Abstract for presentation at The Australian and New Zealand Association of Neurologists Annual Scientific Meeting 2007

Botulinum toxin (Dysport) in upper limb spasticity following stroke – a placebo controlled study

  • Dr Andrew Hughes, Austin Hospital, Australia
  • Dr Ian Baguley, St. Joseph's Hospital, Sydney, Australia
  • Dr Stephen de Graaff, Caulfield General Medical Centre, Melbourne, Australia
  • Ass Prof Leo Davies, Royal Prince Alfred Hospital, Sydney, Australia
  • A/Prof Paul McCrory, Box Hill Hospital, Australia
  • Dr Joseph Sandanam, St Joseph's Hospital, Australia
  • Dr Pesi Katrak, Prince of Wales Hospital, Australia

    • Purpose: To assess the safety and efficacy of botulinum toxin (Dysport) in the treatment of upper limb spasticity following stroke.
    Methods: A prospective, multicentre, placebo-controlled, double blind study was conducted using 2 treatments with botulinum toxin or placebo at 12 week intervals in 102 patients with post-stroke upper limb spasticity. Adverse events were recorded to assess safety. Scales of quality of life (primary end point), spasticity, functional status, goal attainment, depression, pain, patient disability, carer burden and global benefit were used to assess efficacy.
    Results: Six patients withdrew before randomisation leaving 96 patients available for intention to treat analysis. Mean age was 59.5 years (SD 13.2 years) and patients were enrolled a mean of 5.9 years (SD 10.5 years) following their stroke. Adverse events occurred equally in those treated with botulinum toxin or placebo. Eighteen serious adverse events were reported in 11 patients resulting in 2 patients being withdrawn from the study. However, no serious adverse events were classified as possibly or probably related to treatment. Botulinum toxin lead to a significant reduction in spasticity compared to placebo across all three joints studied (fingers, wrist and elbow) at all time points after the first injection. Significant improvement compared to placebo was also seen in the patient rated functional outcome measure, the goal attainment scale, global benefit and pain (only after the initial injection). However no significant improvement was seen in depression, patient disability, carer burden or quality of life.
    Conclusions: Botulinum toxin is a safe treatment for post-stroke upper limb spasticity. Despite significant improvements in spasticity and patient rated functional outcome and goal attainment scales there was no reduction in patient disability, carer burden, or improvement in quality of life. This apparent incongruity will be discussed.

    Conference Organiser - ICMS Pty Ltd