Abstract
Objectives: To determine the effectiveness of botulinum toxin type A (BTX) in reducing sialorrhea for patients with bulbar amyotrophoic lateral sclerosis (ALS), through ultrasound-guided, intrasalivary gland injections, and to titrate to the minimum dosage of BTX required to significantly reduce salivary flow clinically, while minimizing adverse effects. Design: Open-label, nonblinded safety trial. Setting: Outpatient neuromuscular clinic in a large tertiary care center in Ontario, Canada. Participants: Referred sample of 3 patients with advanced bulbar ALS, presenting with disabling sialorrhea unresponsive to previous conventional treatments. Intervention: BTX was injected directly into bilateral parotid and submandibular glands after gland visualization was made using ultrasound. 10, 20 and 30U were injected at baseline, 1 and 2 months postbaseline, respectively. Main Outcome Measures: Subjective evaluation was made using a questionnaire comprised of rating scales for items including severity and frequency of salivation, improvement from baseline, and overall effectiveness of treatment. Objective measurements of salivation was performed by calculating saliva output per minute using the weight of intraoral dental gauze retained in the mouth. Results: All 3 subjects reported moderate to marked improvement in the severity and frequency of their sialorrhea after the 10- and 20-U dose injections, with a reported 37.5% to 75% reduction in salivation from baseline. An apparent supratherapeutic effect was seen after the 30-U injection in 2 subjects. Objective reductions in saliva secretion of 23.9%, 34.0%, and 36.6% were seen after the 10-, 20-, and 30-U injections, respectively. No side effects (eg, worsening of dysarthria, dysphagia, facial nerve paralysis) were reported. Conclusions: Ultrasound-guided injections of BTX into the salivary glands is a minimally invasive, safe, and efficacious treatment alternative for patients with sialorrhea secondary to bulbar ALS. An upper-dose tolerance of 25U was found in our safety trial.
Published Version
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