title: Randomised clinical trial: the efficacy of a 10-day sequential therapy vs. a 14-day standard proton pump inhibitor-based triple therapy for Helicobacter pylori in Korea.
abstract: BACKGROUND
  The eradication rates of Helicobacter pylori (H. pylori) using a proton pump inhibitor (PPI)-based triple therapy have declined due to antibiotic resistance worldwide.
  
  
  OBJECTIVE
  To compare the eradication rate of the 10-day sequential therapy for H. pylori infection with that of the 14-day standard PPI-based triple therapy.
  
  
  METHODS
  This was a prospective, randomised, controlled study. A total of 409 patients with H. pylori infection were randomly assigned to receive either the 10-day sequential therapy regimen, which consisted of pantoprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then pantoprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for another five consecutive days or the 14-day PPI-based triple therapy regimen, which consisted of pantoprazole (40 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice a day for 14 days. The pre- and post-treatment H. pylori status were assessed by rapid urease test, urea breath test, or histology. Successful eradication was confirmed at least 4 weeks after finishing the treatment.
  
  
  RESULTS
  In the intention-to-treat analysis, the eradication rates of the 10-day sequential therapy and of the 14-day PPI-based triple therapy were 85.9% (176/205) and 75.0% (153/205), respectively (P = 0.006). In the per-protocol analysis, the eradication rates were 92.6% (175/205) and 85% (153/204), respectively (P = 0.019). There was no statistically significant difference between the two investigated groups regarding the occurrence of adverse event rates (18.9% vs. 13.3%, P = 0.143).
  
  
  CONCLUSIONS
  The 10-day sequential therapy achieved significantly higher eradication rates than the 14-day standard PPI-based triple therapy in Korea.
authors.affiliation: Department of Internal Medicine, Hallym University College of Medicine, South Korea.
authors.forename: Y S
authors.initials: YS
authors.lastname: Kim
authors.forename: S J
authors.initials: SJ
authors.lastname: Kim
authors.forename: J H
authors.initials: JH
authors.lastname: Yoon
authors.forename: K T
authors.initials: KT
authors.lastname: Suk
authors.forename: J B
authors.initials: JB
authors.lastname: Kim
authors.forename: D J
authors.initials: DJ
authors.lastname: Kim
authors.forename: D Y
authors.initials: DY
authors.lastname: Kim
authors.forename: H J
authors.initials: HJ
authors.lastname: Min
authors.forename: S H
authors.initials: SH
authors.lastname: Park
authors.forename: W G
authors.initials: WG
authors.lastname: Shin
authors.forename: K H
authors.initials: KH
authors.lastname: Kim
authors.forename: H Y
authors.initials: HY
authors.lastname: Kim
authors.forename: G H
authors.initials: GH
authors.lastname: Baik
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage; D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D001944:Breath Tests; D017291:Clarithromycin / Q000008:administration & dosage; D003627:Data Interpretation, Statistical; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D000077402:Pantoprazole; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D056910:Republic of Korea; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D000077402:Pantoprazole; D017291:Clarithromycin