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To the Editor: Dr Dolor and colleagues¹ concluded that intranasal corticosteroids are efficacious in the treatment of acute rhinosinusitis. We believe, however, that the design of their trial significantly limits the conclusions that can be drawn from it.

We believe the trial design was more like that of a large simple trial rather than a well-controlled trial. The primary efficacy variable was "time to clinical success," based solely on telephone reports of whether patients were feeling better. There were no objective measures of compliance or improvement. Direct patient symptom assessments were used as secondary end points, and interestingly, failed to show significant differences between fluticasone and placebo. The entry criteria were also problematic. Since duration of symptoms was not measured at study entry, the diagnosis of acute sinusitis could not be adequately established.^2-3 The entry criterion allowing for mucosal thickening on radiographs is a poor indicator of sinusitis, particularly in . . . [Full Text of this Article]

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RELATED ARTICLE

Comparison of Cefuroxime With or Without Intranasal Fluticasone for the Treatment of Rhinosinusitis: The CAFFS Trial: A Randomized Controlled Trial
Rowena J. Dolor, David L. Witsell, Anne S. Hellkamp, John W. Williams, Jr, Robert M. Califf, David L. Simel, and for the Ceftin and Flonase for Sinusitis Investigators
JAMA. 2001;286(24):3097-3105.
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