A double-blind, randomized, controlled study of botulinum toxin type A in MS-related tremor

作者：Van der Walt Anneke^*; Sung Simon; Spelman Timothy; Marriott Mark; Kolbe Scott; Mitchell Peter; Evans Andrew; Butzkueven Helmut

来源：Neurology, 2012, 79(1): 92-99.

DOI：10.1212/WNL.0b013e31825dcdd9

Objective: To evaluate the safety and efficacy of botulinum toxin type A in disabling multiple sclerosis (MS)-related upper limb tremor.
Methods: Twenty-three patients with MS contributed data from 33 upper limbs to this study. Each limb was randomized in a crossover design to receive botulinum toxin type A or placebo at baseline and the reverse treatment at 12 weeks. The 3 main outcomes were the median changes in Bain tremor rating scores for tremor severity, writing, and drawing an Archimedes spiral from baseline to 6 and 12 weeks after treatment with botulinum toxin type A compared with those after treatment with saline placebo. An independent rater scored randomized video assessments performed every 6 weeks over 6 months.
Results: There was a significant improvement after botulinum toxin compared with that after placebo treatment in the Bain score for tremor severity at 6 weeks (p = 0.0005) and 12 weeks (p = 0.0001), writing at 6 weeks (p = 0.0001) and 12 weeks (p = 0.0003), and Archimedes spiral drawing at 6 weeks (p = 0.0006) and 12 weeks (p = 0.0002). More patients developed weakness after botulinum toxin treatment (42.2%) than after placebo injection (6.1%; (p = 0.0005). Weakness was mild (just detectable) to moderate (still able to use limb) and resolved within 2 weeks.
Conclusions: Targeted botulinum toxin type A injections significantly improve arm tremor and tremor-related disability in patients with MS.
Classification of evidence: This study provides Class III evidence that targeted injection of botulinum toxin type A is associated with significant improvement in MS-related upper limb tremor. Neurology (R) 2012; 79:92-99

• 出版日期2012-7