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Efficacy of Methylprednisolone in Acute Spinal Cord Injury
Michael B. Bracken, PhD;
William F. Collins, MD;
Daniel F. Freeman, PhD;
Mary Jo Shepard, MPH;
Franklin W. Wagner, MD;
Robert M. Silten, MPH;
Karen G. Hellenbrand, MPH;
Joseph Ransohoff, MD;
William E. Hunt, MD;
Phaner L. Perot, Jr, MD;
Robert G. Grossman, MD;
Barth A. Green, MD;
Howard M. Eisenberg, MD;
Nathan Rifkinson, MD;
Joseph H. Goodman, MD;
John N. Meagher, MD;
Boguslav Fischer, MD;
Guy L. Clifton, MD;
Eugene S. Flamm, MD;
Stephen E. Rawe, MD
JAMA. 1984;251(1):45-52.
Abstract
A multicenter double-blind randomized trial was conducted to examine the efficacy of a high dose of methylprednisolone (1,000-mg bolus and daily thereafter for ten days) compared with a standard dose (100-mg bolus and daily thereafter for ten days) in 330 patients with acute spinal cord injury. No difference in neurological recovery of motor function or pinprick and light touch sensation was observed between the two treatment groups six weeks and six months after injury. The lack of a treatment effect was independent of the severity of the initial lesion or the time from injury to starting treatment. Although not statistically significant, early case fatality was greater in the high-dose protocol (relative risk of 3.1 and 1.9, 14 and 15 to 28 days after injury, respectively) but not from 29 to 210 days after injury. Wound infections of both trauma and operative sites were more prevalent in the high-dose regimen (relative risk of 3.6).
(JAMA 1984;251:45-52)
Author Affiliations
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From the Department of Epidemiology and Public Health (Drs Bracken and Freeman, Mss Shepard and Hellenbrand, and Mr Silten) and the Section of Neurological Surgery (Drs Collins and Wagner), Yale University Medical School, New Haven, Conn; the Departments of Neurosurgery (Drs Ransohoff and Flamm) and Neurology (Dr Fischer), New York University-Bellevue Medical Center, New York; the Division of Neurologic Surgery, Ohio State University, Columbus (Drs Hunt and Goodman); the Department of Neurosurgery, Medical University of South Carolina, Charleston (Drs Perot and Rawe); the Department of Neurosurgery, Baylor College of Medicine, Houston (Drs Grossman and Clifton); the Division of Neurosurgery, University of Texas Medical Branch, Galveston (Dr Eisenberg); the Section of Neurological Surgery, University of Puerto Rico, San Juan (Dr Rifkinson); the Department of Neurological Surgery, University of Miami (Dr Green); and the Neurological Section, Riverside Methodist Hospital, Columbus, Ohio (Dr Meagher).
Footnotes
Reprint requests to National Spinal Cord Injury Study, Department of Epidemiology and Public Health, Yale University Medical School, 60 College St, New Haven, CT 06510 (Dr Bracken).
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