According to a report from Lancet, Patients with head injury who were treated with methylprednisolone had a significantly increased risk of death within the following 2 weeks compared with untreated group of patients.
"Our early results show that corticosteroids should not be used routinely to treat head injury, whatever the severity," Dr. Ian Roberts. He is clinical coordinator of the CRASH (corticosteroid randomization after significant head injury) trial. In 1997, a systematic review suggested the risk of death could be reduced by up to 2% by treating head injury victims with steroids, the CRASH trial collaborators note. However, the 95% confidence interval ranged between 6% fewer to 2% more deaths.
CRASH was supposed to enrol 20,000 patients with Glasgow coma score of 14 or lower within 8 hours of head injury. However after studying 10,008 patients in 239 hospitals from 49 countries the trail found 21% mortality rate within 2 weeks for those treated with the 48-hour methylprednisolone infusion, versus 18% among those allocated placebo (relative risk 1.18, p = 0.0001).
"The relative increase in deaths due to corticosteroids did not differ by injury severity (p = 0.22) or time since injury (p = 0.05)," the authors note.
"By clearly refuting a mortality benefit from corticosteroids in head injury, the CRASH trial results should protect many thousands of patients from any increased risk of death associated with these drugs," they add. These findings could have similar implications for use of corticosteroids in spinal cord injury.
The lesson learnt from CRASH according to Dr. Stefan Sauerland, at the University of Cologne, and Dr. Marc Maegele at the University of Witten-Herdecke, in Germany, is that "we should avoid trusting in underpowered clinical trials with surrogate rather than clinical endpoints, and transferring evidence from one disease to another."