Ping I Hsu1, Deng-Chyang Wu, Jeng-Yih Wu, David Y Graham. 1. Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital and National Yang-Ming University, Kaohsiung, Taiwan. williamhsup@yahoo.com.tw
Abstract
BACKGROUND AND AIMS: Ten-day sequential therapy with a proton-pump inhibitor (PPI) and amoxicillin followed by a PPI, clarithromycin, and an imidazole typically achieves Helicobacter pylori (H. pylori) eradication rates between 90 and 94% (i.e., Grade B success). It has been suggested that prolonging the duration of therapy might improve the treatment success. We tested whether prolonging treatment duration to 14-days would improve the results to 95% or greater eradication. METHODS: This was a multi-center, single site, pilot study in which H. pylori-infected patients received a 14-day sequential therapy (esomeprazole and amoxicillin for 7 days followed by esomeprazole, clarithromycin, and metronidazole for 7 days). H. pylori status was assessed 8 weeks after therapy. Success was defined as achieving 95% or greater eradication by per-protocol (PP) analysis. RESULTS:One hundred and twenty-three subjects received the14-day sequential therapy. The eradication rate was 93.9% (95% confidence interval [CI], 89.5-98.3%) by PP and 91.9% (95% CI, 87.1-96.7%) by intention-to-treat analysis. Adverse events were experienced by 21.1%; compliance of 90% or greater was 95.9%. CONCLUSIONS: Extending sequential therapy to 14 days did not result in improving the treatment outcome to 95% or greater.
RCT Entities:
BACKGROUND AND AIMS: Ten-day sequential therapy with a proton-pump inhibitor (PPI) and amoxicillin followed by a PPI, clarithromycin, and an imidazole typically achieves Helicobacter pylori (H. pylori) eradication rates between 90 and 94% (i.e., Grade B success). It has been suggested that prolonging the duration of therapy might improve the treatment success. We tested whether prolonging treatment duration to 14-days would improve the results to 95% or greater eradication. METHODS: This was a multi-center, single site, pilot study in which H. pylori-infectedpatients received a 14-day sequential therapy (esomeprazole and amoxicillin for 7 days followed by esomeprazole, clarithromycin, and metronidazole for 7 days). H. pylori status was assessed 8 weeks after therapy. Success was defined as achieving 95% or greater eradication by per-protocol (PP) analysis. RESULTS: One hundred and twenty-three subjects received the 14-day sequential therapy. The eradication rate was 93.9% (95% confidence interval [CI], 89.5-98.3%) by PP and 91.9% (95% CI, 87.1-96.7%) by intention-to-treat analysis. Adverse events were experienced by 21.1%; compliance of 90% or greater was 95.9%. CONCLUSIONS: Extending sequential therapy to 14 days did not result in improving the treatment outcome to 95% or greater.