Effect of recurrent onabotulinum toxin a injection into the salivary glands: An ultrasound measurement

Cardona, Isabel; Saint‐Martin, Christine; Daniel, Sam J.

doi:10.1002/lary.25222

Cited by 17 publications

(18 citation statements)

References 28 publications

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“…It has been reported that chronic use of intraglandular botulinum toxin reduced gland sizes. 37 A sustained effect of incoBoNT/A after multiple injections could be due to possible atrophy of the glands. It may be worth investigating the causes of the sustained effect with detailed imaging or pathological studies.…”

Section: Discussionmentioning

confidence: 99%

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: Discussionmentioning

confidence: 99%

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children

et al. 2021

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“…This study was a single cohort case series without comparative group and was conducted based on the patients’ subjective reports and subjective measurement of parotid size. Objective studies, such as ultrasound or magnetic resonance imaging, can be used to assess salivary gland size and spherical volume of the salivary glands 6,10 . Also, long‐term effects of repetitive BoNTA injection still need to be confirmed.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of intraglandular botulinum toxin injections for treatment of sialadenosis

Jeon

Hong

Lee

et al. 2021

Clinical Otolaryngology

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“…Botulinum toxin works by temporarily preventing the release of acetylcholine (ACh) from presynaptic vesicles, thus disrupting the effective innervation of the salivary gland. Glandular dysfunction occurring secondary to interruption of ACh has been reported [ 5 ]. As with the chemical blockade, this dysfunction is temporary [ 6 , 7 ].…”

Section: Discussionmentioning

confidence: 99%

“…As with the chemical blockade, this dysfunction is temporary [ 6 , 7 ]. A major advantage of botulinum toxin is that there are few side effects, one of which being transitory dysphagia [ 5 ]. A drawback of this approach is that botulinum toxin therapy for sialorrhea in the paediatric population requires sedation or anaesthesia.…”

Section: Discussionmentioning

confidence: 99%

“…Sialorrhea in children has negative health and social consequences including social isolation, perioral maceration, skin infections, dehydration, and aspiration secondary to pooling of excess saliva in the oral cavity [ 1-5 ]. Current management strategies include oral motor and pharmacologic therapies [ 4 ], botulinum toxin injectable therapy [ 5 ], and surgical interventions [ 6 ]. In addition, one of the strategies employed at our institution in sialorrhea management is percutaneous ethanol ablation of salivary glands.…”

Section: Introductionmentioning

confidence: 99%

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Percutaneous Salivary Gland Ablation using Ethanol in a Rat Model

Burch

Lubeley

Murakami

2017

JOMR

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ObjectivesSialorrhea is a common health and psychosocial problem for children with neuromuscular dysfunction secondary to a variety of disorders such as cerebral palsy. Current accepted treatments include the injection of botulinum toxin into the submandibular glands for temporary symptom relief. The purpose of this study is to demonstrate the feasibility of percutaneous ethanol injection for longer lasting salivary gland ablation in an animal model. Material and MethodsTwenty rats were used in this study. In each rat, 98% ethanol was injected into the right submandibular gland under ultrasound guidance. No intervention was performed on the left gland, which served as the control. Ten rats were sacrificed and glands evaluated at three weeks, with the remaining 10 rats sacrificed and evaluated at three months. Unpaired, 1-tailed T-tests were used to analyse the data.ResultsEthanol injections induced a significant and sustained reduction in salivary gland size. Treated glands were 41% smaller by mass than untreated controls in the 10 rats sacrificed at three weeks (P < 0.001). Treated glands were 43% smaller by mass than untreated controls in the 10 rats sacrificed at three months (P < 0.001). Qualitative histologic analysis demonstrated extensive parenchymal damage, inflammation, and fibrosis at both three week and three month time points.ConclusionsUsing a rat model, we demonstrated dramatic and sustained submandibular gland damage after percutaneous injection of ethanol.

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Effect of recurrent onabotulinum toxin a injection into the salivary glands: An ultrasound measurement

Abstract: 3b

Cited by 17 publications

References 28 publications

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children

Efficacy and safety of intraglandular botulinum toxin injections for treatment of sialadenosis

Percutaneous Salivary Gland Ablation using Ethanol in a Rat Model

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