title: Tailored versus Triple plus Bismuth or Concomitant Therapy as Initial Helicobacter pylori Treatment: A Randomized Trial.
abstract: BACKGROUND
  With markedly increased antibiotic resistance and unsatisfactory efficacies of common empiric eradication regimens in the mainland of China, tailored therapy may be the best choice to achieve good efficacy. This study compared the eradication rates, safety, and compliance of tailored therapy to those of triple therapy plus bismuth and concomitant therapy in the naïve patients with Helicobacter pylori infection.
  
  
  METHODS
  Between September 2013 and April 2014, 1050 patients with H. pylori infection at three tertiary hospitals were randomly assigned to 10-day treatment with tailored, triple plus bismuth, or concomitant regimens. In tailored therapy, medications were adjusted according to clarithromycin sensitivity and cytochrome P450 isoenzyme 2C19 genotype. The antimicrobial susceptibility testing (E test) was performed. Eradication status was assessed 4-12 weeks after treatment.
  
  
  RESULTS
  The eradication rate was significantly higher in tailored group than in triple plus bismuth and concomitant groups in both intention-to-treat (88.7 vs 77.4 vs 78.3%, p < .001) and per-protocol (93.3 vs 87.0 vs 87.4%, p = .021) analyses in a setting with high antibiotic resistance (clarithromycin 48.8%, metronidazole 65.7%, and dual resistance 35.3%). Significantly, fewer adverse effects occurred in tailored group than in concomitant group (22.0 vs 31.7%, p = .018). The eradication rates of dual clarithromycin and metronidazole resistance, isolated clarithromycin resistance, isolated metronidazole resistance, and dual susceptible were 78.7, 82.4, 94.8, and 94.4% in triple therapy plus bismuth and 75.9, 87.2, 92.9, and 95.2% in concomitant therapy, respectively.
  
  
  CONCLUSIONS
  First-line tailored therapy achieves significantly higher eradication rates and fewer side effects, compared to triple therapy plus bismuth and concomitant therapy in a setting with high rates of clarithromycin and metronidazole resistance.
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
authors.forename: Liya
authors.initials: L
authors.lastname: Zhou
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, Chinese Center for Disease Control and Prevention, National Institute for Communicable Disease Control and Prevention, Beijing, China.|Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, Hangzhou, Zhejiang, China.
authors.forename: Jianzhong
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
authors.forename: Zhiqiang
authors.initials: Z
authors.lastname: Song
authors.affiliation: State Key Laboratory for Infectious Disease Prevention and Control, Chinese Center for Disease Control and Prevention, National Institute for Communicable Disease Control and Prevention, Beijing, China.
authors.forename: Lihua
authors.initials: L
authors.lastname: He
authors.affiliation: Department of Gastroenterology, Qilu Hospital of Shandong University, Shandong, China.
authors.forename: Yanqing
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Gastroenterology, Peking Union Medical College Hospital, Beijing, China.
authors.forename: Jiaming
authors.initials: J
authors.lastname: Qian
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
authors.forename: Peng
authors.initials: P
authors.lastname: Bai
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Xue
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
authors.forename: Ye
authors.initials: Y
authors.lastname: Wang
authors.affiliation: Department of Gastroenterology, Peking University Third Hospital, Beijing, China.
authors.forename: Sanren
authors.initials: S
authors.lastname: Lin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001729:Bismuth / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D017291:Clarithromycin / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D065731:Cytochrome P-450 CYP2C19 / Q000235:genetics; D052978:Disk Diffusion Antimicrobial Tests; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D005260:Female; D005838:Genotype; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D008875:Middle Aged; D062606:Tertiary Care Centers; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D008795:Metronidazole; D065731:Cytochrome P-450 CYP2C19; D017291:Clarithromycin; D001729:Bismuth
keywords: Helicobacter pylori; antimicrobial resistance; therapy