Omeprazole and sucralfate in the treatment of NSAID-induced gastric and duodenal ulcer

Aliment Pharmacol Ther. 1998 Apr;12(4):355-60. doi: 10.1046/j.1365-2036.1998.00312.x.


Aim: To establish the healing efficacy of two drugs, omeprazole and sucralfate, when given to patients who had developed gastric or duodenal ulcer while undergoing chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs).

Methods: Ninety-eight patients with arthritis or arthrosis and NSAID-related gastric or duodenal ulcer were admitted to the endoscopic, single-blind study. They were randomized to receive either omeprazole 20 mg o.m. or sucralfate 2 g b.d. for 4-8 weeks. The patients continued to receive the same NSAID during the trial. Upper gastrointestinal endoscopy was performed at entry and after 4 or 8 weeks.

Results: Eighty-eight patients completed the 4-week study, but only 81 were available for final analysis at 8 weeks. Omeprazole was significantly superior to sucralfate in inducing gastric ulcer healing after both 4 (87 vs. 52%, P = 0.007) and 8 weeks (100 vs. 82%, P = 0.04). No statistically significant difference in duodenal ulcer healing rates emerged between the two groups either at 4 (79 vs. 55%) or 8 weeks (95 vs. 73%). The healing rates in patients with combined gastric and duodenal ulcer were 67 vs. 33% after 4 weeks and 6 7 vs. 6 7% after 8 weeks of treatment. The percentages of asymptomatic patients were similar in the two treatment groups both at 4 (70 vs. 73%) and 8 weeks (70 vs. 75%). H. pylori infection did not influence healing rates, but significantly more H. pylori-positive patients healed with omeprazole.

Conclusions: The results of this study show that omeprazole is superior to sucralfate in healing NSAID-induced gastroduodenal ulcer in patients who continue to take anti-inflammatory drugs. The good results observed were unrelated to H. pylori status.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects*
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / therapeutic use*
  • Duodenal Ulcer / chemically induced
  • Duodenal Ulcer / drug therapy*
  • Endoscopy, Digestive System
  • Female
  • Helicobacter Infections
  • Helicobacter pylori
  • Humans
  • Male
  • Middle Aged
  • Omeprazole / administration & dosage
  • Omeprazole / therapeutic use*
  • Single-Blind Method
  • Stomach Ulcer / chemically induced
  • Stomach Ulcer / drug therapy*
  • Sucralfate / administration & dosage
  • Sucralfate / therapeutic use*
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Anti-Ulcer Agents
  • Sucralfate
  • Omeprazole