Background: Recent studies suggest that cetraxate possesses anti-Helicobacter pylori (H. pylori) activity. We therefore conducted this pilot study to investigate the efficacy of a cetraxate-based triple therapy and to compare the regimen with proton pump inhibitor-based triple therapy.
Methods: From April 2001 to January 2002, a total of 58 H. pylori-infected patients were randomly assigned to 1 of 2 regimens for 1 week: cetraxate plus clarithromycin and amoxicillin (CCA group) or pantoprazole plus clarithromycin and amoxicillin (PCA group). Follow-up endoscopy was performed at 8 weeks after the end of treatment to assess the treatment response.
Results: Intention-to-treat analysis showed that the eradication rates of the CCA group (n = 27) and PCA group (n = 31) were 70.4% and 93.5%, respectively. The CCA group had a significantly lower eradication rate than the PCA group (p = 0.03). Per-protocol analysis also showed similar results (69.2% vs. 96.7%, p = 0.01). However, the frequency of adverse events in the CCA group was lower than that of the PCA group (3.7% vs. 25.8%, p = 0.03). Univariate analysis showed that the eradication rate was significantly related to proton pump inhibitor therapy (93.5% vs. 70.4%, p = 0.03 ) and smoking habit (66.7 % vs. 88.4%, p = 0.05), but multivariate analysis disclosed that proton pump inhibitor therapy was the only independent factor predicting treatment success (p < 0.05).
Conclusions: Cetraxate-based triple therapy is less effective than pantoprazole-based triple therapy in the treatment of H. pylori infection. However, the former has a lower frequency of adverse effects than the latter.