A major, international Medical Research Council (MRC) trial has found that a routine treatment for patients with head injuries, widely used around the world for the last 30 years, does not improve survival rates and may do more harm than good. The results of the study are published in full in this week's edition of The Lancet.
Every year millions of people world-wide are treated for serious head injury. One in five die and a substantial proportion are permanently disabled.
Previous studies suggested that giving patients anti-inflammatory treatments called corticosteroids could reduce deaths by preventing the potentially lethal brain swelling that occurs after head injury. But these studies were too small to be able to provide definitive evidence of benefit.
The MRC CRASH* trial was specifically designed to answer this question and with over ten thousand patients recruited from nearly 50 countries is the largest head injury trial ever conducted.
The trial, co-ordinated by researchers from the London School of Hygiene and Tropical Medicine and the Universities of Manchester, Edinburgh, Birmingham, and Oxford, compared patients treated with corticosteroids with patients on a placebo treatment. They found that 21 per cent of those given the corticosteroids died within two weeks compared with 18 per cent of those on the placebo treatment.
When the team looked specifically at whether the severity of injury or how quickly the treatments were administered might affect the outcome, they found no change in the effect.
Patients were only eligible to take part in the trial if, on admission to casualty, their doctor was uncertain whether or not to treat them with corticosteroids. In addition to the usual emergency medical care, the patients were randomly allocated to either corticosteroids or a placebo treatment. Both treatments were delivered by a drip over a 48 hour period.
Dr. Ian Roberts, the clinical co-ordinator of the trial, from the London School of Hygiene and Tropical Medicine, said:
"Head injury is devastating. World-wide, millions of people, particularly young people, are killed or seriously disabled from their injuries each year.
"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."
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 trial involved the international collaboration of doctors from around 400 hospitals showing that it's possible to recruit large numbers of patients to answer important questions, even in an emergency setting."
The impact of corticosteroids on disability among head injury patients is still being investigated by the trial team. Results from the six month patient follow-up will be published at a later date.
The team is putting together proposals to trial other potential treatments, in particular treatments for excessive bleeding which accounts for most trauma deaths worldwide.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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