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

ObjectiveTo 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.DesignA total of 184 786 residents aged 25–54 years were enrolled in this...

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Veröffentlicht in:Gut 2016-01, Vol.65 (1), p.9-18
Hauptverfasser: 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
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container_end_page 18
container_issue 1
container_start_page 9
container_title Gut
container_volume 65
creator 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
description ObjectiveTo 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.DesignA 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.ResultsThe 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
doi_str_mv 10.1136/gutjnl-2015-309197
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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.ResultsThe 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&lt;0.001). However, a dose-response relationship between failure rate and smoking or drinking index was found in men (all Ptrend&lt;0.001), while high body mass index (Ptrend&lt;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.ConclusionsThis 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 numberChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements.</description><identifier>ISSN: 0017-5749</identifier><identifier>EISSN: 1468-3288</identifier><identifier>DOI: 10.1136/gutjnl-2015-309197</identifier><identifier>PMID: 25986943</identifier><identifier>CODEN: GUTTAK</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Adult ; Anti-Bacterial Agents - therapeutic use ; Anti-Ulcer Agents - therapeutic use ; China ; Disease ; Disease prevention ; Double-Blind Method ; Drug Therapy, Combination ; Endoscopy ; Family medical history ; Female ; Gastric cancer ; Helicobacter Infections - complications ; Helicobacter Infections - diagnosis ; Helicobacter Infections - drug therapy ; Helicobacter pylori ; Hospitals ; Humans ; Infections ; Male ; Metronidazole - therapeutic use ; Middle Aged ; Prospective Studies ; Stomach Neoplasms - microbiology ; Stomach Neoplasms - prevention &amp; control ; Studies ; Tetracycline - therapeutic use ; Towns ; Treatment Outcome ; Ulcers</subject><ispartof>Gut, 2016-01, Vol.65 (1), p.9-18</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Copyright: 2015 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b402t-8ad70f1cb11d44fba961c5445c866fd1fde26f0ea7f5c8d11a5b59809a72ad6c3</citedby><cites>FETCH-LOGICAL-b402t-8ad70f1cb11d44fba961c5445c866fd1fde26f0ea7f5c8d11a5b59809a72ad6c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://gut.bmj.com/content/65/1/9.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttps://gut.bmj.com/content/65/1/9.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,314,780,784,3196,23571,27924,27925,77600,77631</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25986943$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pan, Kai-feng</creatorcontrib><creatorcontrib>Zhang, Lian</creatorcontrib><creatorcontrib>Gerhard, Markus</creatorcontrib><creatorcontrib>Ma, Jun-ling</creatorcontrib><creatorcontrib>Liu, Wei-dong</creatorcontrib><creatorcontrib>Ulm, Kurt</creatorcontrib><creatorcontrib>Wang, Jian-xi</creatorcontrib><creatorcontrib>Zhang, Lei</creatorcontrib><creatorcontrib>Zhang, Yang</creatorcontrib><creatorcontrib>Bajbouj, Monther</creatorcontrib><creatorcontrib>Zhang, Lan-fu</creatorcontrib><creatorcontrib>Li, Ming</creatorcontrib><creatorcontrib>Vieth, Michael</creatorcontrib><creatorcontrib>Liu, Rui-yong</creatorcontrib><creatorcontrib>Quante, Michael</creatorcontrib><creatorcontrib>Wang, Le-hua</creatorcontrib><creatorcontrib>Suchanek, Stepan</creatorcontrib><creatorcontrib>Zhou, Tong</creatorcontrib><creatorcontrib>Guan, Wei-xiang</creatorcontrib><creatorcontrib>Schmid, Roland</creatorcontrib><creatorcontrib>Classen, Meinhard</creatorcontrib><creatorcontrib>You, Wei-cheng</creatorcontrib><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</title><title>Gut</title><addtitle>Gut</addtitle><description>ObjectiveTo 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.DesignA 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.ResultsThe 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&lt;0.001). However, a dose-response relationship between failure rate and smoking or drinking index was found in men (all Ptrend&lt;0.001), while high body mass index (Ptrend&lt;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.ConclusionsThis 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 numberChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements.</description><subject>Adult</subject><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Anti-Ulcer Agents - therapeutic use</subject><subject>China</subject><subject>Disease</subject><subject>Disease prevention</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Endoscopy</subject><subject>Family medical history</subject><subject>Female</subject><subject>Gastric cancer</subject><subject>Helicobacter Infections - complications</subject><subject>Helicobacter Infections - diagnosis</subject><subject>Helicobacter Infections - drug therapy</subject><subject>Helicobacter pylori</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Infections</subject><subject>Male</subject><subject>Metronidazole - therapeutic use</subject><subject>Middle Aged</subject><subject>Prospective Studies</subject><subject>Stomach Neoplasms - microbiology</subject><subject>Stomach Neoplasms - prevention &amp; control</subject><subject>Studies</subject><subject>Tetracycline - therapeutic use</subject><subject>Towns</subject><subject>Treatment Outcome</subject><subject>Ulcers</subject><issn>0017-5749</issn><issn>1468-3288</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqNkc1u1DAUhS0EotPCC7BAltiwaKhv4sQ2u2oEFGmkbso6cvwz9chjT22n0jwdr4anKQixYuWrq-8cH92D0DsgnwC64Wo7l13wTUugbzoiQLAXaAV04E3Xcv4SrQgB1vSMijN0nvOOEMK5gNforO0FHwTtVujnNfYybQ1OMui4d9lorGIoKXpfRxeKSY8mFBcDLslJj0vEh2ROO7yVue4UVjIok_B0xCZJ7ZR8wqPFN8Y7FSepqgs-HH1MrlrijQsPM17HOZTjJV7fuyA_40nmSoeaxOTZl4xrIGyrNKY6W2tUcWGLy735-5c36JWVPpu3z-8F-vH1y936ptncfvu-vt40EyVtabjUjFhQE4Cm1E5SDKB6SnvFh8FqsNq0gyVGMltXGkD2U70REZK1Ug-qu0AfF99Dig-zyWWst1LGexlMnPMInHBGaE-hoh_-QXdxTqGmG4ExQVnLBa9Uu1AqxZyTseMhub1MxxHIeKp3XOodT_WOS71V9P7Zep72Rv-R_O6zAs0CTPvd_xj-Am8XtYY</recordid><startdate>20160101</startdate><enddate>20160101</enddate><creator>Pan, Kai-feng</creator><creator>Zhang, Lian</creator><creator>Gerhard, Markus</creator><creator>Ma, Jun-ling</creator><creator>Liu, Wei-dong</creator><creator>Ulm, Kurt</creator><creator>Wang, Jian-xi</creator><creator>Zhang, Lei</creator><creator>Zhang, Yang</creator><creator>Bajbouj, Monther</creator><creator>Zhang, Lan-fu</creator><creator>Li, Ming</creator><creator>Vieth, Michael</creator><creator>Liu, Rui-yong</creator><creator>Quante, Michael</creator><creator>Wang, Le-hua</creator><creator>Suchanek, Stepan</creator><creator>Zhou, Tong</creator><creator>Guan, Wei-xiang</creator><creator>Schmid, Roland</creator><creator>Classen, Meinhard</creator><creator>You, Wei-cheng</creator><general>BMJ Publishing Group LTD</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7QL</scope><scope>7T5</scope><scope>C1K</scope><scope>H94</scope></search><sort><creationdate>20160101</creationdate><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</title><author>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</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b402t-8ad70f1cb11d44fba961c5445c866fd1fde26f0ea7f5c8d11a5b59809a72ad6c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Adult</topic><topic>Anti-Bacterial Agents - therapeutic use</topic><topic>Anti-Ulcer Agents - therapeutic use</topic><topic>China</topic><topic>Disease</topic><topic>Disease prevention</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Endoscopy</topic><topic>Family medical history</topic><topic>Female</topic><topic>Gastric cancer</topic><topic>Helicobacter Infections - complications</topic><topic>Helicobacter Infections - diagnosis</topic><topic>Helicobacter Infections - drug therapy</topic><topic>Helicobacter pylori</topic><topic>Hospitals</topic><topic>Humans</topic><topic>Infections</topic><topic>Male</topic><topic>Metronidazole - therapeutic use</topic><topic>Middle Aged</topic><topic>Prospective Studies</topic><topic>Stomach Neoplasms - microbiology</topic><topic>Stomach Neoplasms - prevention &amp; 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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.ResultsThe 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&lt;0.001). However, a dose-response relationship between failure rate and smoking or drinking index was found in men (all Ptrend&lt;0.001), while high body mass index (Ptrend&lt;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.ConclusionsThis 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 numberChiCTR-TRC-10000979 in accordance with WHO ICTRP requirements.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>25986943</pmid><doi>10.1136/gutjnl-2015-309197</doi><tpages>10</tpages></addata></record>
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source MEDLINE; BMJ Journals - NESLi2; PubMed Central
subjects Adult
Anti-Bacterial Agents - therapeutic use
Anti-Ulcer Agents - therapeutic use
China
Disease
Disease prevention
Double-Blind Method
Drug Therapy, Combination
Endoscopy
Family medical history
Female
Gastric cancer
Helicobacter Infections - complications
Helicobacter Infections - diagnosis
Helicobacter Infections - drug therapy
Helicobacter pylori
Hospitals
Humans
Infections
Male
Metronidazole - therapeutic use
Middle Aged
Prospective Studies
Stomach Neoplasms - microbiology
Stomach Neoplasms - prevention & control
Studies
Tetracycline - therapeutic use
Towns
Treatment Outcome
Ulcers
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
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