Nebulized bacitracin/colimycin: a treatment option in recalcitrant chronic rhinosinusitis with Staphylococcus aureus? A double-blind, randomized, placebo-controlled, cross-over pilot study.

INTRODUCTION: Despite optimal medical therapy and endoscopic sinus surgery there still remains a group of unfortunate patients suffering from exacerbations of recalcitrant chronic sinusitis. We have performed a pilot study in order to determine whether nebulized topical antibiotic therapy improves sinusitis symptoms more than saline-based placebo in patients with recalcitrant chronic rhinosinusitis. PATIENTS AND METHODS: A randomized, placebo-controlled, double-blind, cross-over pilot study was conducted in 14 patients with recalcitrant CRS. Nasal irrigation with bacitracin/colimycin or placebo using the RhinoFlow nebulizer twice daily was administered in combination with oral levofloxacin. Severity of a diversity of symptoms was measured using the VAS score, a Disease-Specific Symptom Score and the SF-36 questionnaire. Nasal endoscopic findings were also assessed.
RESULTS: For most VAS items and Disease-Specific Symptom Scores, a reduction in severity of symptoms was noted in both the bacitracin/colimycin and the placebo group. No significant difference was found between the 2 arms (bacitracin/colimycin vs. placebo). Most SF-36 items improved, compared with the situation before treatment in both groups. However no significant difference was found between the verum and placebo arm. Endoscopic findings did not reveal significant differences when comparing the 2 treatments. CONCLUSION AND DISCUSSION: The outcome of this study suggests a beneficial effect of nebulizing the nose with saline. This study again shows that adding antibiotics to local saline is not effective. Although the placebo-controlled studies looking at the effect of local antibiotics are all small they all point to the same direction: no effect. Definite conclusions however need a large randomized, multicenter study.

RCT Entities:   Population Interventions Outcomes