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.

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.

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.

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.

"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.

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.

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.

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.

The effect of Burns & Wounds (B&W)/burdock leaf therapy on burn-injured Amish patients: a pilot study measuring pain levels, infection rates, and healing times.

PURPOSE: The purposes of this pilot study were to measure pain associated with dressing changes, assess the presence of infection, and document healing times of burn-injured Amish in central Ohio using an herbal therapy consisting of Burns and Wounds™ ointment (B&W) and burdock (Arctium ssp.) leaves. B&W contains honey, lanolin, olive oil, wheat germ oil, marshmallow root, Aloe vera gel, wormwood, comfrey root, white oak bark, lobelia inflata, vegetable glycerin, bees wax, and myrrh. DESIGN: A prospective, case series design guided the study within a community-based participatory research framework. METHODS: Amish burn dressers provided burn care. Registered nurses monitored each case and documented findings. Pain scores were noted and burns were inspected for infection during dressing changes; healing times were measured from day of burn to complete closure of the skin. All cases were photographed. RESULTS: Between October 2011 and May 2013, five Amish were enrolled. All had first- and second-degree burns. B&W/burdock leaf dressing changes caused minimal or no pain; none of the burns became infected, and healing times averaged less than 14 days. CONCLUSION AND IMPLICATIONS: The use of this herbal remedy appears to be an acceptable alternative to conventional burn care for these types of burns. The trauma of dressing changes was virtually nonexistent. Nurses working in communities with Amish residents should be aware of this herbal-based method of burn care and monitor its use when feasible.

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.

The quality of selected South African and international homoeopathic mother tinctures.

The high potential variability of chemical composition of the plant material involved in the manufacture of homoeopathic mother tinctures (a common source of homoeopathic medicines), renders both their quality control and assurance a significant challenge (Pande and Pathak, 2006). The absence of significant regulations regarding the quality of Complementary and Alternative Medicines (CAM) in South Africa contributes to this challenge (Gqaleni et al, 2007). In order to assess any quality differences between local and international manufacturers, the following homoeopathic mother tinctures, Artemisia absinthium, Rosmarinus officinalis e foliis recentibus, Salvia officinalis and Sambucus nigra, were chosen on the basis that they can be grown both locally in South Africa and internationally and are prepared according to the German Homoeopathic Pharmacopoeia (GHP), method 3a. Colour analysis was followed by thin layer chromatographic (TLC) analysis on each selected sample and relevant reference sample using both aluminum-backed TLC plates and glass-backed HPTLC plates. Photographs were taken of the resultant chromatograms, active components were identified, comparisons to the reference chromatograms were made and the overall quality of each homoeopathic mother tincture deduced. The quality of all nine of the selected samples manufactured internationally complied with the minimum quality standards set by the GHP. Five out of the six local samples complied with the minimum standards of the GHP._Notwithstanding the minimum GHP standards, the superior number of high quality international samples implies that their quality exceeded that of the locally manufactured tinctures. Greater regulation regarding the quality of these types of products has therefore been identified.

Effects of homeopathic medicines on mood of adults with histories of coffee-related insomnia.

BACKGROUND/AIMS: The purpose of this within-subjects feasibility study was to determine whether two different homeopathic remedies, Nux Vomica (NV) and Coffea Cruda (CC), exert effects on subjective mood ratings in healthy adults with a history of coffee-induced insomnia. The impact of individual personality traits, anxiety sensitivity or Type A cynical hostility, and homeopathic constitutional type (HTYPE-NV, HTYPE-CC), on remedy effects was examined to evaluate differential responsivity, in accord with clinical claims. SUBJECTS AND METHODS: Young adults of both sexes (ages 18-31) with above-average scores on standardized personality scales for either cynical hostility or anxiety sensitivity, and a history of coffee-induced insomnia, participated in the month-long study. At-home polysomnographic recordings were obtained on successive pairs of nights once per week for a total of 8 recordings (nights 1, 2, 8, 9, 15, 16, 22, 23). Subjects (N = 59) received placebo pellets on night 8 (single-blind) and verum pellets in 30c doses of one of two homeopathic remedies, NV or CC, on night 22 (doubleblind). Subjects completed the Profile of Mood States Scales at bedtime. RESULTS: The remedies produced differential effects on anger and overall mood, with improved mood following CC administration. A similar trend for depression was observed. Anxiety sensitive subjects experienced less tension following CC, whereas hostile subjects receiving CC became more tense. The high HTYPE-CC receiving CC experienced less vigor. The high HTYPE-CC receiving NV experienced more vigor.

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.

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.

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.

A systematic review of homoeopathy for the treatment of fibromyalgia.

Homoeopathy is often advocated for fibromyalgia (FM) and many FM patients use it. To critically evaluate all randomised clinical trials (RCTs) of homoeopathy as a treatment for FM, six electronic databases were searched to identify all relevant studies. Data extraction and the assessment of the methodological quality of all included studies were done by two independent reviewers. Four RCTs were found, including two feasibility studies. Three studies were placebo-controlled. None of the trials was without serious flaws. Invariably, their results suggested that homoeopathy was better than the control interventions in alleviating the symptoms of FM. Independent replications are missing. Even though all RCTs suggested results that favour homoeopathy, important caveats exist. Therefore, the effectiveness of homoeopathy as a symptomatic treatment for FM remains unproven.