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Gut. 2016 Jan;65(1):9-18. doi: 10.1136/gutjnl-2015-309197. Epub 2015 May 18.

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.

Author information

1
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, Beijing, China.
2
Technische Universität München, Munich, Germany.
3
Healthy Bureau of Linqu County, Weifang, China.
4
Institute of Pathology, Klinikum Bayreuth, Bayreuth, Germany.
5
Department of Medicine, 1st Faculty of Medicine, Military University Hospital, Charles University, Prague, Czech Republic.
6
Technische Universität München, Munich, Germany International Digestive Cancer Alliance, Germany.

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 (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.

TRIAL REGISTRATION NUMBER:

ChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements.

KEYWORDS:

GASTRIC CANCER; HELICOBACTER PYLORI

PMID:
25986943
DOI:
10.1136/gutjnl-2015-309197
[Indexed for MEDLINE]

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