ObjectiveTo 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.MethodsA 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.ResultsFifty-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.ConclusionThe 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 identifierNTR3537.Classification of evidenceThis 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.
Background: Eustachian tube dysfunction is a disorder for which there are limited medical and surgical treatments. Recently, eustachian tube balloon dilation has been proposed as a potential solution.Method: A systematic literature review was performed. Abstracts were selected for relevance, and pooled data analysis and qualitative analysis was conducted.Results: Nine prospective studies, describing 713 eustachian tube balloon dilations in 474 patients (aged 18-86 years), were identified. Follow-up duration ranged from 1.5 to 18 months. Ability to perform a Valsalva manoeuvre improved from 20 to 177 out of 245 ears following eustachian tube balloon dilation and, where data were reported in terms of patient numbers, from 15 to 189 out of 210 patients. Tympanograms were classified as type A in 7 out of 141 ears pre-operatively and in 86 out of 141 ears post-operatively.Conclusion: Prospective case series can confirm the safety of eustachian tube balloon dilation. As a potential solution for chronic eustachian tube dysfunction, further investigations are warranted to establish a higher level of evidence of efficacy.
Submandibular duct relocation combined with excision of the sublingual glands appears to be relatively safe and effective in diminishing visible drooling in children with neurological disorders, particularly in children aged 12 years and older and those without a forward head posture.
Aim
This study evaluated whether the effect of submandibular gland botulinum neurotoxin A (BoNT‐A) injection can predict the outcome of submandibular duct relocation with sublingual gland excision (SMDR) in children with drooling. Furthermore, we compared the effectiveness of both procedures.
Method
A retrospective cohort study was performed in 42 children and adolescents (25 males, 17 females; mean [SD] age at BoNT‐A injection 11y [4], range 4–20y; mean [SD] age at SMDR 15y [4], range 7–23y) with cerebral palsy or another non‐progressive developmental disability who had undergone both BoNT‐A injection and SMDR for drooling. Main outcomes were the drooling quotient and the visual analogue scale (VAS) on drooling severity at 8 weeks and 32 weeks follow‐up.
Results
Failure or success of previous BoNT‐A injections had no influence on success of consecutive SMDR. Relative change in main outcomes showed no significant relation between BoNT‐A injection and SMDR for any follow‐up measurement. After 8 weeks, SMDR was more successful than BoNT‐A injection in diminishing VAS (VAS 80.0% vs 54.3%; drooling quotient 56.2% vs 51.0%). After 32 weeks, both drooling quotient (64.3% vs 29.5%) and VAS (75.7% vs 37.1%) showed significantly higher proportions of success for SMDR.
Interpretation
The effect of submandibular BoNT‐A injection does not predict subsequent SMDR success in drooling. Furthermore, SMDR has a larger and longer‐lasting positive effect on drooling than BoNT‐A injections.
What this paper adds
Submandibular botulinum neurotoxin A (BoNT‐A) injection effect does not predict submandibular duct relocation with sublingual gland excision outcome.
Submandibular duct relocation is more effective and more permanent than BoNT‐A injection.
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