Stijn Bekkers1, Corinne P Delsing2, Saskia E Kok2, Karen van Hulst2, Corrie E Erasmus2, Arthur R T Scheffer2, Frank J A van den Hoogen2. 1. 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. Stijn.Bekkers@radboudumc.nl. 2. 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.
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. TRIALREGISTERNL 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.
RCT Entities:
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. TRIALREGISTERNL 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.
Authors: Stijn Bekkers; Kim J van Ulsen; Eddy M M Adang; Arthur R T Scheffer; Frank J A van den Hoogen Journal: Dev Med Child Neurol Date: 2020-07-24 Impact factor: 5.449
Authors: Stijn Bekkers; Ineke M J Pruijn; Jan J W van der Burg; Karen van Hulst; Saskia E Kok; Corinne P Delsing; Arthur R T Scheffer; Frank J A van den Hoogen Journal: Dev Med Child Neurol Date: 2021-05-16 Impact factor: 5.449