Treatment of sialorrhoea with repeated ultrasound-guided injections of botulinum toxin A into the parotid and submandibular glands

Taib, Bilal G.; Williams, Stephen; Sood, S; Ung, K.; Nixon, P P; Sharma, Ravi

doi:10.1016/j.bjoms.2019.04.001

Cited by 14 publications

(19 citation statements)

References 22 publications

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“…In other published studies of botulinum toxin treatment for sialorrhea in children, AEs were often not actively monitored, or the focus was on AEs only, so rates of complications varied widely, but most events were mild. 21 , 23 , 32 , 33 , 38 …”

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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“…It has long been known that botulinum toxin A blocks neuromuscular junction and all autonomic cholinergic fibers, including major secretomotor parasympathetic fibers, to the salivary glands. Although botulinum toxin A injection has been frequently used to treat spasmodic torticollis, hemifacial spasm, blepharospasm, and expressional wrinkles for cosmetic use, it has also been applied to treat parotid fistula, sialocele, recurrent parotitis and salivary secretory disorders such as neurologic sialorrhea and Frey syndrome [8][9][10][11][12][13][14][18][19][20].…”

Section: Discussionmentioning

confidence: 99%

“…Before the introduction of botulinum toxin for clinical use, various treatment Original Article https://doi.org/10.22467/jwmr.2020.01438 modalities had been used for this purpose, including restriction of oral intake, anticholinergic drugs, tympanic neurectomy, radiation, and parotidectomy, with varying results [2][3][4][5][6][7]. Meanwhile, over the last two decades, researchers have advocated injecting botulinum toxin type A into the parotid gland as an alternative treatment option to decrease salivary secretions, and multiple reports have confirmed that botulinum toxin A is effective for treating parotid fistula or sialocele [8][9][10][11][12][13][14]. Herein, we present five cases involving parotid gland or duct injuries that were successfully treated with botulinum toxin A injection (Table 1).…”

Section: Introductionmentioning

confidence: 99%

“…An intraoperative injection can also be performed to prevent parotid fistula when an iatrogenic gland injury occurs during surgery. Some researchers injected the toxin into the parotid parenchyma under ultrasonographic assistance [11,12], and others did so under electromyographic control [10,19]. Although it is not mandatory, preoperative demarcation the parotid gland with an ultrasound scan is very helpful for injecting the toxin into the parotid parenchyma and avoiding untoward side effects.…”

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confidence: 99%

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Adjuvant Role of Botulinum Toxin A in the Management of Wounds Accompanied by Parotid Gland or Duct Injuries

2021

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Background: Parotid gland or duct injuries may occur after facial trauma or surgical procedures around the parotid gland. Such injuries often cause saliva to leak into the wound, and as a result, the autolytic enzymes in the saliva can delay wound healing. To promote wound healing in such cases, salivary leakage must be stopped until the wound has completely healed. Though there are several known measures for preventing salivary leakage, including compressive dressings, suction drainage, food restriction, and anticholinergic drugs, they often yield unsatisfactory results. This study aimed to evaluate the clinical efficacy of botulinum toxin A in stopping salivary secretions and inducing wound healing in wounds accompanied by parotid gland or duct injuries.<br/>Methods: A retrospective study was conducted to evaluate the efficacy of botulinum toxin A for treating salivary leakage due to parotid gland or duct injuries. Five patients were treated between 2011 and 2016, three of whom received postoperative injections with a total dose of 30–40 units of botulinum toxin A. One of the other two patients was injected with the same amount of botulinum toxin A preoperatively, and the other received an intraoperative injection.<br/>Results: All five patients showed an abrupt decrease of salivary leakage on the 3rd day after toxin injection and satisfactory wound healing without untoward side effects.<br/>Conclusion: This study demonstrates the critical role played by botulinum toxin A in management of wounds complicated by abnormal leakage of saliva, when the parotid gland or duct is injured.

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“…Percutaneous BoNT-A injection is an effective intervention with response rates of 80-91% and a complication rate of approximately 3-4% [25,26]. This method of treatment typically requires general anesthesia for a pediatric patient and the effect of the drug wanes 4-6 months post-treatment [2].…”

Section: Discussionmentioning

confidence: 99%

Salivary gland ablation: introducing an interventional radiology treatment alternative in the management of sialorrhea

et al. 2020

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Background Sialorrhea is common in children with neurological disorders and leads to social isolation, aspiration pneumonia and increased caregiver burden. Sialorrhea management includes anticholinergic medications and a variety of surgeries, but these are limited by side effects, recurrence and risks. Objective We present our method of salivary gland ablation, an interventional radiology treatment for sialorrhea, and report safety and efficacy data from pediatric patients who underwent salivary gland ablation. Materials and methods Salivary gland ablation uses image-guided sotradecol and ethanol dual-drug injection into the salivary glands. Submandibular and sublingual glands are injected percutaneously using ultrasound. Parotid glands are injected retrograde through Stensen ducts using fluoroscopy. We conducted a retrospective review of the medical records of patients who underwent salivary gland ablation at our institution between 2005 and 2019. Pre-and post-procedure Drooling Frequency and Drooling Severity (DFDS) scale scores were compared and caregiver satisfaction was assessed. We devised two cohorts, one to study patient safety and a subcohort to study clinical efficacy using DFDS scores. Results One hundred and seventy salivary gland ablation procedures were performed in the 99 patients comprising the safety cohort. Of the procedures, 88.8% resulted in no or minimal complications. Respiratory difficulty, temporary nerve palsy and infection represent the majority of the 11.2% of patients who experienced periprocedural complications. There were no complications resulting in permanent sequelae. Twenty-seven patients met our inclusion criteria for the efficacy subcohort with a mean follow-up time of 5.4 years. DFDS at follow-up decreased from a median score of nine to a seven post-procedure (P=0.000018). The proportion of caregivers who were satisfied with the procedure increased as more glands were ablated, which suggests a causal link between the number of glands ablated and the outcome. Conclusion Salivary gland ablation is a safe and effective procedure with the potential for permanent decrease in symptoms related to sialorrhea.

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Treatment of sialorrhoea with repeated ultrasound-guided injections of botulinum toxin A into the parotid and submandibular glands

Cited by 14 publications

References 22 publications

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children

Placebo-Controlled Clinical Trial of IncobotulinumtoxinA for Sialorrhea in Children

Adjuvant Role of Botulinum Toxin A in the Management of Wounds Accompanied by Parotid Gland or Duct Injuries

Salivary gland ablation: introducing an interventional radiology treatment alternative in the management of sialorrhea

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