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

Bioaron C® syrup is a popular herbal product having an immunostimulant effect, which 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 [1]. A postmarketing surveillance study of the tolerance and the effect of the drug on the course of upper respiratory tract infections in children aged 3 to 10 years susceptible to upper respiratory tract infections was also performed. Monotherapy with Bioaron C® was shown to be the best in the treatment of rhinitis and bronchitis symptoms, and in particular such components as: congested and runny nose, cough and hoarseness. Monotherapy with Bioaron C®was shown to be effective in the treatment of airborn viral infections. Bioaron C® syrup was very well tolerated [2].

Study objective

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, and evaluation of the effect of therapy with Bioaron C® syrup on B-cell and T-cell immune status and phagocytic activity.

Material and methods

Study design: open-label clinical trial; the study was carried out at the Department of Allergology and Clinical Immunology, Paediatric Medicine and Surgery Research Institute in Rosszdrav. Study population: 71 children aged 3 to 12 years including 27 children aged 3 to 6 years and 42 children aged 6 to 12 years in whom there were >6 upper respiratory tract infections in the last 12 months, and the total disease duration was ³ 30 days within the last 6 months. The patients took Bioaron C® syrup according to the manufacturer's instructions for 14 days. Blood samples were taken for immune and clinical chemistry tests on study days 0 and 15. The evaluation of the children's condition was performed by a medical doctor at inclusion (day 0), on study day 1 and 15 and 6 months after study commencement. Study duration: 6 months.

Results

The study was completed by 60 children, which were already registered patients in this hospital before. The group comprised 21 children aged 3 to 6 years and 39 children aged 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 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. A change in the subpopulation composition of T-cells depending on the baseline status was shown. With the reduced baseline values, there was an increasing tendency; however, where the number of T-cells was too high or at the upper normal limit, a reduction in this value was usually seen. The same situation was observed in relation to B-cells.

The results of tests have shown an immunomodulatory model of effect of Bioaron C® syrup. In the phagocytic activity test, a modulatory effect of the drug on the phagocytic activity of neutrophils was also seen (a statistically significant increase or reduction in the Phagocytic Index depending on the baseline status). In the drug safety tests, no biochemical abnormalities in blood parameters have been seen (total protein, ALT, AST, urea, creatinine, glucose) during the therapy with Bioaron C®. During the study, 9.1% of children experienced the following adverse effects: allergic reactions in 4 children with a history of allergic diseases, diarrhoea in 1 child with a history of coeliac disease, and nausea and vomiting in 1 child.

Conclusions

The 14-day preventive application of Bioaron C® in children with recurrent upper respiratory tract infections was associated with a reduction of infection incidence in this group. The immunomodulatory effect of the drug depends on the baseline condition and is manifested by the effect on T-cell immunity and the phagocytic activity of the neutrophils.

[1] Skopińska- Różewska E, Demkow U, Sommer E, Nowak K, Sievers H: Aloe arborescens i Aronia melanocarpa. Rola Immunomodulatorów Pochodzenia Naturalnego W Zapobieganiu i Leczeniu Chorób. [Aloe arborescens and Aronia melanocarpa. The role of natural immunomodulators in the prevention and treatment of Diseases.] Muszyna 2003.

[2] Horoszkiewicz-Hassan M, Beuscher N, Lehnfeld R, Theiß U, Pfarr U: Tolerancja i skutecznoŘć syropu Bioaron C® w leczeniu infekcji górnych dróg oddechowych u dzieci. Wyniki postmarketingowego badania obserwacyjnego przeprowadzonego w Polsce. [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.] Herba Polonica 2005; 5(1/2): 45–54.