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
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.