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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

Flowchart describing the recruitment of patients with neurological diseases into the study groups and the dropouts: 17 patients completed all assessments until 24 weeks; four patients in the 50 U group, six patients in the 100 U group and seven patients in the 200 U group. Note: CP = cerebral palsy; TBI = traumatic brain injury; MND = motor neuron disease, CPA = cerebellopontine angle tumour; PD = Parkinson’s disease.
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toxins-07-03758-f001: Flowchart describing the recruitment of patients with neurological diseases into the study groups and the dropouts: 17 patients completed all assessments until 24 weeks; four patients in the 50 U group, six patients in the 100 U group and seven patients in the 200 U group. Note: CP = cerebral palsy; TBI = traumatic brain injury; MND = motor neuron disease, CPA = cerebellopontine angle tumour; PD = Parkinson’s disease.

Mentions: Figure 1 shows the flowchart describing adult patients with neurological diseases participating in the study and the dropouts. There were 10 patients in every group at the start of the study. One patient who received 50 U of BoNT-A died before the first post-injection assessment and therefore, 29 patients were included in the “intent-to-treat” analysis. For the “per-protocol” analysis, only 17 patients completed the follow-up assessments at the end of week 24 and included in the analysis. Two patients who died before the end of the study period and 11 patients who were lost to follow-up were excluded. Patients failed to follow-up because of caregiver’s inability to bring them to the hospital (n = 4), progression of neurological disease (n = 2), and transportation problems (n = 5). One traumatic brain injury patient died from pneumonia two weeks after the injection and one stroke patient died from status epilepticus 12 weeks after enrolment in the study. Both deaths were confirmed to be unrelated to the BoNT-A treatment. No patient dropped out of the study due to treatment side effects. The lowest BoNT-A dose group (50 U) had the highest dropout rate (n = 5).


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)

Flowchart describing the recruitment of patients with neurological diseases into the study groups and the dropouts: 17 patients completed all assessments until 24 weeks; four patients in the 50 U group, six patients in the 100 U group and seven patients in the 200 U group. Note: CP = cerebral palsy; TBI = traumatic brain injury; MND = motor neuron disease, CPA = cerebellopontine angle tumour; PD = Parkinson’s disease.
© Copyright Policy
Related In: Results  -  Collection

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

toxins-07-03758-f001: Flowchart describing the recruitment of patients with neurological diseases into the study groups and the dropouts: 17 patients completed all assessments until 24 weeks; four patients in the 50 U group, six patients in the 100 U group and seven patients in the 200 U group. Note: CP = cerebral palsy; TBI = traumatic brain injury; MND = motor neuron disease, CPA = cerebellopontine angle tumour; PD = Parkinson’s disease.
Mentions: Figure 1 shows the flowchart describing adult patients with neurological diseases participating in the study and the dropouts. There were 10 patients in every group at the start of the study. One patient who received 50 U of BoNT-A died before the first post-injection assessment and therefore, 29 patients were included in the “intent-to-treat” analysis. For the “per-protocol” analysis, only 17 patients completed the follow-up assessments at the end of week 24 and included in the analysis. Two patients who died before the end of the study period and 11 patients who were lost to follow-up were excluded. Patients failed to follow-up because of caregiver’s inability to bring them to the hospital (n = 4), progression of neurological disease (n = 2), and transportation problems (n = 5). One traumatic brain injury patient died from pneumonia two weeks after the injection and one stroke patient died from status epilepticus 12 weeks after enrolment in the study. Both deaths were confirmed to be unrelated to the BoNT-A treatment. No patient dropped out of the study due to treatment side effects. The lowest BoNT-A dose group (50 U) had the highest dropout rate (n = 5).

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