Efficacy and effectiveness of the herbal medicinal product BNO 1016 in the management of acute rhinosinusitis in the context of antibiotic stewardship.
| Autor: | Bittner CB; Research & Development, Bionorica SE, Neumarkt i. d. OPf, Germany., Steindl H; Research & Development, Bionorica SE, Neumarkt i. d. OPf, Germany., Abramov-Sommariva D; Research & Development, Bionorica SE, Neumarkt i. d. OPf, Germany., Plach M; Research & Development, Bionorica SE, Neumarkt i. d. OPf, Germany., Abels C; Research & Development, Bionorica SE, Neumarkt i. d. OPf, Germany., Bachert C; Department of Otorhinolaryngology, Head and Neck Surgery, University of Muenster, Muenster, Germany. |
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| Jazyk: | angličtina |
| Zdroj: | Postgraduate medicine [Postgrad Med] 2023 Aug; Vol. 135 (6), pp. 607-614. Date of Electronic Publication: 2023 Jul 25. |
| DOI: | 10.1080/00325481.2023.2234274 |
| Abstrakt: | Objectives: To substantiate the clinical efficacy and investigate the real-world effectiveness of the herbal medicinal product BNO 1016 in acute rhinosinusitis (ARS) in the context of antibiotic stewardship. Methods: We performed a meta-analysis of the clinical trials ARhiSi-1 (EudraCT No. 2008-002794-13) and ARhiSi-2 (EudraCT No. 2009-016682-28) comprising 676 patients, analyzing the reduction of the Major Symptom Score (MSS) and improvement of the Sino-Nasal Outcome Test 20 (SNOT-20) by the herbal medicinal product BNO 1016. In addition, we performed a retrospective cohort study including 203,382 patients, comparing the real-life effectiveness of BNO 1016 in reducing ARS-related adverse outcomes in comparison to antibiotics and several other established therapies. Results: Treatment with BNO 1016 ameliorated symptoms of ARS by reducing MSS by 1.9 points ( p < 0.0001) and improved quality of life (QoL) for patients by improving SNOT-20 by 3.5 points ( p = 0.001) in comparison to placebo. In patients with moderate/severe symptoms, the positive effects of BNO 1016 were even more pronounced (MSS: -2.3 points ( p < 0.0001); SNOT-20: -4.9 points ( p = 0.0158)). In addition, treatment with BNO 1016 was as effective or significantly more effective in reducing the risk for adverse ARS-related outcomes such as follow-up antibiotic prescriptions, sick leave ≥7 days or medical appointments due to ARS, especially when compared to antibiotics. Conclusion: BNO 1016 is a safe and effective treatment for ARS that can help reduce the overuse of antibiotics. |
| Databáze: | MEDLINE |
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