A double-blind, randomized, controlled study of botulinum toxin type A in MS-related tremor
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Abstract
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® 2012;79:92–99
GLOSSARY
- BT=
- botulinum toxin type A;
- CRST=
- Combined Rating Score for Tremor;
- ICARS=
- International Cooperative Ataxia Rating Scale;
- IQR=
- interquartile range;
- MS=
- multiple sclerosis;
- MST=
- multiple sclerosis tremor;
- QUEST=
- Quality of Life in Essential Tremor Questionnaire;
- SARA=
- Scale for the Assessment and Rating of Ataxia
Footnotes
↵* These authors contributed equally to this work.
Study funding: Supported by institutional funding from Box Hill MS Research Fund and the Royal Melbourne Hospital Neuroscience Foundation.
Supplemental data at www.neurology.org
- Received August 1, 2011.
- Accepted February 17, 2012.
- Copyright © 2012 by AAN Enterprises, Inc.
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