Efficacy and effectiveness of the herbal medicinal product BNO 1016 in the management of acute rhinosinusitis in the context of antibiotic stewardship.

IF 2.6 4区医学 Q1 MEDICINE, GENERAL & INTERNAL Postgraduate Medicine Pub Date : 2023-08-01 DOI:10.1080/00325481.2023.2234274

Claudia B Bittner, Hubert Steindl, Dimitri Abramov-Sommariva, Michael Plach, Christoph Abels, Claus Bachert

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引用次数: 1

Abstract

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.

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中草药产品bno1016在抗生素管理下治疗急性鼻窦炎的疗效和有效性。

目的:在抗生素管理的背景下，证实中草药bno1016治疗急性鼻窦炎(ARS)的临床疗效并探讨其实际疗效。方法:对临床试验ARhiSi-1 (EudraCT No. 2008-002794-13)和ARhiSi-2 (EudraCT No. 2009-016682-28) 676例患者进行meta分析，分析中草药BNO 1016对主要症状评分(MSS)的降低和对鼻-鼻预后测试20 (SNOT-20)的改善。此外，我们进行了一项包括203,382例患者的回顾性队列研究，比较了BNO 1016与抗生素和其他几种已建立的治疗方法相比，在减少ars相关不良后果方面的实际有效性。结果:与安慰剂相比，bno1016治疗通过将MSS降低1.9个点(p p = 0.001)改善了ARS的症状。在中度/重度症状患者中，bno1016的积极作用更为明显(MSS: -2.3分(p p = 0.0158))。此外，与抗生素相比，BNO 1016治疗在降低ARS相关不良结局(如随访抗生素处方、病假≥7天或因ARS而进行的医疗预约)的风险方面同样有效或显著更有效。结论:bno1016治疗ARS安全有效，可减少抗生素的过度使用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Postgraduate Medicine 医学-医学：内科

CiteScore

6.10

自引率

2.40%

发文量

110

审稿时长

6-12 weeks

期刊介绍： Postgraduate Medicine is a rapid peer-reviewed medical journal published for physicians. Tracing its roots back to 1916, Postgraduate Medicine was established by Charles Mayo, MD, as a peer-to-peer method of communicating the latest research to aid physicians when making treatment decisions, and it maintains that aim to this day. In addition to its core subscriber base, Postgraduate Medicine is distributed to hundreds of US-based physicians within internal medicine and family practice.