The role of noninvasive ventilation (NIV) in the management of acute respiratory distress syndrome (ARDS) is controversial. The aim of this study was to assess the effect of NIV on the rate of endotracheal intubation and intensive care unit (ICU) mortality in patients with ARDS. We searched the MEDLINE database for relevant studies published from 1980 to September 2005, and included studies if (a) the design was a randomized controlled trial; (b) patients had ARDS irrespective of the underlying etiology; (c) the interventions compared NIV and medical therapy with medical therapy alone; and (d) outcomes included need for endotracheal intubation and/or ICU survival. The addition of NIV to standard care in the setting of ARDS did not reduce the rate of endotracheal intubation (absolute risk reduction (RR) 13.5%, 95% confidence interval (CI) -5.2% to 31.3%), and had no effect on ICU survival (absolute RR 4.8%, 95% CI -12.8% to 22.1%). However, the trial results were significantly heterogeneous. Thus, current evidence suggests that patients with ARDS are unlikely to have any significant benefits on outcome when NIV is added to standard therapy. However, this analysis is limited by the presence of significant heterogeneity; hence large randomized controlled trials are required to settle this issue.