Cargando…

A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases

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 rand...

Descripción completa

Detalles Bibliográficos
Autores principales: Mazlan, Mazlina, Rajasegaran, Shivani, Engkasan, Julia Patrick, Nawawi, Ouzreiah, Goh, Khean-Jin, Freddy, Saini Jeffery
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4591664/
https://www.ncbi.nlm.nih.gov/pubmed/26402703
http://dx.doi.org/10.3390/toxins7093758
_version_ 1782393114229473280
author Mazlan, Mazlina
Rajasegaran, Shivani
Engkasan, Julia Patrick
Nawawi, Ouzreiah
Goh, Khean-Jin
Freddy, Saini Jeffery
author_facet Mazlan, Mazlina
Rajasegaran, Shivani
Engkasan, Julia Patrick
Nawawi, Ouzreiah
Goh, Khean-Jin
Freddy, Saini Jeffery
author_sort Mazlan, Mazlina
collection PubMed
description 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.
format Online
Article
Text
id pubmed-4591664
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-45916642015-10-05 A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases Mazlan, Mazlina Rajasegaran, Shivani Engkasan, Julia Patrick Nawawi, Ouzreiah Goh, Khean-Jin Freddy, Saini Jeffery Toxins (Basel) Article 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. MDPI 2015-09-22 /pmc/articles/PMC4591664/ /pubmed/26402703 http://dx.doi.org/10.3390/toxins7093758 Text en © 2015 by the authors; licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Mazlan, Mazlina
Rajasegaran, Shivani
Engkasan, Julia Patrick
Nawawi, Ouzreiah
Goh, Khean-Jin
Freddy, Saini Jeffery
A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases
title A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases
title_full A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases
title_fullStr A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases
title_full_unstemmed A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases
title_short A Double-Blind Randomized Controlled Trial Investigating the Most Efficacious Dose of Botulinum Toxin-A for Sialorrhea Treatment in Asian Adults with Neurological Diseases
title_sort double-blind randomized controlled trial investigating the most efficacious dose of botulinum toxin-a for sialorrhea treatment in asian adults with neurological diseases
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4591664/
https://www.ncbi.nlm.nih.gov/pubmed/26402703
http://dx.doi.org/10.3390/toxins7093758
work_keys_str_mv AT mazlanmazlina adoubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT rajasegaranshivani adoubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT engkasanjuliapatrick adoubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT nawawiouzreiah adoubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT gohkheanjin adoubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT freddysainijeffery adoubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT mazlanmazlina doubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT rajasegaranshivani doubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT engkasanjuliapatrick doubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT nawawiouzreiah doubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT gohkheanjin doubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases
AT freddysainijeffery doubleblindrandomizedcontrolledtrialinvestigatingthemostefficaciousdoseofbotulinumtoxinaforsialorrheatreatmentinasianadultswithneurologicaldiseases