| Background:Muscle spasticity is a positive symptom after stroke and traumatic brain injury.Botulinum toxin type A(BoNT-A)injection is widely used for treating post stroke and traumatic brain injury spasticity.Objective:This study aimed to evaluate efficacy and safety of BoNT-A for upper limb spasticity after stroke and traumatic brain injury and investigate reliability and conclusiveness of available evidence for BoNT-A intervention.Method:We searched electronic databases from inception to December of 2018.Randomized controlled trials comparing the effectiveness between BoNT-A and placebo in stroke or traumatic brain injury adults with upper limb spasticity were included.Reliability and conclusiveness of the available evidence were examined with trial sequential analysis.Result:From 526 citations identified,23 studies were included,reporting results for1834 participants.A statistically significant decrease of muscle tone was observed at each time point after BoNT-A injection compared to placebo(SMD at week 4=-0.98,95%CI:-1.28 to-0.68;I~2=66%,P<0.001;SMD at week 6=-0.85,95%CI:-1.11 to-0.59,I~2=1.2%,P<0.001;SMD at week 8=-0.87,95%CI:-1.15 to-0.6,I~2=0%,P<0.001;SMD at week 12=-0.63,95%CI:-0.83到-0.43,I~2=0%,P<0.001;and SMD over week 12=SMD=-0.77,95%CI:-1.14到0.40,I~2=45.6%,P<0.001).Trial sequential analysis showed that sufficient evidence had been accrued to show significant benefit of BoNT-A over placebo control.BoNT-A treatment also significantly reduced Disability Assessment Scale Score than placebo at 4,6 and12-week follow-up period(WMD=-0.33,95%CI:-0.63 to-0.03,I~2=60%,P=0.03;WMD=-0.54,95%CI:-0.74 to-0.33,I~2=0%,P<0.001 and WMD=-0.3,95%CI:-0.45 to-0.14,I~2=0%,P<0.001 respectively),and significantly increased patients’global assessment score at week 4 and 6 after injection(SMD=0.56,95%CI:0.28 to0.83;I~2=0%,P<0.001 and SMD=1.11,95%CI:0.4 to 1.77;I~2=72.8%,P=0.001respectively).No statistical difference was observed in the frequency of adverse events between BoNT-A and placebo group(RR=1.36,95%CI[0.82,2.27];I~2=0%,P=0.238).Trial sequential analysis showed that the evidence was not sufficient and more studies were needed.Conclusion:As compared with placebo,BoNT-A injections have beneficial effects with improved muscle tone and well-tolerated treatment for patients with upper limb spasticity post stroke or traumatic brain injury.Background: Muscle spasticity is a positive symptom after stroke and traumatic brain injury.Botulinum toxin type A(Bo NT-A)injection is widely used for treating post stroke and traumatic brain injury spasticity.No meta-analysis on the efficacy and safety of botulinum toxin type A for lower limb spasticity after stroke or traumatic brain injury was reported.Objective:This study aimed to evaluate efficacy and safety of Bo NT-A for lower limb spasticity after stroke and traumatic brain injury.Method: We searched electronic databases from inception to January of 2019.Randomized controlled trials comparing the effectiveness between Bo NT-A and placebo in stroke or traumatic brain injury adults with lower limb spasticity were included.Results:From 559 citations identified,7 studies were included,reporting results for 1334 participants.A statistically significant decrease of muscle tone was observed at each time point after Bo NT-A injection compared to placebo(WMD at week 4=-0.53,95% CI:-0.87 to-0.19,I2 = 89.1%,P = 0.002;WMD at week 8=-0.76,95% CI:-1.48 to-0.03,I2 = 93%,P =0.041;WMD at week 12=-0.32,95% CI:-0.62 to-0.03,I2= 69.8%,P=0.031.Bo NT-A treatment also significantly increased the active ankle dorsiflexion at week 4(WMD=1.19,95% CI: 0.50 to 1.88,I2=28%,P= 0.001).No statistical difference was observed in the frequency of adverse events between Bo NT-A and placebo group(RR=1.14,95%CI :0.84 to 1.57,P=0.398).Conclusion: As compared with placebo,Bo NT-A injections have beneficial effects with improved muscle tone and well-tolerated treatment for patients with lower limb spasticity post stroke or traumatic brain injury. |
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