Meta Analysis
Steroids for acute spinal cord injury
This review may be edited
Posted By: Gordon S. Doig
Posted Date: Apr 19, 2005
Title: Steroids for acute spinal cord injury
Authors: Bracken, MB
Reference: Cochrane Database Syst Rev. 2002;(3):CD001046. [Updated 17 Nov 2004]
Link: Click here for a direct link to the paper. A password may be required for access to fulltext.
Abstract: BACKGROUND: Acute spinal cord injury is a devastating condition typically affecting young people with a preponderance being male. Steroid treatment in the early hours of the injury is aimed at reducing the extent of permanent paralysis during the rest of the patient's life.
OBJECTIVES: To review randomized trials of steroids for acute spinal cord injury.
SEARCH STRATEGY: The review draws on the search strategy developed by the Cochrane Injuries Group. In addition, files of the National Acute Spinal Cord Injury Study have been reviewed and a Medline search conducted.
SELECTION CRITERIA: All published or unpublished randomized controlled trials of steroid treatment for acute spinal cord injury in any language.
DATA COLLECTION AND ANALYSIS: Data have been abstracted from original trial reports. For the NASCIS, Japanese and French trials, additional data (e.g. SDs) have been obtained from the original authors.
MAIN RESULTS: There are few trials in this area of medical care. Only one steroid has been extensively studied, methylprednisolone sodium succinate, which has been shown to improve neurologic outcome up to one year post injury if administered within eight hours of injury and in a dose regimen of: bolus 30mg/kg administered over 15 minutes with a maintenance infusion of 5.4 mg/kg per hour infused for 23 hours. The initial North American trial was replicated in a Japanese trial but not in the one from France. Data has been obtained from the latter studies to permit appropriate meta-analysis of all three trials. This analysis indicates significant recovery in motor function after methylprednisolone therapy when administration commences within eight hours of injury. A more recent trial indicates that if methylprednisolone therapy is given for an additional 24 hours (for a total of 48 hours), additional improvement in motor neurologic function and functional status is observed. This is particularly observed if treatment cannot be started until between three to eight hours after injury. The same methylprednisolone therapy has been found effective in whiplash injuries and a modified regimen found to improve recovery after surgery for lumbar disc disease.
REVIEWER'S CONCLUSIONS: High dose methylprednisolone steroid therapy is the only pharmacological therapy shown to have efficacy in a Phase Three randomized trial when it can be administered within eight hours of injury. A recent trial indicates additional benefit by extending the maintenance dose from 24 to 48 hours if start of treatment must be delayed to between three and eight hours after injury. There is an urgent need for more randomized trials of pharmacological therapy for acute spinal cord injury.
Are the Results Valid?
1. Did the overview address a focused clinical question?
Yes. The author attempted to address the role of steroids in acute spinal cord injury. To do this, two main mechanisms of injury were considered: whip lash and lumbar disc disease.
2. Were the criteria used to select articles for inclusion appropriate?
Yes. Although the authors state that pseudo-randomised trials, which are known to violate allocation concealment and thus are prone to severe bias, were to be included, no pseudo-randomised trials were identified.
The authors attempted to identify trials where patients had a similar mechanism of injury.
3. Is it unlikely that important, relevant studies were missed?
Yes. Multiple databases were searched and article retreival was not restricted to English. The addition of searching of conference abstract books and key publications makes it unlikely key publications were missed.
4. Was the validity of the included studies appraised?
Yes. Papers were appraised for the three most important methodological criteria: 1) maintenance of allocation concealment, 2) appropriate use of blinding and 3) presentation of intention-to-treat results.
5. Were assessments of studies reproducible?
Unsure. There was only one reviewer. Validity appraisal and data abstraction agreement was not reported.
6. Were the results similar from study to study?
Unsure. Very few of the questions were addressed by 3 or more trials. It is impossible to formally assess heterogeneity, and thus conduct a meaningful meta-analysis, with only two trials. However the inability to conduct a formal meta-analysis does not preclude this paper from providing a meaningful systematic review of the topic.
What are the Results?
1. What are the overall results of the overview?
The most important question addressed by this systematic review is the comparison of steroids to placebo.
Only three trials addressed this question. It is reported that one of these trials had excessive loss to follow-up. No outcomes were consitently reported between all three trials. Conclusions should be based on the individual interpretation of each trial. Overall, this systematic review does not firmly establish benefit or harm from the use of steroids compared to placebo.
2. How precise were the results?
Will the Results Help Me In Caring For My Patients?
1. Can the results be applied to my patient care
Yes. This systematic review identifies and critically appraises the evidence from a number of trials. The patients entered into these trials can be identified in clinical practice.
2. Were all clinically important outcomes considered?
The authors considered almost all measures reported in each trial. These included measures of neurological function at various follow-up times, survival, measures of harm (wound infections, onset of sepsis, major GI bleeds) and as many other outcomes as possible.
3. Are the benefits worth the harms and costs?
Steroids are cheap. There are suggestions that outcome (neurological function, mortality) may be improved if given early. There may be an increase in non-fatal wound infection rates or GI hemorrhage rates. It is up to the individual clinician to weigh the potential benefits against the possible harms in any specific clinical situation.

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