FDA Guidance on Sinusitis and Its Potential Impact on Treatment

The fact that chronic rhinosinusitis (CRS) appears to be increasing in both prevalence and incidence is an observation that is commonly cited.1,2 This disease is estimated to affect at least 20 million people in the United States annually, as measured by office visits.3 In addition to the symptoms commonly associated with CRS, sufferers are further affected in their daily function, as measured by quality of life. This translates into an impact of this disease that is roughly equivalent to that of other serious chronic medical conditions, such as diabetes and congestive heart failure.4 Unfortunately, despite what appears to be the size of this problem, health care professionals continue to struggle with a clear understanding of the condition, and are further hampered by a lack of consistently effective management algorithms.

Some Reasons for the Current Paucity of Outcomes Data

In order to understand the disconnect that exists between the impact of this disease process and the current lack of consistent medical options, it is important to understand the state of the current knowledge base as it relates to CRS. At present, a clear understanding of this disease remains elusive. Historically, CRS has been treated in a fashion that suggests that it represents an end-stage manifestation of unsuccessfully managed acute bacterial rhinosinusitis.5 This assumes that the disease represents a smoldering form of bacterial infection. To the contrary, studies focusing on the use of antibiotics in a variety of fashions have collectively yielded varied and inconsistent results, challenging the universal application of this modality of therapy and the validity of bacterial infection as a universal cause of CRS. This, in turn, has given rise to the consideration of a number of alternative etiologies and mechanisms that have been proposed as possible instigators of CRS. Fungus, bacterial superantigens, biofilms, aberrations in innate immunity, and genetic factors related to cystic fibrosis are among some of the subjects that are currently under consideration, some of which may hold potential for treatment options.

Looking beyond the present-day uncertainties that underlie the cause of CRS, consistent management strategies have also been challenged by an overall inconsistency in the methodology used to assess treatment outcomes. The issues that affect collective assessment of the current body of literature related to CRS are numerous, and include such problems as variances in study design and outcome measures, use of nonvalidated symptom questionnaires, and inconsistent subject entry criteria. The ultimate effect of this inconsistency is an inability to collate and decipher the literature in a systematic and reliable fashion. A simple query of the Cochrane Database of Systematic Reviews (www.cochrane.org ) illustrates this point. A search of the keywords chronic sinusitis yields only two completed reviews, only one of which addresses medical management. In comparison, a similar search performed for the keyword diabetes results in 135 separated systematic reviews or meta-analyses.