Aug. 8, 2002
Laurie Barclay, MD
Botulinum toxin A (Botox) was safe and effective in the treatment of poststroke spasticity of the fingers and wrist, according to the results of a randomized double-blind trial reported in the Aug. 8 issue of the New England Journal of Medicine.
"This is the first large trial to show that botulinum toxin type A improved function and muscle tone following a stroke," lead author Allison Brashear, MD, from the Indiana University School of Medicine in Indianapolis, says in a news release. "A number of studies have demonstrated that botulinum toxin type A decreases muscle rigidity in spastic muscles and one small study has shown functional improvement from this therapy. However, use of the therapy has become common practice so the point of this clinical trial was to assess the effects of one-time treatment on a large, controlled group."
In this two-year study involving 19 medical centers, 126 subjects with some degree of spasticity in their wrist or fingers after a stroke were randomized to treatment with either placebo or with one-time injections of 200 to 240 units of botulinum toxin type A. Subjects selected one of four areas of disability as the principal target of treatment: personal hygiene, dressing, pain or limb position, rated as moderately to severely disabled on a four-point scale.
Compared with poststroke baseline, 40 (62%) of the 64 subjects treated with botulinum toxin type A reported improvement in the selected area of disability at six weeks after treatment, as did only 17 (27%) of the 62 who received placebo (P<.001). Compared with placebo, most patients treated with botulinum toxin type A had significant improvement in wrist and finger flexor tone at all follow-up visits through 12 weeks (P<.001). There were no major adverse events associated with botulinum toxin type A injections.
At study termination, 111 of the 126 subjects received up to three additional treatments. Each set of injections had positive effects lasting for at least 12 weeks and, in some cases, as long as 18 to 24 weeks. "The findings suggest that botulinum toxin is useful in improving muscle tone, function and quality of life in patients with wrist and finger spasticity after a stroke," Brashear says. In an accompanying article, Lewis P. Rowland, MD, from Columbia-Presbyterian Medical Center in New York, NY, notes that more studies are needed to answer remaining questions about the appropriate role of botulinum toxin in management of poststroke spasticity.
"Which patients are the best candidates for botulinium toxin?" he asks. "Can functional improvement be expected? Will this treatment help patients regain independence in activities of daily living? Why did so many patients have a response to placebo?"
Allergan supported this study and has financial arrangements with some of its authors.
N Engl J Med. 2002;347(6):382-383, 395-400
Reviewed by Gary D. Vogin, MD
Laurie Barclay, MD, is a staff writer with WebMD.
© 2002 Medscape