Efficacy and Safety of Botulinum Toxin Type A in Spasticity Caused by Spinal Cord Injury: A Randomized, Controlled Trial

Abstract

BackgroundBaclofen is approved by the US FDA to treat spasticity, but its sustained use may cause drug addiction. The objective of this study was to compare the efficacy and safety of botulinum toxin type A versus baclofen in spasticity.Material/MethodsA total of 336 patients who had spasticity caused by spinal cord injury were enrolled in a randomized (in 1: 1: 1: ratio) for placebo, controlled trial. Patients had received baclofen (BA group, n=112), local intramuscular injection of 500 U Botulinum toxin type A (BTI group, n=112), or physical therapies alone (placebo group, n=112). Modified Ashworth scale (mAS) score, disability assessment scale (DAS) score, modified medical research council (mMRC) score, the Barthel Index (BI) score, and treatment-emergent adverse effects were evaluated during the follow-up period. Wilcoxon test or one-way ANOVA/Tukey post hoc tests were performed at 95% of confidence level.ResultsBaclofen (1.504±0.045 vs. 1.53±0.06, p=0.003, q=4.068) and botulinum toxin type A (1.49±0.09 vs. 1.528±0.15, p=0.0224, q=3.5541) had improved mAS scores after 2 weeks. Baclofen had a more strongly improved DAS score than botulinum toxin type A at 4 (p=0.0496, q=3.48) and 6 (p<0.0001, q=6.48) weeks. Baclofen and botulinum toxin type A had consistently improved BI scores. Baclofen caused asthenia and sleepiness, while botulinum toxin type A caused bronchitis and elevated blood pressure.ConclusionsBotulinum toxin type A may be an effective therapeutic option for spasticity caused by spinal cord injury.

Protective Effects of MiR-129-5p on Acute Spinal Cord Injury Rats

“…Due to the serious situation of SCI, researcher have been focusing more and more attention on SCI therapy, and made some progress in basic research and/or clinical trials [22]. For example, Yan X et al found that botulinum toxin A, derived from Clostridium botulinum , might be an effective therapeutic option for SCI-induced spasticity in clinical trials [23]. Wu Y et al reported a therapeutic effect of Erbin inhibitor on spinal cord contusion in mice [24].…”

Botulinum Toxin: From Poison to Possible Treatment for Spasticity in Spinal Cord Injury

“…However, a panel of experts in SCI spasticity within the International Spinal Injury Society (ISCoS) called Ability Network, have made several recommendations in the treatment of SCI spasticity, and among them is the use of BoNT/A as complementary to the rest of the treatments of which the most important is patient education and oral drugs [ 55 ]. There is only one study published as a clinical trial in SCI, comparing BoNT/A with baclofen, both treatments showing a significant decrease in tone and functional improvement [ 56 ]. However, this study failed to document the clinical characteristics of SCI (neurological level, grade of severity, functional assessment by SCI scales, etc.).…”

“…There are maximum total doses allowed for each toxin; however, due to the characteristics of the spasticity of SCI, these limits are usually exceeded [ 46 , 58 ]. The maximum doses and the recommended doses for the most frequent cases are shown in Table 3 ; they are based on previous studies and protocols, but not even the clinical trial can provide evidence for those indications and dosages [ 46 , 56 , 58 ].…”

High Dosage of Botulinum Toxin Type A in Adult Subjects with Spasticity Following Acquired Central Nervous System Damage: Where Are We at?

“…In post-traumatic SCI, a prevalence between 60% and 80% has been reported and 35% had severe spasticity [65,66]. Although spasticity is a common disorder following SCI, few investigations have been performed to analyse the effect of BTX-A [67,68] and no studies have investigated high dose BTX-A in reducing spasticity in subjects with SCI.…”