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 |
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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 |
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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 |
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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Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 patients withdrawn (3 placebo, 2 dexamethasone).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 |