A randomized, double-blind, placebo-controlled study to evaluate botulinum toxin type A in essential hand tremor.
Identifieur interne : 004843 ( PubMed/Corpus ); précédent : 004842; suivant : 004844A randomized, double-blind, placebo-controlled study to evaluate botulinum toxin type A in essential hand tremor.
Auteurs : J. Jankovic ; K. Schwartz ; W. Clemence ; A. Aswad ; J. MordauntSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 1996.
English descriptors
- KwdEn :
- Aged, Botulinum Toxins, Type A (administration & dosage), Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Electromyography (drug effects), 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 significant improvement (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 > or = 2). There were no significant improvements in functional rating scales, although trends were observed for some items. Postural accelerometry measurements showed a > or = 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.
DOI: 10.1002/mds.870110306
PubMed: 8723140
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A randomized, double-blind, placebo-controlled study to evaluate botulinum toxin type A in essential hand tremor.</title><author><name sortKey="Jankovic, J" sort="Jankovic, J" uniqKey="Jankovic J" first="J" last="Jankovic">J. Jankovic</name><affiliation><nlm:affiliation>Department of Neurology, Parkinson's Disease Center, Baylor College of Medicine, Houston, Texas 77030, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Schwartz, K" sort="Schwartz, K" uniqKey="Schwartz K" first="K" last="Schwartz">K. Schwartz</name></author><author><name sortKey="Clemence, W" sort="Clemence, W" uniqKey="Clemence W" first="W" last="Clemence">W. Clemence</name></author><author><name sortKey="Aswad, A" sort="Aswad, A" uniqKey="Aswad A" first="A" last="Aswad">A. Aswad</name></author><author><name sortKey="Mordaunt, J" sort="Mordaunt, J" uniqKey="Mordaunt J" first="J" last="Mordaunt">J. Mordaunt</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="1996">1996</date><idno type="RBID">pubmed:8723140</idno><idno type="pmid">8723140</idno><idno type="doi">10.1002/mds.870110306</idno><idno type="wicri:Area/PubMed/Corpus">004843</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">A randomized, double-blind, placebo-controlled study to evaluate botulinum toxin type A in essential hand tremor.</title><author><name sortKey="Jankovic, J" sort="Jankovic, J" uniqKey="Jankovic J" first="J" last="Jankovic">J. Jankovic</name><affiliation><nlm:affiliation>Department of Neurology, Parkinson's Disease Center, Baylor College of Medicine, Houston, Texas 77030, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Schwartz, K" sort="Schwartz, K" uniqKey="Schwartz K" first="K" last="Schwartz">K. Schwartz</name></author><author><name sortKey="Clemence, W" sort="Clemence, W" uniqKey="Clemence W" first="W" last="Clemence">W. Clemence</name></author><author><name sortKey="Aswad, A" sort="Aswad, A" uniqKey="Aswad A" first="A" last="Aswad">A. Aswad</name></author><author><name sortKey="Mordaunt, J" sort="Mordaunt, J" uniqKey="Mordaunt J" first="J" last="Mordaunt">J. Mordaunt</name></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="ISSN">0885-3185</idno><imprint><date when="1996" type="published">1996</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Botulinum Toxins, Type A (administration & dosage)</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Schedule</term><term>Electromyography (drug effects)</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></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 significant improvement (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 > or = 2). There were no significant improvements in functional rating scales, although trends were observed for some items. Postural accelerometry measurements showed a > or = 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><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">8723140</PMID><DateCreated><Year>1996</Year><Month>11</Month><Day>07</Day></DateCreated><DateCompleted><Year>1996</Year><Month>11</Month><Day>07</Day></DateCompleted><DateRevised><Year>2010</Year><Month>11</Month><Day>18</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>11</Volume><Issue>3</Issue><PubDate><Year>1996</Year><Month>May</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>A randomized, double-blind, placebo-controlled study to evaluate botulinum toxin type A in essential hand tremor.</ArticleTitle><Pagination><MedlinePgn>250-6</MedlinePgn></Pagination><Abstract><AbstractText>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 significant improvement (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 > or = 2). There were no significant improvements in functional rating scales, although trends were observed for some items. Postural accelerometry measurements showed a > or = 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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Jankovic</LastName><ForeName>J</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Neurology, Parkinson's Disease Center, Baylor College of Medicine, Houston, Texas 77030, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schwartz</LastName><ForeName>K</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Clemence</LastName><ForeName>W</ForeName><Initials>W</Initials></Author><Author ValidYN="Y"><LastName>Aswad</LastName><ForeName>A</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Mordaunt</LastName><ForeName>J</ForeName><Initials>J</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>UNITED STATES</Country><MedlineTA>Mov Disord</MedlineTA><NlmUniqueID>8610688</NlmUniqueID><ISSNLinking>0885-3185</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>EC 3.4.24.69</RegistryNumber><NameOfSubstance UI="D019274">Botulinum Toxins, Type A</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName MajorTopicYN="N" UI="D000368">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019274">Botulinum Toxins, Type A</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000008">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004305">Dose-Response Relationship, Drug</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004311">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004334">Drug Administration Schedule</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004576">Electromyography</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000187">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="Y" UI="D006225">Hand</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D007273">Injections, Intramuscular</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008297">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D008875">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009048">Motor Skills</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000187">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D009460">Neurologic Examination</DescriptorName><QualifierName MajorTopicYN="N" UI="Q000187">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D012815">Signal Processing, Computer-Assisted</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016896">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D014202">Tremor</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>1996</Year><Month>5</Month><Day>1</Day></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>1996</Year><Month>5</Month><Day>1</Day><Hour>0</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>1996</Year><Month>5</Month><Day>1</Day><Hour>0</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">8723140</ArticleId><ArticleId IdType="doi">10.1002/mds.870110306</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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