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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
  1. Kai-feng Pan1,
  2. Lian Zhang1,
  3. Markus Gerhard2,
  4. Jun-ling Ma1,
  5. Wei-dong Liu3,
  6. Kurt Ulm2,
  7. Jian-xi Wang3,
  8. Lei Zhang1,
  9. Yang Zhang1,
  10. Monther Bajbouj2,
  11. Lan-fu Zhang3,
  12. Ming Li3,
  13. Michael Vieth4,
  14. Rui-yong Liu3,
  15. Michael Quante2,
  16. Le-hua Wang3,
  17. Stepan Suchanek5,
  18. Tong Zhou1,
  19. Wei-xiang Guan1,
  20. Roland Schmid2,
  21. Meinhard Classen2,6,
  22. Wei-cheng You1
  1. 1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China
  2. 2Technische Universität München, Munich, Germany
  3. 3Healthy Bureau of Linqu County, Weifang, China
  4. 4Institute of Pathology, Klinikum Bayreuth, Bayreuth, Germany
  5. 5Department of Medicine, 1st Faculty of Medicine, Military University Hospital, Charles University, Prague, Czech Republic
  6. 6International Digestive Cancer Alliance, Germany
  1. Correspondence to Dr Wei-cheng You, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, 52 Fu-cheng Road, Hai-dian District, Beijing 100142, P. R. China; weichengyou{at} Dr. Meinhard Classen, Technische Universität München, International Digestive Cancer Alliance, 81675 Munich, Germany;


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.


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