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November 1, 1995

Three vs 10 Days of Trimethoprim/Sulfamethoxazole for Acute Maxillary Sinusitis-Reply

Author Affiliations

Audie L. Murphy Memorial Veterans Hospital San Antonio, Tex

JAMA. 1995;274(17):1341-1342. doi:10.1001/jama.1995.03530170021013

In Reply.  —We agree that statistical power is a critical issue for our study and for any clinical trial showing equivalent outcomes for competing therapies. When designing this study, we knew that the existing literature showed a high placebo response rate that was improved only modestly by decongestants and antibiotics. Given these data, we chose "time to clinical response" as the primary outcome variable, thinking that antibiotic therapy may shorten the intensity and duration of symptoms. We chose 2.5 days as a clinically meaningful difference in duration of symptoms, and computed a priori that 40 patients per group would exclude a difference greater than 2.5 days with 80% power (one-sided α=.05). We observed a 0.5-day difference between groups (favoring the 10-day treatment group), and bootstrap estimation of the 95% confidence interval (CI) showed that the 3-day treatment group might experience as much as 2.0 days longer median time to clinical

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