title: Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial.
abstract: BACKGROUND
  Whether sequential treatment can replace triple therapy as the standard treatment for Helicobacter pylori infection is unknown. We compared the efficacy of sequential treatment for 10 days and 14 days with triple therapy for 14 days in first-line treatment.
  
  
  METHODS
  For this multicentre, open-label, randomised trial, we recruited patients (≥20 years of age) with H pylori infection from six centres in Taiwan. Using a computer-generated randomisation sequence, we randomly allocated patients (1:1:1; block sizes of six) to either sequential treatment (lansoprazole 30 mg and amoxicillin 1 g for the first 7 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg for another 7 days; with all drugs given twice daily) for either 10 days (S-10) or 14 days (S-14), of 14 days of triple therapy (T-14; lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg for 14 days; with all drugs given twice daily). Investigators were masked to treatment allocation. Our primary outcome was the eradication rate in first-line treatment by intention-to-treat (ITT) and per-protocol (PP) analyses. This trial is registered with ClinicalTrials.gov, number NCT01042184.
  
  
  RESULTS
  Between Dec 28, 2009, and Sept 24, 2011, we enrolled 900 patients: 300 to each group. The eradication rate was 90·7% (95% CI 87·4-94·0; 272 of 300 patients) in the S-14 group, 87·0% (83·2-90·8; 261 of 300 patients) in the S-10 group, and 82·3% (78·0-86·6; 247 of 300 patients) in the T-14 group. Treatment efficacy was better in the S-14 group than it was in the T-14 group in both the ITT analysis (number needed to treat of 12·0 [95% CI 7·2-34·5]; p=0·003) and PP analyses (13·7 [8·3-40], p=0·003). We recorded no significant difference in the occurrence of adverse effects or in compliance between the three groups.
  
  
  CONCLUSIONS
  Our findings lend support to the use of sequential treatment as the standard first-line treatment for H pylori infection.
  
  
  BACKGROUND
  National Taiwan University Hospital and National Science Council.
authors.affiliation: Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.
authors.forename: Jyh-Ming
authors.initials: JM
authors.lastname: Liou
authors.forename: Chieh-Chang
authors.initials: CC
authors.lastname: Chen
authors.forename: Mei-Jyh
authors.initials: MJ
authors.lastname: Chen
authors.forename: Chien-Chuan
authors.initials: CC
authors.lastname: Chen
authors.forename: Chi-Yang
authors.initials: CY
authors.lastname: Chang
authors.forename: Yu-Jen
authors.initials: YJ
authors.lastname: Fang
authors.forename: Ji-Yuh
authors.initials: JY
authors.lastname: Lee
authors.forename: Shih-Jer
authors.initials: SJ
authors.lastname: Hsu
authors.forename: Jiing-Chyuan
authors.initials: JC
authors.lastname: Luo
authors.forename: Wen-Hsiung
authors.initials: WH
authors.lastname: Chang
authors.forename: Yao-Chun
authors.initials: YC
authors.lastname: Hsu
authors.forename: Cheng-Hao
authors.initials: CH
authors.lastname: Tseng
authors.forename: Ping-Huei
authors.initials: PH
authors.lastname: Tseng
authors.forename: Hsiu-Po
authors.initials: HP
authors.lastname: Wang
authors.forename: Ueng-Cheng
authors.initials: UC
authors.lastname: Yang
authors.forename: Chia-Tung
authors.initials: CT
authors.lastname: Shun
authors.forename: Jaw-Town
authors.initials: JT
authors.lastname: Lin
authors.forename: Yi-Chia
authors.initials: YC
authors.lastname: Lee
authors.forename: Ming-Shiang
authors.initials: MS
authors.lastname: Wu
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D017291:Clarithromycin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D064747:Lansoprazole; D008795:Metronidazole; D000658:Amoxicillin; D015242:Ofloxacin; D017291:Clarithromycin