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.

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.

• Authors: Junling Ma, Weidong Liu, Lian Zhang, Kaifeng Pan, Hongjun Zhao, Tong Zhou, Sidney Winawer, Ann Zauber, Meinhard Classen, Weicheng You
• Journal: European journal of gastroenterology & hepatology (Eur J Gastroenterol Hepatol) Vol. 22 Issue 5 Pg. 597-601 (May 2010) ISSN: 1473-5687 [Electronic] England
• PMID: 19996977 (Publication Type: Controlled Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• 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)