Lay Summary: Aerosolized antibiotics for chronic sinusitis are investigational.
The SinuNEB (SinusPharmacy) is a device that nebulizes antibiotics, anti-fungals, and medications for the treatment of sinusitis. According to the manufacturer of the SinuNEB, administration of anti-infectives via nebulization directly to the lining of the sinuses results in a more rapid response, greater effectiveness, reduced re-infection, and fewer side effects than oral or intravenous anti-infective administration. The brand name for the unique formulations used by SinusPharmacy in their treatment of sinusitis is AdhesENT. These special formulations supposedly can increase the medication’s adherence in the sinus cavities, and improve the effectiveness of the aerosolized treatment by allowing delivery to the disease site.
However, there are insufficient published clinical studies to support these claims. SinusPharmacy (Scheinberg, et al., 2002) reported on the results of an uncontrolled study of nebulized antibiotics 41 patients with sinusitis, reported an “excellent” or “good” outcome in 34 patients (82%) after 3 to 6 weeks of treatment.. Vaughan & Carvahlo (2002) reported on a retrospective chart review of patients with chronic sinusitis who were treated with nebulized antibiotics. The investigators reported clearing of the initial bacteria that the nebulized antibiotic was directed against in 28 patients, clearing of infection and a new infection with a different organism in 10 patients, clearing and re-infection with the same organism in six patients, and persistent infection in six patients. Because these were not prospective, randomized studies, no firm conclusions about the effectiveness of nebulized antibiotics in sinusitis can be drawn from these studies.
The only published randomized clinical study of nebulized antibiotics found that nebulized antibiotics had no significant effect. A randomized clinical study from Desrosiers, et al. (2001) involving 20 patients with chronic, refractory sinusitis found no clinically significant difference in effectiveness between nebulized tobramycin-saline solution and nebulized saline. These results lead the authors to conclude that “addition of tobramycin [to saline nebulizer] appears to be of minimal benefit.”