120 CHAPTER 5 DISCUSSION This RCT aimed to evaluate and compare the effect of BoNT-A and 2-DL on drooling severity in 13 specific positions and daily activities and the impact of drooling on well-being in children and adolescents with neurodevelopmental disorders and chronic and severe drooling. Both BoNT-A and 2-DL have a positive effect on drooling severity, reducing daily care, decreasing material damage to floors and furniture and improving social interaction. Submandibular duct ligation, however, appears to be significantly more effective in drooling reduction on the short- (8 weeks) and medium-term (32 weeks), making daily care less demanding by reducing the amount of hourly saliva wiping and reducing damage to electronic devices when compared to BoNT-A. Additionally, 2-DL -in contrast to BoNT-A- improved the child’s satisfaction with respect to his/her relations within the family and the child’s satisfaction with life in general, having a significant higher impact on these aspects of well-being of these children and caregivers. The reduced effect of BoNT-A injections after 32 weeks was expected since it naturally lasts for a median of 22 weeks.4,6,19 A prolonged effect of BoNT-A on several domains, though not significant, was however experienced at 32 weeks by several participants, which is in line with the observation of a continued effect by Scheffer et al.19 up to one year after injection in a handful of children. Despite this prolonged effect in some participants, and the expected effect of BoNT-A at 8 weeks, 2-DL had a higher impact on several aspects of well-being in both the short- and medium-term. Even though both BoNT-A and 2-DL were found to be effective in reducing drooling,5-7,19-20 the question remains how to define a clinically relevant outcome, as occasional drooling may still be stigmatizing and burdensome. To many patients and caregivers, the effect of treatment is determined by a reduction in drooling frequency and severity, changes in its impact on daily life and care and the improvement in the well-being and quality of life.21 To our knowledge, these factors have not been combined in a randomized controlled setting for BoNT-A and 2-DL before.
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