Archive for category Research into Homeopathy

Adverse drug reactions to anthroposophic and homeopathic solutions for injection: a systematic evaluation of German pharmacovigilance databases

Adverse drug reactions to anthroposophic and homeopathic solutions for injection: a systematic evaluation of German pharmacovigilance databases. Jong MC, Jong MU, Baars EW. Department Healthcare and Nutrition, Louis Bolk Institute, Driebergen, The Netherlands; Department Health Sciences, Mid Sweden University, Sundsvall, Sweden. m.jong@louisbolk.nl. Pharmacoepidemiol Drug Saf. 2012 Jun 13. doi: 10.1002/pds.3298.

Abstract

PURPOSE: Medicinal solutions for injection are frequently applied in anthroposophic medicine and homeopathy. Despite their extensive use, there is little data published on the safety of these products. Therefore, we investigated the safety of anthroposophic and homeopathic solutions for injection through a systematic evaluation of adverse drug reactions (ADRs).

METHODS: ADRs were extracted from the pharmacovigilance databases of eight German manufacturers. Analysed ADRs included case reports in humans only, (spontaneous) case reports from post-marketing surveillance, literature and clinical/safety trials.

RESULTS: Between 2000 and 2009, in total, 303 million ampoules for injection were sold, and 486 case reports were identified, corresponding to a total number of 1180 ADRs. Of all case reports, 71.8% (349/486) included ADRs that were listed (e.g. stated in package leaflet), and 9.5% (46/486) of the reports were classified as serious. The most frequently reported ADRs were pruritus, followed by angioedema, diarrhoea and erythema. A total of 27.3% (322/1180) were localized reactions for example; application or injection site erythema, pain, swelling and inflammation. The overall reporting rate of ADRs associated with injections was less than 4 per 1 million sold ampoules and classified as very rare.

CONCLUSIONS: Our systematic evaluation demonstrated that the reporting rate of ADRs associated with anthroposophic and homeopathic solutions for injection is very low. Most reported ADRs were listed, and one quarter consisted of local reactions. These findings suggest a low risk profile for solutions for injection as therapeutically applied in anthroposophic medicine and homeopathy.

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Identification of Medicinally Active Ingredient in Ultradiluted Digitalis purpurea: Fluorescence Spectroscopic and Cyclic-Voltammetric Study

Identification of Medicinally Active Ingredient in Ultradiluted Digitalis purpurea: Fluorescence Spectroscopic and Cyclic-Voltammetric Study. Sharma A, Purkait B. Indian Institute of Technology, Kharagpur, Kharagpur 721302, India. J Anal Methods Chem. 2012;2012:109058. Epub 2012 Mar 26.

Abstract: Serially diluted and agitated (SAD) drugs available commercially are in use with great faith because of the astonishing results they produce. The scientific viewpoint attached to the centuries-old therapy with SAD drugs, as in homeopathy, remained doubtful for want of appropriate research and insufficient evidence base.

The conflicting points related to SAD drug mostly related to the level of concentrations/dilutions, use of drug in contradictory clinical conditions compared to the modern system of medicine, identification of medicinally active ingredient in concentrations and dilutions used in commercially available SAD drugs, and lack of laboratory-based pharmacological data vis-à-vis modern medicine. Modus operandi of SAD drug is also unknown.

To address some of these issues an analytical study was carried out wherein commercially available SAD drug Digitalis purpurea, commonly used in different systems of medicine, was put to test. Various concentrations of commercially available Digitalis purpurea were analyzed using analytical methods: cyclic voltammetry, emission spectroscopy, and UV-VIS spectroscopy.

These analytical methods apparently identified the medicinal ingredients and effect of serial dilution in commercial preparation of the drugs.

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Testing homeopathy in mouse emotional response models: pooled data analysis of two series of studies

Testing homeopathy in mouse emotional response models: pooled data analysis of two series of studies. Bellavite P, Conforti A, Marzotto M, Magnani P, Cristofoletti M, Olioso D, Zanolin ME. Source Department of Pathology and Diagnostics, University of Verona, 37134 Verona, Italy. Evid Based Complement Alternat Med. 2012;2012:954374. Epub 2012 Apr 4.

Abstract: Two previous investigations were performed to assess the activity of Gelsemium sempervirens (Gelsemium s.) in mice, using emotional response models. These two series are pooled and analysed here.

Gelsemium s. in various homeopathic centesimal dilutions/dynamizations (4C, 5C, 7C, 9C, and 30C), a placebo (solvent vehicle), and the reference drugs diazepam (1 mg/kg body weight) or buspirone (5 mg/kg body weight) were delivered intraperitoneally to groups of albino CD1 mice, and their effects on animal behaviour were assessed by the light-dark (LD) choice test and the open-field (OF) exploration test.

Up to 14 separate replications were carried out in fully blind and randomised conditions. Pooled analysis demonstrated highly significant effects of Gelsemium s. 5C, 7C, and 30C on the OF parameter “time spent in central area” and of Gelsemium s. 5C, 9C, and 30C on the LD parameters “time spent in lit area” and “number of light-dark transitions,” without any sedative action or adverse effects on locomotion.

This pooled data analysis confirms and reinforces the evidence that Gelsemium s. regulates emotional responses and behaviour of laboratory mice in a nonlinear fashion with dilution/dynamization.

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Phenotypic evidence of ultra-highly diluted homeopathic remedies acting at gene expression level: a novel probe on experimental phage infectivity in bacteria

Phenotypic evidence of ultra-highly diluted homeopathic remedies acting at gene expression level: a novel probe on experimental phage infectivity in bacteria. Saha SK, Das S, Khuda-Bukhsh AR. Source Cytogenetics and Molecular Biology Laboratory, Department of Zoology, University of Kalyani, Kalyani 741235, India; E-mail: prof_arkb@yahoo.co.in, khudabukhsh_48@rediffmail.com. Zhong Xi Yi Jie He Xue Bao. 2012 Apr;10(4):462-70.

Abstract

OBJECTIVE: To explore if some ultra-highly diluted homeopathic remedies claimed to have antiviral effects can demonstrate any discernible action in the bacteria Escherichia coli through modulating infectivity potentials of the bacteriophage φX174 DNA.

METHODS: φX174 was selected because of its known host specificity to E. coli and its constitutive expression of lytic gene E when inside the bacterial host. We deployed the “bacteriophage assay system” by “top layer agar plating” method of plaque-counting for evaluation of efficacy of the homeopathic remedies in rendering the bacteria’s protective ability against the attack of φX174. The plaque number in the agar-plated Petri dishes, either containing the phage-bacteria mixture subjected to one of the diluted homeopathic drugs under test (1% volume ratio; Belladonna 30C, Rhus Tox 30C, Arnica 30C) or the succussed 1% “alcoholic vehicle” of the drug was recorded. The plaques represented the bacterial colony actually infected and lysed by φX174. Conversely, we subjected φX174 to the homeopathic drug treatment before allowing them to interact with the bacteria to ascertain if the drug itself had any direct effect on the infective potential of the phage DNA entering into the bacterial cell.

RESULTS: Each homeopathic remedy showed a significant decrease in plaque number on pretreated bacteria (1 h prior to infection) with respect to untreated and placebo-treated controls; there was only an insignificant change in the plaque number when φX174 was pretreated with the drugs. As φX174 starts lytic cycle when inside the bacterial cell, the loss of plaque number would mean that either the lytic gene E in many was repressed or the entire phage DNA was annihilated by the bacterial gene product (restriction enzymes) known to be regulated by a cluster of genes.

CONCLUSION: This provides phenotypic evidence for the ability of ultra-highly diluted homeopathic remedies to regulate expression of certain gene(s) depending on need of the organism.

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Homeopathic aggravation with Quinquagintamillesimal potencies

Homeopathic aggravation with Quinquagintamillesimal potencies. Rossi E, Bartoli P, Bianchi A, Endrizzi C, Da Frè M. Source Homeopathic Clinic, Local Health Unit n. 2 Lucca, Tuscany Regional Reference Centre, Italy. Homeopathy. 2012 Apr;101(2):112-20.

Abstract

INTRODUCTION: Homeopathic aggravation is the exacerbation of some symptoms or the whole pathological situation, followed by improvement of the patient’s conditions.

AIM: To evaluate the typology, intensity and frequency of homeopathic aggravation, especially with Quinquagintamillesimal (Q, LM) potencies and its prognostic value.

METHODS: The homeopathic prescription strategy evaluated consists in the administration of a single homeopathic medicine in Q dilutions, starting with 6Q, then a progressive scale of Q potencies. Patients whose symptoms could be attributed to a wrong and inappropriate prescription, according to the criteria previously described, were excluded.

RESULTS: Data was collected on 1108 patients consecutively visited from 3rd October 2002 to 31st December 2007, and 441 cases followed for at least 2 months (40% of total cases). 63 of these cases (14%) reported homeopathic aggravation: 7% reported ‘slight’, 5% ‘medium’, 2% ‘intense’ and 0.4% ‘very intense’ aggravation. Homeopathic aggravation was present in 21% of paediatric patients (≤14 years). About 50% of the cases manifested homeopathic aggravation 1 or 2 days after the prescription and for 67% of patients the symptoms lasted 1 week or less. Patients with aggravation of the original disease had significantly greater improvement than those patients showing the aggravation of other, new or different, symptoms or conditions, or no aggravation.

CONCLUSIONS: These data show that homeopathic aggravation with Q potencies is quite frequent in homeopathic clinical practice and seems to be associated with better treatment outcome.

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Effects of two homeopathic complexes on bovine sperm mitochondrial activity

Effects of two homeopathic complexes on bovine sperm mitochondrial activity. Aziz DM, Schnurrbusch U, Enbergs H. Source Institute of Physiology, Biochemistry and Hygiene of Animals, Bonn University, Bonn, Germany. Homeopathy. 2012 Apr;101(2):99-102.

Abstract

OBJECTIVES: This study was conducted to evaluate the effect of two homeopathic complexes Ubichinon compositum(®) (Ubi comp) and Coenzyme compositum ad us. vet.(®) (CoQ10 comp) on bovine sperm mitochondrial activity.

METHODS: Sperm viability, acrosomal integrity and sperm chromatin structure were estimated to detect the possible side effect of complexes on other sperm parameters.

RESULTS: Mitochondrial activity was significantly enhanced by both Ubi comp (P<0.01) and CoQ10 comp (P<0.05). No effects were detected in other tested sperm parameters.

CONCLUSION: The tested homeopathic complex medicines stimulate the mitochondrial activity of bovine sperm without effects on their viability, acrosomal integrity or chromatin structure. The possibility that this translates into improved fertilization capacity in artificial insemination should investigated.

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Effects of Calendula officinalis on human gingival fibroblasts

Effects of Calendula officinalis on human gingival fibroblasts. Saini P, Al-Shibani N, Sun J, Zhang W, Song F, Gregson KS, Windsor LJ. Source Department of Periodontics, Indiana University School of Dentistry, 1121 West Michigan Street, DS 423, Indianapolis, IN 46202, USA. Homeopathy. 2012 Apr;101(2):92-8.

Abstract

BACKGROUND: Calendula officinalis is commonly called the marigold. It is a staple topical remedy in homeopathic medicine. It is rich in quercetin, carotenoids, lutein, lycopene, rutin, ubiquinone, xanthophylls, and other anti-oxidants. It has anti-inflammatory properties. Quercetin, one of the active components in Calendula, has been shown to inhibit recombinant human matrix metalloproteinase (MMP) activity and decrease the expression of tumor necrosis factor-α, interleukin-1β (IL), IL-6 and IL-8 in phorbol 12-myristate 13-acetate and calcium ionophore-stimulated human mast cells.

OBJECTIVES: To examine the effects of Calendula on human gingival fibroblast (HGF) mediated collagen degradation and MMP activity.

MATERIAL AND METHODS: Lactate dehydrogenate assays were performed to determine the non-toxic concentrations of Calendula, doxycycline and quercetin. Cell-mediated collagen degradation assays were performed to examine the inhibitory effect on cell-mediated collagen degradation. Gelatin zymography was performed to examine their effects on MMP-2 activity. The experiments were repeated three times and ANOVA used for statistical analyses.

RESULTS: Calendula at 2-3% completely inhibited the MMP-2 activity in the zymograms. Doxycycline inhibited HGF-mediated collagen degradation at 0.005, 0.01, 0.02 and 0.05%, and MMP-2 activity completely at 0.05%. Quercetin inhibited HGF-mediated collagen degradation at 0.005, 0.01 and 0.02%, and MMP-2 activity in a dose-dependent manner. Calendula inhibited HGF-mediated collagen degradation and MMP-2 activity more than the same correlated concentration of pure quercetin.

CONCLUSION: Calendula inhibits HGF-mediated collagen degradation and MMP-2 activity more than the corresponding concentration of quercetin. This may be attributed to additional components in Calendula other than quercetin.

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Homeopathy in chronic sinusitis: a prospective multi-centric observational study.

Homeopathy in chronic sinusitis: a prospective multi-centric observational study. Nayak C, Singh V, Singh VP, Oberai P, Roja V, Shitanshu SS, Sinha MN, Deewan D, Lakhera BC, Ramteke S, Kaushik S, Sarkar S, Mandal NR, Mohanan PG, Singh JR, Biswas S, Mathew G. Source Central Council for Research in Homoeopathy, New Delhi, India. Homeopathy. 2012 Apr;101(2):84-91.

Abstract

OBJECTIVE: The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS).

MATERIALS AND METHODS: Multicentre observational study at Institutes and Units of the Central Council for Research in Homoeopathy, India. Symptoms were assessed using the chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were shortlisted for prescription on the basis of repertorisation for the pathological symptoms of CS. Regimes and adjustment of regimes in the event of a change of symptoms were pre-defined. The follow-up period was for 6 months. Statistical analysis was done using SPSS version 16.

RESULTS: 628 patients suffering from CS confirmed on X-ray were enrolled from eight Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients with at least one follow-up assessment were analyzed. There was a statistically significant reduction in CSAS (P = 0.0001, Friedman test) after 3 and 6 months of treatment. Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having marked improvement. 4/17 medicines were never prescribed. No complications were observed during treatment.

CONCLUSION: Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation.

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Therapeutic Effect of Arsenicum album on Leukocytes

Therapeutic Effect of Arsenicum album on Leukocytes. Elaine C. Ive,1 Ingrid M. S. Couchman,1 and Lalini Reddy2* 1Department of Homoeopathy, Faculty of Health Sciences, Durban University of Technology, P.O. Box 1334, Durban 4000, South Africa; E-Mails: elaine.ive0@gmail.com (E.C.I.); Email: ingridc@dut.ac.za (I.M.S.C.)2Department of Biotechnology and Food Technology, Faculty of Applied Sciences, Durban University of Technology, P.O. Box 1334, Durban 4000, South Africa. Int J Mol Sci. 2012; 13(3): 3979–3987. Published online 2012 March 22. doi: 10.3390/ijms13033979 PMCID: PMC3317753 Copyright © 2012 by the authors; licensee Molecular Diversity Preservation International, Basel, Switzerland.

The therapeutic effects of homeopathic Arsenicum album potencies were investigated in-vitro, using a continuous cell line (MT4), pre-intoxicated with arsenic trioxide (As2O3), and then treated with succussed and unsuccussed homoeopathic potencies, 6CH, 30CH and 200CH.

This study aimed to verify the homoeopathic law of similars and to determine whether potencies diluted beyond Avogadro’s constant had physiological effects on cells; whether various potencies would cause different effects as suggested by the concept of hormesis; whether succussed and unsuccussed homeopathic potencies had different effects on the cells; and to establish whether a biotechnological method could be used to evaluate the above.

As2O3 was used to pre-intoxicate and the MTT assay was used to measure the percentage cytotoxicity and half maximal inhibitory concentration (IC50) of the cells. The homeopathic potencies of Arsenicum album (6CH, 30CH and 200CH) were prepared by either succussing or allowing to diffuse for 30 s.

After pre-intoxication of the MT4 cells with the IC50 As2O3 and treatment with succussed and unsuccussed Arsenicum album (6CH-200CH), the cell viability increased with increasing potency from 81% to 194% (over 72 h). The treatments and the times of exposure were found to be statistically significant determinants of cell viability, whereas succussion did not cause any significant variation in the results.

The study provided evidence that a biotechnological method (namely cell viability) may be used to scientifically evaluate the physiological effects of homeopathic potencies on human cells; it confirmed that the homeopathic potencies did have therapeutic effects; and that succussion was not required in the potentization method in order to produce a curative remedy.

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Extreme homeopathic dilutions retain starting materials: A nanoparticulate perspective

Extreme homeopathic dilutions retain starting materials: A nanoparticulate perspective. Prashant Satish Chikramane 1, kkihebbal K Suresh 1,2, Jayesh Ramesh Bellare 1,2,* and Shantaram Govind Kane 1,* 1 Department of Chemical Engineering, Indian Institute of Technology (IIT), Bombay, Adi Shankaracharya Marg, Powai, Mumbai 400 076, Maharashtra, India 2 Department of Biosciences and Bioengineering, Indian Institute of Technology (IIT), Bombay, Adi Shankaracharya Marg, Powai, Mumbai 400 076, Maharashtra, India. Homeopathy (2010) 99, 231e242.

See also http://www.katonics.com/uploads/2010%20-%20Paper%201%20-%20Do%20serial%20dilutions%20really%20dilute_Editorial.pdf

Homeopathy is controversial because medicines in high potencies such as 30c and 200c involve huge dilution factors (10:60 and 10:400 respectively) which are many orders of magnitude greater than Avogadro’s number, so that theoretically there should be no measurable remnants of the starting materials. No hypothesis which predicts the retention of properties of starting materials has been proposed nor has any physical entity been shown to exist in these high potency medicines.

Using market samples of metalderived medicines from reputable manufacturers, we have demonstrated for the first time by Transmission Electron Microscopy (TEM), electron diffraction and chemical analysis by Inductively Coupled Plasma-Atomic Emission Spectroscopy (ICP-AES), the presence of physical entities in these extreme dilutions, in the form of nanoparticles of the starting metals and their aggregates.

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