title: 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.
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.
  
  
  METHODS
  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 baseline-value 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 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.
  
  
  BACKGROUND
  ChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements.
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.
authors.forename: Kai-feng
authors.initials: KF
authors.lastname: Pan
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.
authors.forename: Lian
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Technische Universität München, Munich, Germany.
authors.forename: Markus
authors.initials: M
authors.lastname: Gerhard
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.
authors.forename: Jun-ling
authors.initials: JL
authors.lastname: Ma
authors.affiliation: Healthy Bureau of Linqu County, Weifang, China.
authors.forename: Wei-dong
authors.initials: WD
authors.lastname: Liu
authors.affiliation: Technische Universität München, Munich, Germany.
authors.forename: Kurt
authors.initials: K
authors.lastname: Ulm
authors.affiliation: Healthy Bureau of Linqu County, Weifang, China.
authors.forename: Jian-xi
authors.initials: JX
authors.lastname: Wang
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.
authors.forename: Lei
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Technische Universität München, Munich, Germany.
authors.forename: Monther
authors.initials: M
authors.lastname: Bajbouj
authors.affiliation: Healthy Bureau of Linqu County, Weifang, China.
authors.forename: Lan-fu
authors.initials: LF
authors.lastname: Zhang
authors.affiliation: Healthy Bureau of Linqu County, Weifang, China.
authors.forename: Ming
authors.initials: M
authors.lastname: Li
authors.affiliation: Institute of Pathology, Klinikum Bayreuth, Bayreuth, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Vieth
authors.affiliation: Healthy Bureau of Linqu County, Weifang, China.
authors.forename: Rui-yong
authors.initials: RY
authors.lastname: Liu
authors.affiliation: Technische Universität München, Munich, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Quante
authors.affiliation: Healthy Bureau of Linqu County, Weifang, China.
authors.forename: Le-hua
authors.initials: LH
authors.lastname: Wang
authors.affiliation: Department of Medicine, 1st Faculty of Medicine, Military University Hospital, Charles University, Prague, Czech Republic.
authors.forename: Stepan
authors.initials: S
authors.lastname: Suchanek
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.
authors.forename: Tong
authors.initials: T
authors.lastname: Zhou
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.
authors.forename: Wei-xiang
authors.initials: WX
authors.lastname: Guan
authors.affiliation: Technische Universität München, Munich, Germany.
authors.forename: Roland
authors.initials: R
authors.lastname: Schmid
authors.affiliation: Technische Universität München, Munich, Germany International Digestive Cancer Alliance, Germany.
authors.forename: Meinhard
authors.initials: M
authors.lastname: Classen
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.
authors.forename: Wei-cheng
authors.initials: WC
authors.lastname: You
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D002681:China; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000382:microbiology / Q000517:prevention & control*; D013752:Tetracycline / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D008795:Metronidazole; D013752:Tetracycline
keywords: GASTRIC CANCER; HELICOBACTER PYLORI