Objective To clarify the full range of benefits and adverse consequences of Helicobacter pylori eradication as a strategy for gastric cancer prevention, the community-based intervention trial was launched in Linqu County, China. Design A total of 184 786 residents aged 25-54 years were enrolled in this trial and received 13 C-urea breath test. H. pylori positive participants were assigned into two groups, either receiving a 10-day quadruple anti-H. pylori treatment or lookalike placebos together with a single dosage of omeprazole and bismuth. Results The prevalence of H. pylori in trial participants was 57.6%. A total of 94 101 subjects completed the treatment. The overall H. pylori eradication rate was 72.9% in the active group. Gender, body mass index, history of stomach disease, baseline delta over baselinevalue of 13 C-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 P trend <0.001). However, a doseresponse relationship between failure rate and smoking or drinking index was found in men (all P trend <0.001), while high body mass index (P trend <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. Conclusions This large community-based intervention trial to eradicate H. pylori is feasible and acceptable. The findings of this trial lead to a distinct evaluation of factors influencing eradication that should be generally considered for future eradication therapies. Trial registration number ChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements.
INTRODUCTIONHelicobacter pylori (H. pylori) is a recognised cause of chronic gastritis and peptic ulcer disease, and may play an important role in the etiology of
Significance of this studyWhat is already known on this subject?▸ Gastric cancer is a global public health burden, nearly one million new cases are diagnosed each year worldwide, of which 42% cases occur in China. ▸ Helicobacter pylori infection is the main risk factor for gastric cancer, and it was classified as a class I carcinogen for gastric cancer by International Agency for Research on Cancer in 1994. ▸ The Shandong Intervention Trial launched in Linqu in 1995 yielded a 39% reduction in gastric cancer incidence rate after 15 years follow-up. ▸ Benefits and adverse consequences of strategy for gastric cancer prevention by eradication of H. pylori are still in concern in the community setting.What are the new findings?▸ The large community-based intervention trial to eradicate H. pylori is feasible and acceptable in a high-risk area of gastric cancer in China. It gained an elimination of 72.9% of H. pylori in such community intervention trial without severe side effects among all the subjects during the entire 30-month trial pe...