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OBJECTIVE: Pharmacopoeias regulate the manufacture of potentised pharmaceutical preparations used in different branches of complementary and integrative medicine. The physicochemical properties and biological activity of these preparations are often investigated in preclinical research, yet no guidelines for experimental research currently exist in this area. The present PrePoP guidelines aim to provide recommendations to promote high-quality, statistically sound, and reproducible preclinical research on potentised preparations. METHODS: Input was gathered from researchers nominated by the relevant scientific societies using a simplified Delphi consensus approach covering the most relevant aspects of basic research methodology in the field including appropriate controls, sample preparation and handling, and statistics. After three rounds of feedback, a consensus was finally reached on the most important aspects and considerations for conducting high-quality research on potentised preparations. RESULTS: We present a series of recommendations on a range of topics including experimental controls, system stability, blinding and randomisation, environmental influences, and procedures for the preparation of potentised samples and controls, and we address some specific challenges of this research field. CONCLUSION: This expert consensus process resulted in a robust set of methodological guidelines for research on potentised preparations and provides a valuable framework that will inform and improve the quality of subsequent research in this emerging field. PLEASE CITE THIS ARTICLE AS: Tournier AL, Bonamin LV, Buchheim-Schmidt S, Cartwright S, Dombrowsky C, Doesburg P, Holandino C, Kokornaczyk MO, van de Kraats EB, López-Carvallo JA, Nandy P, Mazón-Suástegui JM, Mirzajani F, Poitevin B, Scherr C, Thieves K, Würtenberger S, Baumgartner S. Scientific guidelines for preclinical research on potentised preparations manufactured according to current pharmacopoeias-the PrePoP guidelines. J Integr Med. 2024; Epub ahead of print.
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INTRODUCTION: The analysis of the periodic table of elements by Jan Scholten opened the way for a new kind of classification and repertorisation of homeopathic remedies. Thereby, group analysis (resorting to series and stages) makes precise prescriptions possible. This approach appears to yield striking results, even in severe cases. Whereas Hahnemann stressed the emotional state ('Gemüthssymptome', Organon § 210) when choosing a remedy, Scholten 200 years later investigated the mental picture that represents a life conflict or even a life theme that may maintain the disease process. The person's environment, emotional traumas or a conflict drives him or her to suppress and dissect painful emotions. Such compensations can become subconscious and so strong that they can no longer be controlled; they then influence the patient with a highly destructive energy. METHODS: We present five case reports, each dealing with an unusual clinical course of severe cancer associated with homeopathic treatment using the Scholten method. RESULTS: By presenting these cases, we consider how the constitution (lifelong signs and symptoms of the patient) and the mental state are interwoven and, as a complex mechanism, might provoke disease. CONCLUSION: The appropriate homeopathic remedy, reflecting the Scholten approach, seemed to have beneficial impact on the disease process of the five individuals presented.
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Homeopatía/métodos , Neoplasias/tratamiento farmacológico , Adulto , Anciano , Neoplasias Óseas/tratamiento farmacológico , Neoplasias Óseas/psicología , Bryonia/metabolismo , Compuestos de Calcio/uso terapéutico , Femenino , Homeopatía/normas , Humanos , Leucopenia/tratamiento farmacológico , Leucopenia/psicología , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/psicología , Linfoma no Hodgkin/tratamiento farmacológico , Linfoma no Hodgkin/psicología , Masculino , Mesotelioma/tratamiento farmacológico , Mesotelioma/psicología , Mesotelioma Maligno , Persona de Mediana Edad , Neoplasias/psicología , Óxidos/uso terapéutico , Fósforo/uso terapéutico , Thuja/metabolismoRESUMEN
INTRODUCTION: Beauvais presented the application of a so-called 'quantum-like model of homeopathy' by introducing the idea of a type of randomization/unblinding which he called 'in situ'. He predicted that randomized studies based on this type of randomization/unblinding lead to more pronounced effects in placebo controlled randomized homeopathic trials. We designed an experiment regarding wheat germination and stalk length to investigate Beauvais' idea of 'in situ randomization/unblinding' using a homeopathic dilution of sulphur (LM VI) as compared to placebo as well as to water. AIM AND METHOD: The primary aim of this double-blind randomized controlled experiment was to investigate whether there are differences of 'in situ randomization/unblinding' vs 'central randomization/unblinding' with respect to the effect of a homeopathic substance compared to placebo. The secondary aim of our study was to examine possible differences between the sulphur and the placebo group in the 'in situ' arm regarding germination and/or stalk growth of wheat seedlings measured after a seven days exposure. Wheat was treated either with sulphur LM VI, placebo, or water. The wheat grains were placed on glass lids and treatment was performed following the 'in situ randomization/unblinding' as well as 'central randomization/unblinding' method. Germination was measured and classified into three categories. RESULTS: Under 'in situ' randomization/unblinding the odds of a seed not to germinate is 40% lower if treated with sulphur compared to placebo (p=0.004). In contrast, these odds are practically equal in the 'central' meta-group (OR=1.01, p=0.954). Under 'in situ' randomization/unblinding the odds of a seed to germinate with a length ≥1mm is practically equal if treated with sulphur or with placebo (OR=0.96, p=0.717). In contrast, these odds are 21% higher under sulphur compared to placebo in the 'central' meta-group (OR=1.21, p=0.062). In summary, we found a sulphur effect that is significantly different between 'in situ' and 'central' randomization/unblinding relating to all three stages of germination.
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Germinación/efectos de los fármacos , Homeopatía , Modelos Teóricos , Plantones/efectos de los fármacos , Azufre/farmacología , Método Doble Ciego , Teoría Cuántica , Distribución Aleatoria , Triticum/efectos de los fármacosRESUMEN
BACKGROUND: Intoxication with Amanita phalloides is associated with high morbidity and mortality. Treatment therapies include general support, toxin elimination, pharmacotherapy with agents such as the hepatoprotective agent silibinin, and, in extreme states, liver transplantation. Despite these therapeutic interventions, mortality remains relatively high. CASE REPORTS: We present reports of 2 patients with severe hepatic failure following intoxication with Amanita phalloides. Both patients were admitted to the intensive care unit; 1 patient suffered from hepatic failure solely, and the second patient experienced severe 5-organ failure. In addition to conventional intensive care treatment, both patients were treated additively with classical homeopathy. The 2 patients survived without any residual pathological sequelae. CONCLUSION: Based on the 2 cases, including 1 extreme situation, we suggest that adjunctive homeopathic treatment has a role in the treatment of acute Amanita phalloides-induced toxicity following mushroom poisoning. Additional studies may clarify a more precise dosing regimen, standardization, and better acceptance of homeopathic medicine in the intensive care setting.
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The influence of a homeopathic high dilution of gibberellic acid on wheat growth was studied at different seasons of the year. Seedlings were allowed to develop under standardized conditions for 7 days; plants were harvested and stalk lengths were measured. The data obtained confirm previous findings, that ultrahigh diluted potentized gibberellic acid affects stalk growth. Furthermore, the outcome of the study suggests that experiments utilizing the bioassay presented should best be performed in autumn season. In winter and spring, respectively, no reliable effects were found.
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Giberelinas/farmacología , Estaciones del Año , Triticum/crecimiento & desarrolloRESUMEN
Control experiments were performed at different seasons of the year as a follow-up to pilot experiments [1] where a homeopathic high dilution of gibberellic acid had influenced growth in a wheat bio assay (7 days). Grains of winter wheat (Triticum aestivum, Capo variety) were observed under the influence of extremely diluted gibberellic acid (10-30) prepared by stepwise dilution and agitation according to a protocol derived from homeopathy (G30x). Analogously prepared water was used for control (W30x). Following up on 5 pilot experiments (4 in autumn 2007, 1 in spring 2008), 10 experiments were performed (5 in autumn 2008 or 2009 and 5 in winter 2009 or 2010) with a total of 9 experiments in autumn season (5 researchers, about 9,000 grains), and 6 in winter/spring (4 researchers, about 6,000 grains).(AU)
Experimentos controlados foram realizados em diferentes estações do ano, em continuação a um experimento-piloto [1] onde o ácido giberélico altamente diluído e agitado influenciaram o crescimento de trigo, em um ensaio biológico (7 dias). Grão de trigo de inverno (Triticum aestivum, variedade Capo) foram observados sob a influência do ácido giberélico altamente diluído (10-30) preparado por um processo serial de diluição e agitação, de acordo com um protocolo derivado da homeopatia (G30x). Analogamente, o mesmo protocol foi usado para preparar a amostra controle, apenas com água (W30x). Em continuidade a realização de 5 experimentos-piloto (4 no outono de 2007, 1 na primavera de 2008), 10 experimentos foram realizados (5 no outono de 2008 ou 2009 e 5 no inverno de 2009 ou 2010) com um total de 9 experimentos na estação do outono (5 pesquisadores, aproximadamente 9.000 grãos) e 6 no inverno/primavera (4 pesquisadores, aproximadamente 6.000 grãos).(AU)