Botulinum toxin A injections improved wrist and finger spasticity after stroke.

In patients who have had a stroke, is a set of botulinum toxin A (BTA) injections more effective than placebo in improving wrist and finger spasticity? D e s i g n Randomized (unclear allocation conceal-ment*), blinded (clinicians, patients, and outcome assessors),* placebo-controlled trial with 12-week follow-up (Botox Post-Stroke Spasticity Study Group). 126 patients who were ≥ 21 years of age (mean age 61 y, 50% men) and had a stroke in the past 6 months; focal spasticity of the wrist and fingers; and evidence of difficulty with hygiene and dressing, pain, or wrist or finger malposition confirmed by a score of 2 or 3 on the Disability Assessment Scale (DAS) (0 = no disability and 3 = severe disability). Exclusion criteria were fixed con-tracture or muscle atrophy in the spastic limb; treatment of the limb with any botu-linum toxin serotype, phenol, alcohol, or surgery ; change in oral medication for spasticity in the past 3 months; treatment with intrathecal baclofen or agents affecting neu-romuscular transmission; or pregnancy. 122 patients (97%) completed the study. (n = 64) or placebo (n = 62). BTA and placebo were administered as 1 set of injections of 50 units into each of 4 wrist and finger muscles with optional injections into 1 or 2 thumb muscles. M a i n o u t c o m e m e a s u r e s Functional disability at 6 weeks assessed by the DAS. Patients selected 1 of the 4 areas of disability (hygiene, dressing, pain, or limb position) as the principal target of treatment and reported improvement as ≥ 1 point decrease in the DAS. At 6 weeks, more patients who received BTA reported improvement in the principal target of treatment than did patients who received placebo (Table). The difference was maintained at 12 weeks (P = 0.02). More patients who received BTA had greater improvement in all areas of disability than did patients who received placebo (Table). The groups did not differ for any adverse effects. In patients who have had a stroke and have wrist and finger spasticity, botulinum toxin A injections improved functional disability. Improvement in the principal 62% 27% 128% (49 to 262) 3 (2 to 6) target of treatment Improvement in all areas of disability 83% 53% 56% (22 to 106) 4 (3 to 8) †Abbreviations defined in Glossary; RBI, NNT, and CI calculated from data in article. …