Combined management of spasticity and sialorrhea in children with cerebral palsy: a Russian multicenter retrospective study

The use of botulinum toxin therapy to correct spasticity and sialorrhea in a single injection session is an adequate treatment strategy for children with cerebral palsy (CP), as these two conditions are often observed simultaneously in patients and negatively affect the course of the disease and quality of life.

Objective: to evaluate the efficacy and safety of simultaneous correction of spasticity and sialorrhea with incobotulinumtoxin A in patients with CP.

Material and methods. A retrospective analysis was conducted of the medical records of pediatric patients with spastic forms of CP with varying levels of motor ability (from level I to level V according to the Gross Motor Function Classification System, GMFCS) who had spasticity and sialorrhea of varying severity. The analysis included only those patients who underwent simultaneous correction of spasticity and sialorrhea with incobotulinumtoxin A during a single injection session. The total average dose for the correction of spasticity of the upper limbs (UL) and lower limbs (LL), the average dose for the correction of sialorrhea, the total average and maximum dose of the drug per injection session, the dynamics on the modified Ashworth scale (MAS) and the Drooling Impact Scale (DIS), as well as the overall improvement in sialorrhea on the Global Impression of Change Scale (GICS) during treatment were assessed. The severity of the therapeutic effect of the drug after repeated injections was studied, and an analysis of adverse events (AEs) was performed throughout all injection cycles.

The analysis included 162 patients with a mean age of 7.23±3.73 years. Spastic tetraparesis was present in 46.9% of patients, spastic diplegia in 46.3%, and hemiplegic form in 6.8%. 3.1% of patients had GMFCS I, 19.1% had GMFCS II, 18.5% had GMFCS III, 44.4% had GMFCS IV, and 14.8% had GMFCS V. Initially, the severity of spasticity in the upper limbs was 2.33±0.71 points on the MAS, and spasticity in the lower limbs was 2.67±0.74 points on the MAS. The severity of sialorrhea on the DIS scale was 72.96±13.21 points.

Results. All patients underwent one injection cycle (IC), of which 40.1% underwent two ICs, 19.1% underwent three ICs, and 12.3% underwent four ICs. The average dose for correction of spasticity of the upper limbs was 77.10±57.53 U, for NC – 157.10±68.59 U, for sialorrhea – 41.91±19.15 U, the average total dose of the drug per IC – 257.65±92.86 U (13.19±3.91 U/kg), maximum dose – 500 U. After the first IC, UL spasticity decreased by an average of 1.18 points on the MAS, and UL spasticity decreased by 1.23 points. The DIS sialorrhea score decreased by 27.3 points. Repeated ICs showed similar efficacy in correcting spasticity and sialorrhea. The overall improvement in sialorrhea on the GICS scale averaged 1.70±0.51 points after the first IC, and by the fourth IC it increased to 2.00±0.46 points, i.e., a tendency toward an increase in effect was noted. After the first IC, 8% of patients experienced AEs, most commonly pain at the injection site, less commonly dry mouth, increased saliva viscosity, and fever. The frequency of AEs did not increase with repeated ICs.

Conclusion. Simultaneous treatment of spasticity and sialorrhea is a highly effective and safe approach in patients with CP. Repeated injections of incobotulinumtoxin A maintain the high efficacy and safety of this comprehensive therapeutic approach.

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