Background: The efficacy of Helicobacter pylori (H. pylori) eradication has steadily declined, primarily because of antibiotic resistance. This study aimed to evaluate the efficacy and safety of furazolidone eradication therapies as initial treatments for H. pylori infection.
Methods: A national, multicenter, open-label, randomized controlled trial was performed at 16 sites across 13 provinces in China to evaluate the efficacy and safety of furazolidone-containing therapies for H. pylori infection. Treatment naïve patients were randomly assigned to: esomeprazole 20 mg, bismuth 220 mg, amoxicillin 1000 mg, and furazolidone 100 mg twice daily for 10 and 7 days (FAB 10 and FAB 7; the same therapy without bismuth (FA 10 and FA 7). The primary and secondary outcomes were the eradication rate and regimen safety, respectively. Treatment success was assessed by the 13 C urea breath test at least 4 weeks after treatment completion.
Results: Overall, according to intention-to-treat (ITT) analysis, the eradication rates for FAB 10 and FAB 7 were 86.6% (95% confidence interval [CI], 79.9%-93.2%) and 83.6% (95% CI, 76.3%-90.9%) and for FA 10 and FA 7 were 82.4% (95% CI, 74.9%-89.8%) and 77.6% (95% CI, 69.4%-85.8%), respectively. According to per-protocol analysis, the overall eradication rates for FAB 10 and FAB 7 were 94.7% (95% CI, 90.3%-99.1%) and 90.8% (95% CI, 85.1%-96.5%) and for FA 10 and FA 7 were 90.6% (95% CI, 84.9%-96.3%) and 85.1% (95% CI, 78.2%-92.1%), respectively. The overall prevalence of side effects was 8.1%.
Conclusions: Furazolidone-containing therapies, particularly the tested 10-day quadruple therapy, exhibited satisfactory efficacy and safety. This 10-day quadruple therapy represents a promising initial treatment strategy for Chinese patients.
Keywords: Helicobacter pylori; furazolidone; quadruple therapy; triple therapy.
© 2018 John Wiley & Sons Ltd.