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 : 000D61 ( Istex/Corpus ); précédent : 000D60; suivant : 000D62DYSBOT: 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 : Sampaio ; Joaquim J. Ferreira ; Fernanda Sim Es ; Maria J. Rosas ; Marina Magalhães ; Ana P. Correia ; Ant Nio Bastos-Lima ; Rairnundo Martins ; Alexandre Castro-CaldasSource :
- Movement Disorders [ 0885-3185 ] ; 1997-11.
English descriptors
Abstract
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. 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. Patients and Methods: Design: 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. 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. 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.
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DOI: 10.1002/mds.870120627
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<record><TEI wicri:istexFullTextTei="biblStruct"><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" sort="Sampaio" uniqKey="Sampaio" last="Sampaio">Sampaio</name><affiliation><mods:affiliation>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon</mods:affiliation></affiliation></author><author><name sortKey="Ferreira, Joaquim J" sort="Ferreira, Joaquim J" uniqKey="Ferreira J" first="Joaquim J." last="Ferreira">Joaquim J. Ferreira</name><affiliation><mods:affiliation>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</mods:affiliation></affiliation></author><author><name sortKey="Sim Es, Fernanda" sort="Sim Es, Fernanda" uniqKey="Sim Es F" first="Fernanda" last="Sim Es">Fernanda Sim Es</name><affiliation><mods:affiliation>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Rosas, Maria J" sort="Rosas, Maria J" uniqKey="Rosas M" first="Maria J." last="Rosas">Maria J. Rosas</name><affiliation><mods:affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Magalhaes, Marina" sort="Magalhaes, Marina" uniqKey="Magalhaes M" first="Marina" last="Magalhães">Marina Magalhães</name><affiliation><mods:affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Correia, Ana P" sort="Correia, Ana P" uniqKey="Correia A" first="Ana P." last="Correia">Ana P. Correia</name><affiliation><mods:affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Bastos Ima, Ant Nio" sort="Bastos Ima, Ant Nio" uniqKey="Bastos Ima A" first="Ant Nio" last="Bastos-Lima">Ant Nio Bastos-Lima</name><affiliation><mods:affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Martins, Rairnundo" sort="Martins, Rairnundo" uniqKey="Martins R" first="Rairnundo" last="Martins">Rairnundo Martins</name><affiliation><mods:affiliation>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Castro Aldas, Alexandre" sort="Castro Aldas, Alexandre" uniqKey="Castro Aldas A" first="Alexandre" last="Castro-Caldas">Alexandre Castro-Caldas</name><affiliation><mods:affiliation>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8</idno><date when="1997" year="1997">1997</date><idno type="doi">10.1002/mds.870120627</idno><idno type="url">https://api.istex.fr/document/16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000D61</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" 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" sort="Sampaio" uniqKey="Sampaio" last="Sampaio">Sampaio</name><affiliation><mods:affiliation>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon</mods:affiliation></affiliation></author><author><name sortKey="Ferreira, Joaquim J" sort="Ferreira, Joaquim J" uniqKey="Ferreira J" first="Joaquim J." last="Ferreira">Joaquim J. Ferreira</name><affiliation><mods:affiliation>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</mods:affiliation></affiliation></author><author><name sortKey="Sim Es, Fernanda" sort="Sim Es, Fernanda" uniqKey="Sim Es F" first="Fernanda" last="Sim Es">Fernanda Sim Es</name><affiliation><mods:affiliation>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Rosas, Maria J" sort="Rosas, Maria J" uniqKey="Rosas M" first="Maria J." last="Rosas">Maria J. Rosas</name><affiliation><mods:affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Magalhaes, Marina" sort="Magalhaes, Marina" uniqKey="Magalhaes M" first="Marina" last="Magalhães">Marina Magalhães</name><affiliation><mods:affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Correia, Ana P" sort="Correia, Ana P" uniqKey="Correia A" first="Ana P." last="Correia">Ana P. Correia</name><affiliation><mods:affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Bastos Ima, Ant Nio" sort="Bastos Ima, Ant Nio" uniqKey="Bastos Ima A" first="Ant Nio" last="Bastos-Lima">Ant Nio Bastos-Lima</name><affiliation><mods:affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Martins, Rairnundo" sort="Martins, Rairnundo" uniqKey="Martins R" first="Rairnundo" last="Martins">Rairnundo Martins</name><affiliation><mods:affiliation>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</mods:affiliation></affiliation></author><author><name sortKey="Castro Aldas, Alexandre" sort="Castro Aldas, Alexandre" uniqKey="Castro Aldas A" first="Alexandre" last="Castro-Caldas">Alexandre Castro-Caldas</name><affiliation><mods:affiliation>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</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="1997-11">1997-11</date><biblScope unit="vol">12</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="1013">1013</biblScope><biblScope unit="page" to="1018">1018</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8</idno><idno type="DOI">10.1002/mds.870120627</idno><idno type="ArticleID">MDS870120627</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Botox</term><term>Botulinum toxin type A</term><term>DYSBOT</term><term>Drug potency</term><term>Dysport</term><term>Equivalence of formulations</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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. 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. Patients and Methods: Design: 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. 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. 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.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Dr. Sampaio</name><affiliations><json:string>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon</json:string></affiliations></json:item><json:item><name>Joaquim J. Ferreira</name><affiliations><json:string>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</json:string></affiliations></json:item><json:item><name>Fernanda Simões</name><affiliations><json:string>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</json:string></affiliations></json:item><json:item><name>Maria J. Rosas</name><affiliations><json:string>Department of Neurology, St. Antonio Hospital Porto, Portugal</json:string></affiliations></json:item><json:item><name>Marina Magalhães</name><affiliations><json:string>Department of Neurology, St. Antonio Hospital Porto, Portugal</json:string></affiliations></json:item><json:item><name>Ana P. Correia</name><affiliations><json:string>Department of Neurology, St. Antonio Hospital Porto, Portugal</json:string></affiliations></json:item><json:item><name>António Bastos‐Lima</name><affiliations><json:string>Department of Neurology, St. Antonio Hospital Porto, Portugal</json:string></affiliations></json:item><json:item><name>Rairnundo Martins</name><affiliations><json:string>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</json:string></affiliations></json:item><json:item><name>Alexandre Castro‐Caldas</name><affiliations><json:string>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Botox</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Botulinum toxin type A</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Drug potency</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>DYSBOT</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Dysport</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Equivalence of formulations</value></json:item></subject><language><json:string>eng</json:string></language><abstract>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.Objective: To test the hypothesis that the conversion factorfor 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.Patients and Methods: Design: 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.Results: Using this ratio between products, both Dysport andBotox 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.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.</abstract><qualityIndicators><score>6.795</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 827.759 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractCharCount>2071</abstractCharCount><pdfWordCount>3795</pdfWordCount><pdfCharCount>22481</pdfCharCount><pdfPageCount>6</pdfPageCount><abstractWordCount>324</abstractWordCount></qualityIndicators><title>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><genre><json:string>Serial article</json:string></genre><host><volume>12</volume><pages><total>6</total><last>1018</last><first>1013</first></pages><issn><json:string>0885-3185</json:string></issn><issue>6</issue><subject><json:item><value>Article</value></json:item></subject><genre></genre><language><json:string>unknown</json:string></language><title>Movement Disorders</title><doi><json:string>10.1002/(ISSN)1531-8257</json:string></doi></host><publicationDate>1997</publicationDate><copyrightDate>1997</copyrightDate><doi><json:string>10.1002/mds.870120627</json:string></doi><id>16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8/fulltext/tei"><teiHeader type="text"><fileDesc><titleStmt><title level="a" type="main" 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></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>Wiley Subscription Services, Inc., A Wiley Company</p></availability><date>1997</date></publicationStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" 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><persName><surname>Sampaio</surname><roleName type="degree">Dr.</roleName></persName><note type="correspondence"><p>Correspondence: Institute de Farmacologia e Terapeutica Geral, Faculdade de Medicina de Lisboa, Hospital de Santa Maria, 1600 Lisboa, Portugal</p></note><affiliation>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon</affiliation></author><author><persName><forename type="first">Joaquim J.</forename><surname>Ferreira</surname></persName><affiliation>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</affiliation></author><author><persName><forename type="first">Fernanda</forename><surname>Simões</surname></persName><affiliation>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</affiliation></author><author><persName><forename type="first">Maria J.</forename><surname>Rosas</surname></persName><affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</affiliation></author><author><persName><forename type="first">Marina</forename><surname>Magalhães</surname></persName><affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</affiliation></author><author><persName><forename type="first">Ana P.</forename><surname>Correia</surname></persName><affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</affiliation></author><author><persName><forename type="first">António</forename><surname>Bastos‐Lima</surname></persName><affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</affiliation></author><author><persName><forename type="first">Rairnundo</forename><surname>Martins</surname></persName><affiliation>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</affiliation></author><author><persName><forename type="first">Alexandre</forename><surname>Castro‐Caldas</surname></persName><affiliation>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="1997-11"></date><biblScope unit="vol">12</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="1013">1013</biblScope><biblScope unit="page" to="1018">1018</biblScope></imprint></monogr><idno type="istex">16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8</idno><idno type="DOI">10.1002/mds.870120627</idno><idno type="ArticleID">MDS870120627</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>1997</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>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.Objective: To test the hypothesis that the conversion factorfor 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.Patients and Methods: Design: 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.Results: Using this ratio between products, both Dysport andBotox 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.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.</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Botox</term></item><item><term>Botulinum toxin type A</term></item><item><term>Drug potency</term></item><item><term>DYSBOT</term></item><item><term>Dysport</term></item><item><term>Equivalence of formulations</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>Article category</head><item><term>Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="1996-01-03">Received</change><change when="1997-03-03">Registration</change><change when="1997-11">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="short">Mov. Disord.</title></titleGroup></publicationMeta><publicationMeta level="part" position="60"><doi origin="wiley" registered="yes">10.1002/mds.v12:6</doi><numberingGroup><numbering type="journalVolume" number="12">12</numbering><numbering type="journalIssue">6</numbering></numberingGroup><coverDate startDate="1997-11">November 1997</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="27" status="forIssue"><doi origin="wiley" registered="yes">10.1002/mds.870120627</doi><idGroup><id type="unit" value="MDS870120627"></id></idGroup><countGroup><count type="pageTotal" number="6"></count></countGroup><titleGroup><title type="articleCategory">Article</title><title type="tocHeading1">Articles</title></titleGroup><copyright ownership="thirdParty">Copyright © 1997 Movement Disorder Society</copyright><eventGroup><event type="manuscriptReceived" date="1996-01-03"></event><event type="manuscriptRevised" date="1997-02-28"></event><event type="manuscriptAccepted" date="1997-03-03"></event><event type="firstOnline" date="2004-11-04"></event><event type="publishedOnlineFinalForm" date="2004-11-04"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:2.4.7 mode:FullText source:HeaderRef result:HeaderRef" date="2011-02-24"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-02-02"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-31"></event></eventGroup><numberingGroup><numbering type="pageFirst">1013</numbering><numbering type="pageLast">1018</numbering></numberingGroup><correspondenceTo>Institute de Farmacologia e Terapeutica Geral, Faculdade de Medicina de Lisboa, Hospital de Santa Maria, 1600 Lisboa, Portugal</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS870120627.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="0"></count><count type="tableTotal" number="5"></count><count type="referenceTotal" number="16"></count></countGroup><titleGroup><title type="main" 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><title type="short" xml:lang="en">DYSBOT: COMPARISON OF DYSPORT AND BOTOX</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><honorifics>Dr.</honorifics><givenNames>Cristina</givenNames><familyName>Sampaio</familyName></personName></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Joaquim J.</givenNames><familyName>Ferreira</familyName></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Fernanda</givenNames><familyName>Simões</familyName></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Maria J.</givenNames><familyName>Rosas</familyName></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Marina</givenNames><familyName>Magalhães</familyName></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Ana P.</givenNames><familyName>Correia</familyName></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af4"><personName><givenNames>António</givenNames><familyName>Bastos‐Lima</familyName></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Rairnundo</givenNames><familyName>Martins</familyName></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af2"><personName><givenNames>Alexandre</givenNames><familyName>Castro‐Caldas</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="PT" type="organization"><unparsedAffiliation>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="PT" type="organization"><unparsedAffiliation>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="PT" type="organization"><unparsedAffiliation>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="PT" type="organization"><unparsedAffiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Botox</keyword><keyword xml:id="kwd2">Botulinum toxin type A</keyword><keyword xml:id="kwd3">Drug potency</keyword><keyword xml:id="kwd4">DYSBOT</keyword><keyword xml:id="kwd5">Dysport</keyword><keyword xml:id="kwd6">Equivalence of formulations</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p><b>Background:</b> 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.</p><p><b>Objective:</b> 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.</p><p><b>Patients and Methods:</b> Design: 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. <i>Clinical evaluations</i>: 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.</p><p><b>Results:</b> 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.</p><p><b>Conclusions:</b> 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.</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><!--Version 0.6 générée le 3-12-2015--><mods version="3.6"><titleInfo lang="en"><title>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></titleInfo><titleInfo type="abbreviated" lang="en"><title>DYSBOT: COMPARISON OF DYSPORT AND BOTOX</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>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></titleInfo><name type="personal"><namePart type="termsOfAddress">Dr.</namePart><namePart type="family">Sampaio</namePart><affiliation>Institute of Pharmacology and General Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon</affiliation><description>Correspondence: Institute de Farmacologia e Terapeutica Geral, Faculdade de Medicina de Lisboa, Hospital de Santa Maria, 1600 Lisboa, Portugal</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Joaquim J.</namePart><namePart type="family">Ferreira</namePart><affiliation>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Fernanda</namePart><namePart type="family">Simões</namePart><affiliation>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Maria J.</namePart><namePart type="family">Rosas</namePart><affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Marina</namePart><namePart type="family">Magalhães</namePart><affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ana P.</namePart><namePart type="family">Correia</namePart><affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">António</namePart><namePart type="family">Bastos‐Lima</namePart><affiliation>Department of Neurology, St. Antonio Hospital Porto, Portugal</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Rairnundo</namePart><namePart type="family">Martins</namePart><affiliation>Department of Neurology and Neurosurgery, S. João Hospital, Porto, Portugal</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Alexandre</namePart><namePart type="family">Castro‐Caldas</namePart><affiliation>Department of Neurology, Faculty of Medicine, Santa Maria Hospital and University of Lisbon, Lisbon</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre authority="originalCategForm">article</genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">1997-11</dateIssued><dateCaptured encoding="w3cdtf">1996-01-03</dateCaptured><dateValid encoding="w3cdtf">1997-03-03</dateValid><copyrightDate encoding="w3cdtf">1997</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="tables">5</extent><extent unit="references">16</extent></physicalDescription><abstract lang="en">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. 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. Patients and Methods: Design: 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. 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. 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.</abstract><subject lang="en"><genre>Keywords</genre><topic>Botox</topic><topic>Botulinum toxin type A</topic><topic>Drug potency</topic><topic>DYSBOT</topic><topic>Dysport</topic><topic>Equivalence of formulations</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. 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