One-week ranitidine bismuth citrate in combinations with metronidazole, amoxycillin and clarithromycin in the treatment of Helicobacter pylori infection: the RBC-MACH study

Aliment Pharmacol Ther. 1999 Aug;13(8):1079-84. doi: 10.1046/j.1365-2036.1999.00580.x.

Abstract

Background: We have previously shown that ranitidine bismuth citrate (RBC)-based triple therapy is comparable to proton pump inhibitor-based triple therapy in eradicating Helicobacter pylori infection.

Aim: To test the efficacy of different combinations of antimicrobials with RBC in the treatment of H. pylori infection.

Methods: Dyspeptic patients with H. pylori infection were prospectively randomized to receive one of the following regimens: (i) RBC 400 mg, amoxycillin 1 g, clarithromycin 500 mg [RAC]; (ii) RBC 400 mg, metronidazole 400 mg, clarithromycin 500 mg [RMC]; (iii) RBC 400 mg, metronidazole 400 mg, tetracycline 1 g [RMT] (all given twice daily for 1 week); or (iv) RBC 400 mg plus clarithromycin 500 mg twice daily for 2 weeks [RC-2]. Endoscopy (rapid urease test and culture) and 13C-urea breath test (UBT) were performed before randomization. Four weeks after finishing medication, the 13C-UBT was repeated in all cases and endoscopy was offered to patients with peptic ulcers.

Results: Four hundred patients were randomized but in two (one in the RAC group and one in the RMC group) H. pylori infection was not confirmed. Successful eradication of H. pylori (intention-to-treat analysis and 95% CI) of RAC (86% [79-93%]), RMC (90% [84-96%]), RMT (79% [71-87%]) and RC-2 (82% [75-90%]) were comparable, with a trend favouring clarithromycin-containing triple therapy regimens. Among 276 isolates tested for antibiotic sensitivity, primary resistance to metronidazole, clarithromycin and amoxycillin was found in 56%, 2% and 0.4%, respectively. When given RMC or RMT, patients infected by metronidazole-resistant H. pylori had success in eradicating H. pylori similar to patients infected by metronidazole-sensitive H. pylori.

Conclusion: One-week RBC triple therapy is effective in curing H. pylori infection.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Amoxicillin / therapeutic use*
  • Anti-Bacterial Agents / therapeutic use*
  • Anti-Ulcer Agents / therapeutic use*
  • Bismuth / therapeutic use*
  • Clarithromycin / therapeutic use*
  • Double-Blind Method
  • Drug Combinations
  • Dyspepsia / drug therapy
  • Dyspepsia / etiology
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / microbiology
  • Helicobacter pylori* / drug effects
  • Humans
  • Male
  • Metronidazole / therapeutic use*
  • Microbial Sensitivity Tests
  • Middle Aged
  • Penicillins / therapeutic use*
  • Peptic Ulcer / drug therapy
  • Peptic Ulcer / microbiology
  • Prospective Studies
  • Ranitidine / analogs & derivatives*
  • Ranitidine / therapeutic use
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Drug Combinations
  • Penicillins
  • Metronidazole
  • ranitidine bismuth citrate
  • Amoxicillin
  • Ranitidine
  • Clarithromycin
  • Bismuth