ORIGINAL ARTICLES   

Minerva Pediatrica 2011 October;63(5):347-54

Copyright © 2011 EDIZIONI MINERVA MEDICA

language: English

Efficacy of a new medical device based on colloidal silver and carbossimetyl beta glucan in treatment of upper airways disease in children

Damiani V. ¹, Di Carlo M. T. ², Grappasonni G. ², Di Domenico R. ², Dominici P. ³ ✉

¹ Department of Othorynolaringology, San Giovanni Addolorata Hospital, Rome, Italy; ² Private Pratictioner, Rome, Italy; ³ Medical Department, Bracco S.p.A, Milan, Italy

AIM: Nasal congestion is the main symptom in common upper respiratory diseases in childhood. Intranasal administration of sympatheticomimetics decongestants is commonly adopted for this symptom. The Italian Drug Agency stated a warning against the use of these drugs in children under 12 years of age. The aim of this study is to evaluate the efficacy on nasal symptoms and the safety of a new medical device based on colloidal silver and carbossimetyl beta glucan compared with saline solution treatment in a group of children (0-12 years) affected by viral rhinitis.
METHODS:Hundred consecutive outpatient children (0-12 year old), affected by common cold syndrome with evident nasal obstruction were randomly assigned to two type of intervention: group 1. receiving colloidal silver and carbossimetyl beta glucan; group 2. receiving saline solution. Each subject underwent clinical history and objective examination of rhinosinusal district at enrolment. Upper respiratory pathologie-related symptoms were specifically evaluated by using the Canadian Acute Respiratory Illness and Flu Scale (CARIFS).
RESULTS: A significant improvement of CARIFS score was observed into the two groups. The score improvement of these two treatment was confirmed in all the age sub-group. We observed a statistically significant difference in mean post-treatment CARIFS score and CARIFS globas VAS (Visual Analogic Scale) in children of group 1 compared with children in goup 2 (2.28±1.58 vs. 5.08±3.39; P<0.001 and VAS: 1.87±1.38 vs. VAS: 3.34±2.19; P=0.012, respectively). At the end of treatment, 90% of subjects in group 1 resulted completely recovered, whereas 10% experienced some degree of complications (otitis, tracheitis, bronchitis). In group 2 a complete recovering was achieved in 66 % of subjects, the remaining 34 % developed complications. Tolerability profiles were similar in the two groups with no statistical differences in side effects in all age subgroups.
CONCLUSION: Despite both treatments reached significative improvements in CARIFS global score and VAS and in physical examination of nasal mucosa and secretion at the end of the therapy, colloidal silver and carbossimetyl beta glucan showed a better performance with a significant difference in mean post-treatment CARIFS global score and CARIFS VAS compared to treatment with saline solution.