The use of corticosteroids for spinal cord injuries: Where are we now?
Concerns about these trials A number of concerns about poor study execution have been raised about the NASCIS trials, particularly in regards to incomplete reporting, dubious outcomes, and the increased rate of potentially serious complications when high-dose corticosteroids are used to treat SCI. For example, poor reporting is apparent in the NASCIS II and III trials, in which only right-sided motor scores were reported. Although the authors claim that this was done to simplify the results, this elimination omits any potentially significant differences in measuring and is now noted as a weakness of the study design. In addition, during the NASCIS III trial, 8 patients who were labeled "noncompliers" were excluded from the study; this creates the potential for bias, as the researchers gave no explanation for their noncompliance and did not mention these patients' clinical outcomes.10
Another area of serious concern is the fact that the NASCIS trials have never been independently confirmed; moreover, the primary authors are reluctant to release the data for independent review. Also of note is that similar studies on smaller cohorts conducted by Otani, Prendergast, and George, among others, have been unable to duplicate the results of the NASCIS trials.11,12 None of these studies were able to show any improvement in function when high-dose corticosteroids were administered to patients with an SCI, and all showed a significant increase in the rate of complications.
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The Use Of Corticosteroids For Spinal Cord Injuries: Where Are We Now?
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Apparelyzed
, Oct 14 2011 08:33 AM
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