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.