Empirical investigation of preparations produced according to the European Pharmacopoeia monograph 1038

• Published in: European journal of pharmaceutical sciences Vol. 137; p. 104987
• Main Authors: Doesburg, P., Andersen, J.-O., Scherr, C., Baumgartner, S.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.09.2019
• Subjects: Bio-assay; Biological Assay; Crystallization; CuCl2 crystallization; Europe; European Pharmacopoeia; Germination - drug effects; Lactose - chemistry; Lactose - toxicity; Lepidium; Meta-analysis; Metabolomics; Pharmaceutical Preparations; Pharmacopoeias, Homeopathic as Topic; Praeparationes homoeopathicae; Reproducibility of Results; Seeds - drug effects; Seeds - growth & development; Seeds - metabolism; Systematic negative control experiments; Tin - chemistry; Tin - toxicity; Water - chemistry; Europe; Praeparationes homoeopathicae; Systematic negative control experiments; CuCl2 crystallization; European Pharmacopoeia; Bio-assay; Meta-analysis; CuCl crystallization
• ISSN: 0928-0987; 1879-0720
• DOI: 10.1016/j.ejps.2019.104987

According to the European Pharmacopoeia monograph 1038 (Praeparationes homoeopathicae), homeopathic preparations are produced by successive dilution and succussion steps. Dilution levels beyond Avogadro's limit, however, render specific effects implausible according to standard scientific knowledge. Accordingly, we were interested in a critical empirical investigation of preparations produced according to this monograph. Within a precursor study we developed a bioassay based on a fingerprint metabolomic analysis of Lepidium sativum seeds germinated in vitro in either homeopathic preparations or controls in a blinded and randomized assignment. Results of the precursor study were not consistent with the hypothesis that the effects of a Stannum metallicum 30x preparation are identical to placebo. In the present study we investigated the reproducibility of these effects after scrutinizing and optimizing experimental procedures. Ten independent experiments were performed in a blinded and randomized assignment in two independent laboratories. Additionally, 10 systematic negative water control experiments were performed in both laboratories to critically assess the stability of the experimental set-up. The effects of the Stannum metallicum 30x treatment were reproduced. The systematic negative control experiments did not yield false-positive results, indicating a stable experimental set-up. We thus repeatedly observed biological effects conflicting with the assumption that Stannum metallicum 30x is identical to placebo. We therefore wish to discuss whether these findings are to be considered a scientific anomaly or whether they might stimulate further investigations to clarify whether application of the European Pharmacopoeia monograph 1038 may result in pharmaceutical preparations with specific effects. Graphical abstract [Display omitted]