Effectiveness and tolerability of Tonsilgon\xae N in the treatment of recurrent upper respiratory tract infections in children: a non-interventional study in Russia

Abstract

BackgroundAcute upper respiratory tract infections (ARI) in children are quite common and often recurrent. Overuse of antibiotics must be avoided, and thus herbal remedies are a useful therapeutic option, as most ARIs can be treated without antibiotics. The aim of this observational study was to demonstrate the effectiveness and tolerability of the herbal combination preparation Tonsilgon® N in Russian children aged 2–11 years in routine practice.MethodsIn a prospective, non-interventional study a total of 518 paediatric patients (boys and girls) with ARI were enrolled at 14 study sites in Russia (2013 - 2014). Patients must have had at least two episodes of ARI in the last 6 months prior to enrolment (day 1 = visit 1). Tonsilgon® N was given as coated tablets or oral drops in age-corresponding dosages. Treatment duration was approximately 14 days (day 15 = visit 2) with a subsequent 30-day follow-up period (to day 45).The effectiveness of the therapy was assessed on the basis of objective symptoms (mucosal hyperemia and swelling of tonsils; investigator assessment at visits 1 and 2), subjective symptoms (achiness/fatigue, sore throat, pain in the extremities, headache, loss of appetite, cough, and hoarseness; parents rated and recorded the subjective symptoms in patient diaries) and responder rate. Further study parameters included time to symptom resolution, treatment compliance and concomitant medication intake. Adverse drug reactions were recorded to assess the tolerability.ResultsPatient distribution by age and gender was similar in both age groups (2–5; 6–11 years). The three most common inclusion diagnoses were nasopharyngitis, pharyngitis or tonsillitis. For these indications, the objective symptoms hyperemic mucosa and swollen tonsils nearly completely disappeared by visit 2 (range of relief: 93.4 % to 97.9 % of patients). Most subjective symptoms resolved within 4 days compared to 7 days in previous ARIs. Overall, a 3-day-shorter time to symptom resolution was achieved. 99.5 % of the patients were treatment responders, and 97 % tolerated the herbal medicine well or very well. Treatment compliance was very good (88.2 %).ConclusionsTonsilgon® N is a safe and effective treatment of acute upper respiratory tract infections in young children (aged 2–11 years) and is likely to reduce the duration of symptoms of ARI.