Abstract

BackgroundRecalcitrant chronic rhinosinusitis without polyposis (CRSsP) is a challenging condition to manage as traditional medical therapies and surgery fail to provide satisfactory clinical improvements. Colloidal silver (CS), a widely used naturopathic agent, has recently shown anti-biofilm properties both in vitro and within a rhinosinusitis animal model. To date, no trials involving humans have been published in world literature. The purpose of this study was to assess the efficacy of CS as a topical nasal spray in patients with refractory CRSsP.MethodsA prospective cohort study was conducted using a convenience sample of 20 randomized patients with crossover methodology, comparing nasal sprays with CS versus saline. Patients sprayed twice daily for six weeks with the first intervention and then switched to the second for the next six weeks, with measurements made at baseline and each time point. Primary outcomes were changes in SNOT-22 and Lund-Kennedy (LK) endoscopic scores. All analysis was non-parametric and was conducted using STATA 14.ResultsTwenty-two patients were enrolled in the study with 20 completing the entire protocol. Mean 6-week change in SNOT-22 scores were −2.8 and 1.0 for saline and CS, respectively (p = 0.373). Similarly, mean 6-week change in LK scores were −1.4 and −1.1 for saline and CS, respectively (p = 0.794). Significant period effects were observed with the SNOT-22 score between the randomized groups. No participants experienced negative health effects directly attributable to the administration of intranasal CS.ConclusionCommercially available CS nasal spray did not demonstrate any meaningful subjective or objective improvements in patients with recalcitrant CRSsP.Trial registrationNCT02403479. Registered on March 1, 2015.

Highlights

  • Recalcitrant chronic rhinosinusitis without polyposis (CRSsP) is a challenging condition to manage as traditional medical therapies and surgery fail to provide satisfactory clinical improvements

  • The purpose of this study was to assess the efficacy of Colloidal silver (CS) as a topical nasal spray in patients with recalcitrant Chronic rhinosinusitis (CRS)

  • In Group 1 (n = 10), two patients withdrew from the study during the second 6 weeks of the trial, and both withdrew while using the CS nasal spray

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Summary

Introduction

Recalcitrant chronic rhinosinusitis without polyposis (CRSsP) is a challenging condition to manage as traditional medical therapies and surgery fail to provide satisfactory clinical improvements. For the subset of patients who fail conservative treatment strategies surgical intervention is typically recommended [1, 2]. Despite all these efforts, between 6% and. Predicting which patients will have treatment resistant CRS is challenging and has not yet been completely characterized in the literature but bacterial biofilms and changes to the microbiome are believed to play an important role [4]. The reported prevalence of biofilms ranges somewhat within CRS populations but was quoted to be as high as 75% in a recent review published by Tatar et al

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