Position Statement: Botulinum Toxin Treatment

I. Treatment of Spasmodic Dysphonia (Laryngeal Dystonia)

The American Academy of Otolaryngology-Head and Neck Surgery (“AAO-HNS”) considers Botulinum toxin a safe and effective modality for the treatment of spasmodic dysphonia and it may be offered as primary therapy for this disorder.1

II. Botulinum Toxin Treatment for Other Head And Neck Dystonias

A. Blepharospasm
The AAO-HNS considers botulinum toxin a safe and effective modality for the treatment of blepharospasm and it may be offered as a primary form of therapy. Botulinum toxin has been approved as a safe and effective treatment of blepharospasm by the FDA. Cochrane review suggested 90% of patients benefited from botulinum injection treatments.2

B. Cervical Dystonia (Spasmodic Torticollis)
The AAO-HNS considers botulinum toxin a safe and effective modality for the treatment of cervical dystonia. There is some controversy as to whether botulinum toxin or pharmacotherapy should be offered as primary therapy. The benefit from botulinum toxin outweighs that of pharmacotherapy in many cases, certainly for the treatment of rotational cervical dystonia, or cervical dystonia associated with severe pain. In cases where there is inadequate response with pharmacotherapy, or there are intervening side effects, treatment with botulinum toxin may be offered.3

C. Orolinguomandibular Dystonia
The AAO-HNS states that local injections of botulinum toxin into the masseter and temporalis muscles for jaw-closing, and pterygoid and digastric muscles for jaw-opening dystonia is established as a safe and effective modality for managing this disorder.

Considering the difficulty of the procedure in treating complicated jaw deviations and jaw opening, this form of treatment is limited to patients who have failed more conservative therapies. However, the benefit has been dramatic for some in this select group. Use of botulinum toxin for jaw-opening and deviation dystonia, injecting toxin into the pterygoid and digrastic muscles is promising, but additional experience is needed.

Lingual dystonia may be effectively treated with botulinum toxin, but there is a significant risk of dysphagia. Botulinum toxin therapy is investigational for this indication.4

D. Hemifacial Spasm (HFS) and/or Synkinesis
The AAO-HNS considers local injections of botulinum toxin into facial muscles a safe and effective modality in treating hemifacial spasm and/or synkinesis. This modality of therapy may be offered as primary therapy in managing the condition. Botulinum toxin can be particularly helpful in treating synkinesis and reestablishing facial symmetry following a facial nerve paralysis.5

E. Neurogenic Laryngeal Stridor
The AAO-HNS considers local injections of botulinum toxin into laryngeal muscles an effective modality in treating neurogenic laryngeal stridor. This modality of therapy may be offered as primary therapy in managing the condition. While it is generally very safe, the nature of the disorder and the potential contributing problems such as stridor and aspiration should be considered in its case.

F. Frye’s Syndrome
Botulinum toxin can be applied to patients for treatment of Frye’s Syndrome and gustatory sweating related to autonomic dysfunction.

G. Sialorrhea
While a Cochrane review in 2012 was indeterminate in the benefits of botulinum toxin treatment for sialorrhea, there have been several studies since that have shown statistically significant benefit for this treatment. The studies revealed improvement in quality of life surveys and >80% improvement of either market or brief improvement in drooling scores.9-10 All studies reported no significant side effects, thus the benefit outweighed the minimal risk.11

III. Treatment of Other Conditions

A. Facial Dynamic Rhytids
Botulinum toxin can be applied to patients for the treatment of dynamic and hyperkinetic facial lines and furrows, including glabellar furros and wrinkles.

B. Recalcitrant Hyperfuntional Voice Disorders
Botulinum toxin can be injected for management of recalcitrant muscular tension dysphonia, mutational dysphonia, and other hyperfunctional voice disorders (i.e., vocal fold granulomas or traumatic mucosal injury) that do not resolve with more traditional voice therapy methods and other more conservative medical measures.

C. Cricopharyngeus Muscle Hypertonicity
In select patients, botulinum toxin may be useful in the treatment of dysphagia due to hypertonicity of the cricopharyngeus muscle. Botulinum toxin can also be applied to patients with post-laryngectomy cricopharyngeus muscle hypertonicity causing difficulty with the use of voice prostheses.

D. Migraines
Botulinum toxin can be injected in different regions for the prophylactic treatment of migraine headaches that have failed to improve with other medical management. This use of botulinum toxin received FDA approval in 2010. This was based off two studies encompassing 1,384 patients and demonstrated decrease in frequency of headaches. Additional references suggest that its use is a cost-effective means of treatmeant.6-8

Adopted 7/20/1990
Reviewed 9/20/1995
Revised 4/9/1997
Reaffirmed 3/1/1998
Reviewed 1/3/2006
Revised 12/8/2012
Revised 3/12/2017

References:

1. Whurr R, Lorch M. Review of differential diagnosis and management of spasmodic dysphonia. Curr Opin Otolaryngol Head Neck Surg. 2016 Jun;24(3):203-7
2. Costa J, Espirito-Santo C, Borges A, et al. Botulinum toxin type A therapy for blepharospasm. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004900.
3. Hallett M, Albanese A, Dressler D, et al. Evidence-based review and assessment of botulinum neurotoxin for the treatment of movement disorders. Toxicon. 2013 Jun 1;67:94-114.
4. Ibid.
5. Ibid.
6. Aurora SK, Dodick DW, Turkel CC, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 1 trial. Cephalalgia, 2010 July;30:793–803.
7. Diener HC, Dodick DW, Aurora SK, et al. OnabotulinumtoxinA for treatment of chronic migraine: results from the double-blind, randomized, placebo-controlled phase of the PREEMPT 2 trial. Cephalalgia, 2010;30:804–814.
8. Batty AJ, Hansen RN, Bloudek LM, et al. The cost-effectiveness of onabotulinumtoxinA for the prophylaxis of headache in adults with chronic migraine in the UK. J Med Econ. 2013 Jul;16(7):877-87.
9. Mahadevan M, Gruber M, Bilish D, Edwards K, Davies-Payne D, van der Meer G. Botulinum toxin injections for chronic sialorrhoea in children are effective regardless of the degree of neurological dysfunction: A single tertiary institution experience. Int J Pediatr Otorhinolaryngol. 2016 Sep;88:142-5. doi: 10.1016/j.ijporl.2016.06.031. PMID:27497402
10. Montgomery J, McCusker S, Lang K, Grosse S, Mace A, Lumley R, Kubba H. Managing children with sialorrhoea (drooling): Experience from the first 301 children in our saliva control clinic. Int J Pediatr Otorhinolaryngol. 2016 Jun;85:33-9. doi: 10.1016/j.ijporl.2016.03.010. PMID:27240493
11. Banerjee KJ, Glasson C, O’Flaherty SJ. Parotid and submandibular botulinum toxin A injections for sialorrhoea in children with cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):883-7. PMID:17044954

Important Disclaimer Notice (Updated 7/31/14)

Position statements are approved by the American Academy of Otolaryngology—Head and Neck Surgery or Foundation (AAO-HNS/F) Boards of Directors and are typically generated from AAO-HNS/F committees. Once approved by the Academy or Foundation Board of Directors, they become official position statements and are added to the existing position statement library. In no sense do they represent a standard of care. The applicability of position statements, as guidance for a procedure, must be determined by the responsible physician in light of all the circumstances presented by the individual patient. Adherence to these clinical position statements will not ensure successful treatment in every situation. As with all AAO-HNS/F guidance, this position statement should not be deemed inclusive of all proper treatment decisions or methods of care, nor exclusive of other treatment decisions or methods of care reasonably directed to obtaining the same results. Position statements are not intended to and should not be treated as legal, medical, or business advice.