T B Ducker1, S M Zeidman. 1. Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Abstract
STUDY DESIGN: The authors review the evidence supporting the role of glucocorticosteroids in spinal cord injury, critique published studies, and provide recommendations for steroid use in this complex and difficult problem. OBJECTIVES: The authors detail the evolution of the use of glucocorticosteroids for acute spinal cord injury and objectively assess the results of NASCIS I and II. SUMMARY OF BACKGROUND DATA: Glucocorticosteroids were first used in patients with acute spinal cord injury in the 1960s. An initial randomized clinical trial (NASCIS I) did not demonstrate a difference in outcome between the low- and high-dose steroid therapy. A subsequent study (NASCIS II) demonstrated that a treatment could enhance neurologic recovery. METHODS: The authors critically review the preclinical studies of glucocorticosteroids, NASCIS I and NASCIS II: The majority of the critique focuses on NASCIS II and independent analysis of the data generated by that trial. RESULTS: NASCIS II suggests clinical benefit from high-dose intravenous methylprednisolone therapy. The true benefit of steroid therapy is unclear because of the difference in outcome of the two placebo groups who entered the protocol before and after 8 hours. The initial promising results may be negated by the better recovery of the delayed treatment and/or untreated group of patients in the greater than 8-hour placebo group. However, until the raw patient data from NASCIS II is made available for independent review, the actual benefit of intensive steroid therapy will remain elusive. CONCLUSIONS: Even with the controversies and unresolved issues, we advocate initiation of intensive glucocorticosteroid therapy as soon as possible after acute spinal cord injury, and not beyond the first 8 hours. There is too much data available to arrive at any other conclusion.
RCT Entities:
STUDY DESIGN: The authors review the evidence supporting the role of glucocorticosteroids in spinal cord injury, critique published studies, and provide recommendations for steroid use in this complex and difficult problem. OBJECTIVES: The authors detail the evolution of the use of glucocorticosteroids for acute spinal cord injury and objectively assess the results of NASCIS I and II. SUMMARY OF BACKGROUND DATA: Glucocorticosteroids were first used in patients with acute spinal cord injury in the 1960s. An initial randomized clinical trial (NASCIS I) did not demonstrate a difference in outcome between the low- and high-dose steroid therapy. A subsequent study (NASCIS II) demonstrated that a treatment could enhance neurologic recovery. METHODS: The authors critically review the preclinical studies of glucocorticosteroids, NASCIS I and NASCIS II: The majority of the critique focuses on NASCIS II and independent analysis of the data generated by that trial. RESULTS: NASCIS II suggests clinical benefit from high-dose intravenous methylprednisolone therapy. The true benefit of steroid therapy is unclear because of the difference in outcome of the two placebo groups who entered the protocol before and after 8 hours. The initial promising results may be negated by the better recovery of the delayed treatment and/or untreated group of patients in the greater than 8-hour placebo group. However, until the raw patient data from NASCIS II is made available for independent review, the actual benefit of intensive steroid therapy will remain elusive. CONCLUSIONS: Even with the controversies and unresolved issues, we advocate initiation of intensive glucocorticosteroid therapy as soon as possible after acute spinal cord injury, and not beyond the first 8 hours. There is too much data available to arrive at any other conclusion.
Authors: Faith H Brennan; Nyoman D Kurniawan; Jana Vukovic; Perry F Bartlett; Fabian Käsermann; Thiruma V Arumugam; Milan Basta; Marc J Ruitenberg Journal: Ann Clin Transl Neurol Date: 2016-05-25 Impact factor: 4.511
Authors: David Z Cai; Geoffrey Liu; Christopher F Wolf; Zachary M Mansell; Jonathan P Eskander; Mark Eskander Journal: Asian J Neurosurg Date: 2018 Jan-Mar