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- Title
Misoprostol compared with sucralfate in the prevention of nonsteroidal anti-inflammatory drug-induced gastric ulcer. A randomized, controlled trial.
- Authors
Agrawal, Naurang M.; Roth, Sanford; Graham, David Y.; White, Richard H.; Germain, Bernard; Brown, Jeffrey A.; Stromatt, Scott C.; Agrawal, N M; Roth, S; Graham, D Y; White, R H; Germain, B; Brown, J A; Stromatt, S C
- Abstract
<bold>Objectives: </bold>To compare the efficacy and frequency of adverse experiences of misoprostol and sucralfate in the prevention of gastric ulcers in patients receiving nonsteroidal anti-inflammatory drug (NSAID) therapy.<bold>Design: </bold>A prospective, randomized, single-blind, multicenter trial.<bold>Patients: </bold>Patients with osteoarthritis receiving treatment with ibuprofen, piroxicam, or naproxen and experiencing abdominal pain were eligible.<bold>Interventions: </bold>Patients who were expected to receive at least 3 months of NSAID therapy and who did not have a gastric ulcer at the time of the initial screening endoscopy were randomized to receive misoprostol, 200 micrograms four times a day, or sucralfate, 1 g four times a day. A gastric ulcer was defined as a lesion of the gastric mucosa 0.3 cm or greater in diameter. Patients were followed clinically, and repeat endoscopies were performed after 4, 8, and 12 weeks.<bold>Main Measurement: </bold>The development of a gastric ulcer, which was regarded as a prophylaxis failure.<bold>Results: </bold>Two hundred fifty-three patients were evaluable for efficacy analysis. A gastric ulcer developed in 2 of the 122 (1.6%, 95% CI, 0.3% to 6.4%) patients on misoprostol, compared with 21 of 131 patients on sucralfate (16%, CI, 10.4% to 23.7%). The difference in ulcer rates was 14.4% (CI, 10.4% to 19.5%; P less than 0.001).<bold>Conclusion: </bold>In patients receiving chronic NSAID therapy for osteoarthritis, treatment with misoprostol for 3 months was associated with a significantly lower frequency of gastric ulcer formation, compared with treatment with sucralfate (P less than 0.001).
- Subjects
ANTIULCER drugs; SUCRALFATE; GASTROINTESTINAL disease treatment; NONSTEROIDAL anti-inflammatory agents; PEPTIC ulcer prevention; ALUMINUM hydroxide; CLINICAL trials; COMPARATIVE studies; GASTROINTESTINAL agents; LIFE expectancy; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; OSTEOARTHRITIS; PEPTIC ulcer; RESEARCH; STATISTICS; EVALUATION research; VASODILATORS; RANDOMIZED controlled trials; BLIND experiment; MISOPROSTOL; THERAPEUTICS
- Publication
Annals of Internal Medicine, 1991, Vol 115, Issue 3, p195
- ISSN
0003-4819
- Publication type
journal article
- DOI
10.7326/0003-4819-115-3-195