title: Randomized controlled trials in adult traumatic brain injury.
abstract: BACKGROUND
  To optimize strategies for achieving the effectiveness of interdisciplinary interventions, this study conducted a comprehensive literature review of all Randomized Controlled Trials (RCT) in adults with traumatic brain injury (TBI) over the past 30 years.
  
  
  METHODS
  Three major databases including Medline, PsycINFO and CINAHL were searched, yielding 1176 peer reviewed publications. One hundred RCTs were included, encompassing 55 pharmacologic and non-pharmacologic acute phase trials and 45 rehabilitation and pharmacologic post-acute trials.
  
  
  RESULTS
  The majority of acute phase pharmacologic or non-pharmacologic trials (40/55) showed either no effect or adverse effect on TBI outcomes. Several trials involving early nutritional therapy or pre-hospital rapid intubation demonstrated significant treatment effects. The effect of decompressive craniectomy, therapeutic hypothermia and osmotic therapy remained controversial. The majority of post-acute phase trials (36/45), consisting of cognitive rehabilitation, physical rehabilitation and pharmacotherapy, produced various beneficial treatment effects.
  
  
  CONCLUSIONS
  The data indicate that several active interventions during the acute phase of TBI are likely to be more effective than pharmacotherapy, whereas a comprehensive rehabilitation approach is preferred in post-acute phase TBI management. Great progress has been made in understanding the heterogeneous injury mechanisms as well as the complexity of medical management and rehabilitation following the recovery course of TBI.
authors.affiliation: Department of Epidemiology and Community Health, Virginia Commonwealth University, Richmond, VA 23298-0212, USA. jlu1@vcu.edu
authors.forename: Juan
authors.initials: J
authors.lastname: Lu
authors.forename: Kelli W
authors.initials: KW
authors.lastname: Gary
authors.forename: Janet P
authors.initials: JP
authors.lastname: Neimeier
authors.forename: John
authors.initials: J
authors.lastname: Ward
authors.forename: Kate L
authors.initials: KL
authors.lastname: Lapane
mesh_terms: D000328:Adult; D001930:Brain Injuries / Q000453:epidemiology / Q000534:rehabilitation* / Q000601:surgery / Q000628:therapy*; D015928:Cognitive Behavioral Therapy / Q000379:methods* / Q000706:statistics & numerical data; D056424:Decompressive Craniectomy / Q000379:methods* / Q000706:statistics & numerical data; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D014481:United States / Q000453:epidemiology