Efficacy and tolerability of intravenous iron for patients with restless legs syndrome: evidence from randomized trials and observational studies

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#ferric-compounds #ferric-oxide-saccharated #humans #injections-intravenous #iron-dextran-complex

Efficacy and tolerability of intravenous iron for patients with restless legs syndrome: evidence from randomized trials and observational studies

Yang et al., 2019 | Sleep Med | Meta Analysis

Citation

Yang Xinglong, Yang Baiyuan, ... Liu Bin. Efficacy and tolerability of intravenous iron for patients with restless legs syndrome: evidence from randomized trials and observational studies. Sleep Med. 2019-Sep;61:110-117. doi:10.1016/j.sleep.2019.01.040

Abstract

OBJECTIVE: Restless legs syndrome (RLS) is a common neurological disorder of unclear pathophysiology that appears to involve an iron deficiency in the brain. Some studies, but not others, suggest that intravenous injection of iron can reduce RLS severity. METHOD: The databases Web of Science, PubMed, Embase, Chinese National Knowledge Infrastructure, Wanfang, and SinoMed were searched for randomized controlled trials, cohort studies and case-control studies of intravenous iron therapy to treat RLS. Eligible studies were meta-analyzed using Stata 12.0. RESULTS: This analysis indicated that IV iron was more efficacious than placebo in treating RLS (OR: 4.71,95%CI 4.21-5.21,p < 0.0001). According to sub-group analysis, either IV ferric carboxymaltose (FCM) or iron sucrose was more efficacious than placebo in treating RLS. Adverse events did not differ significantly between patients receiving intravenous iron or placebo (OR 1.68, 95%CI 0.92-3.07, p = 0.093). The present study also indicated after accepting IV iron treatment the IRLS score in RLS patients decreased (OR = 6.75,95%CI 4.02-9.49, p < 0.0001). The subgroup analysis showed that IV iron dextran, iron sucrose, and FCM could alleviate the IRLS score. CONCLUSION: The available evidence suggests that intravenous iron is effective and tolerable for patients with RLS regardless of peripheral iron status.

Key Findings

This analysis indicated that IV iron was more efficacious than placebo in treating RLS (OR: 4.71,95%CI 4.21-5.21,p < 0.0001). According to sub-group analysis, either IV ferric carboxymaltose (FCM) or iron sucrose was more efficacious than placebo in treating RLS. Adverse events did not differ significantly between patients receiving intravenous iron or placebo (OR 1.68, 95%CI 0.92-3.07, p = 0.093). The present study also indicated after accepting IV iron treatment the IRLS score in RLS patients

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population rls regardless of peripheral
Sample Size See abstract
Age Range See abstract
Condition deficiency

MeSH Terms

  • Ferric Compounds
  • Ferric Oxide, Saccharated
  • Humans
  • Injections, Intravenous
  • Iron-Dextran Complex
  • Maltose
  • Observational Studies as Topic
  • Randomized Controlled Trials as Topic
  • Restless Legs Syndrome

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't
  • Vertical: iron

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09