Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial

Abstract

BackgroundHomeopathic drug proving is a basic concept in homeopathy. This study aimed to record symptoms produced by a homeopathic drug compared with placebo.MethodsThis 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.ResultsThirty-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.ConclusionsCombined 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.Trial registrationClinicalTrials.gov: NCT01061229

Indications of Okoubaka aubrevillei in oncological supportive care

“…▪ following an infectious disease (sequelae of influenza, tropical disease, toxoplasmosis, childhood diseases) ▪ prophylaxis of traveller gastroenteritis and food intolerance Although David Riley was the first to perform a pathogenesis in 2012 [7], Michael Teut had the merit of performing, soon after, a multicentre, randomised, double blind versus placebo Phase I study [9]. The 2 authors were able to identify and bring out the symptoms specific to okoubaka, some of which were already mentioned in the materia medica of William Boericke [3].…”

“…Discovered in 1970 [5], the okoubaka aubrevillei strain is relatively little known in homeopathic circles. Its use remains very limited despite the existence of two provings [7] [9]. Originally indicated in the treatment of food poisoning, its low dilution use in oncology is newer and brings new scope for this homeopathic strain.…”

Okoubaka Aubrevillei (Pelleg & Norman): A Synthesis of Existing Knowledge for Research and Conservation in West and Central Africa

“…Such concentrations include Okoubaka C200, C30, D12 and C12 granules among others. Teut et al (2013) screened the homeopathic efficacy of Okoubaka C12 on volunteer subjects.…”

Publication and outcome reporting of homeopathy trials registered in ClinicalTrials.gov

“…Brazil and France, two from Austria and one each from Canada, Denmark, Belgium and Sierra Leone. rate From these 35 trials, we found 16 publications[11][12][13][14][15][16][17][18][19][20][21][22][23][24][25][26] (46%) in MEDLINE and Google Scholar: six were indexed in the trial entry, three indexed and published in MEDLINE and the other seven indexed in…”