Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo‐controlled study
Identifieur interne : 001E44 ( Main/Corpus ); précédent : 001E43; suivant : 001E45Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo‐controlled study
Auteurs : Roberta Zangaglia ; Emilia Martignoni ; Margaret Glorioso ; Maria Ossola ; Giulio Riboldazzi ; Daniela Calandrella ; Gabriele Brunetti ; Claudio PacchettiSource :
- Movement Disorders [ 0885-3185 ] ; 2007-07-15.
English descriptors
Abstract
Chronic constipation is the most frequent symptom of autonomic system involvement in Parkinson's disease (PD). Quite often the symptom is severe and impairs patients' quality of life. The objective of this study is to determine the efficacy and safety of an isosmotic macrogol solution for the treatment of constipation in PD patients, in a double‐blind, placebo‐controlled study. A total of 57 PD patients with constipation were randomly assigned to receive an isosmotic macrogol electrolyte solution (MC‐ES; 29 patients) or placebo (28 patients) for 8 weeks. Treatment efficacy was defined as complete relief of the symptom or a marked improvement of two of the following indicators: stool frequency, straining, stool consistency, use of rectal laxatives as a rescue therapy. The responder rates were significantly higher in the MC‐ES group both at the first (4 weeks; P < 0.0003) and at the final evaluation (8 weeks; P < 0.0012). The frequency of bowel movements (P < 0.002) and stool consistency (P < 0.006) were significantly changed in the MC‐ES group compared to the placebo group. At the final evaluation, a rectal laxative was used by 2 (12.5%) patients on placebo, whereas no use was recorded in the MC‐ES group. Responder rate for straining showed a favorable trend in patients treated with macrogol versus placebo. Unified Parkinson's Disease Rating Scale Part III and Parkinson's Disease Questionnaire (PDQ‐39) did not show any significant modification in either group during the 8‐week treatment period. The results of this placebo‐controlled study show the efficacy of MC‐ES in the treatment of constipation in PD. MC‐ES was well‐tolerated and did not affect the course of PD. © 2006 Movement Disorder Society
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DOI: 10.1002/mds.21243
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ISTEX:5569BE0D4CA04BBD915FB959B89020337E2E0F86Le document en format XML
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Quite often the symptom is severe and impairs patients' quality of life. The objective of this study is to determine the efficacy and safety of an isosmotic macrogol solution for the treatment of constipation in PD patients, in a double‐blind, placebo‐controlled study. A total of 57 PD patients with constipation were randomly assigned to receive an isosmotic macrogol electrolyte solution (MC‐ES; 29 patients) or placebo (28 patients) for 8 weeks. Treatment efficacy was defined as complete relief of the symptom or a marked improvement of two of the following indicators: stool frequency, straining, stool consistency, use of rectal laxatives as a rescue therapy. The responder rates were significantly higher in the MC‐ES group both at the first (4 weeks; P < 0.0003) and at the final evaluation (8 weeks; P < 0.0012). The frequency of bowel movements (P < 0.002) and stool consistency (P < 0.006) were significantly changed in the MC‐ES group compared to the placebo group. At the final evaluation, a rectal laxative was used by 2 (12.5%) patients on placebo, whereas no use was recorded in the MC‐ES group. Responder rate for straining showed a favorable trend in patients treated with macrogol versus placebo. Unified Parkinson's Disease Rating Scale Part III and Parkinson's Disease Questionnaire (PDQ‐39) did not show any significant modification in either group during the 8‐week treatment period. The results of this placebo‐controlled study show the efficacy of MC‐ES in the treatment of constipation in PD. MC‐ES was well‐tolerated and did not affect the course of PD. © 2006 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Roberta Zangaglia MD</name><affiliations><json:string>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</json:string></affiliations></json:item><json:item><name>Emilia Martignoni MD</name><affiliations><json:string>Unit of Neurorehabilitation and Movement Disorders, IRCCS “S. Maugeri” Foundation, Scientific Institute of Veruno, Novara, Italy</json:string><json:string>Department of Medical Science, University “A. Avogadro”, Novara, Italy</json:string></affiliations></json:item><json:item><name>Margaret Glorioso MD</name><affiliations><json:string>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</json:string></affiliations></json:item><json:item><name>Maria Ossola MD</name><affiliations><json:string>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</json:string></affiliations></json:item><json:item><name>Giulio Riboldazzi MD</name><affiliations><json:string>Department of Neurology, University of Insubria, Varese, Italy</json:string></affiliations></json:item><json:item><name>Daniela Calandrella MD</name><affiliations><json:string>Department of Neurology, University of Insubria, Varese, Italy</json:string></affiliations></json:item><json:item><name>Gabriele Brunetti MD</name><affiliations><json:string>Promefarm srl, Milan, Italy</json:string></affiliations></json:item><json:item><name>Claudio Pacchetti MD</name><affiliations><json:string>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</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>constipation</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>gastrointestinal dysfunction</value></json:item></subject><articleId><json:string>MDS21243</json:string></articleId><language><json:string>eng</json:string></language><abstract>Chronic constipation is the most frequent symptom of autonomic system involvement in Parkinson's disease (PD). Quite often the symptom is severe and impairs patients' quality of life. The objective of this study is to determine the efficacy and safety of an isosmotic macrogol solution for the treatment of constipation in PD patients, in a double‐blind, placebo‐controlled study. A total of 57 PD patients with constipation were randomly assigned to receive an isosmotic macrogol electrolyte solution (MC‐ES; 29 patients) or placebo (28 patients) for 8 weeks. Treatment efficacy was defined as complete relief of the symptom or a marked improvement of two of the following indicators: stool frequency, straining, stool consistency, use of rectal laxatives as a rescue therapy. The responder rates were significantly higher in the MC‐ES group both at the first (4 weeks; P > 0.0003) and at the final evaluation (8 weeks; P > 0.0012). The frequency of bowel movements (P > 0.002) and stool consistency (P > 0.006) were significantly changed in the MC‐ES group compared to the placebo group. At the final evaluation, a rectal laxative was used by 2 (12.5%) patients on placebo, whereas no use was recorded in the MC‐ES group. Responder rate for straining showed a favorable trend in patients treated with macrogol versus placebo. Unified Parkinson's Disease Rating Scale Part III and Parkinson's Disease Questionnaire (PDQ‐39) did not show any significant modification in either group during the 8‐week treatment period. The results of this placebo‐controlled study show the efficacy of MC‐ES in the treatment of constipation in PD. MC‐ES was well‐tolerated and did not affect the course of PD. © 2006 Movement Disorder Society</abstract><qualityIndicators><score>6.908</score><pdfVersion>1.3</pdfVersion><pdfPageSize>594 x 792 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>3</keywordCount><abstractCharCount>1725</abstractCharCount><pdfWordCount>3908</pdfWordCount><pdfCharCount>24106</pdfCharCount><pdfPageCount>6</pdfPageCount><abstractWordCount>272</abstractWordCount></qualityIndicators><title>Macrogol for the treatment of constipation in Parkinson's disease. 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A randomized placebo‐controlled study</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>WILEY</p></availability><date>2007</date></publicationStmt><notesStmt><note>Promefarm Srl, Milan, Italy</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo‐controlled study</title><author><persName><forename type="first">Roberta</forename><surname>Zangaglia</surname></persName><roleName type="degree">MD</roleName><note type="correspondence"><p>Correspondence: Movement Disorders Unit, IRCCS “C. Mondino,” Via Mondino 2, 27100 Pavia, Italy</p></note><affiliation>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</affiliation></author><author><persName><forename type="first">Emilia</forename><surname>Martignoni</surname></persName><roleName type="degree">MD</roleName><affiliation>Unit of Neurorehabilitation and Movement Disorders, IRCCS “S. Maugeri” Foundation, Scientific Institute of Veruno, Novara, Italy</affiliation><affiliation>Department of Medical Science, University “A. Avogadro”, Novara, Italy</affiliation></author><author><persName><forename type="first">Margaret</forename><surname>Glorioso</surname></persName><roleName type="degree">MD</roleName><affiliation>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</affiliation></author><author><persName><forename type="first">Maria</forename><surname>Ossola</surname></persName><roleName type="degree">MD</roleName><affiliation>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. 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The objective of this study is to determine the efficacy and safety of an isosmotic macrogol solution for the treatment of constipation in PD patients, in a double‐blind, placebo‐controlled study. A total of 57 PD patients with constipation were randomly assigned to receive an isosmotic macrogol electrolyte solution (MC‐ES; 29 patients) or placebo (28 patients) for 8 weeks. Treatment efficacy was defined as complete relief of the symptom or a marked improvement of two of the following indicators: stool frequency, straining, stool consistency, use of rectal laxatives as a rescue therapy. The responder rates were significantly higher in the MC‐ES group both at the first (4 weeks; P < 0.0003) and at the final evaluation (8 weeks; P < 0.0012). The frequency of bowel movements (P < 0.002) and stool consistency (P < 0.006) were significantly changed in the MC‐ES group compared to the placebo group. At the final evaluation, a rectal laxative was used by 2 (12.5%) patients on placebo, whereas no use was recorded in the MC‐ES group. Responder rate for straining showed a favorable trend in patients treated with macrogol versus placebo. Unified Parkinson's Disease Rating Scale Part III and Parkinson's Disease Questionnaire (PDQ‐39) did not show any significant modification in either group during the 8‐week treatment period. The results of this placebo‐controlled study show the efficacy of MC‐ES in the treatment of constipation in PD. 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Mondino,” Via Mondino 2, 27100 Pavia, Italy</correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS21243.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="2"></count><count type="referenceTotal" number="34"></count><count type="wordTotal" number="4362"></count></countGroup><titleGroup><title type="main" xml:lang="en">Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo‐controlled study</title><title type="short" xml:lang="en">Macrogol for Treatment of Constipation in PD</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Roberta</givenNames><familyName>Zangaglia</familyName><degrees>MD</degrees></personName><contactDetails><email>centro.parkinson@mondino.it</email></contactDetails></creator><creator xml:id="au2" creatorRole="author" affiliationRef="#af2 #af5"><personName><givenNames>Emilia</givenNames><familyName>Martignoni</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au3" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Margaret</givenNames><familyName>Glorioso</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au4" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Maria</givenNames><familyName>Ossola</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au5" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Giulio</givenNames><familyName>Riboldazzi</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au6" creatorRole="author" affiliationRef="#af3"><personName><givenNames>Daniela</givenNames><familyName>Calandrella</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au7" creatorRole="author" affiliationRef="#af4"><personName><givenNames>Gabriele</givenNames><familyName>Brunetti</familyName><degrees>MD</degrees></personName></creator><creator xml:id="au8" creatorRole="author" affiliationRef="#af1"><personName><givenNames>Claudio</givenNames><familyName>Pacchetti</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="IT" type="organization"><unparsedAffiliation>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="IT" type="organization"><unparsedAffiliation>Unit of Neurorehabilitation and Movement Disorders, IRCCS “S. Maugeri” Foundation, Scientific Institute of Veruno, Novara, Italy</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="IT" type="organization"><unparsedAffiliation>Department of Neurology, University of Insubria, Varese, Italy</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="IT" type="organization"><unparsedAffiliation>Promefarm srl, Milan, Italy</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="IT" type="organization"><unparsedAffiliation>Department of Medical Science, University “A. Avogadro”, Novara, Italy</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Parkinson's disease</keyword><keyword xml:id="kwd2">constipation</keyword><keyword xml:id="kwd3">gastrointestinal dysfunction</keyword></keywordGroup><fundingInfo><fundingAgency>Promefarm Srl, Milan, Italy</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Chronic constipation is the most frequent symptom of autonomic system involvement in Parkinson's disease (PD). Quite often the symptom is severe and impairs patients' quality of life. The objective of this study is to determine the efficacy and safety of an isosmotic macrogol solution for the treatment of constipation in PD patients, in a double‐blind, placebo‐controlled study. A total of 57 PD patients with constipation were randomly assigned to receive an isosmotic macrogol electrolyte solution (MC‐ES; 29 patients) or placebo (28 patients) for 8 weeks. Treatment efficacy was defined as complete relief of the symptom or a marked improvement of two of the following indicators: stool frequency, straining, stool consistency, use of rectal laxatives as a rescue therapy. The responder rates were significantly higher in the MC‐ES group both at the first (4 weeks; <i>P</i> < 0.0003) and at the final evaluation (8 weeks; <i>P</i> < 0.0012). The frequency of bowel movements (<i>P</i> < 0.002) and stool consistency (<i>P</i> < 0.006) were significantly changed in the MC‐ES group compared to the placebo group. At the final evaluation, a rectal laxative was used by 2 (12.5%) patients on placebo, whereas no use was recorded in the MC‐ES group. Responder rate for straining showed a favorable trend in patients treated with macrogol versus placebo. Unified Parkinson's Disease Rating Scale Part III and Parkinson's Disease Questionnaire (PDQ‐39) did not show any significant modification in either group during the 8‐week treatment period. The results of this placebo‐controlled study show the efficacy of MC‐ES in the treatment of constipation in PD. MC‐ES was well‐tolerated and did not affect the course of PD. © 2006 Movement Disorder Society</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo‐controlled study</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Macrogol for Treatment of Constipation in PD</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo‐controlled study</title></titleInfo><name type="personal"><namePart type="given">Roberta</namePart><namePart type="family">Zangaglia</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</affiliation><description>Correspondence: Movement Disorders Unit, IRCCS “C. Mondino,” Via Mondino 2, 27100 Pavia, Italy</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Emilia</namePart><namePart type="family">Martignoni</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Unit of Neurorehabilitation and Movement Disorders, IRCCS “S. Maugeri” Foundation, Scientific Institute of Veruno, Novara, Italy</affiliation><affiliation>Department of Medical Science, University “A. Avogadro”, Novara, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Margaret</namePart><namePart type="family">Glorioso</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Maria</namePart><namePart type="family">Ossola</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Giulio</namePart><namePart type="family">Riboldazzi</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Insubria, Varese, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Daniela</namePart><namePart type="family">Calandrella</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Neurology, University of Insubria, Varese, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Gabriele</namePart><namePart type="family">Brunetti</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Promefarm srl, Milan, Italy</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Claudio</namePart><namePart type="family">Pacchetti</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Parkinson's Disease and Movement Disorders Unit, IRCCS “C. Mondino Institute of Neurology” Foundation, Pavia, Italy</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">2007-07-15</dateIssued><dateCaptured encoding="w3cdtf">2005-11-10</dateCaptured><dateValid encoding="w3cdtf">2006-08-12</dateValid><copyrightDate encoding="w3cdtf">2007</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="figures">2</extent><extent unit="tables">2</extent><extent unit="references">34</extent><extent unit="words">4362</extent></physicalDescription><abstract lang="en">Chronic constipation is the most frequent symptom of autonomic system involvement in Parkinson's disease (PD). Quite often the symptom is severe and impairs patients' quality of life. The objective of this study is to determine the efficacy and safety of an isosmotic macrogol solution for the treatment of constipation in PD patients, in a double‐blind, placebo‐controlled study. A total of 57 PD patients with constipation were randomly assigned to receive an isosmotic macrogol electrolyte solution (MC‐ES; 29 patients) or placebo (28 patients) for 8 weeks. Treatment efficacy was defined as complete relief of the symptom or a marked improvement of two of the following indicators: stool frequency, straining, stool consistency, use of rectal laxatives as a rescue therapy. The responder rates were significantly higher in the MC‐ES group both at the first (4 weeks; P < 0.0003) and at the final evaluation (8 weeks; P < 0.0012). The frequency of bowel movements (P < 0.002) and stool consistency (P < 0.006) were significantly changed in the MC‐ES group compared to the placebo group. At the final evaluation, a rectal laxative was used by 2 (12.5%) patients on placebo, whereas no use was recorded in the MC‐ES group. Responder rate for straining showed a favorable trend in patients treated with macrogol versus placebo. Unified Parkinson's Disease Rating Scale Part III and Parkinson's Disease Questionnaire (PDQ‐39) did not show any significant modification in either group during the 8‐week treatment period. The results of this placebo‐controlled study show the efficacy of MC‐ES in the treatment of constipation in PD. MC‐ES was well‐tolerated and did not affect the course of PD. © 2006 Movement Disorder Society</abstract><note type="funding">Promefarm Srl, Milan, Italy</note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>constipation</topic><topic>gastrointestinal dysfunction</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></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>2007</date><detail type="volume"><caption>vol.</caption><number>22</number></detail><detail type="issue"><caption>no.</caption><number>9</number></detail><extent unit="pages"><start>1239</start><end>1244</end><total>6</total></extent></part></relatedItem><identifier type="istex">5569BE0D4CA04BBD915FB959B89020337E2E0F86</identifier><identifier type="DOI">10.1002/mds.21243</identifier><identifier type="ArticleID">MDS21243</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2007 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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