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 : 008399 ( Main/Merge ); précédent : 008398; suivant : 008400DYSBOT: 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 [Portugal] ; Maria J. Rosas [Portugal] ; Marina Magalhães [Portugal] ; Ana P. Correia [Portugal] ; Ant Nio Bastos-Lima [Portugal] ; Rairnundo Martins [Portugal] ; Alexandre Castro-CaldasSource :
- Movement Disorders [ 0885-3185 ] ; 1997-11.
English descriptors
- KwdEn :
- Aged, Blepharospasm (drug therapy), Botox, Botulinum Toxins, Type A (therapeutic use), Botulinum toxin type A, DYSBOT, Drug Tolerance, Drug potency, Dysport, Equivalence of formulations, Female, Hemifacial Spasm (drug therapy), Humans, Male, Middle Aged, Neuromuscular Agents (therapeutic use), Single-Blind Method, Time Factors.
- 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
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.
Url:
DOI: 10.1002/mds.870120627
Links toward previous steps (curation, corpus...)
- to stream Istex, to step Corpus: 000D61
- to stream Istex, to step Curation: 000D61
- to stream Istex, to step Checkpoint: 003994
- to stream PubMed, to step Corpus: 004552
- to stream PubMed, to step Curation: 004552
- to stream PubMed, to step Checkpoint: 004681
- to stream Ncbi, to step Merge: 004E33
- to stream Ncbi, to step Curation: 004E33
- to stream Ncbi, to step Checkpoint: 004E33
Links to Exploration step
ISTEX:16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8Le document en format XML
<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>
</author>
<author><name sortKey="Ferreira, Joaquim J" sort="Ferreira, Joaquim J" uniqKey="Ferreira J" first="Joaquim J." last="Ferreira">Joaquim J. Ferreira</name>
</author>
<author><name sortKey="Sim Es, Fernanda" sort="Sim Es, Fernanda" uniqKey="Sim Es F" first="Fernanda" last="Sim Es">Fernanda Sim Es</name>
</author>
<author><name sortKey="Rosas, Maria J" sort="Rosas, Maria J" uniqKey="Rosas M" first="Maria J." last="Rosas">Maria J. Rosas</name>
</author>
<author><name sortKey="Magalhaes, Marina" sort="Magalhaes, Marina" uniqKey="Magalhaes M" first="Marina" last="Magalhães">Marina Magalhães</name>
</author>
<author><name sortKey="Correia, Ana P" sort="Correia, Ana P" uniqKey="Correia A" first="Ana P." last="Correia">Ana P. Correia</name>
</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>
</author>
<author><name sortKey="Martins, Rairnundo" sort="Martins, Rairnundo" uniqKey="Martins R" first="Rairnundo" last="Martins">Rairnundo Martins</name>
</author>
<author><name sortKey="Castro Aldas, Alexandre" sort="Castro Aldas, Alexandre" uniqKey="Castro Aldas A" first="Alexandre" last="Castro-Caldas">Alexandre Castro-Caldas</name>
</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>
<idno type="wicri:Area/Istex/Curation">000D61</idno>
<idno type="wicri:Area/Istex/Checkpoint">003994</idno>
<idno type="wicri:doubleKey">0885-3185:1997:Sampaio:dysbot:a:single</idno>
<idno type="wicri:source">PubMed</idno>
<idno type="RBID">pubmed:9399229</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>
<idno type="wicri:Area/Ncbi/Merge">004E33</idno>
<idno type="wicri:Area/Ncbi/Curation">004E33</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">004E33</idno>
<idno type="wicri:doubleKey">0885-3185:1997:Sampaio C:dysbot:a:single</idno>
<idno type="wicri:Area/Main/Merge">008399</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><wicri:noCountry code="subField">Lisbon</wicri:noCountry>
</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><wicri:noCountry code="subField">Lisbon</wicri:noCountry>
</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 wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology and Neurosurgery, S. João Hospital, Porto</wicri:regionArea>
<wicri:noRegion>Porto</wicri:noRegion>
</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 wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology, St. Antonio Hospital Porto</wicri:regionArea>
<wicri:noRegion>St. Antonio Hospital Porto</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Magalhaes, Marina" sort="Magalhaes, Marina" uniqKey="Magalhaes M" first="Marina" last="Magalhães">Marina Magalhães</name>
<affiliation wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology, St. Antonio Hospital Porto</wicri:regionArea>
<wicri:noRegion>St. Antonio Hospital Porto</wicri:noRegion>
</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 wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology, St. Antonio Hospital Porto</wicri:regionArea>
<wicri:noRegion>St. Antonio Hospital Porto</wicri:noRegion>
</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 wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology, St. Antonio Hospital Porto</wicri:regionArea>
<wicri:noRegion>St. Antonio Hospital Porto</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Martins, Rairnundo" sort="Martins, Rairnundo" uniqKey="Martins R" first="Rairnundo" last="Martins">Rairnundo Martins</name>
<affiliation wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology and Neurosurgery, S. João Hospital, Porto</wicri:regionArea>
<wicri:noRegion>Porto</wicri:noRegion>
</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><wicri:noCountry code="subField">Lisbon</wicri:noCountry>
</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>Aged</term>
<term>Blepharospasm (drug therapy)</term>
<term>Botox</term>
<term>Botulinum Toxins, Type A (therapeutic use)</term>
<term>Botulinum toxin type A</term>
<term>DYSBOT</term>
<term>Drug Tolerance</term>
<term>Drug potency</term>
<term>Dysport</term>
<term>Equivalence of formulations</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>
<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>
<double doi="10.1002/mds.870120627"><ISTEX><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>
</author>
<author><name sortKey="Ferreira, Joaquim J" sort="Ferreira, Joaquim J" uniqKey="Ferreira J" first="Joaquim J." last="Ferreira">Joaquim J. Ferreira</name>
</author>
<author><name sortKey="Sim Es, Fernanda" sort="Sim Es, Fernanda" uniqKey="Sim Es F" first="Fernanda" last="Sim Es">Fernanda Sim Es</name>
</author>
<author><name sortKey="Rosas, Maria J" sort="Rosas, Maria J" uniqKey="Rosas M" first="Maria J." last="Rosas">Maria J. Rosas</name>
</author>
<author><name sortKey="Magalhaes, Marina" sort="Magalhaes, Marina" uniqKey="Magalhaes M" first="Marina" last="Magalhães">Marina Magalhães</name>
</author>
<author><name sortKey="Correia, Ana P" sort="Correia, Ana P" uniqKey="Correia A" first="Ana P." last="Correia">Ana P. Correia</name>
</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>
</author>
<author><name sortKey="Martins, Rairnundo" sort="Martins, Rairnundo" uniqKey="Martins R" first="Rairnundo" last="Martins">Rairnundo Martins</name>
</author>
<author><name sortKey="Castro Aldas, Alexandre" sort="Castro Aldas, Alexandre" uniqKey="Castro Aldas A" first="Alexandre" last="Castro-Caldas">Alexandre Castro-Caldas</name>
</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>
<idno type="wicri:Area/Istex/Curation">000D61</idno>
<idno type="wicri:Area/Istex/Checkpoint">003994</idno>
<idno type="wicri:doubleKey">0885-3185:1997:Sampaio:dysbot:a:single</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><wicri:noCountry code="subField">Lisbon</wicri:noCountry>
</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><wicri:noCountry code="subField">Lisbon</wicri:noCountry>
</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 wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology and Neurosurgery, S. João Hospital, Porto</wicri:regionArea>
<wicri:noRegion>Porto</wicri:noRegion>
</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 wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology, St. Antonio Hospital Porto</wicri:regionArea>
<wicri:noRegion>St. Antonio Hospital Porto</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Magalhaes, Marina" sort="Magalhaes, Marina" uniqKey="Magalhaes M" first="Marina" last="Magalhães">Marina Magalhães</name>
<affiliation wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology, St. Antonio Hospital Porto</wicri:regionArea>
<wicri:noRegion>St. Antonio Hospital Porto</wicri:noRegion>
</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 wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology, St. Antonio Hospital Porto</wicri:regionArea>
<wicri:noRegion>St. Antonio Hospital Porto</wicri:noRegion>
</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 wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology, St. Antonio Hospital Porto</wicri:regionArea>
<wicri:noRegion>St. Antonio Hospital Porto</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Martins, Rairnundo" sort="Martins, Rairnundo" uniqKey="Martins R" first="Rairnundo" last="Martins">Rairnundo Martins</name>
<affiliation wicri:level="1"><country xml:lang="fr">Portugal</country>
<wicri:regionArea>Department of Neurology and Neurosurgery, S. João Hospital, Porto</wicri:regionArea>
<wicri:noRegion>Porto</wicri:noRegion>
</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><wicri:noCountry code="subField">Lisbon</wicri:noCountry>
</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>
<PubMed><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>
<idno type="wicri:Area/Ncbi/Merge">004E33</idno>
<idno type="wicri:Area/Ncbi/Curation">004E33</idno>
<idno type="wicri:Area/Ncbi/Checkpoint">004E33</idno>
<idno type="wicri:doubleKey">0885-3185:1997:Sampaio C:dysbot:a:single</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>
</double>
</record>
Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/Main/Merge
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 008399 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Merge/biblio.hfd -nk 008399 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien |wiki= Wicri/Santé |area= MovDisordV3 |flux= Main |étape= Merge |type= RBID |clé= ISTEX:16CF70D95E8C5B8C8A9153AFA49555853D8BC9D8 |texte= 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 }}
![]() | This area was generated with Dilib version V0.6.23. | ![]() |