Evidence-based and consensus clinical practice guidelines for the iron treatment of restless legs syndrome/Willis-Ekbom disease in adults and children: an IRLSSG task force report

Brain iron deficiency has been implicated in the pathophysiology of RLS, and current RLS treatment guidelines recommend iron treatment when peripheral iron levels are low. In order to assess the evidence on the oral and intravenous (IV) iron treatment of RLS and periodic limb movement disorder (PLMD...

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Published in:	Sleep medicine Vol. 41; pp. 27 - 44
Main Authors:	Allen, Richard P., Picchietti, Daniel L., Auerbach, Michael, Cho, Yong Won, Connor, James R., Earley, Christopher J., Garcia-Borreguero, Diego, Kotagal, Suresh, Manconi, Mauro, Ondo, William, Ulfberg, Jan, Winkelman, John W.
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01.01.2018
Subjects:	Consensus Guidelines Intravenous iron Oral iron Restless legs syndrome Treatment Restless legs syndrome Oral iron Treatment Intravenous iron Consensus Guidelines
ISSN:	1389-9457, 1878-5506, 1878-5506
Online Access:	Get full text
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Abstract	Brain iron deficiency has been implicated in the pathophysiology of RLS, and current RLS treatment guidelines recommend iron treatment when peripheral iron levels are low. In order to assess the evidence on the oral and intravenous (IV) iron treatment of RLS and periodic limb movement disorder (PLMD) in adults and children, the International Restless Legs Syndrome Study Group (IRLSSG) formed a task force to review these studies and provide evidence-based and consensus guidelines for the iron treatment of RLS in adults, and RLS and PLMD in children. A literature search was performed to identify papers appearing in MEDLINE from its inception to July 2016. The following inclusion criteria were used: human research on the treatment of RLS or periodic limb movements (PLM) with iron, sample size of at least five, and published in English. Two task force members independently evaluated each paper and classified the quality of evidence provided. A total of 299 papers were identified, of these 31 papers met the inclusion criteria. Four studies in adults were given a Class I rating (one for IV iron sucrose, and three for IV ferric carboxymaltose); only Class IV studies have evaluated iron treatment in children. Ferric carboxymaltose (1000 mg) is effective for treating moderate to severe RLS in those with serum ferritin <300 μg/l and could be used as first-line treatment for RLS in adults. Oral iron (65 mg elemental iron) is possibly effective for treating RLS in those with serum ferritin ≤75 μg/l. There is insufficient evidence to make conclusions on the efficacy of oral iron or IV iron in children. Consensus recommendations based on clinical practice are presented, including when to use oral iron or IV iron, and recommendations on repeated iron treatments. New iron treatment algorithms, based on evidence and consensus opinion have been developed. •Iron treatments should be considered for all RLS patients.•Morning, fasting serum iron, ferritin, TIBC and %TSAT should be obtained.•No iron treatment should be used if %TSAT >45.•Oral iron treatment if tolerated and safe should be considered for ferritin ≤75 μg/l.•Consider IV iron when oral iron is not appropriate provided ferritin ≤100 μg/l.
AbstractList	Brain iron deficiency has been implicated in the pathophysiology of RLS, and current RLS treatment guidelines recommend iron treatment when peripheral iron levels are low. In order to assess the evidence on the oral and intravenous (IV) iron treatment of RLS and periodic limb movement disorder (PLMD) in adults and children, the International Restless Legs Syndrome Study Group (IRLSSG) formed a task force to review these studies and provide evidence-based and consensus guidelines for the iron treatment of RLS in adults, and RLS and PLMD in children. A literature search was performed to identify papers appearing in MEDLINE from its inception to July 2016. The following inclusion criteria were used: human research on the treatment of RLS or periodic limb movements (PLM) with iron, sample size of at least five, and published in English. Two task force members independently evaluated each paper and classified the quality of evidence provided. A total of 299 papers were identified, of these 31 papers met the inclusion criteria. Four studies in adults were given a Class I rating (one for IV iron sucrose, and three for IV ferric carboxymaltose); only Class IV studies have evaluated iron treatment in children. Ferric carboxymaltose (1000 mg) is effective for treating moderate to severe RLS in those with serum ferritin <300 μg/l and could be used as first-line treatment for RLS in adults. Oral iron (65 mg elemental iron) is possibly effective for treating RLS in those with serum ferritin ≤75 μg/l. There is insufficient evidence to make conclusions on the efficacy of oral iron or IV iron in children. Consensus recommendations based on clinical practice are presented, including when to use oral iron or IV iron, and recommendations on repeated iron treatments. New iron treatment algorithms, based on evidence and consensus opinion have been developed. •Iron treatments should be considered for all RLS patients.•Morning, fasting serum iron, ferritin, TIBC and %TSAT should be obtained.•No iron treatment should be used if %TSAT >45.•Oral iron treatment if tolerated and safe should be considered for ferritin ≤75 μg/l.•Consider IV iron when oral iron is not appropriate provided ferritin ≤100 μg/l. Brain iron deficiency has been implicated in the pathophysiology of RLS, and current RLS treatment guidelines recommend iron treatment when peripheral iron levels are low. In order to assess the evidence on the oral and intravenous (IV) iron treatment of RLS and periodic limb movement disorder (PLMD) in adults and children, the International Restless Legs Syndrome Study Group (IRLSSG) formed a task force to review these studies and provide evidence-based and consensus guidelines for the iron treatment of RLS in adults, and RLS and PLMD in children. A literature search was performed to identify papers appearing in MEDLINE from its inception to July 2016. The following inclusion criteria were used: human research on the treatment of RLS or periodic limb movements (PLM) with iron, sample size of at least five, and published in English. Two task force members independently evaluated each paper and classified the quality of evidence provided. A total of 299 papers were identified, of these 31 papers met the inclusion criteria. Four studies in adults were given a Class I rating (one for IV iron sucrose, and three for IV ferric carboxymaltose); only Class IV studies have evaluated iron treatment in children. Ferric carboxymaltose (1000 mg) is effective for treating moderate to severe RLS in those with serum ferritin <300 μg/l and could be used as first-line treatment for RLS in adults. Oral iron (65 mg elemental iron) is possibly effective for treating RLS in those with serum ferritin ≤75 μg/l. There is insufficient evidence to make conclusions on the efficacy of oral iron or IV iron in children. Consensus recommendations based on clinical practice are presented, including when to use oral iron or IV iron, and recommendations on repeated iron treatments. New iron treatment algorithms, based on evidence and consensus opinion have been developed. Brain iron deficiency has been implicated in the pathophysiology of RLS, and current RLS treatment guidelines recommend iron treatment when peripheral iron levels are low. In order to assess the evidence on the oral and intravenous (IV) iron treatment of RLS and periodic limb movement disorder (PLMD) in adults and children, the International Restless Legs Syndrome Study Group (IRLSSG) formed a task force to review these studies and provide evidence-based and consensus guidelines for the iron treatment of RLS in adults, and RLS and PLMD in children.BACKGROUNDBrain iron deficiency has been implicated in the pathophysiology of RLS, and current RLS treatment guidelines recommend iron treatment when peripheral iron levels are low. In order to assess the evidence on the oral and intravenous (IV) iron treatment of RLS and periodic limb movement disorder (PLMD) in adults and children, the International Restless Legs Syndrome Study Group (IRLSSG) formed a task force to review these studies and provide evidence-based and consensus guidelines for the iron treatment of RLS in adults, and RLS and PLMD in children.A literature search was performed to identify papers appearing in MEDLINE from its inception to July 2016. The following inclusion criteria were used: human research on the treatment of RLS or periodic limb movements (PLM) with iron, sample size of at least five, and published in English. Two task force members independently evaluated each paper and classified the quality of evidence provided.METHODSA literature search was performed to identify papers appearing in MEDLINE from its inception to July 2016. The following inclusion criteria were used: human research on the treatment of RLS or periodic limb movements (PLM) with iron, sample size of at least five, and published in English. Two task force members independently evaluated each paper and classified the quality of evidence provided.A total of 299 papers were identified, of these 31 papers met the inclusion criteria. Four studies in adults were given a Class I rating (one for IV iron sucrose, and three for IV ferric carboxymaltose); only Class IV studies have evaluated iron treatment in children. Ferric carboxymaltose (1000 mg) is effective for treating moderate to severe RLS in those with serum ferritin <300 μg/l and could be used as first-line treatment for RLS in adults. Oral iron (65 mg elemental iron) is possibly effective for treating RLS in those with serum ferritin ≤75 μg/l. There is insufficient evidence to make conclusions on the efficacy of oral iron or IV iron in children.RESULTSA total of 299 papers were identified, of these 31 papers met the inclusion criteria. Four studies in adults were given a Class I rating (one for IV iron sucrose, and three for IV ferric carboxymaltose); only Class IV studies have evaluated iron treatment in children. Ferric carboxymaltose (1000 mg) is effective for treating moderate to severe RLS in those with serum ferritin <300 μg/l and could be used as first-line treatment for RLS in adults. Oral iron (65 mg elemental iron) is possibly effective for treating RLS in those with serum ferritin ≤75 μg/l. There is insufficient evidence to make conclusions on the efficacy of oral iron or IV iron in children.Consensus recommendations based on clinical practice are presented, including when to use oral iron or IV iron, and recommendations on repeated iron treatments. New iron treatment algorithms, based on evidence and consensus opinion have been developed.CONCLUSIONSConsensus recommendations based on clinical practice are presented, including when to use oral iron or IV iron, and recommendations on repeated iron treatments. New iron treatment algorithms, based on evidence and consensus opinion have been developed.
Author	Allen, Richard P. Picchietti, Daniel L. Kotagal, Suresh Ulfberg, Jan Auerbach, Michael Connor, James R. Garcia-Borreguero, Diego Earley, Christopher J. Cho, Yong Won Winkelman, John W. Manconi, Mauro Ondo, William
Author_xml	– sequence: 1 givenname: Richard P. orcidid: 0000-0001-5123-629X surname: Allen fullname: Allen, Richard P. email: richardjhu@mac.com organization: Department of Neurology, Johns Hopkins University, Hopkins Bayview Medical Center, Baltimore, MD, USA – sequence: 2 givenname: Daniel L. surname: Picchietti fullname: Picchietti, Daniel L. organization: University of Illinois College of Medicine at Urbana-Champaign and Carle Foundation Hospital, Urbana, IL, USA – sequence: 3 givenname: Michael surname: Auerbach fullname: Auerbach, Michael organization: Department of Medicine, Georgetown University, Washington DC, USA – sequence: 4 givenname: Yong Won surname: Cho fullname: Cho, Yong Won organization: Department of Neurology, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Republic of Korea – sequence: 5 givenname: James R. surname: Connor fullname: Connor, James R. organization: Department of Neurosurgery, Penn State Hershey Medical Center, Hershey PA, USA – sequence: 6 givenname: Christopher J. surname: Earley fullname: Earley, Christopher J. organization: Department of Neurology, Johns Hopkins University, Hopkins Bayview Medical Center, Baltimore, MD, USA – sequence: 7 givenname: Diego surname: Garcia-Borreguero fullname: Garcia-Borreguero, Diego organization: Sleep Research Institute, Madrid, Spain – sequence: 8 givenname: Suresh surname: Kotagal fullname: Kotagal, Suresh organization: Department of Neurology and the Center for Sleep Medicine, Mayo Clinic, Rochester, MN, USA – sequence: 9 givenname: Mauro surname: Manconi fullname: Manconi, Mauro organization: Sleep and Epilepsy Center, Neurocenter of Southern Switzerland, Civic Hospital of Lugano, Lugano, Switzerland – sequence: 10 givenname: William surname: Ondo fullname: Ondo, William organization: Methodist Neurological Institute, Weill Cornell Medical School Houston, TX, USA – sequence: 11 givenname: Jan surname: Ulfberg fullname: Ulfberg, Jan organization: Sleep Disorders Department, Capio Health Center, Örebro, Sweden – sequence: 12 givenname: John W. surname: Winkelman fullname: Winkelman, John W. organization: Departments of Psychiatry and Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/29425576$$D View this record in MEDLINE/PubMed
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Snippet	Brain iron deficiency has been implicated in the pathophysiology of RLS, and current RLS treatment guidelines recommend iron treatment when peripheral iron...
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SubjectTerms	Consensus Guidelines Intravenous iron Oral iron Restless legs syndrome Treatment
Title	Evidence-based and consensus clinical practice guidelines for the iron treatment of restless legs syndrome/Willis-Ekbom disease in adults and children: an IRLSSG task force report
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