A Comparison between Hybrid Therapy and Standard Triple Therapy for Helicobacter pylori Eradication in Patients with Uremia: A Randomized Clinical Trial

Abstract

BACKGROUND

The prevalence of peptic ulcer disease in hemodialysis patients is more than the general population. They are also more prone to complications including upper gastrointestinal bleeding. The aim of this study was to compare the efficacy of 14 days hybrid regimen with 14 days triple therapy for Helicobacter pylori (H. pylori) eradication in hemodialysis patients.

METHODS

Forty hemodialysis patients with naïve H. pylori infection were randomized to receive either hybrid regimen (pantoprazole 40 mg + amoxicillin 500 mg, both twice a day during the first 7 days, followed by pantoprazole 40 mg + amoxicillin 500 mg + clarithromycin 500 mg + tinidazole 500 mg, all twice a day, for the second 7 days, or standard triple therapy including pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 500 mg, all twice a day for 14 days. H. pylori eradication was assessed by fecal H. pylori antigen test 8 weeks after the treatment.

RESULTS

All the patients completed the study. According to both intention to treat and per-protocol analyses, H. pylori eradication rates were 100% (95% confidence interval (CI): 100) in those who received hybrid therapy and 70% (95% CI: 69.4 – 70.8) in those who were treated by standard triple therapy (p=0.02). Severe adverse effects were not reported by any patient; however, mild adverse effects were more frequent in those who received standard triple therapy (p<0.05).

CONCLUSION

Hybrid regimen could achieve ideal H. pylori eradication rates with low rates of adverse effects.