Effectiveness of Botulinum Toxin for Lower Limbs Spasticity after Stroke: A Systematic Review and Meta-Analysis.

[OBJECTIVES] To evaluate current evidence of the effectiveness of botulinum toxin (BTX) injection for lower limbs spasticity after stroke.

[METHODS] Ovid MEDLINE(R) In-Process and Other Non-Indexed Citations，Ovid MEDLINE(R), Ovid EMBASE, Web of Science, and PubMed (NLM) from database were searched inception through Week 23, 2015. Randomized controlled trials (RCTs) comparing the clinical efficacy of BTX injection to placebo or conventional therapy on lower limbs spasticity after stroke were included. We constructed random effects models and calculated mean difference (MD) or standardized mean difference (SMD) for continuous outcomes.

[RESULTS] One thousand three hundred and forty-three records were identified and among them 7 articles (603 patients) were eligible for the final analysis. A statistically significant decrease in muscle tone was observed at week 4 and 12 after injection (Subgroup analysis, SMD = 0.85, 95% CI: 0.2-1.5; p = 0.001; I(2) = 81% and SMD = 0.42, 95% CI: 0.07-0.77; p = 0.02; I(2) = 45%, respectively). Patients who received in BTX therapy were likely to have significant increased Fugl-Meyer score than control group with MD = 3.19 (95% CI: 0.22-6.16, p = 0.04, I(2) = 96%). There was no difference in gait speed between two groups during whole follow-up period.

[CONCLUSION] BTX showed more persistent clinical benefits in lower limbs spasticity and Fugl-Meyer score than placebo in patients after stroke. These results suggest that BTX could be a useful and safety strategy for the treatment of lower limbs spasticity after stroke. Further investigation is required to determine the effectiveness of BTX injection for stroke patients with optimal timing and dose of intervention.