The ion partition detected in homeopathically manufactured medicine cuprum metallicum and controls

Homeopathy is highly controversial. The main reason for this is its use of very highly dilute medicines (high homeopathic potencies, HHP), diluted beyond the Avogadro/Loschmidt limit. Research using Nano Tracking Analysis has demonstrated the presence of particles in HHPs. This study aims to verify the results of a previous publication that identified the ionic composition of these particles in all dilutions. We used Scanning Electron Microscopy & Energy Dispersive X-Ray Spectroscopy (SEM-EDX) to examine dilutions of a commonly used homeopathic medicine, an insoluble metal, Cuprum metallicum, for the presence of particles (NPs). The homeopathic medicines tested were specially prepared according to the European pharmacopoeia standards. We compared the homeopathic dilutions/dynamizations of copper with simple dilutions and dynamized lactose controls. We observed an ionic diversity common to all preparations including HHPs but also significant differences in the relative quantity of each ion between manufacturing lines of homeopathic copper and lactose controls. The probability that the observed differences could have occurred chance alone (especially above Avogadro limit) can be rejected at p < 0.001. The essential component of these homeopathic medicines is sodium hydrogen carbonate, modulated by some other elements and by its quantity, size and shape. Homeopathic medicines made of Cuprum metallicum do contain material with a specific ionic composition even in HHPs diluted beyond the Avogadro/Loschmidt limit. This specificity can be attributed to the manufacturing process. This material demonstrates that the step-by-step process (dynamized or not) does not match the theoretical expectations of a dilution process. The starting material and dilution/dynamization method influences the nature of these NPs. Further measurements are needed on other raw materials using the same controls (solvent and simply diluted manufacturing lines) to support these findings. The role of sodium bicarbonate must be carefully studied in the future.

The Materiality of Homeopathic Medicines. DynHom Research Program

Homeopathy is controversial because using highly dilute medicines (high homeopathic potencies, HHP) beyond the Avogadro/Loschmidt limit. Previous publications [1,2] using NMR relaxation revealed the involvement of nanobubbles and/or nanoparticles and/or nanometric superstructures in high potentizations. Nano Tracking Analyse (NTA) demonstrated the presence of particles in HHPs [3,4]. WithSEM-EDX [5] we observed an ionic diversity common to all preparations including HHPs and significant differences in the relative quantity of each ion between different homeopathic manufacturing lines and controls. FTIR spectroscopy [6] shows that the molecular composition is that of carbonates, primarily sodium bicarbonate.Methods:To observe the materiality of homeopathic medicines a multidisciplinary approach is necessary. In collaboration with several universities,we canobserve these medications with NMR, NTA, SEM-EDX, FTIR, pH,and EPA. Results:The essential component of all already studied homeopathic medicines is sodium hydrogen carbonate modulated by some other elements in a specific quantity, size,and shape. The probability that the observed results could have occurred just by random chance can be rejected(significantlyabove the Avogadro limit) p < 0,001.Conclusions:The homeopathic medicines do contain material with a specific ionic composition even in HHPs diluted beyond the Avogadro/Loschmidt limit. This specificity can be attributed to the manufacturing process. These results demonstrate that the step-by-step process (dynamized or not) does not match the theoretical expectations in a dilution process. The starting material and dilution/dynamization method influencethe nature of these NPs. The role of carbonates and sodium bicarbonate must be carefully studied in the future. Its aqueous solution is alkaline in nature but itis an amphoteric compound, which means that the compound has both acidic as well as alkaline character. The reaction with acids results in sodium salts and carbonic acid and the reaction with the basic solution producescarbonates and water. Specific electric fields are indeed detectable.

Safety and Evaluation of the Immune Response of Coronavirus Nosode (BiosimCovex) in Healthy Volunteers: A Preliminary Study Extending the Homeopathic Pathogenetic Trial.

Objectives: Regulatory clinical Phase I studies are aimed at establishing the human safety of an active pharmaceutical agent to be later marketed as a drug. Since homeopathic medicines are prepared by a potentizing method using alcohol, past a certain dilution, their toxicity/infectivity is assumed to be unlikely. We aimed to develop a bridge study between homeopathic pathogenetic trials and clinical trials. The primary purpose was to evaluate the safety of a nosode, developed from clinical samples of a COVID-19 patient. The secondary objectives were to explore whether a nosode developed for a specific clinical purpose, such as use during an epidemic, may elicit laboratory signals worthy of further exploration. Methods: An open-label study was designed to evaluate the safety and immune response of the Coronavirus nosode BiosimCovex, given orally on three consecutive days to ten healthy volunteers. Clinical examinations, laboratory safety and immune parameters were established. Interferon-gamma, Interleukin-6, and CD 4 were measured. (CTRI registration number: CTRI/2020/05/025496). Results: No serious/fatal adverse events were reported. Laboratory tests to measure safety were unchanged. Three subjects showed elevated Interleukin-6 (IL-6) on day 17 in comparison to the baseline, and ten subjects showed elevated IL-6 on day 34. A significant difference between IL-6 observations, calculated by repeated measures ANOVA, was found to be highly significant. On day 60, the IL-6 values of nine subjects were found to return to normal. Corresponding CD4 cell elevation was observed on day 60, when compared to day 34. Conclusions: HPT may potentially extend into physiological changes with regards to immune response and should encourage future studies.

Particle characterisation of traditional homeopathically manufactured medicine cuprum metallicum and controls

Homeopathy is highly controversial. The main reason for this is its use of very highly dilute medicines (high homeopathic potencies, HHP), diluted beyond the Avogadro/Loschmidt limit. Research using several different methods has demonstrated the presence of particles, including nanoparticles of source material, in HHPs. This study aims to verify the results of a previous publication that detected the presence of particles in all dilutions. We used the Nano Tracking Analyzer (NTA) to examine dilutions of a commonly used homeopathic medicine, an insoluble metal, Cuprum metallicum, for the presence of particles. The homeopathic medicines tested were specially prepared according to the European pharmacopoeia standards. We compared the homeopathic dilutions/dynamizations with simple dilutions and controls including a soluble medicine. We observed the presence of solid material in all preparations including HHPs (except for pure water). The measurements showed significant differences in particle sizes distribution between homeopathic manufacturing lines and controls. Homeopathic medicines do contain material with a specific size distribution even in HHPs diluted beyond the Avogadro/Loschmidt limit. This specificity can be attributed to the manufacturing and potentization process. This material demonstrates that the step-by-step process (dynamized or not) does not match the theoretical expectations in a dilution process. The starting material and dilution/dynamization method influences the nature and concentration of these NPs.

Nuclear Magnetic Resonance characterization of traditional homeopathically manufactured copper (Cuprum metallicum) and plant (Gelsemium sempervirens) medicines and controls.

BACKGROUND: NMR proton relaxation is sensitive to the dynamics of the water molecule H2O, through the interaction of the spin of the proton (1H) with external magnetic and electromagnetic fields. METHODS: We measured dilution and potentization processes through measurements of 1H spin-lattice T1 and spin-spin T2 relaxation times. In order to interpret the recorded fluctuations in T1- or T2-values, experimental data were linearized by investigating how the area under a fluctuating time = f(dilution) curve (dilution integral or DI) changes with dilution. Two kinds of fitting procedures were considered: chi-square fitting with a goodness-of-fit probability, and least absolute deviations criterion with Pearson's linear correlation coefficient. RESULTS: We showed that fluctuations are not attributable to random noise and/or experimental errors, evidencing a memory effect quantifiable by the slope of the DI = f(dilution) straight line. For all experiments, correlation coefficients were found to lie above 0.9999, against 0.999 for random noise. The discrimination between experimental slopes and slopes associated with random noise data was very good at a five-sigma level of confidence (i.e. probability 3 × 10-7). Discrimination between experimental slopes at a five-sigma level was possible in most cases, with three exceptions: gelsemium aqua pura v gelsemium dilution (four-sigma); copper aqua pura v gelsemium aqua pura (four-sigma) and copper simple dilution v gelsemium simple dilution (three-sigma). All potentized samples show very good discrimination (at least nine-sigma level) against aqua pura, lactose or simple dilution. It was possible to transform the associated relaxation times into a molecular rotational correlation time τc and an average spin-spin distance d. Our experiments thus point to a considerable slowing down of molecular movements (τc > 1300 ps or T = 224-225 K) around water molecules up to a distance of 3.7 Å, values. It was also possible to rule out other possible mechanisms of relaxation (diffusive motion, 17O-1H relaxation or coupling with the electronic spin, S = 1, of dissolved dioxygen molecules). CONCLUSION: There is clear evidence that homeopathic solutions cannot be considered as pure water as commonly assumed. Instead, we have evidenced a clear memory effect upon dilution/potentization of a substance (water, lactose, copper, gelsemium) reflected by different rotational correlation times and average H⋯H distances. A possible explanation for such a memory effect may lie in the formation of mesoscopic water structures around nanoparticles and/or nanobubbles mediated by zero-point fluctuations of the vacuum electromagnetic field as suggested by quantum field theories. The existence of an Avogadro's 'wall' for homeopathically-prepared medicines is not supported by our data. Rather it appears that all dilutions have a specific material configuration determined by the potentized substance, also by the chemical nature of the containers, and dissolved gases and the electromagnetic environment. This sensitivity of homeopathically-prepared medicines to electromagnetic fields may be amplified by the highly non-linear processing routinely applied in the preparation of homeopathic medicines. Future work is needed in such directions. The time is now ripe for a demystification of the preparation of homeopathic remedies.

Preparation, standardization and in vitro safety testing of Mycobacterium nosodes (Emtact- polyvalent nosode).

BACKGROUND: Most of the nosodes in the homeopathic pharmacopeia have been sourced from obscure pathological material over a century ago; of which no scientific documentation is available. METHOD: A method for preparation and standardization of univalent and polyvalent Mycobacterium nosodes (labeled as Emtact), using different strains of Mycobacterium tuberculosis was developed. The committee comprising microbiologists, scientist, pharmacist, homeopaths and clinicians had reviewed and approved the method of preparation of nosode. Preparation of the nosode was based on the reference in the Homeopathy Pharmacopoeia of India (HPI), group N-IV. Strains of M. tuberculosis viz. Standard strain H37Rv, multi-drug resistant (MDR) M. tuberculosis, Mycobacterium bovis (BCG vaccine) and Mycobacterium avium were identified, procured and documented. Twenty billion viable cells for each strain were taken for Original Stock Nosode (OSN). The original stock was prepared by suspending the microbial cells into water for injection (WFI) (1 ml). As per the Indian Pharmacopoeia (IP) monograph, sterility testing was done for different potencies. Polymerase Chain Reaction (PCR) was performed for 30c potency for detection of any DNA material of the source organisms. RESULT: A polyvalent (multi-strain) and univalent M. tuberculosis nosodes were prepared for research and clinical use. No growth of Mycobacterium was observed in any of the samples above 5c potency. The in-vitro testing for nosode (30c) was found to be free from any organism and DNA material. CONCLUSION: Mycobacterium nosodes sourced from individual strain and polyvalent Emtact nosode in vitro testing results found to be satisfactory for its handling and utilization. The nosode seems to be safe and may be tested further in vivo to explore its therapeutic application.

Hepatitis C Nosode: The preparation and homeopathic pathogenetic trial.

BACKGROUND: A double blind, randomized placebo controlled homeopathic pathogenetic trial (proving) of Hepatitis C (Hep C) nosode was conducted with the aim to introduce the new nosode in homeopathic pharmacopeia. METHOD: Documentation included approval by Ethics Committee, Informed Consent Form, Laboratory investigations, safety and ethical measures. The volunteers were trained to write data in prescribed diaries and data were analyzed. A fifteen-step method was used in the preparation of Hep C nosode (genotype I and III), allowing future preparation of an identical nosode. 22 volunteers were entered, 15 received Hep C nosode in 30c potency, 7 received placebo, once a week for four weeks. RESULTS: The Hep C nosode was associated with qualitatively and quantitatively distinct symptoms, which can be applied in clinical practice. A significantly higher incidence of pathogenetic effect of homeopathic medicine compared to placebo was observed. Safety was documented. The nosode produced symptoms comparable with Hep C disease. CONCLUSION: An improved method of nosode preparation was used. A double blind, randomized placebo controlled pathogenetic trial of the Hep C nosode generated guiding symptoms, which may facilitate its prescription in practice. The nosode should be further explored for the treatment of immunologically mediated diseases, infections including Hep C, fibrotic pathology and chronic inflammatory disorders.