Clinical evaluation of the efficacy and safety of Bioaron C® in children with recurrent bacterial and viral infections of the upper respiratory tract

A. Pampura; N. Beuscher; M. Smirnova; M. Horoszkiewicz-Hassan; K. Schönknecht

doi:10.1055/s-2007-986816

Planta Medica, Table of Contents

Clinical evaluation of the efficacy and safety of Bioaron C® in children with recurrent bacterial and viral infections of the upper respiratory tract

A Pampura ¹, N Beuscher ², M Smirnova ¹, M Horoszkiewicz-Hassan ², K Schönknecht ²

¹Paediatric Medicine and Surgery Research Institute, Department of Allergology and Clinical Immunology, Rosszdrav, Russia
²Europlant PhytoPharm Sp. z o.o. Klêka 1, 63–040 Nowe Miasto nad Wartą, Poland

Abstract

Bioaron C® syrup is a popular herbal product having an immunostimulant effect. The product has been used in Poland for the treatment of upper respiratory tract infections and in the prevention of recurrent bacterial and viral infections of the upper respiratory tract. Bioaron C® syrup contains water extract of aloe leaf (Aloe arborescens Mill.), chokeberry fruit juice (Aronia melanocarpa Elliot.) and vitamin C. Pharmacological studies in Balb/c mice have shown a stimulant effect on the B-cell and T-cell responses, a post marketing clinical study good tolerability (1,2). Clinical evaluation of the efficacy of Bioaron C®^, in terms of the frequency and duration of infection in children with recurrent upper respiratory tract infections, was performed in a clinical hospital in Moscow.

The study was completed by 60 children. The group comprised 21 children aged from 3 to 6 years and 39 children aged from 6 to 12 years. The total disease duration within 6 months after medicinal product administration was reduced from 35.64±1.18 to 31.33±1.84 days (p=0.045) compared to the same individual calendar period in the previous year. In the T-cell immunity test, an increase in the relative and total T-cell counts (CD3⁺, CD4⁺, CD8) was seen; there was a statistically significant increase in the relative number of CD3⁺ and CD4⁺ and total T-cell count (CD4⁺, CD8) as well. A statistically significant reduction in the relative number of CD16+ cells was seen. In the drug safety tests, no biochemical abnormalities in blood parameters have been seen.

References: [1] Skopińska-Różewska, E., Demkow, U., Sommer, E., Nowak, K., Sievers, H. (2003), Symposium Muzyna Aloe arborescens i Aronia melanocarpa. Aloe arborescens and Aronia melanocarpa. The Role of Natural Immunomodulators in the Prevention and Treatment of Diseases. [2] Horoszkiewicz-Hassan, M. et al. (2005), Herba Polonica 2005; 5 (1/2): 45–54. The tolerance and efficacy of Bioaron C® syrup in the treatment of upper respiratory tract infections in children. The results of a postmarketing surveillance study carried out in Poland.