A Cochrane review [Abstract] 1 included 10 studies with a total of 397 children with cerebral palsy. Concentration of Botulinum toxin-A (BoNT-A) ranged from 50U/1.0ml to 200U/1.0ml saline with doses of 0.5U to 16U/kg body weight and total doses of 220 to 410 Units (Botox®). BoNT-A as an adjunct to occupational therapy in managing the upper limb in children with spastic cerebral palsy was more effective than occupational therapy alone in reducing impairment, improving activity level outcomes and goal achievement, but not for improving quality of life or perceived self-competence. When compared with placebo or no treatment, BoNT-A alone was not effective.
Another Cochrane review [Abstract] 2 included 31 studies with a total of 1508 children with cerebral palsy. Most studies included ambulatory patients with more than one motor type of CP, and with a mean age of 3 to 7 years. There was a slight predominance of males. Studies compared BoNT-A in the lower limb muscles to usual care or physiotherapy (14 studies), placebo or sham (12 studies), serial casting (4 studies) or orthoses (1 study). The follow-up was as follows: short-term (2 to 8 weeks); medium-term (12 to 16 weeks); and long-term (>24 weeks).
BoNT-A vs. usual care or physiotherapy: BoNT-A might improve overall gait scores at medium-term follow-up (MD 2.80, 95% CI 1.55 to 4.05; 1 study, n=40) and is moderately effective at improving function at short-term (SMD 0.59, 95% CI 0.23 to 0.95; 2 studies, n=123) and medium-term (SMD 1.04, 95% CI 0.16 to 1.91; 4 studies, n=191) follow-up. BoNT-A improves ankle range of motion, satisfaction, and ankle plantarflexors spasticity at one or more time points. The proportion of adverse events in the BoNT-A group was 0.37 (95% CI 0.08 to 0.66). No adverse events were reported in the control group.
BoNT-A vs. placebo or sham: BoNT-A improves overall gait scores at short-term (RR 1.66, 95% CI 1.16 to 2.37; 4 studies, 261 assessments) and medium-term (RR 1.90, 95% CI 1.32 to 2.74; 3 studies, 248 assessments) follow-up, and may improve peak ankle dorsiflexion in stance (MD 15.90 degrees, 95% CI 4.87 to 26.93; 1 study, n=19) and in swing (MD 10.20 degrees, 95% CI 4.01 to 16.39; 1 study, n=19) at short-term follow-up. BoNT-A is not more effective than placebo or sham at improving function at short‐term (SMD 0.24, 95% CI −0.35 to 0.83; 4 studies, n=305) or long‐term (SMD −0.07, 95% CI −0.48 to 0.35; 2 studies, n=91) follow-up, but has a small positive effect at medium-term follow-up (SMD 0.28, 95% CI 0.06 to 0.49; 5 studies, n=327). BoNT-A improves passive ankle range of motion, satisfaction, and ankle plantarflexors spasticity at one or more time points. There was no difference between groups in the rate of adverse events at short-term follow-up (RR 1.29, 95% CI 0.87 to 1.93; 12 studies, n=918).
BoNT-A vs. serial casting: There was no difference between groups for overall gait scores at short‐term (MD 0.00, 95% CI −1.66 to 1.66); medium‐term (MD 0.65, 95% CI −1.21 to 2.51); or long‐term (MD 0.46, 95% CI −1.33 to 2.25) follow‐up in one study (n=18). BoNT-A improved instrumented gait analysis only in terms of ankle dorsiflexion at initial contact (MD 6.59 degrees, 95% CI 1.39 to 11.78; 2 studies, n=47). There was no difference between groups for peak ankle dorsiflexion in stance and swing, and gait speed at any time point. BoNT-A is not more effective than serial casting at improving function, ankle range of motion, and spasticity at any time point. BoNT-A is not associated with a higher risk of adverse events than serial casting (RR 0.59, 95% CI 0.03 to 11.03; 3 studies, n=64).
BoNT-A vs. orthoses: There was no difference between groups for function at medium‐term follow‐up (MD 11.14, 95% CI −0.05 to 22.33; 1 study, n=43), but BoNT-A is more effective than orthoses at improving hip range of motion and hip adductors spasticity.
Comment: The quality of evidence is downgraded by study quality (unclear allocation concealment), imprecise results (few small trials in most comparisons) and indirectness (short follow-up time).
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