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
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 the setting of chronic sinus disease
and other possible comorbid conditions, such as rhinitis or upper respiratory
infections, in which as many as 87% of patients have such radiographic abnormalities.4
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