Randomized clinical trial comparing 10-day sequential, 7-day concomitant and 7-day standard triple therapies for Helicobacter pylori eradication

• Published in: European journal of gastroenterology & hepatology Vol. 28; no. 6; pp. 676 - 683
• Main Authors: Tepeš, Bojan, Vujasinović, Miroslav, Šeruga, Maja, Stefanovič, Milan, Forte, Alenka, Jeverica, Samo
• Format: Journal Article
• Language: English
• Published: England Copyright Wolters Kluwer Health, Inc. All rights reserved 01-06-2016
• Subjects: Adolescent; Adult; Aged; Amoxicillin - administration & dosage; Anti-Bacterial Agents - administration & dosage; Clarithromycin - administration & dosage; Drug Administration Schedule; Drug Therapy, Combination; Duodenal Ulcer - drug therapy; Duodenal Ulcer - microbiology; Dyspepsia - drug therapy; Dyspepsia - microbiology; Esomeprazole - administration & dosage; Female; Helicobacter Infections - drug therapy; Helicobacter Infections - microbiology; Helicobacter pylori; Humans; Male; Metronidazole - administration & dosage; Middle Aged; Peptic Ulcer - drug therapy; Peptic Ulcer - microbiology; Proton Pump Inhibitors - administration & dosage; Stomach Ulcer - drug therapy; Stomach Ulcer - microbiology; Treatment Outcome; Young Adult
• ISSN: 0954-691X; 1473-5687
• DOI: 10.1097/MEG.0000000000000590

OBJECTIVESTo compare triple therapy with sequential and concomitant therapies directly in a head-to-head comparison in Helicobacter pylori-infected patients.
DESIGNPatients were allocated randomly as followsa triple therapy with esomeprazole (20 mg), amoxicillin (1000 mg) and clarithromycin (500 mg) twice daily for 7 days; a sequential therapy with 5 days of esomeprazole (20 mg) and amoxicillin (1000 mg) twice daily, followed by 5 days of esomeprazole (20 mg), clarithromycin (500 mg) and metronidazole (400 mg) twice daily; or a concomitant therapy consisting of esomeprazole (20 mg), amoxicillin (1000 mg), clarithromycin (500 mg) and metronidazole (400 mg) twice daily for 7 days.
RESULTSA total of 356 consecutive patients were included. The eradication rates for the triple, sequential and concomitant therapies were 83.6% [95% confidence interval (CI) 76.9–90.4%], 94.2% (95% CI 90.0–98.4%) and 91.7% (95% CI 86.7–96.6%), respectively, in the intention-to-treat population. The differences were significant only between triple and sequential therapies (P=0.01). The primary resistance rates to amoxicillin, clarithromycin and metronidazole were 0.6, 10.5 and 25.9%, respectively. Concomitant therapy was significantly better than triple therapy in cases with clarithromycin resistance (P=0.01).
CONCLUSIONTen-day sequential therapy was significantly better than 7-day triple therapy in a clinical setting with low rates of clarithromycin and dual resistance. Concomitant therapy was significantly better than standard triple therapy in the subgroup of patients with clarithromycin-resistant strains.