title: Ten day sequential versus 10 day modified bismuth quadruple therapy as empirical firstline and secondline treatment for Helicobacter pylori in Chinese patients: an open label, randomised, crossover trial.
abstract: OBJECTIVE
  Treatments with sequential therapy (SEQ) or bismuth quadruple (QUAD) therapy have been proposed as empirical firstline regimens for Helicobacter pylori. We compared the efficacy and tolerability of 10 day SEQ with 10 day modified QUAD as both firstline and secondline treatments for H pylori in a randomised crossover study.
  
  
  METHODS
  H pylori positive and treatment naïve patients were randomly assigned to receive either 10 day SEQ (esomeprazole for 10 days, amoxicillin for an initial 5 days, followed by clarithromycin and metronidazole for a subsequent 5 days) or modified QUAD (esomeprazole, bismuth subcitrate, tetracycline and metronidazole). H pylori eradication was confirmed by urea breath test at 8 weeks. Patients who failed the initial assigned treatment were crossed over to receive the alternate regimen. The primary outcome was eradication rates of firstline treatment by intention to treat (ITT) and per protocol (PP) analyses.
  
  
  RESULTS
  357 patients were randomised to receive either SEQ or QUAD. The PP eradication rates of the SEQ and QUAD groups were 95.2% and 98.8%, respectively (p=0.10). Based on ITT analysis, the corresponding eradication rates were 89.4% and 92.7%, respectively (p=0.36). Eight (4.8%) patients in the SEQ and two (1.2%) patients in the QUAD who failed the firstline treatment were crossed over to the alternate regimen with 100% retreatment success. The overall incidence of adverse events was higher in the QUAD (16.7%) than in the SEQ (8.1%; p=0.032) group.
  
  
  CONCLUSIONS
  Ten day sequential and modified bismuth quadruple therapies are both highly effective as empirical firstline therapies for H pylori in Chinese patients.
  
  
  BACKGROUND
  NCT 01760824.
authors.affiliation: Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.
authors.forename: Kevin S H
authors.initials: KS
authors.lastname: Liu
authors.affiliation: Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.
authors.forename: Ivan F N
authors.initials: IF
authors.lastname: Hung
authors.affiliation: Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.
authors.forename: W K Walter
authors.initials: WK
authors.lastname: Seto
authors.affiliation: Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.
authors.forename: Teresa
authors.initials: T
authors.lastname: Tong
authors.affiliation: Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.
authors.forename: Axel S J
authors.initials: AS
authors.lastname: Hsu
authors.affiliation: Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.
authors.forename: Frank Y F
authors.initials: FY
authors.lastname: Lam
authors.affiliation: Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.
authors.forename: David Y K
authors.initials: DY
authors.lastname: But
authors.affiliation: Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.
authors.forename: S Y
authors.initials: SY
authors.lastname: Wong
authors.affiliation: Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong, Hong Kong.
authors.forename: Wai K
authors.initials: WK
authors.lastname: Leung
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000627:therapeutic use; D000863:Antacids / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D044466:Asian People; D001944:Breath Tests; D002681:China; D017291:Clarithromycin / Q000627:therapeutic use; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D016480:Helicobacter pylori; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D009942:Organometallic Compounds / Q000627:therapeutic use*; D011446:Prospective Studies; D013752:Tetracycline / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000863:Antacids; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D008795:Metronidazole; D000658:Amoxicillin; D013752:Tetracycline; D017291:Clarithromycin; C002791:bismuth tripotassium dicitrate; D064098:Esomeprazole
keywords: 13C-Urea Breath Test; Antibiotics; Helicobacter Pylori - Treatment