A randomised clinical trial of 10-day concomitant therapy and standard triple therapy for Helicobacter pylori eradication

Dig Liver Dis. 2014 Nov;46(11):980-4. doi: 10.1016/j.dld.2014.07.018. Epub 2014 Aug 12.

Abstract

Background: As a result of increased resistance to antibiotics, Helicobacter pylori eradication rates using standard triple therapy have been declining.

Aim: To validate the efficacy and tolerability of a concomitant regimen as a first-line treatment for H. pylori infection.

Methods: A total of 348 naïve H. pylori-infected patients from six hospitals in Korea were randomly assigned to concomitant therapy and standard triple therapy groups. The concomitant regimen consisted of 30 mg of lansoprazole, 1g of amoxicillin, 500 mg of clarithromycin, and 500 mg of metronidazole, twice daily for 10 days. The standard triple regimen consisted of 30 mg of lansoprazole, 1g of amoxicillin, and 500 mg of clarithromycin, twice daily for 10 days.

Results: Concomitant and standard eradication rates were 78.7% (137/174) vs. 70.7% (123/174) by intention-to-treat (p=0.084) and 88.7% (133/150) vs. 78.4% (120/153) by per-protocol (p=0.016), respectively. The two groups were similar with regard to the incidence of adverse events.

Conclusions: Although 10-day concomitant therapy was validated as a suboptimal treatment option for the treatment of H. pylori infection, this regimen is expected to be a promising starting point in the development of an optimal treatment regimen for H. pylori infection.

Keywords: Concomitant therapy; Helicobacter; Standard therapy.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Amoxicillin / administration & dosage
  • Anti-Bacterial Agents / administration & dosage*
  • Anti-Ulcer Agents / administration & dosage*
  • Chi-Square Distribution
  • Clarithromycin / administration & dosage
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination / standards
  • Female
  • Follow-Up Studies
  • Helicobacter Infections / diagnosis
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori / drug effects*
  • Helicobacter pylori / isolation & purification
  • Humans
  • Lansoprazole / administration & dosage
  • Logistic Models
  • Male
  • Metronidazole / administration & dosage
  • Middle Aged
  • Multivariate Analysis
  • Prospective Studies
  • Republic of Korea
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Lansoprazole
  • Metronidazole
  • Amoxicillin
  • Clarithromycin