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. 2011 Sep 7;2011(9):CD000064. doi: 10.1002/14651858.CD000064.pub2

Bauer 1973.

Methods Double‐blind, placebo controlled 
 Randomised 
 Number of patients excluded after randomisation: 5 (including 1 lost to follow‐up, none included in analysis) 
 Number lost to follow‐up: 1
Participants USA 
 54 in total (after exclusions): 30 female, 24 male 
 Mean age: 66 years 
 Time from onset of stroke to enrolment: within 48 hours 
 Method of diagnosis: clinical, lumbar puncture 100%
28 dexamethasone 
 26 placebo
Interventions Dexamethasone versus placebo
Intervention: dexamethasone 12 mg i.v. stat, 4 mg i.m. 6 hourly for 3 days, 4 mg i.m. 8 hourly for 3 days, 4 mg i.m. 12 hourly for 2 days, 4 mg i.m. 24 hourly for 2 days: total dose: 120 mg dexamethasone
Placebo: unspecified
All patients: prophylactic ulcer diet and antacid (30 cc Maalox) 4 times a day where oral intake possible
Duration: 10 days
Outcomes Death at 14 days 
 Neurological impairment in the level of consciousness, the motor system and of mentation at 14 days
Notes Exclusions: more than 300 red blood cells per cc in the cerebrospinal fluid; history of gastro‐intestinal bleeding or symptomatic duodenal ulcer
Follow‐up: 14 days
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated, but assumed computer‐generated by Merck, Sharp & Dohme
Allocation concealment (selection bias) Unclear risk "randomisation was performed on a consecutive admission basis". Blind until last patient assessed
Blinding (performance bias and detection bias) 
 All outcomes Low risk "coded vials which contained either Decadron [dexamethasone] or a similarly appearing placebo"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 5 patients withdrawn (3 placebo, 2 dexamethasone). These were not included in analyses
Selective reporting (reporting bias) Low risk