Frozen versus fresh reconstituted botox for laryngeal dystonia.

Abstract

OBJECTIVES:

To compare the efficacy and side effects of frozen versus fresh reconstituted botulinum toxin type A (BTX-A) in the treatment of laryngeal dystonia.

STUDY DESIGN AND SETTING:

Prospective open-label crossover study; 43 adult patients with adductor spasmodic dysphonia were randomly treated with fresh or refrozen reconstituted BTX-A at a private voice center. Treatment outcomes were assessed by duration of action and self-rated satisfaction (7 point Likert scale). Side effects of breathiness and dysphagia for liquids were assessed as well.

RESULTS:

There was no statistically significant difference in the duration of action (mean, 16.2 +/- 8.5 vs 16.0 +/- 7.6 weeks) and self-rated satisfaction of the treatment (median, 6.0 vs 6.0 points). The side effects were similar for both BTX-A injection types. In addition, there were no instances of infection for refrozen injections.

CONCLUSIONS:

BTX-A may be safely used after being reconstituted and frozen or refrozen without a significant loss of effectiveness or additional side effects. In our experience, the period of freezing was on 2 occasions for up to 8 weeks.

SIGNIFICANCE:

Refrozen BTX-A may be a cost-effective use of an expensive drug.

EBM RATING:

B-2b.

• Authors: James P Thomas, Nora Siupsinskiene
• Journal: Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery (Otolaryngol Head Neck Surg) Vol. 135 Issue 2 Pg. 204-8 (Aug 2006) ISSN: 0194-5998 [Print] England
• PMID: 16890068 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Neuromuscular Agents
• Botulinum Toxins, Type A

Topics

• Adult
• Aged
• Botulinum Toxins, Type A (therapeutic use)
• Cross-Over Studies
• Dystonic Disorders (drug therapy)
• Female
• Freezing
• Humans
• Laryngeal Diseases (drug therapy)
• Male
• Middle Aged
• Neuromuscular Agents (therapeutic use)