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Indexed/Abstracted in: CINAHL, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 2,063
Online ISSN 1973-9095
Aito S., Cariaggi B., Perazza S.
From the Spinal Unit, Careggi Hospital, Florence, Italy *Specialisation School in Physical Medicine and Rehabilitation Faculty of Medicine and Surgery University of Florence, Florence, Italy
Acute spinal cord injury is pathophysiologically characterized by the release of local endogenous substances that add chemical and biological insult to the previous mechanical injury. NASCIS (National Acute Spinal Cord Injury Study), the largest longitudinal study of acute spinal cord injuries ever conducted, was started in order to define the best pharmacological treatment in the acute stage to counteract such devastating reactions.
NASCIS I (1979-1985), a multicenter, double-blind, randomized clinical trial, examined the efficacy of high-dose methylprednisolone (MP), (1000 mg bolus and 1000 mg daily thereafter for 10 days) vs standard dose (100 mg bolus and 100 mg daily for 10 days) in spinal cord injury patients treated within 48 hours from injury. No difference was observed between the two treatments. NASCIS II (1985-1988) compared the effect of high-dose MP (30 mg/kg bolus and 5.4 mg/kg/hrs for 24 hours) to Naloxone (5.4 mg/kg bolus and 4.0 mg/kg/hrs for 24 hours) administered within 12 hours of injury. Significant neurological recovery was found in patients treated with MP within 8 hours of injury. NASCIS III (1991-1996) compared the efficacy of MP (5.4 mg/kg/h) administered for 24 hours with MP administered for 48 hours and Tirilazad Mesylate (2.5 mg/kg bolus infusion every 6 hours) administered for 48 hours. All patients received an intravenous bolus of MP (30 mg/kg) before randomization and were treated within 8 hours of injury. The best treatment was found to be MP administered for 24 hours in patients treated within 3 hours, and MP administered for 48 hours in those treated in between 3 and 8 hours after injury.
We conducted a literature analysis on the reviews of the 3 studies and compared the critical evaluations and comments the studies received. Some authors criticised the methods of statistical analysis and clinical examination used. The risks of such high dose corticosteroid administration were also underlined. In reply, the NASCIS authors claimed that high-dose MP therapy was efficacious and showed a reassuring safety profile. In assembling evidence for or against innovative therapies, they emphasised the roles of clinical measurement, statistical analysis and risk benefit. The discussion remains open, as does the urgent need for further large-scale studies to define the best pharmacological therapy in acute spinal cord injury.