title: Prospective randomized controlled trial to compare the effects of omeprazole and famotidine in preventing delayed bleeding and promoting ulcer healing after endoscopic submucosal dissection.
abstract: OBJECTIVE
  Proton pump inhibitors (PPIs) are generally used to prevent delayed bleeding after endoscopic submucosal dissection (ESD) and to heal the artificial ulcers. However, it remains controversial whether PPIs or histamine-2 receptor antagonists (H(2) RAs) are more effective in preventing delayed bleeding after ESD. We prospectively compared the effects of omeprazole and famotidine in preventing delayed bleeding and promoting artificial ulcer healing after ESD.
  
  
  METHODS
  A total of 158 patients (155 early gastric cancers and three adenomas) were randomly assigned to the PPI group (omeprazole 20 mg/day) or H(2) RA group (famotidine 40 mg/day) in a prospective randomized controlled trial. The primary end point was the incidence of hematemesis, melena, and/or a decrease in hemoglobin level of 2 g/dL or more requiring endoscopic hemostatic treatment. ESD-induced ulcer healing and changes in ulcer size were also compared at 6 weeks after ESD as a secondary end point.
  
  
  RESULTS
  Of the 158 patients, two were excluded from analysis because they had been treated with a PPI before the present study. Accordingly, data from 77 PPI and 79 H(2) RA subjects were included for analysis. Delayed bleeding after ESD occurred in 6.5% of subjects (PPI group) and in 6.3% (H(2) RA group); there was no significant difference between the two groups. Likewise, the two groups were not significantly different with respect to ulcer stage or ulcer size reduction rate.
  
  
  CONCLUSIONS
  Proton pump inhibitors are not superior to H(2) RAs for the prevention of delayed bleeding or the healing of artificially induced ulcers after ESD.
authors.affiliation: Division of Upper Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Hyogo, Japan.
authors.forename: Toshihiko
authors.initials: T
authors.lastname: Tomita
authors.forename: Yongmin
authors.initials: Y
authors.lastname: Kim
authors.forename: Takahisa
authors.initials: T
authors.lastname: Yamasaki
authors.forename: Takuya
authors.initials: T
authors.lastname: Okugawa
authors.forename: Takashi
authors.initials: T
authors.lastname: Kondo
authors.forename: Fumihiko
authors.initials: F
authors.lastname: Toyoshima
authors.forename: Jun
authors.initials: J
authors.lastname: Sakurai
authors.forename: Junji
authors.initials: J
authors.lastname: Tanaka
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Morita
authors.forename: Tadayuki
authors.initials: T
authors.lastname: Oshima
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Fukui
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Hori
authors.forename: Jiro
authors.initials: J
authors.lastname: Watari
authors.forename: Takayuki
authors.initials: T
authors.lastname: Matsumoto
authors.forename: Hiroto
authors.initials: H
authors.lastname: Miwa
mesh_terms: D000230:Adenocarcinoma / Q000601:surgery; D000236:Adenoma / Q000601:surgery; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D015738:Famotidine / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005753:Gastric Mucosa / Q000601:surgery; D005773:Gastroscopy; D006635:Histamine H2 Antagonists / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000494:pharmacology / Q000627:therapeutic use*; D019106:Postoperative Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D054328:Proton Pump Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D013274:Stomach Neoplasms / Q000601:surgery*; D013276:Stomach Ulcer / Q000188:drug therapy; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D006635:Histamine H2 Antagonists; D054328:Proton Pump Inhibitors; D015738:Famotidine; D009853:Omeprazole