La maladie de Parkinson au Canada (serveur d'exploration)

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Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial.

Identifieur interne : 000564 ( PubMed/Corpus ); précédent : 000563; suivant : 000565

Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial.

Auteurs : Karl Kieburtz ; Barbara C. Tilley ; Jordan J. Elm ; Debra Babcock ; Robert Hauser ; G Webster Ross ; Alicia H. Augustine ; Erika U. Augustine ; Michael J. Aminoff ; Ivan G. Bodis-Wollner ; James Boyd ; Franca Cambi ; Kelvin Chou ; Chadwick W. Christine ; Michelle Cines ; Nabila Dahodwala ; Lorelei Derwent ; Richard B. Dewey ; Katherine Hawthorne ; David J. Houghton ; Cornelia Kamp ; Maureen Leehey ; Mark F. Lew ; Grace S Lin Liang ; Sheng T. Luo ; Zoltan Mari ; John C. Morgan ; Sotirios Parashos ; Adriana Pérez ; Helen Petrovitch ; Suja Rajan ; Sue Reichwein ; Jessie Tatsuno Roth ; Jay S. Schneider ; Kathleen M. Shannon ; David K. Simon ; Tanya Simuni ; Carlos Singer ; Lewis Sudarsky ; Caroline M. Tanner ; Chizoba C. Umeh ; Karen Williams ; Anne-Marie Wills

Source :

RBID : pubmed:25668262

English descriptors

Abstract

There are no treatments available to slow or prevent the progression of Parkinson disease, despite its global prevalence and significant health care burden. The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease program was established to promote discovery of potential therapies.

DOI: 10.1001/jama.2015.120
PubMed: 25668262

Links to Exploration step

pubmed:25668262

Le document en format XML

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<title xml:lang="en">Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial.</title>
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<name sortKey="Hauser, Robert" sort="Hauser, Robert" uniqKey="Hauser R" first="Robert" last="Hauser">Robert Hauser</name>
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<nlm:affiliation>University of South Florida, Tampa.</nlm:affiliation>
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<name sortKey="Luo, Sheng T" sort="Luo, Sheng T" uniqKey="Luo S" first="Sheng T" last="Luo">Sheng T. Luo</name>
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<nlm:affiliation>University of Texas Health Science Center at Houston.</nlm:affiliation>
</affiliation>
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<name sortKey="Mari, Zoltan" sort="Mari, Zoltan" uniqKey="Mari Z" first="Zoltan" last="Mari">Zoltan Mari</name>
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<name sortKey="Morgan, John C" sort="Morgan, John C" uniqKey="Morgan J" first="John C" last="Morgan">John C. Morgan</name>
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<nlm:affiliation>Georgia Regents University, Augusta.</nlm:affiliation>
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<name sortKey="Parashos, Sotirios" sort="Parashos, Sotirios" uniqKey="Parashos S" first="Sotirios" last="Parashos">Sotirios Parashos</name>
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<nlm:affiliation>Struthers Parkinson's Center, Golden Valley, Minnesota.</nlm:affiliation>
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<name sortKey="Perez, Adriana" sort="Perez, Adriana" uniqKey="Perez A" first="Adriana" last="Pérez">Adriana Pérez</name>
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<nlm:affiliation>University of Texas Health Science Center at Houston.</nlm:affiliation>
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<name sortKey="Petrovitch, Helen" sort="Petrovitch, Helen" uniqKey="Petrovitch H" first="Helen" last="Petrovitch">Helen Petrovitch</name>
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<nlm:affiliation>Pacific Health Research and Education Institute, Honolulu, Hawaii.</nlm:affiliation>
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<name sortKey="Rajan, Suja" sort="Rajan, Suja" uniqKey="Rajan S" first="Suja" last="Rajan">Suja Rajan</name>
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<nlm:affiliation>University of Texas Health Science Center at Houston.</nlm:affiliation>
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<name sortKey="Reichwein, Sue" sort="Reichwein, Sue" uniqKey="Reichwein S" first="Sue" last="Reichwein">Sue Reichwein</name>
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<nlm:affiliation>University of Pennsylvania, Philadelphia.</nlm:affiliation>
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<name sortKey="Roth, Jessie Tatsuno" sort="Roth, Jessie Tatsuno" uniqKey="Roth J" first="Jessie Tatsuno" last="Roth">Jessie Tatsuno Roth</name>
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<nlm:affiliation>University of California, San Francisco.</nlm:affiliation>
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<name sortKey="Schneider, Jay S" sort="Schneider, Jay S" uniqKey="Schneider J" first="Jay S" last="Schneider">Jay S. Schneider</name>
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<name sortKey="Shannon, Kathleen M" sort="Shannon, Kathleen M" uniqKey="Shannon K" first="Kathleen M" last="Shannon">Kathleen M. Shannon</name>
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<name sortKey="Simon, David K" sort="Simon, David K" uniqKey="Simon D" first="David K" last="Simon">David K. Simon</name>
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<name sortKey="Simuni, Tanya" sort="Simuni, Tanya" uniqKey="Simuni T" first="Tanya" last="Simuni">Tanya Simuni</name>
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<nlm:affiliation>Northwestern University, Chicago, Illinois.</nlm:affiliation>
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<author>
<name sortKey="Singer, Carlos" sort="Singer, Carlos" uniqKey="Singer C" first="Carlos" last="Singer">Carlos Singer</name>
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<nlm:affiliation>University of Miami, Miami, Florida.</nlm:affiliation>
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<author>
<name sortKey="Sudarsky, Lewis" sort="Sudarsky, Lewis" uniqKey="Sudarsky L" first="Lewis" last="Sudarsky">Lewis Sudarsky</name>
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<name sortKey="Tanner, Caroline M" sort="Tanner, Caroline M" uniqKey="Tanner C" first="Caroline M" last="Tanner">Caroline M. Tanner</name>
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<nlm:affiliation>The Parkinson's Institute and Clinical Center, Sunnyvale, California.</nlm:affiliation>
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<author>
<name sortKey="Umeh, Chizoba C" sort="Umeh, Chizoba C" uniqKey="Umeh C" first="Chizoba C" last="Umeh">Chizoba C. Umeh</name>
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</affiliation>
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<name sortKey="Wills, Anne Marie" sort="Wills, Anne Marie" uniqKey="Wills A" first="Anne-Marie" last="Wills">Anne-Marie Wills</name>
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<title level="j">JAMA</title>
<idno type="eISSN">1538-3598</idno>
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<term>Antiparkinson Agents (therapeutic use)</term>
<term>Creatine (adverse effects)</term>
<term>Creatine (blood)</term>
<term>Creatine (therapeutic use)</term>
<term>Disease Progression</term>
<term>Double-Blind Method</term>
<term>Drug Therapy, Combination</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
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<term>Medication Adherence</term>
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<term>Treatment Outcome</term>
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<term>Creatine</term>
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<term>Disease Progression</term>
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<front>
<div type="abstract" xml:lang="en">There are no treatments available to slow or prevent the progression of Parkinson disease, despite its global prevalence and significant health care burden. The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease program was established to promote discovery of potential therapies.</div>
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<DateCreated>
<Year>2015</Year>
<Month>02</Month>
<Day>11</Day>
</DateCreated>
<DateCompleted>
<Year>2015</Year>
<Month>02</Month>
<Day>19</Day>
</DateCompleted>
<DateRevised>
<Year>2017</Year>
<Month>04</Month>
<Day>13</Day>
</DateRevised>
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<Journal>
<ISSN IssnType="Electronic">1538-3598</ISSN>
<JournalIssue CitedMedium="Internet">
<Volume>313</Volume>
<Issue>6</Issue>
<PubDate>
<Year>2015</Year>
<Month>Feb</Month>
<Day>10</Day>
</PubDate>
</JournalIssue>
<Title>JAMA</Title>
<ISOAbbreviation>JAMA</ISOAbbreviation>
</Journal>
<ArticleTitle>Effect of creatine monohydrate on clinical progression in patients with Parkinson disease: a randomized clinical trial.</ArticleTitle>
<Pagination>
<MedlinePgn>584-93</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1001/jama.2015.120</ELocationID>
<Abstract>
<AbstractText Label="IMPORTANCE" NlmCategory="OBJECTIVE">There are no treatments available to slow or prevent the progression of Parkinson disease, despite its global prevalence and significant health care burden. The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease program was established to promote discovery of potential therapies.</AbstractText>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">To determine whether creatine monohydrate was more effective than placebo in slowing long-term clinical decline in participants with Parkinson disease.</AbstractText>
<AbstractText Label="DESIGN, SETTING, AND PATIENTS" NlmCategory="METHODS">The Long-term Study 1, a multicenter, double-blind, parallel-group, placebo-controlled, 1:1 randomized efficacy trial. Participants were recruited from 45 investigative sites in the United States and Canada and included 1741 men and women with early (within 5 years of diagnosis) and treated (receiving dopaminergic therapy) Parkinson disease. Participants were enrolled from March 2007 to May 2010 and followed up until September 2013.</AbstractText>
<AbstractText Label="INTERVENTIONS" NlmCategory="METHODS">Participants were randomized to placebo or creatine (10 g/d) monohydrate for a minimum of 5 years (maximum follow-up, 8 years).</AbstractText>
<AbstractText Label="MAIN OUTCOMES AND MEASURES" NlmCategory="METHODS">The primary outcome measure was a difference in clinical decline from baseline to 5-year follow-up, compared between the 2 treatment groups using a global statistical test. Clinical status was defined by 5 outcome measures: Modified Rankin Scale, Symbol Digit Modalities Test, PDQ-39 Summary Index, Schwab and England Activities of Daily Living scale, and ambulatory capacity. All outcomes were coded such that higher scores indicated worse outcomes and were analyzed by a global statistical test. Higher summed ranks (range, 5-4775) indicate worse outcomes.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">The trial was terminated early for futility based on results of a planned interim analysis of participants enrolled at least 5 years prior to the date of the analysis (n = 955). The median follow-up time was 4 years. Of the 955 participants, the mean of the summed ranks for placebo was 2360 (95% CI, 2249-2470) and for creatine was 2414 (95% CI, 2304-2524). The global statistical test yielded t1865.8 = -0.75 (2-sided P = .45). There were no detectable differences (P < .01 to partially adjust for multiple comparisons) in adverse and serious adverse events by body system.</AbstractText>
<AbstractText Label="CONCLUSIONS AND RELEVANCE" NlmCategory="CONCLUSIONS">Among patients with early and treated Parkinson disease, treatment with creatine monohydrate for at least 5 years, compared with placebo did not improve clinical outcomes. These findings do not support the use of creatine monohydrate in patients with Parkinson disease.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">clinicaltrials.gov Identifier: NCT00449865.</AbstractText>
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