Relief of nasal symptoms in obstructive rhinopathy with and without rhinosinusitis, with the silsos® hyper medical device. A randomized, double-blind, active comparator (saline)-controlled clinical trial

BACKGRoUND. Nasal obstruction is a primary symptom of common upper respiratory tract disorders, including common cold and acute and chronic rhinosinusitis with/without nasal polyposis. In patients affected by sinonasal diseases, transudation and edema are reported to increase and thicken the periciliary layer impairing the mucociliary clearance (MCC) and/or the mucociliary transport time (MCTt) which are preventative mechanisms against the deposition of inhaled, pro-inflammatory particulate matter as well as the harboring of infections at the level of paranasal sinuses. In clinical practice and in several nasal affections nasal saline solutions are always recommended for the cleansing of nasal cavities and relieving nasal symptoms. MATERiAl AND METHoDs. A randomized, double-blind, active comparator (isotonic, nasal saline solution) controlled, parallel study was conducted to evaluate the safety and the efficacy of SILSOS hyper (a new Medical Device - MD - composed of the synergistic association of the patented silver salt Silver Sucrose Octasulfate and Potassium Sucrose Octasulfate) in patients suffering from obstructive rhinopathy, with nasal obstruction/congestion of moderate severity persistent since at least 10 days in advance of recruitment with/without rhinosinusitis. At baseline (T0), ten days (T10) and twenty days (T20) after saline or SILSOS treatment, study participants were evaluated subjectively with VAS and SNOT-22, and objectively by Active Anterior Rhinomanometry (AAR) and MCC/MCTt determination by means of the charcoal+3% saccharine test. All the patients were followed-up 30 days after the end of the treatment by a phone interview aimed to evaluate the long term effectiveness of the treatment. REsUlTs. All the 50 enrolled outpatients (aged 18-70 years) completed the study. The AAR analysis showed that whereas saline resulted ineffective on improving inspiratory and expiratory flow at any study timepoint, MD patients progressively and significantly (p<0.05) ameliorated in expiratory flow, at T0-T10 as well over the whole study period (T0-T20). Considering MCC and MCTt determination, no improvement in MCTt was observed over the 20 days study period. As the MCC is concerned, the mean values significantly improved at T20 (p<0.0001) in both groups, but the ΔT0-T20 was 4.12 minutes in the MD group and 2.64 minutes in the control group. This difference has to be considered clinically significant. MD showed a continuous VAS total and mean score improvement along all time-intervals, resulting superior to saline at T10-T20 (p<0.001 vs p<0.05 in saline). Nasal obstruction was back 30 days after the end of treatment in both the groups, but in saline patients only it was judged as moderate/severe. The symptom was present in only 3 patients from the MD group, and reported to be in a mild form. CoNClUsioN. The obtained results show that only the MD has added to the mechanical action of removal of secretions a specific decongestant and antiseptic effect lasting longer after the end of the treatment. In view of its natural decongestant activity and of its hydrating effects, SILSOS hyper could help to fluidize thick mucus, improve respiration and promote resolution of symptoms, preventing pathogens adhesion to nasal mucosa