title: Randomized, double-blind, placebo-controlled, pilot trial of high-dose methylprednisolone in aneurysmal subarachnoid hemorrhage.
abstract: OBJECTIVE
  The object of this study was to determine the efficacy of methylprednisolone in reducing symptomatic vasospasm and poor outcomes after subarachnoid hemorrhage (SAH).
  
  
  METHODS
  Ninety-five patients with proven SAH were recruited into a double-blind, placebo-controlled, randomized trial. Starting within 6 hours after angiographic diagnosis of aneurysm rupture, placebo or methylprednisolone, 16 mg/kg, was administered intravenously every day for 3 days to 46 and 49 patients, respectively. Deterioration, defined as development of a focal sign or decrease of more than 1 point on the Glasgow Coma Scale for more than 6 hours, was investigated by using clinical criteria and transcranial Doppler ultrasonography, cerebral angiography, or CT when appropriate. The end points were incidence of symptomatic vasospasm (delayed ischemic neurological deficits associated with angiographic arterial narrowing or accelerated flow on Doppler ultrasonography, or both) and outcome 1 year after entry into the study according to a simplified Rankin scale (Functional Outcome Scale [FOS]) in living patients and the Glasgow Outcome Scale in all patients included.
  
  
  RESULTS
  All episodes of deterioration and all living patients with a 1-year outcome were assessed by a review committee. In patients treated with methylprednisolone, the incidence of symptomatic vasospasm was 26.5% compared with 26.0% in those given placebo. Poor outcomes according to FOS were significantly reduced in the Methylprednisolone Group at 1 year of follow-up; the risk difference was 19.3% (95% CI 0.5-37.9%). The outcome was poor in 15% (6/40) of patients in the Methylprednisolone Group versus 34% (13/38) in the Placebo Group.
  
  
  CONCLUSIONS
  A safe and simple treatment with methylprednisolone did not reduce the incidence of symptomatic vasospasm but improved ability and functional outcome at 1 year after SAH.
authors.affiliation: Departement d'Anesthésie-Réanimation et Biostatistiques, Hôpital Maison Blanche, Reims, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Gomis
authors.forename: Jean Pierre
authors.initials: JP
authors.lastname: Graftieaux
authors.forename: Richard
authors.initials: R
authors.lastname: Sercombe
authors.forename: Dominique
authors.initials: D
authors.lastname: Hettler
authors.forename: Bernard
authors.initials: B
authors.lastname: Scherpereel
authors.forename: Pascal
authors.initials: P
authors.lastname: Rousseaux
mesh_terms: D002533:Cerebral Angiography; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D018696:Neuroprotective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D012306:Risk; D012720:Severity of Illness Index; D013345:Subarachnoid Hemorrhage / Q000000981:diagnostic imaging / Q000188:drug therapy*; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D017585:Ultrasonography, Doppler, Transcranial; D020301:Vasospasm, Intracranial / Q000000981:diagnostic imaging / Q000188:drug therapy
chemical_list: D018696:Neuroprotective Agents; D008775:Methylprednisolone