ABSTRACT
BACKGROUND The aim of this study was to analyze the clinical application of cortex phellodendri compound fluid (CPCF) in the treatment of diabetic foot ulcers. MATERIAL AND METHODS From January 2012 to December 2015, a total of 720 cases of diabetic foot ulcers (DFU) were randomly assigned into an experimental group (n=540) that was treated by CPCF and a control group (n=180) that was treated by a Kangfuxin solution (KFS). After 4 weeks of treatment, their ulcer area, serum growth factor, clinical total effective rate, and incidence of adverse events were assessed. RESULTS There were 720 patients who completed the trial. The experimental group was superior to the control group in reducing ulcer area, increasing growth factor content, and total effective rate (P<0.05). There was no significant difference in the adverse events rates between the 2 groups. CONCLUSIONS CPCF external treatment of diabetic foot ulcer can promote ulcer healing and increase the concentration of growth factors, and it is safe and reliable.
Subject(s)
Diabetic Foot/drug therapy , Drugs, Chinese Herbal/administration & dosage , Drugs, Chinese Herbal/adverse effects , Materia Medica/administration & dosage , Materia Medica/adverse effects , Phellodendron/chemistry , Phytotherapy/adverse effects , Administration, Cutaneous , Aged , Diabetic Foot/blood , Epidermal Growth Factor/blood , Female , Fibroblast Growth Factors/blood , Humans , Male , Middle Aged , Treatment Outcome , Vascular Endothelial Growth Factor A/blood , Wound Healing/drug effectsABSTRACT
Lamb farming is generally a secondary activity for farmers, and many breeding systems suffer from management failures that impair production. One reason for decline in performance is enteritis, usually affecting newborn lambs. Enteritis can be fatal, especially in dairy herds. Generally, lambs are fed sucrose or unprocessed milk from sheep or cow that is heated and fed to animals two or three times a day in baby bottles. However, on most farms, milk temperature differs among feeds, as often the process of alteration among diet adaptations is deficient, contributing to enteritis and consequent diarrhea. Therefore, the objective of the present study was to verify the administration of the homeopathic product (Dia 100®) in newborn and bottle-fed lambs, in order to prevent or minimize the occurrence of diarrhea. We studied 60 lambs, divided into two groups with ten repetitions each (nâ¯=â¯30) and during the nursing period (1-45 days of life). Animals in the treated group received the homeopathic product (36â¯g) orally divided into three doses (1, 7 and 14 days of life). We measured weight gain, mortality, bacterial counts (Escherichia coli and total coliforms) in feces, hematological analysis (leukocytes, hematocrit, hemoglobin and erythrocytes) and biochemical analyses (glucose, triglycerides, cholesterol, albumin, globulin, urea and total protein) at four time-points. There were no differences in weight gain between groups (Pâ¯>â¯0.05); however, there was a higher mortality rate in the control group (13%) than in the treated group (6%). E. coli counts were significantly higher in the stools of control group lambs on days 15 and 45 of the experiment (Pâ¯<â¯0.05). Total leukocyte counts were greater in treated animals due to greater numbers of lymphocytes on day 15 of the experiment (Pâ¯<â¯0.05). In the treated group, we found higher serum levels of total protein, urea (day 15), globulin and triglycerides (days 15 and 30). In the period of administration of the homeopathic product, there was substantial and significant reduction of cases of diarrhea (up to day 14); however, after this period, there were no difference between groups. Based on these results, we concluded that the homeopathic product had moderate efficacy in terms of control of diarrhea. The treated lambs made better use of nutrients, contributing to the development of their immune responses.
Subject(s)
Diarrhea/prevention & control , Materia Medica/administration & dosage , Sheep Diseases/prevention & control , Administration, Oral , Animals , Animals, Newborn , Bacterial Load , Blood Cells , Blood Chemical Analysis , Body Weight , Feces/microbiology , Sheep , Survival Analysis , Treatment OutcomeABSTRACT
Context: Kangfuxin (KFX) is widely used for the treatment of gastric and duodenal ulcer; however, more research is needed to determine the protective mechanisms of KFX in ameliorating gastric ulcer.Objective: To investigate the efficacy and potential mechanism of Kangfuxin liquid (KFX) in water-immersion and restraint stress (WIRS)-induced gastric ulcer.Materials and methods: Seventy rats were randomly divided into seven groups (n = 10) as follows: the control group (normal saline, i.g.), the model group (normal saline, i.g.), the KFX groups (2.5, 5 and 10 mL/kg, i.g.), the omeprazole group (20 mg/kg, i.p.) and Sanjiuweitai Granules group (1850 mg/kg, i.g.). The WIRS model was applied to induce stress ulcers after 7 days of drug administration. Afterwards, rats were sacrificed at 10 h induced by WIRS.Results: Pre-treatment with KFX (5,10 mL/kg) could effectively reduce the area of gastric ulcers and improve the pathological changes of ulcerated tissue. Moreover, KFX (5,10 mL/kg) increased the prostaglandin E2 (52%) and cyclooxygenase-1 (30%) levels, and improved malondialdehyde (54%), superoxide dismutase (58%), catalase (39%), and nitric oxide (11%) and TNF-α (9%), IL-6 (11%), MMP-9 (54%) and MMP-2 (53%) of ulcer tissue. Furthermore, pre-treatment with KFX dramatically increased IGF-1, PTEN, and Akt protein expression.Conclusions: Our results suggest that KFX has protective effects on WIRS-induced gastric ulcer via inflammatory reactions, oxidative stress inhibition, and pro-survival action, which were the results of activating the IGF-1/PTEN/Akt signalling pathway. Our results provide evidence of KFX for treating gastric ulcer.
Subject(s)
Anti-Inflammatory Agents/pharmacology , Anti-Ulcer Agents/pharmacology , Materia Medica/pharmacology , Stomach Ulcer/prevention & control , Animals , Anti-Inflammatory Agents/administration & dosage , Anti-Ulcer Agents/administration & dosage , Antioxidants/administration & dosage , Antioxidants/pharmacology , Disease Models, Animal , Dose-Response Relationship, Drug , Inflammation/prevention & control , Male , Materia Medica/administration & dosage , Omeprazole/pharmacology , Oxidative Stress/drug effects , Rats , Rats, Sprague-Dawley , Restraint, Physical , Stress, Psychological/complicationsABSTRACT
Context ⢠Pertussis cough (whooping cough) is distressing due to the intensity and chronicity of its cough. No specific drugs are available that can alleviate the cough's intensity or significantly shorten its duration. Homeopathic medicines are used for a wide variety of medical conditions, including cough. Objective ⢠The study investigated the benefits of homeopathic medicines for whooping cough, to alleviate the cough's intensity and to shorten its duration. Design ⢠The current study was a case series of patients with whooping cough. Setting ⢠The study took place at one of the suburban hospital clinics of the Ann & Robert H. Lurie Children's Hospital of Chicago (Chicago, IL, USA). Participants ⢠Participants were 20 patients aged 21 mo to 20 y, of whom 11 were female and 18 were male, who visited the hospital clinic for treatment of the chronic cough that is characteristic of whooping cough. The details of the cases of 3 representative participants are highlighted in the text. Intervention ⢠The 3 representative patients all received 1 dose weekly of a 30c dilution of homeopathic pertussinum and a 6c dilution of homeopathic Drosera 3 times daily. The homeopathic medicines most often used for the other participants were the same doses of pertussinum and Drosera. Outcome Measures ⢠Verbal feedback from patient or family were obtained at the follow-up visits. Results ⢠The intensity and duration of participant's coughs were alleviated within days to 1 wk in most cases. Conclusions ⢠Homeopathic medicines can alleviate the intensity or reduce the duration of whooping cough, with no adverse effects.
Subject(s)
Materia Medica/therapeutic use , Whooping Cough/drug therapy , Whooping Cough/physiopathology , Adolescent , Adult , Chicago , Child , Child, Preschool , Drosera , Female , Humans , Infant , Male , Materia Medica/administration & dosage , Young AdultABSTRACT
BACKGROUND: Contact dermatitis (CD) is a frequently occurring medical condition, for which Vinca minor (VM) is one of the recommended homeopathic medicines. However, the symptoms indicating this medicine have not yet been assessed systematically. Likelihood ratio (LR), based on Bayesian statistics, may yield better estimation of a medicine's indication than the existing method of entry of symptoms into materia medica and repertories. METHODS: We investigated LRs of four CD symptoms of VM: (1) great sensitiveness of skin, with redness and soreness from slightest rubbing; (2) weeping eczema with foul, thick crusts; (3) itching amelioration in open air; and (4) CD of scalp. An observational, prospective, patient-outcome study was conducted in five different practice settings on 390 CD patients over 18 months using three outcomes-Glasgow Homeopathic Hospital Outcome Scale (GHHOS), Scoring Atopic Dermatitis (SCORAD), and Dermatology Life Quality Index (DLQI), assessed at baseline, after 3 and 6 months. The LR of each of the four symptoms was estimated as per the patient-rated outcomes on GHHOS. RESULTS: Seventy-four VM and 316 non-VM cases were analyzed. Estimated LRs were as follows: symptom 1, 1.29 (95% confidence interval [CI]: 0.65 to 2.60); symptom 2, 1.48 (95% CI: 0.80 to 2.74); symptom 3, 1.70 (95% CI: 0.94 to 3.07); symptom 4, 1.36 (95% CI: 0.74 to 2.51). There were statistically significant reductions in SCORAD and DLQI scores over 3 and 6 months. CONCLUSION: There was insufficient evidence to attribute any of the four assessed symptoms clearly to VM. Though non-significant, a high LR was observed for "itching amelioration in open air" (symptom 3). Symptoms in the homeopathic materia medica for VM are perhaps over-represented. More research of this nature is warranted.
Subject(s)
Dermatitis, Atopic/drug therapy , Homeopathy/methods , Materia Medica/administration & dosage , Vinca , Adult , Female , Follow-Up Studies , Humans , Male , Placebos , Prospective Studies , Treatment OutcomeABSTRACT
BACKGROUND: Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Homeopathy has been widely used to treat side effects of chemotherapy. The n-of-1 design is a single-patient trial method to study a clinical condition that is either short lived and reversible or is chronic and stable. The n-of-1 design requires a washout/reset period. The feasibility of performing an n-of-1 study in homeopathy has not previously been tested. METHODS: A feasibility n-of-1 trial of individualized homeopathic treatment for fatigue in a single adult undergoing chemotherapy administered periodically was performed. For each matched pair of treatments, the participant was randomly allocated either placebo or verum for the period between treatments. For the subsequent treatment period, the opposite allocation was given. Participant and practitioner were blinded to the allocation. Ongoing conventional treatments were permitted. The ability to recruit and retain was monitored and changes in fatigue and quality of life were measured using two validated outcome measures. RESULTS: Sixty-eight patients were assessed between February 2014 and February 2015. Four patients were eligible for the study and one consented to participate. The participant enrolled in the study for six cycles of chemotherapy and completed all treatment and outcome measures. There was no improvement under homeopathic treatment compared to placebo. There were multiple confounding events such as conventional medication changes and an adverse event unrelated to therapy. CONCLUSION: Adequate recruitment was not feasible in this setting. The n-of-1 study design is feasible in this population from the perspective of the ability to complete the trial. No conclusion on the efficacy of homeopathy for this individual can be made. It is unclear as to whether multiple treatments of chemotherapy would be an appropriate clinical situation in which to apply the n-of-1 trial methodology. Future studies should pilot adaptations to this study design.
Subject(s)
Fatigue/therapy , Homeopathy/methods , Materia Medica/administration & dosage , Adult , Double-Blind Method , Feasibility Studies , Female , Humans , Male , Neoplasms/complications , Pilot Projects , Precision Medicine/methods , Treatment OutcomeABSTRACT
Scopo della presente trattazione è promuovere la consapevolezza del pediatra nei confronti della sintomatologia legata alla dentizione nei bambini con il supporto delle evidenze più significative reperibili nella letteratura scientifica. Dopo la caratterizzazione dei disturbi più comuni, con la relativa incidenza e durata nella popolazione pediatrica, e del ruolo dell'infiammazione saranno definiti i limiti delle terapie attualmente disponibili. Saranno quindi illustrate le prerogative di un medicinale omeopatico, Camilia® (Boiron, Francia), che interviene sull'infiammazione locale e sistemica e sulla composita fenomenologia correlata al processo di dentizione, con il vantaggio di un'azione multifunzionale ed efficace e l'assenza di effetti indesiderati o rischi di interazione con altri farmaci.
Subject(s)
Inflammation/etiology , Materia Medica/administration & dosage , Tooth Eruption , Humans , Infant , Inflammation/therapy , Pediatricians/organization & administrationABSTRACT
BACKGROUND: Primary tooth eruption in infants is associated with a range of local and systemic symptoms although this remains a subject of much debate. In addition, data are limited on the role of physicians in managing infant teething, and on the benefit of homeopathic treatments. METHODS: We conducted an observational, multicenter, prospective survey evaluating teething symptoms, and symptom course following routine medical management by French pediatricians in 597 infants aged from 3 to 24 months. We also examined the response to treatment with routinely prescribed teething medications; the homeopathic agent, Camilia® and topically applied gingival agents (Delabarre® or Dolodent®). RESULTS: Most infants (96.6%) had buccogingival symptoms and 93.3% had at least one general symptom. Fever (≥38 °C) was reported in 15.2% of infants. For teething, 212 infants were prescribed Camilia®, 172 a gingival solution (Delabarre® or Dolodent®) and 213 received Camilia® along with a gingival agent. Infants prescribed both a homeopathic and a gingival treatment had a significantly higher number of symptoms at presentation compared with those prescribed a single agent. There were no significant differences in symptom course across these three treatment groups. Systemic analgesics/antipyretics were prescribed in 68.8% of cases. Parent satisfaction with medical management and prescribed treatments was high. CONCLUSIONS: Teething is frequently associated with transient local and systemic upset in infants and is a significant concern to parents. Camilia® provides a similar benefit to topical therapy, and is frequently used by pediatricians in France.
Subject(s)
Materia Medica/administration & dosage , Parents/psychology , Practice Patterns, Physicians'/statistics & numerical data , Tooth Eruption , Administration, Topical , Benzoates/administration & dosage , Child, Preschool , Female , Fever/epidemiology , Fever/etiology , France , Humans , Infant , Longitudinal Studies , Male , Pediatricians/statistics & numerical data , Prospective Studies , Surveys and Questionnaires , Treatment OutcomeABSTRACT
Recurrent aphthous ulcer (RAU) is a common and frequently occurring disease in the Department of Stomatology. The clinical manifestations are localized ulcer of oral mucosa, and the ulcer mask is self limiting and easy to recur. In this paper, by adopting the randomized study method, the author study the effect of oral ulcer powder combined with traditional Chinese drugs on patients with recurrent aphthous ulcer, and analyze its effect on inflammatory factor. Kangfuxin liquid combined with oral ulcer powder helps reduce recurrent aphthous ulcer patients the levels of inflammatory factors, improve the symptoms of pain. The recurrence rate of the patients in the observation group for 6 months was 12.8%, which was significantly lower than that of the control group (31.42%). The difference was statistically significant (P<0.05). At the same time, the average TNF-a, IL-1 and IL-6 water in the observation group were significantly lower than that of the control group, proving that the treatment regimen could reduce the inflammatory response.
Subject(s)
Drugs, Chinese Herbal/therapeutic use , Materia Medica/therapeutic use , Stomatitis, Aphthous/drug therapy , Adolescent , Adult , Female , Humans , Male , Materia Medica/administration & dosage , Medicine, Chinese Traditional , Middle Aged , Young AdultABSTRACT
The objective of the present study was to evaluate the effectiveness of the application of homeovox for the combined treatment of small vocal cord nodules and acute laryngitis in the professional voice users. A total of 40 subjects presenting with dysphonia were examined after they were divided into two study groups and two groups of comparison depending on the nosological form of the pathological condition. The subjects comprising the study groups were given traditional therapy in the combination with the intake of homeovox whereas the patients included in the two groups of comparison received the traditional treatment alone. The outcome of the treatment was evaluated on days 1, 5, and 10 after the initiation of therapy based on the analysis of the changes in the videoendostroboscopic picture of the larynx and the acoustic characteristics obtained by the computer-assisted analysis of the voice. The analysis of the results of the combined treatment has demonstrated the statistically significant differences in some acoustic parameters of the voice between the subjects with small vocal cord nodules and acute laryngitis belonging to the study groups and the groups of comparison. It is concluded that the introduction of homeovox in the combined treatment of the patients presenting with the small nodules in the vocal cords and acute catarrhal laryngitis accelerates the recovery of the acoustic characteristics of the voice within various periods after the onset of the treatment in comparison with the patients treated with the use of traditional therapy alone.
Subject(s)
Dysphonia , Materia Medica/administration & dosage , Occupational Diseases , Voice Quality/drug effects , Adult , Anti-Inflammatory Agents/administration & dosage , Drug Monitoring , Drug Therapy, Combination/methods , Dysphonia/diagnosis , Dysphonia/drug therapy , Dysphonia/etiology , Dysphonia/physiopathology , Expectorants/administration & dosage , Female , Humans , Laryngoscopy/methods , Male , Middle Aged , Occupational Diseases/diagnosis , Occupational Diseases/drug therapy , Occupational Diseases/etiology , Occupational Diseases/physiopathology , Treatment OutcomeABSTRACT
Silicosis is an occupational pulmonary fibrosis caused by inhalation of silica (SiO2) and there are no ideal drugs to treat this disease. Earthworm extract (EE), a natural nutrient, has been reported to have anti-inflammatory, antioxidant, and anti-apoptosis effects. The purpose of the current study was to test the protective effects of EE against SiO2-induced pulmonary fibrosis and to explore the underlying mechanisms using both in vivo and in vitro models. We found that treatment with EE significantly reduced lung inflammation and fibrosis and improved lung structure and function in SiO2-instilled mice. Further mechanistic investigations revealed that EE administration markedly inhibited SiO2-induced oxidative stress, mitochondrial apoptotic pathway, and epithelial-mesenchymal transition in HBE and A549 cells. Furthermore, we demonstrate that Nrf2 activation partly mediates the interventional effects of EE against SiO2-induced pulmonary fibrosis. Our study has identified EE to be a potential anti-oxidative, anti-inflammatory, and anti-fibrotic drug for silicosis.
Subject(s)
Antioxidants/therapeutic use , Disease Models, Animal , Lung/drug effects , Materia Medica/therapeutic use , Oligochaeta/chemistry , Pulmonary Fibrosis/prevention & control , Silicosis/drug therapy , Tissue Extracts/therapeutic use , Animals , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/pharmacology , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Antioxidants/administration & dosage , Antioxidants/pharmacology , Apoptosis/drug effects , Cell Line , Cells, Cultured , Epithelial-Mesenchymal Transition/drug effects , Injections, Intraperitoneal , Lung/metabolism , Lung/pathology , Lung/physiopathology , Male , Materia Medica/administration & dosage , Materia Medica/pharmacology , Mice, Inbred C57BL , NF-E2-Related Factor 2/agonists , NF-E2-Related Factor 2/antagonists & inhibitors , NF-E2-Related Factor 2/genetics , NF-E2-Related Factor 2/metabolism , Oxidative Stress/drug effects , Pulmonary Fibrosis/etiology , Pulmonary Fibrosis/immunology , RNA Interference , Random Allocation , Respiratory Mucosa/cytology , Respiratory Mucosa/drug effects , Respiratory Mucosa/metabolism , Respiratory Mucosa/pathology , Silicosis/metabolism , Silicosis/pathology , Silicosis/physiopathology , Specific Pathogen-Free Organisms , Tissue Extracts/administration & dosage , Tissue Extracts/pharmacologyABSTRACT
The purpose of this study was to evaluate the effect of two administration methods of a biostimulatory homeopathic complex (Convert H®) on the production of fresh and lyophilized venom of rattlesnakes (Crotalus durissus) under intensive captivity conditions. Sixty snakes were subjected to treatment following a randomized block design. The effects of sex and size were controlled for. Thirteen consecutive extractions were performed over 21 months. The first factor considered in the experiment was the origin of mice used as prey: a conventional colony (A1) or the Convert H colony (A2; mice receiving the homeopathic complex in water at 1%). The type of water given to snakes was the second factor: pure (B1) or amended with 5% of Convert H® (B2). The experiment was structured in a factorial 2 × 2 design combining mouse and water types (A1B1, A1B2, A2B1, and A2B2). No consistent treatment effects on fresh venom production (mL) were observed when the experimental groups were compared with controls (A1B1). However, production of lyophilized venom (mg) was significantly higher (p < 0.05) in A2B2 animals than in controls in eight of 13 extractions performed, and also in aggregate. The results revealed that production of lyophilized venom, measured over multiple extractions, can be increased by administering the homeopathic complex simultaneously to rattlesnakes and prey.
Subject(s)
Crotalid Venoms/biosynthesis , Homeopathy , Materia Medica/administration & dosage , Animals , Crotalus , Diet/veterinary , Drinking Water , Female , Freeze Drying , Male , Mice , Random AllocationABSTRACT
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.
Subject(s)
Formularies, Homeopathic as Topic , Homeopathy/methods , Feasibility Studies , Humans , Materia Medica/administration & dosage , Placebo Effect , Reproducibility of Results , Research , Solvents/chemistryABSTRACT
Gastroparesis is a chronic disorder of abnormal gastric motility causing considerable suffering. We describe two cases of gastroparesis which were treated by methods which were not part of routine conventional therapy, but which, nevertheless, led to significant clinical improvement. In the first case, the patient suffered from gastroparesis following a vagal injury while undergoing a lung transplant. During his illness a mega-bezoar formed, a well-described complication of gastroparesis. After conservative measures failed, and in order to avoid a surgical intervention that carried considerable risk under the circumstances, a successful trial consisting of imbibing large amounts of "Coca Cola" and acupuncture was initiated. The bezoar dissolved completely and considerable improvement of the patient's gastric motility was achieved. In the second case, the patient was a young woman suffering from idiopathic gastroparesis, which responded well to treatment with tricyclic antidepressants. Due to her intention to become pregnant, this treatment was discontinued and she was admitted to receive homeopathic treatment. After two failed attempts in finding the right homeopathic remedy to replace the conventional treatment, the third remedy (Sepia) used brought dramatic improvement in her general condition and her dyspepsia. Today, over two years after her successful homeopathic treatment, she is in the middle of her second pregnancy, without any treatment and free of complaints. These two cases are examples of simple solutions for seemingly complicated and complex conditions alleviated by an integration of conventional and complementary/alternative medicine.
Subject(s)
Complementary Therapies/methods , Gastroparesis/therapy , Materia Medica/administration & dosage , Adult , Aged , Antidepressive Agents, Tricyclic/therapeutic use , Bezoars/complications , Bezoars/therapy , Dyspepsia/etiology , Dyspepsia/therapy , Female , Gastrointestinal Motility , Gastroparesis/etiology , Humans , Male , Pregnancy , Treatment OutcomeSubject(s)
Drug Eruptions/etiology , Lichen Planus/chemically induced , Materia Medica/adverse effects , Methadone/adverse effects , Analgesics, Opioid/administration & dosage , Analgesics, Opioid/adverse effects , Drug Eruptions/diagnosis , Female , Humans , Hyperpigmentation/chemically induced , Hyperpigmentation/diagnosis , Lichen Planus/diagnosis , Materia Medica/administration & dosage , Methadone/administration & dosageABSTRACT
For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products.
Subject(s)
Homeopathy/adverse effects , Materia Medica/adverse effects , Risk Assessment/methods , Animals , Dose-Response Relationship, Drug , Europe , Germany , Homeopathy/legislation & jurisprudence , Humans , Materia Medica/administration & dosage , Materia Medica/chemistryABSTRACT
BACKGROUND: Gelsemium sempervirens L. (Gelsemium s.) is a traditional medicinal plant, employed as an anxiolytic at ultra-low doses and animal models recently confirmed this activity. However the mechanisms by which it might operate on the nervous system are largely unknown. This work investigates the gene expression of a human neurocyte cell line treated with increasing dilutions of Gelsemium s. extract. METHODS: Starting from the crude extract, six 100 × (centesimal, c) dilutions of Gelsemium s. (2c, 3c, 4c, 5c, 9c and 30c) were prepared according to the French homeopathic pharmacopoeia. Human SH-SY5Y neuroblastoma cells were exposed for 24 h to test dilutions, and their transcriptome compared by microarray to that of cells treated with control vehicle solutions. RESULTS: Exposure to the Gelsemium s. 2c dilution (the highest dose employed, corresponding to a gelsemine concentration of 6.5 × 10(-9) M) significantly changed the expression of 56 genes, of which 49 were down-regulated and 7 were overexpressed. Several of the down-regulated genes belonged to G-protein coupled receptor signaling pathways, calcium homeostasis, inflammatory response and neuropeptide receptors. Fisher exact test, applied to the group of 49 genes down-regulated by Gelsemium s. 2c, showed that the direction of effects was significantly maintained across the treatment with high homeopathic dilutions, even though the size of the differences was distributed in a small range. CONCLUSIONS: The study shows that Gelsemium s., a medicinal plant used in traditional remedies and homeopathy, modulates a series of genes involved in neuronal function. A small, but statistically significant, response was detected even to very low doses/high dilutions (up to 30c), indicating that the human neurocyte genome is extremely sensitive to this regulation.
Subject(s)
Anti-Anxiety Agents/pharmacology , Gelsemium/chemistry , Gene Expression/drug effects , Homeopathy , Materia Medica/pharmacology , Neurons/drug effects , Plant Extracts/pharmacology , Alkaloids/administration & dosage , Alkaloids/pharmacology , Anti-Anxiety Agents/administration & dosage , Humans , Materia Medica/administration & dosage , Neurons/metabolism , Plant Extracts/administration & dosage , Receptors, Neuropeptide/genetics , Signal Transduction/geneticsABSTRACT
BACKGROUND: Homeopathic Pathogenetic Trials (HPTs) are a pillar of homeopathy, a key source of the symptoms characteristic of a particular homeopathic medicine. Homeopaths choose homeopathic medicines by comparing these remedy pictures with the symptoms the patient is presenting. Thus, recognition of these symptom sets underpins the clinical practice of homeopathy. OBJECTIVE: To test whether HPTs generate consistent and recognisable sets of symptoms in consecutive trials. DESIGN: Practising homeopaths, blinded to the homeopathic medicine under investigation, were given the set of symptoms generated during an unpublished HPT and asked to identify the homeopathic medicine used. HOMEOPATHIC TRIAL SUBSTANCE: Ozone, prepared by homeopathic method to the ultramolecular dilution of 30c (10(-60) dilution), was chosen at random from twenty potential medicines. RESULTS: Seven practising homeopaths were asked to make three guesses as to the identity of the remedy. Initially from the full list of possible remedies (N = 2372). Two of the seven homeopaths guessed the identity of the remedy correctly (p < 0.0001). Subsequently, when their choice of possible medicines was restricted to a list of 20, the same two homeopaths selected the correct medicine, however none of the other practising homeopaths did so (p = 0.2). DISCUSSION: The selection of the correct homeopathic medicine from the unrestricted list (N = 2372 medicines) by two homeopaths is noteworthy given that the homeopathic medicine used during the HPT was diluted well beyond Avogadro's number and would not be expected to produce any detectable or recognisable symptomatology. Possible reasons why the remaining five homeopaths did not guess correctly are discussed. CONCLUSION: The results show that practising homeopaths may be able to correctly identify a homeopathic medicine from the set of symptoms generated during an HPT. This suggests that such symptom pictures generated by taking an ultramolecular homeopathic medicine are recognisable and specific to the substance taken. Since identification of the remedy was based on past HPT information held in the materia medica, this demonstrates that HPT-generated symptom pictures are reproducible, thus validating the HPT methodology. These promising preliminary findings warrant replication; possible improvements to the trial design to be incorporated in future studies were identified.
Subject(s)
Homeopathy/methods , Materia Medica/administration & dosage , Ozone/administration & dosage , Double-Blind Method , Feasibility Studies , Humans , Pilot Projects , Placebo Effect , Reference Values , Reproducibility of Results , Solvents/chemistry , Water/chemistryABSTRACT
BACKGROUND: The homeopathic complex HomeoAqua Mega 3(®) was designed to stimulate fish liver function resulting in enhanced lipid metabolism and improved overall performance. The effect of the complex in fatty acid compounds in the muscle tissues and the performance of Nile tilapia (O. niloticus) were evaluated. METHODS: A control diet with 40 mL of alcohol solution (30° Gay Lussac (GL) alcohol) per kg of feed and another diet with 40 mL/kg of the homeopathic complex were analysed in sex-reversed juvenile male Nile tilapia with mean initial weights of 89.54 g (±7.97) and 89.74 g (±8.83) and initial total mean lengths of 16.93 cm (±0.56) and 16.85 cm (±0.56) for the control and homeopathy-treated fish, respectively. Overall, 200 fish were distributed into 10 water tanks, with 20 specimens in each 600 L tank, they were kept for 63 days. Monitoring of the water's physical and chemical parameters was performed. Additionally, the percentage chemical composition and the composition of the muscle tissue fatty acids were determined, and fish performance was evaluated. RESULTS: No significant differences (p > 0.05) were found between treatments with regard to the water's physical and chemical parameters, moisture, ashes, proteins of the Nile tilapia muscular tissue and mean rates of total weight and length of the animals in the final period of the assay. The total lipid (TL) rates of the tilapia muscle tissue were 1.133 ± 0.2% at the start (control and homeopathy) and 0.908 ± 0.14% (control) and 0.688 ± 0.14% (homeopathy) at the end of the experiment (p < 0.06). The sum total of the SFAs (saturated fatty acids) was 338.50 ± 0.15 at the start (control and homeopathy) and 271.49 ± 0.34 mg/g of the TLs for the control and 226.12 ± 0.77 mg/g of TL for the homeopathy at the end of the experiment (p < 0.05). The n-6/n-3 ratio was also lower for the homeopathy-treated fish (8.45 ± 0.40) compared with the control fish (9.60 ± 0.14), (p < 0.05) at the end of the 63-day period. CONCLUSION: Nile tilapia juveniles that received the HomeoAqua Mega-3(®) in their diets had a decrease in the TL rates, mainly for the SFAs, and the n-6/n-3 ratio, compared with the control group, without any changes in the animal performance during the experimental period.
Subject(s)
Cichlids/metabolism , Fatty Acids/metabolism , Fish Diseases/metabolism , Homeopathy/methods , Liver/metabolism , Materia Medica/pharmacology , Muscle, Skeletal/metabolism , Animal Feed , Animals , Fish Diseases/drug therapy , Liver/drug effects , Male , Materia Medica/administration & dosage , Muscle, Skeletal/drug effects , Plant Preparations/pharmacologyABSTRACT
OBJECTIVE: To explore the effect of retinociacdi (RA) combined extracts from Testudinis Carapacis et Plastri(PTE) on proliferating in MSCs and its mechanism. METHODS: Transfected PGL3-ID1 using the calcium phosphate co-precipitation method in rat MSCs. PTE combined with RA and retinociacdi receptor inhibitor(Ro41) acted on transfected MSCs with respective concentrations of 10(-6), 10(-7) and 10(-8) mol/L. Luciferase activity measurement was used to detect the activity of RAR and IDI 36 h later. PTE acted on MSCs 36 h,3 d and 7 d for respective concentrations of 1, 3, 30 and 100 microg/mL,then collected cells to detect RAR with RT-PCR. PTE combined with RA for 10(-7) mol/L and Ro41 for 10(-6) mol/L respectively on MSCs for 36 h,and then collected cells to detect RAR and ID1 with RT-PCR. RESULTS: PTE promoted expression of ID1 on MSCs. When combined with RA, the promotion effect became greater and it promoted expression of RAR at the same time; When inhibited RA using Ro41, the promotion of IDI was weaken by PTE. CONCLUSION: RA promotes expression of IDI on MSCs, PTE regulates proliferation and differentiation of MSCs by expression of nuclear receptor RAR.