Abstract

Introduction: KOS represent an innovative non-surgical solution developed at the Karolinska University Hospital in Stockholm (Sweden) which consists of a intranasal stimulation via an air inflated catheter indicated to treat non allergic rhinitis and migraine. The KOS method for rhinitis has proved to be so effective as it simultaneously stimulates the nasal mucosa and the local autonomic nervous system, which represents the predisposing ultrastructural factor and is able to maintain the neurogenic inflammation responsible for the nasal symptoms of chronic rhinitis, very disabling for the quality of life of rhinitic patients. We wanted to verify whether the positive results obtained in the treatment of non-allergic rhinitis that we observed in our previous study could also be obtained in patients with allergic rhinitis, who similarly share many of the nasal symptoms. Materials and Methods: A total of 110 patients (63 males), aged >18 years, consecutively enrolled, all undergoing complete ENT evaluation with physical clinical examination, endoscopy, nasal symptoms VAS and SNOT-22 questionnaire, affected by allergic rhinitis (AR) persistent moderate-to-severe grade. All patients were alternately assigned to 2 homogeneous groups (Group A: Control Subjects, Group B: KOS Treated Patients), each group included 55 individuals. Simple randomization was achieved with a sequence of random numbers from a computer-generated sequence. During the study, both groups received standard medications (Ebastine tablet 10 mg and Mometasone furoate nasal spray 50 mcg/actuation per nostril per day) for 90 days. At the beginning of medical treatment, group B patients underwent first KOS treatment (repeated after 20 days). Both groups were asked to report any side effects during the study. Results: The treated patients already benefited immediately after the extraction of the balloon reporting a sensation of a more patent nose and reduction of nasal secretions which progressively improves in the following days. For the subjective complaints (nasal obstruction, sneezing, rhinorrhea, and itching), the improvement was significant within each group, with the most significant improvements in treatment group B. When the KOS treatment group was compared with medical treatment alone (Group A), greater efficacy was observed in Group B with regards to the reduction of nasal symptoms and nasal endoscopic findings. Regarding the objective results (rhinomanometric assessments), similar trends, such as subjective ones, were observed within each group. The improvements within each treatment group were significant without side effects. Comparison between Groups A and B, before and after treatment, with the SNOT-22 questionnaire relating to the 5 most important questions (5 most important items) showed an improvement in both study groups but with better results, however regards efficacy, in Group B. Discussion: Our results reveal a greater efficacy achieved using a combined approach, with the association between medical treatment and KOS, compared to medical treatment alone, in the control of the sympotms of AR associated with hypertrophy of the inferior turbinates. The symptoms evaluated by VAS showed greater efficacy in their control in those patients in treatment group B, in particular those patients who had undergone treatment with KOS presented objective parameters (AAR, endoscopic score) and SNOT-22 better than the group receives only medical care. Conclusion: KOS treatment, in combination with medical therapy, improves nasal flow more effectively than medical treatment alone in persistent moderate to severe AR. In particular, the local nasal symptoms were significantly reduced. Patients undergoing the KOS treatment report improvement in their nasal rhinitis symptoms within a few days, which improve further, also in our experience, after a second boost application.

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