Efficacy and safety of intravenous ferric carboxymaltose in the treatment of Restless Legs Syndrome: a systematic review and meta-analysis

IntroductionRestless Legs Syndrome (RLS), also known as Willis-Ekbom Disease (WED), is a sensorimotor disorder characterized by an uncontrollable urge to move the legs, typically accompanied by discomfort. Low iron levels, pregnancy, and age are some identified risk factors. RLS is treated using var...

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Main Authors: Ayesha Khan, Harsh Kumar, Kuldeep Dalpat Rai, Anzel Saeed, Jawad Ishtiaq, Muhammad Tanveer Alam, Sakshi Chawla, Md Ariful Haque
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Neurology
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Online Access:https://www.frontiersin.org/articles/10.3389/fneur.2024.1503342/full
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author Ayesha Khan
Harsh Kumar
Kuldeep Dalpat Rai
Anzel Saeed
Jawad Ishtiaq
Muhammad Tanveer Alam
Sakshi Chawla
Md Ariful Haque
Md Ariful Haque
author_facet Ayesha Khan
Harsh Kumar
Kuldeep Dalpat Rai
Anzel Saeed
Jawad Ishtiaq
Muhammad Tanveer Alam
Sakshi Chawla
Md Ariful Haque
Md Ariful Haque
author_sort Ayesha Khan
collection DOAJ
description IntroductionRestless Legs Syndrome (RLS), also known as Willis-Ekbom Disease (WED), is a sensorimotor disorder characterized by an uncontrollable urge to move the legs, typically accompanied by discomfort. Low iron levels, pregnancy, and age are some identified risk factors. RLS is treated using various pharmacological options, including dopamine agonists, benzodiazepines, anticonvulsants, opioids, and bupropion. Iron supplementation, particularly with intravenous Ferric carboxymaltose (FCM), has gained attention due to the role of iron deficiency in RLS pathophysiology. This meta-analysis evaluates the efficacy and safety of FCM in treating RLS symptoms.Materials and methodsA systematic review and meta-analysis were conducted following the PRISMA guidelines, using databases such as PubMed, Google Scholar, and Cochrane. Studies involving intravenous FCM in patients diagnosed with RLS were included. Statistical analysis was performed using Review Manager 5.4.ResultsSeven studies involving 539 participants were analyzed. FCM significantly reduced IRLS scores (WMD = −5.77; 95% CI = [−8.85, −2.70]; p = 0.0002) and improved VAS and SF-36 scores compared to placebo. However, FCM did not significantly improve RLS quality of life scores. Adverse events were more common in the FCM group, particularly nausea, but no significant differences were found for severe adverse events.ConclusionIn conclusion, intravenous ferric carboxymaltose significantly reduces Restless Legs Syndrome symptoms, especially in patients with confirmed iron deficiency. The treatment appears generally well-tolerated, with adverse effects being manageable. However, further long-term studies are needed to fully assess the safety profile and confirm sustained symptom improvement in a broader population.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier: CRD42024585233.
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spelling doaj-art-c40d99dea41a450a9c2fd821a6d328302025-01-07T05:23:45ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-01-011510.3389/fneur.2024.15033421503342Efficacy and safety of intravenous ferric carboxymaltose in the treatment of Restless Legs Syndrome: a systematic review and meta-analysisAyesha Khan0Harsh Kumar1Kuldeep Dalpat Rai2Anzel Saeed3Jawad Ishtiaq4Muhammad Tanveer Alam5Sakshi Chawla6Md Ariful Haque7Md Ariful Haque8Department of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Medicine, Dow University of Health Sciences, Karachi, PakistanDepartment of Public Health, Atish Dipankar University of Science and Technology, Dhaka, BangladeshVoice of Doctors Research School, Dhaka, BangladeshIntroductionRestless Legs Syndrome (RLS), also known as Willis-Ekbom Disease (WED), is a sensorimotor disorder characterized by an uncontrollable urge to move the legs, typically accompanied by discomfort. Low iron levels, pregnancy, and age are some identified risk factors. RLS is treated using various pharmacological options, including dopamine agonists, benzodiazepines, anticonvulsants, opioids, and bupropion. Iron supplementation, particularly with intravenous Ferric carboxymaltose (FCM), has gained attention due to the role of iron deficiency in RLS pathophysiology. This meta-analysis evaluates the efficacy and safety of FCM in treating RLS symptoms.Materials and methodsA systematic review and meta-analysis were conducted following the PRISMA guidelines, using databases such as PubMed, Google Scholar, and Cochrane. Studies involving intravenous FCM in patients diagnosed with RLS were included. Statistical analysis was performed using Review Manager 5.4.ResultsSeven studies involving 539 participants were analyzed. FCM significantly reduced IRLS scores (WMD = −5.77; 95% CI = [−8.85, −2.70]; p = 0.0002) and improved VAS and SF-36 scores compared to placebo. However, FCM did not significantly improve RLS quality of life scores. Adverse events were more common in the FCM group, particularly nausea, but no significant differences were found for severe adverse events.ConclusionIn conclusion, intravenous ferric carboxymaltose significantly reduces Restless Legs Syndrome symptoms, especially in patients with confirmed iron deficiency. The treatment appears generally well-tolerated, with adverse effects being manageable. However, further long-term studies are needed to fully assess the safety profile and confirm sustained symptom improvement in a broader population.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier: CRD42024585233.https://www.frontiersin.org/articles/10.3389/fneur.2024.1503342/fullRestless Legs SyndromeWillis-Ekbom Diseaseferric carboxymaltoseiron therapyneuromuscular disorder
spellingShingle Ayesha Khan
Harsh Kumar
Kuldeep Dalpat Rai
Anzel Saeed
Jawad Ishtiaq
Muhammad Tanveer Alam
Sakshi Chawla
Md Ariful Haque
Md Ariful Haque
Efficacy and safety of intravenous ferric carboxymaltose in the treatment of Restless Legs Syndrome: a systematic review and meta-analysis
Frontiers in Neurology
Restless Legs Syndrome
Willis-Ekbom Disease
ferric carboxymaltose
iron therapy
neuromuscular disorder
title Efficacy and safety of intravenous ferric carboxymaltose in the treatment of Restless Legs Syndrome: a systematic review and meta-analysis
title_full Efficacy and safety of intravenous ferric carboxymaltose in the treatment of Restless Legs Syndrome: a systematic review and meta-analysis
title_fullStr Efficacy and safety of intravenous ferric carboxymaltose in the treatment of Restless Legs Syndrome: a systematic review and meta-analysis
title_full_unstemmed Efficacy and safety of intravenous ferric carboxymaltose in the treatment of Restless Legs Syndrome: a systematic review and meta-analysis
title_short Efficacy and safety of intravenous ferric carboxymaltose in the treatment of Restless Legs Syndrome: a systematic review and meta-analysis
title_sort efficacy and safety of intravenous ferric carboxymaltose in the treatment of restless legs syndrome a systematic review and meta analysis
topic Restless Legs Syndrome
Willis-Ekbom Disease
ferric carboxymaltose
iron therapy
neuromuscular disorder
url https://www.frontiersin.org/articles/10.3389/fneur.2024.1503342/full
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