Trial reportTrials2013
Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial.
Trial report in Trials, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01061229 (Homeopathic Drug Proving Trial), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Homeopathic Drug Proving Trial
Who cites it
0 citing papers in PubMed, 12 citations in OpenAlex.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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.
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