Volume 24, Issue 10 p. 1445-1452
Research Article

A randomized, double-blind, placebo controlled, multi-center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome

Ludger Grote MD, PhD

Corresponding Author

Ludger Grote MD, PhD

Sleep Disorders Center, Department of Pulmonary Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden

Sleep Disorders Center, Department of Pulmonary Medicine, Sahlgrenska University Hospital, SE- 413 45 Gothenburg, SwedenSearch for more papers by this author
Lena Leissner MD

Lena Leissner MD

Sleep Unit, Department of Neurology, Örebro University Hospital, Örebro, Sweden

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Jan Hedner MD, PhD

Jan Hedner MD, PhD

Sleep Disorders Center, Department of Pulmonary Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden

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Jan Ulfberg MD, PhD

Jan Ulfberg MD, PhD

Sleep Disorder Center, Avesta Hospital, Avesta, Sweden

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First published: 01 June 2009
Citations: 98

Potential conflict of interest: Nothing to report.

Abstract

Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome (RLS). We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit. Sixty patients with primary RLS (seven males, age 46 (9) years, S-ferritin ≤45 μg/L) recruited from a cohort of 231 patients were randomly assigned in a 12-months double-blind, multi-centre study of iron sucrose 1000 mg (n = 29) or saline (n = 31). The primary efficacy variable was the RLS severity scale (IRLS) score at week 11. Median IRLS score decreased from 24 to 7 (week 11) after iron sucrose and from 26 to 17 after placebo (P = 0.123, N.S. for between treatment comparison). The corresponding scores at week 7 were 12 and 20 in the two groups (P = 0.017). Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose (Kaplan–Meier estimate, log rank test P = 0.0006) suggesting an iron induced superior long term RLS symptom control. Iron sucrose was well tolerated. This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase (7 weeks) and during long-term follow up in patients with variable degree of iron deficiency. Further studies on target patient groups, dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS. © 2009 Movement Disorder Society