A Minimum Protocol for a Randomised Homeopathic Drug Proving as basis for further research

J. P. Jansen, I. Hildingsson, Miek C. Jong. 2014. A Minimum Protocol for a Randomised Homeopathic Drug Proving as basis for further research. Research in Complementary Medicine. 4. 21
Pagina's / pages: 7
Taal/language: Engels
Abstract / summary in English:

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.

Keywords in English: homeopathic drug provings (HDP), Potentilla anserina