Addition of Clidinium-C to the 14-Day Proton Pump Inhibitor Based Triple Therapy for Helicobacter pylori Eradication

Abstract

Aims: To assess the effect of clidinium-C on H. pylori eradication with a triple therapy including omeprazole, clarithromycin and amoxicillin (OCA) in patients with peptic ulcer disease (PUD). Also, to investigate the efficacy and safety of clidinium-C in prevention of drugs' side effects. Study Design: Prospective double-blinded randomized clinical trial study. Place and Duration of Study: Department of Internal Medicine, Golestan University of Medical Sciences, from March 2011 to November 2012. Methodology: A total of 200 histopathologically proven H. pylori positive patients with PUD enrolled in this study were randomly assigned to participate in two groups: Group A: a 14-day OCA triple therapy with 20 mg omeprazole bid, 1000 mg amoxicillin bid and 500 mg clarithromycin bid; Group B: a 14-day clidinium-C bid plus OCA triple therapy. Subjects were asked to report any side effects of therapy during the treatment period. A13C-urea breath test was performed for eradication assessment 6 weeks after completion of the treatment. Results: Totally 184 of 200 patients (90 in group A and 94 in group B) could continue the treatment protocols. H. pylori eradication was achieved in 71.1% in Group A (OCA without clidinium-C) and in 72.3% in Group B (OCA with clidinium-C), (p=0.73). The frequencies of abdominal pain and stool abnormality, among the side effects recorded during the therapy period, were significantly lower in group B (OCA with clidinium-C) than in group A (p=0.01 and p=0.001, respectively). Conclusion: Addition of clidinium-C to OCA triple therapy does not increase the H. pylori eradication rates; however, it significantly decreases the frequency of abdominal pain and stool abnormality. This suggests a possibility that the addition of clidinium-C might be an option for increasing the patient's compliance.