Clinical efficacy and safety of IV ferric carboxymaltose in restless legs syndrome: A meta-analysis of 537 patients

Abstract

Background: Recent research indicates that intravenous ferric carboxymaltose (IV FCM) presents a promising solution for Restless Legs Syndrome (RLS), distinguishing itself from other iron sources with minimal to no adverse effects. We conducted a systematic review and meta-analysis to evaluate the efficacy and safety profile of administering IV FCM in patients with RLS, assuming that RLS and Iron deficiency anemia (IDA) are correlated.

Methodology: This study was conducted according to the PRISMA guideline, with search conducted on PubMed, Google Scholar, and the Medline library. Data was extracted from each study regarding RLS and the effect of IV FCM on it, while analysis was conducted on Review Manager Software.

Results: This meta-analysis comprises of 7 randomized controlled trials (RCTs). All 7 studies reported international RLS severity scale (IRLS) and the pooled analysis revealed a significant reduction in IRLS score favoring IV FCM [WMD: -6.03, 95 % CI (-10.11, -1.96), p = 0.004]. 3 out of 7 studies reported short form-36 health survey (SF-36) and the pooled analysis revealed that the total score of SF-36 significantly favors the group taking IV FCM [WMD: 7.44, 95%CI (1.67, 13.20) p = 0.01]. 4 out of 7 studies reported visual analogue scale (VAS) for RLS severity and pooled analysis revealed that IV FCM significantly decreased VAS) of RLS severity score as compared to the control [MD -19.21, 95%CI (-31.90, -6.52) p0.003].

Conclusion: The study findings support the efficacy of IVFCM in reducing the severity of RLS symptoms. Significant improvements in the IRLS scores were observed, alongside enhancements in overall quality of life measured by SF-36 scores.

Keywords: Ferric carboxymaltose; Ferric compounds; Ferric maltose; Meta-analysis; Restless leg syndrome; Restless legs syndrome; Systematic review; Willis ekbom disease; Willis-ekbom disease.