Iron supplementation for restless legs syndrome - A systematic review and meta-analysis

source extracted confidence: high 2026-04-09
#administration-intravenous #administration-oral #dietary-supplements #ferric-compounds #humans

Iron supplementation for restless legs syndrome - A systematic review and meta-analysis

Avni et al., 2019 | Eur J Intern Med | Meta Analysis

Citation

Avni Tomer, Reich Shelley, ... Gafter-Gvili Anat. Iron supplementation for restless legs syndrome - A systematic review and meta-analysis. Eur J Intern Med. 2019-May;63:34-41. doi:10.1016/j.ejim.2019.02.009

Abstract

BACKGROUND: Iron supplementation, is recommended for the treatment of restless legs syndrome (RLS). We gathered evidence for the efficacy and safety of iron supplementation for RLS. METHODS: A systematic review and meta-analysis of randomized controlled trials that compared iron supplementation versus no iron for patients with RLS was performed. Multiple databases were searched. The primary outcome was the effect of iron on the International Restless Legs Syndrome score (IRLSS) at 4 weeks after treatment. For dichotomous data, risk ratios (RR) with 95% confidence intervals (CIs) were estimated and pooled. For continuous data, weighted mean differences (WMD) were calculated. RESULTS: Ten trials fulfilled the inclusion criteria. Iron therapy was associated with a significant decrease of the IRLSS of -3.55 [95% CI (-5.41) - (-1.68)] points and an increase in the percentage of patients with improvement of the IRLSS score, RR of 2.16 [95% CI 1.56-2.98]. IV FCM was associated with improvement in both the IRLSS (WMD of -2.79 (95% CI (-4.62) - (-0.96), 4 trials, I2 = 0%) and on the RLS-QOL by WMD of 8.67 (95% CI 1.68-15). Iron was associated with an increased rate of adverse events RR 2.04 (95% CI 1.46-2.85), which were not severe and not associated with increased rate of treatment discontinuation. CONCLUSION: Iron supplementation is associated with improvement of the IRLSS score. Our meta-analysis supports the use of iron, oral or IV, as effective therapy for patients with RLS. Further studies should assess subgroups of patients most likely to benefit from iron supplementation.

Key Findings

Ten trials fulfilled the inclusion criteria. Iron therapy was associated with a significant decrease of the IRLSS of -3.55 [95% CI (-5.41) - (-1.68)] points and an increase in the percentage of patients with improvement of the IRLSS score, RR of 2.16 [95% CI 1.56-2.98]. IV FCM was associated with improvement in both the IRLSS (WMD of -2.79 (95% CI (-4.62) - (-0.96), 4 trials, I2 = 0%) and on the RLS-QOL by WMD of 8.67 (95% CI 1.68-15). Iron was associated with an increased rate of adverse events

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population rls was performed
Sample Size 4
Age Range See abstract
Condition See abstract

MeSH Terms

  • Administration, Intravenous
  • Administration, Oral
  • Dietary Supplements
  • Ferric Compounds
  • Humans
  • Randomized Controlled Trials as Topic
  • Restless Legs Syndrome
  • Treatment Outcome

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Journal Article, Meta-Analysis, Systematic Review
  • Vertical: iron

Provenance

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