1

Background and aims

Idiopathic rhinitis (IR) is an entity of unknown etiology, characterized by nasal obstruction and hydrous rhinorrhea. As a pathophysiological correlate of IR, neural, immunological, and mucosal dysfunctions are discussed; for therapy, corticosteroids, antihistaminergic, or anticholinergic drugs and capsaicin are recommended .

A new promising therapeutic option is botulinum neurotoxin A (BTA), which can effectively reduce the symptoms of IR with, if at all, marginal adverse effects . BTA inhibits transmitter release from cholinergic nerve endings and is therefore used in the treatment of various functional disorders resulting from parasympathetic gland hyperactivity , like IR.

The localization for the injection of BTA in IR described by the literature is the nasal turbinates . Recently, Rohrbach et al reported that application of BTA with a sponge can also ameliorate symptoms in some patients.

In our own clinical experience, submucoperichondrial injection of BTA in the nasal septum is an alternative that is easy to perform for the therapist and also well tolerated by the patient. Its advantages are the good visual control of injection with the typical bleaching effect of the mucosa and the lower risk of intravascular systemic application of BTA. Therefore, we started this pilot study to evaluate symptom control and patient comfort after septal injection of BTA in patients with IR.

2

Methods

In a retrospective approach, we analyzed the medical records of all patients who were treated with BTA for IR in our department in the year 2009. The study was approved by the department’s data protection official.

We chose to analyze in the year 2009 because since this time, the following data for IR patients receiving injections with BTA are systematically documented in the medical records of our department:

• •
  

  nasal symptoms (rhinorrhea, nasal obstruction, urge to sneeze, nasal pruritus), quantified on a 5-point Likert scale (none, mild, moderate, severe, extreme),

  
  
• •
  

  number of facial tissues used daily,

  
  
• •
  

  tolerance of the nasal injection of BTA on a visual analogue scale with the 2 extremes: “not unpleasant” (0 mm) and “extremely unpleasant” (10 mm).

All patients were also encouraged to count the number of facial tissues used daily and were seen 14 days after the injection for a follow-up examination, wherein any complications after the injection of BTA and the nasal symptoms as described above were documented.

All patients had received 2 submucoperichondrial injections of 20 mouse units (MU) BTA, respectively, of Dysport (Ipsen Pharma, Ettlingen, Germany; concentration 200 MU/mL in saline solution) in the anterior nasal septum (region 2, 3) of both sides (ie, 80 MU in total). Before the injection, local anesthesia was applied for 5 minutes in the form of a cotton bud soaked in tetracaine (4%). For the injection, a 27-G hypodermic needle (Sterican; Braun, Melsungen, Germany) was used.

In all patients, IR had been diagnosed after an exhaustive exclusion of allergic, structural, infectious, or systemic causes for the nasal symptoms. All patients were of full age, did not have any contraindications for a therapy with BTA, and had given their written consent to treat their symptoms with BTA on off-label use.

Patients who had taken corticosteroids, anticholinergic, or any other drugs with a potential influence on nasal symptoms in the last 2 months before the nasal injection of BTA were not included in this study.

2

Methods

In a retrospective approach, we analyzed the medical records of all patients who were treated with BTA for IR in our department in the year 2009. The study was approved by the department’s data protection official.

We chose to analyze in the year 2009 because since this time, the following data for IR patients receiving injections with BTA are systematically documented in the medical records of our department:

• •
  

  nasal symptoms (rhinorrhea, nasal obstruction, urge to sneeze, nasal pruritus), quantified on a 5-point Likert scale (none, mild, moderate, severe, extreme),

  
  
• •
  

  number of facial tissues used daily,

  
  
• •
  

  tolerance of the nasal injection of BTA on a visual analogue scale with the 2 extremes: “not unpleasant” (0 mm) and “extremely unpleasant” (10 mm).

All patients were also encouraged to count the number of facial tissues used daily and were seen 14 days after the injection for a follow-up examination, wherein any complications after the injection of BTA and the nasal symptoms as described above were documented.

All patients had received 2 submucoperichondrial injections of 20 mouse units (MU) BTA, respectively, of Dysport (Ipsen Pharma, Ettlingen, Germany; concentration 200 MU/mL in saline solution) in the anterior nasal septum (region 2, 3) of both sides (ie, 80 MU in total). Before the injection, local anesthesia was applied for 5 minutes in the form of a cotton bud soaked in tetracaine (4%). For the injection, a 27-G hypodermic needle (Sterican; Braun, Melsungen, Germany) was used.

In all patients, IR had been diagnosed after an exhaustive exclusion of allergic, structural, infectious, or systemic causes for the nasal symptoms. All patients were of full age, did not have any contraindications for a therapy with BTA, and had given their written consent to treat their symptoms with BTA on off-label use.

Patients who had taken corticosteroids, anticholinergic, or any other drugs with a potential influence on nasal symptoms in the last 2 months before the nasal injection of BTA were not included in this study.