Journal article

A minimum protocol for randomised homeopathic drug proving as basis for further research.

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Author list: HILDINGSSON I, JONG M, JONG M, Jansen J, JONG M, HILDINGSSON I, JONG M

Publication year: 2014

Start page: 232

End page: 8

Number of pages: -223

ISSN: 1661-4119

DOI: http://dx.doi.org/10.1159/000366042

View additional information: View in Web of Science


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.


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