Movement Disorders (revue)

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Botulinum Toxin A Versus B in Sialorrhea: A Prospective, Randomized, Double-Blind, Crossover Pilot Study in Patients with Amyotrophic Lateral Sclerosis or Parkinson's Disease

Identifieur interne : 002614 ( PascalFrancis/Curation ); précédent : 002613; suivant : 002615

Botulinum Toxin A Versus B in Sialorrhea: A Prospective, Randomized, Double-Blind, Crossover Pilot Study in Patients with Amyotrophic Lateral Sclerosis or Parkinson's Disease

Auteurs : Arianna Guidubaldi [Italie] ; Alfonso Fasano [Italie] ; Tamara Lalongo [Italie] ; Carla Piano [Italie] ; Maurizio Pompili [Italie] ; Roberta Masciana [Italie] ; Luisa Siciliani [Italie] ; Mario Sabatelli [Italie] ; Anna Rita Bentivoglio [Italie]

Source :

RBID : Pascal:11-0188474

Descripteurs français

English descriptors

Abstract

Background: Either botulinum toxins (BoNTs) A and B have been used for improving drooling in different neurological conditions. Methods: Consecutive patients affected by Amyotrophic Lateral Sclerosis (ALS) or Parkinson's Disease (PD) accompanied by severe drooling were randomized to receive botulinum neurotoxin type A (BoNT-A) or B (BoNT-B) injections into the salivary glands. Following the first treatment, when sialorrhea returned to baseline (at least three months after the first injection), subjects were re-treated with the other serotype. Ultrasound-guided injections into parotid and submandibular glands were bilaterally performed: total doses were 250 U BoNT-A (Dysport) and 2500 U BoNT-B (Neurobloc). Objective (cotton roll weight) and subjective (ad hoc clinical scales) evaluations were performed at baseline, after 1 and 4 weeks, and every 4 weeks until drooling returned to baseline. Results: Twenty-seven patients (15 ALS and 12 PD) were enrolled, fourteen completed the study. BoNT-A and BoNT-B treatments gave both subjective and objective improvements in all patients. The latency was significantly shorter after BoNT-B treatments (3.2 ± 3.7 days) compared to BoNT-A (6.6 ± 4.1 days; P = 0.002). The mean benefit duration was similar at 75 and 90 days for BoNT-A and BoNT-B, respectively (P = NS). The only toxin-related side effect was a change to saliva thickness. Conclusions: Either 250 U Dysport or 2500 U Neurobloc have similar effectiveness and safety in controlling sialorrhea. BoNT-B has a shorter latency and comparable duration. Cost analysis, considering the doses used in this study protocol favored BoNT-B treatment.
pA  
A01 01  1    @0 0885-3185
A03   1    @0 Mov. disord.
A05       @2 26
A06       @2 2
A08 01  1  ENG  @1 Botulinum Toxin A Versus B in Sialorrhea: A Prospective, Randomized, Double-Blind, Crossover Pilot Study in Patients with Amyotrophic Lateral Sclerosis or Parkinson's Disease
A11 01  1    @1 GUIDUBALDI (Arianna)
A11 02  1    @1 FASANO (Alfonso)
A11 03  1    @1 LALONGO (Tamara)
A11 04  1    @1 PIANO (Carla)
A11 05  1    @1 POMPILI (Maurizio)
A11 06  1    @1 MASCIANA (Roberta)
A11 07  1    @1 SICILIANI (Luisa)
A11 08  1    @1 SABATELLI (Mario)
A11 09  1    @1 RITA BENTIVOGLIO (Anna)
A14 01      @1 Istituto di Neurologia, Università Cattolica del Sacro Cuore @2 Roma @3 ITA @Z 1 aut. @Z 2 aut. @Z 3 aut. @Z 4 aut. @Z 8 aut. @Z 9 aut.
A14 02      @1 Istituto di Medicina Interna e Geriatria, Università Cattolica del Sacro Cuore @2 Roma @3 ITA @Z 5 aut. @Z 6 aut. @Z 7 aut.
A20       @1 313-319
A21       @1 2011
A23 01      @0 ENG
A43 01      @1 INIST @2 20953 @5 354000190829090180
A44       @0 0000 @1 © 2011 INIST-CNRS. All rights reserved.
A45       @0 42 ref.
A47 01  1    @0 11-0188474
A60       @1 P
A61       @0 A
A64 01  1    @0 Movement disorders
A66 01      @0 USA
C01 01    ENG  @0 Background: Either botulinum toxins (BoNTs) A and B have been used for improving drooling in different neurological conditions. Methods: Consecutive patients affected by Amyotrophic Lateral Sclerosis (ALS) or Parkinson's Disease (PD) accompanied by severe drooling were randomized to receive botulinum neurotoxin type A (BoNT-A) or B (BoNT-B) injections into the salivary glands. Following the first treatment, when sialorrhea returned to baseline (at least three months after the first injection), subjects were re-treated with the other serotype. Ultrasound-guided injections into parotid and submandibular glands were bilaterally performed: total doses were 250 U BoNT-A (Dysport) and 2500 U BoNT-B (Neurobloc). Objective (cotton roll weight) and subjective (ad hoc clinical scales) evaluations were performed at baseline, after 1 and 4 weeks, and every 4 weeks until drooling returned to baseline. Results: Twenty-seven patients (15 ALS and 12 PD) were enrolled, fourteen completed the study. BoNT-A and BoNT-B treatments gave both subjective and objective improvements in all patients. The latency was significantly shorter after BoNT-B treatments (3.2 ± 3.7 days) compared to BoNT-A (6.6 ± 4.1 days; P = 0.002). The mean benefit duration was similar at 75 and 90 days for BoNT-A and BoNT-B, respectively (P = NS). The only toxin-related side effect was a change to saliva thickness. Conclusions: Either 250 U Dysport or 2500 U Neurobloc have similar effectiveness and safety in controlling sialorrhea. BoNT-B has a shorter latency and comparable duration. Cost analysis, considering the doses used in this study protocol favored BoNT-B treatment.
C02 01  X    @0 002B17
C02 02  X    @0 002B17F
C03 01  X  FRE  @0 Sclérose latérale amyotrophique @5 01
C03 01  X  ENG  @0 Amyotrophic lateral sclerosis @5 01
C03 01  X  SPA  @0 Esclerosis lateral amiotrófica @5 01
C03 02  X  FRE  @0 Maladie de Parkinson @2 NM @5 02
C03 02  X  ENG  @0 Parkinson disease @2 NM @5 02
C03 02  X  SPA  @0 Parkinson enfermedad @2 NM @5 02
C03 03  X  FRE  @0 Pathologie du système nerveux @5 03
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C03 05  X  ENG  @0 Comparative study @5 10
C03 05  X  SPA  @0 Estudio comparativo @5 10
C03 06  X  FRE  @0 Sialorrhée @5 11
C03 06  X  ENG  @0 Sialorrhea @5 11
C03 06  X  SPA  @0 Sialorrea @5 11
C03 07  X  FRE  @0 Prospective @5 12
C03 07  X  ENG  @0 Prospective @5 12
C03 07  X  SPA  @0 Prospectiva @5 12
C03 08  X  FRE  @0 Etude double insu @5 13
C03 08  X  ENG  @0 Double blind study @5 13
C03 08  X  SPA  @0 Estudio doble ciego @5 13
C03 09  X  FRE  @0 Homme @5 14
C03 09  X  ENG  @0 Human @5 14
C03 09  X  SPA  @0 Hombre @5 14
C03 10  X  FRE  @0 Ultrason @5 15
C03 10  X  ENG  @0 Ultrasound @5 15
C03 10  X  SPA  @0 Ultrasonido @5 15
C03 11  X  FRE  @0 Guidage @5 16
C03 11  X  ENG  @0 Guidance @5 16
C03 11  X  SPA  @0 Guiado @5 16
C07 01  X  FRE  @0 Metalloendopeptidases @2 FE
C07 01  X  ENG  @0 Metalloendopeptidases @2 FE
C07 01  X  SPA  @0 Metalloendopeptidases @2 FE
C07 02  X  FRE  @0 Peptidases @2 FE
C07 02  X  ENG  @0 Peptidases @2 FE
C07 02  X  SPA  @0 Peptidases @2 FE
C07 03  X  FRE  @0 Hydrolases @2 FE
C07 03  X  ENG  @0 Hydrolases @2 FE
C07 03  X  SPA  @0 Hydrolases @2 FE
C07 04  X  FRE  @0 Enzyme @2 FE
C07 04  X  ENG  @0 Enzyme @2 FE
C07 04  X  SPA  @0 Enzima @2 FE
C07 05  X  FRE  @0 Stomatologie @5 37
C07 05  X  ENG  @0 Stomatology @5 37
C07 05  X  SPA  @0 Estomatología @5 37
C07 06  X  FRE  @0 Maladie dégénérative @5 38
C07 06  X  ENG  @0 Degenerative disease @5 38
C07 06  X  SPA  @0 Enfermedad degenerativa @5 38
C07 07  X  FRE  @0 Pathologie de la moelle épinière @5 39
C07 07  X  ENG  @0 Spinal cord disease @5 39
C07 07  X  SPA  @0 Médula espinal patología @5 39
C07 08  X  FRE  @0 Pathologie du système nerveux central @5 40
C07 08  X  ENG  @0 Central nervous system disease @5 40
C07 08  X  SPA  @0 Sistema nervosio central patología @5 40
C07 09  X  FRE  @0 Pathologie de l'encéphale @5 42
C07 09  X  ENG  @0 Cerebral disorder @5 42
C07 09  X  SPA  @0 Encéfalo patología @5 42
C07 10  X  FRE  @0 Syndrome extrapyramidal @5 43
C07 10  X  ENG  @0 Extrapyramidal syndrome @5 43
C07 10  X  SPA  @0 Extrapiramidal síndrome @5 43
N21       @1 122
N44 01      @1 OTO
N82       @1 OTO

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Pascal:11-0188474

Le document en format XML

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<term>Double blind study</term>
<term>Guidance</term>
<term>Human</term>
<term>Nervous system diseases</term>
<term>Parkinson disease</term>
<term>Prospective</term>
<term>Sialorrhea</term>
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</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Sclérose latérale amyotrophique</term>
<term>Maladie de Parkinson</term>
<term>Pathologie du système nerveux</term>
<term>Bontoxilysin</term>
<term>Etude comparative</term>
<term>Sialorrhée</term>
<term>Prospective</term>
<term>Etude double insu</term>
<term>Homme</term>
<term>Ultrason</term>
<term>Guidage</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Prospective</term>
<term>Homme</term>
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<front>
<div type="abstract" xml:lang="en">Background: Either botulinum toxins (BoNTs) A and B have been used for improving drooling in different neurological conditions. Methods: Consecutive patients affected by Amyotrophic Lateral Sclerosis (ALS) or Parkinson's Disease (PD) accompanied by severe drooling were randomized to receive botulinum neurotoxin type A (BoNT-A) or B (BoNT-B) injections into the salivary glands. Following the first treatment, when sialorrhea returned to baseline (at least three months after the first injection), subjects were re-treated with the other serotype. Ultrasound-guided injections into parotid and submandibular glands were bilaterally performed: total doses were 250 U BoNT-A (Dysport) and 2500 U BoNT-B (Neurobloc). Objective (cotton roll weight) and subjective (ad hoc clinical scales) evaluations were performed at baseline, after 1 and 4 weeks, and every 4 weeks until drooling returned to baseline. Results: Twenty-seven patients (15 ALS and 12 PD) were enrolled, fourteen completed the study. BoNT-A and BoNT-B treatments gave both subjective and objective improvements in all patients. The latency was significantly shorter after BoNT-B treatments (3.2 ± 3.7 days) compared to BoNT-A (6.6 ± 4.1 days; P = 0.002). The mean benefit duration was similar at 75 and 90 days for BoNT-A and BoNT-B, respectively (P = NS). The only toxin-related side effect was a change to saliva thickness. Conclusions: Either 250 U Dysport or 2500 U Neurobloc have similar effectiveness and safety in controlling sialorrhea. BoNT-B has a shorter latency and comparable duration. Cost analysis, considering the doses used in this study protocol favored BoNT-B treatment.</div>
</front>
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<fA06>
<s2>2</s2>
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<fA08 i1="01" i2="1" l="ENG">
<s1>Botulinum Toxin A Versus B in Sialorrhea: A Prospective, Randomized, Double-Blind, Crossover Pilot Study in Patients with Amyotrophic Lateral Sclerosis or Parkinson's Disease</s1>
</fA08>
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<s1>GUIDUBALDI (Arianna)</s1>
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<s1>PIANO (Carla)</s1>
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<s1>POMPILI (Maurizio)</s1>
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<s1>SICILIANI (Luisa)</s1>
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<fA11 i1="09" i2="1">
<s1>RITA BENTIVOGLIO (Anna)</s1>
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<fA14 i1="01">
<s1>Istituto di Neurologia, Università Cattolica del Sacro Cuore</s1>
<s2>Roma</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>2 aut.</sZ>
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<sZ>4 aut.</sZ>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
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<fA14 i1="02">
<s1>Istituto di Medicina Interna e Geriatria, Università Cattolica del Sacro Cuore</s1>
<s2>Roma</s2>
<s3>ITA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
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<s1>313-319</s1>
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<s1>© 2011 INIST-CNRS. All rights reserved.</s1>
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<s0>11-0188474</s0>
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<s1>P</s1>
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<s0>A</s0>
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<s0>USA</s0>
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<fC01 i1="01" l="ENG">
<s0>Background: Either botulinum toxins (BoNTs) A and B have been used for improving drooling in different neurological conditions. Methods: Consecutive patients affected by Amyotrophic Lateral Sclerosis (ALS) or Parkinson's Disease (PD) accompanied by severe drooling were randomized to receive botulinum neurotoxin type A (BoNT-A) or B (BoNT-B) injections into the salivary glands. Following the first treatment, when sialorrhea returned to baseline (at least three months after the first injection), subjects were re-treated with the other serotype. Ultrasound-guided injections into parotid and submandibular glands were bilaterally performed: total doses were 250 U BoNT-A (Dysport) and 2500 U BoNT-B (Neurobloc). Objective (cotton roll weight) and subjective (ad hoc clinical scales) evaluations were performed at baseline, after 1 and 4 weeks, and every 4 weeks until drooling returned to baseline. Results: Twenty-seven patients (15 ALS and 12 PD) were enrolled, fourteen completed the study. BoNT-A and BoNT-B treatments gave both subjective and objective improvements in all patients. The latency was significantly shorter after BoNT-B treatments (3.2 ± 3.7 days) compared to BoNT-A (6.6 ± 4.1 days; P = 0.002). The mean benefit duration was similar at 75 and 90 days for BoNT-A and BoNT-B, respectively (P = NS). The only toxin-related side effect was a change to saliva thickness. Conclusions: Either 250 U Dysport or 2500 U Neurobloc have similar effectiveness and safety in controlling sialorrhea. BoNT-B has a shorter latency and comparable duration. Cost analysis, considering the doses used in this study protocol favored BoNT-B treatment.</s0>
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<s0>002B17F</s0>
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<s5>01</s5>
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<s0>Amyotrophic lateral sclerosis</s0>
<s5>01</s5>
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<s5>01</s5>
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<s5>02</s5>
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<s5>02</s5>
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<s0>Parkinson enfermedad</s0>
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<s5>03</s5>
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<s5>03</s5>
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<s5>13</s5>
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<s5>14</s5>
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<s5>14</s5>
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<s5>14</s5>
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<s0>Ultrason</s0>
<s5>15</s5>
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<s5>15</s5>
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<s5>38</s5>
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<s5>39</s5>
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<s5>40</s5>
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<s5>42</s5>
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<s5>42</s5>
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<s5>42</s5>
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<s5>43</s5>
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<s5>43</s5>
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<s0>Extrapiramidal síndrome</s0>
<s5>43</s5>
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<s1>122</s1>
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<s1>OTO</s1>
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<fN82>
<s1>OTO</s1>
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