Journal Mobile Options
Table of Contents
Vol. 7, No. 2, 2000
Issue release date: April 2000
Forsch Komplementärmed Klass Naturheilkd 2000;7:79–84
(DOI:10.1159/000021314)
Original Article · Originalarbeit

Wirksamkeit und Verträglichkeit von Baldrian versus Oxazepam bei nichtorganischen und nichtpsychiatrischen Insomnien: Eine randomisierte, doppelblinde, klinische Vergleichsstudie

Dorn M.
Wissenschaftliche Beratung Pharma, Elz

Abstract

Summary

Objective: To show better improvement of sleep quality when treating non-organic insomniacs with extractum Valerianae radix siccum instead of oxazepam. Design: Randomised, double blind, comparative study. Setting: Out-patients of 8 general practitioners. Patients: Non-organic and non-psychiatric insomniacs aged between 18 and 70 years were included into the trial. Persons with known hypersensitivity to valerian or benzodiazepines, other psychotropic drugs and various contraindications/limitations for benzodiazepines were excluded. Intervention: 75 patients were randomly allocated either to the index group (2 × 300 mg extractum Valerianae radix siccum dragées LI 156) or control group (2 × 5 mg oxazepam dragées). The patients took study medication daily over a period of 28 days 30 min before going to bed. Outcomes: The factor sleep quality of the SF-B was defined as primary outcome. Secondary outcomes were other sleep characteristics of the SF-B, well-being (Bf-S) and anxiety (HAMA). Controls were performed before treatment as well as after 1, 2 and 4 weeks. Vital and laboratory parameters as well as unexpected events were assessed for safety and tolerability. Statistics: For all outcomes effect sizes between groups were calculated. For the main outcome criteria significance was tested by repeated-measures ANOVA considering all cases for which data of at least one follow-up existed (n = 70). Results: Baseline characteristics were well balanced. 70% (54/75) of the patients were females, over 53% (40/75) reported insomnia for more than 1 year. Mean age was 52 ± 12 years. In both groups sleep quality improved significantly (p <0.001), but no statistically significant difference could be found between groups (p = 0.70). Effect sizes between groups varied between 0.02 and 0.25. Five persons withdrew due to possibly adverse drug reactions (2 ( valerian, 3 ( oxazepam). No serious adverse events happened. Conclusions: The study showed no differences in the efficacy for valerian and oxazepam. Because of the more favourable adverse effect profile of valerian compared to oxazepam, this hypothesis should be analysed confirmatorily in an equivalence study.

Copyright © 2000 S. Karger GmbH, Freiburg


 goto top of outline Publication Details

Forschende Komplementärmedizin und Klassische Naturheilkunde
Offizielles Organ der Schweizerischen Medizinischen Gesellschaft für Phytotherapie, European Society for Classical Natural Medicine

Vol. 7, No. 2, Year 2000 (Cover Date: April 2000)

Journal Editor: M. Bühring, München, Germany, K. Linde, München, Germany, W. Marktl, Wien Austria, D. Melchart, München, Germany, K.L. Resch, Bad Elster, Germany, R. Saller, Zürich, Switzerland, M. Ullmann, München, Germany
ISSN: 1424–7364 (print), 1424–7372 (Online)

For additional information: http://www.karger.com/journals/fkm


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.