106 CHAPTER 5 ABSTRACT Aim To compare the effect of bilateral submandibular duct ligation (2-DL) to submandibular botulinum neurotoxin type A (BoNT-A) on drooling severity and its impact on daily life and care in children and adolescents with moderate to severe drooling whose conservative treatment had failed or was not expected to provide a substantial relief. Methods Randomized, interventional, controlled trial in which 53 children and adolescents (31 males, mean age 11 years, SD 2·8y) with cerebral palsy (CP; 58.5%) or other nonprogressive developmental disorders (41.5%) were randomized to BoNT-A (n=26) or 2-DL (n=27). Four children were previously treated with anticholinergics which, due to side effects or lack of effect were stopped prior to participation. A parent questionnaire on the severity of drooling in specific positions and daily activities and the impact of drooling on daily life and care, was filled out at baseline, and 8 and 32 weeks post-treatment. Results Both BoNT-A and 2-DL had a positive effect on daily care, damage to electronics and/or furniture, social interaction and self-esteem. 2-DL, however, has a significant larger and longer lasting short- (8 weeks) and medium-term (32 weeks) effect on daily care, reducing damage to electronic devices and improving social interaction and satisfaction with life in general. Interpretation Previous studies illustrated that 2-DL procedure is a more effective treatment for drooling than BoNT-A, but carries a slightly greater risk of complications and morbidity. This RCT confirms reduced drooling by both BoNT-A and 2-DL, but provides new evidence upon the improved well-being through a reduction in drooling. Even though there is a greater risk of complications and morbidity after
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