Prevention of Nonsteroidal Anti-inflammatory Drug--Induced Gastrointestinal Mucosal Injury: A Meta-analysis of Randomized Controlled Clinical Trials

doi:10.1001/archinte.1996.00440190069008

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Vol. 156 No. 20, 11 NOVEMBER 1996

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Prevention of Nonsteroidal Anti-inflammatory Drug—Induced Gastrointestinal Mucosal Injury

A Meta-analysis of Randomized Controlled Clinical Trials

Maurizio Koch, MD; Angelo Dezi, MD; Fabio Ferrario, MD; Lucio Capurso, MD

Arch Intern Med. 1996;156(20):2321-2332.

Abstract

Background
The policy of prevention of nonsteroidal anti-inflammatory drug(NSAID)—induced gastrointestinal mucosal injury is stilla matter of discussion. Indeed, no consensus exists as to whethercotherapy with histamine type 2 (H₂) blockers or misoprostolis cost-effective.

Methods
Placebo-controlled randomized clinical trials on the use ofH₂ blockers or misoprostol, as preventive agents (publishedbetween January 1970 and December 1994), were identified throughMEDLINE and reference lists from literature reviews. Crude ratesof endoscopic lesions with short-term (<2 weeks) and long-term(>4 weeks) NSAID treatment were systematically assessed by3 independent observers based on the intention-to-treat principle.The method of DerSimonian and Laird was used for pooling data.Heterogeneity was evaluated by using the Q statistic and theplots described by L'Abbé and colleagues.

Results
Twenty-four trials met the criteria for entry into the study.Gastric ulcer was found to be significantly reduced by misoprostol—bothin short-term (pooled rate difference [RD], —13%; 95%confidence interval [CI], —26% to —1%) and long-term(RD, —8%; 95% CI, —18% to —1%) NSAID treatment—butnot by H₂ blockers. The risk for duodenal ulcer was significantlyreduced by H₂ blockers (RD, —2%; 95% CI, —5% to—0.2%) and by misoprostol (RD, —3%; 95% CI, —6%to —0.1%) in long-term but not in short-term administration.

Conclusions
The use of misoprostol, but not that of H₂ blockers, was beneficialin the prevention of NSAID-induced gastric ulcers. The numberof patients to be treated to prevent 1 gastric ulcer with short-and long-term NSAID treatment is 11 and 15, respectively, foran intermediate baseline risk of 10%. Misoprostol and H₂ blockerswere beneficial in the long-term prevention of duodenal ulcers;misoprostol or H₂ blockers in the short-term prevention of duodenalulcers remains to be confirmed.

Arch Intern Med. 1996;156:2321-2332

Author Affiliations

From the Department of Digestive Diseases and Nutrition, General Hospital San Filippo Neri, Rome, Italy.

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