A prospective randomized controlled trial to compare the effects of omeprazole and famotidine in preventing delayed bleeding and promoting ulcer healing after endoscopic submucosal dissection

Journal of Gastroenterology and Hepatology, 04/23/2012

Proton pump inhibitors (PPIs) are not superior to histamine–2 receptor antagonists (H2RAs) for the prevention of delayed bleeding or the healing of artificially induced ulcers after endoscopic submucosal dissection (ESD).

Methods

  • A total of 158 patients (155 early gastric cancers and 3 adenomas) were randomly assigned to the PPI group (omeprazole 20 mg/day) or H2RA 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, 2 were excluded from analysis because they had been treated with a PPI before the present study.
  • Accordingly, data from 77 PPI and 79 H2RA subjects were included for analysis.
  • Delayed bleeding after ESD occurred in 6.5% of subjects (PPI group) and in 6.3% (H2RA group); there was no significant difference between the 2 groups.
  • Likewise, the two groups were not significantly different with respect to ulcer stage or ulcer size reduction rate.

Print Article Summary Cat 2 CME Report