LETTER
Misoprostol and Gastrointestinal Complications in Patients Taking Nonsteroidal Anti-Inflammatory Drugs for Rheumatoid Arthritis
Thomas D. Wendel, MD
15 May 1996 | Volume 124 Issue 10 | Page 926
TO THE EDITOR:
Silverstein and colleagues [1] recently presented the results of an interesting and important study on the prevention of gastrointestinal complications in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). It is unfortunate, however, that the editors of Annals did not demand the types of analyses for which the journal has become known.
The study showed a difference between the misoprostol and placebo groups that was marginally statistically significant (P = 0.049). The fact that the sample size was large implies that the difference was small. Indeed, the incidence of defined serious upper gastrointestinal complications was 0.95% in the placebo group compared with 0.57% in the treatment group. Thus, the number needed to treat (NNT) to prevent one such complication was greater than 300. As the editors of Annals have emphasized, numbers such as the NNT can be useful to busy clinicians who might not otherwise scrutinize the data. To make matters worse, the authors used an odds ratio to express the difference, which resulted in a much more impressive 40% reduction in events. Fortunately, some balance was restored by the accompanying editorial [2].
Annals would do a great service to its readers if attention were given to such issues in the reporting of information that has a potentially large effect on clinical behavior.
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Author and Article Information
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St. Luke's-Roosevelt Hospital Center; New York, NY 10025
1. Silverstein FE, Graham DY, Senior JR, Wyn Davies H, Struthers BJ, Bittman RM, et al. Misoprostol reduces serious gastrointestinal complications in patients with rheumatoid arthritis receiving nonsteroidal anti-inflammatory drugs. A randomized, double-blind, placebo-controlled trial. Ann Intern Med. 1995; 123:241-9.
2. Levine JS. Misoprostol and nonsteroidal anti-inflammatory drugs: a tale of effects, outcomes, and costs [Editorial]. Ann Intern Med. 1995; 123:309-10.
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