49 Randomized controlled trial comparing botulinum versus surgery for drooling in neurodisabilities 2 Table 1 Baseline demographic and clinical characteristics (intention-to-treat population) BoNT-A (n = 26) 2-DL (n = 27) Age, y, mean ± SD 11.2 ± 2.5 11.1 ± 3.2 Female sex 11 (42.3%) 11 (40.7%) Main diagnosis Spastic CP 10 (38.5%) 6 (22.2%) Dyskinetic CP 1 (3.8%) 3 (11.1%) Spastic / dyskinetic CP 5 (19.2%) 5 (18.5%) CP, type is missing 1 (3.8%) 0 Other developmental disability 9 (34.6%) 13 (48.1%) GMFCS level, score only applies to CP (n = 31) II 2 (11.8%) 1 (7.1%) III 3 (17.6%) 0 IV 5 (29.4%) 8 (57.1%) V 7 (41/2%) 5 (35.7% Degree of disability, applies to all participants Ambulant 11 (42.3%) 10 (37.0%) Non-ambulant 15 (57.7%) 17 (63.0%) Developmental age <4 y 15 (57.7%) 15 (55.6%) >4 y 11 (42.3%) 12 (44.4%) Epilepsy Yes 17 (65.4%) 15 (55.6%) Controlled 13 (76.5%) 13 (86.7%) Intractable 4 (23.5%) 2 (13.3%) No 9 (34.6%) 12 (44.4%) GERD Yes 8 (30.8%) 9 (33.3%) No 18 (69.2%) 18 (66.7%) Dental malocclusion Normal occlusion 9 (36.0%) 7 (26.9%) Mild malocclusion 8 (32.0%) 13 (50.0%) Severe malocclusion 8 (32.0%) 6 (23.1%) Missing 1 1 Mouth closure Normal mouth closure 1 (3.8%) 0 Incomplete mouth closure 9 (34.6%) 7 (26.9%) Mouth constantly open 16 (61.5%) 19 (73.1%) Missing 0 1 Gastrostomy feeding Oral 16 (61.5%) 20 (74.1%) Gastrostomy / Gastrostomy and oral (no pharyngeal swallowing problem) 10 (38.5%) 7 (25.9%) BoNT-A pre-trial Yes 15 (57.7%) 17 (63.0%) No 11 (42.3%) 10 (37.0%) Mean BoNT-A, n ± SD 1.6 ± 1.8 1.4 ± 1.3 Abbreviations: BoNT-A = Botulinum neurotoxin type A; 2-DL = 2-duct ligation; CP = Cerebral Palsy; GMFCS = Gross Motor Function Classification System; GMFCS I – III is classified as Ambulant; GMFCS IV –V is classified as Non-ambulant; GERD = Gastroesophageal reflux disease; SD = Standard Deviation
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