatment there was not any major complication but in group A [sequential therapy], two patients complained of minor complications including musculoskeletal pain. None of the patients in group B had any complaint or side effect.The rate of H. pylori eradication in group A was 78.2% [61 patients] while this rate in group B was 83.3% [65 patients] with no significant difference between the two groups [p = 0.42]. In subgroup analysis, the rate of eradication among men in group A and B were 76.9% and 89.7%, respectively [p = 0.22] while the eradication rate among women were 79.4% and 76.9%, respectively [p = 1.00]
Conclusion: It seems that levofloxacin base sequential therapy does not have any advantage in comparison with quadruple regimen and until finding any more effective short course therapy for H. Pylori eradication; we encourage quadruple regimen to be used as the first line therapy