{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T21:02:07Z","timestamp":1791061327708,"version":"4.1.0"},"reference-count":45,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,9,7]],"date-time":"2024-09-07T00:00:00Z","timestamp":1725667200000},"content-version":"vor","delay-in-days":6,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Helicobacter"],"published-print":{"date-parts":[[2024,9]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>We compared efficacy of vonoprazan\u2010dual or triple therapies and bismuth\u2010quadruple therapy for treatment\u2010naive <jats:italic>Helicobacter pylori<\/jats:italic> (HP) infection in Southern China, where primary resistance rates of clarithromycin and levofloxacin are &gt;30%.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This was an investigator\u2010initiated, three\u2010arm, randomized clinical trial in Southern China. Between March 2022 and August 2023, treatment\u2010na\u00efve HP\u2010infected adults were randomly assigned to receive one of three 14\u2010day regimens (1:1:1 ratio): vonoprazan\u2010dual (VA\u2010dual; vonoprazan 20\u2009mg twice daily and amoxicillin 1\u2009g thrice daily), vonoprazan\u2010triple (VAC\u2010triple; vonoprazan 20\u2009mg\/amoxicillin 1\u2009g\/clarithromycin 500\u2009mg twice daily), or bismuth\u2010quadruple therapy containing bismuth, esomeprazole, tetracycline, and metronidazole. Primary outcome was noninferiority in HP eradication, evaluated by UBT 4\u20136\u2009weeks post\u2010treatment by intention\u2010to\u2010treat (ITT) and per\u2010protocol (PP) analysis (based on subjects who completed 14\u2010day treatment and rechecked UBT). Bonferroni\u2010adjusted <jats:italic>p<\/jats:italic>\u2010value of &lt;0.017 was used to determine statistical significance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 298 subjects (mean age: 35.7\u2009\u00b1\u20098.4\u2009years; male: 134 [45.0%]; VC\u2010dual: 100, VAC\u2010triple: 98, bismuth\u2010quadruple: 100) were enrolled, and 292 (98.0%) had UBT rechecked. ITT analysis showed that both VA\u2010dual (eradication rate of 96.0%) and VAC\u2010triple therapies (95.9%) were noninferior to bismuth\u2010quadruple therapy (92.0%) (difference: 4.0%, 95% CI: \u22122.9% to 11.5%, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001; and 3.9%, 95% CI: \u22123.1% to 11.5%, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001, respectively). PP analysis also revealed noninferiority (96.7% or 96.7% vs. 97.4%, with difference: \u22122.9% and \u22122.9%, <jats:italic>p<\/jats:italic>\u2009=\u20090.009 and 0.010, respectively). The frequency of adverse events was 39.0%, 56.1%, and 71.0% in VA\u2010dual, VAC\u2010triple, and bismuth\u2010quadruple therapies, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>VA\u2010dual and VA\u2010triple therapies are highly effective and noninferior to bismuth\u2010quadruple therapy in Southern China. Given the lower adverse effects and fewer antibiotic use, VA\u2010dual therapy is the preferred first\u2010line treatment for HP infection.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>Chinese Clinical Trial Registry (No. ChiCTR2200056375). Registered on February 4, 2022, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/www.chictr.org.cn\/showproj.aspx?proj=14131\">https:\/\/www.chictr.org.cn\/showproj.aspx?proj=14131<\/jats:ext-link>.<\/jats:p><\/jats:sec>","DOI":"10.1111\/hel.13133","type":"journal-article","created":{"date-parts":[[2024,9,8]],"date-time":"2024-09-08T04:28:05Z","timestamp":1725769685000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":30,"title":["Vonoprazan Dual or Triple Therapy Versus Bismuth\u2010Quadruple Therapy as First\u2010Line Therapy for <i>Helicobacter pylori<\/i> Infection: A Three\u2010Arm, Randomized Clinical Trial"],"prefix":"10.1111","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4838-378X","authenticated-orcid":false,"given":"Ka\u00a0Shing","family":"Cheung","sequence":"first","affiliation":[{"name":"Department of Medicine The University of Hong Kong\u2010Shenzhen Hospital  Shenzhen China"},{"name":"Department of Medicine, School of Clinical Medicine The University of Hong Kong  Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tao","family":"Lyu","sequence":"additional","affiliation":[{"name":"Department of Medicine The University of Hong Kong\u2010Shenzhen Hospital  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zijie","family":"Deng","sequence":"additional","affiliation":[{"name":"Department of Medicine The University of Hong Kong\u2010Shenzhen Hospital  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaowei","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Medicine The University of Hong Kong\u2010Shenzhen Hospital  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li","family":"Ni","sequence":"additional","affiliation":[{"name":"Department of Medicine The University of Hong Kong\u2010Shenzhen Hospital  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Wu","sequence":"additional","affiliation":[{"name":"Department of Medicine The University of Hong Kong\u2010Shenzhen Hospital  Shenzhen China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing\u00a0Tong","family":"Tan","sequence":"additional","affiliation":[{"name":"Department of Medicine, School of Clinical Medicine The University of Hong Kong  Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Qin","sequence":"additional","affiliation":[{"name":"Department of Medicine Yulin Traditional Chinese Medicine Hospital  Guangxi China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-7949-5398","authenticated-orcid":false,"given":"Ho\u00a0Yu","family":"Ng","sequence":"additional","affiliation":[{"name":"School of Clinical Medicine The University of Hong Kong  Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wai\u00a0K.","family":"Leung","sequence":"additional","affiliation":[{"name":"Department of Medicine, School of Clinical Medicine The University of Hong Kong  Hong Kong"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wai\u2010Kay","family":"Seto","sequence":"additional","affiliation":[{"name":"Department of Medicine The University of Hong Kong\u2010Shenzhen Hospital  Shenzhen China"},{"name":"Department of Medicine, School of Clinical Medicine The University of Hong Kong  Hong 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