139 Cost-effectiveness of botulinum neurotoxin A versus surgery for drooling: a randomized clinical trial 6 child was randomized for two-duct ligation but opted for, and underwent, BoNT-A injections instead. Fifty-three patients (22 females, 31 males; mean age 11y, range 8–22y) were eligible for analysis (BoNT-A 26, two-duct ligation 27). Detailed reasons for exclusion (n=4), including the flow diagram and demographics (Table 2), were reported in a previous paper.10 Demographics were closely matched and there were no statistically significant differences between the treatment arms at baseline. Table 2: Characteristics of study population at baseline BoNT-A Two-duct ligation Sex, n (%) Male Female 15 (57.7) 11 (42.3) 16 (59.3) 11 (40.7) Age at intervention, mean (range), y:mo 11:2 (8:0–17:9) 11:1 (8:0–22:3) Diagnosis CP Non-CPa 17 (65.4) 9 (34.6) 14 (51.9) 13 (48.1) GMFCS level (n=31)b II III IV V 2 (11.8) 3 (17.6) 5 (29.4) 7 (41/2) 1 (7.1) 0 8 (57.1) 5 (35.7) Degree of mobilityc Ambulant Non-ambulant 11 (42.3) 15 (57.7) 10 (37.0) 17 (63.0) Mental ability Developmental age <4y Developmental age >4y 15 (57.7) 11 (42.3) 15 (55.6) 12 (44.4) Previous BoNT-A injections, mean (SD) 1.62 (1.79) 1.44 (1.25) Data are n (%) unless otherwise stated. a = Non-cerebral palsy (CP) consists mainly of children with a developmental disorder based on a syndrome, genetics, or metabolic disorder. b = Gross Motor Function Classification System (GMFCS) level only applies to CP. c = Based on the GMFCS: patients in levels I–III were graded as ambulatory; patients in levels IV or V were graded as non-ambulatory. BoNT-A, botulinum neurotoxin A. Between the two interventions, there was a statistically significant difference in clinical success proportion in favour of two-duct ligation (difference 36.1%, 95% CI 18.1–54.1, number needed to treat 3, 95% CI 2–6, p = 0.008). This corresponds to a treatment success of 63% 32 weeks after two-duct ligation and 27% after BoNT-A treatment.
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