BACKGROUND: The eradication rate of Helicobacter pylori with a standard triple regimen has been reported as being lower in patients with type 2 diabetes mellitus (DM) than in those without DM. The aim of this study was to evaluate the efficacy and tolerability of 2 different H. pylori eradication regimens in patients with type 2 DM. METHODS:Ninety-eight consecutive type 2 DM and 116 nondiabetic age- and sex-matched patients were enrolled in this study. Patients were randomized to receive either pantoprazole, clarithromycin, and amoxicillin (PCA) for 14 days or ranitidine-bismuth citrate, clarithromycin, and amoxicillin (RCA) for 14 days as the eradication regimen. H. pylori eradication was assessed using C14-urea breath test 6 weeks after the end of therapy. RESULTS: The H. pylori eradication rate with PCA regimen in patients with DM with both intention-to-treat (ITT) and per protocol (PP) analysis was 24/49 (48.9% and 62.9%) and in non-DM patients was 44/58 (75.9% and 86.7%) with ITT and 44/57 (77.2% and 88.2%) with PP analysis (P < 0.05). The H. pylori eradication rates with RCA regimen in patients with DM were 22/49 (45.9% and 59.8%) with ITT and 22/48 (45.8% and 59.9%) with PP analysis and in non-DM patients were 44/58 (75.9% and 86.7%) with ITT and 44/56 (78.6% and 89.3%) with PP analysis. CONCLUSIONS: These data suggest that the eradication rate of H. pylori with PCA or RCA treatment is lower in patients with type 2 diabetes than in nondiabetics and that successful eradication could decrease dyspeptic symptoms.
RCT Entities:
BACKGROUND: The eradication rate of Helicobacter pylori with a standard triple regimen has been reported as being lower in patients with type 2 diabetes mellitus (DM) than in those without DM. The aim of this study was to evaluate the efficacy and tolerability of 2 different H. pylori eradication regimens in patients with type 2 DM. METHODS: Ninety-eight consecutive type 2 DM and 116 nondiabetic age- and sex-matched patients were enrolled in this study. Patients were randomized to receive either pantoprazole, clarithromycin, and amoxicillin (PCA) for 14 days or ranitidine-bismuth citrate, clarithromycin, and amoxicillin (RCA) for 14 days as the eradication regimen. H. pylori eradication was assessed using C14-urea breath test 6 weeks after the end of therapy. RESULTS: The H. pylori eradication rate with PCA regimen in patients with DM with both intention-to-treat (ITT) and per protocol (PP) analysis was 24/49 (48.9% and 62.9%) and in non-DMpatients was 44/58 (75.9% and 86.7%) with ITT and 44/57 (77.2% and 88.2%) with PP analysis (P < 0.05). The H. pylori eradication rates with RCA regimen in patients with DM were 22/49 (45.9% and 59.8%) with ITT and 22/48 (45.8% and 59.9%) with PP analysis and in non-DMpatients were 44/58 (75.9% and 86.7%) with ITT and 44/56 (78.6% and 89.3%) with PP analysis. CONCLUSIONS: These data suggest that the eradication rate of H. pylori with PCA or RCA treatment is lower in patients with type 2 diabetes than in nondiabetics and that successful eradication could decrease dyspeptic symptoms.
Authors: Seung-Joo Nam; Sung Chul Park; Sang Hoon Lee; Dong Wook Choi; Sung Joon Lee; Chang Seok Bang; Gwang Ho Baik; Jong Kyu Park Journal: SAGE Open Med Date: 2019-02-19