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A minimum protocol for randomised homeopathic drug proving as basis for further research.
Mid Sweden University, Faculty of Human Sciences, Department of Nursing Sciences. European Comm Homeopathy, Subcomm Provings, Groningen, Netherlands.
Mid Sweden University, Faculty of Human Sciences, Department of Nursing Sciences.ORCID iD: 0000-0002-3907-2197
Mid Sweden University, Faculty of Human Sciences, Department of Nursing Sciences.ORCID iD: 0000-0001-6985-6729
Mid Sweden University, Faculty of Human Sciences, Department of Nursing Sciences. Louis Bolk Inst, Dept Hlth & Nutr, Driebergen, Netherlands.
2014 (English)In: Forschende Komplementärmedizin, ISSN 1661-4119, E-ISSN 1661-4127, Vol. 21, no 4, 232-8 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2014. Vol. 21, no 4, 232-8 p.
Keyword [en]
Blinding, Data collection, Materia Medica, Minimum trial protocol, Placebo control, Serious adverse events, Report
National Category
Health Sciences
Identifiers
URN: urn:nbn:se:miun:diva-23497DOI: 10.1159/000366042ISI: 000345833700004PubMedID: 25231564Scopus ID: 2-s2.0-84927734205OAI: oai:DiVA.org:miun-23497DiVA: diva2:766428
Available from: 2014-11-27 Created: 2014-11-27 Last updated: 2015-08-13Bibliographically approved

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Jansen, Jean PierreJong, MatsHildingsson, IngegerdJong, Miek C
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