Objective: To gather the evidence for the efficacy and safety of iron supplementation for restless legs syndrome (RLS).

Background: Iron supplementation is used for the treatment of restless leg syndrome (RLS). However, optimal dosage, route of administration and specific formulation are not known. We sought to gather the evidence for the efficacy and safety of iron supplementation for RLS.

Method: Systematic review and meta-analysis of randomized controlled trials that compared iron supplementation versus no iron for patients with RLS. We searched electronic databases, conference proceedings and web-based clinical trials registries. The primary outcome was the effect of iron on the International Restless Legs Syndrome score (IRLSS) 4 weeks after treatment. Secondary outcomes included quality of life and sleep scales and adverse events. Dichotomous data were analysed by calculating the risk ratio (RR) for each trial. Continuous variables were calculated by weighted mean difference (WMD). A fixed effect model was used, except in significant heterogeneity between trials, in which random effects model was used.

Results: Ten trials fulfilled the inclusion criteria. 233 patients were treated by iron versus 222 controls. The methodological quality of the included trials was fair to good. Iron therapy was associated with decreased IRLSS of -2.04 [95% CI (-4.11)-0.04] points. IV iron was associated with significant decrease of the IRLSS of -3.12 [95% CI (-4.85)–(-1.39)] points, derived from Ferric carboxymaltose (FCM) studies. IV iron was associated with an increase in the percentage of patients with improved IRLSS, RR of 2.16 [95% CI 1.56-2.98]. 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 with IV FCM is associated with improvement of the IRLSS score. This is not achieved with other IV iron formulations or oral iron. Further studies should assess subgroup of patients most likely to benefit from IV FCM and the optimal dosage.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/iron-supplementation-for-the-treatment-of-restless-legs-syndrome-a-systematic-review-and-meta-analysis/