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Intramuscular Botulinum Toxin A Curbs Wrist, Finger Spasticity
New England Journal of Medicine (NEJM)
08/08/2002
By Anne MacLennan
One-time intramuscular injections of botulinum toxin A safely reduce spasticity of the wrist and finger muscles, and related disability, in people who have had a stroke, suggest researchers.
This finding is the conclusion of a multicentre placebo-controlled study in the United States for the Botox Post-Stroke Spasticity Study Group.
Injected botulinum toxin A is a common treatment for focal spasticity following stroke; several studies have suggested it decreases muscle tone in spastic muscles. Until now, however, only one small controlled study indicated the therapy actually improved limb function.
Dr Allison Brashear and colleagues from Indiana University School of Medicine, Indianapolis, Indiana, and five other centres, assessed the efficacy and safety over 12 weeks of one-time injections of botulinum toxin A (200 units to 240 units).
Participants were 126 patients with increased flexor tone in the wrist and fingers after a stroke. At baseline, each one of them chose one of four areas of moderate-to-severe disability as the principal target of treatment.
Primary outcome measure was self-reported disability in these four areas: personal hygiene, dressing, pain, and limb position (on a four-point scale ranging from no disability to severe disability) at six weeks.
Of the 126 subjects enrolled in the trial, 122 completed it, all 64 of those on botulinum toxin A versus 58 of the 62 subjects on placebo.
At all follow-up visits through the 12 weeks, patients on botulinum toxin A versus placebo injections had greater improvement in flexor tone in the wrist and fingers.
They also had greater improvement than did placebo patients in the principal target of treatment at weeks four, six, eight and 12.
At week six, 40 (62 percent) of the 64 subjects in the botulinum-toxin group versus 17 (27 percent) of the 62 in the placebo group reported improvement of at least one point on the Disability Assessment Scale in the principal target of treatment.
There were no major adverse events linked with the treatment and no clinically significant changes in biochemical or haematologic variables during the 12 weeks of follow-up.
This study was sponsored by Allergan.
N Engl J Med 2002;347:395-400.
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