Planta Med 2013; 79 - PB29
DOI: 10.1055/s-0033-1351974

Accelerated remission of symptoms of acute viral rhinosinusitis with a dry extract of five herbal drugs (BNO 1016)

R Jund 1, M Mondigler 2, H Steindl 2, H Stammer 3, P Stierna 4, C Bachert 5
  • 1Lochhauser Str.2 – 4, 82178 Puchheim, Germany
  • 2Bionorica SE, Kerschensteinerstr.11 – 15, 92318 Neumarkt, Germany
  • 3Pharmalog GmbH, Neumarkter Straße 18, 81673 Munich, Germany
  • 4Karolinska Institut, 14186 Stockholm, Sweden
  • 5Ghent University Hospital, De Pintelaan 185, 9000 Ghent, Belgium

Background:

BNO 1016 is a dry extract composed of the five herbal drugs Gentian root, Primula flower, Sorrel herb, Elder flower and Verbena herb (ratio 3:3:3:3:1). Clinical efficacy of BNO 1016 was proven in a clinical trial (ARhiSi-2) by visualising a significant group difference regarding the major symptom score (MSS) at the end of treatment1. Here we show the group difference for the per protocol (PP) analysis set and how the difference translates into an acceleration of disease remission.

Methods:

In this randomised placebo-controlled clinical trial in line with EPOS 2012 386 patients with sonographically confirmed acute viral rhinosinusitis were treated with 480 mg BNO 1016 or placebo for a period of 15 days. Primary efficacy criterion was the investigator assessed mean MSS at end of treatment. A difference of 1 score point was prospectively defined as clinically relevant. Additionally, it was analysed how much faster remission of symptoms occurred in the BNO 1016-treated group compared to placebo.

Results:

300 patients were analysed in the PP analysis set (BNO 1016: n = 147; placebo: n = 153). The MSS at end of treatment was 3.47 ± 0.28 for placebo and 2.07 ± 0.18 for the BNO 1016-treated group, resulting in a group difference of 1.40 ± 0.28 score points at end of treatment (p < 0.0001). In the BNO 1016-treated group a MSS of 3.47 was reached approximately 3.8 days earlier than in the placebo treated group.

Conclusion:

BNO 1016 demonstrated a significant and clinically relevant improvement of symptoms, documented by a group difference of 1.40 score points at end of treatment. Remission of symptoms for the BNO 1016-treated group is accelerated by 3.8 days compared to placebo.

Reference:

[1] Jund R et al. Rhinology online 2012