Is tailored therapy based on antibiotic susceptibility effective ? A multicenter, open-label, randomized trial

Abstract

An effective eradication therapy of Helicobacter pylori (H. pylori) should be used for the first time. In this study, we assessed whether tailored therapy based on antibiotic susceptibility testing is more effective than traditional therapy. We also evaluated the factors that cause treatment failure in high-resistance areas. For this multicenter trial, we recruited 467 H. pylori-positive patients. The patients were randomly assigned to receive tailored triple therapy (TATT), tailored bismuth-containing quadruple therapy (TABQT), or traditional bismuth-containing quadruple therapy (TRBQT). For the TATT and TABQT groups, antibiotic selection proceeded via susceptibility testing using an agar-dilution test. The patients in the TRBQT group were given amoxicillin, clarithromycin, esomeprazole, and bismuth. Successful eradication was defined as a negative ¹³C-urea breath test at least eight weeks after the treatment ended. Susceptibility testing was conducted using an agar-dilution test. The eradication rate was examined via intention-to-treat (ITT) and per-protocol (PP) analyses. The clarithromycin, levofloxacin, and metronidazole resistance rates were 26.12%, 28.69%, and 96.79%, respectively. Resistance against amoxicillin and furazolidone was rare. The eradication rates for TATT, TRBQT, and TABQT were 67.32%, 63.69%, and 85.99% in the ITT analysis (P<0.001) and 74.64%, 68.49%, and 91.22% in the PP analysis (P<0.001), respectively. The efficacy of TABQT was affected by clarithromycin resistance, and bismuth exerted a direct influence on TATT failure. TABQT was the most efficacious regimen for use in high-resistance regions, especially among clarithromycin-susceptible patients.

Keywords

tailored triple therapy / tailored bismuth-containing quadruple therapy / traditional bismuth-containing quadruple therapy / antibiotic susceptibility testing / eradication rates

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Acknowledgements

This study is supported by the Science and Technology Program of Wenzhou (No. 2014S0193), Public Technology Application Research of Zhejiang Province Science and Technology Hall (No. 2014C33246), Medical and Health Plan of Zhejiang Province (No. 2015DTA020), and Public Technology Application Research of Zhejiang Province Science and Technology Hall (No. 2016C33232).

Compliance with ethics guidelines

Jie Pan, Zhengchao Shi, Dingsai Lin, Ningmin Yang, Fei Meng, Lang Lin, Zhencheng Jin, Qingjie Zhou, Jiansheng Wu, Jianzhong Zhang, and Youming Li declare that they have no conflict of interest. This trial was approved by the Chinese Ethics Committee of Registering Clinical Trials and the clinical trial registration number was ChiCTR-TRC-13004223 (Date of registration: September 29, 2013) and the approved number of ethic committee was ChiECRCT-2013034 (Date of approved by ethic committee: December 2, 2013). Informed consent was obtained from all patients in this article.

Electronic Supplementary Material

ƒSupplementary material is available in the online version of this article at https://doi.org/10.1007/s11684-019-0706-8 and is accessible for authorized users.

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