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

• Published in: Current therapeutic research Vol. 65; no. 1; pp. 13 - 25
• Main Authors: BUZAS, György M, GYORFFY, Hajnalka, SZELES, Ilona, SZENTMIHALYI, Anna
• Format: Journal Article
• Language: English
• Published: Belle Mead, NJ EM Inc USA 2004; Excerpta medica; Elsevier
• Subjects: Biological and medical sciences; Medical sciences; Pharmacology. Drug treatments; Human; Spirillales; Spirillaceae; ranitidine bismuth citrate; Duodenal ulcer; antimicrobials; Crossover study; proton pump inhibitors; Helicobacter pylori; eradication; Digestive diseases; Bacteria; Intestinal disease
• ISSN: 0011-393X; 1879-0313
• DOI: 10.1016/S0011-393X(04)90001-X

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, Ferencváros 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).