Homeopathy Assessment-Contribution of the Human Sciences.

The recent questions about homeopathy raised by some sceptics have focused an awareness on this therapy and led different protagonists among the scientific community to seek a much-needed re-assessment. The inputs coming from external but benevolent experts will broaden the knowledge and the consciousness of the whole medical community, and more widely of the public, about the meaning and the value of homeopathy.Looking at this from the point of view of the human sciences gives a perspective on the universality of the philosophy that underlies homeopathic thinking, which is particularly visible in the methodological similarities between homeopathic provings and sociological or anthropological observations. It also explains how this view of health and care coincides with the expectations of the public, who no longer want a limited mechanical approach to the human body or more generally to the environment.The input to homeopathy of the human sciences, with their methodological tools and approaches, and highlighting the possibilities offered by mixed-methods research, could enable these notions to be heard and shared in the wider scientific community.

In Vitro Assessment of Cytoprotective Effects of CANOVA against Cell Death Induced by the Anti-malarial Artesunate - A Preliminary Experiment.

BACKGROUND: Artesunate (ATS) is a semi-synthetic compound derived from artemisinin, which is widely accepted in the treatment of malaria. However, there is evidence that ATS, under certain in vitro conditions, induces several impairments to normal cell functions. Canova (CA) is a Brazilian homeopathic formulation indicated for patients with depressed immune system. CA shows both in vitro and in vivo protective effects against mutagenic/carcinogenic compounds. Therefore, we aimed to assess in vitro the cytoprotective effects of CA against the cytotoxicity of ATS in Vero cells. METHODS: Viability of Vero cells exposed to ATS was assessed by MTT assay, whereas the anti-cytotoxic effect of CA was evaluated by apoptosis and necrosis quantification with fluorescent dyes. RESULTS: After 24 hours of ATS treatment, a reduction in cell viability was observed at 32 and 64 µg/mL, the latter being statistically significant (p < 0.05) in relation to the negative control. The concentration of 64 µg/mL was chosen for the subsequent experiments. ATS significantly induced both apoptosis and necrosis in Vero cells in relation to controls (p < 0.01). We also observed a statistically significant decrease in the number of apoptotic cells observed in the CA 16% + ATS co-treatment compared with ATS treatment (p < 0.01). Treatment with CA alone also had no influence on either type of cell death. CONCLUSION: Our results demonstrated that ATS is cytotoxic in the assessed conditions. However, such cytotoxicity was attenuated when the cells were treated simultaneously with ATS and CA.

Material Risks of Homeopathic Medicinal Products: Regulatory Frameworks, Results of Preclinical Toxicology, and Clinical Meta-Analyses and Their Implications.

Homeopathy is widely used and broadly accepted by health care professionals and the general public but less in academic circles. To assess possible material health risks of homeopathic medicinal products, it is necessary to identify, select, and synthesize the findings of recent reviews of controlled homeopathic clinical trials. Matching these findings with experimental data from toxicological studies helps to clarify what is known and not known about the material risks of homeopathic medicines. Rules for toxicological risk assessment and management need to be applied independently of individual attitudes towards specific therapeutic options. European regulatory bodies have developed special protocols and decision trees to assure the safety of nonindividualized homeopathic remedies. This narrative review leads to suggestions that could ease and improve toxicological decision making. No homeopathy-specific type or pattern of side effects could be extracted from the meta-analysis data. No differences in the frequency of adverse reactions between homeopathic treatment and placebo treatment could be seen, no matter whether adverse events were reported in a quantitative or a qualitative manner. Some patterns of side effects show that adverse reactions do not necessarily correlate with treatment but with the condition of the patient. Overall, the controlled clinical data available for the material risk assessment of homeopathic remedies support the statement that, if a risk exists, it must be so small that it has not yet been established. To make our risk findings useful for personal decisions regarding homeopathy, we provide a thought experiment based on four different health situations and ask the question: is homeopathy as a monotherapy or as an add-on treatment an option or should it be rejected?

Safety assessment of homeopathic medicines: The Adonis vernalis paradox and the 'analysis trap' of using different pharmacopeias.

Regulatory agencies have to ensure the end-user safety of botanically derived homeopathic medicines prepared with diluted starting materials derived even from toxic plants. In the case of plant-derived homeopathic products, assessment must consider the particular characteristics of an extract and its component molecules, even if diluted. The identification and quantification of these molecules have a crucial role in risk assessment, as it allows complete toxicological evaluation in a regulatory perspective. Different results can be achieved using different approaches and references supported by the same regulatory framework, as different methods of preparation used, assays and test analysis performed in compliance with different referent pharmacopoeias. All these facts can introduce a bias in the safety assessment and the paradoxical outcome for homeopathic Adonis vernalis underlines the need for caution. The case also demonstrates the relevance of considering the analytical method for assessment of all herbal medicinal products or herbal supplements, with the purpose of finding the total amount of toxicants as a good approach.

Preparation and Standardization of Escherichia coli Nosodes Sourced from Select E. coli Strains.

BACKGROUND: The nosodes are well-known preparations in homeopathy that are sourced from organisms and diseased materials. More than 40 known nosodes have been used in homeopathic practice for over a century. Having identified the need for scientifically developed new nosodes sourced from organisms that are currently prevalent, the preparation of Escherichia coli nosodes from different strains of the bacterium is presented in this article. MATERIALS AND METHODS: Escherichia coli strains (E. coli ATCC 11775E, ATCC 25922, and ATCC 8739) were identified, cultured, and tested for purity, and 20 billion cells were processed following the nosode preparation method given in the Homoeopathic Pharmacopoeia of India, group N1. Serial dilution and potentization for liquid potency were done up to 30c potency. Nosodes were prepared by two methods: from cell-free extract (endotoxin) and from entire-cell extract. RESULT: Six nosodes were developed in total. Three univalent nosodes were prepared using individual endotoxins, one from each of the three E. coli strains; those three univalent nosodes were also combined as "Trivalent nosode-I". "Trivalent nosode-II" was prepared by mixing entire cells of the three E. coli strains. A mix of both Trivalent nosode-I and Trivalent nosode-II was labeled "EC-Polynosode". The safety profile of the potentized nosodes was documented by the non-detectability of traces of source material (absence of contamination, live organisms, or DNA material) through a culture test, sterility test, and molecular testing (polymerase chain reaction). CONCLUSION: Different variants of E. coli nosodes were systematically and scientifically prepared and standardized using the cultures. Homeopathic pathogenetic trials, in-vitro efficacy studies, and clinical evaluation of E. coli nosodes (single, trivalent, or polyvalent nosodes) will be required in future.

Recommendations for Designing, Conducting and Reporting Observational Studies in Homeopathy.

BACKGROUND: Randomized placebo-controlled trials are considered to be the gold standard in clinical research and have the highest importance in the hierarchical system of evidence-based medicine. However, from the viewpoint of decision makers, due to lower external validity, practical results of efficacy research are often not in line with the huge investments made over decades. METHOD: We conducted a narrative review. With a special focus on homeopathy, we give an overview on cohort, comparative cohort, case-control and cross-sectional study designs and explain guidelines and tools that help to improve the quality of observational studies, such as the STROBE Statement, RECORD, GRACE and ENCePP Guide. RESULTS: Within the conventional medical research field, two types of arguments have been employed in favor of observational studies. First, observational studies allow for a more generalizable and robust estimation of effects in clinical practice, and if cohorts are large enough, there is no over-estimation of effect sizes, as is often feared. We argue that observational research is needed to balance the current over-emphasis on internal validity at the expense of external validity. Thus, observational research can be considered an important research tool to describe "real-world" care settings and can assist with the design and inform the results of randomised controlled trails. CONCLUSIONS: We present recommendations for designing, conducting and reporting observational studies in homeopathy and provide recommendations to complement the STROBE Statement for homeopathic observational studies.

Five Years of Practical Experience Using the Revised Proving Guidelines of the Homœopathic Pharmacopœia Convention of the United States.

The Homœopathic Pharmacopœia of the United States (HPUS) is one of the three officially recognized compendia of medical drugs in the United States. A well-conducted homeopathic proving is one pathway to entry into the HPUS. In 2013, guidelines for homeopathic drug provings were updated to better assess the methodology of provings and improve the confidence in the outcomes generated. In addition, the team who developed the revised guidelines included a pragmatic approach to assess the quality of proving outcomes in terms of their usefulness in determining the therapeutic profile. The monograph review team, composed of homeopathic clinicians and researchers, has evaluated 25 new homeopathic medicines for monograph purposes. The team has noted that the guidelines have helped frame and standardize the monograph review process. The revised structure for monograph reporting has enhanced the reviewer's ability to ascertain the therapeutic profile for a new substance. Sponsors have stated that the new guidelines have helped increase their conformance with Good Clinical Practices, helped improve the reporting and transparency of their provings, and may help safeguard provings as a valid research method. Similar harmonized guidelines have been adopted by the European Committee for Homeopathy and the Liga Medicorum Homœopathica Internationalis.

Current Status of Expiry of Homeopathic Medicines in Brazil, Germany, India and the United States: A Critical Review.

BACKGROUND: Assignment of expiry date to homeopathic medicines is a subject of important concern to its pharmacists and practitioners. This study compares the regulatory framework for the expiry of homeopathic medicines in four countries: Brazil, Germany, India and the United States. FINDINGS: Different or no expiry periods are variously followed. Whereas Germany, with some exceptions, employs a maximum expiry of 5 years for both potencies and finished products, Brazil adopts a 5-year expiry for finished products only, potencies used in manufacture being exempted from an assigned expiry date. In India, all homeopathic medicines except dilutions and back potencies have a maximum of 5 years' shelf-life, including those supplied to consumers. In the United States, homeopathic medicines are exempted from expiry dates. COMMENTS: There is neither a rational basis nor scientific evidence for assigning a short (3-5 years) expiry period for homeopathic medicines as followed in some of the countries, particularly in light of the fact that some studies have shown homeopathic medications to be effective even after 25 years. Homeopathic ultra-dilutions seem to contain non-material activity that is maintained over time and, since these exhibit different chemical properties compared to the original starting material, it is quite possible they possess properties of longer activity than conventional medicines. Regulators should acknowledge this feature and differentiate expiry of homeopathic medicinal products from that of conventional drugs.

Effects of Ultra-Low-Dose Aspirin in Thrombosis and Haemorrhage.

BACKGROUND: Aspirin is the oldest and possibly the most widely used pharmacologically active substance still used in allopathic medicine. Its effect on fever and inflammation has paved the way to its anti-thrombotic effect. Dilutions of aspirin have been tested for many years in the University of Bordeaux, in humans as well as in animal models. METHODS: This article is a review of the totality of articles published by the Laboratory of Hematology of the Faculty of Pharmacy of the University of Bordeaux, reporting different doses and dilutions of aspirin, different kinds of inhibitors, transgenic mice and animal models of disease such as portal hypertension and cirrhosis. RESULTS: Homeopathic dilutions of aspirin, notably 15 cH, have shown a pro-thrombotic effect in humans and in in-vivo animal studies. Longitudinal studies in rats have also shown an initial anti-thrombotic effect followed by a pro-thrombotic effect of aspirin several days after a single high-dose administration. This pro-thrombotic effect seems to act by inhibiting the cyclooxygenase (COX)-2 pathway in studies performed with COX selective inhibitors and in knock-out mice without COX-1 or COX-2. This effect may explain the thrombo-embolic complications described after aspirin withdrawal for the purposes of surgery or after non-compliance with anti-platelet therapy, and it may be beneficial in normalising primary haemostasis and decreasing haemorrhage in animal models of portal hypertension and cirrhosis. CONCLUSIONS: Aspirin 15 cH acts through the inhibition of the COX-2 pathway producing a clear pro-thrombotic effect. Further studies should clarify if the pro-thrombotic effect of aspirin withdrawal and the effect of aspirin 15 cH are related, as secondary effects of the same drug. Clarifying this last outcome may be of great significance to public health.

Effects of Homeopathic Phosphorus on Encephalitozoon cuniculi-Infected Macrophages In-Vitro.

INTRODUCTION: Encephalitozoon cuniculi (E. cuniculi), a fungus that acts as an intracellular pathogen, causes a marked neurological syndrome in many host species and is a zoonotic concern. Although no well-established treatment for this syndrome is known, previous successful clinical experience using homeopathic phosphorus has been described in which symptom remission with no mortality occurred in 40/42 animals by means of unknown immunological mechanisms. The latter observation was the main motivation for this study. OBJECTIVE: To verify, in an in-vitro model, if macrophages infected with E. cuniculi can change in function after treatment with different potencies of phosphorus. MATERIALS AND METHODS: RAW 264.7 macrophages were infected with E. cuniculi in-vitro and treated with various homeopathic potencies of phosphorus. The vehicle was used as a control solution (0.06% succussed ethanol). After 1 and 24 hours, the following parameters were analyzed: parasite internalization (by the Calcofluor staining method), lysosome activity (by the acridine orange method), cytokine/chemokine production (by the MAGPIX system), and cell ultrastructure. Automatic image analysis was used when applicable, and the experiments were performed in triplicate. RESULTS: Treatment with vehicle alone increased interleukin (IL)-6, tumor necrosis factor alpha and monocyte chemotactic protein -1 production (p ≤ 0.05) and reduced the number of internalized parasites (p ≤ 0.001). A progressive and time-dependent increase in RANTES (regulated on activation, normal T-cell expressed and secreted) and lysosome activity (p ≤ 0.002) was observed only after treatment with the highest potency of phosphorus (Phos 200cH), together with decreased apoptosis rate, intense parasite digestion, and the presence of non-internalized spores. CONCLUSIONS: Phos 200 cH has a modulatory action on the activity of infected macrophages, especially a specific increase in RANTES, a key element in the prognosis of E. cuniculi-infected and of immunosuppressed patients bearing infections.

Effect of Adjuvant Homeopathy with Usual Care in Management of Thrombocytopenia Due to Dengue: A Comparative Cohort Study.

BACKGROUND: Dengue is an emerging threat to public health. At present, no clear modalities are available for the prevention and management of thrombocytopenia due to dengue. This article reports the clinical outcomes of integrative homeopathic care in a hospital setting during a severe outbreak of dengue in New Delhi, India, during the period September to December 2015. METHODS: Based on preference, 138 patients received a homeopathic medicine along with usual care (H+UC), and 145 patients received usual care (UC) alone. Assessment of thrombocytopenia (platelet count < 100,000/mm3) was the main outcome measure. Kaplan-Meier analysis enabled comparison of the time taken to reach a platelet count of 100,000/mm3. RESULTS: There was a statistically significantly greater rise in platelet count on day 1 of follow-up in the H+UC group compared with UC alone (mean difference = 12,337; 95% confidence interval [CI], 5,421 to 19,252; p = 0.001). This trend persisted until day 5 (mean difference = 14,809; 95% CI, 1,615 to 28,004; p = 0.02). The time taken to reach a platelet count of 100,000/mm3 was nearly 2 days earlier in the H+UC group compared with UC alone (H+UC: 3.44 days ± standard error of the mean [SEM] 0.18; 95% CI, 3.08 to 3.80; UC: 5.28 days ± SEM 0.29; 95% CI, 4.71 to 5.86; p < 0.001). CONCLUSION: These results suggest a positive role of adjuvant homeopathy in thrombocytopenia due to dengue. Randomized controlled trials may be conducted to obtain more insight into the comparative effectiveness of this integrative approach.

An Assessment of a Public Health Initiative of Homeopathy for Primary Teething.

BACKGROUND: During primary teething, children suffer from running nose, mild fever, diarrhoea and other mild irritations and inflammations. A public health programme, 'Homoeopathy for the Healthy Child', was undertaken on a pilot basis focusing on promotion of healthy teething by provision of home-based care through six pre-identified homeopathic medicines for complaints commonly observed during primary teething. This article assesses the feasibility of this programme and reports the impact of this initiative on teething profile in children and episodes of diarrhoea and upper respiratory tract infection (URTI). MATERIALS AND METHODS: Accredited Social Health Activists (ASHAs) were trained in child care and usage of a kit comprising six medicines, namely Calcarea phosphoricum 6X (CP), Ferrum phosphoricum 3X, Magnesium phosphoricum 6X, Belladonna 30C, Chamomilla 30C and Podophyllum 30C. Calcarea phosphoricum was given regularly to each participating child from 6 months to 1 year of age. Home-based care for diarrhoea, URTI and mild fever was provided by ASHAs using the other five medicines in the kit. Dentition pattern and diarrhoea/URTI episodes were recorded over a period of the next 12 months. RESULTS: Eleven thousand four-hundred and twenty-six children were followed up regularly. Amongst those who enrolled at 6-7 months, a larger proportion of children were approaching expected teething in successive months as compared with children enrolled at 12 months, thus indicating that teething delays, if any, were overcome during this period. Incidence of diarrhoea and URTI showed decrease in the months after enrolment. Children responded favourably to the medicines given by ASHAs at the time of diarrhoea/URTI episodes, and ASHAs expressed satisfaction with the programme. CONCLUSION: An approach with regular use of CP and home-based care with homeopathy through health workers for common problems in teething children is acceptable to the community and enhances outreach of services to the public at large. Observations in terms of the healthy teething period may be further validated through studies of homeopathy with suitable comparator group.

Reasons for Use of and Experiences with Homeopathic Treatment as an Adjunct to Usual Cancer Care: Results of a Small Qualitative Study.

BACKGROUND: A significant proportion of patients with cancer consult with homeopaths. No former qualitative study has reported on experiences with homeopathy in this patient group. This study aimed to learn about the reasons for, and experiences with, treatment provided by homeopaths among Danish patients with cancer. METHODS: A small qualitative semi-structured interview study was carried out to collect preliminary knowledge to learn about reasons for and experiences with treatment provided by homeopaths as an adjunct to usual care among patients with cancer. Thematic analysis was used for the development of themes. RESULTS: Five patients, diagnosed with cancer, were interviewed. On the basis of qualitative interviews five themes emerged: concerns and hopes, obstacles and support, internal health locus of control, whole person approach, and improved well-being. CONCLUSION: The cancer patients in this study sought homeopathy to address their hopes and concerns and to help them face obstacles and find support. They were actively taking responsibility for their own health and valued the whole person approach used by their homeopaths. Participants reported improved well-being both at the physical and mental levels. The results provide a basis for further research to learn more from patients' experiences with this intervention. Such knowledge could potentially be helpful to improve healthcare practitioners' communication with patients, and thereby patients' overall care.

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.

Systematic Review and Meta-Analysis of Randomised, Other-than-Placebo Controlled, Trials of Individualised Homeopathic Treatment.

BACKGROUND: This study focuses on randomised controlled trials (RCTs) of individualised homeopathic treatment (IHT) in which the control (comparator) group was other than placebo (OTP). AIMS: To determine the comparative effectiveness of IHT on health-related outcomes in adults and children for any clinical condition that has been the subject of at least one OTP-controlled trial. For each study, to assess the risk of bias and to determine whether its study attitude was predominantly 'pragmatic' or 'explanatory'. METHODS: Systematic review. For each eligible trial, published in the peer-reviewed literature up to the end of 2015, we assessed its risk of bias (internal validity) using the seven-domain Cochrane tool, and its relative pragmatic or explanatory attitude (external validity) using the 10-domain PRECIS tool. We grouped RCTs by whether they examined IHT as an alternative treatment (study design Ia), adjunctively with another intervention (design Ib), or compared with a no-intervention group (design II). For each RCT, we identified a 'main outcome measure' to use in meta-analysis: 'relative effect size' was reported as odds ratio (OR; values >1 favouring homeopathy) or standardised mean difference (SMD; values < 0 favouring homeopathy). RESULTS: Eleven RCTs, representing 11 different medical conditions, were eligible for study. Five of the RCTs (four of which in design Ib) were judged to have pragmatic study attitude, two were explanatory, and four were equally pragmatic and explanatory. Ten trials were rated 'high risk of bias' overall: one of these, a pragmatic study with design Ib, had high risk of bias solely regarding participant blinding (a bias that is intrinsic to such trials); the other trial was rated 'uncertain risk of bias' overall. Eight trials had data that were extractable for analysis: for four heterogeneous trials with design Ia, the pooled OR was statistically non-significant; collectively for three clinically heterogeneous trials with design Ib, there was a statistically significant SMD favouring adjunctive IHT; in the remaining trial of design 1a, IHT was non-inferior to fluoxetine in the treatment of depression. CONCLUSIONS: Due to the low quality, the small number and the heterogeneity of studies, the current data preclude a decisive conclusion about the comparative effectiveness of IHT. Generalisability of findings is limited by the variable external validity identified overall; the most pragmatic study attitude was associated with RCTs of adjunctive IHT. Future OTP-controlled trials in homeopathy should aim, as far as possible, to promote both internal validity and external validity.

Case Reports of Five Cancer Patients with Unusual Course.

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.

[Homeopathy for psychiatric patients-for and against]. / Homöopathie bei psychiatrischen Patienten ­ Für und Wider.

The application of homeopathic treatment quickly becomes a matter of ideological confrontation; however, homeopathy is steadily gaining in sympathy in the population. Although the possible effectiveness and the modes of action are currently not scientifically elucidated and the study situation regarding homeopathic treatment in psychiatry is still manageable, there is a whole series of positive evidence for the effects of homeopathic remedies for mental disorders, such as depression, anxiety disorders and addiction. The most important studies are presented and the most important arguments are weighed up with respect to the pros and cons. It is clear that homoeopathic remedies can only be used as an add-on and not alone. These remedies belong in the hands of physicians experienced in homeopathic and psychiatric psychopharmacology. It would be advisable to at least try out homeopathy for the well-being of the patient not only in the case of very mild disorders but also in severe chronic cases, since due to the generally good tolerability, no avoidable disadvantage should result.