title: Randomized clinical trial comparing 10- or 14-day sequential therapy and 10- or 14-day concomitant therapy for the first line empirical treatment of Helicobacter pylori infection.
abstract: OBJECTIVE
  Whether concomitant therapy is superior to sequential therapy (ST) as first-line therapy of Helicobacter pylori in areas with high clarithromycin resistance remains controversial. The aim of this study was to compare the efficacy and tolerability of 10- or 14-day ST with 10- or 14-day concomitant therapy (CT).
  
  
  METHODS
  This was a prospective randomized study comparing 10- or 14-day ST with 10- or 14-day CT. The ST-10 and ST-14 groups received pantoprazole 40 mg and amoxicillin 1 g twice a day for the first 5 and 7 days followed by pantoprazole 40 mg, clarithromycin 500 mg, and metronidazole 500 mg twice a day for the remaining 5 and 7 days, respectively. The CT-10 and CT-14 groups received pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 10 and 14 days, respectively.
  
  
  RESULTS
  Three hundred forty-one patients were randomly allocated to the four groups. The modified intention-to-treat eradication rates of ST-10, ST-14, CT-10, and CT-14 were 91.7%, 91.2%, 94.2%, and 98.5%, respectively. The corresponding per protocol eradication rates were 91.4%, 91.0%, 95.6%, and 98.5%. There was no difference in compliance and adverse events in the four groups. Eradication rates increased sequentially with statistical significance in the following order: ST-10, ST-14, CT-10, and CT-14 (P = 0.044).
  
  
  CONCLUSIONS
  All four regimens achieved eradication rates >90% in per protocol analyses in a country with high clarithromycin resistance. There was no difference in tolerability among the four regimens.
authors: Division of Gastroenterology, Department of Internal Medicine, College of Medicine, Incheon St. Mary's Hospital, Catholic University of Korea, Incheon, Korea.
authors: Sung Min
authors: SM
authors: Park
authors: Division of Gastroenterology, Department of Internal Medicine, College of Medicine, Incheon St. Mary's Hospital, Catholic University of Korea, Incheon, Korea.
authors: Joon Sung
authors: JS
authors: Kim
authors: Division of Gastroenterology, Department of Internal Medicine, College of Medicine, Incheon St. Mary's Hospital, Catholic University of Korea, Incheon, Korea.
authors: Byung-Wook
authors: BW
authors: Kim
authors: Division of Gastroenterology, Department of Internal Medicine, College of Medicine, Incheon St. Mary's Hospital, Catholic University of Korea, Incheon, Korea.
authors: Jeong-Seon
authors: JS
authors: Ji
authors: Division of Gastroenterology, Department of Internal Medicine, College of Medicine, Incheon St. Mary's Hospital, Catholic University of Korea, Incheon, Korea.
authors: Hwang
authors: H
authors: Choi
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D017291:Clarithromycin / Q000008:administration & dosage* / Q000009:adverse effects; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005756:Gastritis / Q000188:drug therapy* / Q000382:microbiology*; D016481:Helicobacter Infections; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D000077402:Pantoprazole; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D008795:Metronidazole; D000658:Amoxicillin; D000077402:Pantoprazole; D017291:Clarithromycin
keywords: Helicobacter pylori; drug therapy and general practice; gastric cancer; peptic ulcer