Second-line and third-line trial for Helicobacter pylori infection in patients with duodenal ulcers:: A prospective, crossover, controlled study

Background: Following standard first-line triple therapies for Helicobacter pylori infection, up to 20% of patients require further eradication. Objective: The aim of this study was to assess the effects of second-line triple therapies and third-line quadruple therapies for the eradication of H pylori. Methods: This 7-week, prospective, crossover, controlled, second- and third-line trial was conducted at the Department of Gastroenterology, Ferencvaros Health Center (Budapest, Hungary). Patients aged 18 to 80 years with duodenal ulcers and an H pylori infection resistant to first-line triple therapy (pantoprazole 40 mg BID + amoxicillin 1000 mg BID + clarithromycin 500 mg BID [PAC] given as tablets) received a different triple therapy regimen (ranitidine bismuth citrate 400 mg BID + metronidazole 500 mg BID + clarithromycin 500 mg BID [RBC-MC]) for 7 days (group 1A), and nonresponders after RBC + 2 antimicrobials received the pantoprazole-based regimen (group 1B). After secondary failure, patients were randomized to receive quadruple therapies: pantoprazole, amoxicillin, tetracycline, and either nitrofurantoin or bismuth subsalicylate (groups 2A and 2B). Results: One hundred thirty-four patients were enrolled in the second-line study (56 men, 78 women; mean [SD] age, 51.1 [12.4] years; group 1A, 68 patients; group 1B, 66 patients). Subsequently, 41 (30.6%) of these patients were randomized to receive quadruple therapies. Using intent-to-treat (ITT) analysis, the eradication rates did not differ significantly (60.3% and 65.2% in groups 1A and 1B, respectively; 61.9% and 55.0% in groups 2A and 2B, respectively). Perprotocol eradication rates did not differ significantly (66.1% and 68.3% in groups 1A and 1B, respectively); however, the rates were significantly different in group 2A (66.7%) versus group 2B (55.5%) (P = 0.03). Conclusions: In this study of patients with persistent H pylori infection and duodenal ulcer, the PAC and RBC-MC regimens used as second-line therapies and the nonmacrolide, nonimidazole third-line regimens were of moderate efficacy in the eradication of persistent H pylori. On ITT analysis, no significant differences were detected between the second-line triple and the third-line quadruple regimens. Due to the high rates of resistance, determination of antimicrobial susceptibility of H pylori was of little benefit in this study; instead, empiric, nonmacrolide, nonimidazole combinations were preferred. Copyright (C) 2004 Excerpta Medica, Inc.