Thesis

121 Surgery vs botulinum for the impact of drooling on daily life in children with neurodevelopmental disabilities: a randomized controlled trial 5 The effect of BoNT-A and 2-DL on the impact of drooling corresponds to the previously published objective effect in this RCT in which both treatments were effective but response to treatment after 2-DL was higher after 8 (mean difference 35·1%, 95% CI 23·6 to 46·6) and 32 weeks (mean difference 36·1%, 95% CI 18·1 to 54·1) than the response to BoNT-A.5 Although both treatments improved the well-being of these children, this study, like others, also confirmed some loss of gain between 8 and 32 weeks after both 2-DL and BoNT-A.5, 22-24 Additionally, it also highlighted that there were more adverse events and significantly more complaints after 2-DL compared to BoNT-A.5 The slightly greater risk for complications and morbidity that was seen after 2-DL did not outweigh the impact on the well-being of the children as there were higher scores on most aspects of the questionnaire after 2-DL. This might be explained by the relatively mild and temporary complications and complaints after 2-DL. Namely, there were no long-lasting inconveniences, as all adverse events lasted shorter than 6 weeks, complaints lasted for a mean of ten days (range 1 – 14 days, SD 3.9 days) post 2-DL, and there was no indication for surgical re-intervention. Previous studies used the Drooling Impact Scale (DIS) to evaluate drooling related quality of life after BoNT-A.25,26 The DIS is a validated quality of life questionnaire for drooling. Reid et al. reported a drooling reduction (-27·5, p = <0·001) and quality of life improvement in children 1 month after salivary gland BoNT-A injections (n= 24) compared to children in a control group (n= 23) which corresponds to the findings in this article. Chanu et al. assessed benefit in quality of life with the Glasgow Children’s Benefit Inventory (GCBI) 3 months after combined submandibular and parotid duct ligation.27 In this study a mean GCBI score of +36·15 on a scale from -100 (maximum harm) to +100 (maximum benefit) was found. Even though this general scale did not specifically address the consequences of drooling, diminished drooling was shown to have a major impact on the general well-being. The improvement of wellbeing is, however, in line with the findings in the current article. The prospectively collected data on the effect of BoNT-A and 2-DL on the impact of the well-being in children with severe drooling in a randomized controlled setting

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