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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 still a matter of discussion. Indeed, no consensus exists as to whether cotherapy with histamine type 2 (H₂) blockers or misoprostol is cost-effective.

Methods
Placebo-controlled randomized clinical trials on the use of H₂ blockers or misoprostol, as preventive agents (published between January 1970 and December 1994), were identified through MEDLINE and reference lists from literature reviews. Crude rates of endoscopic lesions with short-term (<2 weeks) and long-term (>4 weeks) NSAID treatment were systematically assessed by 3 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 the plots 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—both in 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—but not by H₂ blockers. The risk for duodenal ulcer was significantly reduced 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 beneficial in the prevention of NSAID-induced gastric ulcers. The number of patients to be treated to prevent 1 gastric ulcer with short- and long-term NSAID treatment is 11 and 15, respectively, for an intermediate baseline risk of 10%. Misoprostol and H₂ blockers were beneficial in the long-term prevention of duodenal ulcers; misoprostol or H₂ blockers in the short-term prevention of duodenal ulcers 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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