In this issue of JAMA, Williamson and colleagues10 report their findings from an important, large randomized controlled trial involving patients with a clinical diagnosis of acute sinusitis. The authors used a factorial design including either amoxicillin or budesonide (a topical steroid spray), or both, and concluded that neither regimen was better than placebo for resolving symptoms. This study is a useful contribution to the evidence on the effect of antibiotics and topical steroids in treating sinusitis but has some limitations. First, an objective reference standard was not used. Patients were included who had at least 2 of 4 Berg and Carenfeldt criteria,11 which have not been validated in a primary care setting. Second, the positive likelihood ratio of 6.75 is fairly high, but depends on a high pretest probability of patients with purulent sinusitis. With a possible pretest probability of 20%, the proportion of purulent sinusitis would be 65%, leaving 35% with a possible viral infection. Therefore, it cannot be ruled out that a number of viral cases were included in the study. Third, the recruitment of patients for each clinician was low, around 1 case per primary care physician during 1 year, whereas most primary care physicians might be expected to see as many as 50 cases of sinusitis per year. This may imply a selection bias and limits the external validity of the study. On the other hand, the use of only clinical features as inclusion criteria increases the external validity.