title: A minimum protocol for randomised homeopathic drug proving as basis for further research.
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.
  
  
  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.
authors.affiliation: Department of Health Sciences, Mid-Sweden University, Sundsvall, Sweden.
authors.forename: Jean Pierre
authors.initials: JP
authors.lastname: Jansen
authors.forename: Mats
authors.initials: M
authors.lastname: Jong
authors.forename: Ingegerd
authors.initials: I
authors.lastname: Hildingsson
authors.forename: Miek C
authors.initials: MC
authors.lastname: Jong
mesh_terms: D000328:Adult; D018849:Controlled Clinical Trials as Topic / Q000592:standards; D004311:Double-Blind Method; D005260:Female; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D008297:Male; D008419:Materia Medica / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D010936:Plant Extracts / Q000008:administration & dosage*; D031987:Potentilla / Q000737:chemistry*; D012107:Research Design / Q000592:standards*; D016896:Treatment Outcome
chemical_list: D008419:Materia Medica; D010936:Plant Extracts