Safety and Efficacy of Botulinum Toxin Type A in Children With Spastic Cerebral Palsy Aged <2 Years: A Systematic Review

Abstract

In this study, we reviewed the safety and efficacy of botulinum toxin type A (BoNT-A) injection with respect to motor development in children with spastic cerebral palsy aged &lt;2 years. Randomized controlled trials of BoNT-A published between July 1993 and May 2021 were searched in PubMed, WANFANG, CNKI (Chinese National Knowledge Infrastructure), and Cochrane Library Central Register of Controlled Trials using keywords “Botulinum Toxin,” “cerebral palsy,” “nao xing tan huan,” “nao tan,” and “rou du du su.” The 11-item PEDro Scale was used to rate the quality of all the identified studies. Twelve studies, involving 656 subjects, met the inclusion criteria, and of these, 2 involved patients aged &lt;2 years. Treatment safety was assessed based on adverse event (AE) number and frequency, and efficacy was assessed based on spasticity, range of movement, and motor development. We observed that 3 self-limiting adverse events that were frequently reported included weakness, dysesthesia of the skin, and pain at the injection site. Moreover, there was a significant decrease in the incidence of spasticity and a notable improvement in the range of movement of BoNT-A–treated patients. Therefore, BoNT-A injection shows great safety and efficacy in the treatment of children with cerebral palsy aged &lt;2 years.

Effect of Botulinum Toxin Injections in the Treatment of Spasticity of Different Etiologies: An Umbrella Review

“…Two tables were created, one for systematic reviews ( Table 1 ) and one for meta-analyses ( Table 2 ), showing the characteristics of the studies included in this umbrella review. Of the total number of included studies, 12 were systematic reviews [ 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 ] and 16 were meta-analyses [ 8 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 34 , 35 , 36 , 37 , 38 ]. The studies included in this umbrella review were published between 2001 and 2023.…”

“…The duration of intervention ranged from 0 to 48 months. Almost all the included studies used the MAS [ 8 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 22 , 23 , 24 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 38 , 42 ], five used the Tardieu Scale [ 11 , 18 , 24 , 31 , 32 ], and five used the Modified Tardieu Scale [ 13 , 19 , 25 , 27 , 33 ].…”

“…According to the studies reviewed, botulinum toxin injections can improve lower limb spasticity in children with CP [ 19 ] and can be used in combination with other therapies, such as physiotherapy [ 29 , 38 ] or physical activity [ 27 ]. One study supported the efficacy of botulinum toxin injections in children under two years of age with CP and highlighted the safety of its use [ 33 ]. Regarding patients with poststroke spasticity, the authors reported that botulinum toxin injections reduce spasticity in both the upper and lower limbs, suggesting that botulinum toxin is a safe treatment option [ 11 , 12 , 14 , 15 , 22 , 26 ].…”