Comparative study of Helicobacter pylori eradication rates of concomitant therapy vs modified quadruple therapy comprising proton-pump inhibitor, bismuth, amoxicillin, and metronidazole in Korea.

ABSTRACT

BACKGROUND: The standard triple Helicobacter pylori regimen now shows unacceptably low treatment success in Korea. Administration of the concomitant therapy for 10 days, which has a high cure rate, is recommended as an alternative first-line treatment in areas of high clarithromycin resistance including Korea. Recently, modified bismuth-containing quadruple therapy with amoxicillin (PAM-B therapy) showed excellent results, regardless of dual clarithromycin and metronidazole resistance. This study compared the concomitant therapy with PAM-B therapy as a first-line treatment for H. pylori infection. METHOD: Subjects infected with H. pylori and naïve to treatment were performed a head-to-head comparison between 10-day concomitant therapy [rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily] and 14-day PAM-B therapy [rabeprazole 20 mg, amoxicillin 1 g, metronidazole 750 mg, and tripotassium dicitrato bismuthate 600 mg (elemental bismuth 240 mg) twice daily]. Six weeks after treatment, H. pylori eradication was assessed. RESULTS: Two hundred and seventy subjects were randomized. Both regimens achieved high cure rates 83.0% (112/135) and 88.1% (119/135) by the intention-to-treat analysis and 95.5% (106/111) and 96.6% (114/118) by the per-protocol analysis, respectively. The intention-to-treat and per-protocol analyses revealed no statistically significant difference in the eradication rate (P = .299 and P = .743, respectively). Rates of adverse events were similar between groups (25.2% vs 23.0%, P -value .776) Adverse events, which resulted in poor compliance, occurred in six patients of each group, but there were no serious complications. CONCLUSIONS: PAM-B therapy is as effective as concomitant therapy for eradicating H. pylori with comparative safety. PAM-B therapy is regarded as a promising alternative to standard triple therapy for a first-line eradication in Korea.