Format

Send to

Choose Destination
Neurology. 2019 Mar 12;92(11):e1195-e1204. doi: 10.1212/WNL.0000000000007081. Epub 2019 Feb 6.

Randomized controlled trial comparing botulinum vs surgery for drooling in neurodisabilities.

Author information

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.

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center