Drooling

Nordgarden, Hilde; Østerhus, Ingvild; Møystad, Anne; Åsten, Pamela; Johnsen, U. L.-H.; Storhaug, Kari; Loven, Jens Øyvind

doi:10.1177/0883073811419365

Cited by 25 publications

(17 citation statements)

References 32 publications

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“…16 However, higher doses also appear to lead to more safety issues. 16,[31][32][33][34] DQ results in several published studies were comparable to the present trial. In SIPEXI, the DQ for the incoBoNT/A group decreased by 11%-14% after 1 treatment cycle.…”

Section: Discussionsupporting

confidence: 90%

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children

et al. 2021

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Background and Objectives:This prospective phase III study (SIPEXI) investigated efficacy and safety of repeated injections of incobotulinumtoxinA (incoBoNT/A) for treatment of chronic sialorrhea (drooling) associated with neurological disorders (e.g., cerebral palsy, traumatic brain injury) and/or intellectual disability in children/adolescents.Methods:The study enrolled 2-17-year-olds with sialorrhea due to neurological disorders and/or intellectual disability. Patients received body weight-dependent doses of incoBoNT/A (20 U to 75 U). A main period with 1 injection cycle (placebo-controlled, double-blind, 6-17-year-olds) was followed by an open-label extension with up to 3 further cycles. An additional cohort of 2-5-year-olds received active treatment throughout the study. Co-primary endpoints were the change in unstimulated salivary flow rate (uSFR) from baseline to week 4, and the carers’ global impression of change scale (GICS) rating at week 4. Adverse events were recorded.Results:In the main period, 220 patients aged 6-17 years were randomized and treated (148 patients in incoBoNT/A group, 72 patients in placebo group). 35 patients aged 2-5 years received incoBoNT/A (no placebo). 214 patients aged 6-17 years and 33 patients aged 2-5 years continued treatment in the open-label extension period. For the 6-17-year-olds, a significant difference between incoBoNT/A and placebo was seen in the mean uSFR decrease (difference: -0.06 g/min; p = 0.0012) and the carers’ GICS rating (difference: 0.28 points; p = 0.032) at week 4, in favor of active treatment. The secondary endpoints consistently supported these results. A sustained benefit was observed during the extension. Incidences of adverse events were comparable between incoBoNT/A and placebo and did not increase notably with repeated injections. The most common adverse events were respiratory infections. Efficacy and safety were also favorable in the uncontrolled cohort of 2-5-year-olds.Discussion:Both co-primary efficacy endpoints were reached and superiority of incoBoNT/A over placebo was confirmed. IncoBoNT/A (up to 75 U, up to 4 cycles) is an effective and well-tolerated treatment for sialorrhea associated with neurological disorders in children.Study registrations:Clinicaltrials.gov: NCT02270736 (www.clinicaltrials.gov/ct2/show/results/NCT02270736); EU Clinical Trials Register: 2013-004532-30 (www.clinicaltrialsregister.eu/ctr-search/search?query=2013-004532-30).Classification of evidence:This study provides Class I evidence that injection of incobotulinumtoxinA decreases drooling in children aged 6-17 years with neurological disorders.

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Section: Discussionsupporting

confidence: 90%

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children

et al. 2021

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“…Most of the studies reported drooling improvement on subjective and objective methods, but no statistical assessment was performed in order to find the relationship between the subjective and objective scales. Four studies however did not find an agreement in the subjective and objective responses (Jeung et al, 2012;Lin et al, 2008;Nordgarden et al, 2012;Wu et al, 2011). Thus, it is difficult to conclude that drooling reduction was assessed accurately.…”

Section: Wu Et Al Evaluated Botulinum Toxin-a Injections On Droolingmentioning

confidence: 90%

“…Thus, direct comparison cannot be made. Nordgarden et al (2012) used DQ, VAS, and Cotton rolls to measure drooling severity and flow rate in a study on Botulinum toxin for drooling. Their results showed discrepancies between subjective and objective responses.…”

Section: Comparison To Other Studiesmentioning

confidence: 99%

Drooling quantification: Correlation of different techniques

Rashnoo

Daniel

2015

International Journal of Pediatric Otorhinolaryngology

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“…The doses in these reports were similar to the present Series C–E with short-lasting side effects in only in 2% of the treatments. Longer lasting side effects such as eating and swallowing problems after treatment of submandibular and parotid glands were reported in 25%–35% of treatment series with BoNT-A and BoNT-B [ 17 , 28 ]. In the present study, with the comparable doses in Series E and F, longer lasting side effects were observed in only 11% of the treatment series.…”

Section: Resultsmentioning

confidence: 99%

Onabotulinumtoxin A Treatment of Drooling in Children with Cerebral Palsy: A Prospective, Longitudinal Open-Label Study

Möller

Pedersen

Vinicoff

et al. 2015

Toxins

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The aim of this prospective open-label study was to treat disabling drooling in children with cerebral palsy (CP) with onabotulinumtoxin A (A/Ona, Botox®) into submandibular and parotid glands and find the lowest effective dosage and least invasive method. A/Ona was injected in 14 children, Mean age 9 years, SD 3 years, under ultrasonic guidance in six successive Series, with at least six months between injections. Doses and gland involvement increased from Series A to F (units (U) per submandibular/parotid gland: A, 10/0; B, 15/0; C, 20/0; D, 20/20; E, 30/20; and F, 30/30). The effect was assessed 2, 4, 8, 12, and 20 weeks after A/Ona (drooling problems (VAS), impact (0–7), treatment effect (0–5), unstimulated whole saliva (UWS) flow and composition)) and analyzed by two-way ANOVA. The effect was unchanged–moderate in A to moderate–marked in F. Changes in all parameters were significant in E and F, but with swallowing problems ≤5 weeks in 3 of 28 treatments. F had largest VAS and UWS reduction (64% and 49%). We recommend: Start with dose D A/Ona (both submandibular and parotid glands and a total of 80 U) and increase to E and eventually F (total 120 U) without sufficient response.

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Drooling

Cited by 25 publications

References 32 publications

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children

Drooling quantification: Correlation of different techniques

Onabotulinumtoxin A Treatment of Drooling in Children with Cerebral Palsy: A Prospective, Longitudinal Open-Label Study

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