Development and Validation of Chromatographic Method for the Standardization of Homeopathic Formulation of Syzygium Cumini.

BACKGROUND: Syzygium cumini (Lam.), family Myrtaceae, has a long history of use in folk and traditional systems of indigenous medicine. Many homeopathic formulations of Jamun seeds are available in the market for their crucial usage as an anti-diabetic. Despite the popularity of homeopathic products, a lack of standard quality is a significant impediment in their acceptance. The present study aimed to develop and validate a chromatographic method for the standardization of the homeopathic formulation of Syzygium cumini. METHODS: The seeds of Syzygium cumini were studied for physicochemical evaluation and preliminary phytochemical screening. Also, the in-house standard and marketed homeopathic formulations of Syzigium cumini were standardized for pH, total fatty content, total phenolic and flavonoid content, with quantitative high-performance liquid chromatography- photodiode array detector (HPLC-PDA) analysis by using ellagic acid as a marker. RESULTS: The physicochemical characteristics of crude material were found to be within pharmacopeial limits. The phytochemical screening showed the presence of various secondary metabolites. The total phenolic and flavonoid content was higher in the in-house standard than in marketed formulations. A validated quantitative HPLC-PDA analysis showed variations of ellagic acid content in different homeopathic formulations. CONCLUSION: Physicochemical analysis and the HPLC method for quantitative estimation of ellagic acid can be used to standardize a homeopathic formulation of Syzygium cumini.

Salve and Burdock: A Safe, Effective Amish Remedy for Treatment of Traumatic Wounds?

BACKGROUND: Amish patients show a demonstrated preference for traditional, herbal remedies over modern medical interventions such as skin grafting. One such remedy is a mixture of Burn & Wound Ointment (B & W Ointment; Holistic Acres, LLC; Newcomerstown, Ohio) and steeped burdock leaves. Although both have demonstrated some antimicrobial and wound healing properties, burdock and/or the combination of B & W Ointment and burdock has never been studied to determine its purported ability to reduce pain, prevent infection, and accelerate wound healing. METHODS: A retrospective chart review was performed on 6 Amish patients treated with salve and burdock leaves instead of skin grafting following complex traumatic wounds to determine whether the traditional treatment incurred any patient harm. RESULTS: The time of wound epithelialization and healing complications were noted, among other data points. Time to full epithelialization ranged from 1 to 7 months. Time to full wound healing was proportional to wound size. CONCLUSIONS: Although the treatment presented here is unconventional, it did not cause harm to the patients studied.

A review of machines and devices to potentize homeopathic medicines.

BACKGROUND: Potentization, consisting of serial dilution and succussion, is a key step in the manufacture of homeopathic medicines. Originally prescribed as a manual process, several attempts at mechanization have been published, patented and even commercialised in order to remove the human element and introduce reproducibility without drudgery. Various machines have been used over the years to prepare homeopathic medicines. Although these machines follow the same principles, i.e. energetically mixing the medicines and diluting them significantly, their mode of operation is different from each other. METHODS: This review paper surveys the main methods of preparation of homeopathic medicines. The main machines discussed are: Boericke's potentizer, Tyler Kent's instrument, John Alphonse's machine and the fluxion potentizer, which were used in the past, as well as more recent potentizers like arm-and-weight instruments, the K-Tronic potentizer and Quinn's machine. We review the construction and operating principle of each of these machines, along with their advantages and limitations. A scheme for relative performance assessment of these machines is proposed based on the parameters mechanical efficiency, physico-chemical efficiency, turbulence generation, energy dissipation, and accuracy of dilution. RESULTS: Quinn's machine and the arm-and-weight potentizer perform well for generating turbulence due to high impaction forces, while John Alphonse's machine is much more accurate in diluting the homeopathic medicines at every step. CONCLUSIONS: Both the commercial potentizers, Quinn's machine and the K-Tronic potentizer, are completely automated and therefore reduce the manual labour and variation in succussive forces during each step, which may produce uniformity in physico-chemical changes within the resulting homeopathic medicines.

"Ultra High Dilution 1994" revisited 2015--the state of follow-up research.

BACKGROUND: The "Ultra High Dilution 1994" project was an endeavour to take stock of the findings and theories on homeopathic extreme dilutions that were under research at the time in areas of biology, biophysics, physics and medicine. The project finally materialized into an anthology assembling contributions of leading scientists in the field. Over the following two decades, it became widely quoted within the homeopathic community and also known in other research communities. The aim of the present project was to re-visit and review the 1994 studies from the perspective of 2015. METHOD: The original authors from 1994 or close laboratory colleagues were asked to contribute papers covering their research efforts and learnings in the period from 1994 up to 2015. These contributions were edited and cross-referenced, and a selection of further contributions was added. RESULTS: About a dozen contributions reported on follow-up experiments and studies, including further developments in theory. Only few of the models that had seemed promising in 1994 had not been followed up later. Most models presented in the original publication had meanwhile been submitted to intra-laboratory, multicentre or independent scrutiny. The results of the follow-up research seemed to have rewarded the efforts. Furthermore, contributions were provided on new models that had been inspired by the original ones or that may be candidates for further in-depth ultra high dilution (UHD) research. CONCLUSION: The project "Ultra High Dilution 1994 revisited 2015" is the latest output of what might be considered the "buena vista social club" of homeopathy research. However, it presents new developments and results of the older, established experimental models as well as a general survey of the state of UHD research.

Experimental physical methods and theories--then and now.

INTRODUCTION: A first evaluation of fundamental research into the physics and physiology of Ultra high dilutions (UHDs) was conducted by the author in 1994(1). In this paper we revisit methods and theories from back then and follow their paths through their evolution and contribution to new knowledge in UHD research since then. METHOD: Physical methods and theories discusses in our anthology on UHD in 1994(1) form the basis for tracing ideas and findings along their path of further development and impact on new knowledge in UHD. RESULTS: Experimental approaches to probe physical changes in homeopathic preparations have become more sophisticated over past two decades, so did the desire to report results to a scientific standard that is on par with those in specialist literature. The same cannot be said about underlying supporting theoretical models and simulations. CONCLUSION: Grant challenges in science often take a more targeted and more concerted approach to formulate a research question and then look for answers. A concerted effort to focus on one hypothesized physical aspect of a well-defined homeopathic preparation may help aligning experimental methods with theoretical models and, in doing so, help to gain a deeper understanding of the whole body of insights and data produced.

Physiological effects of homeopathic medicines in closed phials--a critical evaluation.

BACKGROUND: Phials containing high dilutions of homeopathic remedies are commonly utilized in diagnostic tools in combination with electro acupuncture measuring electrical conductivity of the skin. The present research aimed to elucidate the interaction of the homeopathic remedy and the human organism. METHOD: The study protocol included the transition of a healthy subject to a diseased state utilizing a sub-harmful dose of a toxin. Subsequently, the subject was exposed to a homeopathic or placebo remedy in a closed glass phial and electrical conductivity was measured in open as well as in blind trials. A total of 229 data were collected from open trials and 750 data from blind trials. RESULT: The experimental data showed that homoeopathic remedies in closed glass phials may influence the electrical skin conductivity. The results of the blind trials differed considerably from those of the open trials. The percentage of correctly identified (verum and placebo) phials in the open trials (85%) was statistically different from those in the blind trials (65%). In both types of trials, however, the difference between the sealed phials containing the homeopathic medicine and the placebo was statistically significant. The results of measurements are directly linked to the way in which the tester holds the electrode in one hand and the subject's finger in the other, while putting pressure on the electrode. CONCLUSION: It was concluded that the tester's muscle tone is the intermediary in unconsciously selecting which phial influenced him in his specific contact with the subject.

Homeopathic remedies with antineoplastic properties have immunomodulatory effects in experimental animals.

BACKGROUND: Our previous work suggests that Thuja occidentalis, Carcinosinum and Ruta graveolens have antineoplastic properties. The mechanism of this action has not previously been studied. We studied the hypothesis that the mechanism of action is through the immune modulation. METHODS: We evaluated the effects of Thuja occidentalis, Carcinosinum and Ruta graveolens 1M, 200c and 30c on the immune system of Balb/c mice. The homeopathic preparations were administered orally for ten consecutive days. Haematological parameters (Total White Blood Cell (WBC) Count, Differential Count and Haemoglobin content), haematopoietic parameters (bone marrow cellularity and α-esterase positive cells) and immune parameters for antibody response and lymphoid cell proliferation were assessed using standard methods. Results were analysed by statistical comparison with the control. RESULTS: We observed significant enhancement of haematological parameters including total WBC count, haematopoietic parameters such as bone marrow cellularity and the number of α-esterase positive cells, other parameters of immune response such as circulating antibody titre and the number of plaque forming cells (PFC), particularly with higher dilutions of Thuja and Ruta. Enhanced proliferation of B and T lymphoid cells was also observed. No toxic effects were observed. CONCLUSIONS: The results suggest immunomodulatory activity of homeopathic preparations in high dilution. This may be a mechanism through which homeopathic preparations act.

Comparison of effectiveness of frequently and infrequently used homeopathic medicines.

RATIONALE: Patients treated with homeopathy may respond to infrequently used or even 'new' medicines. But does the introduction of an unlimited number of (new) medicines improve homeopathy? Do new medicines solve old problems? METHODS: 1. Consensus meetings to evaluate best cases. 2. Patient outcome study in 10 Dutch practices. RESULTS: Good cases are scarce for many medicines, random variance is an important source of uncertainty. 50 Medicines are responsible for 72% of all successful prescriptions. There is no difference in effectiveness of frequently and less frequently used medicines. Confirmation bias is found for a few well-known symptom-medicine combinations. CONCLUSION: 'New' and infrequently medicines are as effective as 'old' frequently used medicines. Improving the use of frequently used medicines is more effective in improving results than seldom used medicines. Large numbers are required and old mistakes should be avoided developing new medicines. A research agenda for improving the use of homeopathic medicines is imperative.

Canova medication modifies parasitological parameters in mice infected with Trypanosoma cruzi.

The goals of this study were to evaluate the effect of the Canova medication, a homeopathic immune-system modulator, on the evolution of infection induced by the Trypanosoma cruzi Y strain in mice. The animals were divided into five groups: (i) untreated infected controls (I), (ii) infected animals treated with benznidazole (Bz), (iii) infected animals treated with the Canova medication (CM), (iv) infected animals treated with benznidazole and the Canova medication (Bz+CM), and (v) uninfected controls that received only the vehicle (grain alcohol) (C). The parameters evaluated were: parasitemia, mortality, control of cure, and tissue parasitism analysis. Our results showed that the evolution of the experimental infection was modified by treatment with CM, and that daily and consecutive doses were harmful to the animals, causing death in 100% of the infected animals in a brief period. The analysis of parasitism performed on the organs on the 12th day postinfection showed that in infected animals treated with CM, the number of amastigote/nests in the spleen was significantly reduced, while in cardiac tissue, intestine, and liver the number was significantly increased compared with infected control animals. These results indicate that CM has a negative influence on the host-parasite relationship, modifying the tropism of the parasite for tissues, and increasing the parasitemia peak in this experimental model.

Evaluation of homeopathic Arnica montana for ecchymosis after upper blepharoplasty: a placebo-controlled, randomized, double-blind study.

PURPOSE: Ecchymosis is commonly encountered after upper eyelid blepharoplasty. The use of homeopathic preparations of Arnica montana, a flowering herb, has been advocated by physicians, patients, and manufacturers for reduction of postsurgical ecchymosis. The authors evaluate its efficacy after upper eyelid blepharoplasty. METHODS: A prospective, placebo-controlled, double-blind study was performed in which patients were randomly assigned to the administration of homeopathic A. montana or placebo concurrent with unilateral upper eyelid blepharoplasty followed by contralateral treatment at least 1 month later. Ecchymosis was evaluated at days 3 and 7 by rank order of severity and measurement of surface area of observable ecchymosis. RESULTS: There was no statistically significant difference in area of ecchymosis or rank order of ecchymosis severity for days 3 and 7 after treatment with A. montana versus placebo. Additionally, there was no difference in ease of recovery per patient report, and there was no difference in the rate of ecchymosis resolution. CONCLUSIONS: The authors find no evidence that homeopathic A. montana, as used in this study, is beneficial in the reduction or the resolution of ecchymosis after upper eyelid blepharoplasty.

Infection models in basic research on homeopathy.

INTRODUCTION: The objective of this study was to search for effective agents for the treatment of infections in animals or infected cell lines. METHODS: The Homeopathic Basic Research experiments (HomBRex) database (http://www.carstens-stiftung.de/hombrex) on model biological systems in homeopathic research was searched. Eligible experiments were reviewed and analysed. RESULTS: The database contains 48 eligible experiments published from 1832 to 2009. Causative pathogens were bacteria, fungi, viruses, proto- and metazoa. In the experiments, various parameters were observed and a large set of medicines was investigated. In eight of the 48 experiments, at least one of the investigated medicines was selected according to the similia principle. Nosodes and homeopathic complexes were investigated in 8 and 14 experiments respectively. Mice were the most often used host organisms (13 experiments). In 31 experiments at least one homeopathic medicine was found effective for treatment. CONCLUSION: The results of basic research experiments may invigorate new clinical trials that investigate complementary treatments for infectious diseases. However, all experiments reviewed here await replication and no clear-cut conclusion can be drawn regarding the transferability of in vitro results to in vivo outcomes.

Lymphocyte proliferation stimulated by activated human macrophages treated with Canova.

INTRODUCTION: Canova (CA) is a homeopathic medication with immunomodulatory properties, recommended for patients with a depressed immune system. CA has been reported to increase in leukocyte numbers, cellular differentiation and reduction in tumor size. AIM AND METHOD: Since CA may stimulate lymphocyte differentiation, proliferation, and/or survival, the aim of the present study was to compare the mitotic index (MI) of phytohemagglutinin-stimulated human lymphocytes cultured in a medium supplemented with human macrophages activated by CA, with lymphocytes cultured in a medium without CA-treated macrophages. RESULTS: In this study, the MI of lymphocyte cultured received the medium containing CA-stimulated macrophages showed a higher proliferation index (p<0.01) than the lymphocytes cultured in a medium without CA-treated macrophages. Our results suggest that CA treatment, in addition to activating macrophages, indirectly induces lymphocyte proliferation and has potential as a new adjuvant therapeutic approach.

Activation of mononuclear bone marrow cells treated in vitro with a complex homeopathic medication.

Canova is a Brazilian homeopathic medication with immunomodulatory properties, recommended for patients where the immune system is depressed. Previous studies demonstrated that Canova induces up-regulation in numbers of leukocytes. The bone marrow microenvironment is composed of growth factors, stromal cells, extracellular matrix and progenitor cells that differentiate into mature blood cells. We now report the effect of in vitro administration of the medication on the mononuclear differentiation of the bone marrow cell. Swiss mice femurs were dissected cleaned and the cells of the marrow were flushed. The cells were plated, treated or not, incubated for different times and processed for light, transmission and scanning electron, and confocal microscopy analysis. Bone marrow cells showed an enhanced proliferation in vitro in response to Canova medication and Canova plus M-CSF and an increase was also observed in the numbers of the cell niches and ring-shaped nuclei cells. Confocal and transmission and scanning electron microscopy showed the stages of monocyte maturation, with resting and activated cells. With Canova treatment there was a marked increase in cell size, which is mainly attributable to the augmented cytoplasm, an increase in the number of mitochondria, expansion of the RER and an enlarged Golgi. The response to Canova treatment indicates that it influences mononuclear differentiation and activation of bone marrow progenitor and stromal cells.

Differentiation of human monocytes in vitro following exposure to Canova in the absence of cytokines.

Canova is an immunomodulatory, homeopathic preparation that has been shown to activate macrophages in vitro and in vivo, with resultant enhanced spreading of the cells and formation of microvillus extensions from the cell body. Since monocytes are the precursor cells of macrophages and dendritic cells, the objective of the current study was to investigate the effects of Canova on the differentiation of human blood monocytes in vitro. Monocytes were isolated, grown in culture, and exposed to 10 and 20% Canova without the addition of cytokines. After 48 h, monocytes were prepared for analysis by scanning electron microscopy, while cells kept in culture for 7 days and exposed to Canova on days 1, 3, and 4 were analyzed by flow cytometry for alterations in the levels of expression of CD1a, CD11c, CD14, CD80, CD83, CD86, and HLA-DR. SEM revealed that monocytes exposed to 10% Canova had a morphological appearance similar to that of macrophages. Various cytoplasmic projections were observed with pseudopodia formation. Flow cytometric analysis after exposure of monocytes to 10 and 20% Canova indicated high cell viability and upregulation of CD80, compatible with differentiation into either macrophages or dendritic cells. Exposure to Canova per se causes activation of monocytes with resultant differentiation into large macrophage-like cells of indeterminate phenotype that have increased expression of CD80. Like cytokines, Canova induces differentiation of monocytes, an activity that may underpin the immunomodulatory activity of this product.

Possible dangers for patients using homeopathy: may a homeopathic medicinal product contain active substances that are not homeopathic dilutions?

OBJECTIVE: To conclude in an objective and reasonable way whether, from an ethical and legal point of view, in homeopathic medicinal products all the active components have to be in homeopathic dilutions or if it is correct and appropriate for one, some or all of the active components to exist in homeopathic medicinal products without having been subjected to homeopathic potentisations (dilutions followed by succussion). METHODS: Collection and analysis of Spanish and European Union legislation regarding this topic. Revision of the European Pharmacopoeia. Criteria from the homeopathic bibliography. Analysis from the standpoint of ethical principles. RESULTS AND CONCLUSIONS: "Mother tinctures", and other products containing substances that have not been subjected to homeopathic dilutions, cannot be accepted as constitutive components of homeopathic medicinal products. We consider unacceptable the existence of products under the denomination of homeopathic medicinal product if they do not meet the minimal requirements to be considered as such: manufacture by a homeopathic production procedure, which means that all its active components are present in homeopathic dilutions. We recommend that physicians should ask their patients not only if they use homeopathic pharmaceuticals in general but to specify which products they are using, bearing in mind the possibility that they may contain "mother tinctures" or products at such low dilutions that they may interfere with conventional treatment.

[Homeopathic prophylaxis in dairy cows on an organic farm part 1--fertility]. / Homöopathische Prophylaxe in der Bestandsbetreuung von Milchkühen Teil 1--Fruchtbarkeit.

The objective of the study was to assess the efficacy of different prophylactically applied homeopathic compounds on health and fertility during the periparturient period on an organic dairy farm. In a randomised double blinded study 146 dairy cows were enrolled in two treatment groups. The average milk yield was about 5100 kg per cow per lactation. The treatment group received the homeopathic compounds Carduus comp. and Coenzyme comp. at drying off, Traumeel on the day of calving, Lachesis comp. on day 7 post partum (p.p.) and Carduus comp. and Coenzyme comp. on day 14 days p.p. The control group followed the same protocol with a placebo (physiological saline solution). Each drug was administered subcutaneously in a dosage of 5 ml. At drying off, the day of calving and in weekly intervals until day 35 p.p. clinical examinations as well as blood sampling were performed. The effect of treatment was measured by clinical parameters, reproductive performance and serum profiles (Ca, P, AST, Urea, Bilirubin). Data of reproductive performance (days to first service, days open, conception rate) were compared between treatment groups and to those in the previous lactation. There was no significant difference between both treatment groups. Cows of the treatment group had an earlier onset of cyclic activity, especially when milk yield was considered as an influencing factor (82% vs. 57%, P < 0,05). In contrast the cows of the treatment group had a significant lower submission rate. The prophylactic treatment of all cows did not have an effect in general, but in cows with increased milk yield, especially in the current lactation. The reproductive performance in the previous lactation did not have any effects on the success of the homeopathic treatment. Reproductive performance in the herd could be enhanced slightly compared to the previous lactation.

Regulation of homeopathic drug products.

PURPOSE: The regulation of homeopathic drug products is discussed. SUMMARY: Homeopathy is a system of medicine based on the observation that high doses of pharmacologically active substances cause symptoms when administered to healthy individuals. These same substances, when prepared in very dilute form, may relieve similar symptoms in conditions resulting from different etiologies. Unlike dietary supplements, homeopathic drugs are subject to the Food, Drug, and Cosmetic Act and regulations issued by FDA. Instead of the new-drug-approval process, premarket approval for homeopathic drugs is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Monographs are published in the Homeopathic Pharmacopoeia of the United States (HPUS). The criteria for inclusion in the HPUS require that a homeopathic drug product be determined by HPCUS to be safe and effective and to be prepared according to the specifications of the HPUS general pharmacy section. The long history and established nature of homeopathic drug regulation may provide a model for the regulation of dietary supplements. CONCLUSION: Homeopathic drugs in the United States are subject to well-defined regulatory processes that more closely resemble those that apply to allopathic medications than to dietary supplements.

Risk of interactions between complementary and alternative medicine and medication for comorbidities in patients with melanoma.

Complementary and alternative medicine (CAM) is used widely among cancer patients. Beside the risk of interaction with cancer therapies, interactions with treatment for comorbidities are an underestimated problem. The aim of this study was to assess prevalence of interactions between CAM and drugs for comorbidities from a large CAM usage survey on melanoma patients and to classify herb-drug interactions with regard to their potential to harm. Consecutive melanoma outpatients of seven skin cancer centers were asked to complete a standardized CAM questionnaire including questions to their CAM use and their taken medication for comorbidities and cancer. Each combination of conventional drugs and complementary substances was evaluated for their potential of interaction. 1089 questionnaires were eligible for evaluation. From these, 61.6% of patients reported taking drugs regularly from which 34.4% used biological-based CAM methods. Risk evaluation for interaction was possible for 180 CAM users who listed the names or substances they took for comorbidities. From those patients, we found 37.2% at risk of interaction of their co-consumption of conventional and complementary drugs. Almost all patients using Chinese herbs were at risk (88.6%). With a high rate of CAM usage at risk of interactions between CAM drugs and drugs taken for comorbidities, implementation of a regular assessment of CAM usage and drugs for comorbidities is mandatory in cancer care.