Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo-controlled study
Identifieur interne : 001602 ( PascalFrancis/Checkpoint ); précédent : 001601; suivant : 001603Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo-controlled study
Auteurs : Roberta Zangaglia [Italie] ; Emilia Martignoni [Italie] ; Margaret Glorioso [Italie] ; Maria Ossola [Italie] ; Giulio Riboldazzi [Italie] ; Daniela Calandrella [Italie] ; Gabriele Brunetti [Italie] ; Claudio Pacchetti [Italie]Source :
- Movement disorders [ 0885-3185 ] ; 2007.
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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 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.
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Mondino Institute of Neurology" Foundation</s1><s2>Pavia</s2><s3>ITA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Pavia</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">07-0391072</idno><date when="2007">2007</date><idno type="stanalyst">PASCAL 07-0391072 INIST</idno><idno type="RBID">Pascal:07-0391072</idno><idno type="wicri:Area/PascalFrancis/Corpus">001624</idno><idno type="wicri:Area/PascalFrancis/Curation">001697</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001602</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo-controlled study</title><author><name sortKey="Zangaglia, Roberta" sort="Zangaglia, Roberta" uniqKey="Zangaglia R" first="Roberta" last="Zangaglia">Roberta Zangaglia</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Unit, IRCCS "C. Mondino Institute of Neurology" Foundation</s1><s2>Pavia</s2><s3>ITA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Pavia</wicri:noRegion></affiliation></author><author><name sortKey="Martignoni, Emilia" sort="Martignoni, Emilia" uniqKey="Martignoni E" first="Emilia" last="Martignoni">Emilia Martignoni</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Unit of Neurorehabilitation and Movement Disorders, IRCCS "S. Maugeri" Foundation, Scientific Institute of Veruno, Novara and Department of Medical Science, University "A. Avogadro"</s1><s2>Novara</s2><s3>ITA</s3><sZ>2 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Novara</wicri:noRegion></affiliation></author><author><name sortKey="Glorioso, Margaret" sort="Glorioso, Margaret" uniqKey="Glorioso M" first="Margaret" last="Glorioso">Margaret Glorioso</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Unit, IRCCS "C. Mondino Institute of Neurology" Foundation</s1><s2>Pavia</s2><s3>ITA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Pavia</wicri:noRegion></affiliation></author><author><name sortKey="Ossola, Maria" sort="Ossola, Maria" uniqKey="Ossola M" first="Maria" last="Ossola">Maria Ossola</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Unit, IRCCS "C. Mondino Institute of Neurology" Foundation</s1><s2>Pavia</s2><s3>ITA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Pavia</wicri:noRegion></affiliation></author><author><name sortKey="Riboldazzi, Giulio" sort="Riboldazzi, Giulio" uniqKey="Riboldazzi G" first="Giulio" last="Riboldazzi">Giulio Riboldazzi</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Neurology, University of Insubria</s1><s2>Varese</s2><s3>ITA</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Varese</wicri:noRegion></affiliation></author><author><name sortKey="Calandrella, Daniela" sort="Calandrella, Daniela" uniqKey="Calandrella D" first="Daniela" last="Calandrella">Daniela Calandrella</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of Neurology, University of Insubria</s1><s2>Varese</s2><s3>ITA</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Varese</wicri:noRegion></affiliation></author><author><name sortKey="Brunetti, Gabriele" sort="Brunetti, Gabriele" uniqKey="Brunetti G" first="Gabriele" last="Brunetti">Gabriele Brunetti</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Promefarm srl</s1><s2>Milan</s2><s3>ITA</s3><sZ>7 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Pacchetti, Claudio" sort="Pacchetti, Claudio" uniqKey="Pacchetti C" first="Claudio" last="Pacchetti">Claudio Pacchetti</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Unit, IRCCS "C. Mondino Institute of Neurology" Foundation</s1><s2>Pavia</s2><s3>ITA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Pavia</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Constipation</term><term>Dysfunction</term><term>Gastrointestinal</term><term>Macrogol</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Placebo</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term><term>Constipation</term><term>Parkinson maladie</term><term>Macrogol</term><term>Traitement</term><term>Placebo</term><term>Gastrointestinal</term><term>Trouble fonctionnel</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml: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 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.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0885-3185</s0></fA01><fA03 i2="1"><s0>Mov. disord.</s0></fA03><fA05><s2>22</s2></fA05><fA06><s2>9</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo-controlled study</s1></fA08><fA11 i1="01" i2="1"><s1>ZANGAGLIA (Roberta)</s1></fA11><fA11 i1="02" i2="1"><s1>MARTIGNONI (Emilia)</s1></fA11><fA11 i1="03" i2="1"><s1>GLORIOSO (Margaret)</s1></fA11><fA11 i1="04" i2="1"><s1>OSSOLA (Maria)</s1></fA11><fA11 i1="05" i2="1"><s1>RIBOLDAZZI (Giulio)</s1></fA11><fA11 i1="06" i2="1"><s1>CALANDRELLA (Daniela)</s1></fA11><fA11 i1="07" i2="1"><s1>BRUNETTI (Gabriele)</s1></fA11><fA11 i1="08" i2="1"><s1>PACCHETTI (Claudio)</s1></fA11><fA14 i1="01"><s1>Parkinson's Disease and Movement Disorders Unit, IRCCS "C. Mondino Institute of Neurology" Foundation</s1><s2>Pavia</s2><s3>ITA</s3><sZ>1 aut.</sZ><sZ>3 aut.</sZ><sZ>4 aut.</sZ><sZ>8 aut.</sZ></fA14><fA14 i1="02"><s1>Unit of Neurorehabilitation and Movement Disorders, IRCCS "S. Maugeri" Foundation, Scientific Institute of Veruno, Novara and Department of Medical Science, University "A. Avogadro"</s1><s2>Novara</s2><s3>ITA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Department of Neurology, University of Insubria</s1><s2>Varese</s2><s3>ITA</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ></fA14><fA14 i1="04"><s1>Promefarm srl</s1><s2>Milan</s2><s3>ITA</s3><sZ>7 aut.</sZ></fA14><fA20><s1>1239-1244</s1></fA20><fA21><s1>2007</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000146732490050</s5></fA43><fA44><s0>0000</s0><s1>© 2007 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>34 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>07-0391072</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Movement disorders</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>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 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.</s0></fC01><fC02 i1="01" i2="X"><s0>002B17</s0></fC02><fC02 i1="02" i2="X"><s0>002B17G</s0></fC02><fC02 i1="03" i2="X"><s0>002B02Q</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Système nerveux pathologie</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Nervous system diseases</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Sistema nervioso patología</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Constipation</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Constipation</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Constipación</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Parkinson maladie</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Parkinson disease</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Parkinson enfermedad</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Macrogol</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Macrogol</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Macrogol</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Traitement</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Treatment</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Tratamiento</s0><s5>10</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Placebo</s0><s5>11</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Placebo</s0><s5>11</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Placebo</s0><s5>11</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Gastrointestinal</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Gastrointestinal</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Gastrointestinal</s0><s5>12</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Trouble fonctionnel</s0><s5>13</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Dysfunction</s0><s5>13</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Trastorno funcional</s0><s5>13</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Appareil digestif pathologie</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Digestive diseases</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Aparato digestivo patología</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Intestin pathologie</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Intestinal disease</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Intestino patología</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Encéphale pathologie</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Cerebral disorder</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Encéfalo patología</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Extrapyramidal syndrome</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0><s5>40</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Maladie dégénérative</s0><s5>41</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Degenerative disease</s0><s5>41</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0><s5>41</s5></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Système nerveux central pathologie</s0><s5>42</s5></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Central nervous system disease</s0><s5>42</s5></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0><s5>42</s5></fC07><fN21><s1>253</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><affiliations><list><country><li>Italie</li></country><region><li>Lombardie</li></region><settlement><li>Milan</li></settlement></list><tree><country name="Italie"><noRegion><name sortKey="Zangaglia, Roberta" sort="Zangaglia, Roberta" uniqKey="Zangaglia R" first="Roberta" last="Zangaglia">Roberta Zangaglia</name></noRegion><name sortKey="Brunetti, Gabriele" sort="Brunetti, Gabriele" uniqKey="Brunetti G" first="Gabriele" last="Brunetti">Gabriele Brunetti</name><name sortKey="Calandrella, Daniela" sort="Calandrella, Daniela" uniqKey="Calandrella D" first="Daniela" last="Calandrella">Daniela Calandrella</name><name sortKey="Glorioso, Margaret" sort="Glorioso, Margaret" uniqKey="Glorioso M" first="Margaret" last="Glorioso">Margaret Glorioso</name><name sortKey="Martignoni, Emilia" sort="Martignoni, Emilia" uniqKey="Martignoni E" first="Emilia" last="Martignoni">Emilia Martignoni</name><name sortKey="Ossola, Maria" sort="Ossola, Maria" uniqKey="Ossola M" first="Maria" last="Ossola">Maria Ossola</name><name sortKey="Pacchetti, Claudio" sort="Pacchetti, Claudio" uniqKey="Pacchetti C" first="Claudio" last="Pacchetti">Claudio Pacchetti</name><name sortKey="Riboldazzi, Giulio" sort="Riboldazzi, Giulio" uniqKey="Riboldazzi G" first="Giulio" last="Riboldazzi">Giulio Riboldazzi</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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