Ten and eight-day sequential therapy in comparison to standard triple therapy for eradicating Helicobacter pylori infection: a randomized controlled study on efficacy and tolerability

J Clin Gastroenterol. 2010 Apr;44(4):261-6. doi: 10.1097/MCG.0b013e3181acebef.

Abstract

Background: Sequential therapy (SQT) is effective in the eradication of Helicobacter pylori and could become an alternative to standard triple therapy (STT).

Aim: To compare the efficacy and tolerability of SQT, for either 8 or 10 days, with a 7-day STT.

Methods: A total of 270 naive H. pylori-positive patients were randomized to receive: SQT for 8 days (SQT-8, n=90) or 10 days (SQT-10, n=90) including esomeprazole 20 mg twice daily (bid) associated with amoxicillin 1000 mg bid (early 4 and 5 d, respectively), followed by esomeprazole 20 mg bid associated with clarithromycin 500 mg bid plus tinidazole 500 mg bid (last 4 and 5 d, respectively); STT (n=90) including esomeprazole 20 mg bid plus amoxicillin 1000 mg bid and clarithromycin 500 mg bid for 7 days. Tolerability was assessed by scoring the severity of symptoms.

Results: Eradication rates after SQT-8 and SQT-10 were higher than that of after STT at both intention-to-treat (83% and 86% vs. 66%, P<0.02) and per-protocol analysis (90% and 88% vs. 75%, P<0.05), whereas no difference was found between the 2 SQTs.

Conclusions: This study shows that SQT, for 8 or 10 days, is well tolerated and highly effective in H. pylori eradication and could represent a valid alternative to STT. Further studies, with more power, on larger populations and from other countries are necessary to validate the present findings.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amoxicillin / administration & dosage
  • Amoxicillin / adverse effects
  • Amoxicillin / therapeutic use
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use
  • Anti-Ulcer Agents* / administration & dosage
  • Anti-Ulcer Agents* / adverse effects
  • Anti-Ulcer Agents* / therapeutic use
  • Breath Tests
  • Clarithromycin* / administration & dosage
  • Clarithromycin* / adverse effects
  • Clarithromycin* / therapeutic use
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Esomeprazole* / administration & dosage
  • Esomeprazole* / adverse effects
  • Esomeprazole* / therapeutic use
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / microbiology
  • Helicobacter pylori / drug effects*
  • Humans
  • Male
  • Middle Aged
  • Tinidazole* / administration & dosage
  • Tinidazole* / adverse effects
  • Tinidazole* / therapeutic use
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Tinidazole
  • Amoxicillin
  • Clarithromycin
  • Esomeprazole