title: Efficacy and safety of 1-week Helicobacter pylori eradication therapy and 7-week rebamipide treatment after endoscopic submucosal dissection of early gastric cancer in comparison with 8-week PPI standard treatment: a randomized, controlled, prospective, multicenter study.
abstract: BACKGROUND
  Endoscopic submucosal dissection (ESD) has been developed for early gastric cancer (EGC). Helicobacter pylori eradication therapy has been reported to have a preventive effect against metachronous recurrence of EGC after ESD. However, the efficacy and safety of eradication therapy on ESD-induced ulcer healing are not clear. In a randomized control study, we compared the standard therapy (8-week proton pump inhibitor) and eradication therapy combined with subsequent treatment with 7-week rebamipide for healing ESD-induced ulcers.
  
  
  METHODS
  A multicenter, randomized, open-label study was conducted. In group A, patients received 20 mg of omeprazole for 56 days. In group B, patients received 40 mg of omeprazole, 1,500 mg of amoxicillin, and 800 mg of clarithromycin for 7 days, and then 300 mg of rebamipide for 49 days. The primary end point was to evaluate the scarring ratio.
  
  
  RESULTS
  The scarring rate in group A was significantly higher than that in group B [85.0 % (34/40) vs. 56.8 % (21/37), P = 0.011]. The scarring rate of ulcers with an area ≥565.5 mm(2) in group A was significantly higher than that in group B [78.9 % (15/19) vs. 37.5 % (6/16), P = 0.018]. There was no significant difference between the groups in the scarring rate of smaller ulcers. No serious adverse events were observed in any of the patients in either group.
  
  
  CONCLUSIONS
  H. pylori eradication therapy and 7-week rebamipide monotherapy were not superior to PPI monotherapy, but this combination therapy for smaller sized ulcers was an optimal therapeutic option for healing. Serious adverse events were not observed in either group.
authors.affiliation: 2nd Department of Internal Medicine, Osaka Medical College, 2-7 Daigaku-machi, Osaka, Takatsuki, 569-8686, Japan, higuchi@poh.osaka-med.ac.jp.
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Higuchi
authors.forename: Toshihisa
authors.initials: T
authors.lastname: Takeuchi
authors.forename: Noriya
authors.initials: N
authors.lastname: Uedo
authors.forename: Yoji
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Yuji
authors.initials: Y
authors.lastname: Naito
authors.forename: Nobuaki
authors.initials: N
authors.lastname: Yagi
authors.forename: Kazunari
authors.initials: K
authors.lastname: Tominaga
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Machida
authors.forename: Takashi
authors.initials: T
authors.lastname: Tamada
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Morita
authors.forename: Shujiro
authors.initials: S
authors.lastname: Yazumi
authors.forename: Junichi
authors.initials: J
authors.lastname: Yamao
authors.forename: Mikitaka
authors.initials: M
authors.lastname: Iguchi
authors.forename: Takeshi
authors.initials: T
authors.lastname: Azuma
mesh_terms: D000368:Aged; D000409:Alanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D017291:Clarithromycin / Q000627:therapeutic use; D004210:Dissection; D055088:Early Detection of Cancer; D005260:Female; D005753:Gastric Mucosa / Q000601:surgery; D005773:Gastroscopy / Q000379:methods; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D015363:Quinolones / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000175:diagnosis; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D015363:Quinolones; D017291:Clarithromycin; D009853:Omeprazole; C052785:rebamipide; D000409:Alanine
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