Antibiotics have not been shown to prevent the sequelae of acute sinusitis. One of the major difficulties in treating sinusitis is the lack of agreement about which outcomes are desired.19,20 Nearly 66% of patients diagnosed with sinusitis will get better without treatment, though nearly two thirds of patients will continue to have such symptoms as cough and nasal discharge for up to 3 weeks.21,22 Thus, we believe that to give antibiotics only to individuals who would truly benefit from them, policy makers, primary care physicians, and patients need to reassess clinically what constitutes sinusitis, and what outcomes are most desired. If the goal is to cure purulent nasal discharge, we are likely over-treating with antibiotics; as our study showed, after 2 weeks most patients in both groups still had nasal symptoms.
Our pilot of the clinical prediction rule failed to predict a proper response to antibiotics or the time to improvement. Although our numbers were not large, no trend was observed towards improvement in individuals with a higher score on the clinical prediction rule.
Our study has some important limitations. Interestingly we found different results when we used the dichotomous outcome of totally improved versus the 10-point Likert scale. A priori we decided our primary outcome was the dichotomous improvement, but which measure is more important and should be used is open to varying interpretations. Additionally, our study office unexpectedly closed and thus we could not recruit the number of patients we initially had planned. This limited our power to find differences between groups based on the number of cardinal clinical features. We encountered noncompliance with follow-up, as expected with the study design. We also arbitrarily stopped follow-up at 14 days, and cases that had not entirely improved were considered clinical failures in all but the Likert scale analysis. It is possible our results may have differed if we had continued to follow patients at 21 or 28 days, or if we had conducted the study at more than one office.
Methodologically, we conducted a rigorous study and showed that patients diagnosed with clinical sinusitis fared no better with amoxicillin or placebo, when measuring the patient-oriented outcome of complete improvement. But a subgroup of patients who were given antibiotics did improve at a much quicker rate. The difficulty is in clinically identifying this group and treating them with antibiotics. Conversely, using antibiotics in patients unnecessarily would only cause potential individual and societal harm. More clinically oriented studies need to be conducted to address this issue and elucidate what signs and symptoms these patients exhibit, to help clarify who should be treated with antibiotics.
ACKNOWLEDGMENTS
When this article was prepared, Dan Merenstein was an assistant professor of Family Medicine and Pediatrics at Georgetown University. This study was part of the Capricorn Research Network of Georgetown University. This projectwas supported by a grant from the American Academy ofFamily Physicians and the American Academy of FamilyPhysicians Foundation “Joint AAFP/F-AAFP Grant AwardsProgram” (JGAP). Support was also provided by the CapitolArea Primary Care Research Network. Research presentedat NAPRCG 2003, Banff, Canada.
We thank Joel Merenstein for insightful feedback and intelligent comments about study design and input with manuscript. We thank Goutham Rao and Traci Reisner for editorial help. We thank Community Drug Compounding Center of Pittsburgh and pharmacist Susan Freedenberg for drug development.
Corresponding author
Dan Merenstein, MD, Robert Wood Johnson Clinical Scholar, The Johns Hopkins Hospital, 600 North Wolfe St., Carnegie 291, Baltimore, MD 21287-6220. E-mail: dmerenstein@jhu.edu.