A randomized, double‐blind, placebo‐controlled study to evaluate botulinum toxin type A in essential hand tremor
Identifieur interne : 005720 ( Main/Exploration ); précédent : 005719; suivant : 005721A randomized, double‐blind, placebo‐controlled study to evaluate botulinum toxin type A in essential hand tremor
Auteurs : Jankovic [États-Unis] ; K. Schwartz [États-Unis] ; W. Clemence [États-Unis] ; A. Aswad [États-Unis] ; J. Mordaunt [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 1996-05.
English descriptors
- KwdEn :
- Aged, Botulinum Toxins, Type A (administration & dosage), Botulinum toxin type A, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Electromyography (drug effects), Essential hand tremor, Female, Hand, Humans, Injections, Intramuscular, Male, Middle Aged, Motor Skills (drug effects), Neurologic Examination (drug effects), Signal Processing, Computer-Assisted, Treatment Outcome, Tremor (drug therapy).
- MESH :
- chemical , administration & dosage : Botulinum Toxins, Type A.
- drug effects : Electromyography, Motor Skills, Neurologic Examination.
- drug therapy : Tremor.
- Aged, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Hand, Humans, Injections, Intramuscular, Male, Middle Aged, Signal Processing, Computer-Assisted, Treatment Outcome.
Abstract
Twenty‐five patients with hand tremor of 2 + (moderate) to 4 + (severe) on the tremor severity rating scale were randomized to receive either 50 U of botulinum toxin (BTX) type A (Allergan, Irvine, CA) or placebo injections into the wrist flexors and extensors of the dominant limb. If patients failed to respond to the initial injection, they were eligible to receive another injection of 100 U 4 weeks later. Rest, postural, and kinetic tremors were evaluated at 2‐ to 4‐week intervals over a 16‐week study period using tremor severity rating scales, accelerometry, and assessments of improvement and disability. A signigicant improvment (p < 0.05) was observed on the tremor severity rating scale 4 weeks after injection in patients treated with BTX as compared with placebo, and this effect was maintained for the duration of the study. Four weeks after injection, 75% of BTX‐treated patients vs. 27% of placebo‐treated patients (p < 0.05). reported mild to moderate improvement (peak effect rating ≥2). There were no significant improvements in functional rating scales, although trends were observed for some items. Postural accelerometry measurements showed a ≥30% reduction in amplitude in nine of 12 BTX‐treated subjects and in one of nine placebo‐treated subjects (p < 0. 05). Although all patients treated with BTX reported some degree of finger weakness, no severe, irreversible, or unexpected adverse events occurred. Chemodenervation with BTX may significantly ameliorate essential hand tremor in patients who fail to improve with conventional pharmacologic therapy.
Url:
DOI: 10.1002/mds.870110306
Affiliations:
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Schwartz</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Department of Neurology, Parkinson's disease Center and Movement Disorders Clinic, Baylor College of Medicine, Houston</wicri:cityArea></affiliation></author><author><name sortKey="Clemence, W" sort="Clemence, W" uniqKey="Clemence W" first="W." last="Clemence">W. Clemence</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Texas</region></placeName><wicri:cityArea>Department of Neurology, Parkinson's disease Center and Movement Disorders Clinic, Baylor College of Medicine, Houston</wicri:cityArea></affiliation></author><author><name sortKey="Aswad, A" sort="Aswad, A" uniqKey="Aswad A" first="A." last="Aswad">A. Aswad</name><affiliation wicri:level="1"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Allergan, Inc., Irvine, Calfornia</wicri:regionArea><wicri:noRegion>Calfornia</wicri:noRegion></affiliation></author><author><name sortKey="Mordaunt, J" sort="Mordaunt, J" uniqKey="Mordaunt J" first="J." last="Mordaunt">J. Mordaunt</name><affiliation wicri:level="1"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Allergan, Inc., Irvine, Calfornia</wicri:regionArea><wicri:noRegion>Calfornia</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="1996-05">1996-05</date><biblScope unit="vol">11</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="250">250</biblScope><biblScope unit="page" to="256">256</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">D8B6E602DBD5565208D398C0BA6D8489B69D60F5</idno><idno type="DOI">10.1002/mds.870110306</idno><idno type="ArticleID">MDS870110306</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Botulinum Toxins, Type A (administration & dosage)</term><term>Botulinum toxin type A</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Electromyography (drug effects)</term><term>Essential hand tremor</term><term>Female</term><term>Hand</term><term>Humans</term><term>Injections, Intramuscular</term><term>Male</term><term>Middle Aged</term><term>Motor Skills (drug effects)</term><term>Neurologic Examination (drug effects)</term><term>Signal Processing, Computer-Assisted</term><term>Treatment Outcome</term><term>Tremor (drug therapy)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Botulinum Toxins, Type A</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Electromyography</term><term>Motor Skills</term><term>Neurologic Examination</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Tremor</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Female</term><term>Hand</term><term>Humans</term><term>Injections, Intramuscular</term><term>Male</term><term>Middle Aged</term><term>Signal Processing, Computer-Assisted</term><term>Treatment Outcome</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Twenty‐five patients with hand tremor of 2 + (moderate) to 4 + (severe) on the tremor severity rating scale were randomized to receive either 50 U of botulinum toxin (BTX) type A (Allergan, Irvine, CA) or placebo injections into the wrist flexors and extensors of the dominant limb. If patients failed to respond to the initial injection, they were eligible to receive another injection of 100 U 4 weeks later. Rest, postural, and kinetic tremors were evaluated at 2‐ to 4‐week intervals over a 16‐week study period using tremor severity rating scales, accelerometry, and assessments of improvement and disability. A signigicant improvment (p < 0.05) was observed on the tremor severity rating scale 4 weeks after injection in patients treated with BTX as compared with placebo, and this effect was maintained for the duration of the study. Four weeks after injection, 75% of BTX‐treated patients vs. 27% of placebo‐treated patients (p < 0.05). reported mild to moderate improvement (peak effect rating ≥2). There were no significant improvements in functional rating scales, although trends were observed for some items. Postural accelerometry measurements showed a ≥30% reduction in amplitude in nine of 12 BTX‐treated subjects and in one of nine placebo‐treated subjects (p < 0. 05). Although all patients treated with BTX reported some degree of finger weakness, no severe, irreversible, or unexpected adverse events occurred. Chemodenervation with BTX may significantly ameliorate essential hand tremor in patients who fail to improve with conventional pharmacologic therapy.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Texas</li></region></list><tree><country name="États-Unis"><region name="Texas"><name sortKey="Jankovic" sort="Jankovic" uniqKey="Jankovic" last="Jankovic">Jankovic</name></region><name sortKey="Aswad, A" sort="Aswad, A" uniqKey="Aswad A" first="A." last="Aswad">A. Aswad</name><name sortKey="Clemence, W" sort="Clemence, W" uniqKey="Clemence W" first="W." last="Clemence">W. Clemence</name><name sortKey="Mordaunt, J" sort="Mordaunt, J" uniqKey="Mordaunt J" first="J." last="Mordaunt">J. Mordaunt</name><name sortKey="Schwartz, K" sort="Schwartz, K" uniqKey="Schwartz K" first="K." last="Schwartz">K. Schwartz</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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