Gastric cancer prevention by community eradication of Helicobacter pylori: a cluster-randomized trial

This repository houses and documents the codes used for all statistical analyses in our recent published manuscript: Gastric cancer prevention by community eradication of Helicobacter pylori: a cluster-randomized trial

[INSERT CITATION INFO][DOI]

Authors

Kai-Feng Pan^1,†,*, M.D., Ph.D., Wen-Qing Li^1,†,*, Ph.D., Lian Zhang², M.D., Wei-Dong Liu³, M.D., Jun-Ling Ma², M.D., Yang Zhang², M.D., Ph.D., Kurt Ulm⁴, Ph.D., Jian-Xi Wang³, M.D., Lei Zhang², Ph.D., Monther Bajbouj^4,‡, M.D., Lan-Fu Zhang³, B.S., Ming Li³, B.S., Michael Vieth⁵, M.D., Michael Quante^4,6, M.D., Ph.D., Le-Hua Wang³, M.D., Stepan Suchanek⁷, M.D., Raquel Mejías-Luque⁴, Ph.D., Heng-Min Xu¹, Ph.D., Xiao-Han Fan¹, Ph.D., Xuan Han¹, B.S., Zong-Chao Liu¹, M.S., Tong Zhou², B.S., Wei-Xiang Guan², B.S., Roland M. Schmid⁴, M.D., Markus Gerhard^4,*, M.D., Ph.D., Meinhard Classen^4,‡, M.D., and Wei-Cheng You^2,*, M.D.

†Drs. Kai-Feng Pan and Wen-Qing Li contributed equally to this work.
* These authors contributing equally as senior authors and co-corresponding authors.
‡Deceased authors

Affiliations

State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, China
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, China
Health Bureau of Linqu County, China
School of Medicine and Health, Technical University of Munich, Germany
Institute of Pathology, Friedrich-Alexander University Erlangen-Nuremberg, Klinikum Bayreuth, Germany
Freiburg: Klinik für Innere Medizin II, Universitätsklinikum Freiburg, Germany
Department of Medicine & Department of Gastrointestinal Oncology, 1st Faculty of Medicine, Charles University and Military University Hospital, Prague, Czech Republic

Corresponding authors

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. Phone: +86-10-8819-6866; Fax: +86-10-8812-2437; E-mail: weichengyou2022@outlook.com.
Markus Gerhard, Institute of Medical Microbiology, Immunology and Hygiene, School of Medicine and Health, Technical University of Munich, 81675 Munich, Germany. Phone: +49 89 4140 2477; Fax: +49 89 4140 4149; E-mail: markus.gerhard@tum.de
Kai-Feng Pan, State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, 52 Fu-cheng Road, Hai-dian District, Beijing 100142, P. R. China. Phone: +86-10-8819-6866; Fax: +86-10-8812-2437; E-mail: pan-kf@263.net.
Wen-Qing Li, State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Cancer Epidemiology, Peking University Cancer Hospital & Institute, 52 Fu-cheng Road, Hai-dian District, Beijing 100142, P. R. China. Phone: +86-10-8819-4829; Fax: +86-10-8812-2437; E-mail: wenqing_li@bjmu.edu.cn

Abstract

Gastric cancer is one leading cause of cancer-related deaths in China and worldwide. Infecting more than 40% of the world’s population, Helicobacter pylori (H. pylori) is responsible for over 70% of all gastric cancers. We conducted a community-based cluster-randomized, controlled, superiority intervention trial in Linqu county, China , with individuals who tested positive for H.pylori via ¹³C-urea breath test randomly assigned to either receiving a 10-day quadruple anti-H.pylori treatment with 20 mg omeprazole bid, 750 mg tetracycline tid, 400 mg metronidazole tid, and 300 mg bismuth citrate bid, or symptom alleviation treatment with single dosage of omeprazole and bismuth citrate. H.pylori negative individuals did not receive treatment. We examined the incidence of gastric cancer as the primary outcome. A total of 180,284 eligible participants from 980 villages were enrolled with 11.8 years’ follow-up, and a total of 1035 incident gastric cancer cases were documented. Individuals receiving anti-H.pylori therapy had a modest reduction in gastric cancer incidence in the intention-to-treat analyses (hazard ratio=0.86, 95% confidence interval =0.74-0.99), with stronger effect observed for those having successful H.pylori eradication (hazard ratio=0.81, 95%confidence interval=0.69-0.96) than those who failed treatment. Moderate adverse effects were reported in 1345 participants during the 10-day treatment. We did not observe severe intolerable events during the treatment, nor receive any related records during follow-up. The findings suggest the potential for H.pylori mass screening and eradication as a public health policy for gastric cancer prevention.

Clinical Trial Registry identifier

ChiCTR-TRC-10000979

Description of scripts

/ext_data/: scripts for extended data
/main/: scripts for main results
/sup/: scripts for supplementary materials

Note: Group A represents the H.pylori treatment group; Group B represents the symptom alleviation treatment group with single dosage of omeprazole and bismuth citrate; Group C represents the H.pylori negative group.