Number of pages: 7
Type of document: Journal Article
More information on authors/freelancers connected to LBI :
Miek C. Jong Ph.D.;
Miek C. Jong Ph.D.
Language of document: English
Title in English: A Minimum Protocol for a Randomised Homeopathic Drug Proving as basis for further research
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