Botulinum toxin type A on an intranasal sponge for chronic allergic rhinitis: randomized clinical trial

ABSTRACT

In this study, we examined the effect of botulinum toxin A [BTA] on chronic allergic rhinitis [CAR]. We tested the effects of BTA, applied to an intranasal sponge, on patients who had CAR for a minimum of three years and had been treated unsuccessfully with conventional medications. The study was an interventional case-control single-blind randomized clinical trial. Forty-four male and female CAR patients who were referred to Tehran's Saee and Pasargad Hospitals, and Saadat-Abaad, Sarv and Karimkhan Clinics in 2012; aged 20-40 years were selected on the basis of inclusion and exclusion criteria. The subjects were randomly assigned to the intervention [n=22] or control group [n=22]. The intervention group received BTA [100 IU/ml; Dysport], on a 5 cm nasal sponge retained in each nasal cavity for 30 minutes. The control group received normal saline. The groups were evaluated by the same examiner. Pre- and post-tests [1, 3, 6, and 12 weeks] were performed according to the authors' pre-designed checklist, the validity and reliability of which was previously established. The symptoms scored from none [0] to severe [10] at the test points. The statistical analysis was conducted with SPSS-19, with a significance level of 0.05. Based on ANOVA, there was a significant difference [P<0.05] in symptomatic relief between the intervention and control groups. No marked adverse effects were observed during the study. An intranasal 5 cm sponge impregnated with 100 IU/ml BTA, retained in each nasal cavity for 30 minutes, may alleviate CAR symptoms with no significant adverse effects