[Gut] A large randomised controlled intervention trial to prevent gastric cancer by eradication of Helicobacter pylori in Linqu County, China: baseline results and factors affecting the eradication [中国临朐县通过根除幽门螺旋杆菌而预防胃癌的一项大型随机对照干预试验]

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Authors
Kai-feng Pan, Lian Zhang, Markus Gerhard, Jun-ling Ma, Wei-dong Liu, Kurt Ulm, Jian-xi Wang, Lei Zhang, Yang Zhang, Monther Bajbouj, Lan-fu Zhang, Ming Li, Michael Vieth, Rui-yong Liu, Michael Quante, Le-hua Wang, Stepan Suchanek, Tong Zhou, Wei-xiang Guan, Roland Schmid, Meinhard Classen, Wei-cheng You 

Abstract
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<0.001). However, 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.

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.

Gut 2016;65:9–18. doi:10.1136/gutjnl-2015-309197