P Alderson1, I Roberts. 1. Australian Cochrane Centre, Monash Institue of Public Health, Monash Medical Centre, Clayton Vic 3168, Australia. Philip.Alderson@med.monash.edu.au
Abstract
BACKGROUND: Traumatic brain injury is a leading cause of death and disability. Corticosteroids have been widely used in treating people with traumatic brain injury. OBJECTIVES: To quantify the effectiveness and safety of corticosteroids in the treatment of acute traumatic brain injury. SEARCH STRATEGY: Electronic sources: MEDLINE, EMBASE, Cochrane Library and specialised database searches. Additional hand searching and contact with trialists. Date of the most recent search June 1999. SELECTION CRITERIA: All randomized controlled trials of corticosteroid use in acute traumatic brain injury with adequate or unclear allocation concealment. DATA COLLECTION AND ANALYSIS: Quality of allocation concealment was scored. Data on numbers of participants randomized, numbers lost to follow up, length of follow up, case fatality rates, disablement, infections and gastrointestinal bleeds were extracted independently and checked. MAIN RESULTS: We identified 19 trials with 2295 randomized participants. The effect of corticosteroids on the risk of death was reported in 16 included trials. The pooled relative risk for the 16 trials was 0.96 (95% confidence interval 0.85 to 1. 08). Pooled risk difference was 1.3% (5.2% to 2.5% more). For the nine trials that reported death or severe disability, the pooled relative risk was 1.01 (0.91 to 1.11). For infections the pooled relative risk was 0.94 (0.76 to 1.16) and for the nine trials reporting gastrointestinal bleeding 1.11 (0.54 to 2.26). Using only those trials with the best quality of allocation concealment, the pooled relative risk estimate for death became closer to unity. REVIEWER'S CONCLUSIONS: Neither moderate benefits nor moderate harmful effects of steroids can be excluded. The widely practicable nature of the drugs and the importance of the health problem suggest that large simple trials are feasible, and worthwhile, to establish whether there are any benefits from corticosteroids in this situation.
BACKGROUND:Traumatic brain injury is a leading cause of death and disability. Corticosteroids have been widely used in treating people with traumatic brain injury. OBJECTIVES: To quantify the effectiveness and safety of corticosteroids in the treatment of acute traumatic brain injury. SEARCH STRATEGY: Electronic sources: MEDLINE, EMBASE, Cochrane Library and specialised database searches. Additional hand searching and contact with trialists. Date of the most recent search June 1999. SELECTION CRITERIA: All randomized controlled trials of corticosteroid use in acute traumatic brain injury with adequate or unclear allocation concealment. DATA COLLECTION AND ANALYSIS: Quality of allocation concealment was scored. Data on numbers of participants randomized, numbers lost to follow up, length of follow up, case fatality rates, disablement, infections and gastrointestinal bleeds were extracted independently and checked. MAIN RESULTS: We identified 19 trials with 2295 randomized participants. The effect of corticosteroids on the risk of death was reported in 16 included trials. The pooled relative risk for the 16 trials was 0.96 (95% confidence interval 0.85 to 1. 08). Pooled risk difference was 1.3% (5.2% to 2.5% more). For the nine trials that reported death or severe disability, the pooled relative risk was 1.01 (0.91 to 1.11). For infections the pooled relative risk was 0.94 (0.76 to 1.16) and for the nine trials reporting gastrointestinal bleeding 1.11 (0.54 to 2.26). Using only those trials with the best quality of allocation concealment, the pooled relative risk estimate for death became closer to unity. REVIEWER'S CONCLUSIONS: Neither moderate benefits nor moderate harmful effects of steroids can be excluded. The widely practicable nature of the drugs and the importance of the health problem suggest that large simple trials are feasible, and worthwhile, to establish whether there are any benefits from corticosteroids in this situation.