A placebo-controlled trial of 10-day bismuth-based quadruple therapy to eradicate Helicobacter pylori infection; a pilot study for the large Linqu County trial

Eur J Gastroenterol Hepatol. 2010 May;22(5):597-601. doi: 10.1097/MEG.0b013e3283337146.

Abstract

Aim: To explore a low-cost and highly-effective therapy for eradication of Helicobacter pylori (H. pylori), a placebo-controlled trial of quadruple therapy was conducted in a population at high risk of gastric cancer in Linqu County of Shandong Province, China.

Methods: Two hundred and seventy-seven adults aged 35-54 years with H. pylori infection in three villages were assigned to two groups: treatment (n=189 in two villages) and placebo (n=88 in one village). Participants received either a 10-day oral quadruple therapy regimen with omeprazole (20 mg, twice daily); tetracycline (750 mg, three times daily); metronidazole (500 mg, three times daily) and bismuth potassium citrate (300 mg, twice daily), or a similar lookalike placebo regimen. The status of H. pylori infection in each trial participant before and after six weeks of treatment was determined by a 13C-urea breath test.

Results: One hundred and seventy-four of 189 participants completed the quadruple therapy (92.1%) and 84 participants completed the placebo therapy (95.5%). The H. pylori eradication rate by intention-to-treat analysis was 76.7% (145 of 189) in the treatment group and 1.1% (1 of 88) in the placebo group, respectively; by per-protocol analysis it was 83.3% (145 of 174) in the treatment group and 1.2% (1 of 84) in the placebo group, respectively.

Conclusion: In a high-risk area of gastric cancer, we conducted a high compliance, tolerable, low side-effect and lowcost therapy of anti-H. pylori. The eradication rate of the 10-day quadruple treatment was more than 80% and significantly higher than the triple therapy regimen used in this population in an earlier trial.

Publication types

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

MeSH terms

  • Adult
  • Antacids / administration & dosage*
  • Anti-Bacterial Agents / administration & dosage
  • Anti-Infective Agents / administration & dosage
  • Anti-Ulcer Agents / administration & dosage
  • Bismuth / administration & dosage*
  • Breath Tests
  • Carbon Isotopes
  • China / epidemiology
  • Drug Therapy, Combination
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter pylori / drug effects*
  • Humans
  • Male
  • Metronidazole / administration & dosage
  • Middle Aged
  • Omeprazole / administration & dosage
  • Patient Compliance
  • Pilot Projects
  • Placebos
  • Rural Population
  • Tetracycline / administration & dosage
  • Urea / metabolism

Substances

  • Antacids
  • Anti-Bacterial Agents
  • Anti-Infective Agents
  • Anti-Ulcer Agents
  • Carbon Isotopes
  • Placebos
  • Metronidazole
  • Urea
  • Tetracycline
  • Omeprazole
  • Bismuth