The effectiveness of topical colloidal silver in recalcitrant chronic rhinosinusitis: a randomized crossover control trial

John R Scott, Rohin Krishnan, Brian W Rotenberg, Leigh J Sowerby, John R Scott, Rohin Krishnan, Brian W Rotenberg, Leigh J Sowerby

Abstract

Background: Recalcitrant 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.

Methods: A 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.

Results: Twenty-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.

Conclusion: Commercially available CS nasal spray did not demonstrate any meaningful subjective or objective improvements in patients with recalcitrant CRSsP.

Trial registration: NCT02403479 . Registered on March 1, 2015.

Keywords: Chronic rhinosinusitis; Colloidal silver; Effectiveness; Nasal spray; Recalcitrant; Topical.

Conflict of interest statement

Ethics approval and consent to participate

Health sciences research ethics board approval was granted from Western University (File No. 106309). All patients provided consent to participate in the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Patient flow diagram. CS- colloidal silver; SL- saline

References

    1. Desrosiers M, Evans GA, Keith PK, et al. Canadian clinical practice guidelines for acute and chronic rhinosinusitis. J Otolaryngol Head Neck Surg. 2011;40(Suppl 2):S99–193.
    1. Orlandi RR, Kingdom TT, Hwang PH, et al. International consensus statement on allergy and rhinology: rhinosinusitis. Int Forum Allergy Rhinol. 2016;6:S22–S209.
    1. Fokkens WJ, Lund VJ, Mullol J, et al. European position paper on rhinosinusitis and nasal polyps 2012. Rhinol Suppl. 2012;23:3.
    1. Foreman A, Wormald PJ. Different biofilms, different disease? A clinical outcomes study. Laryngocope. 2010;120:1701–1706. doi: 10.1002/lary.21024.
    1. You H, Zhuge P, Li D, et al. Factors affecting bacterial biofilm expression in chronic rhinosinusitis and the influences on prognosis. Am J Otolaryngol. 2011;32:583–590. doi: 10.1016/j.amjoto.2010.11.017.
    1. Sanclement JA, Webster P, Thomas J, Ramadan HH. Bacterial biofilms in surgical specimens of patients with chronic rhinosinusitis. Laryngoscope. 2005;115:578–582. doi: 10.1097/01.mlg.0000161346.30752.18.
    1. Palmer J. Bacterial biofilms in chronic rhinosinusitis. Ann Otol Rhinol Laryngol. 2006;196:35–39. doi: 10.1177/00034894061150S906.
    1. Psaltis AJ, Ha KR, Beule AG, Tan LW, Wormald PJ. Confocal scanning laser microscopy evidence of biofilms in patients with chronic rhinosinusitis. Laryngoscope. 2007;117:1302–1306. doi: 10.1097/MLG.0b013e31806009b0.
    1. Tatar EC, Tatar I, Ocal B, et al. Prevalence of biofilms and their response to medical treatment in chronic rhinosinusitis without polyps. Otolaryngol Head Neck Surg. 2012;146:669–675. doi: 10.1177/0194599811434101.
    1. Ramakrishnan Y, Shields RC, Elbadawey MR, Wilson JA. Biofilms in chronic rhinosinusitis: what is new and where next? J Laryngol Otol. 2015;129:744–751. doi: 10.1017/S0022215115001620.
    1. Singhal D, Foreman A, Jervis-Bardy J, Wormald PJ. Staphylococcus Aureus biofilms: nemesis of endoscopic sinus surgery. Laryngoscope. 2011;121:1578–1583. doi: 10.1002/lary.21805.
    1. Rai M, Yadav A, Gade A. Silver nanoparticles as a new generation of antimicrobials. Biotechnol Adv. 2009;27:76–83. doi: 10.1016/j.biotechadv.2008.09.002.
    1. Atiyeh BS, Costagliola M, Hayek SN, Dibo SA. Effect of silver on burn wound infection control and healing: review of the literature. Burns. 2007;33:139–148. doi: 10.1016/j.burns.2006.06.010.
    1. Chernousova S, Epple M. Silver as antibacterial agent; ion, nanoparticle, and metal. Angew Chem Int Ed. 2013;52:1636–1653. doi: 10.1002/anie.201205923.
    1. Zhang XF, Liu ZG, Shen W, Gurunathan S. Silver nanoparticles: synthesis, characterization, properties, applications, and therapeutic approaches. Int J Mol Sci. 2016;17:1534–1568. doi: 10.3390/ijms17091534.
    1. Goggin R, Jardeleza C, Wormald PJ, Vreugde S. Colloidal silver: a novel treatment for Staphylococcus Aureus biofilms? Int Forum Allergy Rhinol. 2014;4:171–175. doi: 10.1002/alr.21259.
    1. Rajiv S, Drilling A, Bassiouni A, James C, Vreugde S, Wormald PJ. Topical collidal silver as an anti-biofilm agent in a Staphylococcus Aureus chronic rhinosinusitis sheep model. Int Forum Allergy Rhinol. 2015;5:283–288. doi: 10.1002/alr.21459.
    1. Hopkins C, Gillett S, Slack R, Lund VJ, Browne JP. Psychometric validity of the 22-item Sinonasal outcome test. Clin Otolaryngol. 2009;34:447–454. doi: 10.1111/j.1749-4486.2009.01995.x.
    1. Lund VJ, Kennedy DW. Staging for rhinosinusitis. Otolaryngol Head Neck Surg. 1997;117:S35–S40. doi: 10.1016/S0194-5998(97)70005-6.
    1. Rank MA, Wollan P, Kita H, Yawn BP. Acute exacerbations of chronic rhinosinusitis occur in a distinct seasonal pattern. J Allergy Clin Immunol. 2010;1:168–169. doi: 10.1016/j.jaci.2010.03.041.
    1. Raimondo L, Garzaro M, Molinaro L. Iatrogenic rhinopharyngeal isolated argyria induced by silver-containing nasal drug. J Craniofac Surg. 2014;2:149–151. doi: 10.1097/SCS.0000000000000416.
    1. Hadrup N, Lam HR. Oral toxicity of silver ions, silver nanoparticles and colloidal silver- a review. Regul Toxicol Pharmacol. 2014;68:1–7. doi: 10.1016/j.yrtph.2013.11.002.
    1. Chung IS, Lee MY, Shin DH, Jung HR. Three systemic argyria cases after ingestion of colloidal silver solution. Int J Dermatol. 2010;49:1175–1177. doi: 10.1111/j.1365-4632.2009.04380.x.
    1. Kim Y, Suh HS, Cha HJ, et al. A case of generalized argyria after ingestion of colloidal silver solution. Am J Ind Med. 2009;52:246–250. doi: 10.1002/ajim.20670.
    1. Thomas WW, Harvey RJ, Rudmik L, Hwang PH, Schlosser RJ. Distribution of topical agents to the paranasal sinuses: an evidence-based review with recommendations. Int Forum Allergy Rhinol. 2013;9:691–703. doi: 10.1002/alr.21172.

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