Assessment of efficacy and safety of the herbal medicinal product BNO 1016 in chronic rhinosinusitis

Palm, Jürgen; Steiner, Ilse; Abramov-Sommariva, Dimitri; Ammendola, Aldo; Mitzenheim, S; Steindl, Hubert; Wonnemann, Meinolf; Bachert, Claus

doi:10.4193/rhin16.103

Cited by 23 publications

(14 citation statements)

References 2 publications

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“…The intranasal administration of EI 10 mg/mL (nasal spray) for 10 days caused a significant positive effect on the course of the induced pathological process and showed reducing signs of the inflammatory infiltration, swelling and destruction of epithelial cells. Besides, the EI impact was not inferior to the reference drug Sinupret®, which is the well-known medicine with evidence-based efficacy used for RS treatment in the national and global clinical practice (25).…”

Section: Discussionmentioning

confidence: 86%

Histomorphological Study of a New Nasal Spray with Anti-inflammatory Properties Efficacy in Rabbits with Rhinosinusitis

et al. 2020

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Introduction: The high world prevalence of rhinosinusitis (RS) initiates the ways of a favorable search for effective and safe medicines for its pathogenetic treatment. The important part of this process is the choice of the most comfortable dosage form, which will enhance therapeutic compliance and ensure the appropriate medicine efficacy and safety. Aim: To substantiate the efficacy of a new nasal spray with anti-inflammatory properties containing Enisamium Iodide (EI) at a concentration of 10 mg/mL by histomorphological study of the nasal cavity and paranasal sinuses mucosal in rabbits with experimental rhinosinusitis (ERS). Methods: EI (nasal spray) was a test object. Sinupret ® was a reference drug. ERS was induced in rabbits on the first day of the study by tamponade of the right half of the nasal cavity under general anesthesia. The study was performed using 24 rabbits (4 groups, 6 rabbits in each group). The histomorphological examination was performed on the 25 th day of the study by the standard light microscopy methods. Results: The histomorphological examination of EI 10 mg/mL (nasal spray) impact on RS in rabbits, which administered during 10 days intranasally, revealed the significant therapeutic effect presented by reduced inflammation signs in the epithelium of the nasal cavities and paranasal sinuses mucosal. Besides, the EI impact was not inferior to the reference drug Sinupret ® in tablets. The study of the pharmacological properties of the EI (nasal spray) on ERS showed the high rate of onset of EI actions when used intranasally which was superior to the rate of actions of the reference drug Sinupret ® (tablets) administered intragastrically. Conclusion: The EI (nasal spray) is a promising drug for a pathogenetic therapy of acute RS, which demands further pre-clinical and clinical studies aiming to substantiate its implementation to the clinical practice.

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Section: Discussionmentioning

confidence: 86%

Histomorphological Study of a New Nasal Spray with Anti-inflammatory Properties Efficacy in Rabbits with Rhinosinusitis

et al. 2020

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“…Sinupret® (Bionorica SE, Neumarkt, Germany) is a phytopharmaceutical that has been available for therapy of rhinosinusitis in Europe for decades, and more recently in the United States. 19,20 The product is an extract of 5 herbs: gentian root (Gentianae radix), primrose flowers (Primulae flos), elder flowers (Sambuci flos), common sorrel herb (Rumicis herba) and vervain herb (Verbenae herba). In the United States, it is considered a supplement and is not regulated by the Food and Drug Administration (FDA), but is a regulated drug in Europe.…”

Section: Introductionmentioning

confidence: 99%

Herbal dry extract BNO 1011 improves clinical and mucociliary parameters in a rabbit model of chronic rhinosinusitis

Cho

Skinner

Mackey

et al. 2019

Int Forum Allergy Rhinol

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Introduction: Enhancing chloride (Cl −) secretion in sinus epithelia represents a novel therapeutic approach to chronic rhinosinusitis (CRS). Herbal dry extract BNO 1011 enhances mucociliary clearance (MCC) via upregulation of Cl − secretion in sinonasal cultures in vitro and murine epithelium in vivo. The objective of this study is to evaluate whether the BNO 1011 improves MCC and clinical parameters in a rabbit model of CRS. Methods: After the development of CRS in 30 New Zealand white rabbits, animals were randomly assigned to receive oral placebo (n=10), BNO 1011 (low dose (LD), 25mg/kg/daily) (n=10), or BNO1011 (high dose (HD), 125mg/kg/daily) (n=10) for 4 weeks. Outcomes included sinus opacification (Kerschner's rabbit sinus CT grade), maxillary epithelial Clsecretion (sinus potential difference (PD) assay), airway surface liquid (ASL) depth using (micro optical coherence tomography (μOCT, and submucosal gland density (SMD) on histopathology. Outcome parameters were analyzed by 2 blinded investigators. Results: BNO 1011 significantly cleared sinus opacification (HD=1.21+/−0.63, LD=1.26+/ −0.37,) compared to placebo (4.02+/−0.92) (p=0.009). BNO 1011 resulted in markedly greater mean sinus PD polarization (HD=−12.23+/−1.4mV, LD=−12.0+/−3.0mV) when compared to rabbits treated with placebo (−4.1+/−1.1mV) (p=0.03). ASL depth was significantly improved when treated with HD (4.08+/−0.06μm) and LD (4.05+/− 0.06μm) compared to placebo (3.5+/

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“…In our study we focused on symptom relief and health-related QoL patterns by using the MSS, SNOT-22 and patients' verbally rated QoL as outcome measures. The MSS was explicitly designed to measure the severity of the most relevant rhinosinusitis symptoms and has been previously applied in numerous rhinosinusitis clinical trials in this field (5,40,(44)(45)(46) . Our results revealed a significant improvement of the mean MSS in verum treated patients after 7 days of full medication (p<0.001), however, the initially aimed-for difference of 20% in the mean MSS between Tavipec® and placebo after both 4 and 7 days of full medication was not achieved.…”

Section: Discussionmentioning

confidence: 99%

Tavipec® in acute rhinosinusitis: a multi-centre, doubleblind, randomized, placebo-controlled, clinical trial

Dejaco

Bocian-Sobkowska²,

Szymański³

et al. 2019

Rhin

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Background: This randomized clinical trial was designed to evaluate the efficacy and safety of Tavipec® (Spicae aetheroleum), a phytomedicine obtained by steam distillation of the flowering tops of Lavandula latifolia, as compared to placebo in adult patients suffering from acute viral rhinosinusitis. Methodology: Patients with acute viral rhinosinusitis were randomly assigned to treatment with 2 capsules Tavipec® 150 mg or placebo thrice daily over a period of 7 days in a double-blind, parallel-group design. No additional treatment was admitted. The efficacy endpoints comprised the improvement of the main rhinosinusitis symptoms as per Major Symptom Score (MSS) and Sino-Nasal Outcome Test (SNOT-22) as well as of quality of life (QoL) by global assessment scale, evaluated at baseline, day 5 and day 8, respectively. Results: 288 patients were enrolled and randomized to treatment. At day 8 the patients in the Tavipec® group had a significantly lower MSS compared to placebo and the impact of rhinosinusitis symptoms on QoL was significantly reduced. A significantly higher proportion of Tavipec® treated patients experienced a change in SNOT-22 score ≥ 10 points at day 5 or day 8. No new safety signals were identified. Conclusions:The treatment with Tavipec® effectively reduced the symptoms of acute rhinosinusitis in adult patients.

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Assessment of efficacy and safety of the herbal medicinal product BNO 1016 in chronic rhinosinusitis

Cited by 23 publications

References 2 publications

Histomorphological Study of a New Nasal Spray with Anti-inflammatory Properties Efficacy in Rabbits with Rhinosinusitis

Histomorphological Study of a New Nasal Spray with Anti-inflammatory Properties Efficacy in Rabbits with Rhinosinusitis

Herbal dry extract BNO 1011 improves clinical and mucociliary parameters in a rabbit model of chronic rhinosinusitis

Tavipec® in acute rhinosinusitis: a multi-centre, doubleblind, randomized, placebo-controlled, clinical trial

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