OBJECTIVES: To evaluate the effect on neurologic outcome and the safety of nimodipine (N), methylprednisolone (M), or both (MN) versus no medical treatment (P) in spinal cord injury at the acute phase. STUDY DESIGN: Prospective, randomized clinical trial. PATIENTS: One hundred and six patients with a spinal trauma, including 48 with paraplegia and 58 with tetraplegia. METHOD: After eligibility, patients were randomly allocated in one of the following groups: M = methylprednisolone 30 mg.kg-1 over 1 hour, followed by 5.4 mg.kg-1.h-1 for 23 hours, N = nimodipine 0.015 mg.kg-1.h-1 over 2 hours followed by 0.03 mg.kg-1.h-1 for 7 days, MN or P. Neurologic assessment (ASIA score) was performed by a senior neurologist before treatment and at the 1-year follow-up. Early spinal decompression and stabilization was performed as soon as possible after injury. RESULTS:One hundred patients were reassessed at the 1-year follow-up. Neurologic improvement was seen in each group (P < 0.0001), however no neurologic benefit from treatment was observed. Infectious complications occurred more often in patients treated with M. Early surgery (49 patients), within the first 8 hours did not influence the neurologic outcome. The only predictor of the latter was the extent of the spinal injury (complete or incomplete lesion). CONCLUSION: Currently, no evidence of the benefit of medical treatment in this indication is existing. Because of the lack of clinical studies proving efficacy of pharmacological treatment in this specific pathology, a systematic use of medications cannot be recommended.
RCT Entities:
OBJECTIVES: To evaluate the effect on neurologic outcome and the safety of nimodipine (N), methylprednisolone (M), or both (MN) versus no medical treatment (P) in spinal cord injury at the acute phase. STUDY DESIGN: Prospective, randomized clinical trial. PATIENTS: One hundred and six patients with a spinal trauma, including 48 with paraplegia and 58 with tetraplegia. METHOD: After eligibility, patients were randomly allocated in one of the following groups: M = methylprednisolone 30 mg.kg-1 over 1 hour, followed by 5.4 mg.kg-1.h-1 for 23 hours, N = nimodipine 0.015 mg.kg-1.h-1 over 2 hours followed by 0.03 mg.kg-1.h-1 for 7 days, MN or P. Neurologic assessment (ASIA score) was performed by a senior neurologist before treatment and at the 1-year follow-up. Early spinal decompression and stabilization was performed as soon as possible after injury. RESULTS: One hundred patients were reassessed at the 1-year follow-up. Neurologic improvement was seen in each group (P < 0.0001), however no neurologic benefit from treatment was observed. Infectious complications occurred more often in patients treated with M. Early surgery (49 patients), within the first 8 hours did not influence the neurologic outcome. The only predictor of the latter was the extent of the spinal injury (complete or incomplete lesion). CONCLUSION: Currently, no evidence of the benefit of medical treatment in this indication is existing. Because of the lack of clinical studies proving efficacy of pharmacological treatment in this specific pathology, a systematic use of medications cannot be recommended.
Authors: Martin M Mortazavi; Ketan Verma; Aman Deep; Fatemeh B Esfahani; Patrick R Pritchard; R Shane Tubbs; Nicholas Theodore Journal: Childs Nerv Syst Date: 2010-12-21 Impact factor: 1.475