Multicenter, Randomized, Open-Label, Comparative Study of Therapeutic Efficacy, Safety, and Tolerability of BNO 1030 application in the technology of delayed prescription of antibiotics in patients with severe acute tonsillitis.

Acute bacterial tonsillitis occurs in 20 -30 % of immunocompetent children; however, the frequency of antibacterial drug prescriptions reaches up to 90 %. Delayed antibiotic prescription is recommended by current guidelines. The study objective was to determine the efficacy of phytoneering extract BNO 1030 in the technology of delayed antibiotic prescription in patients with severe acute tonsillitis. MethodsIn the multicenter, randomized, open-label, comparative study, 182 out of 200 randomized children with acute tonsillitis aged 6 -12 years completed the study. Evaluation criteria: a reduced severity of sore throat when swallowing and at rest, throat irritation at rest, hyperemia of the tonsils assessed by a physician according to a 4-point scale at each visit compared to Visit 1, dynamics of self-assessment of general well-being, intensity of sore throat and difficulty swallowing according to a 10-point visual analogue scale, frequency of antibiotic prescriptions, therapeutic benefit from BNO 1030 in days. ResultsThe use of phytotherapeutic medicinal product BNO 1030 in addition to the standard symptomatic treatment of severe acute tonsillitis provides a clinically significant, adequate reduction in the symptom severity assessed by a physician at V2 (p < 0.005). There are significant differences in the patients self-assessment of the symptoms from treatment Day 2 (p < 0.005). This allows to significantly reduce the duration of systemic antipyretic administration (p < 0.005). In the first days of treatment, when a decision on delay of antibiotic prescription is made, a therapeutic benefit in two days in patients of the treatment group was observed compared to the control group. The use of BNO 1030 in patients with severe acute tonsillitis significantly reduces, by 43.7 % or 2.3 times, the need for prescribing antibiotic therapy as part of the technology of delayed antibiotic prescription (p < 0.005). During treatment, no side effects and complications of the disease were recorded. ConclusionBNO 1030 is a safe and effective medicinal product for the treatment of severe acute tonsillitis in children aged 6 -12 years. It provides a significant therapeutic benefit when administered in addition to standard symptomatic therapy and reduces the irrational antibiotic prescription. Trial registrationClinicalTrials.gov Identifier: NCT04537819 https://clinicaltrials.gov/ct2/show/NCT04537819?term=ATi-2&draw=2&rank=1