76 CHAPTER 3 (n=232) treated with BoNT-A (76.5 vs 63.5; U=3874, p=0.002; CI=0.001–0.003). The baseline drooling quotient scores were comparable (24.4 vs 29.9; U=5584, p=0.628; CI=0.62–0.64]) between the two groups: drooling quotient scores at 8 weeks (14.3 vs 16.5; U=5880, p=0.973; CI=0.97–0.98); drooling quotient scores at 32 weeks (16 vs 17.9; U=5357, p=0.826; CI=0.81–0.83) after BoNT-A treatment. Patient characteristics that may influence drooling severity, such as age (9.6 vs 10.2; p=0.475; 95% CI=−0.18 to 0.21), epilepsy (72% vs 57%; p=0.299; 95% CI=−0.34 to 0.11), developmental age (59% vs 64% <4y; p=0.554; 95% CI=−0.25 to 0.14), CP diagnosis (52% vs 66%; p=0.145; 95% CI=−0.05 to 0.34), and Gross Motor Function Classification System level ≥IV (80% vs 84% p=0.461; 95% CI=−0.27 to 0.13), did not differ significantly between the children included in this study and the 232 children treated with BoNT-A injections at our centre. DISCUSSION This study evaluated the effect of bilateral submandibular duct ligation after BoNT-A treatment and the predictive value of treatment success after BoNT-A on the treatment success derived from bilateral submandibular duct ligation in children with severe drooling. The findings show that both BoNT-A and bilateral submandibular duct ligation are effective in treating drooling. However, in patients first treated with BoNT-A who later received bilateral submandibular duct ligation, surgery provided a significantly larger and longer-lasting subjective reduction in drooling at 32 weeks follow-up compared to the effect of BoNT-A administered previously. However, the difference could not be confirmed objectively (i.e. with the drooling quotient). Even though both VAS and drooling quotient significantly dropped 8 weeks after bilateral submandibular duct ligation, both increased significantly (z-score=−3.0, p<0.001 and z-score=−2.2, p=0.001 respectively) 32 weeks after bilateral submandibular duct ligation, suggesting recurrence. Although submandibular duct ligation in rats eventually results in salivary gland atrophy and cessation in saliva
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