Evidence-based systematic review on the efficacy and safety of botulinum toxin-A therapy in post-stroke spasticity
Rent the article at a discountRent now
* Final gross prices may vary according to local VAT.Get Access
Background. Botulinum toxin type A (BoNTA) has been suggested as an effective anti-spastic drug. In this article, we summarized the data of randomized, placebo-controlled, double- blind trials and conducted a meta-analysis to assess if BoNTA is an adequate treatment for spasticity following stroke.
Objectives. To evaluate the relevant literature and assess the effectiveness and safety of BoNTA in (1) reducing spasticity based on mean change in the Modified Ashworth Scale (MAS) for upper and lower limb spasticity from baseline; (2) reducing spasticity based on the percent of patients having > or = 1point(s) change in the MAS; (3) improving the patient’s or caregivers’ Global Assessment Scale (GAS); and (4) total adverse events.
Method. We selected all randomized, placebo controlled, double-blind clinical trials or previous meta-analyses evaluating the efficacy and safety of BoNTA (Botox® or Dysport®) for the treatment of spasticity in both upper and lower limbs after stroke. Validity assessment of studies was performed, and Revman 4.2.7 from Cochrane Collaboration and SPSS (statistical package for the social sciences), v 9.0, were applied for analysis.
Results. Overall analysis showed clinical improvement between baseline and 4–6 weeks after application of BoNTA of the patient’s spasticity score using the MAS (weighted mean difference [WMD] = 0.87, 95% CI = 0.52–1.22). The odds ratio of the MAS spasticity score showing one or more points improvement at 4–6 weeks after giving BoNTA showed clinically significant improvement (OR = 4.5, 95% CI = 2.79–7.25). The odds ratio of having an improved GAS at 4–6 weeks after injecting BoNTA showed clinically significant improvement (Odds ratio = 5.85, 95% CI = 3.12–10.95). The odds ratio of having an adverse event during the entire study did not show any significant difference between placebo and BoNTA (odds ratio = 0.84, 95% CI = 0.55–1.28).
Reviewers’ conclusions. BoNTA improves muscle tone in upper and lower limb spasticity following stroke. A global assessment of improvement was noted by the patients or the caregivers following BoNTA injection. BoNTA is considered a safe therapeutic agent.
- Bakheit, AMO, Pittock, S, Moore, AP (2001) A randomized double-blind, placebo-controlled study of the efficacy and safety of botulinum toxin type A in upper limb spasticity in patients with stroke. Eur J Neurol 8: pp. 559-565 CrossRef
- Bakheit, AMO, Thilman, AF, Ward, AB (2000) A randomized double-blind, placebo-controlled, dose-ranging study to compare the efficacy and safety of three doses of botulinum toxin type a with placebo in upper limb spasticity after stroke. Stroke 31: pp. 2402-2406
- Bohannon, R, Smith, MB (1987) Inter-rater reliability of the modified Ashworth scale of muscle spasticity. Phys Ther 67: pp. 206-207
- Brashear, A, Gordon, MF, Elovic, E (2002) Intra-muscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. New Engl J Med 347: pp. 395-400 CrossRef
- Brashear, A, McAfee, A, Kuhn, E, Fyffe, J (2004) Botulinum toxin type B in upper limb post-stroke spasticity: a double blind, placebo-controlled trial. Arch Phys Med Rehab 85: pp. 705-709 CrossRef
- Burbaud, P, Wiart, L, Dubos, JL (1996) A randomized, double-blind, placebo-controlled trial of botulinum toxin in the treatment of spastic foot in hemiparetic patients. J Neurol Neurosurg Psychiatry 61: pp. 265-269 CrossRef
- Cardoso, E, Rodrigues, B, Lucena, R (2005) Botulinum toxin type A for the treatment of the upper limb spasticity after stroke: a meta-analysis. Arquives Neuropsiquiatry 63: pp. 30-33
- Childers, MK, Brashear, A, Jozefczyk, P (2004) Dose dependent response to intramuscular botulinum toxin type A for upper limb spasticity in patients after a stroke. Arch Phys Med Rehab 85: pp. 1063-1069 CrossRef
- Francis, HP, Wade, DT, Turner-Stokes, L (2004) Does reducing spasticity translate into functional benefit? An exploratory meta-analysis. J Neurol Neurosurg Psychiatry 75: pp. 1547-1551 CrossRef
- Francisco, GE (2007) Botulinum toxin for post-stroke spastic hypertonia: a review of its efficacy and application in clinical practice. Ann Acad Med Singapore 36: pp. 22-30
- Fugoso, L, Rosales, RL, Delgado, M, Espiritu, G, Yusay, M, Salazar, G (2006) Poststroke spasticity in the Philippines: definition, epidemiology and its pharmacologic therapy: a consensus statement of the Philippine Society of NeuroRehabilitation. Neurorehab Neural Repair 20: pp. 198
- Hesse, S, Reiter, F, Konrad, M (1998) Botulinum toxin type A and short term electrical stimulation in the treatment of upper limb flexor spasticity after stroke: a randomized double blind, placebo controlled trial. Clin Rehabil 12: pp. 381-388 CrossRef
- Mezaki, T, Kaji, R, Hirota, N (1999) Treatment of spasticity with muscle afferent block. Neurology 53: pp. 1156-1157
- Pathak, MS, Nguyen, HT, Graham, HK, Moore, AP (2006) Management of spasticity in adults: practical application of botulinum toxin. Eur J Neurol 13: pp. 42-50 CrossRef
- Pittock, SJ, Moore, AP, Hardiman, O (2003) A double blind randomized placebo-controlled evaluation of three doses of botulinum toxin type A (Dysport®) in the treatment of spastic equinovarus deformity after stroke. Cerebrovasc Dis 15: pp. 289-300 CrossRef
- Rosales, RL, Bigalke, H, Dressler, D (2006) Pharmacology of botulinum toxin: differences between type A preparations. Eur J Neurol 13: pp. 2-10 CrossRef
- Simpson, DM, Alexander, DN, O’Brien, CF (1996) Botulinum toxin type A in the treatment of upper extremity spasticity: a randomized, double-blind, placebo-controlled trial. Neurology 46: pp. 1306-1310
- Smith, SJ, Ellis, E, White, S (2000) A double-blind placebo-controlled study of botulinum toxin in upper limb spasticity after stroke or head injury. Clin Rehabil 14: pp. 5-13 CrossRef
- Sommerfeld, DK, Eek, EUB, Svennson, AK (2004) Spasticity after stroke. Stroke 35: pp. 134-140 CrossRef
- Watkins, CL, Leathley, MJ, Gregson, JM (2002) Prevalence of spasticity post stroke. Clin Rehabil 16: pp. 515-522 CrossRef
- Evidence-based systematic review on the efficacy and safety of botulinum toxin-A therapy in post-stroke spasticity
Journal of Neural Transmission
Volume 115, Issue 4 , pp 617-623
- Cover Date
- Print ISSN
- Online ISSN
- Additional Links
- Keywords: Botulinum toxin A; Botox®; Dysport®; spasticity; stroke; RCT; double-blind; placebo controlled; modified Ashworth scale; global assessment scale
- Industry Sectors