Original Article · Originalarbeit
A Minimum Protocol for Randomised Homeopathic Drug Proving as Basis for Further ResearchJansen J.P.a, b · Jong M.a · Hildingsson I.a · Jong M.C.a, c
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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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
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