title: Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial.
abstract: BACKGROUND
  Homeopathic drug proving is a basic concept in homeopathy. This study aimed to record symptoms produced by a homeopathic drug compared with placebo.
  
  
  METHODS
  This multicentre, randomised, double-blind, placebo-controlled phase 1 trial consisted of a 7-day run-in period, a 5-day intervention period and a 16-day post-intervention observation period. Subjects, investigators and statisticians were blinded for intervention groups and identity of the homeopathic drug. Subjects in the intervention group received Okoubaka aubrevillei (potency C12) and subjects in the placebo group received the optically identical sucrose globules. Dosage in both groups was five globules taken five times per day over a maximum period of 5 days. Subjects documented the symptoms they experienced in a semistructured online diary. The primary outcome parameter was the number of characteristic proving symptoms compared with placebo after a period of 3 weeks. Characteristic symptoms were categorised using content analysis. Secondary outcome parameters were the qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms was quantitatively analysed on an intention-to-treat basis using analyses of covariance with the subject's expectation and baseline values as covariates.
  
  
  RESULTS
  Thirty-one subjects were included (19 Okoubaka and 12 placebo). Data for 29 participants could be analysed. No significant differences in number of characteristic symptoms in both groups were observed between Okoubaka (mean±standard deviation 5.4±6.0) and placebo (4.9±5.6). The odds ratio for observation of a characteristic symptom was 1.11 (95% confidence interval 0.4 to 3.05, P=0.843). Females and subjects expecting a higher number of symptoms at baseline or feeling more sensitive to homeopathic drugs experienced more characteristic symptoms regardless of allocation. The qualitative analysis showed an inter-coder reliability of 0.69 (95% confidence interval 0.62 to 0.76). The qualitative comparison of symptom profiles was inconclusive.
  
  
  CONCLUSIONS
  Combined results of qualitative and quantitative methods did not result in a significant difference of characteristic proving symptoms between O. aubrevillei C12 and placebo. The qualitative comparison of the symptom profiles leaves some open questions. The nocebo effect might be a plausible explanation for most of the phenomena observed in this trial.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01061229.
authors.forename: Michael
authors.initials: M
authors.lastname: Teut
authors.forename: Joern
authors.initials: J
authors.lastname: Dahler
authors.forename: Ute
authors.initials: U
authors.lastname: Hirschberg
authors.forename: Rainer
authors.initials: R
authors.lastname: Luedtke
authors.forename: Henning
authors.initials: H
authors.lastname: Albrecht
authors.forename: Claudia M
authors.initials: CM
authors.lastname: Witt
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008419:Materia Medica / Q000008:administration & dosage*; D008875:Middle Aged; D064786:Nocebo Effect; D016017:Odds Ratio; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D008419:Materia Medica
references.citation: Forsch Komplementmed. 2009 Apr;16(2):105-10
references.pmid: 19420956
references.citation: Cephalalgia. 2011 Apr;31(5):550-61
references.pmid: 21216874
references.citation: Dtsch Arztebl Int. 2012 Jun;109(26):459-65
references.pmid: 22833756
references.citation: Philos Trans R Soc Lond B Biol Sci. 2011 Jun 27;366(1572):1879-88
references.pmid: 21576145
references.citation: Drug Saf. 2009;32(11):1041-56
references.pmid: 19810776
references.citation: J Psychosom Res. 2001 Mar;50(3):155-60
references.pmid: 11316508
references.citation: Pain. 2009 Dec;146(3):261-269
references.pmid: 19781854
references.citation: Clin J Pain. 2012 Jun;28(5):437-51
references.pmid: 22336767
references.citation: Homeopathy. 2004 Oct;93(4):179-85
references.pmid: 15532695
references.citation: Eval Health Prof. 2006 Dec;29(4):394-406
references.pmid: 17102062
references.citation: J Psychosom Res. 2009 Apr;66(4):323-8
references.pmid: 19302890
references.citation: Planta Med. 1985 Oct;51(5):404-7
references.pmid: 17342595
references.citation: Forsch Komplementmed. 2008 Aug;15(4):211-7
references.pmid: 18787330
references.citation: Homeopathy. 2007 Jan;96(1):4-16
references.pmid: 17227742
references.citation: J Psychopharmacol. 2008 Jul;22(5):543-52
references.pmid: 18701641
references.citation: Trials. 2010 Jul 22;11:80
references.pmid: 20649979
references.citation: Forsch Komplementarmed Klass Naturheilkd. 2004 Oct;11(5):274-80
references.pmid: 15572868