COMPARATIVE ANALYSIS OF EFFECTIVENESS AND SAFETY OF PHYTO- AND ANTIBIOTIC THERAPY OF ACUTE BRONCHITIS IN CHILDREN: RESULTS OF A MULTICENTER DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

Although viruses cause most cases of acute bronchitis, antibacterial drugs are still widely used to treat children with such diseases; this results in development of antibiotic resistance. Therefore, one of the key objectives of clinical medicine is now an effort to reduce unreasonable use of antibacterial agents. A multicenter double blind randomized clinical trial (E-BRO-PCT) involved 182 2-6-years-old children and was aimed at assessing effectiveness and safety of phytotherapy (the syrup characterized by a fixed combination of thyme herb and ivy leaf extracts) of acute bronchitis. Patients were divided into groups according to the type of therapy: phyto-, antibacterial or multimodal therapy. The level of procalcitonin (PCT) – a bacterial inflammation marker – was measured retrospectively in the blood samples of all the children obtained at inclusion to the study. Therapy effectiveness was assessed by means of overall assessment of response to treatment on day 7. The share of children with low PCT and positive response to phytotherapy was comparable to the share of children subjected to antibiotic therapy. This is also true for all the patients included in the study regardless of the PCT level. Phyto- and antibacterial therapy featured a comparable safety profile; however, according to the researchers, the former one came out slightly better. Results of this study convincingly demonstrate that phytotherapy is an effective and well-tolerated type of treatment of acute bronchitis in children.

1. Kronenberg R.S., Griffith D.E. Bronchitis and acute febrile tracheobronchitis. In: Respiratory infections. A scientific basis for management. Ed. Niederman, Sarosis, Glassroth. New York: W.B. Saunders Company. 1994. Р. 91−102.

2. Balabanova Y., Fedorin I., Kuznetsov S. et al. Antimicrobial prescribing patterns for respiratory diseases including tuberculosis in Russia: a possible role in drug resistance? JAC. 2004; 54 (3): 673−9.

3. Smith S.M., Fahey T., Smucny J., Becker L.A. Antibiotics for acute bronchitis. Cochrane Database of Systematic Reviews. 2004; Issue 4. Art. №: DC000245. Doi: 10.1002/14651858.CD000245.pub2.

4. Nyquist A.C., Gonzales R., Steiner J.F., Sande M.A. Antibiotic prescribing for children with colds, upper respiratory tract infections, and bronchitis. JAMA. 1998; 279 (11): 875−7.

5. Stratchounski L.S., Andreeva I.V., Ratchina S.A. et al. The inventory of antibiotics in Russian home medicine cabinets. Clin Infect Dis. 2003; 37 (4): 498 505.

6. Hersh A.L., Shapiro D.J., Pavia A.T. et al. Antibiotic Prescribing in Ambulatory Pediatrics in the United States. Pediatrics. 2011; 128: 1053−1061.

7. Hanberger H., Diekema D., Fluit A. et al. Surveillance of antibiotic resistance in European ICUs. J Hosp Infect. 2001; 48 (3): 161−76.

8. Shann F., Hart K., Thomas D. Acute lower respiratory tract infections in children: possible criteria for selection of patients for antibiotic therapy and hospital admission. 1984. Bull World Health Organ. 2003; 81 (4): 301−5.

9. Christ-Crain M., Jaccard-Stolz D., Bingisser R. et al. Effect of procalcitonin-guided treatment on antibiotic use and outcome in lower respiratory tract infections: cluster-randomised, single-blinded intervention trial. Lancet. 2004; 363 (9409): 600−7.

10. Little P., Stuart B., Moore M. et al. Amoxicillin for acute lower-respiratory-tract infection in primary care when pneumonia is not suspected: a 12-country, randomised, placebo-controlled trial. Lancet Infect Dis. 2013; 13 (2): 123−9.

11. Kemmerich B., Eberhardt R., Stammer H. Efficacy and tolerability of a fluid extract combination of thyme herb and ivy leaves and matched placebo in adults suffering from acute bronchitis with productive cough. A prospective, double-blind, placebo-controlled clinical trial. Arzneimittelforschung. 2006; 56 (9): 652−660.

12. Marzian O. Treatment of acute bronchitis in children and adolescents. Non-interventional postmarketing surveillance study confirms the benefit and safety of a syrup made of extracts from thyme and ivy leaves [Article in German]. MMW Fortschr Med. 2007; 149 (11): 69−74.