THURSDAY, Oct. 7, 2004 (HealthDayNews) -- Giving steroids to reduce brain swelling can be deadly for patients with severe head injuries, according to the largest study ever done on the subject.
The research, which included more than 10,000 patients treated at 239 hospitals in 49 countries, found that 21 percent of those who were given steroids died within two weeks, compared to 18 percent of those given a placebo. A report on the findings appears in the Oct. 9 issue of The Lancet.
The study was done because "if you looked at previous trials, use of steroids seemed pretty beneficial," said Dr. Ian G. Roberts, a professor of epidemiology at the London School of Hygiene and Public Medicine and clinical coordinator of the study. "Some doctors gave steroids, some didn't, so it was important to find their value one way or another."
The study gave "a very clear-cut answer," Roberts said. "Corticosteroids do not reduce mortality after head injuries and, if anything, could increase the risk of mortality."
The original intent was to enroll 20,000 head injury patients for the study. The trial was cut short when evidence of damage emerged.
None of the study hospitals were in the United States, but Roberts said a 1995 survey found that 64 percent of trauma units in this country used steroids in head injury treatment. That number appears to have been reduced, but "still a lot of people use them," he said.
An American Association of Neurological Surgeons fact sheet does not mention steroids as part of head injury treatment and says that "prevention of secondary insults is a major part of the intensive care management of head-injured patients."
Dr. Stefan Sauerland, a biochemist at the University of Cologne in Germany who wrote an accompanying commentary, explained that "the damage done by a head injury is not just the result of the first impact. Swelling can prevent blood from coming into the brain, causing damage."
Steroids have been given because they reduce the inflammation that causes the brain to swell, Sauerland said, but their value had not been confirmed by large-scale studies. The "key message" of the newly reported study, he said, is that "applying treatments with unproven effectiveness is like flying blindly. In [the] future, we should avoid trusting in underpowered clinical trials."
Steroids still are widely used in treating spinal cord injuries, Roberts noted, "but after these results there may be some serious debate about their use."
While small studies on steroid treatment of spinal cord injuries "are more promising, we need a large-scale trial," Sauerland said.
In general, Roberts said, "there is little clinical research in brain injuries. Most treatments for brain injuries are unproven. They may be useless or harmful as well."
Roberts contended there is a lack of interest in head injury research because "the people who suffer these injuries tend to be poor." Many of the injuries are caused by person-to-person violence, he said, and "there is a strong relationship between pedestrian injuries and poverty. Poor people are the ones who walk around, and they are the ones most likely to by hit by an automobile."
More information
The Brain Injury Association of America explains treatment and rehabilitation.
