February 2005
Common head injury treatment raises death rate
The use of
anti‑inflammatory drugs to treat patients with severe head injuries ‑‑ a
common practice around the world for the past 30 years ‑‑ is actually
dangerous and associated with around a 20% increase in death within two
weeks of hospital admission, concluded authors of an international study in
The Lancet.
Around three million
people worldwide die of trauma every year, many after arrival at the
hospital. While findings of a 1997 systematic review suggested that these
drugs might reduce the risk of death by a few percentage points, previous
individual trials had been too small to provide a clear‑cut answer. The
CRASH trial (corticosteroid randomization after significant head injury) ‑‑
a multicenter international collaboration ‑‑ sought to confirm or refute
such an effect by recruiting 20,000 patients. In May, 2004, the data
monitoring committee disclosed the unmasked results to the steering
committee, which stopped recruitment to the trial.
From 239 hospitals in
49 countries, 10,008 adults with head injury were randomly allocated
corticosteroids (methylprednisolone) or placebo for 48 hours after admission
to a hospital emergency department. Those patients given corticosteroids had
a higher death rate within two weeks (21% of patients) than those given
placebo (18%). The six‑month follow‑up data was due to be presented in a
subsequent paper.
Clinical co‑ordinator
of the study, Prof. Ian Roberts (London School of Hygiene and Tropical
Medicine) commented: "Our early results show that corticosteroids should not
be used routinely to treat head injury, whatever the severity. 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... Many other treatments of
uncertain effectiveness for head injury are in widespread use, and further
large‑scale randomized trials are needed."
In an accompanying
commentary, Stefan Sauerland (University of Cologne, Germany) concluded:
"CRASH partly shakes our pathophysiological understanding of what is of
primary importance after traumatic brain injury. The role of inflammatory
mediators and the presumed effects of blocking their release must now be
elucidated in more detail. Other mechanisms leading to increased
intracranial pressure must also be targeted. The key message of CRASH,
however, is that applying treatments with unproven effectiveness is like
flying blindly. In future, we should avoid trusting in underpowered clinical
trials with surrogate rather than clinical endpoints, and transferring
evidence from one disease to another."
SOURCES:
"Effect of intravenous corticosteroids on death within 14 days in 10 008
adults with clinically significant head injury," by CRASH trial
collaborators. The Lancet 2004; 364: 1321‑28 (October).
"A CRASH landing in
severe head injury," by Stefan Sauerland, Marc Maegele. Lancet 2004;
364: 1321‑28 (October 2004).
NOTE: This article
appeared in the World Chiropractic Alliance Health Watch electronic
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