DYSBOT: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A--Dysport and Botox--assuming a ratio of 4:1.
Identifieur interne : 004681 ( PubMed/Checkpoint ); précédent : 004680; suivant : 004682DYSBOT: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A--Dysport and Botox--assuming a ratio of 4:1.
Auteurs : C. Sampaio [Portugal] ; J J Ferreira ; F. Sim Es ; M J Rosas ; M. Magalhães ; A P Correia ; A. Bastos-Lima ; R. Martins ; A. Castro-CaldasSource :
- Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 1997.
English descriptors
- KwdEn :
- MESH :
- chemical , therapeutic use : Botulinum Toxins, Type A, Neuromuscular Agents.
- drug therapy : Blepharospasm, Hemifacial Spasm.
- Aged, Drug Tolerance, Female, Humans, Male, Middle Aged, Single-Blind Method, Time Factors.
Abstract
Elston and Russell discovered a difference in the biological potency of the English formulation of botulinum toxin type A or BTX-A (Dysport) and the American formulation (Botox). Potency of both is expressed in LD50 mouse units, but because of assay differences, these units are not equivalent. Since the first warning by Quinn and Hallet on the clinical importance of this issue, it has been impossible to reach a consensus on the conversion factor for the potency of these formulations.
DOI: 10.1002/mds.870120627
PubMed: 9399229
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">DYSBOT: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A--Dysport and Botox--assuming a ratio of 4:1.</title><author><name sortKey="Sampaio, C" sort="Sampaio, C" uniqKey="Sampaio C" first="C" last="Sampaio">C. Sampaio</name><affiliation wicri:level="1"><nlm:affiliation>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon, Portugal.</nlm:affiliation><country xml:lang="fr">Portugal</country><wicri:regionArea>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon</wicri:regionArea><wicri:noRegion>University of Lisbon</wicri:noRegion></affiliation></author><author><name sortKey="Ferreira, J J" sort="Ferreira, J J" uniqKey="Ferreira J" first="J J" last="Ferreira">J J Ferreira</name></author><author><name sortKey="Sim Es, F" sort="Sim Es, F" uniqKey="Sim Es F" first="F" last="Sim Es">F. Sim Es</name></author><author><name sortKey="Rosas, M J" sort="Rosas, M J" uniqKey="Rosas M" first="M J" last="Rosas">M J Rosas</name></author><author><name sortKey="Magalhaes, M" sort="Magalhaes, M" uniqKey="Magalhaes M" first="M" last="Magalhães">M. Magalhães</name></author><author><name sortKey="Correia, A P" sort="Correia, A P" uniqKey="Correia A" first="A P" last="Correia">A P Correia</name></author><author><name sortKey="Bastos Lima, A" sort="Bastos Lima, A" uniqKey="Bastos Lima A" first="A" last="Bastos-Lima">A. Bastos-Lima</name></author><author><name sortKey="Martins, R" sort="Martins, R" uniqKey="Martins R" first="R" last="Martins">R. Martins</name></author><author><name sortKey="Castro Caldas, A" sort="Castro Caldas, A" uniqKey="Castro Caldas A" first="A" last="Castro-Caldas">A. Castro-Caldas</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="1997">1997</date><idno type="RBID">pubmed:9399229</idno><idno type="pmid">9399229</idno><idno type="doi">10.1002/mds.870120627</idno><idno type="wicri:Area/PubMed/Corpus">004552</idno><idno type="wicri:Area/PubMed/Curation">004552</idno><idno type="wicri:Area/PubMed/Checkpoint">004681</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">DYSBOT: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A--Dysport and Botox--assuming a ratio of 4:1.</title><author><name sortKey="Sampaio, C" sort="Sampaio, C" uniqKey="Sampaio C" first="C" last="Sampaio">C. Sampaio</name><affiliation wicri:level="1"><nlm:affiliation>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon, Portugal.</nlm:affiliation><country xml:lang="fr">Portugal</country><wicri:regionArea>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon</wicri:regionArea><wicri:noRegion>University of Lisbon</wicri:noRegion></affiliation></author><author><name sortKey="Ferreira, J J" sort="Ferreira, J J" uniqKey="Ferreira J" first="J J" last="Ferreira">J J Ferreira</name></author><author><name sortKey="Sim Es, F" sort="Sim Es, F" uniqKey="Sim Es F" first="F" last="Sim Es">F. Sim Es</name></author><author><name sortKey="Rosas, M J" sort="Rosas, M J" uniqKey="Rosas M" first="M J" last="Rosas">M J Rosas</name></author><author><name sortKey="Magalhaes, M" sort="Magalhaes, M" uniqKey="Magalhaes M" first="M" last="Magalhães">M. Magalhães</name></author><author><name sortKey="Correia, A P" sort="Correia, A P" uniqKey="Correia A" first="A P" last="Correia">A P Correia</name></author><author><name sortKey="Bastos Lima, A" sort="Bastos Lima, A" uniqKey="Bastos Lima A" first="A" last="Bastos-Lima">A. Bastos-Lima</name></author><author><name sortKey="Martins, R" sort="Martins, R" uniqKey="Martins R" first="R" last="Martins">R. Martins</name></author><author><name sortKey="Castro Caldas, A" sort="Castro Caldas, A" uniqKey="Castro Caldas A" first="A" last="Castro-Caldas">A. Castro-Caldas</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="1997" type="published">1997</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Blepharospasm (drug therapy)</term><term>Botulinum Toxins, Type A (therapeutic use)</term><term>Drug Tolerance</term><term>Female</term><term>Hemifacial Spasm (drug therapy)</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Neuromuscular Agents (therapeutic use)</term><term>Single-Blind Method</term><term>Time Factors</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Botulinum Toxins, Type A</term><term>Neuromuscular Agents</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Blepharospasm</term><term>Hemifacial Spasm</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Drug Tolerance</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Single-Blind Method</term><term>Time Factors</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Elston and Russell discovered a difference in the biological potency of the English formulation of botulinum toxin type A or BTX-A (Dysport) and the American formulation (Botox). Potency of both is expressed in LD50 mouse units, but because of assay differences, these units are not equivalent. Since the first warning by Quinn and Hallet on the clinical importance of this issue, it has been impossible to reach a consensus on the conversion factor for the potency of these formulations.</div></front></TEI><pubmed><MedlineCitation Owner="NLM" Status="MEDLINE"><PMID Version="1">9399229</PMID><DateCreated><Year>1998</Year><Month>02</Month><Day>10</Day></DateCreated><DateCompleted><Year>1998</Year><Month>02</Month><Day>10</Day></DateCompleted><DateRevised><Year>2014</Year><Month>07</Month><Day>29</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0885-3185</ISSN><JournalIssue CitedMedium="Print"><Volume>12</Volume><Issue>6</Issue><PubDate><Year>1997</Year><Month>Nov</Month></PubDate></JournalIssue><Title>Movement disorders : official journal of the Movement Disorder Society</Title><ISOAbbreviation>Mov. Disord.</ISOAbbreviation></Journal><ArticleTitle>DYSBOT: a single-blind, randomized parallel study to determine whether any differences can be detected in the efficacy and tolerability of two formulations of botulinum toxin type A--Dysport and Botox--assuming a ratio of 4:1.</ArticleTitle><Pagination><MedlinePgn>1013-8</MedlinePgn></Pagination><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Elston and Russell discovered a difference in the biological potency of the English formulation of botulinum toxin type A or BTX-A (Dysport) and the American formulation (Botox). Potency of both is expressed in LD50 mouse units, but because of assay differences, these units are not equivalent. Since the first warning by Quinn and Hallet on the clinical importance of this issue, it has been impossible to reach a consensus on the conversion factor for the potency of these formulations.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To test the hypothesis that the conversion factor for the clinical potency of Dysport to Botox is approximately 4:1. DYSBOT is an acronym that results from adding "DYS" from Dysport with "BOT" from Botox.</AbstractText><AbstractText Label="PATIENTS AND METHODS" NlmCategory="METHODS"></AbstractText><AbstractText Label="DESIGN" NlmCategory="METHODS">A single-blind, randomized, parallel comparison. A total of 91 patients with blepharospasm or hemifacial spasm were randomized to treatment with Dysport or Botox using a fixed potency ratio of 4:1. Clinical evaluations: The patients were evaluated at baseline (day of the treatment). 1 month after treatment, and whenever the effect was judged to be fading. Objective and functional rating scales were used as quantitative measures of the change in clinical status. Adverse reactions were collected using a systematic questionnaire.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Using this ratio between products, both Dysport and Botox groups produced similar clinical efficacy and tolerability. For patients showing a positive response without the need of a booster, the duration of effect was 13.3 +/- 5.9 weeks for the Dysport group and 11.2 +/- 5.8 weeks for the Botox group. Of 48 patients, 11 (23%) needed booster treatment in the Dysport group compared with five (12%) of 43 in Botox group. Adverse events were noted in 24 (50%) of 48 patients in the Dysport group and 20 (47%) of 43 of the Botox-treated group.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Using a 4:1 conversion ratio for Dysport and Botox, similar results were obtained for the two treatments in an appropriately powered study, suggesting that this conversion factor is a good estimate of their comparative clinical potencies.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Sampaio</LastName><ForeName>C</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon, Portugal.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ferreira</LastName><ForeName>J J</ForeName><Initials>JJ</Initials></Author><Author ValidYN="Y"><LastName>Simões</LastName><ForeName>F</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Rosas</LastName><ForeName>M J</ForeName><Initials>MJ</Initials></Author><Author ValidYN="Y"><LastName>Magalhães</LastName><ForeName>M</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Correia</LastName><ForeName>A P</ForeName><Initials>AP</Initials></Author><Author ValidYN="Y"><LastName>Bastos-Lima</LastName><ForeName>A</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Martins</LastName><ForeName>R</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Castro-Caldas</LastName><ForeName>A</ForeName><Initials>A</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D003160">Comparative Study</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>0</RegistryNumber><NameOfSubstance UI="D009465">Neuromuscular Agents</NameOfSubstance></Chemical><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="D001764">Blepharospasm</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019274">Botulinum Toxins, Type A</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D004361">Drug Tolerance</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D005260">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D019569">Hemifacial Spasm</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000188">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D006801">Humans</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="D009465">Neuromuscular Agents</DescriptorName><QualifierName MajorTopicYN="Y" UI="Q000627">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D016037">Single-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName MajorTopicYN="N" UI="D013997">Time Factors</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>1997</Year><Month>12</Month><Day>17</Day></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>1997</Year><Month>12</Month><Day>17</Day><Hour>0</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>1997</Year><Month>12</Month><Day>17</Day><Hour>0</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">9399229</ArticleId><ArticleId IdType="doi">10.1002/mds.870120627</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Portugal</li></country></list><tree><noCountry><name sortKey="Bastos Lima, A" sort="Bastos Lima, A" uniqKey="Bastos Lima A" first="A" last="Bastos-Lima">A. Bastos-Lima</name><name sortKey="Castro Caldas, A" sort="Castro Caldas, A" uniqKey="Castro Caldas A" first="A" last="Castro-Caldas">A. Castro-Caldas</name><name sortKey="Correia, A P" sort="Correia, A P" uniqKey="Correia A" first="A P" last="Correia">A P Correia</name><name sortKey="Ferreira, J J" sort="Ferreira, J J" uniqKey="Ferreira J" first="J J" last="Ferreira">J J Ferreira</name><name sortKey="Magalhaes, M" sort="Magalhaes, M" uniqKey="Magalhaes M" first="M" last="Magalhães">M. Magalhães</name><name sortKey="Martins, R" sort="Martins, R" uniqKey="Martins R" first="R" last="Martins">R. Martins</name><name sortKey="Rosas, M J" sort="Rosas, M J" uniqKey="Rosas M" first="M J" last="Rosas">M J Rosas</name><name sortKey="Sim Es, F" sort="Sim Es, F" uniqKey="Sim Es F" first="F" last="Sim Es">F. Sim Es</name></noCountry><country name="Portugal"><noRegion><name sortKey="Sampaio, C" sort="Sampaio, C" uniqKey="Sampaio C" first="C" last="Sampaio">C. 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