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

ABSTRACT: 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.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.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.Commercially available CS nasal spray did not demonstrate any meaningful subjective or objective improvements in patients with recalcitrant CRSsP.NCT02403479 . Registered on March 1, 2015.

SUBMITTER: Scott JR

PROVIDER: S-EPMC5702207 | biostudies-literature | 2017 Nov

REPOSITORIES: biostudies-literature

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

Scott John R JR Krishnan Rohin R Rotenberg Brian W BW Sowerby Leigh J LJ

Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale 20171125 1

<h4>Background</h4>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 ...[more]

PMID: 29178954

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Project description:OBJECTIVE:The aim of this prospective multicenter randomized controlled trial was to compare the efficacy of silver nitrate cauterization against that of topical steroid ointment in the treatment of neonatal umbilical granuloma. METHODS:An open-label, non-inferiority randomized controlled trial was conducted from January 2013 to January 2016. The primary endpoint for the silver nitrate cauterization and topical steroid ointment groups was the healing rate after 2 weeks of treatment, applying a non-inferiority margin of 10%. The healing rate was evaluated until completion of 3 weeks of treatment. RESULTS:Participants comprised 207 neonates with newly diagnosed umbilical granuloma, randomized to receive silver nitrate cauterization (n = 104) or topical steroid ointment (n = 103). Healing rates after 2 weeks of treatment were 87.5% (91/104) in the silver nitrate cauterization and 82% (82/100) in the topical steroid ointment group group. The difference between groups was -5.5% (95% confidence interval, -19.1%, 8.4%), indicating that the non-inferiority criterion was not met. After 3 weeks of treatment, the healing rate with topical steroid ointment treatment was almost identical to that of silver nitrate cauterization (94/104 [90.4%] vs. 91/100 [91.0%]; 0.6% [-13.2 to 14.3]). No major complications occurred in either group. CONCLUSIONS:This study did not establish non-inferiority of topical steroid ointment treatment relative to silver nitrate cauterization, presumably due to lower healing rates than expected leading to an underpowered trial. However, considering that silver nitrate cauterization carries a distinct risk of chemical burns and that the overall efficacy of topical steroid ointment treatment is similar to that of silver nitrate cauterization, topical steroid ointment might be considered as a good alternative in the treatment of neonatal umbilical granuloma due to its safety and simplicity. To clarify non-inferiority, a larger study is needed.

Project description:ObjectivesThe concept of disease control incorporates independent disease characteristics that are longitudinally reflective of disease status and which can be used to make treatment decisions. Chronic rhinosinusitis (CRS) is a chronic condition for which the determination of disease control by both the patient and the treating physician is important. Our objectives were to determine CRS disease characteristics that are associated with patient-reported and physician-rated CRS disease control.Study typeCross-sectional.MethodsA total of 209 participants were prospectively recruited. Participants were asked to rate their global level of CRS control as "not at all," "a little," "somewhat," "very," and "completely." All participants completed a 22-item Sinonasal Outcome Test (SNOT-22) and also reported the number of sinus infections, CRS-related antibiotic courses taken, CRS-related oral corticosteroid courses taken, and missed days of work or school due to CRS, all in the last 3 months. Clinical and demographic characteristics were also collected from each participant. A Lund-Kennedy endoscopy score was calculated for each participant from nasal endoscopy. Two rhinologists were then given each participant's SNOT-22 score (as well as SNOT-22 nasal, sleep, otologic/facial pain, and emotional subdomain scores), endoscopy score, and the number of sinus infections, CRS-related antibiotics, CRS-related oral corticosteroid courses and missed days of work or school due to CRS in the preceding 3 months as reported by the patient. The two rhinologists were blinded to all other participant characteristics and each rhinologist independently rated every participant's global control level as "not at all," "a little," "somewhat," "very," and "completely." Associations were sought between CRS disease characteristics (SNOT-22 score, endoscopy score, sinus infections, CRS-related antibiotic usage, CRS-related oral corticosteroid usage, and lost productivity due to CRS) and patient-reported CRS control as well as mean physician-rated CRS control.ResultsPatient-reported global CRS control was associated only with SNOT-22 (adjusted relative risk [RR]?=?0.99, 95% CI: 0.98-0.99, P?<?.001) but no other CRS disease characteristic. Patient-reported CRS control was specifically associated only with nasal symptoms and not extra-nasal symptoms of CRS. Physician-rated CRS control was associated with SNOT-22 score (adjusted RR [for each 1-unit increase of SNOT-22]?=?0.99, 95% CI: 0.98-0.99, P?<?.001), number of acute bacterial CRS exacerbations-reflected by number of antibiotic courses taken (or sinus infections)-in the last 3 months (adjusted RR?=?0.89, 95% CI: 0.82-0.98, P?=?.014) and the number of CRS-related oral corticosteroid courses taken in the last 3 months (adjusted RR?=?0.87, 95% CI: 0.78-0.97, P?=?.012). Nasal, sleep, and otologic/facial pain symptoms were all associated with physician-rated CRS control. Having used at least one course of antibiotics or oral corticosteroids in the last 3 months was the optimal threshold for detecting poorly controlled CRS.ConclusionsPatients and physicians use different criteria to determine the level of CRS control. While both rely on the burden of CRS symptomatology, patients consider primarily nasal symptoms while physicians include nasal and extra-nasal symptoms of CRS in determining CRS control. Physicians also independently consider CRS-related antibiotic use, as a reflection of acute bacterial CRS exacerbations, and CRS-related oral corticosteroid use in the determination of global CRS control.Level of evidence2c.

Dataset Information

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

Publications

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

Similar Datasets

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