CLINICAL EVIDENCE FOR CYCLAMEN EUROPAEUM L. NASAL SPRAY

CLINICAL TRIALS
There are 15 controlled clinical trials, involving 1300 adults and 300 children, 600 of them included in controlled, randomized clinical trials (450 adults and 150 children), treated for 7 days, and some of them for 10 or 14 days. The earlier studies that evaluated the clinical efficacy and tolerability of Cyclamen extract nasal spray were relatively small, of varying design and conducted in Eastern Europe.
Despite the size of these trials they present coherence in their results, demonstrating the efficacy of Cyclamen extract nasal spray in the resolution or improvement of objective and subjective symptoms with greater, or at least similar, efficacy as standard combined treatment and with only minor adverse events reported in adults and children with rhinosinusitis [1,2, 3, 4-26]. As monotherapy, Cyclamen extract nasal spray is a good first-line treatment option for rhinosinusitis symptoms.
Cyclamen extract nasal spray can contribute to reducing disease progression time, decreasing the need for antibiotics or boosting their effects, as well as reducing the number of complications and chronic outcomes; thus, Cyclamen extract nasal spray has proven clinical benefit as an initial treatment for rhinosinusitis symptoms.
In patients with bacterial infections and with unfavourable progression, Cyclamen extract nasal spray shows evidence of an improvement in treatment efficacy when it is administered in combination with antibiotics Cyclamen extract nasal spray relieves symptoms and provides rapid recovery in acute rhinosinusitis due to its sinonasal drainage properties. The two randomized, double blind placebo-controlled trials show similar results, [4, 5] supporting the earlier studies.

Of particular note, the first large randomized, double-blind, placebo-controlled clinical trial with Cyclamen europaeum in patients with acute rhinosinusitis, showed marked clinical benefits for extract nasal spray [5]. A similar trend had been reported previously in a randomized, controlled, proof-of-concept study of Cyclamen europaeum L. nasal spray conducted in the USA [4].
Thus, Cyclamen extract. nasal spray is an effective and well tolerated treatment for patients with acute or chronic rhinosinusitis of mild-moderate severity. Of note, Cyclamen extract nasal spray is available commercially, and used successfully, worldwide; it can be recommended for use as monotherapy and it has also been shown to increase the efficacy of standard therapy, which generally included an
antibacterial drug and/or topical corticosteroids, shortening the time to symptom resolution and complete cure [27].
Cyclamen extract nasal spray treatment has also been associated with improvements in patient Quality of Life, an important finding in this debilitating disorder. Cyclamen extract. nasal spray has also shown benefits in terms of reducing symptoms when compared with painful, invasive procedures including maximallary sinus punctures.
Clinical studies have reported good tolerability, with no unexpected or serious Adverse events. Adverse events experienced were generally related to the mechanism of action of Cyclamen extract or are symptoms of rhinosinusitis, and included nasal irritation/burning. The clinical benefits of Cyclamen extract nasal spray, along with its good tolerability profile, indicate that it has a favourable benefit-to-risk profile in patients with rhinosinusitis.
This new product, with ideal characteristics and properties to combat rhinosinusitis and avoid its complications, possess some differentiating features
2012