Ranitidine bismuth citrate with clarithromycin alone or with metronidazole for the eradication of Helicobacter pylori

Aliment Pharmacol Ther. 2001 Aug;15(8):1199-204. doi: 10.1046/j.1365-2036.2001.01040.x.


Background: Both triple therapy with ranitidine bismuth citrate (RBC) plus two antibiotics for 7 days and dual therapy of RBC with clarithromycin for 14 days have been extensively studied; both regimens effectively eradicate Helicobacter pylori. However, few studies have assessed the efficacy of dual therapy given for 7 days.

Aim: To compare the efficacy and safety of RBC 400 mg with clarithromycin 500 mg, alone or with metronidazole 400 mg, given twice daily for 7 days for the eradication of H. pylori.

Methods: This single centre, randomized, double-blind study involved 118 patients with dyspepsia or a history of peptic ulcer disease. H. pylori infection was detected initially by CLO test, and confirmed in 109 patients by urea breath test and/or microbiology culture. H. pylori eradication was assessed 4 and 12 weeks after the end of treatment by urea breath test. H. pylori antibiotic susceptibility was assessed pre-study in all patients, and post-treatment in patients with a positive post-treatment urea breath test. Adverse events were recorded throughout the study.

Results: H. pylori was eradicated in 93% of patients who received RBC with clarithromycin and metronidazole and in 84% of patients who received RBC with clarithromycin (intention-to-treat rates). Per protocol eradication rates were 98% and 90% for triple therapy and dual therapy, respectively. The eradication of metronidazole-resistant H. pylori was achieved in 100% and 88% of patients following dual therapy and triple therapy, respectively, and acquired resistance to clarithromycin occurred in only one patient following treatment failure. Both treatments were well-tolerated; only one patient (2%) was withdrawn from each treatment group due to adverse events.

Conclusions: RBC with clarithromycin and metronidazole is a highly effective and well-tolerated triple therapy regimen for the eradication of H. pylori. RBC with clarithromycin dual therapy has a similar efficacy, and offers an alternative to triple therapy when there are concerns about treatment with metronidazole or the use of multiple antibiotics. Both regimens are effective against antibiotic-resistant strains of H. pylori.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anti-Bacterial Agents / therapeutic use*
  • Anti-Ulcer Agents / therapeutic use*
  • Bismuth / therapeutic use*
  • Breath Tests
  • Carbon Isotopes
  • Clarithromycin / therapeutic use*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Dyspepsia / drug therapy*
  • Dyspepsia / microbiology
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / microbiology
  • Helicobacter pylori*
  • Humans
  • Male
  • Metronidazole / therapeutic use*
  • Middle Aged
  • Peptic Ulcer / drug therapy*
  • Peptic Ulcer / microbiology
  • Ranitidine / analogs & derivatives*
  • Ranitidine / therapeutic use*
  • Treatment Outcome
  • Urea / analysis
  • Urea / blood
  • Urease / biosynthesis


  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Carbon Isotopes
  • Metronidazole
  • ranitidine bismuth citrate
  • Ranitidine
  • Urea
  • Urease
  • Clarithromycin
  • Bismuth