Background: Previous open-label trials have shown iron to be efficacious in the treatment of restless legs syndrome. We performed a randomized, double-blind, placebo-controlled trial of iron sulfate. Methods: Twenty-eight patients were randomized to receive either ferrous sulfate 325 mg b.i.d. or placebo for 12 weeks. The primary outcome measure was the dichotomous variable of improvement or no improvement in average quality of sleep as recorded by a visual analog scale nightly over a 2-week period, comparing a pretreatment 2-week baseline to weeks 13–14. Secondary outcome measures included a comparison of the quality of sleep as measured by a visual analog scale, effect of restless legs syndrome on life as a whole as measured by a different visual analog scale, and the percentage of nights patients were symptomatic. Results: No significant differences were noted between iron and placebo groups for both primary and secondary outcome measures. Responders taking iron did have a significant increase in their iron saturation compared to nonresponders taking iron. Conclusions: Iron sulfate does not appear to be an effective empiric treatment for restless legs syndrome.

Keywords:
Restless legs syndrome, Iron, Clinical trials
1.
Ondo W, Jankovic J: Restless legs syndrome: Clinicoetiologic correlates. Neurology 1996;47:1435–1441.
2.
Kruger BR: Restless legs syndrome and periodic movements of sleep. Mayo Clin Proc 1990;65:999–1006.
3.
O’Keeffe ST, Noel J, Lavan JN: Restless legs syndrome in the elderly. Postgrad Med J 1993;69:701–703.
4.
Montplaisir J, Lorrain D, Godbout R: Restless legs syndrome and periodic leg movements in sleep: The primary role of dopaminergic mechanism. Eur Neurol 1991;31:41–43.
5.
Walters AS, Wagner ML, Hening WA, Grasing K, Mills R, Chokroverty S, Kavey N: Successful treatment of the idiopathic restless legs syndrome in a randomized double-blind trial of oxycodone versus placebo. Sleep 1993;16:327–332.
6.
Brodeur C, Montplaisir J, Godbout R, Marinier R: Treatment of restless legs syndrome and periodic movements during sleep with L-dopa: A double-blind, controlled study. Neurology 1988;38:1845–1848.
7.
Kaplan PW, Allen RP, Buchholz DW, Walters JK: A double-blind, placebo-controlled study of the treatment of periodic limb movements in sleep using carbidopa/levodopa and propoxyphene. Sleep 16:717–723.
8.
Telstad W, Sørensen Ø, Larsen S, Lillevold PE, Stensrud P, Nyberg-Hansen R: Treatment of the restless legs syndrome with carbamazepine: A double blind study. BMJ 1984;288:444–446.
9.
Motagna P, de Bianchi LS, Zucconi M, Cirignotta F, Lugaresi E: Clonazepam and vibration in restless legs syndrome. Acta Neurol Scand 1984;69:428–430.
10.
Walters AS, Hening WA, Kavey N, Chokroverty S, Gidro-Frank S: A double-blind randomized crossover trial of bromocriptine and placebo in restless legs syndrome. Ann Neurol 1988;24:455–458.
11.
Wetter TC, Stiasny K, Winkelmann J, Buhlinger A, Brandenburg U, Peter JH, Medori R, Rubin M, Homburg B, Oertel WH, Trenkwalder C: A polysomnographic controlled study of pergolide in the treatment of restless legs syndrome. Neurology 1998;50(suppl 4):A69.
12.
Wagner ML, Walters AS, Coleman RG, Hening WA, Grasing K, Chokreverty S: A randomized, double-blind, placebo-controlled study of clonidine in restless legs syndrome. Sleep 1996;19:52–58.
13.
Norlander NB: Therapy in restless legs. Acta Med Scand 1953;145:453–457.
14.
Ekbom KA: Restless legs syndrome. Neurology 1960;10:868–873.
15.
O’Keeffe ST, Gavin K, Lavan JN: Iron status and restless legs syndrome in the elderly. Age Aging 1994;23:200–203.
16.
Aul EA, Davis BJ, Rodnitzky RL: The importance of formal serum iron studies in the assessment of restless legs syndrome. Neurology 1998;51:912.
17.
Sun ER, Chen CA, Ho G, Earley CJ, Allen RA: Iron and the restless legs syndrome. Sleep 1998;21:371–377.
18.
Walters AS, Aldrich MS, Allen R, Ancoli-Israel A, Buchholz D, Chokroverty S, Coccagna G, Earley C, Ehrenberg B, Feest TG, Hening W, Kavey N, Lavigne G, Lipinski J, Lugaresi E, Montagna P, Montplaisir J, Mosko SS, Oertel W, Picchietti D, Pollmacher T, Shafor R, Smith RC, Telstad W, Trenkwalder C, von Scheele C, Ware JC, Zucconi M: Toward a better definition of the restless legs syndrome. Mov Disord 1995;10:634–642.
© 2000 S. Karger AG, Basel
2000
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.