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

Van Der Walt, A.; Sung, S.; Spelman, T.; Marriott, M.; Kolbe, S.; Mitchell, P.; Evans, A.; Butzkueven, H.

Neurology 79(1): 92-99

2012


ISSN/ISBN: 1526-632X
PMID: 22753445
DOI: 10.1212/wnl.0b013e31825dcdd9
Accession: 051129569

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Abstract
To evaluate the safety and efficacy of botulinum toxin type A in disabling multiple sclerosis (MS)-related upper limb tremor. 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. 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. Targeted botulinum toxin type A injections significantly improve arm tremor and tremor-related disability in patients with MS. 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.