title: Hybrid vs sequential therapy for eradication of Helicobacter pylori in Taiwan: A prospective randomized trial.
abstract: OBJECTIVE
  To evaluate the efficacy of sequential vs hybrid therapy in patients with Helicobacter pylori (H. pylori) infection.
  
  
  METHODS
  From March 2013 to May 2014, one hundred and seventy-five H. pylori infected patients who had not been treated for H. pylori before were randomized to receive either sequential therapy (rabeprazole 20 mg and amoxicillin 1 g twice daily for 5 d, followed by rabeprazole 20 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 5 d) or hybrid therapy (rabeprazole 20 mg and amoxicillin 1 g for 7 d, followed by rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 d). H. pylori status was confirmed by positive results of both rapid urease test and histology examination or a positive result of culture. Eradication efficacy was assessed by follow-up endoscopy with rapid urease test and histological examination 8 wk after the end of anti-H. pylori therapy, or (13)C-urea breath test at least 4 wk after completion of treatment. The primary outcome was H. pylori eradication by intention-to-treat (ITT) and per-protocol (PP) analyses.
  
  
  RESULTS
  One hundred and sixty-seven patients (83 patients in the sequential group and 84 patients in the hybrid group) completed the study. The compliance rates were 97.6% and 97.7% for the two groups, respectively. The eradication rate was 78.2% for the sequential group and 92% for the hybrid group by ITT analysis (P = 0.01). The eradication rate was 81.9% for the sequential group and 96.4% for the hybrid group by PP analysis (P = 0.01). Univariate analysis for the clinical and bacterial factors did not identify any risk factors associated with treatment failure. Severe adverse events were observed in 2.3% of patients in the sequential group and 2.4% of those in the hybrid group.
  
  
  CONCLUSIONS
  Due to a grade A (> 95%) success rate for H. pylori eradication by PP analysis, similar compliance and adverse events, hybrid therapy seems to be an appropriate eradication regimen in Taiwan.
authors.affiliation: Kuan-Yang Chen, Institute of Clinical Medicine, National Yang-Ming University, Taipei City 10629, Taiwan.
authors.forename: Kuan-Yang
authors.initials: KY
authors.lastname: Chen
authors.affiliation: Kuan-Yang Chen, Institute of Clinical Medicine, National Yang-Ming University, Taipei City 10629, Taiwan.
authors.forename: Tsung-Jung
authors.initials: TJ
authors.lastname: Lin
authors.affiliation: Kuan-Yang Chen, Institute of Clinical Medicine, National Yang-Ming University, Taipei City 10629, Taiwan.
authors.forename: Chin-Lin
authors.initials: CL
authors.lastname: Lin
authors.affiliation: Kuan-Yang Chen, Institute of Clinical Medicine, National Yang-Ming University, Taipei City 10629, Taiwan.
authors.forename: Hsi-Chang
authors.initials: HC
authors.lastname: Lee
authors.affiliation: Kuan-Yang Chen, Institute of Clinical Medicine, National Yang-Ming University, Taipei City 10629, Taiwan.
authors.forename: Chung-Kwe
authors.initials: CK
authors.lastname: Wang
authors.affiliation: Kuan-Yang Chen, Institute of Clinical Medicine, National Yang-Ming University, Taipei City 10629, Taiwan.
authors.forename: Deng-Chyang
authors.initials: DC
authors.lastname: Wu
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D017291:Clarithromycin / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D064750:Rabeprazole / Q000008:administration & dosage; D013624:Taiwan; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D064750:Rabeprazole; D000658:Amoxicillin; D017291:Clarithromycin
keywords: Helicobacter pylori; Hybrid therapy; Sequential therapy