The National Acute Spinal Cord Injury Study (NASCIS) 2 and 3 trials are often cited as evidence that high-dose methyl-prednisolone is an efficacious intervention in the management of acute spinal cord injury. Neither of these studies convincingly demonstrate the benefit of steroids. There are concerns about the statistical analysis, randomization, and clinical end points. Even if the putative gains are statistically valid, the clinical benefits are questionable. Furthermore, the benefits of this intervention may not warrant the possible risks. This paper comments on these two clinical trials.
From the Boston University School of Medicine and New England Regional Spinal Cord Center, Boston Medical Center, Boston, Massachusetts.
This work was supported in part by grant H133N950014-97 from the National Institute on Disability and Rehabilitation Research.
Address for reprints: Shanker Nesathurai, MD, F511, East Newton Campus, Boston Medical Center, 1 Boston Medical Center Place, Boston, MA 02118-2393.