Treatment may worsen head injury outcome

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Steroids are widely used to treat people who suffer severe Head injury, but a new study indicates that the therapy does more harm than good.

Patients with Head injury who were treated with methylprednisolone had a significantly increased risk of dying within the following two weeks compared with untreated patients, according to the results of a large study reported in this week’s issue of The Lancet medical journal.

"Our early results show that corticosteroids should not be used routinely to treat Head injury, whatever the severity,” Dr. Ian Roberts comments in a Lancet press release.

Roberts, at the London School of Hygiene and Tropical Medicine, is clinical coordinator of the CRASH (corticosteroid randomization after significant Head injury) trial.

In 1997, an analysis of previous trials suggested that the risk of death could be reduced somewhat by treating Head injury victims with steroids, the CRASH trial collaborators note. However, the results had a wide margin of error.

The intent of CRASH was to enroll 20,000 adults within 8 hours of Head injury, and treat them randomly with a 48-hour infusion of either methylprednisolone or an inactive placebo.

After 10,000 patients had been enrolled, recruitment to the trial was ended because unmasked results showed a 21 percent mortality rate within two weeks among those treated with methylprednisolone, versus 18 percent among those allocated to placebo.

“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,” the investigator state.

SOURCE: Lancet, October 9, 2004.

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