Linqu Trial

Since 2011 we are conducting a large randomized controlled intervention trial at Linqu County in order to assess whether gastric cancer incidence, which is extremely high in this area, is lowered by eradication of Helicobacter pylori infection. This large-scale trial is a prospective, randomized, placebo-controlled study with well-organized quality control in a high-risk population.

First results of this study indicated that the prevalence of H. pylori among trial participants was 57.6%.

A total of 94 101 subjects completed the treatment, and the overall H. pylori eradication rate was 72.9% in the active group. Different factors, such as gender, body mass index, history of stomach disease, baseline delta over baseline-value of 13C-urea breath test, missed medication doses, smoking and drinking, were independent predictors of eradication failure.

The missed doses and high baseline delta over baseline-value were important contributors in men and women (all Ptrend<0.001). A dose-response relationship between failure rate and smoking or drinking index was found in men (all Ptrend<0.001), while high body mass index (Ptrend<0.001) and history of stomach disease were significant predictors in women.

The treatment failure rate increased up to 48.8% (OR 2.87, 95% CI 2.24 to 3.68) in men and 39.4% (OR 2.67, 95% CI 1.61 to 4.42) in women with multiple factors combined. Thus, we have already identified and confirmed several risk factors affecting eradication (Pan et al. Gut. 2016 Jan;65(1):9-18. doi: 10.1136/gutjnl-2015-309197). This will help to improve the personalized efficacy of the therapy in the future, particularly in a community-based treatment.

Together, this important trial will help to evaluate the cost-benefit relation of H. pylori eradication for the prevention of gastric cancer.

Funded by: Federal Ministry of Education and Research (BMBF)  |  Ministry of Science and Technology of the People’s Republic of China  |  Beijing Municipal Science and Technology Commission