Megadose steroids in severe head injury. Results of a prospective double-blind clinical trial

J Neurosurg. 1983 Mar;58(3):326-30. doi: 10.3171/jns.1983.58.3.0326.


A prospective double-blind clinical trial was performed on 161 patients to determine the effectiveness of high-dose steroid therapy in patients admitted comatose after a non-missile-related head injury. Patients were randomized into a high-dose dexamethasone phosphate group and a placebo group. The initial dose of 100 mg of dexamethasone was administered within 6 hours of the accident. For statistical analysis, a sequential test was chosen, using survival at 1 month as a basic criterion of effectiveness. No significant difference was found in the 1-month survival rate or in the distribution of outcome after 6 months, either within the group as a whole, or in subgroups with varying severity of brain damage on admission. The authors conclude that dexamethasone in high doses has no statistically significant effect on morbidity or mortality in head-injured patients who are comatose on admission.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Brain Injuries / drug therapy*
  • Brain Injuries / mortality
  • Clinical Trials as Topic
  • Coma / drug therapy
  • Coma / etiology
  • Dexamethasone / administration & dosage*
  • Double-Blind Method
  • Humans
  • Placebos
  • Prospective Studies


  • Placebos
  • Dexamethasone