Consequences of High-Dose Steroid Therapy for Acute Spinal Cord Injury

Gerndt, Steven J.; Rodriguez, J. L.; Pawlik, Jarosław; Taheri, Paul A.; Wahl, Wendy L.; Micheals, A. J.; Papadopoulos, Stephen M.

doi:10.1097/00005373-199702000-00017

Cited by 159 publications

(98 citation statements)

References 7 publications

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“…The present results obtained with methylprednisolone con®rmed those of several recently published clinical trials. 14,18 However, comparison of the latter results and the present ®ndings is not straightforward for two reasons. Since 1991 in the United States the administration of methylprednisolone has become a standard procedure in the management of spinal cord injury, even though the Food and Drug Administration has not yet authorized its use in this indication.…”

Section: Discussionmentioning

confidence: 66%

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Pharmacological therapy of spinal cord injury during the acute phase

et al. 2000

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Study design: Prospective, randomized clinical trial. Setting: France. Objectives: To evaluate the safety and e ect on neurological outcome of nimodipine, 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 with paraplegia and 58 with tetraplegia) were randomly separated into four groups: M=methylprednisolone (30 mg×kg 71 over 1 h, followed by 5.4 mg×kg 71 ×h 71 for 23 h), N=nimodipine (0.015 mg×kg 71 ×h 71 for 2 h followed by 0.03 mg×kg 71 ×h 71 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. Early spinal decompression and stabilization was performed as soon as possible after injury. Results: One hundred patients were reassessed at 1 year. Neurological improvement was seen in each group (P50.0001), however no additional neurological bene®t from treatment was observed. Infectious complications occurred more often in patients treated with M. Early surgery (49 patients underwent surgery within 8 h of their accident) did not in¯uence the neurological outcome. The only predictor of the latter was the extent of the spinal injury (complete or incomplete lesion). Conclusion: The present study con®rms the absence of bene®t of pharmacological therapy in this indication. Because of the paucity of clinical studies that demonstrate the e cacy of pharmacological treatment in spinal injury during the acute phase, systematic use of pharmaceutical agents should be reconsidered. Spinal Cord (2000) 38, 71 ± 76

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Section: Discussionmentioning

confidence: 66%

“…This tendency has been observed in other studies. 14,18 The action of corticoids on the immune system is well known, but their direct responsibility should be tempered. 21,22 Over the last few years, complex interactions among the immune system, central nervous system and endocrine system have been discovered.…”

Section: Discussionmentioning

confidence: 99%

Pharmacological therapy of spinal cord injury during the acute phase

et al. 2000

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“…22,23 Clinically, high-dose MP increases the risks of severe sepsis and pneumonia. [26][27][28] These risks are dose dependent. 28 Sepsis and pneumonia lead to intubation, which involves manipulation of the neck, and ACM may contribute to difficulty in weaning the SCI patients from the ventilators.…”

Section: Discussionmentioning

confidence: 99%

“…28 Sepsis and pneumonia lead to intubation, which involves manipulation of the neck, and ACM may contribute to difficulty in weaning the SCI patients from the ventilators. [26][27][28] This prolongs hospitalization of the SCI patients and increases costs of the SCI patient care. 26 In the cases we presented, the muscle biopsies from cases 1 and 2 were performed 5 and 7 days after MP treatment and showed clear evidence of muscle necrosis and severe type II muscle atrophy.…”

Section: Discussionmentioning

confidence: 99%

High-dose methylprednisolone may cause myopathy in acute spinal cord injury patients

Guo²,

et al. 2004

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Study design: Prospective cohort study. Objective: Although Bracken et al have demonstrated a significant neuroprotective effect of high-dose intravenous (i.v.) methylprednisolone (MP) within 8 h post spinal cord injury (SCI), this practice has recently been challenged. We hypothesized it is possible that acute corticosteroid myopathy (ACM) may occur secondary to the MP. This pilot study was performed to test this hypothesis. Setting: University of Miami School of Medicine/Jackson Memorial Hospital, Miami VA Medical Center, FL, USA. Methods: Subjects included five nonpenetrating traumatic SCI patients, who received 24 h MP according to National Acute Spinal Cord Injury Studies (NASCIS) protocol, and three traumatic patients who suffered SCI and did not receive MP. Muscle biopsies and electromyography (EMG) were performed to determine if myopathic changes existed in these patients. Results: Muscle biopsies from the SCI patients who received 24 h of MP showed muscle damage consistent with ACM in four out of five cases. EMG studies demonstrated myopathic changes in the MP-treated patients. In the three patients who had SCI but did not receive MP, muscle biopsies were normal and EMGs did not reveal evidence of myopathy. Conclusion: Our data suggest that MP in the dose recommended by the NASCIS may cause ACM. If this is true, part of the improvement of neurological recovery showed in NASCIS may be only a recording of the natural recovery of ACM, instead of any protection that MP offers to the injured spinal cord. Sponsorship:

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“…16,17 At the same time, the safety of MP treatment was being challenged by the publication of a number of non-randomized case series reports, suggesting an association between treatment and immune system compromise, pneumonia, mechanical ventilation days, gastrointestinal complications and myopathy. [18][19][20][21] The Great Debate: the quality of NASCIS evidence While the debate over the validity of NASCIS 2 and 3 conclusions may have been motivated by many factors including timing of the public dissemination, and feelings that a far-reaching standard had been imposed without proper vetting, the substance of the argument revolved around the quality of the evidence. While a thorough review of the various positions is well beyond the scope of this communication, the interested reader is encouraged to consult the abundant literature on the topic that has been published over the past 20 years.…”

Section: The Methylprednisolone Story Nascis 1: Prevailing Dogma Is Omentioning

confidence: 99%

Clinical trials in spinal cord injury: lessons learned on the path to translation. The 2011 International Spinal Cord Society Sir Ludwig Guttmann Lecture

Lammertse

2012

Spinal Cord

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After three decades of clinical research on interventions to improve neurological outcomes in persons with spinal cord injury (SCI), the promise of preclinical discovery has yet to be translated into a consensus standard of care treatment. Nonetheless, SCI researchers remain hopeful that advances in preclinical discovery coupled with improved clinical trial performance will yield effective restorative treatment. This historical review of key studies in SCI over the past 30 years illustrates the progress that has been achieved in establishing a high standard in the conduct of clinical research while providing important lessons for improving trial design, conduct and reporting. Through application of these lessons, the performance of SCI trials can be improved, thereby shortening the pathway to successful translation and the development of effective therapies.

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Consequences of High-Dose Steroid Therapy for Acute Spinal Cord Injury

Abstract: Although the NASCIS-2 protocol may promote early infectious complications, it has no adverse impact on long-term outcome in patients with ASCIs.

Cited by 159 publications

References 7 publications

Pharmacological therapy of spinal cord injury during the acute phase

Pharmacological therapy of spinal cord injury during the acute phase

High-dose methylprednisolone may cause myopathy in acute spinal cord injury patients

Clinical trials in spinal cord injury: lessons learned on the path to translation. The 2011 International Spinal Cord Society Sir Ludwig Guttmann Lecture

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