Pharmacological therapy of spinal cord injury during the acute phase

Study design: Prospective, randomized clinical trial. Setting: France. Objectives: To evaluate the safety and effect on neurological outcome of ni modipine, methylprednisolone, or both versus no medical treatment in spinal -cord injury during the acute phase. Method: One hundred and six patients who had spinal trauma (including 48 wi th paraplegia and 58 with tetraplegia) were randomly separated into four gr oups: M = methylprednisolone (30 mg . kg(-1) over 1 h, followed by 5.4 mg . kg(-1) . h(-1) for 23 h), N = nimodipine (0.015 mg . kg(-1) . h(-1) for 2 h followed by 0.03 mg . kg(-1) . h(-1) for 7 days), MN (both agents) or P ( neither medication). Neurological assessment (ASIA score) was performed by a blinded senior neurologist before treatment and at 1-year follow-up. Earl y spinal decompression and stabilization was performed as soon as possible after injury. Results: One hundred patients were reassessed at 1 year. Neurological impro vement was seen in each group (P<0.0001), however no additional neurologica l benefit from treatment was observed. Infectious complications occurred mo re often in patients treated with M. Early surgery (49 patients underwent s urgery within 8 h of their accident) did not influence the neurological out come. The only predictor of the latter was the extent of the spinal injury (complete or incomplete lesion). Conclusion: The present study confirms the absence of benefit of pharmacolo gical therapy in this indication. Because of the paucity of clinical studie s that demonstrate the efficacy of pharmacological treatment in spinal inju ry during the acute phase, systematic use of pharmaceutical agents should b e reconsidered.