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A randomized, double masked, controlled trial of botulinum toxin type A in essential hand tremor

From the Department of Neurology (Drs. Brin and Pullman), Columbia University, New York, NY; Department of Neurology (Drs. Lyons and Koller), University of Miami Medical Center, FL; Department of Community and Preventive Medicine (Dr. Doucette), Mount Sinai Medical Center, New York, NY; Department of Neurology (Drs. Adler and Caviness), Mayo Clinic Scottsdale, Scottsdale, AZ; Department of Neurology (Dr. Comella), Rush-Presbyterian St. Luke’s Medical Center, Chicago, IL; Department of Neurology (Dr. Dubinsky), University of Kansas Medical Center, Kansas City; Department of Neurology (Dr. Friedman), Brown University, Providence, RI; Department of Neurology (Dr. Manyam), Scott and White Clinic/Texas A+M College of Medicine, Temple, TX; Department of Neurology (Dr. Matsumoto), Mayo Clinic, Rochester, MN; Department of Neurology (Dr. Rajput), Royal University, Saskatoon, Saskatchewan, Canada; Department of Neurology (Dr. Sethi), Medical College of Georgia, Augusta; and Parkinson Institute (Dr. Tanner), Sunnyvale, CA.

Address correspondence and reprint requests to Dr. William C. Koller, Department of Neurology, University of Miami Medical Center, 1501 NW Ninth Avenue, Miami, FL 33136; e-mail: wkoller{at}med.miami.edu

Objective: To evaluate the safety and efficacy of botulinum toxin type A injection in essential tremor of the hand. Background: Botulinum toxin type A is an effective treatment for dystonia, spasticity, and other movement disorders and has been found to be useful in open-label studies and one double-masked study of essential hand tremor. Methods: One hundred thirty-three patients with essential tremor were randomized to low-dose (50 U) or high-dose (100 U) botulinum toxin type A (Botox) or vehicle placebo treatment. Injections were made into the wrist flexors and extensors. Patients were followed for 16 weeks. The effect of treatment was assessed by clinical rating scales, measures of motor tasks and functional disability, and global assessment of treatment. Hand strength was evaluated by clinical rating and by a dynamometer. Results: Both doses of botulinum toxin type A significantly reduced postural tremor on the clinical rating scales after 4 to 16 weeks. However, kinetic tremor was significantly reduced only at the 6-week examination. Measures of motor tasks and functional disability were not consistently improved with botulinum toxin type A treatment. Grip strength was reduced for the low- and high-dose botulinum toxin type A groups as compared with the placebo group. Adverse reactions consisted mainly of dose-dependent hand weakness. Conclusion: Botulinum toxin type A injections for essential tremor of the hands resulted in significant improvement of postural, but not kinetic, hand tremors and resulted in limited functional efficacy. Hand weakness is a dose-dependent significant side effect of treatment at the doses used in this study.

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