RESUMO
BACKGROUND: Sore throat frequently occurs in children aged between four and fifteen years and is often associated to inflammation of the upper respiratory tract mucosa. A reliable approach to limit the damage caused by inflammation and, therefore, to alleviate associated symptoms might be the protection of the mucosa. Aim of this study was to assess the efficacy and tolerability of a medical device, formulated as a gummy lozenge and containing a combination of natural functional components (Erysimum, aloe vera and Xilogel®) able to exert a barrier effect on the mucosa, as ancillary treatment in children with sore throat. METHODS: This was an observational, prospective, parallel-group, multiple-dose trial of a medical device given in association to standard pharmacological prescribed therapy with an open label comparison vs. standard pharmacological prescribed therapy alone. The outcome measures of the study were assessed at baseline and after three days of treatment. RESULTS: One hundred and twelve school children with sore throat symptoms were recruited for this study and 69 were assigned to the group taking the study product. At the end of the treatment a statistically higher reduction in Sore Throat Pain Intensity Score and Pharyngitis Symptom Score was observed in the group taking the medical device. Moreover, the treatment with the medical device is associated to a statistically significant higher improvement of Child's General Conditions. The pediatrician assessed the efficacy and tolerability of the product under study as good/very good in 91% and 94%, respectively, of treated children. The consumer satisfaction questionnaire revealed that most of the children taking the lozenge rated it very positively in regard to its flavor and easiness of administration. CONCLUSIONS: The medical device used in this study may represent a valid choice as an adjuvant treatment in children with sore throat associated to upper respiratory tract infection.
