Oct. 7, 2004 -- A commonly used treatment for head injuries may actually do more harm than good, according to a major new international study.
Researchers found people with head injuries who were treated with anti-inflammatory drugs called corticosteroids were nearly 20% more likely to die within two weeks after their head injury than those who weren't.
Surveys show that corticosteroids are used by about 64% of trauma centers in the U.S. to treat head injuries. The startling results prompted researchers to end the CRASH (corticosteroid randomization after significant head injury) study early, and the preliminary results appear in the Oct. 9 issue of The Lancet.
"Our early results show that corticosteroids should not be used routinely to treat head injury, whatever the severity," says researcher Ian Roberts of the London School of Hygiene and Tropical Medicine, in a news release. "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."
Researchers say additional information on the effect of corticosteroid treatment on disability six months after head injury will be reported as soon as the data are available.
Head Injury Treatment in Doubt
Researchers say that millions of people are treated for head injuries and trauma each year worldwide. Many of them die or suffer permanent disability as a result of brain damage.
Although much of the damage is done at the time of the head injury, post-injury inflammation and pressure on the skull is thought to contribute to brain damage and death risks.
Corticosteroids have been used to treat head injuries for 30 years, and a review of research published in 1997 suggested that corticosteroids might reduce inflammation and the subsequent risk of death by 1% to 2%.
In the study, researchers randomly assigned more than 10,000 patients with a head injury from 49 countries who arrived at the hospital within eight hours of their head injury to receive either a 48-hour infusion of corticosteroids or a placebo.
Researchers found that those who were given the corticosteroids were 21% more likely to die within two weeks of their head injury than those who received the placebo.
In an editorial that accompanies the study, Stefan Suerland and Marc Maegle of the University of Cologne and University of Witten-Herdecke say most doctors expected this study to confirm the benefits of corticosteroids for head injury. But the results are "a complete and alarming surprise for all."
"When extrapolating the results of the CRASH trial to the annual incidence of severe head injuries worldwide, it is frightening to calculate how many patients might have been harmed by corticosteroids," they write. "The key message of CRASH, however, is that applying treatments with unproven effectiveness is like flying blindly."