Corticosteroids in acute traumatic brain injury: systematic review of randomised controlled trials

Abstract

Objective: To quantify the effectiveness and safety of corticosteroids in the treatment of acute traumatic brain injury. Design: Systematic review of randomised controlled trials of corticosteroids in acute traumatic brain injury. Summary odds ratios were estimated as an inverse variance weighted average of the odds ratios for each study. Setting: Randomised trials available by March 1996. Subjects: The included trials with outcome data comprised 2073 randomised participants. Results: The effect of corticosteroids on the risk of death was reported in 13 included trials. The pooled odds ratio for the 13 trials was 0.91 (95% confidence interval 0.74 to 1.12). Pooled absolute risk reduction was 1.8% ( − 2.5% to 5.7%). For the 10 trials that reported death or disability the pooled odds ratio was 0.90 (0.72 to 1.11). For infections of any type the pooled odds ratio was 0.92 (0.69 to 1.23) and for the seven trials reporting gastrointestinal bleeding it was 1.05 (0.44 to 2.52). With only those trials with the best quality of concealment of allocation, the pooled odds ratio estimates for death and death or disability became closer to unity. Conclusions: This systematic review of randomised controlled trials of corticosteroids in acute traumatic brain injury shows that there remains considerable uncertainty over their effects. Neither moderate benefits nor moderate harmful effects 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 worth while to establish whether there are any benefits from use of corticosteroids in this setting.

Critical appraisal of neuroprotection trials in head injury: What have we learned?

“…Specific lessons, however, have been learned from previous attempts and general principles can be suggested: 1) better understanding of the pathophysiology of head injury both severe and moderate is imperative, and the mechanism should be demonstrated in both animal models and human TBI; 2) better translational processes are very important to design therapeutic interventions that have relevance to the clinical practice, brain tissue penetration and pharmacokinetics in human TBI should be carefully considered and investigated, safety data should include interactions with other agents, and the possibility of multiple agent treatment should be explored; 3) the appropriate therapeutic time-window should be identified and dynamic processes should be developed to allow individual patient adjustments, e.g., giving the trial medication at the site of the accident; 4) as a result of the above, specific consideration of the actual consent procedure and serious thought should be given to the concept of waived consent for trials in head injury; 5) proper patient selection is necessary, which will expose to treatment those patients that will benefit most from any potential intervention; 6) identification of an appropriate surrogate endpoint is highly desirable, but it has to be fully validated before it can be applied; 7) careful statistical evaluation before and during any trial will ensure avoidance of pitfalls in recruitment and analysis; protocol adherence and center monitoring is important in establishing internal validity and smoothing out the significant variability in treatment, and 8) full publication of the results of any trial, irrespective of the outcome, is imperative for all investigators to scrutinize the data and draw appropriate conclusions as early as possible. [71][72][73][74][75][76][77][78][79] …”

Help a Buddy Take a Knee: Creating Persuasive Messages for Military Service Members to Encourage Others to Seek Mental Health Help

“…Alderson and Roberts (1997) reviewed studies of corticosteroids to treat acute TBI using randomized trials available by March 1996. It is known that in the acute period of TBI, corticosteroids are not recommended for improving or reduc-ing increased intracranial pressure (Roberts, 2000;Whyte et al, 2005).…”

Conduta frente à criança com trauma craniano

“…Estudos recentes não mostraram mudanças significantes na mortalidade e morbidade em pacientes tratados com corticóide logo após o trauma craniano. Portanto, a sua utilização não tem benefício comprovado, e a sua indicação não tem sido estimulada 30,31 .…”