Placebo response in Parkinson's disease: Comparisons among 11 trials covering medical and surgical interventions
Identifieur interne : 000B26 ( Main/Corpus ); précédent : 000B25; suivant : 000B27Placebo response in Parkinson's disease: Comparisons among 11 trials covering medical and surgical interventions
Auteurs : Christopher G. Goetz ; Joanne Wuu ; Michael P. Mcdermott ; Charles H. Adler ; Stanley Fahn ; Curt R. Freed ; Robert A. Hauser ; Warren C. Olanow ; Ira Shoulson ; P. K. Tandon ; Sue LeurgansSource :
- Movement Disorders [ 0885-3185 ] ; 2008-04-15.
English descriptors
Abstract
Placebo‐associated improvements have been previously documented in small series of Parkinson's disease (PD) patients. Using a strict definition of placebo‐associated improvement, we examined rates and timing of placebo responses to identify patient‐ and study‐based characteristics, predicting positive placebo response in several PD clinical trials. We collected individual patient data from the placebo groups of 11 medical and surgical treatment trials involving PD patients with differing PD severities and placebo‐assignment likelihoods. We defined a positive placebo response as ≥50% improvement in total Unified Parkinson's Disease Rating Scale motor (UPDRSm) score or a decrease by ≥2 points on at least two UPDRSm items compared to baseline. We calculated positive placebo response rates at early (3–7 weeks), mid (8–18 weeks), and late (23–35 weeks) stages of follow‐up. Odds ratios for patient‐ and study‐based characteristics were obtained from a model fitted using generalized estimating equations. There were 858 patients on placebo who met inclusion criteria for analysis. Three studies involved patients without need of symptomatic treatment, two involved patients without motor fluctuations needing symptomatic treatment, and six (three medical and three surgical) involved patients with motor fluctuations. The overall placebo response rate was 16% (range: 0–55%). Patients with higher baseline UPDRSm scores and studies that focused on PD with motor fluctuations, surgical interventions, or those with a higher probability of placebo assignment showed increased odds of positive placebo response. Placebo responses were temporally distributed similarly during early, mid, and late phases of follow‐up. Placebo‐related improvements occur in most PD clinical trials and are similarly distributed across all 6 months of follow‐up. Recognition of factors that impact placebo response rates should be incorporated into individual study designs for PD clinical trials. © 2008 Movement Disorder Society
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DOI: 10.1002/mds.21894
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Olanow</name><affiliation><mods:affiliation>Department of Neurology, Mount Sinai School of Medicine, New York, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Shoulson, Ira" sort="Shoulson, Ira" uniqKey="Shoulson I" first="Ira" last="Shoulson">Ira Shoulson</name><affiliation><mods:affiliation>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Tandon, P K" sort="Tandon, P K" uniqKey="Tandon P" first="P. K." last="Tandon">P. K. 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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="2008-04-15">2008-04-15</date><biblScope unit="volume">23</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="690">690</biblScope><biblScope unit="page" to="699">699</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">82643ADC619ABE1A6F2150AE9F9D4CBDD8F1CD7A</idno><idno type="DOI">10.1002/mds.21894</idno><idno type="ArticleID">MDS21894</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>placebo</term><term>randomized clinical trials</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Placebo‐associated improvements have been previously documented in small series of Parkinson's disease (PD) patients. Using a strict definition of placebo‐associated improvement, we examined rates and timing of placebo responses to identify patient‐ and study‐based characteristics, predicting positive placebo response in several PD clinical trials. We collected individual patient data from the placebo groups of 11 medical and surgical treatment trials involving PD patients with differing PD severities and placebo‐assignment likelihoods. We defined a positive placebo response as ≥50% improvement in total Unified Parkinson's Disease Rating Scale motor (UPDRSm) score or a decrease by ≥2 points on at least two UPDRSm items compared to baseline. We calculated positive placebo response rates at early (3–7 weeks), mid (8–18 weeks), and late (23–35 weeks) stages of follow‐up. Odds ratios for patient‐ and study‐based characteristics were obtained from a model fitted using generalized estimating equations. There were 858 patients on placebo who met inclusion criteria for analysis. Three studies involved patients without need of symptomatic treatment, two involved patients without motor fluctuations needing symptomatic treatment, and six (three medical and three surgical) involved patients with motor fluctuations. The overall placebo response rate was 16% (range: 0–55%). Patients with higher baseline UPDRSm scores and studies that focused on PD with motor fluctuations, surgical interventions, or those with a higher probability of placebo assignment showed increased odds of positive placebo response. Placebo responses were temporally distributed similarly during early, mid, and late phases of follow‐up. Placebo‐related improvements occur in most PD clinical trials and are similarly distributed across all 6 months of follow‐up. Recognition of factors that impact placebo response rates should be incorporated into individual study designs for PD clinical trials. © 2008 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Christopher G. Goetz MD</name><affiliations><json:string>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</json:string></affiliations></json:item><json:item><name>Joanne Wuu ScM</name><affiliations><json:string>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</json:string><json:string>Department of Neurology, Emory University, Atlanta, Georgia, USA</json:string></affiliations></json:item><json:item><name>Michael P. McDermott PhD</name><affiliations><json:string>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Charles H. Adler MD, PhD</name><affiliations><json:string>Department of Neurology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USA</json:string></affiliations></json:item><json:item><name>Stanley Fahn MD</name><affiliations><json:string>Department of Neurology, Columbia University, New York, New York, USA</json:string></affiliations></json:item><json:item><name>Curt R. Freed MD</name><affiliations><json:string>Department of Neurology, University of Colorado Medical Center, Denver, Colorado, USA</json:string></affiliations></json:item><json:item><name>Robert A. Hauser MD</name><affiliations><json:string>Department of Neurology, University of South Florida, Tampa, Florida, USA</json:string></affiliations></json:item><json:item><name>Warren C. Olanow MD</name><affiliations><json:string>Department of Neurology, Mount Sinai School of Medicine, New York, New York, USA</json:string></affiliations></json:item><json:item><name>Ira Shoulson MD</name><affiliations><json:string>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</json:string><json:string>Department of Neurology, University of Rochester, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>P.K. Tandon PhD</name><affiliations><json:string>Global BioMedical Operations, Genzyme Corporation, Cambridge, Massachusetts, USA</json:string></affiliations></json:item><json:item><name>Sue Leurgans PhD</name><affiliations><json:string>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>placebo</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>randomized clinical trials</value></json:item></subject><articleId><json:string>MDS21894</json:string></articleId><language><json:string>eng</json:string></language><abstract>Placebo‐associated improvements have been previously documented in small series of Parkinson's disease (PD) patients. Using a strict definition of placebo‐associated improvement, we examined rates and timing of placebo responses to identify patient‐ and study‐based characteristics, predicting positive placebo response in several PD clinical trials. We collected individual patient data from the placebo groups of 11 medical and surgical treatment trials involving PD patients with differing PD severities and placebo‐assignment likelihoods. We defined a positive placebo response as ≥50% improvement in total Unified Parkinson's Disease Rating Scale motor (UPDRSm) score or a decrease by ≥2 points on at least two UPDRSm items compared to baseline. We calculated positive placebo response rates at early (3–7 weeks), mid (8–18 weeks), and late (23–35 weeks) stages of follow‐up. Odds ratios for patient‐ and study‐based characteristics were obtained from a model fitted using generalized estimating equations. There were 858 patients on placebo who met inclusion criteria for analysis. Three studies involved patients without need of symptomatic treatment, two involved patients without motor fluctuations needing symptomatic treatment, and six (three medical and three surgical) involved patients with motor fluctuations. The overall placebo response rate was 16% (range: 0–55%). Patients with higher baseline UPDRSm scores and studies that focused on PD with motor fluctuations, surgical interventions, or those with a higher probability of placebo assignment showed increased odds of positive placebo response. Placebo responses were temporally distributed similarly during early, mid, and late phases of follow‐up. Placebo‐related improvements occur in most PD clinical trials and are similarly distributed across all 6 months of follow‐up. Recognition of factors that impact placebo response rates should be incorporated into individual study designs for PD clinical trials. © 2008 Movement Disorder Society</abstract><qualityIndicators><score>8</score><pdfVersion>1.3</pdfVersion><pdfPageSize>594 x 792 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>3</keywordCount><abstractCharCount>2014</abstractCharCount><pdfWordCount>6000</pdfWordCount><pdfCharCount>39874</pdfCharCount><pdfPageCount>10</pdfPageCount><abstractWordCount>281</abstractWordCount></qualityIndicators><title>Placebo response in Parkinson's disease: Comparisons among 11 trials covering medical and surgical interventions</title><corporate><json:item><name>Parkinson Study Group</name></json:item></corporate><genre><json:string>article</json:string></genre><host><volume>23</volume><publisherId><json:string>MDS</json:string></publisherId><pages><total>10</total><last>699</last><first>690</first></pages><issn><json:string>0885-3185</json:string></issn><issue>5</issue><subject><json:item><value>Research Article</value></json:item></subject><genre><json:string>Journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1531-8257</json:string></eissn><title>Movement Disorders</title><doi><json:string>10.1002/(ISSN)1531-8257</json:string></doi></host><publicationDate>2008</publicationDate><copyrightDate>2008</copyrightDate><doi><json:string>10.1002/mds.21894</json:string></doi><id>82643ADC619ABE1A6F2150AE9F9D4CBDD8F1CD7A</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/82643ADC619ABE1A6F2150AE9F9D4CBDD8F1CD7A/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/82643ADC619ABE1A6F2150AE9F9D4CBDD8F1CD7A/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/82643ADC619ABE1A6F2150AE9F9D4CBDD8F1CD7A/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Placebo response in Parkinson's disease: Comparisons among 11 trials covering medical and surgical interventions</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>WILEY</p></availability><date>2008</date></publicationStmt><notesStmt><note>NIH - No. 1 R21AT001440‐91A2;</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Placebo response in Parkinson's disease: Comparisons among 11 trials covering medical and surgical interventions</title><author><orgName>Parkinson Study Group</orgName></author><author><persName><forename type="first">Christopher G.</forename><surname>Goetz</surname></persName><roleName type="degree">MD</roleName><note type="correspondence"><p>Correspondence: Department of Neurological Sciences, Rush University Medical Center, Suite 755, 1725 West Harrison Street, Chicago, IL 60612</p></note><affiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</affiliation></author><author><persName><forename type="first">Joanne</forename><surname>Wuu</surname></persName><roleName type="degree">ScM</roleName><affiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</affiliation><affiliation>Department of Neurology, Emory University, Atlanta, Georgia, USA</affiliation></author><author><persName><forename type="first">Michael P.</forename><surname>McDermott</surname></persName><roleName type="degree">PhD</roleName><affiliation>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Charles H.</forename><surname>Adler</surname></persName><roleName type="degree">MD, PhD</roleName><affiliation>Department of Neurology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USA</affiliation></author><author><persName><forename type="first">Stanley</forename><surname>Fahn</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Columbia University, New York, New York, USA</affiliation></author><author><persName><forename type="first">Curt R.</forename><surname>Freed</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University of Colorado Medical Center, Denver, Colorado, USA</affiliation></author><author><persName><forename type="first">Robert A.</forename><surname>Hauser</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</affiliation></author><author><persName><forename type="first">Warren C.</forename><surname>Olanow</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Mount Sinai School of Medicine, New York, New York, USA</affiliation></author><author><persName><forename type="first">Ira</forename><surname>Shoulson</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</affiliation><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">P.K.</forename><surname>Tandon</surname></persName><roleName type="degree">PhD</roleName><affiliation>Global BioMedical Operations, Genzyme Corporation, Cambridge, Massachusetts, USA</affiliation></author><author><persName><forename type="first">Sue</forename><surname>Leurgans</surname></persName><roleName type="degree">PhD</roleName><affiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</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="2008-04-15"></date><biblScope unit="volume">23</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="690">690</biblScope><biblScope unit="page" to="699">699</biblScope></imprint></monogr><idno type="istex">82643ADC619ABE1A6F2150AE9F9D4CBDD8F1CD7A</idno><idno type="DOI">10.1002/mds.21894</idno><idno type="ArticleID">MDS21894</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2008</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Placebo‐associated improvements have been previously documented in small series of Parkinson's disease (PD) patients. Using a strict definition of placebo‐associated improvement, we examined rates and timing of placebo responses to identify patient‐ and study‐based characteristics, predicting positive placebo response in several PD clinical trials. We collected individual patient data from the placebo groups of 11 medical and surgical treatment trials involving PD patients with differing PD severities and placebo‐assignment likelihoods. We defined a positive placebo response as ≥50% improvement in total Unified Parkinson's Disease Rating Scale motor (UPDRSm) score or a decrease by ≥2 points on at least two UPDRSm items compared to baseline. We calculated positive placebo response rates at early (3–7 weeks), mid (8–18 weeks), and late (23–35 weeks) stages of follow‐up. Odds ratios for patient‐ and study‐based characteristics were obtained from a model fitted using generalized estimating equations. There were 858 patients on placebo who met inclusion criteria for analysis. Three studies involved patients without need of symptomatic treatment, two involved patients without motor fluctuations needing symptomatic treatment, and six (three medical and three surgical) involved patients with motor fluctuations. The overall placebo response rate was 16% (range: 0–55%). Patients with higher baseline UPDRSm scores and studies that focused on PD with motor fluctuations, surgical interventions, or those with a higher probability of placebo assignment showed increased odds of positive placebo response. Placebo responses were temporally distributed similarly during early, mid, and late phases of follow‐up. Placebo‐related improvements occur in most PD clinical trials and are similarly distributed across all 6 months of follow‐up. Recognition of factors that impact placebo response rates should be incorporated into individual study designs for PD clinical trials. © 2008 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Parkinson's disease</term></item><item><term>placebo</term></item><item><term>randomized clinical trials</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2007-09-03">Received</change><change when="2007-11-11">Registration</change><change when="2008-04-15">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/82643ADC619ABE1A6F2150AE9F9D4CBDD8F1CD7A/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. 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type="manuscriptAccepted" date="2007-11-11"></event><event type="firstOnline" date="2008-01-28"></event><event type="publishedOnlineFinalForm" date="2008-04-24"></event><event type="publishedOnlineAcceptedOrEarlyUnpaginated" date="2008-01-28"></event><event type="xmlConverted" agent="Converter:JWSART34_TO_WML3G version:2.4.7 mode:FullText source:FullText result:FullText" 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">690</numbering><numbering type="pageLast">699</numbering></numberingGroup><correspondenceTo>Department of Neurological Sciences, Rush University Medical Center, Suite 755, 1725 West Harrison Street, Chicago, IL 60612</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS21894.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="0"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="41"></count><count type="wordTotal" number="7031"></count></countGroup><titleGroup><title type="main" xml:lang="en">Placebo response in Parkinson's disease: Comparisons among 11 trials covering medical and surgical interventions</title><title type="short" xml:lang="en">Placebo Response in Parkinson's Disease</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Christopher G.</givenNames><familyName>Goetz</familyName><degrees>MD</degrees></personName><contactDetails><email>cgoetz@rush.edu</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af1 #af2"><personName><givenNames>Joanne</givenNames><familyName>Wuu</familyName><degrees>ScM</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Michael P.</givenNames><familyName>McDermott</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Charles H.</givenNames><familyName>Adler</familyName><degrees>MD, PhD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af5"><personName><givenNames>Stanley</givenNames><familyName>Fahn</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af6"><personName><givenNames>Curt R.</givenNames><familyName>Freed</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af7"><personName><givenNames>Robert A.</givenNames><familyName>Hauser</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af8"><personName><givenNames>Warren C.</givenNames><familyName>Olanow</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au9" creatorRole="author" affiliationRef="#af3 #af9"><personName><givenNames>Ira</givenNames><familyName>Shoulson</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au10" creatorRole="author" affiliationRef="#af10"><personName><givenNames>P.K.</givenNames><familyName>Tandon</familyName><degrees>PhD</degrees></personName></creator><creator xml:id="au11" creatorRole="author" affiliationRef="#af11"><groupName>Parkinson Study Group</groupName></creator><creator xml:id="au12" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Sue</givenNames><familyName>Leurgans</familyName><degrees>PhD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Emory University, Atlanta, Georgia, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Columbia University, New York, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of Colorado Medical Center, Denver, Colorado, USA</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</unparsedAffiliation></affiliation><affiliation xml:id="af8" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Mount Sinai School of Medicine, New York, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af9" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af10" countryCode="US" type="organization"><unparsedAffiliation>Global BioMedical Operations, Genzyme Corporation, Cambridge, Massachusetts, USA</unparsedAffiliation></affiliation><affiliation xml:id="af11" countryCode="US" type="organization"><unparsedAffiliation>Karl Kieburtz, MD, Chair, Parkinson Study Group, University of Rochester, Rochester, New York, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Parkinson's disease</keyword><keyword xml:id="kwd2">placebo</keyword><keyword xml:id="kwd3">randomized clinical trials</keyword></keywordGroup><fundingInfo><fundingAgency>NIH</fundingAgency><fundingNumber>1 R21AT001440‐91A2</fundingNumber></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Placebo‐associated improvements have been previously documented in small series of Parkinson's disease (PD) patients. Using a strict definition of placebo‐associated improvement, we examined rates and timing of placebo responses to identify patient‐ and study‐based characteristics, predicting positive placebo response in several PD clinical trials. We collected individual patient data from the placebo groups of 11 medical and surgical treatment trials involving PD patients with differing PD severities and placebo‐assignment likelihoods. We defined a positive placebo response as ≥50% improvement in total Unified Parkinson's Disease Rating Scale motor (UPDRSm) score or a decrease by ≥2 points on at least two UPDRSm items compared to baseline. We calculated positive placebo response rates at early (3–7 weeks), mid (8–18 weeks), and late (23–35 weeks) stages of follow‐up. Odds ratios for patient‐ and study‐based characteristics were obtained from a model fitted using generalized estimating equations. There were 858 patients on placebo who met inclusion criteria for analysis. Three studies involved patients without need of symptomatic treatment, two involved patients without motor fluctuations needing symptomatic treatment, and six (three medical and three surgical) involved patients with motor fluctuations. The overall placebo response rate was 16% (range: 0–55%). Patients with higher baseline UPDRSm scores and studies that focused on PD with motor fluctuations, surgical interventions, or those with a higher probability of placebo assignment showed increased odds of positive placebo response. Placebo responses were temporally distributed similarly during early, mid, and late phases of follow‐up. Placebo‐related improvements occur in most PD clinical trials and are similarly distributed across all 6 months of follow‐up. Recognition of factors that impact placebo response rates should be incorporated into individual study designs for PD clinical trials. © 2008 Movement Disorder Society</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Placebo response in Parkinson's disease: Comparisons among 11 trials covering medical and surgical interventions</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Placebo Response in Parkinson's Disease</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Placebo response in Parkinson's disease: Comparisons among 11 trials covering medical and surgical interventions</title></titleInfo><name type="personal"><namePart type="given">Christopher G.</namePart><namePart type="family">Goetz</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</affiliation><description>Correspondence: Department of Neurological Sciences, Rush University Medical Center, Suite 755, 1725 West Harrison Street, Chicago, IL 60612</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Joanne</namePart><namePart type="family">Wuu</namePart><namePart type="termsOfAddress">ScM</namePart><affiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</affiliation><affiliation>Department of Neurology, Emory University, Atlanta, Georgia, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Michael P.</namePart><namePart type="family">McDermott</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Charles H.</namePart><namePart type="family">Adler</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>Department of Neurology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Stanley</namePart><namePart type="family">Fahn</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Columbia University, New York, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Curt R.</namePart><namePart type="family">Freed</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Colorado Medical Center, Denver, Colorado, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Robert A.</namePart><namePart type="family">Hauser</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of South Florida, Tampa, Florida, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Warren C.</namePart><namePart type="family">Olanow</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, Mount Sinai School of Medicine, New York, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ira</namePart><namePart type="family">Shoulson</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USA</affiliation><affiliation>Department of Neurology, University of Rochester, Rochester, New York, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.K.</namePart><namePart type="family">Tandon</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Global BioMedical Operations, Genzyme Corporation, Cambridge, Massachusetts, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="corporate"><namePart>Parkinson Study Group</namePart><description>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USADepartment of Neurology, Emory University, Atlanta, Georgia, USADepartment of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York, USADepartment of Neurology, Mayo Clinic Scottsdale, Scottsdale, Arizona, USADepartment of Neurology, Columbia University, New York, New York, USADepartment of Neurology, University of Colorado Medical Center, Denver, Colorado, USADepartment of Neurology, University of South Florida, Tampa, Florida, USADepartment of Neurology, Mount Sinai School of Medicine, New York, New York, USADepartment of Neurology, University of Rochester, Rochester, New York, USAGlobal BioMedical Operations, Genzyme Corporation, Cambridge, Massachusetts, USAKarl Kieburtz, MD, Chair, Parkinson Study Group, University of Rochester, Rochester, New York, USA</description></name><name type="personal"><namePart type="given">Sue</namePart><namePart type="family">Leurgans</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2008-04-15</dateIssued><dateCaptured encoding="w3cdtf">2007-09-03</dateCaptured><dateValid encoding="w3cdtf">2007-11-11</dateValid><copyrightDate encoding="w3cdtf">2008</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">3</extent><extent unit="references">41</extent><extent unit="words">7031</extent></physicalDescription><abstract lang="en">Placebo‐associated improvements have been previously documented in small series of Parkinson's disease (PD) patients. Using a strict definition of placebo‐associated improvement, we examined rates and timing of placebo responses to identify patient‐ and study‐based characteristics, predicting positive placebo response in several PD clinical trials. We collected individual patient data from the placebo groups of 11 medical and surgical treatment trials involving PD patients with differing PD severities and placebo‐assignment likelihoods. We defined a positive placebo response as ≥50% improvement in total Unified Parkinson's Disease Rating Scale motor (UPDRSm) score or a decrease by ≥2 points on at least two UPDRSm items compared to baseline. We calculated positive placebo response rates at early (3–7 weeks), mid (8–18 weeks), and late (23–35 weeks) stages of follow‐up. Odds ratios for patient‐ and study‐based characteristics were obtained from a model fitted using generalized estimating equations. There were 858 patients on placebo who met inclusion criteria for analysis. Three studies involved patients without need of symptomatic treatment, two involved patients without motor fluctuations needing symptomatic treatment, and six (three medical and three surgical) involved patients with motor fluctuations. The overall placebo response rate was 16% (range: 0–55%). Patients with higher baseline UPDRSm scores and studies that focused on PD with motor fluctuations, surgical interventions, or those with a higher probability of placebo assignment showed increased odds of positive placebo response. Placebo responses were temporally distributed similarly during early, mid, and late phases of follow‐up. Placebo‐related improvements occur in most PD clinical trials and are similarly distributed across all 6 months of follow‐up. Recognition of factors that impact placebo response rates should be incorporated into individual study designs for PD clinical trials. © 2008 Movement Disorder Society</abstract><note type="funding">NIH - No. 1 R21AT001440‐91A2; </note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>placebo</topic><topic>randomized clinical trials</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>23</number></detail><detail type="issue"><caption>no.</caption><number>5</number></detail><extent unit="pages"><start>690</start><end>699</end><total>10</total></extent></part></relatedItem><identifier type="istex">82643ADC619ABE1A6F2150AE9F9D4CBDD8F1CD7A</identifier><identifier type="DOI">10.1002/mds.21894</identifier><identifier type="ArticleID">MDS21894</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2008 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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