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.

中文翻译：

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草药产品 BNO 1016 在抗生素管理背景下治疗急性鼻窦炎的功效和效果

摘要

目标

旨在证实草药产品 BNO 1016 在抗生素管理背景下治疗急性鼻窦炎 (ARS) 的临床疗效并研究其真实有效性。

方法

我们对包含 676 名患者的临床试验 ARhiSi-1（EudraCT 编号 2008-002794-13）和 ARhiSi-2（EudraCT 编号 2009-016682-28）进行了荟萃分析，分析了主要症状评分的降低（ MSS）以及草药产品 BNO 1016 改善鼻腔结果测试 20 (SNOT-20)。此外，我们还进行了一项包括 203,382 名患者的回顾性队列研究，比较了 BNO 1016 在减少 ARS 方面的实际效果与抗生素和其他几种既定疗法相比，相关的不良后果。

结果

与安慰剂相比，BNO 1016 治疗可通过将 MSS 降低 1.9 分 ( p < 0.0001)来改善 ARS 症状，并通过将 SNOT-20 提高 3.5 分 ( p  = 0.001) 来 改善患者的生活质量 (QoL) 。对于中度/重度症状的患者，BNO 1016 的积极作用甚至更加明显（MSS：-2.3 分（p  < 0.0001）；SNOT-20：-4.9 分（p  = 0.0158））。此外，BNO 1016 治疗在降低 ARS 相关不良后果（例如后续抗生素处方、病假 ≥7 天或因 ARS 导致的医疗预约）方面同样有效或显着更有效，尤其是与抗生素相比。

结论

BNO 1016 是一种安全有效的 ARS 治疗方法，有助于减少抗生素的过度使用。