February 2012
Chinnapongse
R, Gullo
K, Nemeth
P, Zhang
Y, Griggs
L.
Sialorrhea (drooling) is a common symptom of Parkinson's disease (PD)
that can significantly impair a patient's health and quality of life.
Fifty-four PD subjects with troublesome sialorrhea were enrolled using a
multicenter, randomized, double-blind, sequential-dose escalation
design in which subjects received a single intraglandular treatment with
botulinum toxin type B (doses of 1,500 Units [0.3 mL]; 2,500 Units [0.5
ml]; or 3,500 Units [0.7 ml]) or placebo.
Postinjection, subjects were
followed acutely for 4 weeks and long-term for up to 20 weeks.
Safety/tolerability, as assessed by adverse events, was the primary
outcome measure. Efficacy, as assessed by the Drooling Frequency and
Severity Scale and unstimulated salivary flow rate, was secondary.
Gastrointestinal-related adverse events occurred more frequently in the
active groups versus placebo group (31% vs 7%), with dry mouth being
most common (15%). There were no serious adverse events attributed to
botulinum toxin type B or discontinuations due to adverse events from
treatment. At 4 weeks postinjection, Drooling Frequency and Severity
Scale scores significantly improved versus placebo (−1.3 ± 1.3) in a
dose-related manner (−2.1 ± 1.2, P = 0.0191; −3.3 ± 1.4, P < 0.0001; −3.5 ± 1.1, P < 0.0001, respectively) and unstimulated salivary flow rates significantly decreased in all active groups versus placebo (P
≤ 0.0009). Furthermore, treated subjects appeared to have more
sustained improvement in sialorrhea than placebo subjects.
We conclude
that intraglandular injection of botulinum toxin type B was safe,
tolerable, and efficacious in treating sialorrhea in PD patients.
Additional studies are warranted to further confirm the drug's robust
efficacy, as well as evaluate its effect with repeated dosing.
