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February 06, 2019Article

Randomized controlled trial comparing botulinum vs surgery for drooling in neurodisabilities

View ORCID ProfileStijn Bekkers, Corinne P. Delsing, Saskia E. Kok, Karen van Hulst, Corrie E. Erasmus, Arthur R.T. Scheffer, Frank J.A. van den Hoogen
First published February 6, 2019, DOI: https://doi.org/10.1212/WNL.0000000000007081
Stijn Bekkers
From the Department of Otorhinolaryngology and Head and Neck Surgery (S.B., C.P.D., S.E.K., A.R.T.S., F.J.A.v.d.H.), Radboud University Medical Centre, Nijmegen; and Departments of Rehabilitation (K.v.H.) and Paediatric Neurology (C.E.E.), Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.
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  • ORCID record for Stijn Bekkers
Corinne P. Delsing
From the Department of Otorhinolaryngology and Head and Neck Surgery (S.B., C.P.D., S.E.K., A.R.T.S., F.J.A.v.d.H.), Radboud University Medical Centre, Nijmegen; and Departments of Rehabilitation (K.v.H.) and Paediatric Neurology (C.E.E.), Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.
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Saskia E. Kok
From the Department of Otorhinolaryngology and Head and Neck Surgery (S.B., C.P.D., S.E.K., A.R.T.S., F.J.A.v.d.H.), Radboud University Medical Centre, Nijmegen; and Departments of Rehabilitation (K.v.H.) and Paediatric Neurology (C.E.E.), Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.
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Karen van Hulst
From the Department of Otorhinolaryngology and Head and Neck Surgery (S.B., C.P.D., S.E.K., A.R.T.S., F.J.A.v.d.H.), Radboud University Medical Centre, Nijmegen; and Departments of Rehabilitation (K.v.H.) and Paediatric Neurology (C.E.E.), Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.
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Corrie E. Erasmus
From the Department of Otorhinolaryngology and Head and Neck Surgery (S.B., C.P.D., S.E.K., A.R.T.S., F.J.A.v.d.H.), Radboud University Medical Centre, Nijmegen; and Departments of Rehabilitation (K.v.H.) and Paediatric Neurology (C.E.E.), Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.
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Arthur R.T. Scheffer
From the Department of Otorhinolaryngology and Head and Neck Surgery (S.B., C.P.D., S.E.K., A.R.T.S., F.J.A.v.d.H.), Radboud University Medical Centre, Nijmegen; and Departments of Rehabilitation (K.v.H.) and Paediatric Neurology (C.E.E.), Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.
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Frank J.A. van den Hoogen
From the Department of Otorhinolaryngology and Head and Neck Surgery (S.B., C.P.D., S.E.K., A.R.T.S., F.J.A.v.d.H.), Radboud University Medical Centre, Nijmegen; and Departments of Rehabilitation (K.v.H.) and Paediatric Neurology (C.E.E.), Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Centre, Nijmegen, the Netherlands.
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Citation
Randomized controlled trial comparing botulinum vs surgery for drooling in neurodisabilities
Stijn Bekkers, Corinne P. Delsing, Saskia E. Kok, Karen van Hulst, Corrie E. Erasmus, Arthur R.T. Scheffer, Frank J.A. van den Hoogen
Neurology Feb 2019, 10.1212/WNL.0000000000007081; DOI: 10.1212/WNL.0000000000007081

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Abstract

Objective To compare the effect of submandibular duct ligation (2-DL) and submandibular botulinum neurotoxin type A (BoNT-A) for drooling in children and adolescents with neurodevelopmental disabilities.

Methods A randomized, interventional, controlled, and partly single-blinded study was performed in which submandibular BoNT-A was compared with 2-DL to treat excessive drooling. Main outcomes included a Visual Analog Scale (VAS), drooling quotient (DQ), drooling severity (DS) scale and drooling frequency (DF) scale. Each was obtained at baseline, and 8 and 32 weeks post treatment.

Results Fifty-seven patients (mean age: 11 years, mean baseline VAS score 7.9, mean baseline DQ 27.3%) were randomized to the 2-DL or BoNT-A group. Four patients were excluded from analyses, leaving 53 patients for intention-to-treat analyses. Response to treatment, defined as a ≥50% reduction in DQ or VAS score, was higher for 2-DL after 32 weeks (63.0% vs 26.9%, p = 0.008). Both VAS score (24.5, p < 0.001) and DQ (−9.3%, p = 0.022) were significantly lower at follow-up after 2-DL vs BoNT-A. The total number of adverse events (p = 0.088, 40.7% vs 19.2%) and postoperative complaints was higher (p < 0.001, mean 9.6 vs 3.6 days) for 2-DL than for BoNT-A.

Conclusion The 2-DL procedure is a more effective treatment for drooling than botulinum toxin, but carries a slightly greater risk of complications and morbidity.

Trialregister.nl identifier NTR3537.

Classification of evidence This study provides Class III evidence that for children and adolescents with neurodevelopmental disabilities and severe drooling, 2-DL compared to a one-time intraglandular BoNT-A injection is more effective at reducing drooling at 32 weeks.

  • Received March 17, 2018.
  • Accepted in final form November 4, 2018.
  • © 2019 American Academy of Neurology

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