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Excerpt
In a series of well-designed clinical trials, Bracken et al demonstrated a modest, although significant, neuroprotective effect of MPSS when administered within 8 hours after SCI. 1–4 The clinical evidence supporting the use of MPSS and the overall safety of this intervention is summarized by Dr. Bracken in this focus issue. 5 Despite these promising results, the National Acute Spinal Cord Injury Studies (NASCIS) II and NASCIS III trials have been subjected to intense criticism. Indeed, some clinicians, including Dr. Hurlbert, have argued against the use of MPSS in acute SCI. 8,13,14,18 These arguments are summarized in Tables 1 and 2.
Despite the criticisms leveled against NASCIS II and NASCIS III, MPSS remains to date one of the few neuroprotective agents available (if one includes GM-1 ganglioside; see Geisler et al 10 in this issue) to treat acute SCI. Moreover, even modest improvements in axonal integrity or segmental function (especially at the cervical level; see Burns and Ditunno 6 in this issue) can be associated with clinically important functional gains.
How does the clinician weigh the evidence for and against the use of MPSS? Medical evidence is classified as Class I (well-designed and conducted randomized controlled clinical trials), Class II (randomized clinical trials with methodologic flaws; prospective controlled trials), or Class III (case series, expert opinion). 19 Based on the level of evidence, interventions may be recommended at the level of a standard (Class I data), guideline (Class II), or option (Class III).
The development of clinical guidelines is a complex process. However, it would appear appropriate to try to make sense out of the conflicting arguments for and against the use of steroids in acute SCI. With this intention, Table 3 presents suggested indications for the use of MPSS in acute SCI. Based on such an analysis, it is suggested that MPSS be recommended at the level of a guideline (Class II evidence) for acute, nonpenetrating SCI (within 8 hours of trauma). Although the NASCIS II trial was a well-designed and conducted randomized controlled clinical trial, the primary outcome analysis was negative and the beneficial effects, admittedly modest, were limited to post hoc analyses. Moreover, MPSS is not recommended for acute nonpenetrating SCI (>8 hours after injury) or after penetrating SCI (lack of effect, potentially deleterious). The NASCIS III recommendation for a 48-hour infusion of MPSS for acute patients with an acute SCI who present within a 3- to 8-hour time window appears reasonable at the level of a guideline, although the evidence supporting this is also limited to post hoc analyses. Finally, other indications for the use of MPSS (pediatric SCI, cauda equina injury, surgical prophylaxis in high-risk spine cases) represent reasonable options but are not supported by convincing data.
