title: Can rebamipide and proton pump inhibitor combination therapy promote the healing of endoscopic submucosal dissection-induced ulcers? A randomized, prospective, multicenter study.
abstract: BACKGROUND
  There has been no consensus regarding the optimal treatment durations and drug regimens in patients with endoscopic submucosal dissection (ESD)-induced ulcers.
  
  
  OBJECTIVE
  To assess the efficacy of proton pump inhibitor (PPI) and rebamipide combination therapy compared with PPI monotherapy for ESD-induced ulcer healing.
  
  
  METHODS
  Randomized, prospective, controlled study; clinical trial.
  
  
  METHODS
  Five hospitals in a University Medical Center group in Korea.
  
  
  METHODS
  This study involved 290 adults (309 lesions) who underwent ESD for gastric adenoma or early gastric cancer.
  
  
  METHODS
  PPI and rebamipide combination therapy.
  
  
  METHODS
  The ulcer healing rate at 4 weeks after ESD.
  
  
  RESULTS
  The ulcer healing rates at 4 weeks after ESD in the PPI and rebamipide combination therapy group were significantly higher than those in the PPI alone group, both in the full analysis (94.9% vs 89.9%; P < .0001) and in the per-protocol analysis (94.5% vs 91.2%; P = .020). This combination therapy was an independent predictive factor for a high ulcer healing rate (adjusted odds ratio [OR] 5.572; 95% confidence interval [CI], 2.615-11.876; P = .014). Additionally, the combination therapy group exhibited a higher quality of ulcer healing than the PPI monotherapy group (reviewer 1: P = .027; OR 1.949; 95% CI, 1.077-3.527; reviewer 2: P = .027; OR 1.933; 95% CI, 1.074-3.481).
  
  
  CONCLUSIONS
  Open-label study.
  
  
  CONCLUSIONS
  PPI and rebamipide combination therapy had a superior 4-week ESD-induced ulcer healing rate and quality of ulcer healing compared with PPI monotherapy. (
  
  
  BACKGROUND
  NCT01167101.).
authors.affiliation: Department of Internal Medicine, Kangdong Sacred Heart Hospital, Seoul, Korea.
authors.forename: Woon Geon
authors.initials: WG
authors.lastname: Shin
authors.forename: Sung Jung
authors.initials: SJ
authors.lastname: Kim
authors.forename: Min Ho
authors.initials: MH
authors.lastname: Choi
authors.forename: Kyoung Oh
authors.initials: KO
authors.lastname: Kim
authors.forename: Hyun Joo
authors.initials: HJ
authors.lastname: Jang
authors.forename: Cheol Hee
authors.initials: CH
authors.lastname: Park
authors.forename: Il Hyun
authors.initials: IH
authors.lastname: Baek
authors.forename: Kyung Ho
authors.initials: KH
authors.lastname: Kim
authors.forename: Gwang Ho
authors.initials: GH
authors.lastname: Baik
authors.forename: Sea Hyub
authors.initials: SH
authors.lastname: Kae
authors.forename: Jong Hyeok
authors.initials: JH
authors.lastname: Kim
authors.forename: Hak Yang
authors.initials: HY
authors.lastname: Kim
mesh_terms: D000236:Adenoma / Q000601:surgery*; D000368:Aged; D000409:Alanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D002277:Carcinoma / Q000601:surgery*; D016009:Chi-Square Distribution; D016001:Confidence Intervals; D004210:Dissection / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D005753:Gastric Mucosa / Q000601:surgery; D005773:Gastroscopy; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D054328:Proton Pump Inhibitors / Q000627:therapeutic use*; D015363:Quinolones / Q000627:therapeutic use*; D013274:Stomach Neoplasms / Q000601:surgery*; D013276:Stomach Ulcer / Q000188:drug therapy* / Q000209:etiology
chemical_list: D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D015363:Quinolones; C052785:rebamipide; D000409:Alanine