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

Eur J Gastroenterol Hepatol. 2016 Jun;28(6):676-83. doi: 10.1097/MEG.0000000000000590.

Abstract

Objectives: To compare triple therapy with sequential and concomitant therapies directly in a head-to-head comparison in Helicobacter pylori-infected patients.

Design: Patients were allocated randomly as follows: a 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.

Results: A 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).

Conclusion: Ten-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.

Publication types

  • Clinical Trial, Phase IV
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • 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

Substances

  • Anti-Bacterial Agents
  • Proton Pump Inhibitors
  • Metronidazole
  • Amoxicillin
  • Clarithromycin
  • Esomeprazole