55 Randomized controlled trial comparing botulinum versus surgery for drooling in neurodisabilities 2 Table 3 Adverse events and complaints (intention-to-treat population) BoNT-A (n = 26) 2-DL (n = 27) P-value Total amount of Adverse Events, n (%) 5 (19.2%) 11 (40.7%) 0.088 AE, n (%) 5 (19.2% 8 (29.6%) Dysphagia, n (%) 2 (7.7%) 1 (3.7%) Xerostomia, n (%) 2 (7.4%) Prolonged pain medication, n (%) 3 (11.1%) Diminished feeding due to nausea, n (%) 1 (3.8%) Antibiotics for pneumonia, n (%) possibly related to the intervention 1 (3.8%) 2 (7.4%) Antibiotics for pharyngitis, n (%) 1 (3.8%)* SAE, n (%) 0 3 (11.1%) Admission due to nausea, n (%) related to the intervention 1 (3.7%) Admission due to nausea, n (%) unrelated to the intervention 1 (3.7%)* Admission because of dehydration due to gastroenteritis, n (%) 1 (3.7%)* Completed the complaints diary N = 18 N = 21 Mean days of complaints ± SD 3.1 ± 3.6 9.6 ± 3.9 < 0.001 Mean days of pain ± SD 0.3 ± 0.5 4.1 ± 4.1 Mean days of diminished feeding ± SD 1.4 ± 2.0 5.1 ± 4.4 Mean days of swelling of the submandibular region ± SD 0.4 ± 1.1 5.8 ± 5.2 Mean days of tiredness, irritability or apathy ± SD 1.7 ± 2.4 6.1 ± 4.5 BoNT-A = Botulinum neurotoxin type A; 2-DL = 2-duct ligation; AE = Adverse Event; SAE = Serious Adverse Event; SD = Standard Deviation; * = unrelated to the intervention DISCUSSION The purpose of this randomized controlled trial was to compare the effect of 2-DL with BoNT-A for drooling in neurodevelopmentally disabled children and adolescents. Response to treatment, defined as a 50% reduction in (the objective outcome) DQ or (the subjective outcome) VAS, was significantly higher both 8 weeks and 32, after 2-DL compared to BoNT-A. Response for both interventions declined after 32 weeks compared to 8 weeks post-intervention. This decline in response was expected for BoNT-A, since it is a by nature shortterm agent. However, there was an unexpected similar decline in response 32 weeks after 2-DL, which is in contrast with an animal study that reported atrophy in histological examination, and loss of function of the acinar cells after unilateral
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