Abstract
This study aims to determine the most efficacious dose of Botulinum neurotoxin type A (BoNT-A) in reducing sialorrhea in Asian adults with neurological diseases. A prospective, double-blind randomized controlled trial was conducted over 24 weeks. Thirty patients with significant sialorrhea were randomly assigned to receive a BoNT-A (Dysport®) injection into the submandibular and the parotid glands bilaterally via an ultrasound guidance. The total dose given per patient was either BoNT-A injection of (i) 50 U; (ii) 100 U; or (iii) 200 U. The primary outcome was the amount of saliva reduction, measured by the differential weight (wet versus dry) of intraoral dental gauze at baseline and at 2, 6, 12, and 24 weeks after injection. The secondary outcome was the subjective report of drooling using the Drooling Frequency and Severity Scale (DFS). Saliva reduction was observed in response to all BoNT-A doses in 17 patients who completed the assessments. Although no statistically significant difference among the doses was found, the measured reduction was greater in groups that received higher doses (100 U and 200 U). The group receiving 200 U of Dysport® showed the greatest reduction of saliva until 24 weeks and reported the most significant improvement in the DFS score.
Highlights
Sialorrhea is a well-recognized disabling symptom associated with 10% of chronic neurological diseases [1,2]
A previous meta-analysis study has shown the efficacy of Botulinum neurotoxin type A (BoNT-A) compared with placebo in reducing sialorrhea in various neurological diseases such as Parkinson’s disease (PD), amyotrophic lateral sclerosis, and cerebral palsy, but the dose and preparation of BoNT-A has varied across studies [8]
19 patients had suffered from a stroke; four patients had a traumatic brain injury; two patients had a motor neuron disease and PD, respectively; and one patient each had encephalitis, cerebral palsy, and a cerebellopontine angle tumor
Summary
Sialorrhea is a well-recognized disabling symptom associated with 10% of chronic neurological diseases [1,2]. Significant sialorrhea can lead to social and functional impairments, including social embarrassment and isolation, oral and skin fungal infections, aspiration, skin maceration, halitosis, and dehydration [1,2,3,4,5]. Both non-invasive interventions (e.g., oral medications) and invasive interventions (e.g., surgery) are currently offered as treatments for the management of sialorrhea. The total dose of Dysport® used in studies for sialorrhea treatment in adult patients has ranged from 250 U to
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