A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: Results of the second national acute spinal cord injury study

Michael B. Bracken, Mary Jo Shepard, William F. Collins, Theodore R. Holford, Wise Young, David S. Baskin, Howard M. Eisenberg, Eugene S. Flamm, Linda Leo-Summers, Joseph Maroon, Lawrence F. Marshall, Phanor L. Perot, Joseph Piepmeier, Volker K H Sonntag, Franklin C. Wagner, Jack E. Wilberger, H. Richard Winn

Research output: Contribution to journalArticle

1946 Citations (Scopus)

Abstract

Studies in animals indicate that methylprednisolone and naloxone are both potentially beneficial in acute spinal-cord injury, but whether any treatment is clinically effective remains uncertain. We evaluated the efficacy and safety of methylprednisolone and naloxone in a multicenter randomized, doubleblind, placebo-controlled trial in patients with acute spinalcord injury, 95 percent of whom were treated within 14 hours of injury. Methylprednisolone was given to 162 patients as a bolus of 30 mg per kilogram of body weight, followed by infusion at 5.4 mg per kilogram per hour for 23 hours. Naloxone was given to 154 patients as a bolus of 5.4 mg per kilogram, followed by infusion at 4.0 mg per kilogram per hour for 23 hours. Placebos were given to 171 patients by bolus and infusion. Motor and sensory functions were assessed by systematic neurologic examination on admission and six weeks and six months after injury. After six months the patients who were treated with methylprednisolone within eight hours of their injury had significant improvement as compared with those given placebo in motor function (neurologic change scores of 16.0 and 11.2, respectively; P = 0.03) and sensation to pinprick (change scores of 11.4 and 6.6; P = 0.02) and touch (change scores, 8.9 and 4.3; P = 0.03). Benefit from methylprednisolone was seen in patients whose injuries were initially evaluated as neurologically complete, as well as in those believed to have incomplete lesions. The patients treated with naloxone, or with methylprednisolone more than eight hours after their injury, did not differ in their neurologic outcomes from those given placebo. Mortality and major morbidity were similar in all three groups. We conclude that in patients with acute spinal-cord injury, treatment with methylprednisolone in the dose used in this study improves neurologic recovery when the medication is given in the first eight hours. We also conclude that treatment with naloxone in the dose used in this study does not improve neurologic recovery after acute spinalcord injury.

Original languageEnglish (US)
Pages (from-to)1405-1411
Number of pages7
JournalNew England Journal of Medicine
Volume322
Issue number20
StatePublished - May 17 1990
Externally publishedYes

Fingerprint

Methylprednisolone
Naloxone
Spinal Cord Injuries
Randomized Controlled Trials
Wounds and Injuries
Nervous System
Placebos
Therapeutics
Neurologic Examination
Touch
Body Weight
Morbidity
Safety
Mortality

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Bracken, M. B., Shepard, M. J., Collins, W. F., Holford, T. R., Young, W., Baskin, D. S., ... Winn, H. R. (1990). A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: Results of the second national acute spinal cord injury study. New England Journal of Medicine, 322(20), 1405-1411.

A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury : Results of the second national acute spinal cord injury study. / Bracken, Michael B.; Shepard, Mary Jo; Collins, William F.; Holford, Theodore R.; Young, Wise; Baskin, David S.; Eisenberg, Howard M.; Flamm, Eugene S.; Leo-Summers, Linda; Maroon, Joseph; Marshall, Lawrence F.; Perot, Phanor L.; Piepmeier, Joseph; Sonntag, Volker K H; Wagner, Franklin C.; Wilberger, Jack E.; Winn, H. Richard.

In: New England Journal of Medicine, Vol. 322, No. 20, 17.05.1990, p. 1405-1411.

Research output: Contribution to journalArticle

Bracken, MB, Shepard, MJ, Collins, WF, Holford, TR, Young, W, Baskin, DS, Eisenberg, HM, Flamm, ES, Leo-Summers, L, Maroon, J, Marshall, LF, Perot, PL, Piepmeier, J, Sonntag, VKH, Wagner, FC, Wilberger, JE & Winn, HR 1990, 'A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: Results of the second national acute spinal cord injury study', New England Journal of Medicine, vol. 322, no. 20, pp. 1405-1411.
Bracken, Michael B. ; Shepard, Mary Jo ; Collins, William F. ; Holford, Theodore R. ; Young, Wise ; Baskin, David S. ; Eisenberg, Howard M. ; Flamm, Eugene S. ; Leo-Summers, Linda ; Maroon, Joseph ; Marshall, Lawrence F. ; Perot, Phanor L. ; Piepmeier, Joseph ; Sonntag, Volker K H ; Wagner, Franklin C. ; Wilberger, Jack E. ; Winn, H. Richard. / A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury : Results of the second national acute spinal cord injury study. In: New England Journal of Medicine. 1990 ; Vol. 322, No. 20. pp. 1405-1411.
@article{1d104daea7e3438ea5bd338f5e2a8419,
title = "A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury: Results of the second national acute spinal cord injury study",
abstract = "Studies in animals indicate that methylprednisolone and naloxone are both potentially beneficial in acute spinal-cord injury, but whether any treatment is clinically effective remains uncertain. We evaluated the efficacy and safety of methylprednisolone and naloxone in a multicenter randomized, doubleblind, placebo-controlled trial in patients with acute spinalcord injury, 95 percent of whom were treated within 14 hours of injury. Methylprednisolone was given to 162 patients as a bolus of 30 mg per kilogram of body weight, followed by infusion at 5.4 mg per kilogram per hour for 23 hours. Naloxone was given to 154 patients as a bolus of 5.4 mg per kilogram, followed by infusion at 4.0 mg per kilogram per hour for 23 hours. Placebos were given to 171 patients by bolus and infusion. Motor and sensory functions were assessed by systematic neurologic examination on admission and six weeks and six months after injury. After six months the patients who were treated with methylprednisolone within eight hours of their injury had significant improvement as compared with those given placebo in motor function (neurologic change scores of 16.0 and 11.2, respectively; P = 0.03) and sensation to pinprick (change scores of 11.4 and 6.6; P = 0.02) and touch (change scores, 8.9 and 4.3; P = 0.03). Benefit from methylprednisolone was seen in patients whose injuries were initially evaluated as neurologically complete, as well as in those believed to have incomplete lesions. The patients treated with naloxone, or with methylprednisolone more than eight hours after their injury, did not differ in their neurologic outcomes from those given placebo. Mortality and major morbidity were similar in all three groups. We conclude that in patients with acute spinal-cord injury, treatment with methylprednisolone in the dose used in this study improves neurologic recovery when the medication is given in the first eight hours. We also conclude that treatment with naloxone in the dose used in this study does not improve neurologic recovery after acute spinalcord injury.",
author = "Bracken, {Michael B.} and Shepard, {Mary Jo} and Collins, {William F.} and Holford, {Theodore R.} and Wise Young and Baskin, {David S.} and Eisenberg, {Howard M.} and Flamm, {Eugene S.} and Linda Leo-Summers and Joseph Maroon and Marshall, {Lawrence F.} and Perot, {Phanor L.} and Joseph Piepmeier and Sonntag, {Volker K H} and Wagner, {Franklin C.} and Wilberger, {Jack E.} and Winn, {H. Richard}",
year = "1990",
month = "5",
day = "17",
language = "English (US)",
volume = "322",
pages = "1405--1411",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "20",

}

TY - JOUR

T1 - A randomized, controlled trial of methylprednisolone or naloxone in the treatment of acute spinal-cord injury

T2 - Results of the second national acute spinal cord injury study

AU - Bracken, Michael B.

AU - Shepard, Mary Jo

AU - Collins, William F.

AU - Holford, Theodore R.

AU - Young, Wise

AU - Baskin, David S.

AU - Eisenberg, Howard M.

AU - Flamm, Eugene S.

AU - Leo-Summers, Linda

AU - Maroon, Joseph

AU - Marshall, Lawrence F.

AU - Perot, Phanor L.

AU - Piepmeier, Joseph

AU - Sonntag, Volker K H

AU - Wagner, Franklin C.

AU - Wilberger, Jack E.

AU - Winn, H. Richard

PY - 1990/5/17

Y1 - 1990/5/17

N2 - Studies in animals indicate that methylprednisolone and naloxone are both potentially beneficial in acute spinal-cord injury, but whether any treatment is clinically effective remains uncertain. We evaluated the efficacy and safety of methylprednisolone and naloxone in a multicenter randomized, doubleblind, placebo-controlled trial in patients with acute spinalcord injury, 95 percent of whom were treated within 14 hours of injury. Methylprednisolone was given to 162 patients as a bolus of 30 mg per kilogram of body weight, followed by infusion at 5.4 mg per kilogram per hour for 23 hours. Naloxone was given to 154 patients as a bolus of 5.4 mg per kilogram, followed by infusion at 4.0 mg per kilogram per hour for 23 hours. Placebos were given to 171 patients by bolus and infusion. Motor and sensory functions were assessed by systematic neurologic examination on admission and six weeks and six months after injury. After six months the patients who were treated with methylprednisolone within eight hours of their injury had significant improvement as compared with those given placebo in motor function (neurologic change scores of 16.0 and 11.2, respectively; P = 0.03) and sensation to pinprick (change scores of 11.4 and 6.6; P = 0.02) and touch (change scores, 8.9 and 4.3; P = 0.03). Benefit from methylprednisolone was seen in patients whose injuries were initially evaluated as neurologically complete, as well as in those believed to have incomplete lesions. The patients treated with naloxone, or with methylprednisolone more than eight hours after their injury, did not differ in their neurologic outcomes from those given placebo. Mortality and major morbidity were similar in all three groups. We conclude that in patients with acute spinal-cord injury, treatment with methylprednisolone in the dose used in this study improves neurologic recovery when the medication is given in the first eight hours. We also conclude that treatment with naloxone in the dose used in this study does not improve neurologic recovery after acute spinalcord injury.

AB - Studies in animals indicate that methylprednisolone and naloxone are both potentially beneficial in acute spinal-cord injury, but whether any treatment is clinically effective remains uncertain. We evaluated the efficacy and safety of methylprednisolone and naloxone in a multicenter randomized, doubleblind, placebo-controlled trial in patients with acute spinalcord injury, 95 percent of whom were treated within 14 hours of injury. Methylprednisolone was given to 162 patients as a bolus of 30 mg per kilogram of body weight, followed by infusion at 5.4 mg per kilogram per hour for 23 hours. Naloxone was given to 154 patients as a bolus of 5.4 mg per kilogram, followed by infusion at 4.0 mg per kilogram per hour for 23 hours. Placebos were given to 171 patients by bolus and infusion. Motor and sensory functions were assessed by systematic neurologic examination on admission and six weeks and six months after injury. After six months the patients who were treated with methylprednisolone within eight hours of their injury had significant improvement as compared with those given placebo in motor function (neurologic change scores of 16.0 and 11.2, respectively; P = 0.03) and sensation to pinprick (change scores of 11.4 and 6.6; P = 0.02) and touch (change scores, 8.9 and 4.3; P = 0.03). Benefit from methylprednisolone was seen in patients whose injuries were initially evaluated as neurologically complete, as well as in those believed to have incomplete lesions. The patients treated with naloxone, or with methylprednisolone more than eight hours after their injury, did not differ in their neurologic outcomes from those given placebo. Mortality and major morbidity were similar in all three groups. We conclude that in patients with acute spinal-cord injury, treatment with methylprednisolone in the dose used in this study improves neurologic recovery when the medication is given in the first eight hours. We also conclude that treatment with naloxone in the dose used in this study does not improve neurologic recovery after acute spinalcord injury.

UR - http://www.scopus.com/inward/record.url?scp=0025344617&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0025344617&partnerID=8YFLogxK

M3 - Article

C2 - 2278545

AN - SCOPUS:0025344617

VL - 322

SP - 1405

EP - 1411

JO - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 20

ER -