The Pharmaceutical Journal
Vol 273 No 7321 p552
16 October 2004

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Corticosteroids raise two-week death rate

Compared with placebo, the use of corticosteroids to treat head injury is associated with an 18 per cent higher risk of death within two weeks, a new study has shown (Lancet 2004;364:1321).

Corticosteroids have been used in the treatment of head injury for 30 years, because it is thought that post-traumatic inflammatory changes contribute to neuronal degeneration. Although previous studies had suggested that corticosteroids may slightly reduce the risk of death, the trials had been too small to provide conclusive results.

The CRASH (corticosteroid randomisation after significant head injury) trial aimed to provide a definitive answer. In May 2004, the data monitoring committee disclosed the unmasked results to the steering committee, which stopped recruitment to the trial.

A total of 10,008 patients with head injury from 239 hospitals in 49 countries were randomly allocated corticosteroids (methylprednisolone) or placebo for 48 hours after admission to a hospital emergency department. Mortality data during the first two weeks were obtained for 9,964 patients: 21 per cent of patients allocated corticosteroids died, compared with 18 per cent of patients allocated placebo.

Although the mechanism behind this increased mortality is not clear, the authors highlight the importance of their finding: “Our early results show that corticosteroids should not be used routinely to treat head injury, whatever the severity.

“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.”

Given the importance of the two-week findings, the authors decided to publish early; the results of their six-month data will be reported in a later paper.