A randomized, open-label, multicentre, comparative study of therapeutic efficacy, preventive potential and tolerability of BNO 1030 extract, containing Althea root, Chamomile flowers, horsetail herb, walnut leaves, yarrow herb, oak bark, dandelion herb in the treatment of acute non-bacterial tonsillitis in children aged 6 to 18 years

Abstract

Abstract Acute tonsillitis tends to recur. In cases where patients do not meet the Paradise criteria, the possibilities of non-surgical treatment are more often considered. The objective of this study was to evaluate the therapeutic efficacy during the long-term follow-up and the effect on the recurrence of the phytoneering extract BNO 1030 (Imupret®) in patients with acute non-bacterial tonsillitis. Methods In this Randomized, Open-Label, Multicentre, Comparative Study, 238 outpatients aged 6–18 years were randomized to receive either BNO 1030 (Imupret®) for 4 weeks in addition to standard symptomatic treatment, or to receive standard treatment. Evaluation criteria: reduction in the symptom severity less than 1 point, the number of tonsillitis recurrences at each control point after 3, 6 and 12 months during the one-year follow-up. Results A significant reduction in the severity of local symptoms and the general condition at each control point within the year of follow-up and a significant decrease (by 66.56%) in the recurrence rate of tonsillitis were noted. The anti-recurrent action was manifested during within the year of follow-up. All patients tolerated phytotherapy well; no adverse reactions were noted. Conclusions BNO 1030 (Imupret®) is a safe and effective medicinal product for acute non-bacterial tonsillitis in children aged 6–18 years. In addition to the main symptomatic treatment, it leads to a significant reduction in the clinical manifestations and the number of recurrences of tonsillitis within the year of follow-up. Trial registration This trial was registered in German Clinical Trials Register retrospectively on June 27, 2018. Trial Acronym: ATi-1 DRKS-ID: DRKS00015020

Keywords

• Acute tonsillitis
• Recurrent tonsillitis
• Recurrence
• Phytotherapy
• BNO 1030
• Imupret®