Randomized trial of botulinum toxin injections into the salivary glands to reduce drooling in children with neurological disorders

Abstract

The primary aim of this randomized, controlled trial was to assess the effectiveness of botulinum toxin A (BoNT‐A) injections into the submandibular and parotid glands on drooling in children with cerebral palsy (CP) and other neurological disorders. Secondary aims were to ascertain the duration of any such effect and the timing of maximal response. Of the 48 participants (27 males, 21 females; mean age 11y 4mo [SD 3y 3mo], range 6‐18y), 31 had a diagnosis of CP and 15 had a primary intellectual disability; 27 children were non‐ambulant. Twenty‐four children randomized to the treatment group received 25 units of BoNT‐A into each parotid and submandibular gland. Those randomized to the control group received no treatment. The degree and impact of drooling was assessed by carers using the Drooling Impact Scale questionnaire at baseline and at monthly intervals up to 6 months postinjection/baseline, and again at 1 year. Maximal response was at 1 month at which time there was a highly significant difference in the mean scores between the groups. This difference remained statistically significant at 6 months. Four children failed to respond to the injections, four had mediocre results, and 16 had good results. While the use of BoNT‐A can help to manage drooling in many children with neurological disorders, further research is needed to fully understand the range of responses.

Saliva management options for difficult-to-wean people with tracheostomy following severe acquired brain injury (ABI): A review of the literature

“…There is broad evidence for the efficacy of botulinum toxin injections in people with cerebral palsy, brain lesions, ALS and Parkinson's disease [16,17,23,24,31,[76][77][78][79]. In addition to medical therapy, treatment of sialorrhoea can be accomplished with botulinum toxin (Botox Õ or Dysport Õ ) type A [19,76,[80][81][82][83] or type B [84][85][86] injections into the submandibular [19,76,[80][81][82][83][84][85][86] or parotid glands [19,76,81,82,84,85].…”

“…Reported side-effects of botulinum toxin injections have been reported which include pain, swelling and bleeding [64]. Additionally, dysphagia, altered speech and thickened saliva have been found [14,79,83]. Given that dysphagia is a key reason for prolonged tracheostomy in adults with severe ABI, it is important that decisions are made in a multidisciplinary context to assess the appropriateness of botulinum injections for the population group.…”

Botulinum toxin assessment, intervention and aftercare for paediatric and adult drooling: international consensus statement

“…If constructed carefully in relation to content and construct validity, they can be sensitive enough to reflect the concerns of parents or carers and to measure clinical change. One of these is the Drooling Impact Scale [35], which consists of ten items, rated on a 1‐ to 10‐point scale. The individual patient, their carer(s), or someone who knows the patient well completes the questionnaire.…”

A systematic review of noninvasive and invasive sialorrhoea management

“…Both botulinum toxins (BoNT) A and B are used for the management of sialorrhoea, and they have shown fewer side effects than anticholinergic medication while also decreasing aspiration pneumonia risk in people with neurological diseases (Faria, Harb, Hilton, Yacobucci, & Pizzuto, ). Studies show that botulinum injections are tolerable and effective in the management of sialorrhoea (Jackson et al, ; Jongerius et al, ; Lagalla, Millevolte, Capecci, Provinciali, & Ceravolo, ; Mancini et al, ; Martínez‐Poles et al, ; Reid, Johnstone, Westbury, Rawicki, & Reddihough, ; Tiigimäe‐Saar, Tamme, Rosenthal, Kadastik‐Eerme, & Taba, ). However, BoNT does have some side effects which relate to trauma at the injection site as well as adverse effects associated with the botulinum toxin, such as dry mouth, thickened bronchial secretion and viscous saliva, and difficulty chewing (Jackson et al, ; Jongerius et al, ; Lagalla et al, ; Mancini et al, ; Martínez‐Poles et al, ; Reid et al, ).…”

“…Studies show that botulinum injections are tolerable and effective in the management of sialorrhoea (Jackson et al, ; Jongerius et al, ; Lagalla, Millevolte, Capecci, Provinciali, & Ceravolo, ; Mancini et al, ; Martínez‐Poles et al, ; Reid, Johnstone, Westbury, Rawicki, & Reddihough, ; Tiigimäe‐Saar, Tamme, Rosenthal, Kadastik‐Eerme, & Taba, ). However, BoNT does have some side effects which relate to trauma at the injection site as well as adverse effects associated with the botulinum toxin, such as dry mouth, thickened bronchial secretion and viscous saliva, and difficulty chewing (Jackson et al, ; Jongerius et al, ; Lagalla et al, ; Mancini et al, ; Martínez‐Poles et al, ; Reid et al, ). Trauma at the injection site can cause adverse effects such as soreness, haematoma, bleeding in the mouth and swollen salivary gland leading to difficulty in swallowing, and it might also cause facial nerve trauma when the injection is performed in the parotid gland (Reddihough et al, ).…”