Thursday, December 27, 2012

strong scientific support

Nasodren: strong scientific support

Over the years, many studies to prove the efficacy and safety of Nasodren have been conducted, involving around 2,000 patients. Most of these articles have been published and many of them in journals indexed in PubMed.  
Last April, Rhinology (official Journal of the International Rhinologic Society) published the article “Cyclamen europaeum nasal spray, a novel phytotherapeutic product for the management of acute rhinosinusitis: a randomized double-blind, placebo controlled trial” by Oliver Pfaar et al. From this study we obtain the following key messages:

  • Nasodren is effective and safe for the treatment of patients with ARS assessed subjectively and objectively.
  • The specific symptom of facial pain/pressure significantly improved after 5 - 7 days treatment with CE. This is important since facial pain/pressure is undoubtedly one of the most severe symptoms affecting the patient’s quality of life in ARS.
  • Endoscopic evaluation showed that mucus oedema/nasal obstruction improved significantly with CE. Improvement (defined as a sum of endoscopy scores of 0) was significantly higher with CE than placebo at the end of the study.
  • Both patients and investigators reported signi­ficantly greater treatment satisfaction with CE than placebo
  • CE is a safe product for the treatment of ARS

In March, another unique and impressive study was accepted for publication in The Laryngoscope, (organ of the American Laryngological, Rhinological and Otological Society): “An exploratory Trial of Cyclamen Europaeum Extract for Acute Rhinosinusitis” by J. Ponikau et al.
The key messages learnt from this study are:
In patients with Acute Rhinosinusitis, Cyclamen extract (Nasodren / Sinuforte):
  • Improves objective outcomes compared to placebo
  • Produces a clinically relevant symptoms improvement
  • Is the only product marketed for Rhinosinusitis that has been tested in this way (CT); other products, such as corticosteroids, antibiotics or decongestants, measure only symptomatic improvement.
The results of these studies have led, as mentioned above, to the inclusion of Cyclamen europaeum, in the EPOS 2012, the European Guidelines on Rhinosinusitis. Therefore, we can claim to possess a unique product for the treatment of this prevalent condition.

Pfaar O, Mullol J, Anders C, Hormann K, Klimek L. Cyclamen europaeum nasal spray, a novel phytotherapeutic product for the management of acute Rhinosinusitis: a randomized double-blind, placebo-controlled trial. Rhinology. 2012 Mar;50(1):37-44. PMID: 22469604
Ponikau J, Hamilos D, Barreto A, Cecil J, Jones S, Manthei S.  An exploratory trial of Cyclamen europaeum extract for acute Rhinosinusitis. Accepted for publication  Laryngoscope, March, 2012. PMID: 22675486

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