Intranasal insulin and budesonide combination films for treatment of anosmia: randomized clinical trial

Abstract

Abstract Background Anosmia has been considered one of the serious health conditions. Different treatment regimens were reported as an auxiliary therapy for management of olfactory dysfunction but have not been approved as an effective therapy. Recently, intranasal insulin has been developed as a treatment of anosmia. The aim of the current study is to present a more specific, effective, and safe treatment for anosmia, by adding strong steroid to insulin in the same film. This study was conducted on 40 patients with post-viral anosmia. Methodology was built in multiple steps: study compatibility between steroid and insulin, preparation and characterization of intranasal films, and clinical assessment. Patients were assigned in a random manner into two groups; the intervention and placebo groups, with endoscopic insertion of intranasal insulin-budesonide combination films and saline films into the olfactory cleft in both groups, respectively. The maneuver was done for eight sessions every 2 weeks. Results The results of compatibility and film characterization showed a compatible combination in addition to flexible, homogenous, and controlled-release films. Clinical assessment showed significant improvement of the intervention group compared to the control group in both the butanol test and olfactory discrimination test ( p value 0.004 in the second visit and p < 0.001 in the third visit, respectively). Conclusion According to our results, it can be concluded that a combination of anti-inflammatory steroids and growth factor elevator as insulin can be used as a safe and effective combination for smell restoration.