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To the Editor.—Dr Meduri and colleagues¹ present data from 24 patients with acute respiratory distress syndrome (ARDS) persisting for a week or longer who were initially randomized to either methylprednisolone treatment or placebo. We disagree with Meduri et al that the data are sufficient to conclude methylprednisolone offers clinical benefit. As noted in the accompanying Editorial,² the trial's small size and its crossover design limit conclusions that can be drawn from this study. Of the 8 patients initially randomized to receive placebo, 4 (50%) crossed over to methylprednisolone, and 3 (75%) of these 4 patients subsequently died. We are concerned that use of an intent-to-treat analysis in a small crossover study may be uninterpretable. If the outcomes of the patients randomized to placebo but treated with methylprednisolone are included in the methylprednisolone arm, 17 (85%) of 20 treated patients survived the intensive care unit (ICU), whereas 3 (75%) of . . . [Full Text of this Article]

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