Homeopathic Medicinal Products Research Articles

Assessing the Feasibility of a Two-Cohort Design to Assess the Potential of Homeopathic Medicinal Products to Reduce Antimicrobial Resistance in Turkeys (The HOMAMR Project)-Study Protocol.

Antimicrobial resistance (AMR) is a serious public health concern worldwide. The European Union requires a reduction in the use of antibiotics by 50% by 2030, with separate regulations on organic production that give preference to homeopathy and phytotherapy in organic farms before the use of conventional medicines (including antibiotics). We have therefore designed a two-phased project whose overarching aim is to investigate the potential role of homeopathic medicinal products (HMPs) in combating AMR in turkeys (the HOMAMR project): a two-cohort feasibility study using turkey-farm data that have been collected and analyzed retrospectively, followed by a prospective two-cohort study in turkey farms that would examine the impact of HMPs on changing antibiotic use. The objective of this paper is to describe the protocol for the first phase of HOMAMR, which is a study under field conditions to assess the feasibility of collecting data retrospectively about turkeys that have been managed conventionally only or with HMPs. Surveys performed on farms in Germany and Austria, including interviews with consenting farmers, will determine the feasibility of comparing retrospectively gathered data on antibiotic use and performance/production data in two cohorts of turkeys: (1) homeopathic treatment with conventional care (antibiotics) added if necessary or (2) conventional care (antibiotics) only. Co-primary outcomes to be studied are the amount of antimicrobial use and production period-related mortality. In addition, other production/performance parameters will be compared between the two treated cohorts. To our knowledge, this is the first feasibility study on the treatment of turkeys using homeopathy, and whose retrospectively obtained data will inform a prospective study that would examine the impact of HMPs on antibiotic use in commercial turkey raising, fattening and breeding production.

Homeopathic Medicinal Products and Importance in Diabetes

Background: Diabetes is a condition that happens when your blood sugar (glucose) is too high. It develops when your pancreas doesn’t make enough insulin or any at all, or when your body isn’t responding to the effects of insulin properly. Diabetes affects people of all ages. Most forms of diabetes are chronic (lifelong), and all forms are manageable with medications and/or lifestyle changes. So many health problems can develop in diabetic people, like heart diseases, kidney diseases, eye problems, etc. Diabetes mellitus is a chronic disease. A qualified homeopathic doctor needs to be consulted for the selection of the right medicine and its potency. Objective: There are many allopathic medicines available for the treatment of diabetes, but they have lots of side effects. The main objective of this study is to find out the appropriate homeopathic medicines for the treatment of diabetes. Methods: A literature search was conducted on the databases, namely Science Direct and PubMed, with the help of different keywords such as "homeopathic medicine treatment of diabetes." The search was customized by applying the appropriate filters so as to get the most relevant articles to meet the objective of this review article. Result: There are different research and review papers based on the homeopathic medicine treatment of diabetes and the activity of new drug molecules. Conclusion: On the basis of our study, we found that some treatments approach homeopathic medicines for the treatment of diabetes and suggested that if we used homeopathic medicine to reduce the side effects of allopathic medicines.

Individualized homeopathic medicines in preventing the progression from pre-diabetes to diabetes: A double-blind, randomized, placebo-controlled, parallel-arm trial

ContextPre-diabetes is a significant public health problem worldwide. India has a very high rate of progression from pre-diabetes to diabetes, 75–78 per thousand persons per year. ObjectiveTo study the efficacy of individualized homeopathic medicinal products (HMPs) against placebos in preventing the progression from pre-diabetes to diabetes. DesignSix-month, double-blind, randomized (1:1), two parallel arms, placebo-controlled trial. SettingOutpatient departments of D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India. PatientsSixty participants with pre-diabetes. InterventionsVerum: HMPs plus yoga therapy (YT; n = 30); control: identical-looking placebos plus YT (n = 30). Main outcome measuresThe primary efficacy endpoint was the proportion of participants progressing from pre-diabetes to diabetes, measured after three and six months. Secondary outcomes comprised of fasting blood glucose (FBS), oral glucose tolerance test (OGTT), glycated hemoglobin percentage (HbA1c%), lipid profile, liver enzymes (alanine transaminase, aspartate transaminase), urea and creatinine, and Measure Yourself Medical Outcome Profile version 2 (MYMOP-2); all measured after 3 and 6 months. ResultsThe proportion of participants converted from pre-diabetics to diabetics (n/N; n = diabetics, N = prediabetics) was significantly less in the verum group than control: HbA1C% (month 3: verum – 2/30 versus control – 11/30, p = 0.003; month 6: 3/30 vs. 2/30, p = 0.008), OGTT (month 3: 0/30 vs. 8/30, p = 0.015; month 6: 0/30 vs. 1/30, p = 0.008), but not according to FBS (month 3: 1/30 vs. 1/30, p = 0.779; month 6: 1/30 vs. 3/30, p = 0.469). Several secondary outcomes also revealed significant improvements in the verum group than in placebo: HbA1C% (p < 0.001), OGTT (p = 0.001), serum ALT (p = 0.031), creatinine (p = 0.012), and MYMOP-2 profile scores (p < 0.001). Sulphur, Bryonia alba, and Thuja occidentalis were the most frequently indicated medicines. Thus, HMPs outperformed placebos by successfully preventing the progression of pre-diabetes to diabetes. Trial registrationClinical Trials Registry – India CTRI/2022/04/042,026; UTN: U1111–1277–0021

Homoeopathic eye drops in the treatment of mild-to-moderate dry eye disease: Randomised, prospective, multicentre, single-masked study

Introduction To compare the efficacy and safety of a homeopathic eye drop medicinal product (Homeoptic®) with 0.9% sodium hydrochloride eye drops (Larmabak®) in patients with mild-to-moderate dry eye disease (DED). Methods Prospective, single-masked, observer-blinded, multicentre study on adult patients. Non-inferiority primary endpoint of the relative change between treatment groups in a composite Visual Analogue Scale (VAS) score covering five symptoms of DED, namely pain, itching, sensation of dry eye, impression of foreign body presence and burning, after 30 days of treatment. Details of all Adverse Events (AEs) were recorded and analysed. Results Ninety three patients were randomised to each treatment arm. At Day 30, the mean VAS symptom score was 26.0 ± 18.8 in the Homeoptic® group and 32.8 ± 21.2 Larmabak® group. Homeoptic® was demonstrated to be non-inferior to Larmabak®: the mean treatment difference of −7 being below the 10 mm upper limit of the 95% CI ([-12.9; −1.0]) pre-set as significant. The superiority of Homeoptic® over Larmabak® was then established with detection of a significant difference between the two treatment groups (p = 0.022). Significant differences between the treatment groups in favour of Homeoptic® were also detected in isolated VAS scores for the symptoms dry eye sensation ( p = 0.009) and burning ( p = 0.004). Results of ocular surface staining tests to estimate corneal and conjunctival damage as well as patient satisfaction were also significantly in favour of Homeoptic®. No new safety concerns were identified. Conclusion Homeoptic® is more effective than Larmabak® at relieving the symptoms of DED and constitutes an effective treatment for mild-to-moderate DED.

What are the effects of homeopathic medicinal products for treating acute respiratory tract infections in children?

What are the effects of homeopathic medicinal products for treating acute respiratory tract infections in children?

What are the effects of homeopathic medicinal products for preventing acute respiratory tract infections in children?

What are the effects of homeopathic medicinal products for preventing acute respiratory tract infections in children?

Access to medicines for rare diseases: A European regulatory roadmap for academia.

Background: Novel or repurposed medicines for rare diseases often emerge from fundamental research or empirical findings in academia. However, researchers may be insufficiently aware of the possibilities and requirements to bring novel medicinal treatment options to the patient. This paper aims to provide an easily applicable, comprehensive roadmap designed for academic researchers to make medicines for rare diseases available for patients by addressing the relevant regulatory frameworks, including marketing authorization and alternative routes. Methods: Key points of the regulatory chapters "Placing on the Market" and "Scope" of Directive 2001/83/EC relating to medicinal products for human use were summarized. Provisions in EU directives regarding blood products, radiopharmaceuticals, and herbal and homeopathic medicinal products were excluded. Cross-referencing to other provisions was included. European case-law was retrieved from the InfoCuria database to exemplify the implications of alternative routes. Results: Medicines may only be placed on the market with a valid marketing authorization. To obtain such authorization in Europe, a "Common Technical Document" comprising reports on quality and non-clinical and clinical studies must be submitted to a "competent authority", a national medicine agency or the European Medicines Agency. Timely interaction of academic researchers with regulators via scientific advice may lead to better regulatory alignment and subsequently a higher chance for approval of academic inventions. Furthermore, reimbursement by national payers could be essential to ensure patient access. Apart from the marketing authorization route, we identified multiple alternative routes to provide (early) access. These include off-label use, named-patient basis, compassionate use, pharmacy compounding, and hospital exemption for Advanced Therapy Medicinal Products. Discussion: Aligning academic (non-)clinical studies on rare diseases with regulatory and reimbursement requirements may facilitate fast and affordable access. Several alternative routes exist to provide (early) pharmaceutical care at a national level, but case-law demonstrates that alternative routes should be interpreted strictly and for exceptional situations only. Academics should be aware of these routes and their requirements to improve access to medicines for rare diseases.

Homeopathic medicinal products for preventing and treating acute respiratory tract infections in children.

Acute respiratory tract infections (ARTIs) are common and may lead to complications. Most children experience between three and six ARTIs annually. Although most infections are self-limiting, symptoms can be distressing. Many treatments are used to control symptoms and shorten illness duration. Most treatments have minimal benefit and may lead to adverse events. Oral homeopathic medicinal products could play a role in childhood ARTI management if evidence for their effectiveness is established. This is an update of a review first published in 2018. To assess the effectiveness and safety of oral homeopathic medicinal products compared with placebo or conventional therapy to prevent and treat ARTIs in children. We searched CENTRAL (2022, Issue 3), including the Cochrane Acute Respiratory Infections Specialised Register, MEDLINE (1946 to 16 March 2022), Embase (2010 to 16 March 2022), CINAHL (1981 to 16 March 2022), AMED (1985 to 16 March 2022), CAMbase (searched 16 March 2022), and British Homeopathic Library (searched 26 June 2013 - no longer operating). We also searched the WHO ICTRP and ClinicalTrials.gov (16 March 2022), checked references, and contacted study authors to identify additional studies. We included double-blind randomised controlled trials (RCTs) or double-blind cluster-RCTs comparing oral homeopathy medicinal products with identical placebo or self-selected conventional treatments to prevent or treat ARTIs in children aged 0 to 16 years. We used standard methodological procedures expected by Cochrane. In this 2022 update, we identified three new RCTs involving 251 children, for a total of 11 included RCTs with 1813 children receiving oral homeopathic medicinal products or a control treatment (placebo or conventional treatment) for ARTIs. All studies focused on upper respiratory tract infections (URTIs), with only one study including some lower respiratory tract infections (LRTIs). Six treatment studies examined the effect on URTI recovery, and five studies investigated the effect on preventing URTIs after one to four months of treatment. Two treatment and three prevention studies involved homeopaths individualising treatment. The other studies used predetermined, non-individualised treatments. All studies involved highly diluted homeopathic medicinal products, with dilutions ranging from 1 x 10-4 to 1 x 10-200. We identified several limitations to the included studies, in particular methodological inconsistencies and high attrition rates, failure to conduct intention-to-treat analysis, selective reporting, and apparent protocol deviations. We assessed three studies as at high risk of bias in at least one domain, and many studies had additional domains with unclear risk of bias. Four studies received funding from homeopathy manufacturers; one study support from a non-government organisation; two studies government support; one study was co-sponsored by a university; and three studies did not report funding support. Methodological inconsistencies and significant clinical and statistical heterogeneity precluded robust quantitative meta-analysis. Only four outcomes were common to more than one study and could be combined for analysis. Odds ratios (OR) were generally small with wide confidence intervals (CI), and the contributing studies found conflicting effects, so there was little certainty that the efficacy of the intervention could be ascertained. All studies assessed as at low risk of bias showed no benefit from oral homeopathic medicinal products, whilst trials at unclear or high risk of bias reported beneficial effects. For the comparison of individualised homeopathy versus placebo or usual care for the prevention of ARTIs, two trials reported on disease severity; due to heterogeneity the data were not combined, but neither study demonstrated a clinically significant difference. We combined data from two trials for the outcome need for antibiotics (OR 0.79, 95% CI 0.35 to 1.76; low-certainty evidence). For the comparison of non-individualised homeopathy versus placebo or usual care for the prevention of ARTIs, only the outcome recurrence of ARTI was reported by more than one trial; data from three studies were combined for this outcome (OR 0.60, 95% CI 0.21 to 1.72; low-certainty evidence). For the comparison of both individualised and non-individualised homeopathy versus placebo or usual care for the treatment of ARTIs, two studies provided data on short-term cure (OR 1.31, 95% CI 0.09 to 19.54) and long-term cure (OR 1.01, 95% CI 0.10 to 9.96; very low-certainty evidence). The studies demonstrated an opposite direction of effect for both outcomes. Six studies reported on disease severity but were not combined as they used different scoring systems and scales. Three studies reported adverse events (OR 0.79, 95% CI 0.16 to 4.03; low-certainty evidence). Pooling of five prevention and six treatment studies did not show any consistent benefit of homeopathic medicinal products compared to placebo on ARTI recurrence or cure rates in children. We assessed the certainty of the evidence as low to very low for the majority of outcomes. We found no evidence to support the efficacy of homeopathic medicinal products for ARTIs in children. Adverse events were poorly reported, and we could not draw conclusions regarding safety.

Correct calculations of a “safe” daily dose of raw materials for homeopathic remedies. Re: Toxicological assessment compilation of selected examples of raw materials for homeopathic and anthroposophic medicinal products - Part 2. Regulatory Toxicology and Pharmacology, 2022. 134

Correct calculations of a “safe” daily dose of raw materials for homeopathic remedies. Re: Toxicological assessment compilation of selected examples of raw materials for homeopathic and anthroposophic medicinal products - Part 2. Regulatory Toxicology and Pharmacology, 2022. 134

Evidence-Based Human Homeopathy and Veterinary Homeopathy. Comment on Bergh et al. A Systematic Review of Complementary and Alternative Veterinary Medicine: "Miscellaneous Therapies". Animals 2021, 11, 3356.

Simple SummaryAccording to the simile principle (Similia similibus curentur, or ‘Let like be cured by like’), classical (=individualized) homeopathic therapy is based on the individual and not on the indication. Based on the following three facts, the discussion of the evidence in human and veterinary homeopathy lays the foundations for a comprehensive presentation of the evidence on homeopathy: (a) homeopathic medicinal products without indication are 100% identical with regard to production, quality, safety, and principles of application, regardless of whether they are used in animals or humans; (b) if the simile principle is adhered to that classical (=individualized) homeopathic therapy is based on the individual and not on the indication; and (c) if the proof of effectiveness of individualized homeopathy in one or more indications is available, the logical consequence seems to be that it can be concluded that it is effective in other indications. When criteria for evidence-based medicine for design, conduction, documentation, and rating of studies in homeopathy are considered, effects on all quality levels according to Cochrane criteria are recognizable, especially for individualized homeopathy, even in methodologically high-quality studies. In view of One Health and of the demands of the European Green Deal (Farm2Fork Strategy) and the EU Organic Regulation 2018/848, the application of homeopathy in the sense of integrative veterinary medicine (a combination of patient-oriented conventional and complementary veterinary medicine) and the integration of complementary medicine including homeopathy at the universities seems a necessary consequence and requirement in the interests of the patient.(1) Background: Classical (=individualized) homeopathic therapy is based on the individual and not on the indication. (2) Methods: The prerequisite for conducting methodologically high-quality studies on indvidualized homeopathy is that the principles of homeopathy are considered, since the selection of the simile (the individually appropriate homeopathic medicinal product) is decisive for the effectiveness of the homeopathic treatment, because only an application lege artis can be effective for the respective patient. Apart from this, criteria for evidence-based medicine must be considered for design, conduction, documentation, and rating of studies in homeopathy. (3) Results: When criteria for evidence-based medicine for design, conduction, documentation, and rating of studies in homeopathy are considered, effects on all quality levels according to Cochrane criteria are recognizable, especially for individualized homeopathy, even in the methodologically high-quality studies. (4) Conclusions: Based on the following three facts, the discussion of the evidence in human and veterinary homeopathy lays the foundations for a comprehensive presentation of the evidence on homeopathy: (a) homeopathic medicinal products without indication are 100% identical with regard to production, quality, safety, and principles of application, regardless of whether they are used in animals or humans; (b) if the simile principle (Similia similibus curentur, or ‘Let like be cured by like’) is adhered to that classical (=individualized) homeopathic therapy is based on the individual and not on the indication; and (c) if the proof of effectiveness of individualized homeopathy in one or more indications is available, the logical consequence seems to be that it can be concluded that it is effective in other indications. In view of One Health and of the demands of the European Green Deal (Farm2Fork Strategy) and the EU Organic Regulation 2018/848, the application of homeopathy in the sense of integrative veterinary medicine and the integration of complementary medicine including homeopathy at universities seems a necessary consequence and requirement in the interests of the patient, which is already expressed in the American consensus guidelines for an integrative veterinary medicine curriculum and is legally anchored in Switzerland by the Medical Professions Act for university teaching and research.

Toxicological assessment compilation of selected examples of raw materials for homeopathic and anthroposophic medicinal products – Part 2

The present successor article comprises more than 180 substances representing a continuative compilation of toxicologically evaluated starting materials prompted by the wide use and high number of homeopathic and anthroposophic medicinal products (HMP) on the market together with the broad spectrum of active substances of botanical, mineral, chemical or animal origin contained therein, and by the equally important requirement of applying adequate safety principles as with conventional human medicinal products in line with the European regulatory framework. The February 2019 issue of the Regulatory Toxicology and Pharmacology journal includes the antecedent article bearing the same title and entailing safety evaluations of more than 170 raw materials processed in HMP. This part 2 article highlights scientific evaluation following recognized methods used in toxicology with a view to drug-regulatory authority's assessment principles and practice in the context of HMP, and offers useful systematic, scientifically substantiated and simultaneously pragmatic approaches in differentiated HMP risk assessment. As a unique feature, both articles provide the most extensive publicly available systematic compilation of a considerable number of substances processed in HMP as a transparent resource for applicants, pharmaceutical manufacturers, the scientific community and healthcare authorities to actively support regulatory decision making in practice.

The use of biopreparations in the therapy of mastitis in cows

With the aim of improving productive potential of black pied cattle, preventing and treating clinical mastitis we used biopreparations developed by scientists of the Federal State Budgetary Establishment of Higher Education ‘Chuvash State Agrarian University’: Prevention-N-E and Prevention-N-B-S, as well as Mastinol, homeopathic medicinal product for treatment of mastitis. It follows from the results of our studies that the biological preparations used in the experiments did not influence the physiological condition of animals but activated cell factors of non-specific organism protection. The most obvious effect was demonstrated by Prevention-N-B-S, rather than Prevention-N-E, however this difference was insignificant (P>0.05). Prevention of mastitis in cows with Prevention-N-B-S biopreparation turned out to be more effective than with Prevention-N-E and Mastinol. Recovery of one cow of the 1st experimental group treated by Prevention-N-E took place in 4±0.08 days, which is 7±52 less than in the 3rd experimental group, where Mastinol was used. Atrophy of an udder lobe was observed in one cow in the 3rd experimental group. As a result, the issue of pathogenetic therapy of mastitis in cows is still relevant and we plan to solve it with the use of immunostimulants.

Cedrus libani, a homeopathic medicinal product coming from a symbolic tree. From the pathogenetic trial, clinical cases and a reflection on the myths and botany of the Lebanon cedar

The homeopathic medicinal product Cedrus libani featured unexpected therapeutic properties during a multicentre pathogenetic trial performed in 2016, concerning the treatment of vascular congestion in the upper part of the body for patients with a specific psychological profile. The important symbolism linked to this tree, involved in the three main monotheistic religions expressed itself in the experimenters’ testimonies and in the clinical pictures of the few cured cases. The study of the botany and of the myths regarding the tree gives us an insight into the richness of this medicine, before further clinical practices confirm its indications.

Homeopathy and levels of Ca++ salivary in the prevention of dental caries

Comparative studies between systemic inducing bone neoformation medications showed favorable results for homeopathic medicines. (Almeida et al., 2000; Werkman et al., 2006, FARINA, 2010). The Calcareas, are described in the literature for their action in the mineralization processes and increase of the levels of Ca ++ tissue ((LATHOUD, 1998; ARGENTA, 2005; VIJNOVSKY, 1999; VOISIN, 1971). NARDY-MELO, 2013, found that Calcarea carbonica 6CH, Calcarea phosphorica 6CH and Calcarea fluorica 6CH, when given as a compound, are statistically significant for increasing tissue Ca ++ levels. Objective This randomized controlled multicentric study, approved by the UniFOA's Human beings Research Ethics Committee CAAE:39002914.0.0000.5237, has aspiration to quantify the level of Ca + + salivary in front of the administration of homeopathic medicines Calcarea Carbonica, Calcarea Phosphorica, Calcarea Fluorica, as supporting in the prevention of dental caries, Demineralization and Dental l, from the stimulus to increase of Ca + + salivary. Method (n=48) Children in the age range of 04 to 16 years, with high rate of dental caries, submitted to dental treatment, without the preventive application of fluoride topical and specific food guidelines were divided randomly, in 2 groups according to the medication experienced: GI – Calcarea Carbonica 6CH; Calcarea phosphorica 6 CH; Calcarea fluorica 6CH, in the dose of 3 daily drops for 15 days a month for three months. GII – Upward scales of Calcarea Carbonica 6CH; Calcarea phosphorica 6CH; Calcarea fluorica 6CH, in the dose of 3 daily drops, in the first month. Calcarea Carbonica 9CH; Calcarea phosphorica 9CH; Calcarea fluorica 9CH, in the dose of 3 daily drops, in the second month. Calcarea Carbonica 12CH; Calcarea phosphorica 12CH; Calcarea fluorica 12CH, in the dose of 3 daily drops, in the third month. The salivary Ca + + levels was measured before the administration of the first dose and monthly, for 03 consecutive months. The calcium (mg/dl) salivary indices were determined by optical emission spectrometry (ICP-OES). Results The results were submitted to statistical analysis with Student T-Test (significance with P &lt; 0.05) and analysis of variance Shapiro-Wilk normality test. Conclusion: The averages of calcium increase under the action of homeopathic medicinal products: Calcarea Carbonica, Calcarea Phosphorica and Calcarea Fluorica, in this study, do not differ in G I and G II and in both groups the increase in salivary calcium level was statistically significant to 0.5%.

Homeopathic medicinal products for preventing and treating acute respiratory tract infections in children (Review).

International Journal of Nursing PracticeVolume 27, Issue 4 e12904 COCHRANE NURSING NETWORK Homeopathic medicinal products for preventing and treating acute respiratory tract infections in children (Review) Susan Mace Weeks DNP, RN, CNS, LMFT, LCDC, FNAP, Corresponding Author FAAN Vice Provost, Professor, Executive Director s.weeks@tcu.edu Health Innovation Institute, Texas Christian University, Fort Worth, Texas, USA Correspondence Susan Mace Weeks, Health Innovation Institute, Texas Christian University, Fort Worth, TX, USA. Email: s.weeks@tcu.eduSearch for more papers by this author Susan Mace Weeks DNP, RN, CNS, LMFT, LCDC, FNAP, Corresponding Author FAAN Vice Provost, Professor, Executive Director s.weeks@tcu.edu Health Innovation Institute, Texas Christian University, Fort Worth, Texas, USA Correspondence Susan Mace Weeks, Health Innovation Institute, Texas Christian University, Fort Worth, TX, USA. Email: s.weeks@tcu.eduSearch for more papers by this author First published: 01 December 2020 https://doi.org/10.1111/ijn.12904Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume27, Issue4August 2021e12904 RelatedInformation

Evidence-based homeopathy and veterinary homeopathy, and its potential to help overcome the anti-microbial resistance problem - an overview

The basic principles of homeopathy, and its legal and scientific foundations, are discussed in an overview to address the positions of the World Health Organization (WHO) and the commission of the European Union (EU) on complementary medicine. According to the WHO,the antimicrobial resistance problem poses aglobal threat. The EU Commission's current One Health Action Plan requests research in complementary medicine, the WHO urges member states to include complementary medicine in their national health policies. Regarding external evidence on the general use of human and veterinary homeopathy, evidence level 1a studies are reviewed. Focusing on the external evidence on the use of homeopathy in infections, some evidence level 1a, 1b, 2c studies, and a case report, are described in more detail. In conclusion, evidence for the effectiveness of human and veterinary homeopathy in general, and in particular, of homeopathic treatment for infections, is available. Especially, individualized homeopathy demonstrates effects at all quality levels according to Cochrane criteria, even in the methodologically high-quality studies. As in most areas of veterinary medicine and medicine, further good/excellent studies are necessary. In compliance with the principles of homeopathy, further methodologically high-quality trials focusing on the homeopathic treatment of infections are the next logical step. The selection of the simile (individually fitting homeopathic medicinal product) by appropriately trained homeopathic doctors/veterinarians is essential for the effectiveness of homeopathy. Implementation of studies at university facilities is a prerequisite for quality assurance.Consequently, further integration of homeopathy at universities is a necessary requirement for the patients'best interests.

The preclinical studies of the stress-protective activity of “Tonus-aktiv” homeopathic granules

Aim. To perform the preclinical studies of the stress-protective activity of a new “Tonus-Aktiv” homeopathic medicinal product.Materials and methods. The stress-protective effect of the “Tonus-Aktiv” homeopathic medicinal product (MP) and the reference drug – “Stress-gran” homeopathic granules were studied on the model of neuromuscular tension by Selye. The stress-protective effect of the drugs was assessed by the conventional methods described in the scientific literature and the corresponding current instructional guidelines. All factual material was processed by variational statistics methods using parametric (Newman-Keuls test) and non-parametric methods of analysis (Kruskal-Wallis, Mann-Whitney).Results and discussion. It was found that “Tonus-Aktiv” had a pronounced gastro-protective effect, reducing the area of ulcers by almost 3 times, having a statistically significant antioxidant effect, reducing the level of TBA (thiobarbituric acid) active products in the liver homogenate. It did not have a normalizing effect on the protein metabolism, but it did contribute to enhancing energy-supplying metabolic processes: aerobic glycolysis indicated by a reliable increase of the pyruvic acid level in the blood serum, and lipolysis, as evidenced by a significantly higher level of the total blood lipids. “Tonus-Aktiv” showed a pronounced antioxidant activity: it reduced the TBA level of active products in the liver homogenate. At the same time, the level of endogenous antioxidant of reduced glutathione was observed to be lower than in the stressed animals against the background of the “Tonus-Aktiv” application. It indicates the physiological nature of the stress protective activity of the drug.Conclusions. A moderate stress-protective activity of “Tonus-Aktiv” homeopathic granules can be observed; it is caused by antioxidant properties, as well as a probable activating effect on the hypothalamic-pituitary-adrenal system, which may be manifested by the protective action.

Ulva lactuca, green algae, a homeopathic medicine in line with current environmental questions

Ulva lactuca, the green algae, is a homeopathic medicinal product whose Materia Medica has been discovered thanks to a pathogenetical trial realized in 2012.Up till then, its use was mostly phytotherapeutic. By studying the natural history of the plant, of its pathogenetical features and with clinical cases we can describe the indications of this medicine and notice their correlation with the invasive and polluting nature of this seaweed.

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

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. 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. 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.

The Coherency of Regulatory Requirements for Homeopathic Medicinal Products in the EU and the EAEU

The Coherency of Regulatory Requirements for Homeopathic Medicinal Products in the EU and the EAEU