Su1187 Randomised, Multicenter Clinical Trial: Comparison of 10-Day Standard Triple Therapy and Non-Bismuth-Containing Concomitant Therapy for Helicobacter pylori Infection in Korea (Interim Result)

Abstract

Background Clarithromycin-based standard triple therapy for the first-line treatment of Helicobacter pylori (H. pyloi) has not achieved acceptable eradication rates in some parts of the world, especially in China. This is driven, in part, by clarithromycin resistance. The plant alkaloid berberine and allicin were known to significantly inhibit proliferation of H. pylori in vitro. Moreover, they also seemed to be potentially effective agent for H. pylori eradication in vivo. Whether berberine or allicin treatment could replace clarithromycin as the first-line treatment for Helicobacter pylori infection is unknown. We compared the efficacy of berberine-, allicinor clarithromycin-based triple therapy for 14 days in first-line treatment. Methods For this single-center, randomized trial, we recruited 336 patients (≥18 years old) with H pylori infection from PLA General Hospital between April and December, 2013. Using a permuted block randomization with a block size of six, we randomly allocated eligible patients to receive one of the following regimens (1:1:1): standard triple regimen of clarithromycin 500 mg, omeprazole 20 mg and amoxicillin 1000 mg taken twice a day for 14 days; berberine-based triple regimen of berberine, 300mg 3 times a day and omeprazole 20 mg, amoxicillin 1000 mg twice a day for 14 days; or allicin-based regimen of allicin 8 mg 3 times a day and omeprazole 20 mg, amoxicillin 1000 mg twice a day for 14 days. Investigators were mask to treatment allocation. Eradication was assessed by 13C urea breath test at least 1 month after the treatment. Our primary outcome was probablity of H pylori eradication. The prior patients' consent and approval were obtained from Institutional Review Board of the Chinese PLA General Hospital (Number 2013FC-TSYS-1009). Results We enrolled a total of 336 participants: 112 to each group. In the intention-to-treat population, H. pylori eradication rate was higher with berberine-based therapy (80.4%, 95% CI 73.087.7) than with standard-based therapy (67.0%, 95% CI 58.3-75.7) and allicin-based therapy(65.2%, 95% CI 56.4-74.0). In the per-protocol population, eradication rate was 70.8% (95% CI 62.1-79.4; 75 of 106 patients) in standard triple therapy, 84.1% (95% CI 77.291.0; 90 of 107 patients) in berberine-based therapy, and 73% (95% CI 64.3-81.7; 73 of 100 patients) in allicin-based therapy. Safety profiles for each treatments was similar andmain adverse events were gastrointestinal disorders. Conclusion Berberine-based triple regimen (berberine, amoxicillin and PPI) can achieve a > 80% ITT success rate with similar safety and tolerability to standard regimen for first-line treatment of H. pylori infection.