Drooling in Parkinson’s disease: A randomized controlled trial of incobotulinum toxin A and meta-analysis of Botulinum toxins

Abstract Introduction Botulinum toxins are a therapeutic option for drooling in Parkinson’s Disease (PD). The aims of this study were to: 1. evaluate the efficacy of incobotulinum toxin A for drooling in PD. 2. Perform a meta-analysis of studies of Botulinum toxins for drooling in PD. Methods 1. Pri...

Full description

Saved in:
Bibliographic Details
Published in:Parkinsonism & related disorders 2016-09, Vol.30, p.73-77
Main Authors: Narayanaswami, Pushpa, Geisbush, Thomas, Tarulli, Andrew, Raynor, Elizabeth, Gautam, Shiva, Tarsy, Daniel, Gronseth, Gary
Format: Article
Language:English
Subjects:
Aged
Analysis of Variance
Botulinum toxin
Botulinum Toxins - therapeutic use
Clinical trials randomized controlled
Clinical trials systematic reviews/meta-analysis
Cross-Over Studies
Double-Blind Method
Humans
Male
Meta-Analysis as Topic
Middle Aged
Neurology
Parkinson Disease - complications
Parkinson Disease - drug therapy
Parkinson’s disease
Parotid Gland - metabolism
Severity of Illness Index
Sialorrhea
Sialorrhea - diagnosis
Sialorrhea - drug therapy
Treatment Outcome
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Abstract Introduction Botulinum toxins are a therapeutic option for drooling in Parkinson’s Disease (PD). The aims of this study were to: 1. evaluate the efficacy of incobotulinum toxin A for drooling in PD. 2. Perform a meta-analysis of studies of Botulinum toxins for drooling in PD. Methods 1. Primary study: Randomized, double blind, placebo controlled, cross over trial. Incobotulinum toxin (100 units) or saline was injected into the parotid (20 units) and submandibular (30 units) glands. Subjects returned monthly for three evaluations after each injection. Outcome measures were saliva weight and Drooling Frequency and Severity Scale. 2. Systematic review of literature, followed by inverse variance meta-analyses using random effects models. Results 1. Primary Study: Nine of 10 subjects completed both arms. There was no significant change in the primary outcome of saliva weight one month after injection in the treatment period compared to placebo period (mean difference, gm ± SD: −0.194 ± 0.61, range: −1.28 to 0.97, 95% CI −0.71 to 0.32). Secondary outcomes also did not change. 2. Meta-analysis of six studies demonstrated significant benefit of Botulinum toxin on functional outcomes (effect size, Cohen’s d: −1.32, CI −1.86 to −0.78). The other studies used a higher dose of Botulinum toxin A into the parotid glands. Conclusions This study did not demonstrate efficacy of incobotulinum toxin A for drooling in PD, but lacked precision to exclude moderate benefit. The parotid/submandibular dose-ratio may have influenced results. Studies evaluating higher doses of incobotulinum toxin A into the parotid glands may be useful.
ISSN:1353-8020
1873-5126
DOI:10.1016/j.parkreldis.2016.07.001