A randomized, open-label, multicenter, comparative study of therapeutic efficacy, safety and tolerability of BNO 1030 extract
Am J Otolaryngol. 2018 Oct 24. Epub 2018 Oct 24. PMID: 30554882
: Seventy to 95% of acute tonsillitis episodes are caused by viral infection, therefore why antibiotic therapy is not indicated in majority of cases. In such cases, acetaminophen or ibuprofen are used to alleviate the symptoms. The objective of this study was assessment of efficacy of phytoneering extract BNO 1030 (Imupret®) in patients with acute non-bacterial tonsillitis.
METHODS: This randomized, open-label, multicenter, comparative study randomised 238 outpatients aged 6-18 years to receive either BNO 1030 (Imupret®) as a supplement to standard symptomatic therapy, or standard therapy. Assessment criteria were as follows: sore throat dynamics at rest and at swallowing, throat irritation associated with cough, general condition, day of withdrawal of antipyretics, the share of treatment responders, as well as assessment of"therapeutic benefit"from the use of BNO 1030.
RESULTS: Decreased intensity of acute tonsillitis symptoms to 1 point and lower, assessed using 4-point scale starting from the day 5 of treatment (p < 0.005), alleviation of local symptoms and general condition starting from day 2 of the disease (р < 0.001), withdrawal of antipyretics starting from day 4 of treatment (p < 0.005), increase of the number of treatment responders to 81.6% (p < 0.005) versus the control were reported."Therapeutic benefit"was 4.2 days. All patients tolerated phytotherapy well, and no adverse reactions were seen.
CONCLUSION: BNO 1030 (Imupret®) is a safe and effective product for treatment of acute non-bacterial tonsillitis in children aged 6-18 years, assuring therapeutic benefit when prescribed additionally to the standard symptomatic therapy.