Materials and Methods
This prospective single-arm pilot study was planned to include 40 adult patients who received a diagnosis of moderate to severe uncontrolled AR and were recruited in between December 2018 and October 2019 in a single institution. The study was approved by the Committee for Medical Research Ethics in Minia University, Faculty of Medicine, Egypt. All patients signed a written consent prior being included in the study.
Patients with AR as described in the ARIA guidelines based on history, clinical findings and positive skin prick test were recruited. Inclusion criteria included moderate to severe AR, initial mean five-point visual analogue scale (VAS) score above 3 for all the three cardinal symptoms of AR (nasal hypersecretions, nasal congestion and sneezing), and uncontrolled disease (defined as insufficient control of allergic symptoms with VAS scores for nasal symptoms remained higher to 3 after 4 weeks of regular medical treatment). According to ARIA, intranasal steroids complemented by antihistamines as add-on treatment are recommended for treatment of severe persistent AR.
Patients with previous turbinate surgery, marked septal deviation, nasal polyps or tumors were excluded. Additional exclusion criteria included pregnancy, lactation, patients receiving treatment with oral corticosteroids, anticholinergics, drugs affecting hypothyroidism or hyperthyroidism during the 2 months before the beginning of the study.
Each patient had complete medical history and complete endoscopic examination. Local anesthesia of nasal mucosa was carried out using a ribbon gauze soaked with ephedrine: saline (1:1000) + Xylocaine in both nasal cavities for 15 minutes before the injection. A diluted 100 units of BTX-A (Medytox inc., South Korea) in normal saline to a final concentration of 100 units/ml (15 units in 0.15 ml), was slowly injected using a long needle syringe. Injection was done in 3 fixed points: 1- Intermediate part of inferior turbinate, 2- Anterior end of middle turbinate, and 3- Submucoperichondrial at the anterior part of nasal septum (Fig.1.A,B,C,D). Each patient received 45IU in each side of the nose (90IU, in total) divided as: 15IU in inferior turbinate, 15IU in middle turbinate and 15IU in the nasal septum. After the application, patients were reminded they should not use additional allergic therapies.
Subjective symptoms including severity of nasal hypersecretions, congestion and sneezing were measured by a five-point visual analogue scale (VAS). The evaluations were made prior to the therapy and at 1, 2, 4, 8 and 12 weeks after the therapy. Each symptom was evaluated according the scale as follow; (0= no, 1= mild, 2= moderate, 3= moderate to severe and 4= severe).
Software package SPSSĀ® version 16.0 (Chicago, U.S.) was used in the statistical analysis of the data. Wilcoxon signed-rank test for nonparametric quantitative data was used upon comparing the pre- and post-injection mean scores. A value of p < 0.05 was considered to be statistically significant.