PT - JOURNAL ARTICLE AU - Kai-feng Pan AU - Lian Zhang AU - Markus Gerhard AU - Jun-ling Ma AU - Wei-dong Liu AU - Kurt Ulm AU - Jian-xi Wang AU - Lei Zhang AU - Yang Zhang AU - Monther Bajbouj AU - Lan-fu Zhang AU - Ming Li AU - Michael Vieth AU - Rui-yong Liu AU - Michael Quante AU - Le-hua Wang AU - Stepan Suchanek AU - Tong Zhou AU - Wei-xiang Guan AU - Roland Schmid AU - Meinhard Classen AU - Wei-cheng You TI - A large randomised controlled intervention trial to prevent gastric cancer by eradication of <em>Helicobacter pylori</em> in Linqu County, China: baseline results and factors affecting the eradication AID - 10.1136/gutjnl-2015-309197 DP - 2016 Jan 01 TA - Gut PG - 9--18 VI - 65 IP - 1 4099 - http://gut.bmj.com/content/65/1/9.short 4100 - http://gut.bmj.com/content/65/1/9.full SO - Gut2016 Jan 01; 65 AB - 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 13C-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 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&lt;0.001). However, a dose-response relationship between failure rate and smoking or drinking index was found in men (all Ptrend&lt;0.001), while high body mass index (Ptrend&lt;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.