Steroids Useless for Head Trauma
07 Oct
2004 EDT
LONDON - Doctors have been giving steroids to head trauma
patients for more than 30 years, but the first major study
of the practice has shown they are useless and may even have
killed thousands of people.
Experts said the findings, published this week in The Lancet
medical journal, are "a complete and alarming surprise for
all."
Head trauma, usually from car crashes, violence or falls, is
the leading cause of death and disability in children and
young adults in the developed world, and globally second
only to HIV in causing the death of people under 40. About 3
million people die each year from head trauma.
Steroids had been used for decades in head trauma patients
because it was believed their anti-inflammatory effects
could help bring down swelling in the brain.
However, there was never reliable evidence steroids helped
in cases of severe head injury, and their use has been
controversial.
In the mid-1990s, existing evidence indicated they were
probably not effective. Many doctors stopped using them, but
not all.
The latest study, involving hundreds of doctors in 49
countries treating more than 10,000 patients, was stopped
halfway through recruitment as it became clear steroids did
not help and could be harmful.
"Most clinicians expected the trial to confirm the benefits
of steroids, while others suspected that the effectiveness
of steroids would turn out to be small or nonexistent," said
Dr. Stefan Sauerland and Dr. Marc Maegele, experts from the
University of Witten-Herdecke and the University of Cologne
in Germany.
"Instead of a treatment benefit or at least equality, there
were actually 159 excess deaths in the steroid group," the
experts wrote in an independent critique of the study. "When
extrapolating the results ... to the annual incidence of
severe head injuries worldwide, it is frightening to
calculate how many patients might have been harmed by
steroids."
Sauerland, who was not connected with the research,
estimated doctors killed about 10,000 head trauma patients
with steroids in the 1980s and earlier.
The study, coordinated at the London School of Hygiene and
Tropical Medicine, involved 10,008 adults with severe head
injuries who were randomly allocated either a steroid drip
or a fake drip for 48 hours after being admitted to the
emergency room.
Within two weeks, 21 percent of the patients given steroids
had died, compared with 18 percent of those given the fake
drug. The results were the same regardless of how quickly
the treatment was administered and regardless of the type or
severity of the head injury.
Dr. Philip Stieg, chair of neurological surgery at Weill
Cornell Medical Center in New York, said he was not sure the
study settles the question.
"They picked one dose of steroids. Would a different dose be
more effective?" asked Stieg, who was not connected with the
research.
It also remains to be seen whether patients getting steroids
fare better in the long term from the disabling effects of
the trauma, he noted.
"If the long-term one-year follow up data suggest that
steroids improve morbidity, that the patient has a better
neurological outcome, then physicians would reevaluate their
use of steroids," he said.
However, Sauerland said it was unlikely any long-term
benefit in disability reduction could outweigh the concern
about the higher death rate early in treatment.
"This is a tombstone trial," Sauerland said by telephone.
"It will close the issue for ever."
Dr. Ian Roberts, coordinator of the trial, said many other
treatments commonly used in trauma patients also were open
to question. Approaches such as hyperventilation,
barbiturates and fluid resuscitation have not been proven to
help, he said.
"Trauma care has really been the poor relation of medical
research," he said. "Maybe there are other surprising and
alarming results out there. We don't know."
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