Spinal Cord Injury: Progress, Promise, and Priorities (2005)

Multicenter, double-blind randomized trial comparing different MP doses (1,000 versus 100 mg/d for 11 d) for treatment of 330 ASCI patients (NASCIS I study)

III (study design, data presentation, interpretation, and analysis flaws)

No treatment effect at 6 wk and 6 mo postinjury, no control group

Bracken et al. (1984)

1-yr follow-up of NASCIS I study

III (study design, data presentation, interpretation, and analysis flaws)

No significant difference in neurological recovery of motor or sensory function at 1 yr postinjury

Bracken et al. (1985)

Multicenter, randomized, double-blind, placebo-controlled trial comparing MP treatment with naloxone and placebo treatment in 487 patients (NASCIS II study)

III (study design, data presentation, interpretation, and analysis flaws)

Significant improvement in motor change scores (P = 0.03) and sensation change scores (P = 0.02) at 6 mo postinjury for patients treated with MP within 8 h of injury

Bracken et al. (1990)

1-yr follow-up of NASCIS II study

III (study design, data presentation, interpretation, and analysis flaws)

Significant improvement in motor change scores 1 yr postinjury for patients treated with MP within 8 h of injury (P = 0.03); administration of MP was detrimental if it was given more than 8 h after injury

Bracken et al. (1992)

Prospective assessment of 15 patients from 1990 to 1993 with retrospective review of 17 patients from 1987 to 1990 to assess differences in treatment outcomes with MP treatment compared with those with treatment without corticosteroids

III

No difference in neurological outcomes between the two sets of patients; patients treated with MP had immune response alterations, higher rates of pneumonia, and longer hospital stays than patients who did not receive corticosteroids

Galandiuk et al. (1993)

Concurrent cohort comparison study (population based) of 363 ASCI patients managed from 1990 to 1991 and 1993; 188 patients received the NASCIS II MP regimen, whereas 90 patients did not receive MP

III (inadequate statistical power)

No differences in neurological outcomes between MP-treated and non-MP-treated patients by use of the Frankel classification; however, insufficient numbers of patients may have been included to show significant differences

Gerhart et al. (1995)

Retrospective review of 145 ASCI patients: 80 treated with MP and 65 not treated

III

No difference in mortality or neurological outcome between groups, despite the younger age and less severe injuries in MP-treated patients

George et al. (1995)

Retrospective review with historical control of 231 ASCI patients; 91 were excluded; comparison of medical complications among 93 MP-treated patients with those among 47 who received no corticosteroid

III

MP-treated patients had significant increases in pneumonia (P = 0.02), acute pneumonia (P = 0.03), number of days with ventilation (P = 0.04), and lengths of ICU stay (P = 0.45); but MP had no adverse effect on long-term outcome

Gerndt et al. (1997)

Case-control analysis of 71 consecutive ASCI admissions; 63 were available for 13 to 57 mo of follow-up; 38 patients were treated with MP, and 25 patients referred >8 h after injury received no MP

III

Multiple factors influenced recovery after SCI; neither MP nor surgery had an effect on the outcome

Poynton et al. (1997)

Multicenter, randomized, double-blind trial comparing MP administered for 24 h with MP administered for 48 h and TM for treatment of 499 ASCI patients (NASCIS III study)

III (study design, data presentation, interpretation, and analysis flaws)

Patients administered MP for 48 h had improved motor recovery at 6 wk and at 6 mo compared with those treated with MP for 24 h and TM for 48 h (P = NS); when treatment was initiated between 3 and 8 h after injury, MP treatment for 48 h resulted in significant improvements in motor scores at 6 wk (P = 0.04) and 6 mo (P = 0.01); MP administered for 48 h was associated with high rates of sepsis and pneumonia; no control group

Bracken et al. (1997)

1-yr follow-up of NASCIS III study

III (study design, data presentation, interpretation, and analysis flaws)

Recovery rates were equal in all three groups when treatment was initiated within 8 h; patients treated with MP for 24 h had diminished recovery; patients treated with MP for 48 h had increased motor recovery (P = 0.053)

Bracken et al. (1998)

Multicenter, prospective, randomized clinical trial of 106 ASCI patients treated with MP, nimopidine, neither, or both

III (inadequate statistical power)

No significant difference in neurological outcome between groups at 1 yr of follow-up; patients with incomplete ASCIs had significant improvements below the level of injury compared with that for patients with complete ASCIs (P < 0.0001); higher incidence of infectious complications among patients receiving corticosteroids (P = NS)

Pointillart et al. (2000)

Prospective, randomized, double-blind study comparing incidence of complications (56.5 and complications among 46 ASCI patients: 23 treated with MP and 23 treated with placebo

I

Patients treated with MP had a higher incidence of medical 34.8%, respectively); differences in respiratory complications (P = 0.009) and gastrointestinal bleed (P = 0.036) were most significant between groups; no data on neurological improvement

Matsumoto et al. (2001)