On examining the pros and cons of the extract of Cyclamen europaeum L. for ARS treatment, one othe main advantages of this treatment is that it offers therapeutically multi-action functions, opening the ostiomeatal complex, and activating the mucociliary system. Consequently, it increases the drainage of mucus retained in the sinonasal area; produces fast dehydration

and a detumescent effect (calms and relieves swelling). Unlike other products used in Rhinosinusitis treatment, Nasodren is not indicated for a specific etiology, but rather aimed at improving the symptomatology regardless of the cause that produces it.

This Product has no systemic effect while producing positive effects when treating Acute Rhinosinusitis. To understand how this is possible, it is necessary to look at the way that Cyclamen europaeum L. extract acts.

Without being dispersed through the entire mucosa of the nose, and possibly not even entering the sinuses at all, the Cyclamen europaeum L. extract produces a positive effect. The main secret that may be behind Cyclamen europaeum L. is the saponins, which produce a nociceptive response from the trigeminal nerve. A type of reflex is produced, thereby stimulating secretion and also ciliary transport

In actual fact, the saponins stimulate the lipid membranes of the neuronal cells in the sinuses, thereby producing a reflex that stimulates secretion. Additional advantages the action of this extract offers in treating Acute and Chronic Rhinosinusitis are helping to dilute secretions, as well as increasing the transport of said secretions. So, finally there are some innovative new treatment options in Rhinosinusitis.

There have already been a number of studies carried out on this new Product, the most interesting of which have been selected for this presentation to illustrate the effectiveness of Cyclamen europaeum L. One study (Trial code 4334-083) was conducted in the US, in accordance with all the criteria you would expect from a modern trial – randomized, double-blind, placebo-controlled – using Cyclamen europaeum L. nasal spray on patients with mild to moderate Acute Rhinosinusitis. For this reason, the Cyclamen europaeum L. extract was used as a monotherapy, without any other medication whatsoever.

The study concludes that Cyclamen europaeum L. nasal spray improved both subjective & objective measurements of sinusitis. Cyclamen europaeum L. shows an important reduction in the percentage of sinus occlusion in Total Symptom Score, and a significant reduction in Sinus Occlusion when Cyclamen europaeum is compared to placebo in patients with ARS. The placebo effect observed with patient-reported symptom score is not supported by objective measurements. No serious or unexpected adverse events were observed in the study. Despite the relatively small number of patients, the data indicates that there is indeed a clear benefit from treatment with the Cyclamen europaeum L. extract Nasodren® can contribute to reducing disease progression time, to decreasing the need for antibiotics or to boosting their effects, as well as reducing the number of complications and chronification. Nasodren® is indicated as a first line treatment for rhinosinusitis symptoms in monotherapy, and in combined treatments has shown to be at least of the same efficacy as standard combined treatment.

Neither of the studies reported any serious adverse events, or indeedunexpected events, with the new Product displaying excellent safety aspects.