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.

Verification of Nuclear Magnetic Resonance Characterization of Traditional Homeopathically Manufactured Metal (Cuprum metallicum) and Plant (Gelsemium sempervirens) Medicines and Controls.

BACKGROUND: Nuclear magnetic resonance (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. NMR relaxation times describe how quickly the spin of 1H, forced in a direction by an external electromagnetic field, returns to a normal resting position. As a result, such measurements allow us potentially to describe higher structuring of water in homeopathic medicines. OBJECTIVE: The purpose of the present study was to verify whether specific NMR relaxation times could be measured in full lines of cH dynamizations of a metal (copper) and of a plant substance (Gelsemium sempervirens), compared with a solvent control, a potentized lactose control and a control prepared by simple dilution, in three production lines. It is aimed at verification of a previous publication (2017) on two new manufacturing lines of the same starting material and controls. MATERIALS AND METHODS: To monitor dilution and potentization processes, measurements of 1H spin-lattice T1 and spin-spin T2 relaxation times were used. T1 and T2 relaxation times were measured at 25°C with a spin analyser working at a frequency of 20 MHz. To account for its possible role as a confounding factor, free oxygen was also measured in all samples, using a MicroOptode meter. RESULTS: When the values of the three production lines were pooled, a statistically significant discrimination of NMR relaxation times between the medicines and their controls was confirmed. We found for copper cH and Gelsemium sempervirens cH a highly significant influence of the starting material (p = 0.008), a highly significant influence of level of dilution (p < 0.001), and a significant influence of the O2 concentration (p = 0.04). CONCLUSIONS: We have evidence of an obvious retention of a specific magnetic resonance signal when a substance (lactose, copper, Gelsemium) is diluted/potentized in pure water. This means that homeopathic solutions cannot be considered to be pure water. O2 is a covariant and not an explanatory variable: this factor itself is too weak to explain the NMR signal specificities in potentized samples. Homeopathic dilutions may thus have a specific material configuration governed not only by the potentized substance but also by the chemical nature of the containers, the chemical nature of dissolved gases and even by the electromagnetic environment. This sensitivity of homeopathically prepared medicines to electromagnetic fields may be amplified by the processes routinely applied during their preparation; because it occurs only when a dynamization has been performed, we may call this phenomenon "dynamic pharmacy".

Nanoparticle Characterisation of Traditional Homeopathically Manufactured Cuprum metallicum and Gelsemium sempervirens Medicines and Controls.

BACKGROUND: Homeopathy is controversial due to its use of very highly diluted medicines (high potencies/dynamisations). METHODS: We used a multi-technology approach to examine dilutions of two commonly used homeopathic medicines: an insoluble metal, Cuprum metallicum, and a soluble plant tincture, Gelsemium sempervirens, for the presence of nanoparticles (NPs) of original substance. The homeopathic medicines tested were specially prepared, according to the European pharmacopoeia standards. We compared the homeopathic dilutions/dynamisations with simple dilutions and controls. RESULTS: Using Mass Spectrometry (Single Particle-Inductively Coupled Plasma-Mass Spectrometry) and Dynamic Light Scattering (DLS) we could not find the expected copper in the 4cH potentisation and could not confirm the results previously obtained by Chikramane et al (2010). For Gelsemium medicines, using sensitive chromatography (HPLC-UV) up to a dilution level of 6 dH (3cH = dilution 10e-6), there was no significant difference in alkaloid content between a simple dilution and a homeopathic potency.For higher potentisations, however, NP tracking analysis findings revealed the presence of particles in all samples (except for pure water). The measurements showed large differences in particle quantities, mean particle sizes and standard deviations of the mean sizes between manufacturing lines of different starting material.There was always more material in potentised medicines than in potentised pure water. Gelsemium yielded the largest quantity of material (36 times more than that from copper at the same potentisation, 30 cH). The shapes and the chemical composition of the material are differentiable between different medicines and controls. CONCLUSION: Potentisation influences specifically the nature of NPs detected. This material demonstrates that the step-by-step process (dynamised or not) does not match with the theoretical expectations in a dilution process. The Avogadro/Loschmidt limit is not relevant at all. It was not possible to reproduce the findings of Chikramane et al (2010) using inductively coupled plasma-mass spectrometry with copper. Copper NPs could not be detected at 4cH and above.

Model validity of randomised placebo-controlled trials of non-individualised homeopathic treatment.

BACKGROUND: The comprehensive systematic review of randomised placebo-controlled trials (RCTs) in homeopathy requires examination of a study's model validity of homeopathic treatment (MVHT) as well as its risk of bias (extent of reliable evidence). OBJECTIVE: To appraise MVHT in those RCTs of non-individualised homeopathy that an associated investigation had judged as 'not at high risk of bias'. DESIGN: Systematic review. METHODS: An assessment of MVHT was ascribed to each of 26 eligible RCTs. Another 49 RCTs were ineligible due to their high risk of bias. MAIN OUTCOME MEASURES: MVHT and the prior risk of bias rating per trial were merged to obtain a single overall quality designation ('high', 'moderate', 'low'), based on the GRADE principle of downgrading. RESULTS: The trials were rated as 'acceptable MVHT' (N = 9), 'uncertain MVHT' (N = 10) and 'inadequate MVHT' (N = 7); and, previously, as 'reliable evidence' (N = 3) and 'non-reliable evidence' (N = 23). The 26 trials were designated overall as: 'high quality' (N = 1); 'moderate quality' (N = 18); 'low quality' (N = 7). CONCLUSION: Of the 26 RCTs of non-individualised homeopathy that were judged 'not at high risk of bias', nine have been rated 'acceptable MVHT'. One of those nine studies was designated 'high quality' overall ('acceptable MVHT' and 'reliable evidence'), and is thus currently the only reported RCT that represents best therapeutic practice as well as unbiased evidence in non-individualised homeopathy. As well as minimising risk of bias, new RCTs in this area must aim to maximise MVHT and clarity of reporting.

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.

Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment.

BACKGROUND: To date, our programme of systematic reviews has assessed randomised controlled trials (RCTs) of individualised homeopathy separately for risk of bias (RoB) and for model validity of homeopathic treatment (MVHT). OBJECTIVES: The purpose of the present paper was to bring together our published RoB and MVHT findings and, using an approach based on GRADE methods, to merge the quality appraisals of these same RCTs, examining the impact on meta-analysis results. DESIGN: Systematic review with meta-analysis. METHODS: As previously, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were the subject of study. MAIN OUTCOME MEASURES: For each trial, the separate ratings for RoB and MVHT were merged to obtain a single overall quality designation ('high', 'moderate, "low", 'very low'), based on the GRADE principle of 'downgrading'. RESULTS: Merging the assessment of MVHT and RoB identified three trials of 'high quality', eight of 'moderate quality', 18 of 'low quality' and three of 'very low quality'. There was no association between a trial's MVHT and its RoB or its direction of treatment effect (P>0.05). The three 'high quality' trials were those already labelled 'reliable evidence' based on RoB, and so no change was found in meta-analysis based on best-quality evidence: a small, statistically significant, effect favouring homeopathy. CONCLUSION: Accommodating MVHT in overall quality designation of RCTs has not modified our pre-existing conclusion that the medicines prescribed in individualised homeopathy may have small, specific, treatment effects.

Model validity of randomised placebo-controlled trials of individualised homeopathic treatment.

BACKGROUND: Though potentially an important limitation in the literature of randomised controlled trials (RCTs) of homeopathy, the model validity of homeopathic treatment (MVHT) has not previously been systematically investigated. OBJECTIVE: As an integral part of a programme of systematic reviews, to assess MVHT of eligible RCTs of individualised homeopathic treatment. METHODS: From 46 previously identified papers in the category, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were thus the subject of the study. For each of six domains of assessment per trial, MVHT was judged independently by three randomly allocated assessors from our group, who reached a final verdict by consensus discussion as necessary. RESULTS: Nineteen trials were judged overall as 'acceptable' MVHT, nine as 'uncertain' MVHT, and four as 'inadequate' MVHT. CONCLUSIONS: These results do not support concern that deficient MVHT has frequently undermined the published findings of RCTs of individualised homeopathy. However, the 13 trials with 'uncertain' or 'inadequate' MVHT will be a focus of attention in supplementary meta-analysis. New RCTs of individualised homeopathy must aim to maximise MVHT and to enable its assessment through clear reporting.

Homeopathy and health related Quality of Life: a patient satisfaction survey in six European countries and Brazil.

BACKGROUND: Many patients throughout the world consult homeopathic medical doctors. Using a similar methodology as in a first survey published in 2002 a second survey was done including 919 adults receiving homeopathic treatment in six European countries and Brazil aimed to look at who are they, their reasons for consultations and expectations and satisfaction with homeopathy prescribed by a homeopathic doctor after a follow-up time of six months. METHOD: An initial questionnaire included demographic information and questions for assessing health-related Quality of Life (QoL). A follow-up questionnaire collected data on changes in QoL. RESULTS: 77% patients had initially used conventional treatments and 23% other non-conventional treatments. Satisfaction of patients with the medical homeopathic consultation is high. The difference between the final QoL scores after six months and the baseline are positive. Reported differences between baseline and final index range from 3.87 to 10.41 depending on diagnosis. Taking 7% as a reference value for 'minimal clinically significant difference', this is reached for 3 of 8 conditions. Changes in complaint limitations visual scales are positive. Conclusions on clinical impact must be cautious. 6% of the patients experienced side-effects which they attributed to homeopathic treatment. 7.8% of the patients reported significant aggravation at the beginning of the homeopathic treatment and 26.2% slight aggravation of symptoms. CONCLUSIONS: The satisfaction of patients using a medical homeopathic approach is linked to the perceived competence of the doctor homeopath, the perceived improvement of the main complaints limitations and the time dedicated to them by the doctor.

Pediatric homeopathy: a prospective observational survey based on parent proxy-reports of their children's health-related Quality of Life in six European countries and Brazil.

BACKGROUND: Many European citizens regularly consult homeopathic doctors. Especially for children there is very little data available about the reasons they visit a homeopathic doctor. What are the expectations of the parents consulting a Homeopath MD with their child, who are they and last but not least are they satisfied with their initiative? This study including 773 children from six European countries and Brazil is aimed to look at parent-proxy satisfaction with homeopathic treatment prescribed for their children by a homeopathic doctor after a follow-up of two months. The questionnaire was developed from the methodology used in a survey of adults published in 2002. METHOD: An initial questionnaire included demographic information and questions for assessing health-related Quality of Life (QoL). A follow-up questionnaire collected data on changes in QoL. RESULTS: The demographic characteristics of respondents showed more male children (53.1%) but more female parent-proxies (93.4%). 73.7% of respondents had previously tried conventional treatments; 26.3% non-conventional approaches. Satisfaction with the medical homeopathic consultation was high. Reported differences between baseline and final QoL ondexes are positive for all four studied conditions. It range from 3.206 to 10.188. Considering 7% as a reference value for "minimal clinical difference", this is reached for 2 on 4 conditions (8.473 and 10.188). Changes in complaint limitations visual scales are positive, even if uncertain for skin complaints and influenced parents satisfaction. Conclusions on clinical impact must be cautious. 4.2% of patients experienced side-effects which they attribute to homeopathic treatment. 10.1% of patients reported significant aggravation at the beginning of homeopathic treatment, 19% slight aggravation of symptoms. CONCLUSIONS: The satisfaction of parents using a medical homeopathic approach for their children is linked to the perceived competence of the doctor homeopath, the perceived improvement of the main complaint limitations and the completeness of the received information.

Clinical verification in homeopathy and allergic conditions.

BACKGROUND: The literature on clinical research in allergic conditions treated with homeopathy includes a meta-analysis of randomised controlled trials (RCT) for hay fever with positive conclusions and two positive RCTs in asthma. Cohort surveys using validated Quality of Life questionnaires have shown improvement in asthma in children, general allergic conditions and skin diseases. Economic surveys have shown positive results in eczema, allergy, seasonal allergic rhinitis, asthma, food allergy and chronic allergic rhinitis. AIMS: This paper reports clinical verification of homeopathic symptoms in all patients and especially in various allergic conditions in my own primary care practice. RESULTS: For preventive treatments in hay fever patients, Arsenicum album was the most effective homeopathic medicine followed by Nux vomica, Pulsatilla pratensis, Gelsemium, Sarsaparilla, Silicea and Natrum muriaticum. For asthma patients, Arsenicum iodatum appeared most effective, followed by Lachesis, Calcarea arsenicosa, Carbo vegetabilis and Silicea. For eczema and urticaria, Mezereum was most effective, followed by Lycopodium, Sepia, Arsenicum iodatum, Calcarea carbonica and Psorinum. CONCLUSIONS: The choice of homeopathic medicine depends on the presence of other associated symptoms and 'constitutional' features. Repertories should be updated by including results of such clinical verifications of homeopathic prescribing symptoms.

Plausibility and evidence: the case of homeopathy.

Homeopathy is controversial and hotly debated. The conclusions of systematic reviews of randomised controlled trials of homeopathy vary from 'comparable to conventional medicine' to 'no evidence of effects beyond placebo'. It is claimed that homeopathy conflicts with scientific laws and that homoeopaths reject the naturalistic outlook, but no evidence has been cited. We are homeopathic physicians and researchers who do not reject the scientific outlook; we believe that examination of the prior beliefs underlying this enduring stand-off can advance the debate. We show that interpretations of the same set of evidence--for homeopathy and for conventional medicine--can diverge. Prior disbelief in homeopathy is rooted in the perceived implausibility of any conceivable mechanism of action. Using the 'crossword analogy', we demonstrate that plausibility bias impedes assessment of the clinical evidence. Sweeping statements about the scientific impossibility of homeopathy are themselves unscientific: scientific statements must be precise and testable. There is growing evidence that homeopathic preparations can exert biological effects; due consideration of such research would reduce the influence of prior beliefs on the assessment of systematic review evidence.

Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study.

BACKGROUND: A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice. METHODS: Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic. RESULTS: The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one. CONCLUSION: Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity.

Towards an evidence based repertory: clinical evaluation of Veratum album

The analysis of data collected by applying information techonology in daily practice opens the possibility validating homeopathic prescribinh symptoms. The author has collected data on repertory rubrics, homopathic medicines prescribed, and clinical outcomes, for 16 yars. As an example of clinical verication the outcomes of patients prescribed Veraturum album are corelated against rubrics. Remarkeble results were obtained when ... (AU)

Le placebo / The placebo

Si le recours a la technique du placebo n'est pas interessant pour "demontrer" l'homeopathie, il est essentiel pour faire la part de l'effet "consultation" de l'effet reel de nos traitements homeopathiques. Il permet de reveler... (AU)

Les veritables maladies chroniques / The true chronic diseases

Au cours d'une tres recente etude realisee dans six pays europeens, dont la France, on a pu constater que le motif de 57 percent des premieres consultations chez le medecin homeopathe est une maladie qui persiste chez le... (AU)

A retrospective study of cardiac rhythm disorders

Retrospective studies can be considered as the first step towards an evaluation and improvement of homoeopathic practice. Throught these preliminary studies, criteria for future prospective studies can be chosen as well as suitable homoeopathic practitioners to conduct them. From this study, we can conclude that disorders of heart rhythm seem to be an... (AU)

Electric measurement of ultra-high dilutions: a blinded controlleds experiment

This experiment was designed to test the hypothesis put forward by P. Bourkas, A. Delinick and C. Karragiannopoulos of the National Technical University of Athens (NTUA) that Ultra High Succussed Dilutions (UHSD) can be distinguished from control solutions by an Electric Measurement Device (EMD), developed by the NTUA team. A pre-formulated experimental protocol was followed, measuring in random sequence test solutions of double-distilled and deionised water... (AU)