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.
Bradley J. Davis, MD
Montana Epilepsy Program
1101 26th St. South
Great Falls, MT 59405 (USA)
Tel. +1 406 727-3720, Fax +1 406 727-0007, E-Mail email@example.com
Received: Received: April 29, 1999
Accepted: August 30, 1999
Number of Print Pages : 6
Number of Figures : 1, Number of Tables : 4, Number of References : 18
Founded 1897 as ‘Monatsschrift für Psychiatrie und Neurologie’
Vol. 43, No. 2, Year 2000 (Cover Date: Released February 2000)
Journal Editor: J. Bogousslavsky, Lausanne
ISSN: 0014–3022 (print), 1421–9913 (Online)
For additional information: http://www.karger.com/journals/ene
Article / Publication Details
Published online: 2/23/2000
Issue release date: February 2000
Number of Print Pages: 6
Number of Figures: 1
Number of Tables: 4
ISSN: 0014-3022 (Print)
eISSN: 1421-9913 (Online)
For additional information: http://www.karger.com/ENE
Copyright / Drug Dosage
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 or, in the case of photocopying, direct payment of a specified fee to the Copyright Clearance Center.
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 goverment 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.