1. Acute Spinal Cord Trauma Robert L Wears, MD, MS Practice Guidelines: A Pan-American Symposium Santiago de Chile 7 October 2003

2. Critical Question 20 yr old male fell 5 meters –C4-5 fracture – dislocation –Motor deficit Should he be given steroids? –What is the evidence for benefit? –What is the evidence for harm?

3. Epidemiology ~ 40 per million population annually Typically –Young (20 – 35) –Male Major disability Shortened life expectancy Major cost

4. Study Selection Randomized or quasi-randomized trials Patients admitted for acute spinal cord injury –Exclude nerve root only, cauda equina syndrome Outcome measures –Recovery of motor function (6 weeks, 6 months, 1 yr) (0 – 70 scale | 14 muscles 0-5) –Mortality

5. Studies Included StudyInterventionAllocationAssessmentN Bracken 85Hi / low doseBB330 Bracken 90Hi / naloxone /placebo BB487 Otani 94Hi / noneN?158 Bracken 98F/U dosageBB499 Petijean 98Hi / nimodipine factorial NB77 *Matsumoto 01Hi / noneBN46

6. Studies Excluded StudyAllocationAssessmentOther GlasserBNDisc surgery PettersonBBWhiplash, no motor outcomes KiwerskiNNNot randomized PointillarBBDuplicate (translation) of Petitjean

7. Efficacy (Overall) StudyChange in motor score 6 wks6 months1 year Bracken 901.23-0.01-0.86 Otani 943.90 Petitjean-5.70 Pooled CI-1.1, 3.5-1.8, 3.5-4.8, 2.5

8. Efficacy (< 8 hrs) StudyChange in motor score 6 wks6 months1 year Bracken 903.474.785.20 Otani 943.90 Petitjean-5.70 Pooled CI*0.6, 7.6 *pooled at either 6 mo or 1 yr

9. 24 Vs 48 Hours Treatment StudyPlaceboBolus+24hBolus+48h NASCIS 112.0 (13.4)17.2 (13.4) NASCIS 213.7 (14.1)19.0 (19.6) Mean (SD)

10. Safety Mortality, wound infection, GI bleed –No significant difference –Wide CI Mortality RR.24 to 1.25 –Acute trauma studies low powered –Sauerland 2000 systematic review 51 trials (including back surgery), > 2000 pts No significant difference mortality, GI bleed, infection

11. Conclusion Benefit is modest at best –5 – 8 points on 70 point scale –Class B Minimum clinically important benefit undefined Must be given early to be effective No convincing evidence of harm –Low power limits safety assessment