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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.

Document type:
Journal Article; 1
Author(s):
Pan, Kai-Feng; Zhang, Lian; Gerhard, Markus; Ma, Jun-Ling; Liu, Wei-Dong; Ulm, Kurt; Wang, Jian-Xi; Zhang, Lei; Zhang, Yang; Bajbouj, Monther; Zhang, Lan-Fu; Li, Ming; Vieth, Michael; Liu, Rui-Yong; Quante, Michael; Wang, Le-Hua; Suchanek, Stepan; Zhou, Tong; Guan, Wei-Xiang; Schmid, Roland; Classen, Meinhard; You, Wei-Cheng
Abstract:
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.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.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.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.ChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements.
Journal title abbreviation:
Gut
Year:
2016
Journal volume:
65
Journal issue:
1
Pages contribution:
9-18
Language:
eng
Fulltext / DOI:
doi:10.1136/gutjnl-2015-309197
Pubmed ID:
http://view.ncbi.nlm.nih.gov/pubmed/25986943
Print-ISSN:
0017-5749
TUM Institution:
II. Medizinische Klinik und Poliklinik (Gastroenterologie); Institut für Medizinische Mikrobiologie, Immunologie und Hygiene; Institut für Medizinische Statistik und Epidemiologie
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