Journal Mobile Options
Table of Contents
Vol. 11, No. 3, 2004
Issue release date: June 2004
Add to my selection Citation Download
Forsch Komplementärmed Klass Naturheilkd 2004;11:150–157
(DOI:10.1159/000079444)
Original Article · Originalarbeit

Problematik randomisierter Studien in der Komplementärmedizin dargestellt am Beispiel der Misteltherapie bei Patientinnen mit Mammakarzinom

Gerhard I.a · Abel U.b · Loewe-Mesch A.a · Huppmann S.a · Kuehn J.J.c
aAmbulanz für Naturheilkunde, Universitäts-Frauenklinik, Heidelberg; bTumorzentrum Heidelberg/Mannheim, Abt. Medizinische Biometrie, Universität Heidelberg, Germany; cLukasklinik, Arlesheim, Switzerland Forsch Komplementärmed Klass Naturheilkd 2004;11:150–157 (DOI:10.1159/000079444)

Abstract

Problems of Randomized Studies in Complementary Medicine Demonstrated in a Study on Mistletoe Treatment of Patients with Breast Cancer Background: Prospective randomized studies on mistletoe therapy repeatedly demonstrated that there is a basic problem in the matter of enrolling the appropriate number of patients within a reasonable amount of time. Most studies have to face this problem. However, recent experience suggests that this problem is more pronounced in the case of mistletoe treatment of cancer patients. Objective: Possibility of recruitment and randomization of breast cancer patients for a mistletoe study. Patients: During a period of 28 months every patient was registered who was admitted to the Gynecological Hospital of the University of Heidelberg because of suspected cancer. Results: Out of 1,922 patients who were operated on for breast tumor, 521 first met the inclusion and exclusion criteria. 154 out of these 521 patients agreed to take part in the study. After availability of the final results on tumor staging and the therapy plan for conventional treatment, 80 out of the 154 women had to be excluded from the study. From the remaining 74 patients (48%), however, only 29 (39%) would have agreed to take part in a randomized mistletoe study. Conclusions: This confirms our suspicion that the difficulties of enrolment and randomization in the case of mistletoe studies exceed those of studies conducted in conventional oncology. The reasons for this dramatic effect and the possibility of alternative study designs are discussed.

 goto top of outline Publication Details

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

Vol. 11, No. 3, Year 2004 (Cover Date: June 2004)

Journal Editor: H. Walach, Freiburg i.Br., Germany
ISSN: 1424–7364 (print), 1424–7372 (Online)

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