Proposed Standards and Regulatory Mechanisms for New Homeopathic Drug Development

Introduction Researchers working with new insights and new targets in new drug discovery in the homeopathy space observe that the path of drug-development and market authorisation has been less travelled and the pathway is not yet well-mapped. The need of the time is to define clear guidelines and regulatory mechanisms to facilitate the process of new drug discovery. Overview The article is about the proposed methods for identifying the new homeopathic substances for therapeutic use. An overview of the current regulations for drug development in India is discussed in this article. Method of new drug development in homeopathy, standards and regulatory mechanism for approval of new drugs are proposed with few illustrations and references. An introductory plan, based on the perspective and experience of researcher, practitioner, academician and inventor for drug discovery is proposed. Discussion An urgent need for setting up the guidelines for new drug discovery has been identified and a basic proposition is made for the same, suggesting practical, pragmatic and achievable measures, and independent regulatory body to encourage drug development and research.

Hypermethylation involved in DNA profiles of lung cancer specific tumour suppressor genes and epigenetic modification caused by an ultra-highly diluted homeopathic drug, Condurango 30C, in vitro and in vivo

Background and objectives: DNA hyper-methylation is an important aspect involved in carcinogenesis and cancer progression, which affects mainly CpG islands of DNA and causes inactivation of tumour suppressor genes. Therefore DNA hypermethylation status of the genomic DNA in both the transformed cancerous cell lines and in carcinogen-induced lung cancer was ascertained by analysis of expressions of certain major lung cancer specific tumour suppressor genes. The other objective was to examine if ultra highly diluted homeopathic drug, Condurango 30C, had ability to modulate DNA methylation. Methods: DNA methylation activity, if any, has been ascertained in H460-NSCLC cells in vitro and in BaP-induced lung cancer of rats in vivo, in respect of tumour suppressor genes like p15, p16, p18 and p53 by using PCR-SSCP analyses. The ability of modulation of DNA methylation, if any, by Condurango 30C was also verified against placebo control in a blinded manner. Results: Condurango 30C-treated DNA showed significant decrease in band-intensity of p15 and p53 genes especially in methylated condition, in vitro, at the IC50 dose (2.43µl/100µl). SSCP analysis of p15 and p53 genes in Condurango 30C-treated DNA also supported ability of Condurango 30C to modulate methylation state, in vitro. Inhibition of p15 hypermethylation was observed after post cancer treatment of rat with Condurango 30C. SSCP results gave a better indication of differences in band-position and single strand separation of p15 and p53 in Condurango 30C treated samples. Conclusion: Condurango 30C could trigger epigenetic modification in lung cancer via modulation of DNA hypermethylation but placebos could not.

Mastalgia in infertility: search for additional possibilities of therapy

Aim. To assess the efficacy and safety of using the homeopathic drug Mastopol for the relief of mastalgia in women with infertility, including those associated with endometriosis, as well as to study the drug tolerability and adherence to the treatment, as well as to determine its antiproliferative and analgesic effects in patients of the study cohort. Study design: open-label, randomized, non-comparative, observational study. Material and methods. 79 infertile women with mastalgia (67 with cyclic mastalgia and 12 with acyclic mastalgia) were examined and treated with Mastopol. Mastopol was prescribed 1 tablet 3 times a day sublingually. The course of treatment was 8 weeks. The efficacy of mastalgia relief was assessed using a Visual Analogue Scale (VAS). Treatment outcomes were considered good if pain severity by the VAS decreased by 4 or more points from the baseline levels at the end of Mastopol treatment course. Results. One Mastopol treatment course provided good treatment outcomes in 76,2% of patients with cyclic mastalgia and in 33,3% of patients with acyclic mastalgia. There were no adverse reactions or complications in patients treated with Mastopol. Conclusions. Mastopol has established itself as a quite effective and safe drug in patients of the study cohort; if there is an insufficient effect, Mastopol can supplement traditional pharmacological agents recorded in the current clinical guidelines.

An evaluation of Avogadro’s number in the light of HRTEM and EDS studies of high dilutions of Ferrum metallicum 6, 30, 200, 1M, 10M and 50Mc

As a therapeutic tool high dilutions (HDs) are always at the center of controversies due to problems to validate them as a function of Avogadro’s number. Nevertheless, homeopathy is practiced around the world as a complementary and alternative medicine. The present study sought to evaluate HDs of homeopathic drug Ferrum metallicum (Ferr) 6, 30, 200, 1M, 10Mc and 50Mc, all of which except for 6c surpass Avogadro’s number. Using HRTEM and EDS it was conclusively shown that: 1) all the investigated HDs of Ferr contained plenty of nanoparticles (NPs); 2) the size of NPs were within the quantum dots (QD) size range, except for 50Mc, in which larger particles were found (12.61nm); 3) NPs contained iron in various weight percentages; 4) the weight percentage of iron was highest in HDs 10Mc and 50Mc.

Homeopathic drug standardization through biological evaluations: An untrodden avenue

Background: There is a dearth of chemico-analytical or instrumental methods for standardization and quality control of higher dilutions of homeopathic drugs. Aim: This review highlights the challenges in standardization of anti-inflammatory homeopathic drugs and suggests a battery of biological assays for their standardization. Methods: We retrieved a total 57 scientific reports from the experimental studies and scientific reviews published between January 1999 and June 2014 related to anti-inflammatory homeopathic drugs and their high dilutions. These comprised of 18 reports on preclinical evaluation, 15 on source materials, 9 on isolated constituents and 15 studies on in-vitro experiments. Few recent citations which supported the initial studies were added later during the compilation of the manuscript. Conclusion: Standardization and quality control of homeopathic mother tinctures and high dilutions warrants an urgent attention. As biological activities are observed to be attributed to the high dilutions which are practically devoid of active ingredients, their standardization may be done through the suggested battery of biological investigations. It is suggested that the current methods of standardization of homeopathic drugs need to be upgraded to include sensitive, reproducible and relevant biological assays so that the end users are assured of the quality, efficacy, and safety of homeopathic dilutions.

Protective action by homeopathic drug Cina C6cH and immune modulator «Recombinant human INTERLEUKIN-2» against experimental trichinosis of mice

Trichinellosis caused by the gastrointestinal nematode Trichinella spiralis occurs in humans, domestic animals and wild animals. This heavy ubiquitous parasitic disease. The muscle phase of the parasite of difficult to controlling. Homeopathic drugs such as Cina have anthelmintic and immunostimulation properties. The purpose of this study was assess the protective efficiency of homeopathic drug such as Cina C6cH and Roncoleukin ® (recombinant interleukin-2 (rIL-2) immunostimulation) against experimental trichinosis, that can affect the muscle phase of the parasite T. spiralis in mice. An assay was carried out on 30 white outbred mice. These were divided into tree groups of ten mice each. The group 1 were treated with the Roncoleukin ® (100 IU/per mouse in 0,2 ml sterile saline intramuscularly, twice with 48 hours intervals); the group 2 - desoldering dissolved in water Cina C6cH (under the scheme). The group 3 received 0.2 ml of sterile 0.9% NaCl. After a 21 day regimen, the groups were inoculated with a dose of 80 ± 5 units of Trihinella spiralis larva per mouse. After 90 days of incubation, the mice were euthanized and dissected for evaluation. The maximum protection was obtained in mice immunized with Roncoleukin ® (80,61%; 869,5±16,6 larva/per animal). The protective effect in the group immunized by Cina C6cH was of 36,67 ( (2840,5±183,3 larva/per animal)%. In control group invasion on muscle phase T.spiralis was 4485±430,6 larva/per animal/ In conclusion, the use of homeopathic drugs also reduces in the number of infective Trichinella spiralis larvae in mice and has a synergistic effect on the treatment.

Zincum Metallicum an Homeopathic Drug Alleviates Zn-Induced Toxic Effects, Promotes Plant Growth and Antioxidants Capacity in Lepidium Sativum

In this study, we investigated the effect of Zincum Metallicum (ZM) on zinc (Zn) toxicity in the plant species Lepidium sativum. We focused on growth, Zn uptake and numerous biochemical parameters. Seedlings were hydroponically subjected during 7 days to 0.05, 500, 1000, 1500 and 2000 µM Zn2+, in the absence or presence of 15ch or 9ch ZM. In the absence of ZM, Zn induced negative effect on growth especially at the dose of 2mM. Zn induced also chlorosis, reduced total chlorophyll and/or carotenoid content and increased the level of malondialdehyde (MDA). Under Zn-toxicity (500, 1000 and 1500 µM), the superoxide dismutase (SOD), catalase (CAT), gaiacol peroxidase (GPX) and glutathione reductase (GR) activities were increased and/or unaltered, while at 2000 µM Zn affected the activity of these enzymes. At the highest Zn level (2 mM), proline and total polyphenols and flavonoids contents were markedly induced in leaves and roots of L. sativum. Additionally, the supply of ZM in the nutrient medium considerably ameliorated the plant growth, photosynthetic pigments and the studied non-enzymatic antioxidant molecules and enzymatic activities against Zn induced-oxidative stress. Our data suggest that the potential homeopathy properties of ZM may be efficiently involved in the restriction of Zn-induced oxidative damages, by lowering Zn accumulation and translocation in the leaves and roots of Lepidium sativum.

Extremely dilution of Strychnos Nux vomica mitigates alcohol-induced reduction in enthalpies associated with free water molecules in fish brain

Background: Alcoholism is a global health problem. Extract of the seeds of Strychnos Nux vomica and its high dilution have long been used in homeopathy for alcohol induced diseases of patients. Alcoholism leads to reduced brain volume. Glial cells like astroglia contain large number of water channel proteins or aquaporin (AQP4) which mediate glial oedema resulting from ethanol intoxication. Nux vomica, a homeopathic drug of plant origin, is known to counteract alcohol effect. Aim: The objective of this present study is to find out the level of free water molecules in the brain of a teleost fish under ethanol intoxication. The other purpose is to determine whether Nux vomica could restore the level of free water in the alcohol treated fish. Methodology: One group of fish was exposed to 456 mM ethanol for 30 min, another exposed first to a solution of Nux vomica 200c for 20 min and then to 456 mM ethanol for 30 min. The third group served as an untreated control. The mid brain of each fish was kept in an aluminium sample pan and its free water level was assessed by differential scanning calorimetry (DSC). Data were analyzed by ANOVA. Results and discussion: The results show that there was no significant variation in melting and freezing temperature of brain samples but the enthalpies, both freezing and melting varied significantly (P