Treatment of restless legs syndrome: An evidence‐based review and implications for clinical practice
Identifieur interne : 000138 ( Istex/Corpus ); précédent : 000137; suivant : 000139Treatment of restless legs syndrome: An evidence‐based review and implications for clinical practice
Auteurs : Claudia Trenkwalder ; Wayne A. Hening ; Pasquale Montagna ; Wolfgang H. Oertel ; Richard P. Allen ; Arthur S. Walters ; Joao Costa ; Karin Stiasny-Kolster ; Cristina SampaioSource :
- Movement Disorders [ 0885-3185 ] ; 2008-12-15.
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- KwdEn :
Abstract
Only in the last three decades, the restless legs syndrome (RLS) has been examined in randomized controlled trials. The Movement Disorder Society (MDS) commissioned a task force to perform an evidence‐based review of the medical literature on treatment modalities used to manage patients with RLS. The task force performed a search of the published literature using electronic databases. The therapeutic efficacy of each drug was classified as being either efficacious, likely efficacious, investigational, nonefficacious, or lacking sufficient evidence to classify. Implications for clinical practice were generated based on the levels of evidence and particular features of each modality, such as adverse events. All studies were classed according to three levels of evidence. All Level‐I trials were included in the efficacy tables; if no Level‐I trials were available then Level‐II trials were included or, in the absence of Level‐II trials, Level‐III studies or case series were included. Only studies published in print or online before December 31, 2006 were included. All studies published after 1996, which attempted to assess RLS augmentation, were reviewed in a separate section. The following drugs are considered efficacious for the treatment of RLS: levodopa, ropinirole, pramipexole, cabergoline, pergolide, and gabapentin. Drugs considered likely efficacious are rotigotine, bromocriptine, oxycodone, carbamazepine, valproic acid, and clonidine. Drugs that are considered investigational are dihydroergocriptine, lisuride, methadone, tramadol, clonazepam, zolpidem, amantadine, and topiramate. Magnesium, folic acid, and exercise are also considered to be investigational. Sumanirole is nonefficacious. Intravenous iron dextran is likely efficacious for the treatment of RLS secondary to end‐stage renal disease and investigational in RLS subjects with normal renal function. The efficacy of oral iron is considered investigational; however, its efficacy appears to depend on the iron status of subjects. Cabergoline and pergolide (and possibly lisuride) require special monitoring due to fibrotic complications including cardiac valvulopathy. Special monitoring is required for several other medications based on clinical concerns: opioids (including, but not limited to, oxycodone, methadone and tramadol), due to possible addiction and respiratory depression, and some anticonvulsants (particularly, carbamazepine and valproic acid), due to systemic toxicities. © 2008 Movement Disorder Society
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DOI: 10.1002/mds.22254
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<front><div type="abstract" xml:lang="en">Only in the last three decades, the restless legs syndrome (RLS) has been examined in randomized controlled trials. The Movement Disorder Society (MDS) commissioned a task force to perform an evidence‐based review of the medical literature on treatment modalities used to manage patients with RLS. The task force performed a search of the published literature using electronic databases. The therapeutic efficacy of each drug was classified as being either efficacious, likely efficacious, investigational, nonefficacious, or lacking sufficient evidence to classify. Implications for clinical practice were generated based on the levels of evidence and particular features of each modality, such as adverse events. All studies were classed according to three levels of evidence. All Level‐I trials were included in the efficacy tables; if no Level‐I trials were available then Level‐II trials were included or, in the absence of Level‐II trials, Level‐III studies or case series were included. Only studies published in print or online before December 31, 2006 were included. All studies published after 1996, which attempted to assess RLS augmentation, were reviewed in a separate section. The following drugs are considered efficacious for the treatment of RLS: levodopa, ropinirole, pramipexole, cabergoline, pergolide, and gabapentin. Drugs considered likely efficacious are rotigotine, bromocriptine, oxycodone, carbamazepine, valproic acid, and clonidine. Drugs that are considered investigational are dihydroergocriptine, lisuride, methadone, tramadol, clonazepam, zolpidem, amantadine, and topiramate. Magnesium, folic acid, and exercise are also considered to be investigational. Sumanirole is nonefficacious. Intravenous iron dextran is likely efficacious for the treatment of RLS secondary to end‐stage renal disease and investigational in RLS subjects with normal renal function. The efficacy of oral iron is considered investigational; however, its efficacy appears to depend on the iron status of subjects. Cabergoline and pergolide (and possibly lisuride) require special monitoring due to fibrotic complications including cardiac valvulopathy. Special monitoring is required for several other medications based on clinical concerns: opioids (including, but not limited to, oxycodone, methadone and tramadol), due to possible addiction and respiratory depression, and some anticonvulsants (particularly, carbamazepine and valproic acid), due to systemic toxicities. © 2008 Movement Disorder Society</div>
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<abstract>Only in the last three decades, the restless legs syndrome (RLS) has been examined in randomized controlled trials. The Movement Disorder Society (MDS) commissioned a task force to perform an evidence‐based review of the medical literature on treatment modalities used to manage patients with RLS. The task force performed a search of the published literature using electronic databases. The therapeutic efficacy of each drug was classified as being either efficacious, likely efficacious, investigational, nonefficacious, or lacking sufficient evidence to classify. Implications for clinical practice were generated based on the levels of evidence and particular features of each modality, such as adverse events. All studies were classed according to three levels of evidence. All Level‐I trials were included in the efficacy tables; if no Level‐I trials were available then Level‐II trials were included or, in the absence of Level‐II trials, Level‐III studies or case series were included. Only studies published in print or online before December 31, 2006 were included. All studies published after 1996, which attempted to assess RLS augmentation, were reviewed in a separate section. The following drugs are considered efficacious for the treatment of RLS: levodopa, ropinirole, pramipexole, cabergoline, pergolide, and gabapentin. Drugs considered likely efficacious are rotigotine, bromocriptine, oxycodone, carbamazepine, valproic acid, and clonidine. Drugs that are considered investigational are dihydroergocriptine, lisuride, methadone, tramadol, clonazepam, zolpidem, amantadine, and topiramate. Magnesium, folic acid, and exercise are also considered to be investigational. Sumanirole is nonefficacious. Intravenous iron dextran is likely efficacious for the treatment of RLS secondary to end‐stage renal disease and investigational in RLS subjects with normal renal function. The efficacy of oral iron is considered investigational; however, its efficacy appears to depend on the iron status of subjects. Cabergoline and pergolide (and possibly lisuride) require special monitoring due to fibrotic complications including cardiac valvulopathy. Special monitoring is required for several other medications based on clinical concerns: opioids (including, but not limited to, oxycodone, methadone and tramadol), due to possible addiction and respiratory depression, and some anticonvulsants (particularly, carbamazepine and valproic acid), due to systemic toxicities. © 2008 Movement Disorder Society</abstract>
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<notesStmt><note type="content">*Produced by a task force commissioned by The Movement Disorder Society.</note>
<note type="content">*Potential conflicts of interest: Claudia Trenkwalder, MD, has been an advisor for Boehringer Ingelheim, Cephalon, Mundipharm, Orion Pharma and Schwarz Pharma. She has received consultant honoraria from GlaxoSmithKline, Boehringer Ingelheim GmbH, UCB/Schwarz Pharma, and Novartis; Wayne A. Hening, MD, PhD, has received grant support from GlaxoSmithKline, and consultancy and speaking honoraria from Boehringer Ingelheim, and consultancy honoraria from Schwarz‐Pharma; Pasquale Montagna, MD, has received research funding from GlaxoSmithKline and Schwarz Pharma, and has received consultant honoraria from Boehringer Ingelheim GmbH; Wolfgang H. Oertel, MD, has been an advisor for Boehringer Ingelheim, GlaxoSmithKline, Novartis and Orion, and Schwarz Pharma and has received consultant honoraria from Boehringer Ingelheim, Hoffmann LaRoche, and Schwarz Pharma; Richard P. Allen, PhD, has received consultant honoraria from GlaxoSmithKline, Boehringer Ingelheim, UCB, Xenoport, Sepracor, Norvatis, Orion Pharma. Respironics, IM systems. Pfizer, Jazz, Schwarz Pharama, and Neurogen. He has received grant support from the NIH, GlaxoSmithKline and Sepracor; Arthur S. Walters, MD, has been an advisor for GlaxoSmithKline, Boehringer Ingelheim, Xenoport, UCB/Schwarz Pharma, and Orion/Novartis. He has received research funding from GlaxoSmithKline, Boehringer Ingelheim, Xenoport, UCB/Schwarz Pharma and Kyowa; Karin Stiasny‐Kolster, MD, has been an advisor for Boehringer Ingelheim, Orion, Mundipharma, Pfizer, Schwarz Pharma, Synosia and UCB and has received consultant honoraria from Schwarz Pharma, UCB, and Boehringer Ingelheim; Cristina Sampaio, MD, PhD and Joao Costa's, MD, department has received grants from or payments from the following companies: Kyowa, Schering‐Plough, Lundbeck, UCB, Neurobiotech, Solvay, Servier, Xytis, Gruenthal, Eisai, Novartis, Fujisawa/Astellas, Neuron/Serono, Bial, GlaxoSmithKline and Novartis. In no circumstances were these grants/payments related to a development program concerning RLS.</note>
<note>Boehringer Ingelheim GmbH</note>
<note>Hoffmann‐LaRoche Ltd.</note>
<note>Orion Pharma</note>
<note>GlaxoSmithKline</note>
<note>Schwarz Pharma AG</note>
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<sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Treatment of restless legs syndrome: An evidence‐based review and implications for clinical practice</title>
<author><persName><forename type="first">Claudia</forename>
<surname>Trenkwalder</surname>
<roleName type="degree">MD</roleName>
</persName>
<note type="biography">Chairperson RLS EBM task force.</note>
<affiliation>Chairperson RLS EBM task force.</affiliation>
<note type="correspondence"><p>Correspondence: Paracelsus‐Elena Hospital, Center of Parkinsonism and Movement Disorders, Klinikstr. 16, 34128 Kassel, Germany</p>
</note>
<affiliation>Paracelsus‐Elena Hospital, Kassel, Germany</affiliation>
<affiliation>Department of Clinical Neurophysiology, University of Göttingen, Germany</affiliation>
</author>
<author><persName><forename type="first">Wayne A.</forename>
<surname>Hening</surname>
<roleName type="degree">MD, PhD</roleName>
</persName>
<note type="biography">RLS EBM task force member.</note>
<affiliation>RLS EBM task force member.</affiliation>
<affiliation>Department of Neurology, UMDNJ‐RW Johnson Medical School, New Brunswick, New Jersey, USA</affiliation>
</author>
<author><persName><forename type="first">Pasquale</forename>
<surname>Montagna</surname>
<roleName type="degree">MD</roleName>
</persName>
<note type="biography">RLS EBM task force member.</note>
<affiliation>RLS EBM task force member.</affiliation>
<affiliation>Department of Neurological Sciences, University of Bologna, Bologna, Italy</affiliation>
</author>
<author><persName><forename type="first">Wolfgang H.</forename>
<surname>Oertel</surname>
<roleName type="degree">MD</roleName>
</persName>
<note type="biography">RLS EBM task force member.</note>
<affiliation>RLS EBM task force member.</affiliation>
<affiliation>Department of Neurology, Philipps‐University Marburg, Marburg, Germany</affiliation>
</author>
<author><persName><forename type="first">Richard P.</forename>
<surname>Allen</surname>
<roleName type="degree">PhD</roleName>
</persName>
<note type="biography">Representative of the World Association of Sleep Medicine (WASM)</note>
<affiliation>Representative of the World Association of Sleep Medicine (WASM)</affiliation>
<affiliation>Department of Neurology and Sleep Medicine, Johns Hopkins University, Baltimore, Maryland, USA</affiliation>
</author>
<author><persName><forename type="first">Arthur S.</forename>
<surname>Walters</surname>
<roleName type="degree">MD</roleName>
</persName>
<note type="biography">Representative of the International RLS study group (IRLSSG).</note>
<affiliation>Representative of the International RLS study group (IRLSSG).</affiliation>
<affiliation>New Jersey Neuroscience Institute, JFK Medical Center, Edison, and Seton Hall University School of Graduate Medical Education, New Jersey, USA</affiliation>
</author>
<author><persName><forename type="first">Joao</forename>
<surname>Costa</surname>
<roleName type="degree">MD</roleName>
</persName>
<note type="biography">RLS EBM task force member.</note>
<affiliation>RLS EBM task force member.</affiliation>
<affiliation>Neurological Clinical Research Unit, Institute of Molecular Medicine, Lisbon, Portugal</affiliation>
</author>
<author><persName><forename type="first">Karin</forename>
<surname>Stiasny‐Kolster</surname>
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<titleGroup><title type="main" xml:lang="en">Treatment of restless legs syndrome: An evidence‐based review and implications for clinical practice<link href="#fn1"></link>
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<supportingInformation><p> Additional Supporting Information may be found in the online version of this article. </p>
<supportingInfoItem><mediaResource alt="supporting information" href="urn-x:wiley:08853185:media:mds22254:Table1"></mediaResource>
<caption>Table 1: Levels of evidence</caption>
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<p>Only in the last three decades, the restless legs syndrome (RLS) has been examined in randomized controlled trials. The <i>Movement</i>
Disorder Society (MDS) commissioned a task force to perform an evidence‐based review of the medical literature on treatment modalities used to manage patients with RLS. The task force performed a search of the published literature using electronic databases. The therapeutic efficacy of each drug was classified as being either efficacious, likely efficacious, investigational, nonefficacious, or lacking sufficient evidence to classify. Implications for clinical practice were generated based on the levels of evidence and particular features of each modality, such as adverse events. All studies were classed according to three levels of evidence. All Level‐I trials were included in the efficacy tables; if no Level‐I trials were available then Level‐II trials were included or, in the absence of Level‐II trials, Level‐III studies or case series were included. Only studies published in print or online before December 31, 2006 were included. All studies published after 1996, which attempted to assess RLS augmentation, were reviewed in a separate section. The following drugs are considered efficacious for the treatment of RLS: levodopa, ropinirole, pramipexole, cabergoline, pergolide, and gabapentin. Drugs considered likely efficacious are rotigotine, bromocriptine, oxycodone, carbamazepine, valproic acid, and clonidine. Drugs that are considered investigational are dihydroergocriptine, lisuride, methadone, tramadol, clonazepam, zolpidem, amantadine, and topiramate. Magnesium, folic acid, and exercise are also considered to be investigational. Sumanirole is nonefficacious. Intravenous iron dextran is likely efficacious for the treatment of RLS secondary to end‐stage renal disease and investigational in RLS subjects with normal renal function. The efficacy of oral iron is considered investigational; however, its efficacy appears to depend on the iron status of subjects. Cabergoline and pergolide (and possibly lisuride) require special monitoring due to fibrotic complications including cardiac valvulopathy. Special monitoring is required for several other medications based on clinical concerns: opioids (including, but not limited to, oxycodone, methadone and tramadol), due to possible addiction and respiratory depression, and some anticonvulsants (particularly, carbamazepine and valproic acid), due to systemic toxicities. © 2008 Movement Disorder Society</p>
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<noteGroup><note xml:id="fn1"><p>Produced by a task force commissioned by The Movement Disorder Society.</p>
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<note xml:id="fn2"><p>Potential conflicts of interest: Claudia Trenkwalder, MD, has been an advisor for Boehringer Ingelheim, Cephalon, Mundipharm, Orion Pharma and Schwarz Pharma. She has received consultant honoraria from GlaxoSmithKline, Boehringer Ingelheim GmbH, UCB/Schwarz Pharma, and Novartis; Wayne A. Hening, MD, PhD, has received grant support from GlaxoSmithKline, and consultancy and speaking honoraria from Boehringer Ingelheim, and consultancy honoraria from Schwarz‐Pharma; Pasquale Montagna, MD, has received research funding from GlaxoSmithKline and Schwarz Pharma, and has received consultant honoraria from Boehringer Ingelheim GmbH; Wolfgang H. Oertel, MD, has been an advisor for Boehringer Ingelheim, GlaxoSmithKline, Novartis and Orion, and Schwarz Pharma and has received consultant honoraria from Boehringer Ingelheim, Hoffmann LaRoche, and Schwarz Pharma; Richard P. Allen, PhD, has received consultant honoraria from GlaxoSmithKline, Boehringer Ingelheim, UCB, Xenoport, Sepracor, Norvatis, Orion Pharma. Respironics, IM systems. Pfizer, Jazz, Schwarz Pharama, and Neurogen. He has received grant support from the NIH, GlaxoSmithKline and Sepracor; Arthur S. Walters, MD, has been an advisor for GlaxoSmithKline, Boehringer Ingelheim, Xenoport, UCB/Schwarz Pharma, and Orion/Novartis. He has received research funding from GlaxoSmithKline, Boehringer Ingelheim, Xenoport, UCB/Schwarz Pharma and Kyowa; Karin Stiasny‐Kolster, MD, has been an advisor for Boehringer Ingelheim, Orion, Mundipharma, Pfizer, Schwarz Pharma, Synosia and UCB and has received consultant honoraria from Schwarz Pharma, UCB, and Boehringer Ingelheim; Cristina Sampaio, MD, PhD and Joao Costa's, MD, department has received grants from or payments from the following companies: Kyowa, Schering‐Plough, Lundbeck, UCB, Neurobiotech, Solvay, Servier, Xytis, Gruenthal, Eisai, Novartis, Fujisawa/Astellas, Neuron/Serono, Bial, GlaxoSmithKline and Novartis. In no circumstances were these grants/payments related to a development program concerning RLS.</p>
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<note xml:id="fn3"><p>Chairperson RLS EBM task force.</p>
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<abstract lang="en">Only in the last three decades, the restless legs syndrome (RLS) has been examined in randomized controlled trials. The Movement Disorder Society (MDS) commissioned a task force to perform an evidence‐based review of the medical literature on treatment modalities used to manage patients with RLS. The task force performed a search of the published literature using electronic databases. The therapeutic efficacy of each drug was classified as being either efficacious, likely efficacious, investigational, nonefficacious, or lacking sufficient evidence to classify. Implications for clinical practice were generated based on the levels of evidence and particular features of each modality, such as adverse events. All studies were classed according to three levels of evidence. All Level‐I trials were included in the efficacy tables; if no Level‐I trials were available then Level‐II trials were included or, in the absence of Level‐II trials, Level‐III studies or case series were included. Only studies published in print or online before December 31, 2006 were included. All studies published after 1996, which attempted to assess RLS augmentation, were reviewed in a separate section. The following drugs are considered efficacious for the treatment of RLS: levodopa, ropinirole, pramipexole, cabergoline, pergolide, and gabapentin. Drugs considered likely efficacious are rotigotine, bromocriptine, oxycodone, carbamazepine, valproic acid, and clonidine. Drugs that are considered investigational are dihydroergocriptine, lisuride, methadone, tramadol, clonazepam, zolpidem, amantadine, and topiramate. Magnesium, folic acid, and exercise are also considered to be investigational. Sumanirole is nonefficacious. Intravenous iron dextran is likely efficacious for the treatment of RLS secondary to end‐stage renal disease and investigational in RLS subjects with normal renal function. The efficacy of oral iron is considered investigational; however, its efficacy appears to depend on the iron status of subjects. Cabergoline and pergolide (and possibly lisuride) require special monitoring due to fibrotic complications including cardiac valvulopathy. Special monitoring is required for several other medications based on clinical concerns: opioids (including, but not limited to, oxycodone, methadone and tramadol), due to possible addiction and respiratory depression, and some anticonvulsants (particularly, carbamazepine and valproic acid), due to systemic toxicities. © 2008 Movement Disorder Society</abstract>
<note type="content">*Produced by a task force commissioned by The Movement Disorder Society.</note>
<note type="content">*Potential conflicts of interest: Claudia Trenkwalder, MD, has been an advisor for Boehringer Ingelheim, Cephalon, Mundipharm, Orion Pharma and Schwarz Pharma. She has received consultant honoraria from GlaxoSmithKline, Boehringer Ingelheim GmbH, UCB/Schwarz Pharma, and Novartis; Wayne A. Hening, MD, PhD, has received grant support from GlaxoSmithKline, and consultancy and speaking honoraria from Boehringer Ingelheim, and consultancy honoraria from Schwarz‐Pharma; Pasquale Montagna, MD, has received research funding from GlaxoSmithKline and Schwarz Pharma, and has received consultant honoraria from Boehringer Ingelheim GmbH; Wolfgang H. Oertel, MD, has been an advisor for Boehringer Ingelheim, GlaxoSmithKline, Novartis and Orion, and Schwarz Pharma and has received consultant honoraria from Boehringer Ingelheim, Hoffmann LaRoche, and Schwarz Pharma; Richard P. Allen, PhD, has received consultant honoraria from GlaxoSmithKline, Boehringer Ingelheim, UCB, Xenoport, Sepracor, Norvatis, Orion Pharma. Respironics, IM systems. Pfizer, Jazz, Schwarz Pharama, and Neurogen. He has received grant support from the NIH, GlaxoSmithKline and Sepracor; Arthur S. Walters, MD, has been an advisor for GlaxoSmithKline, Boehringer Ingelheim, Xenoport, UCB/Schwarz Pharma, and Orion/Novartis. He has received research funding from GlaxoSmithKline, Boehringer Ingelheim, Xenoport, UCB/Schwarz Pharma and Kyowa; Karin Stiasny‐Kolster, MD, has been an advisor for Boehringer Ingelheim, Orion, Mundipharma, Pfizer, Schwarz Pharma, Synosia and UCB and has received consultant honoraria from Schwarz Pharma, UCB, and Boehringer Ingelheim; Cristina Sampaio, MD, PhD and Joao Costa's, MD, department has received grants from or payments from the following companies: Kyowa, Schering‐Plough, Lundbeck, UCB, Neurobiotech, Solvay, Servier, Xytis, Gruenthal, Eisai, Novartis, Fujisawa/Astellas, Neuron/Serono, Bial, GlaxoSmithKline and Novartis. In no circumstances were these grants/payments related to a development program concerning RLS.</note>
<note type="funding">Boehringer Ingelheim GmbH</note>
<note type="funding">Hoffmann‐LaRoche Ltd.</note>
<note type="funding">Orion Pharma</note>
<note type="funding">GlaxoSmithKline</note>
<note type="funding">Schwarz Pharma AG</note>
<subject lang="en"><genre>Keywords</genre>
<topic>restless legs syndrome (RLS)</topic>
<topic>evidence‐based medicine</topic>
<topic>guidelines</topic>
<topic>MDS recommendations</topic>
<topic>therapy</topic>
<topic>treatment</topic>
</subject>
<relatedItem type="host"><titleInfo><title>Movement Disorders</title>
<subTitle>Official Journal of the Movement Disorder Society</subTitle>
</titleInfo>
<titleInfo type="abbreviated"><title>Mov. Disord.</title>
</titleInfo>
<note type="content"> Additional Supporting Information may be found in the online version of this article.Supporting Info Item: Table 1: Levels of evidence - Table 2: Definitions for specific recommendations - Table 3: Efficacy - Table 4: Augmentation - </note>
<subject><genre>article category</genre>
<topic>Review</topic>
</subject>
<identifier type="ISSN">0885-3185</identifier>
<identifier type="eISSN">1531-8257</identifier>
<identifier type="DOI">10.1002/(ISSN)1531-8257</identifier>
<identifier type="PublisherID">MDS</identifier>
<part><date>2008</date>
<detail type="volume"><caption>vol.</caption>
<number>23</number>
</detail>
<detail type="issue"><caption>no.</caption>
<number>16</number>
</detail>
<extent unit="pages"><start>2267</start>
<end>2302</end>
<total>33</total>
</extent>
</part>
</relatedItem>
<identifier type="istex">62C607DA2C3CAB80B46E0532545E5F559E3B8422</identifier>
<identifier type="DOI">10.1002/mds.22254</identifier>
<identifier type="ArticleID">MDS22254</identifier>
<accessCondition type="use and reproduction" contentType="copyright">Copyright © 2008 Movement Disorder Society</accessCondition>
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<recordContentSource>WILEY</recordContentSource>
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