An Exploratory Trial of Cyclamen Extract for Acute RhinosinusitisKey messages from this study
* In patients with Acute Rhinosinusitis, Cyclamen extract (Nasodren®/Sinuforte®):
* Improves objective outcomes compared to placebo
* Produces a clinically relevant improvement in symptoms
* Is the only product marketed for rhinosinusitis that has been tested in this way (CT scan). Other products, such as corticosteroids, antibiotics or decongestants, measure only symptomatic improvement.
Study Design: prospective, randomized, placebo-controlled, double-blind and parallel group.
Objective: evaluate the efficacy and safety of a 7-day treatment with Cyclamen europaeum in ARS patients.
Primary outcomes: reduction in percentage of sinus opacification on CT scan, as well as a reduction in Total Symptom Score.
Study method: 48 patients suffering from ARS were randomly distributed in 2 groups receiving either Cyclamen extract nasal spray or a placebo spray.
There was a significant difference between treatment groups, in change from baseline to end point, in percentage of sinus opacification in favour of Cyclamen. The percentage of sinus opacification was reduced in ARS patients treated with Cyclamen, whereas there was no improvement in the placebo group.
The Cyclamen extract patients obtained a better Total Symptom Score improvement from baseline to end.
Patients with ARS treated with Cyclamen europaeum nasal spray significantly improve objective outcomes compared to placebo. The improvement in symptoms is also clinically relevant.
What this study highlights is that there is a clear difference in the evolution of the objective and subjective efficacy parameters, establishing the clinically significant superiority of Cyclamen over placebo. Hence, although patients notice the placebo effect in the subjective efficacy parameter (symptoms improvement) this is not confirmed by the objective efficacy parameter (sinus opacification improvement). It is thus clear that rinsing the nose with water will temporarily relieve rhinosinusitis symptoms, but will not drain mucus from the sinuses, as Cyclamen extract nasal spray does, which is the main objective of any rhinosinusitis treatment.
It should also be noted that Nasodren® is the only product marketed for rhinosinusitis that has been tested in this way. Other products, such as corticosteroids, antibiotics or decongestants, measure only symptomatic improvement.
JU Ponikau, DL Hamilos, A Barreto, J Cecil, SW Jones, SE Manthei, J Collins
The Laryngoscope, 2012