Movement Disorders (revue)

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Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo-controlled study

Identifieur interne : 001697 ( PascalFrancis/Curation ); précédent : 001696; suivant : 001698

Macrogol 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 :

RBID : Pascal:07-0391072

Descripteurs français

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 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.
pA  
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A08 01  1  ENG  @1 Macrogol for the treatment of constipation in Parkinson's disease. A randomized placebo-controlled study
A11 01  1    @1 ZANGAGLIA (Roberta)
A11 02  1    @1 MARTIGNONI (Emilia)
A11 03  1    @1 GLORIOSO (Margaret)
A11 04  1    @1 OSSOLA (Maria)
A11 05  1    @1 RIBOLDAZZI (Giulio)
A11 06  1    @1 CALANDRELLA (Daniela)
A11 07  1    @1 BRUNETTI (Gabriele)
A11 08  1    @1 PACCHETTI (Claudio)
A14 01      @1 Parkinson's Disease and Movement Disorders Unit, IRCCS "C. Mondino Institute of Neurology" Foundation @2 Pavia @3 ITA @Z 1 aut. @Z 3 aut. @Z 4 aut. @Z 8 aut.
A14 02      @1 Unit of Neurorehabilitation and Movement Disorders, IRCCS "S. Maugeri" Foundation, Scientific Institute of Veruno, Novara and Department of Medical Science, University "A. Avogadro" @2 Novara @3 ITA @Z 2 aut.
A14 03      @1 Department of Neurology, University of Insubria @2 Varese @3 ITA @Z 5 aut. @Z 6 aut.
A14 04      @1 Promefarm srl @2 Milan @3 ITA @Z 7 aut.
A20       @1 1239-1244
A21       @1 2007
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A44       @0 0000 @1 © 2007 INIST-CNRS. All rights reserved.
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C01 01    ENG  @0 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.
C02 01  X    @0 002B17
C02 02  X    @0 002B17G
C02 03  X    @0 002B02Q
C03 01  X  FRE  @0 Système nerveux pathologie @5 01
C03 01  X  ENG  @0 Nervous system diseases @5 01
C03 01  X  SPA  @0 Sistema nervioso patología @5 01
C03 02  X  FRE  @0 Constipation @5 02
C03 02  X  ENG  @0 Constipation @5 02
C03 02  X  SPA  @0 Constipación @5 02
C03 03  X  FRE  @0 Parkinson maladie @5 03
C03 03  X  ENG  @0 Parkinson disease @5 03
C03 03  X  SPA  @0 Parkinson enfermedad @5 03
C03 04  X  FRE  @0 Macrogol @2 NK @2 FR @5 09
C03 04  X  ENG  @0 Macrogol @2 NK @2 FR @5 09
C03 04  X  SPA  @0 Macrogol @2 NK @2 FR @5 09
C03 05  X  FRE  @0 Traitement @5 10
C03 05  X  ENG  @0 Treatment @5 10
C03 05  X  SPA  @0 Tratamiento @5 10
C03 06  X  FRE  @0 Placebo @5 11
C03 06  X  ENG  @0 Placebo @5 11
C03 06  X  SPA  @0 Placebo @5 11
C03 07  X  FRE  @0 Gastrointestinal @5 12
C03 07  X  ENG  @0 Gastrointestinal @5 12
C03 07  X  SPA  @0 Gastrointestinal @5 12
C03 08  X  FRE  @0 Trouble fonctionnel @5 13
C03 08  X  ENG  @0 Dysfunction @5 13
C03 08  X  SPA  @0 Trastorno funcional @5 13
C07 01  X  FRE  @0 Appareil digestif pathologie @5 37
C07 01  X  ENG  @0 Digestive diseases @5 37
C07 01  X  SPA  @0 Aparato digestivo patología @5 37
C07 02  X  FRE  @0 Intestin pathologie @5 38
C07 02  X  ENG  @0 Intestinal disease @5 38
C07 02  X  SPA  @0 Intestino patología @5 38
C07 03  X  FRE  @0 Encéphale pathologie @5 39
C07 03  X  ENG  @0 Cerebral disorder @5 39
C07 03  X  SPA  @0 Encéfalo patología @5 39
C07 04  X  FRE  @0 Extrapyramidal syndrome @5 40
C07 04  X  ENG  @0 Extrapyramidal syndrome @5 40
C07 04  X  SPA  @0 Extrapiramidal síndrome @5 40
C07 05  X  FRE  @0 Maladie dégénérative @5 41
C07 05  X  ENG  @0 Degenerative disease @5 41
C07 05  X  SPA  @0 Enfermedad degenerativa @5 41
C07 06  X  FRE  @0 Système nerveux central pathologie @5 42
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N21       @1 253
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Pascal:07-0391072

Le document en format XML

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<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>
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<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>
</record>

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