3 research outputs found
Randomized Controlled Trial Comparing Standard Triple and Sequential Regimens for Helicobacter pylori Eradication
Objectives: The aim of this study was to compare effectiveness of sequential therapy to the standard triple therapy to eradicate Helicobacter pylori (H. pylori) in Mongolia. Methods: From September 2014 to February 2016, 140 patients with confirmed H. pylori infection (upper gastrointestinal tract (GI) endoscopy, rapid urease test, histology, H. pylori stool antigen test (HpStAg)) randomly received 10 days standard triple therapy (20 mg pantoprazole, 1 g amoxicillin, 500 mg clarithromycin, all twice daily for 10 days; STT group, n = 70), and sequential therapy (20 mg pantoprazole, 1 g amoxicillin twice daily for 5 days followed by 20 mg pantoprazole, 500 mg clarithromycin, 500 mg metronidazole twice daily for 5 days; SQT group, n = 70). Successful eradication therapy for H. pylori infection was defined as a negative HpStAg test 4 weeks after the end of eradication treatment. Results: The eradication rates by intention to treat (ITT) analysis were 71.4% (50/70) and 50% (35/70) in the STT and SQT groups, respectively (p = 0.033). The eradication rates by per-protocol (PP) analysis were 72.5% (50/69) and 51.5% (35/68) in the STT and SQT groups, respectively (p = 0.018). The adverse event rates were 7.6% (5/70) and 18.6% (13/70) in the STT and SQT groups, respectively (p = 0.043). Conclusion: The eradication rate was significantly higher in the STT group compared with the SQT group. But the eradication efficacies of both STT and SQT for H. pylori infection in Mongolia are unacceptable
Initial Trials With Susceptibility-Based and Empiric Anti-H. pylori Therapies in Mongolia
Background: Mongolia has a high prevalence of Helicobacter pylori infection and gastric cancer. We conducted a prospective, randomized, single-blind study to evaluate the efficacy of common regimens in Mongolia and to obtain specimens for susceptibility testing.Methods: Empiric treatments: 270 patients with confirmed H. pylori infection were randomized to receive 10 days clarithromycin-triple therapy (Clari-TT) (n = 90), modified bismuth quadruple therapy (M-BQT) (n = 90), or sequential therapy (ST) (n = 90). A second group of 46 patients received susceptibility-based Clari-TT. H. pylori was cultured from 131 patients and susceptibility testing was performed. H. pylori eradication was confirmed by stool antigen 4 weeks after the therapy.Results: Intention-to-treat (ITT) analysis cure rates were 71.1% (95% CI = 61.7โ80.5%) for Clari-TT, 87.8% (95% CI = 81โ94.6%) for M-BQT, 67.8% (95% CI = 58.1โ77.5%) for ST vs. 89.1% (95% CI = 86โ98.2%) for susceptibility-based Clari-TT. Per-protocol (PP) analysis results for these therapies were 72.7% (63.4โ82%), 89.8% (83.5โ96.1%), 68.5% (58.8โ78.2%), and 97.6% (89.5โ99.8%), respectively. Among 131 cultured H. pylori, resistance rates to amoxicillin, clarithromycin, and metronidazole were 8.4, 37.4, and 74%, respectively.Conclusion: In Mongolia, the prevalence of H. pylori resistance is high requiring bismuth quadruple therapy or susceptibility-based therapy to obtain acceptable cure rates