Randomized, double‐blind, pilot evaluation of intravenous glutathione in Parkinson's disease
Identifieur interne : 002098 ( Main/Exploration ); précédent : 002097; suivant : 002099Randomized, double‐blind, pilot evaluation of intravenous glutathione in Parkinson's disease
Auteurs : Robert A. Hauser [États-Unis] ; Kelly E. Lyons [États-Unis] ; Terry Mcclain [États-Unis] ; Summer Carter [États-Unis] ; David Perlmutter [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2009-05-15.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antioxidant, Antiparkinson Agents (therapeutic use), Double-Blind Method, Drug Evaluation, Evaluation, Female, Glutathione, Glutathione (therapeutic use), Humans, Injections, Intravenous (methods), Intravenous administration, Male, Mental Status Schedule, Middle Aged, Nervous system diseases, Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Pilot Projects, Severity of Illness Index, Time Factors, Treatment, UPDRS, antioxidant, glutathione, neuroprotection, treatment.
- MESH :
- chemical , therapeutic use : Antiparkinson Agents, Glutathione.
- drug therapy : Parkinson Disease.
- methods : Injections, Intravenous.
- Adult, Aged, Aged, 80 and over, Double-Blind Method, Drug Evaluation, Female, Humans, Male, Mental Status Schedule, Middle Aged, Pilot Projects, Severity of Illness Index, Time Factors.
Abstract
The objective of this study was to evaluate the safety, tolerability, and preliminary efficacy of intravenous glutathione in Parkinson's disease (PD) patients. This was a randomized, placebo‐controlled, double‐blind, pilot trial in subjects with PD whose motor symptoms were not adequately controlled with their current medication regimen. Subjects were randomly assigned to receive intravenous glutathione 1,400 mg or placebo administered three times a week for 4 weeks. Twenty‐one subjects were randomly assigned, 11 to glutathione and 10 to placebo. One subject who was assigned to glutathione withdrew from the study for personal reasons prior to undergoing any postrandomization efficacy assessments. Glutathione was well tolerated and there were no withdrawals because of adverse events in either group. Reported adverse events were similar in the two groups. There were no significant differences in changes in Unified Parkinson's Disease Rating Scale (UPDRS) scores. Over the 4 weeks of study medication administration, UPDRS ADL + motor scores improved by a mean of 2.8 units more in the glutathione group (P = 0.32), and over the subsequent 8 weeks worsened by a mean of 3.5 units more in the glutathione group (P = 0.54). Glutathione was well tolerated and no safety concerns were identified. Preliminary efficacy data suggest the possibility of a mild symptomatic effect, but this remains to be evaluated in a larger study. © 2009 Movement Disorder Society
Url:
DOI: 10.1002/mds.22401
Affiliations:
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Le document en format XML
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Lyons</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Department of Neurology, University of Kansas Medical Center, NPF Center of Excellence</wicri:cityArea></affiliation></author><author><name sortKey="Mcclain, Terry" sort="Mcclain, Terry" uniqKey="Mcclain T" first="Terry" last="Mcclain">Terry Mcclain</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Department of Neurology, University of South Florida and Tampa General Healthcare, NPF Center of Excellence, Tampa</wicri:cityArea></affiliation></author><author><name sortKey="Carter, Summer" sort="Carter, Summer" uniqKey="Carter S" first="Summer" last="Carter">Summer Carter</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Department of Neurology, University of South Florida and Tampa General Healthcare, NPF Center of Excellence, Tampa</wicri:cityArea></affiliation></author><author><name sortKey="Perlmutter, David" sort="Perlmutter, David" uniqKey="Perlmutter D" first="David" last="Perlmutter">David Perlmutter</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><placeName><region type="state">Floride</region></placeName><wicri:cityArea>Perlmutter Health Center, Naples</wicri:cityArea></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2009-05-15">2009-05-15</date><biblScope unit="vol">24</biblScope><biblScope unit="issue">7</biblScope><biblScope unit="page" from="979">979</biblScope><biblScope unit="page" to="983">983</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">1407C0561231B6FB576C5AD76E051767532B17ED</idno><idno type="DOI">10.1002/mds.22401</idno><idno type="ArticleID">MDS22401</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Antioxidant</term><term>Antiparkinson Agents (therapeutic use)</term><term>Double-Blind Method</term><term>Drug Evaluation</term><term>Evaluation</term><term>Female</term><term>Glutathione</term><term>Glutathione (therapeutic use)</term><term>Humans</term><term>Injections, Intravenous (methods)</term><term>Intravenous administration</term><term>Male</term><term>Mental Status Schedule</term><term>Middle Aged</term><term>Nervous system diseases</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson disease</term><term>Parkinson's disease</term><term>Pilot Projects</term><term>Severity of Illness Index</term><term>Time Factors</term><term>Treatment</term><term>UPDRS</term><term>antioxidant</term><term>glutathione</term><term>neuroprotection</term><term>treatment</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiparkinson Agents</term><term>Glutathione</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Injections, Intravenous</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Double-Blind Method</term><term>Drug Evaluation</term><term>Female</term><term>Humans</term><term>Male</term><term>Mental Status Schedule</term><term>Middle Aged</term><term>Pilot Projects</term><term>Severity of Illness Index</term><term>Time Factors</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Antioxydant</term><term>Evaluation</term><term>Glutathion</term><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Traitement</term><term>Voie intraveineuse</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study was to evaluate the safety, tolerability, and preliminary efficacy of intravenous glutathione in Parkinson's disease (PD) patients. This was a randomized, placebo‐controlled, double‐blind, pilot trial in subjects with PD whose motor symptoms were not adequately controlled with their current medication regimen. Subjects were randomly assigned to receive intravenous glutathione 1,400 mg or placebo administered three times a week for 4 weeks. Twenty‐one subjects were randomly assigned, 11 to glutathione and 10 to placebo. One subject who was assigned to glutathione withdrew from the study for personal reasons prior to undergoing any postrandomization efficacy assessments. Glutathione was well tolerated and there were no withdrawals because of adverse events in either group. Reported adverse events were similar in the two groups. There were no significant differences in changes in Unified Parkinson's Disease Rating Scale (UPDRS) scores. Over the 4 weeks of study medication administration, UPDRS ADL + motor scores improved by a mean of 2.8 units more in the glutathione group (P = 0.32), and over the subsequent 8 weeks worsened by a mean of 3.5 units more in the glutathione group (P = 0.54). Glutathione was well tolerated and no safety concerns were identified. Preliminary efficacy data suggest the possibility of a mild symptomatic effect, but this remains to be evaluated in a larger study. © 2009 Movement Disorder Society</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Floride</li></region></list><tree><country name="États-Unis"><region name="Floride"><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name></region><name sortKey="Carter, Summer" sort="Carter, Summer" uniqKey="Carter S" first="Summer" last="Carter">Summer Carter</name><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name><name sortKey="Lyons, Kelly E" sort="Lyons, Kelly E" uniqKey="Lyons K" first="Kelly E." last="Lyons">Kelly E. Lyons</name><name sortKey="Mcclain, Terry" sort="Mcclain, Terry" uniqKey="Mcclain T" first="Terry" last="Mcclain">Terry Mcclain</name><name sortKey="Perlmutter, David" sort="Perlmutter, David" uniqKey="Perlmutter D" first="David" last="Perlmutter">David Perlmutter</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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