Efficacy of gummy lozenges containing erysimum as ancillary treatment in children with sore throat.

Abstract

BACKGROUND\nSore throat frequently occurs in children aged between 4 and 15 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.\n\n\nMETHODS\nThis 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 3 days of treatment.\n\n\nRESULTS\n112 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 paediatrician 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 flavour and easiness of administration.\n\n\nCONCLUSIONS\nThe 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.