A
head injury treatment used for the past 30 years could be
killing rather than saving patients, experts warn.
A Medical
Research Council study of more than 10,000 patients found giving
anti-inflammatory drugs to reduce brain swelling increased the
risk of death.
The London School of Hygiene and Tropical Medicine scientists
told doctors to stop using these drugs to treat people with
head injuries.
More data is expected from the trial, which is published in
the Lancet.
Deaths
The effect of the anti-inflammatory drugs, called corticosteroids,
on disability six months after head injury would be reported
soon, the researchers said.
Their current findings showed the drugs increased the risk of
death by about 20% within two weeks of patients with head injuries
being admitted to hospital.
The study involved patients treated at 239 hospitals in 49 countries
around the world.
"[This
will] protect thousands of future patients from increased
risk of death from corticosteroids" --- Lead
researcher Dr Ian Roberts
Half of the 10,008 patients were randomly allocated to receive
corticosteroid treatment. The other half were given a dummy
drug.
There were 156 more deaths in the steroid group than in the
fake drug group, which was the opposite of what the researchers
had expected based on previous smaller studies.
Commenting on the findings in an editorial to the Lancet, Dr
Stefan Sauerland from the University of Cologne in Germany,
said the results were "a complete and alarming surprise for
us all."
"In future, we should avoid trusting in underpowered clinical
trials," he said.
Change in practice
Lead researcher Dr Ian Roberts said: "Obviously we'd have preferred
to find out that corticosteroids improve patients' chances of
surviving head injury.
"But our results are important because they'll improve patient
care and protect thousands of future patients from increased
risk of death from corticosteroids."
He said it also raised the question of whether these drugs might
be harmful for patients with spinal injuries.
Professor Colin Blakemore, chief executive of the MRC, said:
"This is an excellent example of how research evidence contributes
to changing clinical practice with the potential to improve
patient care."
The team is putting together proposals to trial other potential
treatments, in particular treatments for excessive bleeding
which accounts for most trauma deaths worldwide.
About three million people worldwide die from trauma every year.
Of those who survive to reach hospital, blood loss accounts
for many of the subsequent deaths.
Peter McCabe, chief executive of Headway, the brain injury association,
said: "There is a real lack of comprehensive research into brain
injury.
"We welcome any new research that will help throw light on ways
to improve people's survival rates and long-term outcome."
A
head injury treatment used for the past 30 years could be
killing rather than saving patients, experts warn.
