NSAIDs: GI injury: misoprostol decreases injury.

Clinical bottom line (level 1a)

  1. Patients who use NSAIDs short-term who are given misoprostol, are less likely to suffer gastrointestinal injury than those given placebo.
  2. Patients who use NSAIDs long-term who are given misoprostol, are less likely to suffer gastrointestinal injury than those given placebo.
Koch et al: Archives of Internal Medicine 1996; 156: 2321-2332
Expires October 2002

The study

Systematic review of randomised clinical of
  • Patients: healthy subjects, osteoarthritis of rheumatoid arthritis
  • Intervention: misoprostol compared with placebo
  • Outcome: number of patients in whom a gastric ulcer, gastric lesions, duodenal ulcer or duodenal lesions developed


Articles found in English using MEDLINE, January 1970 to December 1994 (search terms: anti-inflammatory, nonsteroidal; stomach diseases or duodenal diseases, or peptic ulcer; prevention; RCTs; histamine H 2 receptor antagonists; and misoprostol ) and manual search by using references from review articles

Selection criteria: Patients were included if an endoscopy had been performed before and during NSAID treatment, individuals at admission had no evidence of an ulcer at the first endoscopy, treatment regimens had been randomly allocated, NSAID therapy had been given for at least 5 days, a placebo arm was included
Appraisal criteria: detailed in text
Articles excluded if: not controlled, designed to test blood losses, impossible to extract a separate analysis of gastric or duodenal damage, used only a single dose of NSAID, no placebo group, therapy study instead of prevention, no control endoscopy, insufficient data to construct contingency tables

24 studies
Q statistics and L'Abbe plot used to test heterogeneity.

The evidence

control event was 1.3%
Outcome Time to outcome CER OR
(95% CI)		 NNT
(95% CI)
prevention of gastric ulcer in the short-term unknown /
(%)		 0.06
(0.03 to 0.15) 		82
(79 to 91)
prevention of gastric lesions (short-term) unknown /
(%)		 0.05
(0.04 to 0.08) 		81
(80 to 84)
prevention of duodenal ulcer (short-term) unknown /
(%)		 0.11
(0.03 to 0.44) 		87
(79 to 138)
prevention of duodenal lesions (short-term) unknown /
(%)		 0.12
(0.06 to 0.21) 		88
(82 to 98)
prevention of gastric ulcer in the long-term unknown /
(%)		 0.29
(0.20 to 0.42) 		109
(96 to 133)
prevention of gastric lesion (long-term) unknown /
(%)		 0.44
(0.30 to 0.63) 		138
(110 to 210)
prevention of duodenal ulcer (long-term) unknown /
(%)		 0.28
(0.16 to 0.48) 		107
(92 to 149)
prevention of duodenal lesions (long-term) unknown /
(%)		 0.29
(0.17 to 0.48) 		109
(93 to 149)

Comments

  1. Unpublished investigations or data from abstracts, presentations at meetings or letters to the editor were not included.
  2. Recently, the American College of Rheumatology has added the use of proton pump inhibitors to prevent GI lesions in patients requiring NSAID therapy, and at sufficient risk of GI bleeding.

Citation

  1. Koch M, Dezi A, Ferrario F, et al: Prevention of nonsteroidal anti-inflammatory drug-induced gastrointestinal mucosal injury: A meta-analysis of randomized controlled clinical trials. Archives of Internal Medicine 1996; 156: 2321-2332
Contributor: Clare Wotton and Musab Hayatli, October 1999
Reviewer: Daniel Sontheimer

Clinical Question.
    Patient healthy subjects, osteoarthritis, rheumatoid arthritis
    Intervention or Exposure misoprostol
    Comparison placebo
    Outcome prevention of NSAID induced gastrointestinal injury