Effect of Helicobacter pylori Eradication on Gastric Cancer Prevention: Updated Report from a Randomized Controlled Trial with 26.5 Years of Follow-up
Abstract
BACKGROUND & AIMS
Helicobacter pylori (H. pylori) infection is considered as the most important risk factor in the pathogenesis of gastric cancer. This study aims to evaluate the long-term effects of H. pylori eradication treatment on the incidence and mortality of gastric cancer among a high-risk population.
METHODS
This prospective, randomized, placebo-controlled trial was conducted in a high-risk area in southern China in July 1994. A total of 1630 asymptomatic, H. pylori-infected individuals were randomly assigned to receive standard triple therapy for H. pylori eradication (n=817) or placebo (n=813), and were followed up until December 2020. The primary outcome was incidence of gastric cancer. Total and cause-specific mortalities were the secondary outcomes.
RESULTS
During 26.5 years of follow-up, 21 participants (2.57%) in the treatment arm and 35 (4.31%) in the placebo arm were diagnosed with gastric cancer. Participants receiving H. pylori treatment, compared with their placebo counterparts, had a lower incidence of gastric cancer (hazard ratio [HR]=0.57, 95% confidence interval [CI]: 0.33-0.98). More obvious risk reduction was observed among those without premalignant gastric lesions (HR=0.37, 95%CI: 0.15-0.95) and those without dyspepsia symptoms at baseline (HR=0.44, 95%CI: 0.21-0.94). Further, compared to 32 cases of gastric cancer observed among 527 participants with persistent H. pylori infection in the placebo group, only 16 were identified in 625 subjects…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 817 participants or records.
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