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Randomized Controlled Trial Multicenter Study
A double-blind, randomized, controlled study of botulinum toxin type A in MS-related tremor.
- Anneke Van Der Walt, Simon Sung, Timothy Spelman, Mark Marriott, Scott Kolbe, Peter Mitchell, Andrew Evans, and Helmut Butzkueven.
- Royal Melbourne Hospital, Melbourne, Australia. anneke.vanderwalt@mh.org.au
- Neurology. 2012 Jul 3; 79 (1): 92-9.
ObjectiveTo evaluate the safety and efficacy of botulinum toxin type A in disabling multiple sclerosis (MS)-related upper limb tremor.MethodsTwenty-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.ResultsThere 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.ConclusionsTargeted botulinum toxin type A injections significantly improve arm tremor and tremor-related disability in patients with MS.Classification Of EvidenceThis study provides Class III evidence that targeted injection of botulinum toxin type A is associated with significant improvement in MS-related upper limb tremor.
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