The results of the international Medical Research Council (MRC) trial are published in 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 steroids could reduce deaths by preventing the potentially lethal brain swelling that occurs after head injury. But those studies were too small to be able to provide definitive evidence of benefit.

The MRC CRASH (corticosteroid randomisation after significant head injury) trial, with over ten thousand patients recruited from nearly 50 countries, is the largest head injury trial ever conducted. It was designed specifically to determine whether corticosteroids provide benefit to patients with head injuries.

The trial, co-ordinated by researchers from the London School of Hygiene & Tropical Medicine and the Universities of Manchester, Edinburgh, Birmingham and Oxford, compared patients treated with corticosteroids with patients on a placebo treatment. Researchers found that 21 percent of those given the corticosteroids died within two weeks compared with 18 percent 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 eligible to take part in the trial only 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 allocated to either corticosteroids or a placebo treatment on a random basis. Both treatments were delivered by a drip over a 48-hour period.

"Head injury is devastating. World-wide, millions of people, particularly young people, are killed or seriously disabled from their injuries each year," said Dr. Ian Roberts of the London School of Hygiene and Tropical Medicine, the clinical co-ordinator of the trial.

"Obviously we'd have preferred to find out that corticosteroids improve patients' chances of surviving head injury," Roberts said, "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, offered the following comment: "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.