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Original Article · Originalarbeit

A Minimum Protocol for Randomised Homeopathic Drug Proving as Basis for Further Research

Jansen J.P.a, b · Jong M.a · Hildingsson I.a · Jong M.C.a, c

Author affiliations

a Department of Health Sciences, Mid-Sweden University, Sundsvall, Sweden b European Committee for Homeopathy, Subcommittee for Provings, Groningen, The Netherlands c Department of Health and Nutrition, Louis Bolk Institute, Driebergen, The Netherlands

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Forsch Komplementmed 2014;21:232-238

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Article / Publication Details

First-Page Preview
Abstract of Original Article <i>· </i> Originalarbeit

Published online: August 21, 2014
Issue release date: August 2014

ISSN: 2504-2092 (Print)
eISSN: 2504-2106 (Online)

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

Abstract

Background: In order to further improve the methodology and quality of data collection in homeopathic drug provings (HDP), there is a need for a minimum standardised HDP protocol. The objective of the present study was to test the feasibility of this type of protocol. Materials and Methods: The study protocol embraced a multi-centre, randomised, double-blind, placebo-controlled trial with 2 parallel groups. It was approved by an ethics review committee. During the pre-approval phase, discordances between the regulatory and homeopathic requirements for the protocol were checked and solutions found. The study medication was Potentilla anserina. 6 participants received verum and 4 placebo. The resulting symptom list will be published elsewhere. The procedure was accepted by all participants. Results: Three important issues were addressed: the requirement to keep all participants blinded; the adverse events reporting to regulatory authorities; and the necessity of a placebo control group. Other issues that need further investigations were identified, e.g. sample size, observation period and dosage regimen. Conclusions: A minimum protocol of a HDP is feasible. All important design elements of HDP could be solved in discussions with the respective regulatory authorities, and participating homeopaths accepted the procedure.

© 2014 S. Karger GmbH, Freiburg


Article / Publication Details

First-Page Preview
Abstract of Original Article <i>· </i> Originalarbeit

Published online: August 21, 2014
Issue release date: August 2014

ISSN: 2504-2092 (Print)
eISSN: 2504-2106 (Online)

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


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 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 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.
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