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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 M, Rajasegaran S, Engkasan JP, Nawawi O, Goh KJ, Freddy SJ - Toxins (Basel) (2015)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Rehabilitation Medicine, Faculty of Medicine, University of Malaya, 12th Floor, Menara Selatan, University Malaya Medical Centre, Jalan Universiti, 59100 Kuala Lumpur, Malaysia. drmazlina@gmail.com.

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.

No MeSH data available.


Related in: MedlinePlus

The mean dental gauze weights (wet versus dry gauze) in the experimental groups at baseline; before botulinum toxin type A injection, and at 2, 6, 12, and 24 weeks; after botulinum toxin type A injection into bilateral parotid and submandibular salivary glands (n = 17). Note; BoNT-A = botulinum toxin type A.
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toxins-07-03758-f002: The mean dental gauze weights (wet versus dry gauze) in the experimental groups at baseline; before botulinum toxin type A injection, and at 2, 6, 12, and 24 weeks; after botulinum toxin type A injection into bilateral parotid and submandibular salivary glands (n = 17). Note; BoNT-A = botulinum toxin type A.

Mentions: The results from the “intent-to-treat” and “per-protocol” analyses are discussed together because similar findings were found in both analyses. Figure 2 shows the comparative mean dental gauze weights for 17 patients who completed the study. At 2 weeks post-injection, sialorrhea was reduced in all three BoNT-A dose groups, as seen from the lower mean values of the differential weight between wet and dry gauze compared with baseline.


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 M, Rajasegaran S, Engkasan JP, Nawawi O, Goh KJ, Freddy SJ - Toxins (Basel) (2015)

The mean dental gauze weights (wet versus dry gauze) in the experimental groups at baseline; before botulinum toxin type A injection, and at 2, 6, 12, and 24 weeks; after botulinum toxin type A injection into bilateral parotid and submandibular salivary glands (n = 17). Note; BoNT-A = botulinum toxin type A.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4591664&req=5

toxins-07-03758-f002: The mean dental gauze weights (wet versus dry gauze) in the experimental groups at baseline; before botulinum toxin type A injection, and at 2, 6, 12, and 24 weeks; after botulinum toxin type A injection into bilateral parotid and submandibular salivary glands (n = 17). Note; BoNT-A = botulinum toxin type A.
Mentions: The results from the “intent-to-treat” and “per-protocol” analyses are discussed together because similar findings were found in both analyses. Figure 2 shows the comparative mean dental gauze weights for 17 patients who completed the study. At 2 weeks post-injection, sialorrhea was reduced in all three BoNT-A dose groups, as seen from the lower mean values of the differential weight between wet and dry gauze compared with baseline.

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Rehabilitation Medicine, Faculty of Medicine, University of Malaya, 12th Floor, Menara Selatan, University Malaya Medical Centre, Jalan Universiti, 59100 Kuala Lumpur, Malaysia. drmazlina@gmail.com.

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.

No MeSH data available.


Related in: MedlinePlus