Safety and tolerability of growth hormone therapy in multiple system atrophy : A double-blind, placebo-controlled study
Identifieur interne : 001476 ( PascalFrancis/Checkpoint ); précédent : 001475; suivant : 001477Safety and tolerability of growth hormone therapy in multiple system atrophy : A double-blind, placebo-controlled study
Auteurs : Björn Holmberg [Suède] ; Jan-Ove Johansson [Suède] ; Werner Poewe [Autriche] ; Gregor Wenning [Autriche] ; Niall P. Quinn [Royaume-Uni] ; Chris Mathias [Royaume-Uni] ; Eduardo Tolosa [Espagne] ; Adriana Cardozo [Espagne] ; Nil Dizdar [Suède] ; Olivier Rascol [France] ; Tarik Slaoui [France]Source :
- Movement disorders [ 0885-3185 ] ; 2007.
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Abstract
The objective of this study was to investigate tolerability and possible neurotrophic effects of growth hormone (GH) in treatment of multiple system atrophy (MSA). In this double-blind pilot study, MSA patients were randomized to recombinant human growth hormone (r-hGH, n = 22), I mg every second day (6 months) followed by alternating daily injections of 1 mg and 0.5 mg (6 months), or matched placebo (n = 21). Safety analysis demonstrated no obvious between-group differences. In both groups, there was progressive worsening of Unified Parkinson's Disease Rating Scale total score, which tended to be less in r-hGH-treated patients (12.9% at 6 months, 25.3% at 12 months) than in placebo (17.0%; and 35.7%). Similarly, there was a trend to less worsening in Unified MSA Rating Scale total score with r-hGH (13.2% and 21.2%) than with placebo (21.1% and 36.5%). Cardiovascular reflex autonomic testing also tended to show less deterioration with r-hGH than with placebo at 12 months. However, 95% Cl did not indicate treatment differences for any efficacy measures. In conclusion, r-hGH administration in MSA patients for up to 1 year appears safe and might influence disease symptoms, signs and, possibly, progression. The results support further studies utilizing higher doses in more patients.
Affiliations:
- Autriche, Espagne, France, Royaume-Uni, Suède
- Angleterre, Catalogne, Grand Londres, Götaland, Midi-Pyrénées, Suède occidentale, Tyrol (Land)
- Barcelone, Göteborg, Innsbruck, Londres, Toulouse
- Université Toulouse III - Paul Sabatier, Université de Göteborg, Université de Toulouse, Université de médecine d'Innsbruck
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Safety and tolerability of growth hormone therapy in multiple system atrophy : A double-blind, placebo-controlled study</title><author><name sortKey="Holmberg, Bjorn" sort="Holmberg, Bjorn" uniqKey="Holmberg B" first="Björn" last="Holmberg">Björn Holmberg</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University</s1><s3>SWE</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Göteborg</settlement><region nuts="1">Götaland</region><region nuts="1">Suède occidentale</region></placeName><orgName type="university">Université de Göteborg</orgName></affiliation></author><author><name sortKey="Johansson, Jan Ove" sort="Johansson, Jan Ove" uniqKey="Johansson J" first="Jan-Ove" last="Johansson">Jan-Ove Johansson</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University</s1><s3>SWE</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Göteborg</settlement><region nuts="1">Götaland</region><region nuts="1">Suède occidentale</region></placeName><orgName type="university">Université de Göteborg</orgName></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Neurology, University Hospital Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Wenning, Gregor" sort="Wenning, Gregor" uniqKey="Wenning G" first="Gregor" last="Wenning">Gregor Wenning</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Neurology, University Hospital Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Quinn, Niall P" sort="Quinn, Niall P" uniqKey="Quinn N" first="Niall P." last="Quinn">Niall P. Quinn</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology</s1><s2>London</s2><s3>GBR</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Mathias, Chris" sort="Mathias, Chris" uniqKey="Mathias C" first="Chris" last="Mathias">Chris Mathias</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology</s1><s2>London</s2><s3>GBR</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Hospital Clinic de Barcelona, Servicio de Neurologia</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Cardozo, Adriana" sort="Cardozo, Adriana" uniqKey="Cardozo A" first="Adriana" last="Cardozo">Adriana Cardozo</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Hospital Clinic de Barcelona, Servicio de Neurologia</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Dizdar, Nil" sort="Dizdar, Nil" uniqKey="Dizdar N" first="Nil" last="Dizdar">Nil Dizdar</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Neurology, Linköping University Hospital</s1><s3>SWE</s3><sZ>9 aut.</sZ></inist:fA14><country>Suède</country><wicri:noRegion>Department of Neurology, Linköping University Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Pharmacology, Clinical Investigation Center, Hopital Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Pharmacology, Clinical Investigation Center, Hopital Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">07-0349117</idno><date when="2007">2007</date><idno type="stanalyst">PASCAL 07-0349117 INIST</idno><idno type="RBID">Pascal:07-0349117</idno><idno type="wicri:Area/PascalFrancis/Corpus">001642</idno><idno type="wicri:Area/PascalFrancis/Curation">001679</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001476</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Safety and tolerability of growth hormone therapy in multiple system atrophy : A double-blind, placebo-controlled study</title><author><name sortKey="Holmberg, Bjorn" sort="Holmberg, Bjorn" uniqKey="Holmberg B" first="Björn" last="Holmberg">Björn Holmberg</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University</s1><s3>SWE</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Göteborg</settlement><region nuts="1">Götaland</region><region nuts="1">Suède occidentale</region></placeName><orgName type="university">Université de Göteborg</orgName></affiliation></author><author><name sortKey="Johansson, Jan Ove" sort="Johansson, Jan Ove" uniqKey="Johansson J" first="Jan-Ove" last="Johansson">Jan-Ove Johansson</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University</s1><s3>SWE</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ></inist:fA14><country>Suède</country><placeName><settlement type="city">Göteborg</settlement><region nuts="1">Götaland</region><region nuts="1">Suède occidentale</region></placeName><orgName type="university">Université de Göteborg</orgName></affiliation></author><author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Neurology, University Hospital Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion><placeName><settlement type="city">Innsbruck</settlement><region nuts="2" type="region">Tyrol (Land)</region></placeName><orgName type="university">Université de médecine d'Innsbruck</orgName></affiliation></author><author><name sortKey="Wenning, Gregor" sort="Wenning, Gregor" uniqKey="Wenning G" first="Gregor" last="Wenning">Gregor Wenning</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Neurology, University Hospital Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Quinn, Niall P" sort="Quinn, Niall P" uniqKey="Quinn N" first="Niall P." last="Quinn">Niall P. Quinn</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology</s1><s2>London</s2><s3>GBR</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Mathias, Chris" sort="Mathias, Chris" uniqKey="Mathias C" first="Chris" last="Mathias">Chris Mathias</name><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology</s1><s2>London</s2><s3>GBR</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Hospital Clinic de Barcelona, Servicio de Neurologia</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Cardozo, Adriana" sort="Cardozo, Adriana" uniqKey="Cardozo A" first="Adriana" last="Cardozo">Adriana Cardozo</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Hospital Clinic de Barcelona, Servicio de Neurologia</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation></author><author><name sortKey="Dizdar, Nil" sort="Dizdar, Nil" uniqKey="Dizdar N" first="Nil" last="Dizdar">Nil Dizdar</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Neurology, Linköping University Hospital</s1><s3>SWE</s3><sZ>9 aut.</sZ></inist:fA14><country>Suède</country><wicri:noRegion>Department of Neurology, Linköping University Hospital</wicri:noRegion></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Pharmacology, Clinical Investigation Center, Hopital Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Pharmacology, Clinical Investigation Center, Hopital Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>France</country><placeName><settlement type="city">Toulouse</settlement></placeName></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>Double blind study</term><term>Multiple system atrophy</term><term>Nervous system diseases</term><term>Placebo</term><term>Safety</term><term>Somatotropin hormone</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term><term>Atrophie multisystématisée</term><term>Sécurité</term><term>STH</term><term>Traitement</term><term>Etude double insu</term><term>Placebo</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study was to investigate tolerability and possible neurotrophic effects of growth hormone (GH) in treatment of multiple system atrophy (MSA). In this double-blind pilot study, MSA patients were randomized to recombinant human growth hormone (r-hGH, n = 22), I mg every second day (6 months) followed by alternating daily injections of 1 mg and 0.5 mg (6 months), or matched placebo (n = 21). Safety analysis demonstrated no obvious between-group differences. In both groups, there was progressive worsening of Unified Parkinson's Disease Rating Scale total score, which tended to be less in r-hGH-treated patients (12.9% at 6 months, 25.3% at 12 months) than in placebo (17.0%; and 35.7%). Similarly, there was a trend to less worsening in Unified MSA Rating Scale total score with r-hGH (13.2% and 21.2%) than with placebo (21.1% and 36.5%). Cardiovascular reflex autonomic testing also tended to show less deterioration with r-hGH than with placebo at 12 months. However, 95% Cl did not indicate treatment differences for any efficacy measures. In conclusion, r-hGH administration in MSA patients for up to 1 year appears safe and might influence disease symptoms, signs and, possibly, progression. The results support further studies utilizing higher doses in more patients.</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>8</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Safety and tolerability of growth hormone therapy in multiple system atrophy : A double-blind, placebo-controlled study</s1></fA08><fA11 i1="01" i2="1"><s1>HOLMBERG (Björn)</s1></fA11><fA11 i1="02" i2="1"><s1>JOHANSSON (Jan-Ove)</s1></fA11><fA11 i1="03" i2="1"><s1>POEWE (Werner)</s1></fA11><fA11 i1="04" i2="1"><s1>WENNING (Gregor)</s1></fA11><fA11 i1="05" i2="1"><s1>QUINN (Niall P.)</s1></fA11><fA11 i1="06" i2="1"><s1>MATHIAS (Chris)</s1></fA11><fA11 i1="07" i2="1"><s1>TOLOSA (Eduardo)</s1></fA11><fA11 i1="08" i2="1"><s1>CARDOZO (Adriana)</s1></fA11><fA11 i1="09" i2="1"><s1>DIZDAR (Nil)</s1></fA11><fA11 i1="10" i2="1"><s1>RASCOL (Olivier)</s1></fA11><fA11 i1="11" i2="1"><s1>SLAOUI (Tarik)</s1></fA11><fA14 i1="01"><s1>Movement Disorders Unit, Sahlgrenska University Hospital, Göteborg University</s1><s3>SWE</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ></fA14><fA14 i1="02"><s1>Department of Neurology, University Hospital Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>3 aut.</sZ><sZ>4 aut.</sZ></fA14><fA14 i1="03"><s1>Sobell Department of Motor Neuroscience and Movement Disorders, Institute of Neurology</s1><s2>London</s2><s3>GBR</s3><sZ>5 aut.</sZ><sZ>6 aut.</sZ></fA14><fA14 i1="04"><s1>Hospital Clinic de Barcelona, Servicio de Neurologia</s1><s2>Barcelona</s2><s3>ESP</s3><sZ>7 aut.</sZ><sZ>8 aut.</sZ></fA14><fA14 i1="05"><s1>Department of Neurology, Linköping University Hospital</s1><s3>SWE</s3><sZ>9 aut.</sZ></fA14><fA14 i1="06"><s1>Department of Pharmacology, Clinical Investigation Center, Hopital Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></fA14><fA14 i1="07"><s1>Department of Neurosciences, Clinical Investigation Center, Hôpital Purpan</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>10 aut.</sZ><sZ>11 aut.</sZ></fA14><fA17 i1="01" i2="1"><s1>Behalf of the Growth-Hormone MSA Study Group, and of the European MSA Study Group (EMSA-SG)</s1><s3>INC</s3></fA17><fA20><s1>1138-1144</s1></fA20><fA21><s1>2007</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000159429990120</s5></fA43><fA44><s0>0000</s0><s1>© 2007 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>23 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>07-0349117</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>The objective of this study was to investigate tolerability and possible neurotrophic effects of growth hormone (GH) in treatment of multiple system atrophy (MSA). In this double-blind pilot study, MSA patients were randomized to recombinant human growth hormone (r-hGH, n = 22), I mg every second day (6 months) followed by alternating daily injections of 1 mg and 0.5 mg (6 months), or matched placebo (n = 21). Safety analysis demonstrated no obvious between-group differences. In both groups, there was progressive worsening of Unified Parkinson's Disease Rating Scale total score, which tended to be less in r-hGH-treated patients (12.9% at 6 months, 25.3% at 12 months) than in placebo (17.0%; and 35.7%). Similarly, there was a trend to less worsening in Unified MSA Rating Scale total score with r-hGH (13.2% and 21.2%) than with placebo (21.1% and 36.5%). Cardiovascular reflex autonomic testing also tended to show less deterioration with r-hGH than with placebo at 12 months. However, 95% Cl did not indicate treatment differences for any efficacy measures. In conclusion, r-hGH administration in MSA patients for up to 1 year appears safe and might influence disease symptoms, signs and, possibly, progression. The results support further studies utilizing higher doses in more patients.</s0></fC01><fC02 i1="01" i2="X"><s0>002B17</s0></fC02><fC02 i1="02" i2="X"><s0>002B17F</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>Atrophie multisystématisée</s0><s2>NM</s2><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Multiple system atrophy</s0><s2>NM</s2><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Atrofia multisistematizada</s0><s2>NM</s2><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Sécurité</s0><s5>09</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Safety</s0><s5>09</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Seguridad</s0><s5>09</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>STH</s0><s5>10</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Somatotropin hormone</s0><s5>10</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>STH</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Traitement</s0><s5>11</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Treatment</s0><s5>11</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Tratamiento</s0><s5>11</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Etude double insu</s0><s5>12</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Double blind study</s0><s5>12</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Estudio doble ciego</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Placebo</s0><s5>13</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Placebo</s0><s5>13</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Placebo</s0><s5>13</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Hormone adénohypophysaire</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Adenohypophyseal hormone</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Hormona adenohipofisaria</s0><s5>37</s5></fC07><fN21><s1>225</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard></inist><affiliations><list><country><li>Autriche</li><li>Espagne</li><li>France</li><li>Royaume-Uni</li><li>Suède</li></country><region><li>Angleterre</li><li>Catalogne</li><li>Grand Londres</li><li>Götaland</li><li>Midi-Pyrénées</li><li>Suède occidentale</li><li>Tyrol (Land)</li></region><settlement><li>Barcelone</li><li>Göteborg</li><li>Innsbruck</li><li>Londres</li><li>Toulouse</li></settlement><orgName><li>Université Toulouse III - Paul Sabatier</li><li>Université de Göteborg</li><li>Université de Toulouse</li><li>Université de médecine d'Innsbruck</li></orgName></list><tree><country name="Suède"><region name="Götaland"><name sortKey="Holmberg, Bjorn" sort="Holmberg, Bjorn" uniqKey="Holmberg B" first="Björn" last="Holmberg">Björn Holmberg</name></region><name sortKey="Dizdar, Nil" sort="Dizdar, Nil" uniqKey="Dizdar N" first="Nil" last="Dizdar">Nil Dizdar</name><name sortKey="Johansson, Jan Ove" sort="Johansson, Jan Ove" uniqKey="Johansson J" first="Jan-Ove" last="Johansson">Jan-Ove Johansson</name></country><country name="Autriche"><region name="Tyrol (Land)"><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name></region><name sortKey="Wenning, Gregor" sort="Wenning, Gregor" uniqKey="Wenning G" first="Gregor" last="Wenning">Gregor Wenning</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Quinn, Niall P" sort="Quinn, Niall P" uniqKey="Quinn N" first="Niall P." last="Quinn">Niall P. Quinn</name></region><name sortKey="Mathias, Chris" sort="Mathias, Chris" uniqKey="Mathias C" first="Chris" last="Mathias">Chris Mathias</name></country><country name="Espagne"><region name="Catalogne"><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name></region><name sortKey="Cardozo, Adriana" sort="Cardozo, Adriana" uniqKey="Cardozo A" first="Adriana" last="Cardozo">Adriana Cardozo</name></country><country name="France"><noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name><name sortKey="Slaoui, Tarik" sort="Slaoui, Tarik" uniqKey="Slaoui T" first="Tarik" last="Slaoui">Tarik Slaoui</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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