BACKGROUND: New triple therapy for eradication of Helicobacter pylori based on a proton pump inhibitor (PPI) provides a cure rate of approximately 90% with few adverse effects. Recently, a PPI-based quadruple therapy, which consists of a PPI plus bismuth-based triple therapy for 7 days, has been studied, and a sufficient eradication rate has been achieved. However, a shorter duration results in improved compliance. In this study, newly developed short-term, simple twice-daily quadruple therapy consisting of rabeprazole, amoxicillin, clarithromycin, and metronidazole (RACM) was compared with a PPI-based triple-therapy regimen for eradication of H. pylori. PATIENTS AND METHODS: This study was designed as a randomized open, prospective single-center study. Of a total of 105 H. pylori-positive patients, 55 received the RACM regimen for 5 days (rabeprazole, 10 mg bid; amoxicillin, 750 mg bid; clarithromycin, 200 mg bid; and metronidazole, 250 mg bid), and 50 received the RAC regimen for 5 days (rabeprazole, 10 mg bid; amoxicillin, 750 mg bid; and clarithromycin, 200 mg bid). Cure of the infection was assessed by HpSA (H. pylori stool antigen immunoassay) 1 month after completion of therapy. RESULTS: The rates of eradication of H. pylori by RACM versus RAC were 94.5% (95% CI, 85-99) versus 80.0% (95% CI, 66-90) by intention-to-treat analysis; 98.1% (95% CI, 90-100) versus 87.0% (95% CI, 74-95) by all-patients-treated analysis; and 98.1% (95% CI, 90-100) versus 86.7% (95% CI, 73-95) by per-protocol analysis. No major adverse effects were reported, and 98.0% of patients reported complete compliance. CONCLUSIONS: The simple twice-daily and short-term quadruple regimen for only 5 days provided an excellent eradication rate. Compliance with the regimen was high, and serious adverse effects were few. Therefore, the RACM regimen can be considered as safe and effective.
RCT Entities:
BACKGROUND: New triple therapy for eradication of Helicobacter pylori based on a proton pump inhibitor (PPI) provides a cure rate of approximately 90% with few adverse effects. Recently, a PPI-based quadruple therapy, which consists of a PPI plus bismuth-based triple therapy for 7 days, has been studied, and a sufficient eradication rate has been achieved. However, a shorter duration results in improved compliance. In this study, newly developed short-term, simple twice-daily quadruple therapy consisting of rabeprazole, amoxicillin, clarithromycin, and metronidazole (RACM) was compared with a PPI-based triple-therapy regimen for eradication of H. pylori. PATIENTS AND METHODS: This study was designed as a randomized open, prospective single-center study. Of a total of 105 H. pylori-positive patients, 55 received the RACM regimen for 5 days (rabeprazole, 10 mg bid; amoxicillin, 750 mg bid; clarithromycin, 200 mg bid; and metronidazole, 250 mg bid), and 50 received the RAC regimen for 5 days (rabeprazole, 10 mg bid; amoxicillin, 750 mg bid; and clarithromycin, 200 mg bid). Cure of the infection was assessed by HpSA (H. pylori stool antigen immunoassay) 1 month after completion of therapy. RESULTS: The rates of eradication of H. pylori by RACM versus RAC were 94.5% (95% CI, 85-99) versus 80.0% (95% CI, 66-90) by intention-to-treat analysis; 98.1% (95% CI, 90-100) versus 87.0% (95% CI, 74-95) by all-patients-treated analysis; and 98.1% (95% CI, 90-100) versus 86.7% (95% CI, 73-95) by per-protocol analysis. No major adverse effects were reported, and 98.0% of patients reported complete compliance. CONCLUSIONS: The simple twice-daily and short-term quadruple regimen for only 5 days provided an excellent eradication rate. Compliance with the regimen was high, and serious adverse effects were few. Therefore, the RACM regimen can be considered as safe and effective.