Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China: a randomized controlled trial

JAMA. 2004 Jan 14;291(2):187-94. doi: 10.1001/jama.291.2.187.


Context: Although chronic Helicobacter pylori infection is associated with gastric cancer, the effect of H pylori treatment on prevention of gastric cancer development in chronic carriers is unknown.

Objective: To determine whether treatment of H pylori infection reduces the incidence of gastric cancer.

Design, setting, and participants: Prospective, randomized, placebo-controlled, population-based primary prevention study of 1630 healthy carriers of H pylori infection from Fujian Province, China, recruited in July 1994 and followed up until January 2002. A total of 988 participants did not have precancerous lesions (gastric atrophy, intestinal metaplasia, or gastric dysplasia) on study entry.

Intervention: Patients were randomly assigned to receive H pylori eradication treatment: a 2-week course of omeprazole, 20 mg, a combination product of amoxicillin and clavulanate potassium, 750 mg, and metronidazole, 400 mg, all twice daily (n = 817); or placebo (n = 813).

Main outcome measures: The primary outcome measure was incidence of gastric cancer during follow-up, compared between H pylori eradication and placebo groups. The secondary outcome measure was incidence of gastric cancer in patients with or without precancerous lesions, compared between the 2 groups.

Results: Among the 18 new cases of gastric cancers that developed, no overall reduction was observed in participants who received H pylori eradication treatment (n = 7) compared with those who did not (n = 11) (P =.33). In a subgroup of patients with no precancerous lesions on presentation, no patient developed gastric cancer during a follow-up of 7.5 years after H pylori eradication treatment compared with those who received placebo (0 vs 6; P =.02). Smoking (hazard ratio [HR], 6.2; 95% confidence interval [CI], 2.3-16.5; P<.001) and older age (HR, 1.10; 95% CI, 1.05-1.15; P<.001) were independent risk factors for the development of gastric cancer in this cohort.

Conclusions: We found that the incidence of gastric cancer development at the population level was similar between participants receiving H pylori eradication treatment and those receiving placebo during a period of 7.5 years in a high-risk region of China. In the subgroup of H pylori carriers without precancerous lesions, eradication of H pylori significantly decreased the development of gastric cancer. Further studies to investigate the role of H pylori eradication in participants with precancerous lesions are warranted.

Publication types

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

MeSH terms

  • Adult
  • Amoxicillin-Potassium Clavulanate Combination / therapeutic use
  • Anti-Infective Agents / therapeutic use
  • Anti-Ulcer Agents / therapeutic use
  • China / epidemiology
  • Drug Therapy, Combination
  • Female
  • Helicobacter Infections / complications
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / pathology
  • Helicobacter pylori*
  • Humans
  • Incidence
  • Male
  • Metronidazole / therapeutic use
  • Middle Aged
  • Omeprazole / therapeutic use
  • Precancerous Conditions / epidemiology
  • Precancerous Conditions / microbiology*
  • Precancerous Conditions / pathology
  • Precancerous Conditions / prevention & control*
  • Prospective Studies
  • Risk Factors
  • Stomach Neoplasms / epidemiology
  • Stomach Neoplasms / microbiology*
  • Stomach Neoplasms / pathology
  • Stomach Neoplasms / prevention & control*


  • Anti-Infective Agents
  • Anti-Ulcer Agents
  • Metronidazole
  • Amoxicillin-Potassium Clavulanate Combination
  • Omeprazole