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. 2004 Oct 18;2004(4):CD004477. doi: 10.1002/14651858.CD004477.pub2
Methods n = 24, 4 centres
Allocation concealment: not described
Baseline similarity: age, MODS, sepsis; analyses adjusted for variables used to calculate severity of illness scores
Blinding: caregivers
Cointerventions: lung protective ventilation (limitation of plateau pressure to 35 cmH20) used in both groups
Withdrawals: none
Losses to follow‐up: none
Participants Inclusions: AECC definition for ARDS; at least 7 days of mechanical ventilation; lung injury score at least 2.5 with a reduction of less than 1 point from day 1 of ARDS
Exclusions: ARDS of 3 or more weeks' duration; untreated infection; burns; recent gastrointestinal bleed
Interventions IV methylprednisolone, 2 mg/kg/day IV for 14 days, tapering to zero over the next 18 days, or placebo
Outcomes ICU mortality: 0/16 (methylprednisolone group) and 5/8 (placebo group); RR 0.05 (95% CI 0 to 0.78)
Hospital mortality: 2/16 (methylprednisolone group) and 5/8 (placebo group); RR 0.20 (95% CI 0.05 to 0.81)
Duration of ventilation (median days): 11.5 (methylprednisolone group); 23 (placebo group); p = 0.001
Adverse events leading to discontinuation of therapy not reported
Other safety data: infections per 100 patient‐days of treatment: 8 (methylprednisolone group); 7 (placebo group)
Notes The mean duration of ARDS at randomization was 9.4 days (standard error 0.9 days) in the methyprednisolone group and 8.8 days (standard error 1.2 days) in the placebo group.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear