Serious mistakes in meta-analysis of homeopathic research

PubMed Central

Vithoulkas, G

2017-01-01

The article discussed the immanent problems of meta-analyses selecting a number of independent trials in homeopathy, within which, the purpose was to examine the effectiveness of homeopathic treatment. Our focus lied in clarifying that the complex effects of homeopathic treatment known from history and day-to-day practice have not been respected so far. The examination of most of the homeopathic trials showed that studies rarely account for homeopathic principles, in order to assess the effectiveness of the treatment. The main flaw was that trials reflect the point of view that the treatment with a specific remedy could be administered in a particular disease. However, homeopathy aims to treat the whole person, rather than the diseases and each case has to be treated individually with an individualized remedy. Furthermore, the commonly known events during the course of homeopathic treatment, such as “initial aggravation” and “symptom-shift” were not considered in almost all the studies. Thus, only few trials were eligible for meta-analyses, if at all. These and other factors were discussed and certain homeopathic principles were suggested to be respected in further trials. It is expected, that a better understanding of homeopathic principles would provide guidelines for homeopathic research, which are more acceptable to both homeopathy and conventional medicine. PMID:28255376

Bleeding risks of herbal, homeopathic, and dietary supplements: a hidden nightmare for plastic surgeons?

PubMed

Wong, Wendy W; Gabriel, Allen; Maxwell, G Patrick; Gupta, Subhas C

2012-03-01

The utilization of complementary and alternative medicine has increased tremendously in the last two decades. Herbal products, homeopathic medicines, and dietary supplements are extremely popular and are available without a prescription (which likely contributes to their popularity). Despite their "natural" characteristics, these remedies have the potential to cause bleeding in patients who undergo surgery. The high use of these supplements among cosmetic surgery patients, coupled with increasing reports of hematomas associated with herbal and homeopathic medicines, prompted the authors to conduct a comprehensive review focused on bleeding risks of such products in an effort to raise awareness among plastic surgeons. This review focuses on 19 herbs, three herbal formulas, two herbal teas, and several other supplements that can cause bleeding perioperatively and postoperatively. In addition to being aware of such adverse effects, plastic surgeons must adequately screen all patients and educate them on the possible dangers associated with these treatments.

Permanent physico-chemical properties of extremely diluted aqueous solutions of homeopathic medicines.

PubMed

Elia, V; Baiano, S; Duro, I; Napoli, E; Niccoli, M; Nonatelli, L

2004-07-01

The purpose of this study was to obtain information about the influence of successive dilutions and succussions on the water structure. 'Extremely diluted solutions' (EDS) are solutions obtained through the iteration of two processes: dilution in stages of 1:100 and succussion, typically used in homeopathic medicine. The iteration is repeated until extreme dilutions are reached, so that the chemical composition of the solution is identical to that of the solvent. Nine different preparations, were studied from the 3cH to 30cH (Hahnemannian Centesimal Dilution). Four of those were without the active principle (potentized water). Two different active principles were used: Arsenicum sulphuratum rubrum (ASR), As4S4, 2,4-dichlorophenoxyacetic acid (2,4D). The solvents were: a solution of sodium bicarbonate and of silicic acid at 5 x 10(-5) M (mol/l) each, and solutions of sodium bicarbonate 5 x 10(-5), 7.5 x 10(-5) and 10 x 10(-5) M (mol/l) in double-distilled water. The containers were Pyrex glass to avoid the release of alkaline oxide and silica from the walls. Conductivity measurements of the solutions were carried out as a function of the age of the potencies. We found increases of electrical conductivity compared to untreated solvent. Successive dilution and succussion can permanently alter the physico-chemical properties of the aqueous solvent. But we also detected changes in physio-chemical parameters with time. This has not previously been reported. The modification of the solvent could provide an important support to the validity of homeopathic medicine, that employs 'medicines without molecules'. The nature of the phenomena here described remains still unexplained, nevertheless some significant experimental results were obtained.

Effects of Homeopathic Medicines on Polysomnographic Sleep of Young Adults with Histories of Coffee-Related Insomnia

PubMed Central

Bell, Iris R.; Howerter, Amy; Jackson, Nicholas; Aickin, Mikel; Baldwin, Carol M.; Bootzin, Richard R.

2010-01-01

Background Homeopathy, a common form of alternative medicine worldwide, relies on subjective patient reports for diagnosis and treatment. Polysomnography offers a modern methodology for evaluating the objective effects of taking homeopathic remedies that clinicians claim exert effects on sleep quality in susceptible individuals. Animal studies have previously shown changes in non rapid eye movement sleep with certain homeopathic remedies. Methods Young adults of both sexes (ages 18–31) with above-average scores on standardized personality scales for either cynical hostility or anxiety sensitivity (but not both), and a history of coffee-induced insomnia, participated in the month-long study. At-home polysomnographic recordings were obtained on successive pairs of nights once per week for a total of eight recordings (nights 1, 2, 8, 9, 15, 16, 22, 23). Subjects (N=54) received placebo pellets on night 8 (single-blind) and verum pellets on night 22 (double-blind) in 30c doses of one of two homeopathic remedies, Nux Vomica or Coffea Cruda. Subjects completed daily morning sleep diaries and weekly Pittsburgh Sleep Quality Index scales, as well as Profile of Mood States Scales at bedtime on polysomnography nights. Results Verum remedies significantly increased PSG total sleep time and NREM, as well as awakenings and stage changes. Changes in actigraphic and self-rated scale effects were not significant. Conclusions The study demonstrated the feasibility of using in-home all-night sleep recordings to study homeopathic remedy effects. Findings are similar though not identical to those reported in animals with the same remedies. Possible mechanisms include initial disruption of the nonlinear dynamics of sleep patterns by the verum remedies. PMID:20673648

The anticancer homeopathic composite "Canova Method" is not genotoxic for human lymphocytes in vitro.

PubMed

Seligmann, Igor C; Lima, Patrícia D L; Cardoso, Plínio C S; Khayat, André S; Bahia, Marcelo O; Buchi, Dorli de Freitas; Cabral, Isabel R; Burbano, Rommel R

2003-06-30

The Canova Method (CM) is a homeopathic medicine indicated for the treatment of patients with cancer and for pathologies that involve a depressed immune system, such as AIDS. This product is composed of homeopathic dilutions of Aconitum napellus, Arsenicum album (arsenic trioxide), Bryonia alba, Lachesis muta venom and Thuya occidentalis. It stimulates the immune system by activating macrophages. Activated macrophages stimulate the lymphocytes so that they increase their cytotoxic action in response to tumoral growth or infection. Given that the CM stimulates and accelerates the activity of macrophages and lymphocytes, we evaluated genotoxic effects induced in human lymphocytes treated with this homeopathic medication in vitro. Structural and numerical chromosomal aberrations were scored for the assessment of induced genotoxic effects, while the variation in mitotic index was considered as a monitor for induced cellular toxicity. The lymphocytes were cultivated for 24, 48 or 72 h in the following final concentrations of the medicinal composite CM: 4, 8 and 12%. Treatments with the CM did not affect mitotic indexes, nor did they provoke chromosomal aberrations, when compared with untreated controls. There was no cytotoxicity or genotoxicity at the chromosomal level.

The School Nurse's Role in Homeopathic Interventions.

ERIC Educational Resources Information Center

Selekman, Janice; Thomas, Elizabeth; McLean, Kay

1998-01-01

Describes the practices of homeopathy and how they affect the scope of practice of school nurses. Includes a definition of homeopathy, a discussion of remedies and the specific symptoms for which they are effective, and an examination of conditions treatable by homeopathic physicians. Nine guidelines for managing homeopathic products in the school…

Dielectric Dispersion Studies Indicate Change in Structure of Water by Potentised Homeopathic Medicines

NASA Astrophysics Data System (ADS)

Mahata, C. R.

2012-12-01

Response of living bodies to different vastly `diluted' homeopathic medicines are different (rejecting the sceptic's view of `placebo' effect), though they are chemically same. Till now there is no satisfactory answer to how one such medicine differs from another in terms of scientifically measurable parameters. This paper tries to address this basic issue by taking two medicines of the same potency and two different potencies of the same medicine, namely, Arnica Mont 30c, 200c and Anacardium Orient 30c, 200c. These potencies are well above the Avogadro limit. The investigation reported here proceeds with the concept of `induced molecular structure' advanced by a number of scientists. Dielectric dispersion is used as the tool for experimental verification. It is based on the fact that when the exciting frequency of applied electric field equals the characteristic frequency, then macromolecules resonate leading to anomalous dielectric dispersion associated with sharp increase in dielectric loss, the resonance frequencies being different for macromolecules of different structures or dimensions. The results suggest that medicine- and potency-specific attributes are acquired by the vehicle (i.e. water) in the form of macromolecules generated by the potentization process of homeopathy making one medicine structurally different from another.

Should Anthroposophic Medicinal Products Be Regulated in Europe?

PubMed

Michaux, Geneviève

2017-03-01

European Commission’s reports suggest that the European Union should address the status of anthroposophic products, i.e. products that are developed, manufactured and prescribed in accordance with the holistic approach on which anthroposophic medicine is based. Anthroposophic products cannot be placed as such on the European market because they cannot meet the marketing authorisation or even registration requirements set out by European or national pharmaceutical law. Yet, the 95-year European tradition and good safety profile of anthroposophic products justify giving them an easier access to market. Such access can result from specific rules on anthroposophic products, but can be more efficiently achieved by encouraging the Member States to better apply the existing rules on marketing authorisation procedures or on registration of homeopathic and traditional herbal medicinal products, or by including anthroposophic substances, manufacturing methods or uses in monographs.

The Use of Intuition in Homeopathic Clinical Decision Making: An Interpretative Phenomenological Study

PubMed Central

Brien, Sarah; Dibb, Bridget; Burch, Alex

2011-01-01

While intuition plays a role in clinical decision making within conventional medicine, little is understood about its use in complementary and alternative medicine (CAM). The aim of this qualitative study was to investigate intuition from the perspective of homeopathic practitioners; its' manifestation, how it was recognized, its origins and when it was used within daily clinical practice. Semi-structured interviews were carried out with clinically experienced non-National Health Service (NHS) UK homeopathic practitioners. Interpretative phenomenological analysis was used to analyze the data. Homeopaths reported many similarities with conventional medical practitioner regarding the nature, perceived origin and manifestation of their intuitions in clinical practice. Intuition was used in two key aspects of the consultation: (i) to enhance the practitioner-patient relationship, these were generally trusted; and (ii) intuitions relating to the prescribing decision. Homeopaths were cautious about these latter intuitions, testing any intuitive thoughts through deductive reasoning before accepting them. Their reluctance is not surprising given the consequences for patient care, but we propose this also reflects homeopaths' sensitivity to the academic and medical mistrust of both homeopathy and intuition. This study is the first to explore the use of intuition in decision making in any form of complementary medicine. The similarities with conventional practitioners may provide confidence in validating intuition as a legitimate part of the decision making process for these specific practitioners. Further work is needed to elucidate if these findings reflect intuitive use in clinical practice of other CAM practitioners in both private and NHS (i.e., time limited) settings. PMID:19773389

Homeopathic treatment of minor aphthous ulcer: a randomized, placebo-controlled clinical trial.

PubMed

Mousavi, Fahimeh; Mojaver, Yalda Nozad; Asadzadeh, Mehdi; Mirzazadeh, Mustafa

2009-07-01

The objectives of this study were to clinically determine the efficacy of individualised homeopathy in the treatment of minor recurrent aphthous ulceration (MiRAU). A randomized, single blind, placebo-controlled clinical trial of individualised homeopathy. One hundred patients with minor aphthous ulcer were treated with individualised homeopathic medicines or placebo and followed up for 6 days. Patients received two doses of individualised homeopathic medicines in the 6C potency as oral liquid at baseline and 12 h later. Pain intensity and ulcer size were recorded at baseline during and at the end of the trial (mornings of days 4 and 6). All 100 patients completed treatment. Between group differences for pain intensity and ulcer size were statistically significant at day 4 and at day 6 (P<0.05). No adverse effects were reported. The results suggest that homeopathic treatment is an effective and safe method in the treatment of MiRAU.

[The technicoregulatory situation in France for manufactured homeopathic medications].

PubMed

Santini, Cl

2005-06-01

Many homeopathic medications are marketed in France on the basis of old national regulations: homeopathic medications with a common denomination (unit or complex products) whose former approval was transformed into a marketing authorization in 1984; "normal formulations" with a special denomination, often dating from before 1941 (date when drug approval was instituted) including certain produces whose marketing approval was obtained under different mechanisms but still sold today. After the EEC excluded homeopathic drugs from the "medication" directives, in 1975 the 92/72/EEC directive stated that beyond the normal requirements for quality and safety, the same obligations could not be required for homeopathic and allopathic medications. A "registration" system was thus instituted for "traditional" medications en lieu of marketing approval. This included a dual obligation: 1) abstention from claiming therapeutic indications, 2) avoiding any formulation which could carry a risk for the patients (i.e. oral and topical formulations exclusive and degree of dilution guaranteeing safety). Beyond this restrictive framework, these medications have marketing approval, but, for the specific features of homeopathic medications, the directive leaves it up to the member States with a "homeopathic tradition" to apply special rules for evaluating the results of clinical trials designed to establish safety and efficacy. For the efficacy feature, traditional use can be used as an argument for marketing approval (article R5143 CSP). In order to create a more rational technicoregulatory environment, older products marketed before 1994 are being "validated" by group according to a calendar established in 2003 and which should run from 2004 to 2012. At the end of this validation procedure, all manufactured homeopathic products will either receive marketing approval or be recorder in compliance with general or specific European regulations. In conclusion, we make a few personal comments

Embryonic Zebrafish Model - A Well-Established Method for Rapidly Assessing the Toxicity of Homeopathic Drugs: - Toxicity Evaluation of Homeopathic Drugs Using Zebrafish Embryo Model.

PubMed

Gupta, Himanshu R; Patil, Yogesh; Singh, Dipty; Thakur, Mansee

2016-12-01

Advancements in nanotechnology have led to nanoparticle (NP) use in various fields of medicine. Although the potential of NPs is promising, the lack of documented evidence on the toxicological effects of NPs is concerning. A few studies have documented that homeopathy uses NPs. Unfortunately, very few sound scientific studies have explored the toxic effects of homeopathic drugs. Citing this lack of high-quality scientific evidence, regulatory agencies have been reluctant to endorse homeopathic treatment as an alternative or adjunct treatment. This study aimed to enhance our insight into the impact of commercially-available homeopathic drugs, to study the presence of NPs in those drugs and any deleterious effects they might have, and to determine the distribution pattern of NPs in zebrafish embryos ( Danio rerio ). Homeopathic dilutions were studied using high-resolution transmission electron microscopy with selected area electron diffraction (SAED). For the toxicity assessment on Zebrafish, embryos were exposed to a test solution from 4 - 6 hours post-fertilization, and embryos/larvae were assessed up to 5 days post-fertilization (dpf) for viability and morphology. Toxicity was recorded in terms of mortality, hatching delay, phenotypic defects and metal accumulation. Around 5 dpf was found to be the optimum developmental stage for evaluation. The present study aimed to conclusively prove the presence of NPs in all high dilutions of homeopathic drugs. Embryonic zebrafish were exposed to three homeopathic drugs with two potencies (30CH, 200CH) during early embryogenesis. The resulting morphological and cellular responses were observed. Exposure to these potencies produced no visibly significant malformations, pericardial edema, and mortality and no necrotic and apoptotic cellular death. Our findings clearly demonstrate that no toxic effects were observed for these three homeopathic drugs at the potencies and exposure times used in this study. The embryonic zebrafish

The Effectiveness and Safety of a Homeopathic Medicinal Product in Pediatric Upper Respiratory Tract Infections With Fever

PubMed Central

van Haselen, Robert; Thinesse-Mallwitz, Manuela; Maidannyk, Vitaliy; Buskin, Stephen L.; Weber, Stephan; Keller, Thomas; Burkart, Julia; Klement, Petra

2016-01-01

We investigated the clinical effectiveness of a homeopathic add-on therapy in a pediatric subpopulation with upper respiratory tract infections (URTI) in a randomized, controlled, multinational clinical trial. Patients received either on-demand symptomatic standard treatment (ST-group) or the same ST plus a homeopathic medication (Influcid; IFC-group) for 7 days. Outcome assessment was based on symptom and fever resolution and the Wisconsin Upper Respiratory Symptom Survey–21 (WURSS-21). A total of 261 pediatric (<12 years) patients (130 IFC-group; 131 ST-group) were recruited in Germany and the Ukraine. The IFC-group used less symptomatic medication, symptoms resolved significantly earlier (P = .0001), had higher proportions of fever-free children from day 3 onwards, and the WURSS-assessed global disease severity was significantly less (P < .0001) during the entire URTI episode. One adverse event (vomiting) was possibly related to IFC. IFC as add-on treatment in pediatric URTI reduced global disease severity, shortened symptom resolution, and was safe in use. PMID:27493984

Homeopathic Preparations of Quartz, Sulfur and Copper Sulfate Assessed by UV-Spectroscopy

PubMed Central

Wolf, Ursula; Wolf, Martin; Heusser, Peter; Thurneysen, André; Baumgartner, Stephan

2011-01-01

Homeopathic preparations are used in homeopathy and anthroposophic medicine. Although there is evidence of effectiveness in several clinical studies, including double-blinded randomized controlled trials, their nature and mode of action could not be explained with current scientific approaches yet. Several physical methods have already been applied to investigate homeopathic preparations but it is yet unclear which methods are best suited to identify characteristic physicochemical properties of homeopathic preparations. The aim of this study was to investigate homeopathic preparations with UV-spectroscopy. In a blinded, randomized, controlled experiment homeopathic preparations of copper sulfate (CuSO4; 11c–30c), quartz (SiO2; 10c–30c, i.e., centesimal dilution steps) and sulfur (S; 11×–30×, i.e., decimal dilution steps) and controls (one-time succussed diluent) were investigated using UV-spectroscopy and tested for contamination by inductively coupled plasma mass spectrometry (ICP-MS). The UV transmission for homeopathic preparations of CuSO4 preparations was significantly lower than in controls. The transmission seemed to be also lower for both SiO2 and S, but not significant. The mean effect size (95% confidence interval) was similar for the homeopathic preparations: CuSO4 (pooled data) 0.0544% (0.0260–0.0827%), SiO2 0.0323% (–0.0064% to 0.0710%) and S 0.0281% (–0.0520% to 0.1082%). UV transmission values of homeopathic preparations had a significantly higher variability compared to controls. In none of the samples the concentration of any element analyzed by ICP-MS exceeded 100 ppb. Lower transmission of UV light may indicate that homeopathic preparations are less structured or more dynamic than their succussed pure solvent. PMID:19474239

A protocol for a trial of homeopathic treatment for irritable bowel syndrome

PubMed Central

2012-01-01

Background Irritable bowel syndrome is a chronic condition with no known cure. Many sufferers seek complementary and alternative medicine including homeopathic treatment. However there is much controversy as to the effectiveness of homeopathic treatment. This three-armed study seeks to explore the effectiveness of individualised homeopathic treatment plus usual care compared to both an attention control plus usual care and usual care alone, for patients with irritable bowel syndrome. Methods/design This is a three-armed pragmatic randomised controlled trial using the cohort multiple randomised trial methodology. Patients are recruited to an irritable bowel syndrome cohort from primary and secondary care using GP databases and consultants lists respectively. From this cohort patients are randomly selected to be offered, 5 sessions of homeopathic treatment plus usual care, 5 sessions of supportive listening plus usual care or usual care alone. The primary clinical outcome is the Irritable Bowel Syndrome Symptom Severity at 26 weeks. From a power calculation, it is estimated that 33 people will be needed for the homeopathic treatment arm and 132 for the usual care arm, to detect a minimal clinical difference at 80 percent power and 5 percent significance allowing for loss to follow up. An unequal group size has been used for reasons of cost. Analysis will be by intention to treat and will compare homeopathic treatment with usual care at 26 weeks as the primary analysis, and homeopathic treatment with supportive listening as an additional analysis. Discussion This trial has received NHS approval and results are expected in 2013. Trial registration Current Controlled Trials ISRCTN90651143 PMID:23131064

Homeopathic drug discovery: theory update and methodological aspect.

PubMed

Khuda-Bukhsh, Anisur Rahman; Pathak, Surajit

2008-08-01

Homeopathy treats patient on the basis of totality of symptoms and is based on the principle of 'like cures like'. It uses ultra-low doses of highly diluted natural substances as remedies that originate from plants, minerals or animals. The objectives of this review are to discuss concepts, controversies and research related to understanding homeopathy in the light of modern science. Attempts have been made to focus on current views of homeopathy and to delineate its most plausible mechanism(s) of action. Although some areas of concern remain, research carried out so far both in vitro and in vivo validates the effects of highly diluted homeopathic medicines in a wide variety of organisms. The precise mechanism(s) and pathway(s) of action of highly diluted homeopathic drugs are still unknown.

Homeopathic Prevention and Management of Epidemic Diseases.

PubMed

Jacobs, Jennifer

2018-05-12

 Homeopathy has been used to treat epidemic diseases since the time of Hahnemann, who used Belladonna to treat scarlet fever. Since then, several approaches using homeopathy for epidemic diseases have been proposed, including individualization, combination remedies, genus epidemicus, and isopathy.  The homeopathic research literature was searched to find examples of each of these approaches and to evaluate which were effective.  There is good experimental evidence for each of these approaches. While individualization is the gold standard, it is impractical to use on a widespread basis. Combination remedies can be effective but must be based on the symptoms of a given epidemic in a specific location. Treatment with genus epidemicus can also be successful if based on data from many practitioners. Finally, isopathy shows promise and might be more readily accepted by mainstream medicine due to its similarity to vaccination.  Several different homeopathic methods can be used to treat epidemic diseases. The challenge for the future is to refine these approaches and to build on the knowledge base with additional rigorous trials. If and when conventional medicine runs out of options for treating epidemic diseases, homeopathy could be seen as an attractive alternative, but only if there is viable experimental evidence of its success. The Faculty of Homeopathy.

Remission of Schizoaffective Disorder Using Homeopathic Medicine: 2 Case Reports.

PubMed

Grise, Diane E; Peyman, Tara; Langland, Jeffrey

2018-03-01

Context • Research on the schizophrenia spectrum is primarily focused on pharmaceutical interventions, although alternative treatments have been gaining increasing popularity in recent years because patients are seeking treatments that are effective and have reduced side effects. A significant body of evidence already exists supporting the effectiveness of homeopathy to treat a wide array of illnesses. Objective • The research team intended to demonstrate the need for using both alternative and conventional treatments to improve clinical outcomes in the treatment of schizoaffective disorder. Design • The research team performed 2 case studies. Setting • The study took place at Arizona Natural Health Center (Tempe, AZ, USA), an outpatient clinic where Dr Tara Peyman worked as a naturopathic doctor from 2008 to 2014. Participants • The participants were a 23-y-old female (case 1) and a 34-y-old female (case 2), both of whom had been diagnosed with schizoaffective disorder of the bipolar type. Intervention • Individualized homeopathic treatment was initiated for the 2 patients, who previously had received medication of atypical antipsychotics and mood stabilizers. Outcome Measures • A Likert scale was used to evaluate the intensity of each patient's symptoms at each follow-up, based on self-reporting, using a scale from 1 to 10, with a score of 10 being the highest. Results • During the course of treatment, both patients' symptoms normalized, and they regained their ability to hold jobs, attend school, and maintain healthy relationships with their families and partners while requiring fewer pharmaceutical interventions. Conclusions • The 2 current case reports demonstrate a successful integrative approach to the treatment of schizoaffective disorder. They illustrate the value of individualized homeopathic prescriptions with proper case management in the successful treatment of that disorder. Future large-scale, double-blind, placebo

Homeopathic drug therapy. Homeopathy in Chikungunya Fever and Post-Chikungunya Chronic Arthritis: an observational study.

PubMed

Wadhwani, Gyandas G

2013-07-01

To observe the effect of homeopathic therapy in Chikungunya Fever (CF) and in Post-Chikungunya Chronic Arthritis (PCCA) in a primary health care setting. A prospective observational study was conducted at Delhi Government Homeopathic Dispensary, Aali Village, New Delhi, India, for a period of 6 months, from 1st October 2010 to 31st March 2011. 126 patients (75 CF, 51 PCCA) were enrolled based on predefined inclusion criteria. A single homeopathic medicine was prescribed for each patient after case taking with the help of Materia Medica and/or Repertory. Results were evaluated on the basis of visual analogue scale and symptom scores. Complete recovery was seen in 84.5% CF cases in a mean time of 6.8 days. 90% cases of PCCA recovered completely in a mean time of 32.5 days. Homeopathic therapy may be effective in CF and PCCA. A randomized controlled trial should be considered. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Homeopathic medications as clinical alternatives for symptomatic care of acute otitis media and upper respiratory infections in children.

PubMed

Bell, Iris R; Boyer, Nancy N

2013-01-01

The public health and individual risks of inappropriate antibiotic prescribing and conventional over-the-counter symptomatic drugs in pediatric treatment of acute otitis media (AOM) and upper respiratory infections (URIs) are significant. Clinical research suggests that over-the-counter homeopathic medicines offer pragmatic treatment alternatives to conventional drugs for symptom relief in children with uncomplicated AOM or URIs. Homeopathy is a controversial but demonstrably safe and effective 200-year-old whole system of complementary and alternative medicine used worldwide. Numerous clinical studies demonstrate that homeopathy accelerates early symptom relief in acute illnesses at much lower risk than conventional drug approaches. Evidence-based advantages for homeopathy include lower antibiotic fill rates during watchful waiting in otitis media, fewer and less serious side effects, absence of drug-drug interactions, and reduced parental sick leave from work. Emerging evidence from basic and preclinical science research counter the skeptics' claims that homeopathic remedies are biologically inert placebos. Consumers already accept and use homeopathic medicines for self care, as evidenced by annual US consumer expenditures of $2.9 billion on homeopathic remedies. Homeopathy appears equivalent to and safer than conventional standard care in comparative effectiveness trials, but additional well-designed efficacy trials are indicated. Nonetheless, the existing research evidence on safety supports pragmatic use of homeopathy in order to "first do no harm" in the early symptom management of otherwise uncomplicated AOM and URIs in children.

Homeopathic Medications as Clinical Alternatives for Symptomatic Care of Acute Otitis Media and Upper Respiratory Infections in Children

PubMed Central

Boyer, Nancy N

2013-01-01

The public health and individual risks of inappropriate antibiotic prescribing and conventional over-the-counter symptomatic drugs in pediatric treatment of acute otitis media (AOM) and upper respiratory infections (URIs) are significant. Clinical research suggests that over-the-counter homeopathic medicines offer pragmatic treatment alternatives to conventional drugs for symptom relief in children with uncomplicated AOM or URIs. Homeopathy is a controversial but demonstrably safe and effective 200-year-old whole system of complementary and alternative medicine used worldwide. Numerous clinical studies demonstrate that homeopathy accelerates early symptom relief in acute illnesses at much lower risk than conventional drug approaches. Evidence-based advantages for homeopathy include lower antibiotic fill rates during watchful waiting in otitis media, fewer and less serious side effects, absence of drug-drug interactions, and reduced parental sick leave from work. Emerging evidence from basic and preclinical science research counter the skeptics' claims that homeopathic remedies are biologically inert placebos. Consumers already accept and use homeopathic medicines for self care, as evidenced by annual US consumer expenditures of $2.9 billion on homeopathic remedies. Homeopathy appears equivalent to and safer than conventional standard care in comparative effectiveness trials, but additional well-designed efficacy trials are indicated. Nonetheless, the existing research evidence on safety supports pragmatic use of homeopathy in order to “first do no harm” in the early symptom management of otherwise uncomplicated AOM and URIs in children. PMID:24381823

Action of antibiotic oxacillin on in vitro growth of methicillin-resistant Staphylococcus aureus (MRSA) previously treated with homeopathic medicines.

PubMed

Passeti, Tânia Aguiar; Bissoli, Leandro Ribeiro; Macedo, Ana Paula; Libame, Registila Beltrame; Diniz, Susana; Waisse, Silvia

2017-02-01

Resistance to antibiotics is a major public health concern worldwide. New treatment options are needed and homeopathy is one such option. We sought to assess the effect of the homeopathic medicine Belladonna (Bell) and a nosode (biotherapy) prepared from a multi-drug resistant bacterial species, methicillin-resistant Staphylococcus aureus (MRSA), on the same bacterium. Bell and MRSA nosode were prepared in 6cH and 30cH potencies in 30% alcohol and sterile water, according to the Brazilian Homeopathic Pharmacopeia and tested on MRSA National Collection of Type Cultures (NCTC) 10442. We assessed in vitro bacterial growth, deoxyribonuclease (DNAase) and hemolysin activity, and in vitro bacterial growth in combination with oxacillin (minimum inhibitory concentration - MIC). All values were compared to control: 30% alcohol and water. In vitro growth of MRSA was statistically significantly inhibited in the presence of Bell and nosode 6cH and 30cH compared to controls (p < 0.0001); and with combination of Bell or nosode 6cH and 30cH and oxacillin (p < 0.001). Bell 30cH and nosode 6cH and 30cH significantly decreased bacterial DNAse production (p < 0.001) and reduced red blood cell lysis. Cultures of MRSA treated with Belladonna or MRSA nosode exhibited reduced growth in vitro, reduced enzymatic activity and became more vulnerable to the action of the antibiotic oxacillin. Further studies are needed on the biomolecular basis of these effects. Copyright © 2016 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Effect of homeopathic treatment on gene expression in Copenhagen rat tumor tissues.

PubMed

Thangapazham, Rajesh L; Rajeshkumar, N V; Sharma, Anuj; Warren, Jim; Singh, Anoop K; Ives, John A; Gaddipati, Jaya P; Maheshwari, Radha K; Jonas, Wayne B

2006-12-01

Increasing evidence suggests that the inability to undergo apoptosis is an important factor in the development and progression of prostate cancer. Agents that induce apoptosis may inhibit tumor growth and provide therapeutic benefit. In a recent study, the authors found that certain homeopathic treatments produced anticancer effects in an animal model. In this study, the authors examined the immunomodulating and apoptotic effects of these remedies. The authors investigated the effect of a homeopathic treatment regimen containing Conium maculatum, Sabal serrulata, Thuja occidentalis, and a MAT-LyLu Carcinosin nosode on the expression of cytokines and genes that regulate apoptosis. This was assessed in prostate cancer tissues, extracted from animals responsive to these drugs, using ribonuclease protection assay or reverse transcription polymerase chain reaction. There were no significant changes in mRNA levels of the apoptotic genes bax, bcl-2, bcl-x, caspase-1, caspase-2, caspase-3, Fas, FasL, or the cytokines interleukin (IL)-1alpha, IL-1beta, tumor necrosis factor (TNF)-beta, IL-3, IL-4, IL-5, IL-6, IL-10, TNF-alpha, IL-2, and interferon-gamma in prostate tumor and lung metastasis after treatment with homeopathic medicines. This study indicates that treatment with the highly diluted homeopathic remedies does not alter the gene expression in primary prostate tumors or in lung metastasis. The therapeutic effect of homeopathic treatments observed in the in vivo experiments cannot be explained by mechanisms based on distinct alterations in gene expression related to apoptosis or cytokines. Future research should explore subtle modulations in the expression of multiple genes in different biological pathways.

Prospective Evaluation of Few Homeopathic Rubrics of Kent's Repertory From Bayesian Perspective.

PubMed

Koley, Munmun; Saha, Subhranil; Das, Kaushik Deb; Roy, Sushabhan; Goenka, Rachna; Chowdhury, Pulak Roy; Hait, Himangsu; Bhattacharyya, Chapal Kanti; Sadhukhan, Sanjoy Kumar

2016-10-01

Absolute grading system of homeopathic repertories poses substantial threat to reliability; however, it may be resolved by evaluating rubrics prospectively using likelihood ratio (LR). The authors evaluated few "physical general" rubrics from Kent's repertory-"chilly," "hot," "ambithermal," "preference for hot/cold food," "desire/aversion for fish/egg/meat/sour/pungent/salt/sweet/bitter"-prospectively in West Bengal, India, for 1.5 years using the Outcome Related to Impact on Daily Living scale. Per symptom/rubric, LRs < 1.5 were discarded. A total of 2039 encounters were analyzed for thermal relations and 4715 for desires/aversions for specific food items. Comparison with Kent's repertory revealed discrepancies. One new rubric with corresponding medicines was suggested to be introduced, new entries of medicines were recommended, and some seemed to maintain their ascribed importance. The authors refrained from converting LRs into typefaces prematurely; still they propose introducing LR to repertories for a structural update, changing its use, and enabling homeopaths to make more reliable predictions. © The Author(s) 2015.

Embryonic Zebrafish Model - A Well-Established Method for Rapidly Assessing the Toxicity of Homeopathic Drugs

PubMed Central

Gupta, Himanshu R; Patil, Yogesh; Singh, Dipty

2016-01-01

Objectives: Advancements in nanotechnology have led to nanoparticle (NP) use in various fields of medicine. Although the potential of NPs is promising, the lack of documented evidence on the toxicological effects of NPs is concerning. A few studies have documented that homeopathy uses NPs. Unfortunately, very few sound scientific studies have explored the toxic effects of homeopathic drugs. Citing this lack of high-quality scientific evidence, regulatory agencies have been reluctant to endorse homeopathic treatment as an alternative or adjunct treatment. This study aimed to enhance our insight into the impact of commercially-available homeopathic drugs, to study the presence of NPs in those drugs and any deleterious effects they might have, and to determine the distribution pattern of NPs in zebrafish embryos (Danio rerio). Methods: Homeopathic dilutions were studied using high-resolution transmission electron microscopy with selected area electron diffraction (SAED). For the toxicity assessment on Zebrafish, embryos were exposed to a test solution from 4 - 6 hours post-fertilization, and embryos/larvae were assessed up to 5 days post-fertilization (dpf) for viability and morphology. Toxicity was recorded in terms of mortality, hatching delay, phenotypic defects and metal accumulation. Around 5 dpf was found to be the optimum developmental stage for evaluation. Results: The present study aimed to conclusively prove the presence of NPs in all high dilutions of homeopathic drugs. Embryonic zebrafish were exposed to three homeopathic drugs with two potencies (30CH, 200CH) during early embryogenesis. The resulting morphological and cellular responses were observed. Exposure to these potencies produced no visibly significant malformations, pericardial edema, and mortality and no necrotic and apoptotic cellular death. Conclusion: Our findings clearly demonstrate that no toxic effects were observed for these three homeopathic drugs at the potencies and exposure times used

Additive homeopathy in cancer patients: Retrospective survival data from a homeopathic outpatient unit at the Medical University of Vienna.

PubMed

Gaertner, Katharina; Müllner, Michael; Friehs, Helmut; Schuster, Ernst; Marosi, Christine; Muchitsch, Ilse; Frass, Michael; Kaye, Alan David

2014-04-01

Current literature suggests a positive influence of additive classical homeopathy on global health and well-being in cancer patients. Besides encouraging case reports, there is little if any research on long-term survival of patients who obtain homeopathic care during cancer treatment. Data from cancer patients who had undergone homeopathic treatment complementary to conventional anti-cancer treatment at the Outpatient Unit for Homeopathy in Malignant Diseases, Medical University Vienna, Department of Medicine I, Vienna, Austria, were collected, described and a retrospective subgroup-analysis with regard to survival time was performed. Patient inclusion criteria were at least three homeopathic consultations, fatal prognosis of disease, quantitative and qualitative description of patient characteristics, and survival time. In four years, a total of 538 patients were recorded to have visited the Outpatient Unit Homeopathy in Malignant Diseases, Medical University Vienna, Department of Medicine I, Vienna, Austria. 62.8% of them were women, and nearly 20% had breast cancer. From the 53.7% (n=287) who had undergone at least three homeopathic consultations within four years, 18.7% (n=54) fulfilled inclusion criteria for survival analysis. The surveyed neoplasms were glioblastoma, lung, cholangiocellular and pancreatic carcinomas, metastasized sarcoma, and renal cell carcinoma. Median overall survival was compared to expert expectations of survival outcomes by specific cancer type and was prolonged across observed cancer entities (p<0.001). Extended survival time in this sample of cancer patients with fatal prognosis but additive homeopathic treatment is interesting. However, findings are based on a small sample, and with only limited data available about patient and treatment characteristics. The relationship between homeopathic treatment and survival time requires prospective investigation in larger samples possibly using matched-pair control analysis or randomized

Gas discharge visualization evaluation of ultramolecular doses of homeopathic medicines under blinded, controlled conditions.

PubMed

Bell, Iris R; Lewis, Daniel A; Brooks, Audrey J; Lewis, Sabrina E; Schwartz, Gary E

2003-02-01

To determine the feasibility of using a computerized biophysical method, gas discharge visualization (GDV), to differentiate ultramolecular doses of homeopathic remedies from solvent controls and from each other. Blinded, randomized assessment of four split samples each of 30c potencies of three homeopathic remedies from different kingdoms, for example, Natrum muriaticum (mineral), Pulsatilla (plant), and Lachesis (animal), dissolved in a 20% alcohol-water solvent versus two different control solutions (that is, solvent with untreated lactose/sucrose pellets and unsuccussed solvent alone). GDV measurements, involving application of a brief electrical impulse at four different voltage levels, were performed over 10 successive images on each of 10 drops from each bottle (total 400 images per test solution per voltage). The dependent variables were the quantified image characteristics of the liquid drops (form coefficient, area, and brightness) from the resultant burst of electron-ion emission and optical radiation in the visual and ultraviolet ranges. The procedure generated measurable images at the two highest voltage levels. At 17 kV, the remedies exhibited overall lower image parameter values compared with solvents (significant for Pulsatilla and Lachesis), as well as differences from solvents in fluctuations over repeated images (exposures to the same voltage). At 24 kV, other patterns emerged, with individual remedies showing higher or lower image parameters compared with other remedies and the solvent controls. GDV technology may provide an electromagnetic probe into the properties of homeopathic remedies as distinguished from solvent controls. However, the present findings also highlight the need for additional research to evaluate factors that may affect reproducibility of results.

Can the caged bird sing? Reflections on the application of qualitative research methods to case study design in homeopathic medicine

PubMed Central

Thompson, Trevor DB

2004-01-01

Background Two main pathways exist for the development of knowledge in clinical homeopathy. These comprise clinical trials conducted primarily by university-based researchers and cases reports and homeopathic "provings" compiled by engaged homeopathic practitioners. In this paper the relative merits of these methods are examined and a middle way proposed. This consists of the "Formal Case Study" (FCS) in which qualitative methods are used to increase the rigour and sophistication with which homeopathic cases are studied. Before going into design issues this paper places the FCS in an historical and academic context and describes the relative merits of the method. Discussion Like any research, the FCS should have a clear focus. This focus can be both "internal", grounded in the discourse of homeopathy and also encompass issues of wider appeal. A selection of possible "internal" and "external" research questions is introduced. Data generation should be from multiple sources to ensure adequate triangulation. This could include the recording and transcription of actual consultations. Analysis is built around existing theory, involves cross-case comparison and the search for deviant cases. The trustworthiness of conclusions is ensured by the application of concepts from qualitative research including triangulation, groundedness, respondent validation and reflexivity. Though homeopathic case studies have been reported in mainstream literature, none has used formal qualitative methods – though some such studies are in progress. Summary This paper introduces the reader to a new strategy for homeopathic research. This strategy, termed the "formal case study", allows for a naturalistic enquiry into the players, processes and outcomes of homeopathic practice. Using ideas from qualitative research, it allows a rigorous approach to types of research question that cannot typically be addressed through clinical trials and numeric outcome studies. The FCS provides an opportunity

Is metabolic dysregulation associated with antidepressant response in depressed women in climacteric treated with individualized homeopathic medicines or fluoxetine? The HOMDEP-MENOP Study.

PubMed

Macías-Cortés, Emma Del Carmen; Llanes-González, Lidia; Aguilar-Faisal, Leopoldo; Asbun-Bojalil, Juan

2017-02-01

Climacteric is associated with both depression and metabolic dysregulation. Scarce evidence suggests that metabolic dysregulation may predict poor response to conventional antidepressants. Response to depression treatment has not been studied in homeopathic medicine. The aim of this study was to investigate the prevalence of metabolic disorders in depressed climacteric women treated with homeopathic medicines, fluoxetine or placebo, and if these alterations have any association with response to depression treatment. One hundred and thirty-three Mexican women (40-65 years) with depression, enrolled in the HOMDEP-MENOP study, a randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a 6 week follow-up, underwent a complete medical history and clinical examination. Metabolic parameters were assessed at baseline. Association between baseline metabolic parameters and response to depression treatment was analyzed with bivariate analysis in the three groups. Odds ratios (OR) with their 95% confidence interval (95% CI) were calculated. Metabolic parameters were considered for inclusion in the logistic regression model if they had a statistically significant relationship with response rate on bivariate analysis at p<0.05 or if they were clinically relevant. Overall combined prevalence (obesity and overweight) was 86.5%; 52.3% had hypertriglyceridemia; 44.7% hypercholesterolemia; 46.7% insulin resistance; and 16% subclinical hypothyroidism. There was no statistically significant association between dyslipidemia, overweight, or insulin resistance and non-response in the homeopathy group [OR (95% CI) 1.57 (0.46-5.32), p=0.467; 0.37 (0.003-1.11), p=0.059; 0.67 (0.16-2.7), p=0.579, respectively]. Metabolic dysregulation was not significantly associated with response to depression treatment in depressed climacteric women treated with individualized homeopathic treatment (IHT), fluoxetine or placebo. Due to the high prevalence of metabolic disorders and

[Procedure for Latrodectus reproduction in the laboratory setting and the preparation of the first Russian matrix from its venom to manufacture homeopathic remedies with antiparasitic activity].

PubMed

Streliaeva, A V; Gasparian, E R; Polzikov, V V; Sagieva, A T; Lazareva, N B; Kurilov, D V; Chebyshev, N V; Sadykov, V M; Zuev, S S; Shcheglova, T A

2012-01-01

The investigation was undertaken to study the biology and ecology of Latrodectus, the possibilities of its importation to Russia from other countries, to breed Latrodectus in the laboratory setting, and to design the first homeopathic matrix of Latrodectus to manufacture homeopathic remedies. The authors were the first to devise a method for Latrodectus breeding in the laboratory setting of Moscow and its vicinities. The Latrodectus bred in the laboratory is suitable to manufacture drugs and in captivity they do not lose its biological activity. The authors were the first to prepare a homeopathic Latrodectus matrix for homeopathic medicines, by using the new Russian extragent petroleum. Chromatography mass spectrometry was used to identify more than a hundred chemical compounds in the Russian petroleum. The biological activity of the petroleum Latrodectus matrix for the manufacture of homeopathic remedies was highly competitive with that of the traditional Latrodectus venom matrix made using ethyl alcohol. The homeopathic Latrodectus matrix made using glycerol lost its biological activity because of glycerol. The biological activity of homeopathic matrixes made from Latrodectus inhabiting the USA, Uzbekistan, and the south of Russia and from that bred in the laboratory was studied. The homeopathic matrix made from the Latrodectus living in the Samarkand Region, Republic of Uzbekistan, has the highest biological activity.

Nonlinear dynamical systems effects of homeopathic remedies on multiscale entropy and correlation dimension of slow wave sleep EEG in young adults with histories of coffee-induced insomnia.

PubMed

Bell, Iris R; Howerter, Amy; Jackson, Nicholas; Aickin, Mikel; Bootzin, Richard R; Brooks, Audrey J

2012-07-01

Investigators of homeopathy have proposed that nonlinear dynamical systems (NDS) and complex systems science offer conceptual and analytic tools for evaluating homeopathic remedy effects. Previous animal studies demonstrate that homeopathic medicines alter delta electroencephalographic (EEG) slow wave sleep. The present study extended findings of remedy-related sleep stage alterations in human subjects by testing the feasibility of using two different NDS analytic approaches to assess remedy effects on human slow wave sleep EEG. Subjects (N=54) were young adult male and female college students with a history of coffee-related insomnia who participated in a larger 4-week study of the polysomnographic effects of homeopathic medicines on home-based all-night sleep recordings. Subjects took one bedtime dose of a homeopathic remedy (Coffea cruda or Nux vomica 30c). We computed multiscale entropy (MSE) and the correlation dimension (Mekler-D2) for stages 3 and 4 slow wave sleep EEG sampled in artifact-free 2-min segments during the first two rapid-eye-movement (REM) cycles for remedy and post-remedy nights, controlling for placebo and post-placebo night effects. MSE results indicate significant, remedy-specific directional effects, especially later in the night (REM cycle 2) (CC: remedy night increases and post-remedy night decreases in MSE at multiple sites for both stages 3 and 4 in both REM cycles; NV: remedy night decreases and post-remedy night increases, mainly in stage 3 REM cycle 2 MSE). D2 analyses yielded more sporadic and inconsistent findings. Homeopathic medicines Coffea cruda and Nux vomica in 30c potencies alter short-term nonlinear dynamic parameters of slow wave sleep EEG in healthy young adults. MSE may provide a more sensitive NDS analytic method than D2 for evaluating homeopathic remedy effects on human sleep EEG patterns. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Nonlinear Dynamical Systems Effects of Homeopathic Remedies on Multiscale Entropy and Correlation Dimension of Slow Wave Sleep EEG in Young Adults with Histories of Coffee-Induced Insomnia

PubMed Central

Bell, Iris R.; Howerter, Amy; Jackson, Nicholas; Aickin, Mikel; Bootzin, Richard R.; Brooks, Audrey J.

2012-01-01

Background Investigators of homeopathy have proposed that nonlinear dynamical systems (NDS) and complex systems science offer conceptual and analytic tools for evaluating homeopathic remedy effects. Previous animal studies demonstrate that homeopathic medicines alter delta electroencephalographic (EEG) slow wave sleep. The present study extended findings of remedy-related sleep stage alterations in human subjects by testing the feasibility of using two different NDS analytic approaches to assess remedy effects on human slow wave sleep EEG. Methods Subjects (N=54) were young adult male and female college students with a history of coffee-related insomnia who participated in a larger 4-week study of the polysomnographic effects of homeopathic medicines on home-based all-night sleep recordings. Subjects took one bedtime dose of a homeopathic remedy (Coffea cruda or Nux vomica 30c). We computed multiscale entropy (MSE) and the correlation dimension (Mekler-D2) for stage 3 and 4 slow wave sleep EEG sampled in artifact-free 2-minute segments during the first two rapid-eye-movement (REM) cycles for remedy and post-remedy nights, controlling for placebo and post-placebo night effects. Results MSE results indicate significant, remedy-specific directional effects, especially later in the night (REM cycle 2) (CC: remedy night increases and post-remedy night decreases in MSE at multiple sites for both stages 3 and 4 in both REM cycles; NV: remedy night decreases and post-remedy night increases, mainly in stage 3 REM cycle 2 MSE). D2 analyses yielded more sporadic and inconsistent findings. Conclusions Homeopathic medicines Coffea cruda and Nux vomica in 30c potencies alter short-term nonlinear dynamic parameters of slow wave sleep EEG in healthy young adults. MSE may provide a more sensitive NDS analytic method than D2 for evaluating homeopathic remedy effects on human sleep EEG patterns. PMID:22818237

A systematic review of the quality of homeopathic pathogenetic trials published from 1945 to 1995.

PubMed

Dantas, F; Fisher, P; Walach, H; Wieland, F; Rastogi, D P; Teixeira, H; Koster, D; Jansen, J P; Eizayaga, J; Alvarez, M E P; Marim, M; Belon, P; Weckx, L L M

2007-01-01

The quality of information gathered from homeopathic pathogenetic trials (HPTs), also known as 'provings', is fundamental to homeopathy. We systematically reviewed HPTs published in six languages (English, German, Spanish, French, Portuguese and Dutch) from 1945 to 1995, to assess their quality in terms of the validity of the information they provide. The literature was comprehensively searched, only published reports of HPTs were included. Information was extracted by two reviewers per trial using a form with 87 items. Information on: medicines, volunteers, ethical aspects, blinding, randomization, use of placebo, adverse effects, assessments, presentation of data and number of claimed findings were recorded. Methodological quality was assessed by an index including indicators of internal and external validity, personal judgement and comments of reviewers for each study. 156 HPTs on 143 medicines, involving 2815 volunteers, produced 20,538 pathogenetic effects (median 6.5 per volunteer). There was wide variation in methods and results. Sample size (median 15, range 1-103) and trial duration (mean 34 days) were very variable. Most studies had design flaws, particularly absence of proper randomization, blinding, placebo control and criteria for analysis of outcomes. Mean methodological score was 5.6 (range 4-16). More symptoms were reported from HPTs of poor quality than from better ones. In 56% of trials volunteers took placebo. Pathogenetic effects were claimed in 98% of publications. On average about 84% of volunteers receiving active treatment developed symptoms. The quality of reports was in general poor, and much important information was not available. The HPTs were generally of low methodological quality. There is a high incidence of pathogenetic effects in publications and volunteers but this could be attributable to design flaws. Homeopathic medicines, tested in HPTs, appear safe. The central question of whether homeopathic medicines in high dilutions can

Homeopathic potentization based on nanoscale domains.

PubMed

Czerlinski, George; Ypma, Tjalling

2011-12-01

The objectives of this study were to present a simple descriptive and quantitative model of how high potencies in homeopathy arise. The model begins with the mechanochemical production of hydrogen and hydroxyl radicals from water and the electronic stabilization of the resulting nanodomains of water molecules. The life of these domains is initially limited to a few days, but may extend to years when the electromagnetic characteristic of a homeopathic agent is copied onto the domains. This information is transferred between the original agent and the nanodomains, and also between previously imprinted nanodomains and new ones. The differential equations previously used to describe these processes are replaced here by exponential expressions, corresponding to simplified model mechanisms. Magnetic stabilization is also involved, since these long-lived domains apparently require the presence of the geomagnetic field. Our model incorporates this factor in the formation of the long-lived compound. Numerical simulation and graphs show that the potentization mechanism can be described quantitatively by a very simplified mechanism. The omitted factors affect only the fine structure of the kinetics. Measurements of pH changes upon absorption of different electromagnetic frequencies indicate that about 400 nanodomains polymerize to form one cooperating unit. Singlet excited states of some compounds lead to dramatic changes in their hydrogen ion dissociation constant, explaining this pH effect and suggesting that homeopathic information is imprinted as higher singlet excited states. A simple description is provided of the process of potentization in homeopathic dilutions. With the exception of minor details, this simple model replicates the results previously obtained from a more complex model. While excited states are short lived in isolated molecules, they become long lived in nanodomains that form coherent cooperative aggregates controlled by the geomagnetic field. These

Homeopathic pathogenetic trials produce specific symptoms different from placebo.

PubMed

Möllinger, Heribert; Schneider, Rainer; Walach, Harald

2009-04-01

Homeopathy uses information gathered from healthy volunteers taking homeopathic substances (pathogenetic trials) for clinical treatment. It is controversial whether such studies produce symptoms different from those produced by placebo. To test whether homeopathic preparations produce different symptoms than placebo in healthy volunteers. Three armed, double-blind, placebo controlled randomised experimental pathogenetic study in 25 healthy volunteers who took either one of two homeopathic remedies, Natrum muriaticum and Arsenicum album in 30CH or identical placebo. Main outcome parameter was the number of remedy-specific symptoms per group. On average, 6 symptoms typical for Arsenicum album were experienced by participants taking arsenicum album, 5 symptoms typical for Natrum muriaticum by those taking natrum muriaticum, and 11 non-specific symptoms by those in the placebo group. Differences were significant overall (Kruskall Wallis test, p = 0.0002,) and significantly different from placebo (Mann-Whitney test, p = 0.001). Homeopathic remedies produce different symptoms than placebo. Copyright (c) 2009 S. Karger AG, Basel.

[Research to achieve a homeopathic lotion].

PubMed

Verbuţă, A; Cojocaru, I

1996-01-01

A formulation of homeopathic lotion was elaborated. It uses as mother-solutions: the Calendula tincture and the Fumaria tincture prepared according to the homeopathic rules, and a vegetal soft extract conventionally named by us Pt2a, and the 42 C alcohol was used as a vehicle. All dilutions were made at 3CH. The pH, the refraction index and the electrical conductivity of the three solutions prove a good stability of the preparation. The 2 CH a dilution was well tolerated at the administration with juvenile acne and the simple dry phthiriasis, an improving being noted after 3-4 days of treatment.

Homeopathic Individualized Q-Potencies versus Fluoxetine for Moderate to Severe Depression: Double-Blind, Randomized Non-Inferiority Trial

PubMed Central

Adler, U. C.; Paiva, N. M. P.; Cesar, A. T.; Adler, M. S.; Molina, A.; Padula, A. E.; Calil, H. M.

2011-01-01

Homeopathy is a complementary and integrative medicine used in depression, The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day−1 (up to 40 mg day−1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Åsberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = .654) and 8th weeks (P = .965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were −3.04 (95% CI −6.95, 0.86) and −2.4 (95% CI −6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients

The use of Complementary and Alternative Medicine in pregnancy: data from the Avon Longitudinal Study of Parents and Children (ALSPAC).

PubMed

Bishop, J L; Northstone, K; Green, J R; Thompson, E A

2011-12-01

To report the frequency of Complementary and Alternative Medicine (CAM) use by a population of pregnant women in the UK. Four postal self-completion questionnaires completed at 8, 12, 18 and 32 weeks' gestation provided the source of CAMs used. Questions asked for written descriptions about the use of any treatments, pills, medicines, ointments, homeopathic medicines, herbal medicines, supplements, drinks and herbal teas. An observational, population-based, cohort study of parents and children of 14,541 pregnant women residing within the former county of Avon in south-west England. Data was available for 14,115 women. Over a quarter (26.7%; n=3774) of women had used a CAM at least once in pregnancy, the use rising from 6% in the 1st trimester to 12.4% in the 2nd to 26.3% in the 3rd. Herbal teas were the most commonly reported CAM at any time in pregnancy (17.7%; n=2499) followed by homeopathic medicine (14.4%; n=2038) and then herbal medicine (5.8%; n=813). The most commonly used herbal product was chamomile used by 14.6% of women, the most commonly used homeopathic product was Arnica used by 3.1% of women. Other CAMs (osteopathy, aromatherapy, acupuncture/acupressure, Chinese herbal medicine, chiropractic, cranial sacral therapy, hypnosis, non-specific massage and reflexology) accounted for less than 1% of users. CAM use in pregnancy, where a wide range of CAMs has been assessed, has not been widely reported. Studies that have been conducted report varying results to this study (26.7%) by between 13.3% and 87% of pregnant women. Survey results will be affected by a number of factors namely the inclusion/exclusion of vitamins and minerals, the timing of data collection, the country of source, the number of women surveyed, and the different selection criteria of either recruiting women to the study or of categorising and identifying a CAM treatment or product. Copyright © 2011 Elsevier Ltd. All rights reserved.

[On the effectiveness of the homeopathic remedy Arnica montana].

PubMed

Lüdtke, Rainer; Hacke, Daniela

2005-11-01

Arnica montana is a homeopathic remedy often prescribed after traumata and injuries. To assess whether Arnica is effective beyond placebo and to identify factors which support or contradict this effectiveness. All prospective, controlled trials on the effectiveness of homeopathic Arnica were included. Overall effectiveness was assessed by meta-analysis and meta-regression techniques. 68 comparisons from 49 clinical trials show a significant effectiveness of Arnica in traumatic injuries in random effects meta-analysis (odds ratio [OR], 0.36; 95% confidence interval [CI], 0.24-0.55), but not in meta-regression models (OR, 0.37; CI, 0.11-1.24). We found no evidence for publication bias. Studies from Medline-listed journals and high-quality studies are less likely to report positive results (p = 0.0006 and p = 0.0167). The hypothesis that homeopathic Arnica is effective could neither be proved nor rejected. All trials were highly heterogeneous, meta-regression does not help to explain this heterogeneity substantially.

Integrative nanomedicine: treating cancer with nanoscale natural products.

PubMed

Bell, Iris R; Sarter, Barbara; Koithan, Mary; Banerji, Prasanta; Banerji, Pratip; Jain, Shamini; Ives, John

2014-01-01

Finding safer and more effective treatments for specific cancers remains a significant challenge for integrative clinicians and researchers worldwide. One emerging strategy is the use of nanostructured forms of drugs, vaccines, traditional animal venoms, herbs, and nutraceutical agents in cancer treatment. The recent discovery of nanoparticles in traditional homeopathic medicines adds another point of convergence between modern nanomedicine and alternative interventional strategies. A way in which homeopathic remedies could initiate anticancer effects includes cell-to-cell signaling actions of both exogenous and endogenous (exosome) nanoparticles. The result can be a cascade of modulatory biological events with antiproliferative and pro-apoptotic effects. The Banerji Protocols reflect a multigenerational clinical system developed by homeopathic physicians in India who have treated thousands of patients with cancer. A number of homeopathic remedy sources from the Banerji Protocols (eg, Calcarea phosphorica; Carcinosin-tumor-derived breast cancer tissue prepared homeopathically) overlap those already under study in nonhomeopathic nanoparticle and nanovesicle tumor exosome cancer vaccine research. Past research on antineoplastic effects of nano forms of botanical extracts such as Phytolacca, Gelsemium, Hydrastis, Thuja, and Ruta as well as on homeopathic remedy potencies made from the same types of source materials suggests other important overlaps. The replicated finding of silica, silicon, and nano-silica release from agitation of liquids in glassware adds a proven nonspecific activator and amplifier of immunological effects. Taken together, the nanoparticulate research data and the Banerji Protocols for homeopathic remedies in cancer suggest a way forward for generating advances in cancer treatment with natural product-derived nanomedicines.

Usage and appraisal of educational media by homeopathic therapists – A cross sectional survey

PubMed Central

2012-01-01

Background During recent years the market for homeopathic education media has increasingly diversified with old (books, seminars) and new media (video-seminars, pc-programs, homeo-wiki and internet-courses). However, little is known about homeopaths’ preferences in using educational media and their requirements of this topic. Aim This survey was designed to gain a better understanding of the usage and appraisal of educational media by homeopaths. Methods 192 homeopathic practitioners (GPs and health practitioners) at a educational conference were asked to answer a standardized questionnaire covering the topics “formal education and context of work” (9 items), “homeopathic practise and usage (24 items), “utilization of educational media” (9 items) and “favoured attributes for educational media” (11 items). Results Out of 192 homeopaths who attended the conference, 118 completed the questionnaire (response rate 61.5%). For their continuing homeopathic education they predominantly indicated to use books (scale value from 0 = never to 2 = always: 1.72) and seminars (1.54) whereas journals (0.98) and the internet (0.65) were used less often. The most favoured attributes concerning medical education media were reliability (1.76), relevance for clinical practice (1.74) and user friendliness (1.6). Less favoured attributes were inexpensiveness (1.1), graphical material (0.92) and interactivity (0.88). Conclusions The survey illustrates the current situation of medical education media in homeopathy. Although there are parallels to earlier research conducted in conventional GPs, homeopaths are more likely to refer to classical media. New education tools should be designed according to these preferences. PMID:22794310

Homeopathic practitioner views of changes in patients undergoing constitutional treatment for chronic disease.

PubMed

Bell, Iris R; Koithan, Mary; Gorman, Margaret M; Baldwin, Carol M

2003-02-01

To identify areas that classical homeopathic practitioners would want to see evaluated in a patient self-report questionnaire sensitive to change during constitutional treatment. Open-ended, written practitioner questionnaire, analyzed using inductive content analysis. Two classical homeopathic meetings held in the western United States. Homeopathic practitioners attending the above professional meetings and volunteering to complete the questionnaire in response to announcements prior to sessions. Practitioners completed a demographic questionnaire and answered an open-ended question inquiring for changes about which to ask people undergoing classical homeopathic constitutional treatment. The categories that the 38 homeopaths identified included changes in: (1) emotions; (2) mentation; (3) specific physical functioning; (4) general physical changes; (5) perception of self; (6) relationships; (7) spirituality; (8) lifestyle; (9) energy; (10) dream content and tone; (11) well-being; (12) perceptions by others; (13) life relationships; (14) a sense of freedom or feeling less "stuck"; (15) sleep; (16) coping; (17) ability to adapt; (18) creativity; and (19) recall of past experiences. Sixteen percent (16%) of participants added more in-depth description of the nature of changes across categories (i.e., a rhythmical process of innovation and flux). The findings are consistent with the systemic orientation of classical homeopathic philosophy to evaluate and treat the patient as a whole. Taken together, the results support the need for development of new, multidimensional outcome measures for clinical research in homeopathy beyond the disease-specific and health-related quality-of-life scales available from conventional medical research.

A systematic review of the quality of homeopathic clinical trials

PubMed Central

Jonas, Wayne B; Anderson, Rachel L; Crawford, Cindy C; Lyons, John S

2001-01-01

Background While a number of reviews of homeopathic clinical trials have been done, all have used methods dependent on allopathic diagnostic classifications foreign to homeopathic practice. In addition, no review has used established and validated quality criteria allowing direct comparison of the allopathic and homeopathic literature. Methods In a systematic review, we compared the quality of clinical-trial research in homeopathy to a sample of research on conventional therapies using a validated and system-neutral approach. All clinical trials on homeopathic treatments with parallel treatment groups published between 1945–1995 in English were selected. All were evaluated with an established set of 33 validity criteria previously validated on a broad range of health interventions across differing medical systems. Criteria covered statistical conclusion, internal, construct and external validity. Reliability of criteria application is greater than 0.95. Results 59 studies met the inclusion criteria. Of these, 79% were from peer-reviewed journals, 29% used a placebo control, 51% used random assignment, and 86% failed to consider potentially confounding variables. The main validity problems were in measurement where 96% did not report the proportion of subjects screened, and 64% did not report attrition rate. 17% of subjects dropped out in studies where this was reported. There was practically no replication of or overlap in the conditions studied and most studies were relatively small and done at a single-site. Compared to research on conventional therapies the overall quality of studies in homeopathy was worse and only slightly improved in more recent years. Conclusions Clinical homeopathic research is clearly in its infancy with most studies using poor sampling and measurement techniques, few subjects, single sites and no replication. Many of these problems are correctable even within a "holistic" paradigm given sufficient research expertise, support and methods

Treatment of canine atopic dermatitis with a commercial homeopathic remedy: A single-blinded, placebo-controlled study

PubMed Central

Scott, Danny W.; Miller, William H.; Senter, David A.; Cook, Christopher P.; Kirker, J. Edward; Cobb, Shaun M.

2002-01-01

A commercial homeopathic remedy and a placebo were administered orally as individual agents to 18 dogs with atopic dermatitis. The pruritus was reduced by less than 50% in only 2/18 dogs; 1 of these dogs was receiving the homeopathic remedy, the other was receiving the placebo. One dog vomited after administration of the homeopathic remedy. PMID:12170834

The frequency of dietary references in homeopathic consultations.

PubMed

Filho, Rubens Dolce

2011-07-01

A retrospective quantitative study on dietary references found in medical records of 2753 patients attending consultations from 10/1/1994 to 5/31/2007 was conducted. The symptoms found in the rubrics relating to food and drink aggravation and amelioration, aversion and craving of homeopathic repertories reflect diets at different places and times and do not correspond fully, to contemporary gastronomy. Desires for sweet and spicy foods were statistically more frequent, revealing the prevailing taste for such food among the studied population. Food cravings should be carefully analyzed before considering them as indications for choosing homeopathic therapy, they are less significant than aversions, aggravations and ameliorations. Copyright © 2011 Elsevier Ltd. All rights reserved.

Systematic Review of Plant-Based Homeopathic Basic Research: An Update.

PubMed

Ücker, Annekathrin; Baumgartner, Stephan; Sokol, Anezka; Huber, Roman; Doesburg, Paul; Jäger, Tim

2018-05-01

 Plant-based test systems have been described as a useful tool for investigating possible effects of homeopathic preparations. The last reviews of this research field were published in 2009/2011. Due to recent developments in the field, an update is warranted. Publications on plant-based test systems were analysed with regard to publication quality, reproducibility and potential for further research.  A literature search was conducted in online databases and specific journals, including publications from 2008 to 2017 dealing with plant-based test systems in homeopathic basic research. To be included, they had to contain statistical analysis and fulfil quality criteria according to a pre-defined manuscript information score (MIS). Publications scoring at least 5 points (maximum 10 points) were assumed to be adequate. They were analysed for the use of adequate controls, outcome and reproducibility.  Seventy-four publications on plant-based test systems were found. Thirty-nine publications were either abstracts or proceedings of conferences and were excluded. From the remaining 35 publications, 26 reached a score of 5 or higher in the MIS. Adequate controls were used in 13 of these publications. All of them described specific effects of homeopathic preparations. The publication quality still varied: a substantial number of publications (23%) did not adequately document the methods used. Four reported on replication trials. One replication trial found effects of homeopathic preparations comparable to the original study. Three replication trials failed to confirm the original study but identified possible external influencing factors. Five publications described novel plant-based test systems. Eight trials used systematic negative control experiments to document test system stability.  Regarding research design, future trials should implement adequate controls to identify specific effects of homeopathic preparations and include systematic negative control

Impact of physician preferences for homeopathic or conventional medicines on patients with musculoskeletal disorders: results from the EPI3-MSD cohort.

PubMed

Rossignol, Michel; Begaud, Bernard; Engel, Pierre; Avouac, Bernard; Lert, France; Rouillon, Frederic; Bénichou, Jacques; Massol, Jacques; Duru, Gerard; Magnier, Anne-Marie; Guillemot, Didier; Grimaldi-Bensouda, Lamiae; Abenhaim, Lucien

2012-10-01

The objective of this study was to assess the effect of physician practicing preferences (PPP) in primary care for homeopathy (Ho), CAM (Complementary and alternative medicines) with conventional medicine (Mx) or exclusively conventional medicine (CM) on patients with musculoskeletal disorders (MSDs), with reference to clinical progression, drug consumption, side effects and loss of therapeutic opportunity. The EPI3-MSD study was a nationwide observational cohort of a representative sample of general practitioners (GP) and their patients in France. Recruitment of GP was stratified by PPP, which was self-declared. Diagnoses and comorbidities were recorded by GP at inclusion. Patients completed a standardized telephone interview at inclusion, one, three and twelve months, including MSD-functional scales and medication consumption. 1153 MSD patients were included in the three PPP groups. Patients did not differ between groups except for chronicity of MSDs (>12 weeks), which was higher in the Ho group (62.1%) than in the CM (48.6%) and Mx groups (50.3%). The twelve-month development of specific functional scores was identical across the three groups after controlling for baseline score (p > 0.05). After adjusting for propensity scores, NSAID use over 12 months was almost half in the Ho group (OR, 0.54; 95%CI, 0.38-0.78) as compared to the CM group; no difference was found in the Mx group (OR, 0.81; 95% CI: 0.59-1.15). MSD patients seen by homeopathic physicians showed a similar clinical progression when less exposed to NSAID in comparison to patients seen in CM practice, with fewer NSAID-related adverse events and no loss of therapeutic opportunity. Copyright © 2012 John Wiley & Sons, Ltd.

[Acute otitis media in children. Comparison between conventional and homeopathic therapy].

PubMed

Friese, K H; Kruse, S; Moeller, H

1996-08-01

Within a prospective group study of five practicing otorhinolaryngologists, conventional therapy of acute otitis media in children was compared with homeopathic treatments. Group A (103 children) was primarily treated with homeopathic single remedies (Aconitum napellus, Apis mellifica, Belladonna, Capsicum, Chamomilla, Kalium bichromicum, Lachesis, Lycopodium, Mercurius solubilis, Okoubaka, Pulsatilla, Silicea). Group B (28 children) was treated by decongestant nose-drops, antibiotics, secretolytics and/or antipyretics. Comparisons were done by symptoms, physical findings, duration of therapy and number of relapses. The children of the study were between 1 and 11 years of age. The difference in numbers was explained by the children with otitis media being primarily treated by pediatricians using conventional methods. The median duration of pain in group A was 2 days and in group B 3 days. Median therapy in group A lasted 4 days and in group B 10 days. Antibiotics were given over a period of 8-10 days, while homeopathic treatments were stopped after healing. In group A 70.7% of the patients were free of relapses within 1 years and 29.3% had a maximum of three relapses. Group B had 56.5% without relapses and 43.5% a maximum of six relapses. Five children in group A were given antibiotics and 98 responded solely to homeopathic treatments. No side effects of treatment were found in either group.

Efficacy of a homeopathic complex on acute viral tonsillitis.

PubMed

Malapane, Eunice; Solomon, Elizabeth M; Pellow, Janice

2014-11-01

Acute viral tonsillitis is an upper respiratory tract infection prevalent in school-aged children. Because this condition is self-limiting, conventional treatment options are usually palliative. Homeopathic remedies are a useful alternative to conventional medications in acute uncomplicated upper respiratory tract infections in children, offering earlier symptom resolution, cost-effectiveness, and fewer adverse effects. This study aimed to determine the efficacy of a homeopathic complex on the symptoms of acute viral tonsillitis in African children in South Africa. This was a randomized, double-blind, placebo-controlled, 6-day pilot study. Thirty children, age 6 to 12 years, with acute viral tonsillitis were recruited from a primary school in Gauteng, South Africa. Participants took two tablets of the medication four times daily. The treatment group received lactose tablets medicated with the homeopathic complex (Atropa belladonna D4, Calcarea phosphoricum D4, Hepar sulphuris D4, Kalium bichromat D4, Kalium muriaticum D4, Mercurius protoiodid D10, and Mercurius biniodid D10). The placebo consisted of the unmedicated vehicle only. The Wong-Baker FACES Pain Rating Scale measured pain intensity, and a Symptom Grading Scale assessed changes in tonsillitis signs and symptoms. The treatment group had a statistically significant improvement in the following symptoms compared with the placebo group: pain associated with tonsillitis, pain on swallowing, erythema and inflammation of the pharynx, and tonsil size. The homeopathic complex used in this study exhibited significant anti-inflammatory and pain-relieving qualities in children with acute viral tonsillitis. No patients reported any adverse effects. These preliminary findings are promising; however, the sample size was small and therefore a definitive conclusion cannot be reached. A larger, more inclusive research study should be undertaken to verify the findings of this study.

Where Does Homeopathy Fit in Pharmacy Practice?

PubMed Central

Johnson, Teela

2007-01-01

Homeopathy has been the cause of much debate in the scientific literature with respect to the plausibility and efficacy of homeopathic preparations and practice. Nonetheless, many consumers, pharmacists, physicians, and other health care providers continue to use or practice homeopathic medicine and advocate its safety and efficacy. As drug experts, pharmacists are expected to be able to counsel their patients on how to safely and effectively use medications, which technically includes homeopathic products. Yet many pharmacists feel that the homeopathic system of medicine is based on unscientific theories that lack supporting evidence. Since consumers continue to use homeopathic products, it is necessary for pharmacists to have a basic knowledge of homeopathy and to be able to counsel patients about its general use, the current state of the evidence and its use in conjunction with other medications. PMID:17429507

Homeopathic arnica therapy in patients receiving knee surgery: results of three randomised double-blind trials.

PubMed

Brinkhaus, B; Wilkens, J M; Lüdtke, R; Hunger, J; Witt, C M; Willich, S N

2006-12-01

We investigated the effectiveness of homeopathic Arnica montana on postoperative swelling and pain after arthroscopy (ART), artificial knee joint implantation (AKJ), and cruciate ligament reconstruction (CLR). Three randomised, placebo-controlled, double-blind, sequential clinical trials. Single primary care unit specialised in arthroscopic knee surgery. Patients suffering from a knee disease that necessitated arthroscopic surgery. Prior to surgery, patients were given 1 x 5 globules of the homeopathic dilution 30x (a homeopathic dilution of 1:10(30)) of arnica or placebo. Following surgery, 3 x 5 globules were administered daily. The primary outcome parameter was difference in knee circumference, defined as the ratio of circumference on day 1 (ART) or day 2 (CLR and AKJ) after surgery to baseline circumference. A total of 227 patients were enrolled in the ART (33% female, mean age 43.2 years;), 35 in the AKJ (71% female, 67.0 years), and 57 in the CLR trial (26% female; 33.4 years). The percentage of change in knee circumference was similar between the treatment groups for ART (group difference Delta=-0.25%, 95% CI: -0.85 to 0.41, p=0.204) and AKJ (Delta=-1.68%, -4.24 to 0.77, p=0.184) and showed homeopathic arnica to have a beneficial effect compared to placebo in CLR (Delta=-1.80%, -3.30 to -0.30, p=0.019). In all three trials, patients receiving homeopathic arnica showed a trend towards less postoperative swelling compared to patients receiving placebo. However, a significant difference in favour of homeopathic arnica was only found in the CLR trial.

Homeopathic potencies of Arnica montana L. change gene expression in a Tamm-Horsfall protein-1 cell line in vitro model: the role of ethanol as a possible confounder and statistical bias.

PubMed

Chirumbolo, Salvatore; Bjørklund, Geir

2017-07-01

Marzotto et al. showed that homeopathic preparations of Arnica montana L. acted directly on gene expression of Tamm-Horsfall protein-1 (THP-1) monocyte/macrophage cell lines activated with phorbol12-myristate13-acetate and interleukin-4 (IL-4). A. montana homeopathic dilutions are used in complementary and alternative medicine to treat inflammation disorders and post-traumatic events as well as for wound repair. The French Pharmacopoeia of these remedies uses 0.3% ethanol in each centesimal dilution. In this paper, we discuss how ethanol-containing A. montana homeopathic centesimal dilutions can change gene expression in IL-4-treated monocyte/macrophage THP-1. We assessed the role of ethanol in the Arnica homeopathic dilutions containing this alcohol by investigating its action on gene expression of THP-1 cell. Evidence would strongly suggest that the presence of ethanol in these remedies might play a fundamental role in the dilutions ability to affect gene expression, particularly for doses from 5c to 15c. Where, rather than playing a major role in the mesoscopic structure of water, the ethanol might have a chemical-physical role in the induction of THP-1 gene expression, apoptosis, and deoxyribonucleic acid function. This evidence generates a debate about the suggestion that the use of a binary-mixed solvent in homeopathic chemistry, used by Hahnemann since 1810, may be fundamental to explain the activity of homeopathy on cell models.

Homeopathic drug selection using Intuitionistic fuzzy sets.

PubMed

Kharal, Athar

2009-01-01

Using intuitionistic fuzzy set theory, Sanchez's approach to medical diagnosis has been applied to the problem of selection of single remedy from homeopathic repertorization. Two types of Intuitionistic Fuzzy Relations (IFRs) and three types of selection indices are discussed. I also propose a new repertory exploiting the benefits of soft-intelligence.

Testing the Nanoparticle-Allostatic Cross Adaptation-Sensitization Model for Homeopathic Remedy Effects

PubMed Central

Bell, Iris R.; Koithan, Mary; Brooks, Audrey J.

2012-01-01

Key concepts of the Nanoparticle-Allostatic Cross-Adaptation-Sensitization (NPCAS) Model for the action of homeopathic remedies in living systems include source nanoparticles as low level environmental stressors, heterotypic hormesis, cross-adaptation, allostasis (stress response network), time-dependent sensitization with endogenous amplification and bidirectional change, and self-organizing complex adaptive systems. The model accommodates the requirement for measurable physical agents in the remedy (source nanoparticles and/or source adsorbed to silica nanoparticles). Hormetic adaptive responses in the organism, triggered by nanoparticles; bipolar, metaplastic change, dependent on the history of the organism. Clinical matching of the patient’s symptom picture, including modalities, to the symptom pattern that the source material can cause (cross-adaptation and cross-sensitization). Evidence for nanoparticle-related quantum macro-entanglement in homeopathic pathogenetic trials. This paper examines research implications of the model, discussing the following hypotheses: Variability in nanoparticle size, morphology, and aggregation affects remedy properties and reproducibility of findings. Homeopathic remedies modulate adaptive allostatic responses, with multiple dynamic short- and long-term effects. Simillimum remedy nanoparticles, as novel mild stressors corresponding to the organism’s dysfunction initiate time-dependent cross-sensitization, reversing the direction of dysfunctional reactivity to environmental stressors. The NPCAS model suggests a way forward for systematic research on homeopathy. The central proposition is that homeopathic treatment is a form of nanomedicine acting by modulation of endogenous adaptation and metaplastic amplification processes in the organism to enhance long-term systemic resilience and health. PMID:23290882

Anisocoria Secondary to Anticholinergic Mydriasis from Homeopathic Pink Eye Relief Drops.

PubMed

Chen, Lin; Yeung, Joseph C; Anderson, Dennis R

2017-12-01

A woman, aged 70 years, developed anisocoria after applying homeopathic eye drops (Similasan Pink Eye Relief) to her left eye. Her pupil was dilated for two weeks and did not respond to light or near stimuli for one week. Both 0.1% and 1% pilocarpine failed to constrict her left pupil, and magnetic resonance imaging of her brain did not reveal any abnormality. The eye drops she had used contain belladonna extracts which have a natural atropine component. This case demonstrates the importance, when evaluating a patient presenting with anisocoria, of knowing the chemical ingredients of the homeopathic eye drops, which often are not listed. © 2017 Marshfield Clinic.

Randomized, blinded, controlled clinical trial shows no benefit of homeopathic mastitis treatment in dairy cows.

PubMed

Ebert, Fanny; Staufenbiel, Rudolf; Simons, Julia; Pieper, Laura

2017-06-01

Mastitis is one of the most common diseases in dairy production, and homeopathic remedies have been used increasingly in recent years to treat it. Clinical trials evaluating homeopathy have often been criticized for their inadequate scientific approach. The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals. The homeopathic treatment was selected based on clinical symptoms but most commonly consisted of a combination of nosodes with Streptococcinum, Staphylococcinum, Pyrogenium, and Escherichia coli at a potency of 200c. Treatment was administered to cows in the homeopathy group at least once per day for an average of 5 d. The cows in the placebo group were treated similarly, using a placebo preparation instead (lactose globules without active ingredients). If necessary, we also used allopathic drugs (e.g., antibiotics, udder creams, and anti-inflammatory drugs) in both groups. We recorded data relating to the clinical signs of mastitis, treatment, time to recovery, milk yield, somatic cell count at first milk recording after mastitis, and culling. We observed cows for up to 200 d after clinical recovery. Base-level data did not differ between the homeopathy and placebo groups. Mastitis lasted for an average of 6 d in both groups. We observed no significant differences in time to recovery, somatic cell count, risk of clinical cure within 14 d after disease occurrence, mastitis recurrence risk, or culling risk. The results indicated no additional effect of homeopathic treatment compared with placebo. The advantages or disadvantages of homeopathy should be carefully assessed for individual farms. Copyright © 2017 American Dairy Science Association. Published by

New diagnostic and therapeutic approach to thyroid-associated orbitopathy based on applied kinesiology and homeopathic therapy.

PubMed

Moncayo, Roy; Moncayo, Helga; Ulmer, Hanno; Kainz, Hartmann

2004-08-01

To investigate pathogenetic mechanisms related to the lacrimal and lymphatic glands in patients with thyroid-associated orbitopathy (TAO), and the potential of applied kinesiology diagnosis and homeopathic therapeutic measures. Prospective. Thyroid outpatient unit and a specialized center for complementary medicine (WOMED, Innsbruck; R.M. and H.M.). Thirty-two (32) patients with TAO, 23 with a long-standing disease, and 9 showing discrete initial changes. All patients were euthyroid at the time of the investigation. Clinical investigation was done, using applied kinesiology methods. Departing from normal reacting muscles, both target organs as well as therapeutic measures were tested. Affected organs will produce a therapy localization (TL) that turns a normal muscle tone weak. Using the same approach, specific counteracting therapies (i.e., tonsillitis nosode and lymph mobilizing agents) were tested. Change of lid swelling, of ocular movement discomfort, ocular lock, tonsil reactivity and Traditional Chinese Medicine criteria including tenderness of San Yin Jiao (SP6) and tongue diagnosis were recorded in a graded fashion. Positive TL reactions were found in the submandibular tonsillar structures, the pharyngeal tonsils, the San Yin Jiao point, the lacrimal gland, and with the functional ocular lock test. Both Lymphdiaral (Pascoe, Giessen, Germany) and the homeopathic preparation chronic tonsillitis nosode at a C3 potency (Spagyra, Grödig, Austria) counteracted these changes. Both agents were used therapeutically over 3-6 months, after which all relevant parameters showed improvement. Our study demonstrates the involvement of lymphatic structures and flow in the pathogenesis of TAO. The tenderness of the San Yin Jiao point correlates to the above mentioned changes and should be included in the clinical evaluation of these patients.

Toxic optic neuropathy following ingestion of homeopathic medication Arnica-30.

PubMed

Venkatramani, Devendra V; Goel, Shubhra; Ratra, Vineet; Gandhi, Rashmin Anilkumar

2013-03-01

We report a case of acute, bilateral and severe vision loss after inadvertent consumption of a large quantity of the homoeopathic medication Arnica-30. Severe vomiting which required hospitalization preceded visual symptoms. In the acute stage, pupillary responses to light were absent and fundus examination was normal. Vision loss followed a fluctuating course, with profound loss noted after 6 weeks along with bilateral optic disc pallor. Neuro-ophthalmic examination and detailed investigations were performed, including magnetic resonance imaging, electroretinography (ERG) and visual evoked potentials (VEP). Ocular coherence tomography (OCT) showed gross thinning of the retinal nerve fiber layer. While a differential diagnosis of posterior ischemic optic neuropathy was kept in mind, these findings supported a diagnosis of bilateral toxic optic neuropathy. Arnica-30 is popularly used to accelerate wound healing, including after oculoplastic surgery. While homeopathic medicines are generally considered safe due to the very low concentrations involved, Arnica-30 may be neurotoxic if consumed internally in large quantities.

A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy.

PubMed

Brulé, David; Gillmeister, Biljana; Lee, Michelle; Alexander, Sarah; Gassas, Adam; Hendershot, Eleanor; Zupanec, Sue; Dupuis, Lee; Sung, Lillian

2016-12-01

Fatigue is a major problem in children with cancer. The objective was to examine the feasibility of performing a clinical trial of homeopathic treatment for fatigue in children receiving chemotherapy. This was a single-institution, open-label, pilot study. Children 2 to 18 years old, diagnosed with cancer, and receiving chemotherapy were eligible. Participants were given individualized homeopathic treatment for a maximum of 14 days. In-home or clinic assessments were conducted up to 3 times weekly. Feasibility was defined as the ability to recruit and administer homeopathy to 10 participants within 1 year. Fatigue was measured using the Symptom Distress Scale daily and the PedsQL Multidimensional Fatigue Module weekly. Between April 2012 and April 2014, 155 potential participants were identified. There were 45 eligible and contacted patients; 36 declined participation, 30 because they were not interested; 9 agreed to participate, but 1 participant withdrew prior to treatment initiation. Median length of homeopathic treatment was 10.5 (range = 6 to 14) days. All parents found homeopathic treatment to be easy or very easy to follow. Trials of individualized homeopathy for fatigue reduction in pediatric cancer are not feasible in this context; lack of interest was a primary reason. Alternative approaches to evaluating homeopathy efficacy are needed. © The Author(s) 2015.

Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study

PubMed Central

2012-01-01

Background A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice. Methods Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic. Results The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one. Conclusion Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity. PMID:22510227

[The administration of homeopathic drugs for the treatment of acute mastitis in cattle].

PubMed

Merck, C C; Sonnenwald, B; Rollwage, H

1989-08-01

The general principles of homeopathic therapy are described together with a number of homeopathic drugs used for the treatment of acute bovine mastitis. Fifty cows with acute mastitis were used in the study. The initial treatment comprised aconitum D 4, phytolacca D 1 and bryonia D 4. In subsequent treatments phytolacca D 1, bryonia D 4 and lachesis D 8 either singly or in combination were used; mercurius solubilis D 4 was also used. Encouraging results, especially in the treatment of cases of E.coli mastitis, were achieved.

Complementary and alternative medicine in inflammatory bowel diseases: what is the future in the field of herbal medicine?

PubMed

Gilardi, Daniela; Fiorino, Gionata; Genua, Marco; Allocca, Mariangela; Danese, Silvio

2014-09-01

The use of complementary and alternative medicine is wide-spread not only in Eastern countries, but also in the Western world. Despite the increasing evidence on the harmful effects induced by several naturopathic/homeopathic products, patients seem to appreciate these remedies, in particular because they consider them to be absolutely safe. This same phenomenon is common among inflammatory bowel disease (IBD) patients. As a result there is a significant request for scientific data to evaluate both the efficacy and safety of these remedies, and to support the use of such medications as adjuvant treatments to biological and synthetic drugs. We aimed to review the current evidence on efficacy and safety of some natural products that are believed to be effective in inflammatory bowel disease. Further perspectives for the clinical use of herbal products and strategies for improving knowledge about herbal products in IBD are also discussed.

Effects of homeopathic mother tinctures on breath alcohol testing.

PubMed

Boatto, Gianpiero; Trignano, Claudia; Burrai, Lucia; Spanu, Andrea; Nieddu, Maria

2015-01-01

In some countries, it is illegal to drive with any detectable amount of alcohol in blood; in others, the legal limit is 0.5 g/L or lower. Recently, some defendants charged with driving under the influence of alcohol and have claimed that positive breath alcohol test results were due to the ingestion of homeopathic mother tinctures. These preparations are obtained by maceration, digestion, infusion, or decoction of herbal material in hydroalcoholic solvent. A series of tests were conducted to evaluate the alcoholic content of three homeopathic mother tinctures and their ability to produce inaccurate breath alcohol results. Nine of 30 subjects gave positive results (0.11-0.82 g/L) when tests were taken within 1 min after drinking mother tincture. All tests taken at least 15 min after the mother tincture consumption and resulted in alcohol-free readings. An observation period of 15-20 min prior to breath alcohol testing eliminates the possibility of false-positive results. © 2014 American Academy of Forensic Sciences.

Characteristics of patients consulting their regular primary care physician according to their prescribing preferences for homeopathy and complementary medicine.

PubMed

Lert, France; Grimaldi-Bensouda, Lamiae; Rouillon, Frederic; Massol, Jacques; Guillemot, Didier; Avouac, Bernard; Duru, Gerard; Magnier, Anne-Marie; Rossignol, Michel; Abenhaim, Lucien; Begaud, Bernard

2014-01-01

Homeopathic care has not been well documented in terms of its impact on patients' utilization of drugs or other complementary and alternative medicines (CAM). The objective of this study was to describe and compare patients who visit physicians in general practice (GPs) who prescribe only conventional medicines (GP-CM), regularly prescribe homeopathy within a mixed practice (GP-Mx), or are certified homeopathic GPs (GP-Ho). The EPI3-LASER study was a nationwide observational survey of a representative sample of GPs and their patients from across France. Physicians recorded their diagnoses and prescriptions on participating patients who completed a self-questionnaire on socio-demographics, lifestyle, quality of life Short Form 12 (SF-12) and the complementary and alternative medicine beliefs inventory (CAMBI). A total of 6379 patients (participation rate 73.1%) recruited from 804 GP practices participated in this survey. Patients attending a GP-Ho were slightly more often female with higher education than in the GP-CM group and had markedly healthier lifestyle. They did not differ greatly in their comorbidities or quality of life but exhibited large differences in their beliefs in holistic medicine and natural treatments, and in their attitude toward participating to their own care. Similar but less striking observations were made in patients of the GP-Mx group. Patients seeking care with a homeopathic GP did not differ greatly in their socio-demographic characteristics but more so by their healthier lifestyle and positive attitude toward CAM. Further research is needed to explore the directionality of those associations and to assess the potential economic benefits of homeopathic management in primary care. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Rat models of acute inflammation: a randomized controlled study on the effects of homeopathic remedies

PubMed Central

Conforti, Anita; Bellavite, Paolo; Bertani, Simone; Chiarotti, Flavia; Menniti-Ippolito, Francesca; Raschetti, Roberto

2007-01-01

Background One of the cardinal principles of homeopathy is the "law of similarities", according to which patients can be treated by administering substances which, when tested in healthy subjects, cause symptoms that are similar to those presented by the patients themselves. Over the last few years, there has been an increase in the number of pre-clinical (in vitro and animal) studies aimed at evaluating the pharmacological activity or efficacy of some homeopathic remedies under potentially reproducible conditions. However, in addition to some contradictory results, these studies have also highlighted a series of methodological difficulties. The present study was designed to explore the possibility to test in a controlled way the effects of homeopathic remedies on two known experimental models of acute inflammation in the rat. To this aim, the study considered six different remedies indicated by homeopathic practice for this type of symptom in two experimental edema models (carrageenan- and autologous blood-induced edema), using two treatment administration routes (sub-plantar injection and oral administration). Methods In a first phase, the different remedies were tested in the four experimental conditions, following a single-blind (measurement) procedure. In a second phase, some of the remedies (in the same and in different dilutions) were tested by oral administration in the carrageenan-induced edema, under double-blind (treatment administration and measurement) and fully randomized conditions. Seven-hundred-twenty male Sprague Dawley rats weighing 170–180 g were used. Six homeopathic remedies (Arnica montana D4, Apis mellifica D4, D30, Atropa belladonna D4, Hamamelis virginiana D4, Lachesis D6, D30, Phosphorus D6, D30), saline and indomethacin were tested. Edema was measured using a water-based plethysmometer, before and at different times after edema induction. Data were analyzed by ANOVA and Student t test. Results In the first phase of experiments, some

Rat models of acute inflammation: a randomized controlled study on the effects of homeopathic remedies.

PubMed

Conforti, Anita; Bellavite, Paolo; Bertani, Simone; Chiarotti, Flavia; Menniti-Ippolito, Francesca; Raschetti, Roberto

2007-01-17

One of the cardinal principles of homeopathy is the "law of similarities", according to which patients can be treated by administering substances which, when tested in healthy subjects, cause symptoms that are similar to those presented by the patients themselves. Over the last few years, there has been an increase in the number of pre-clinical (in vitro and animal) studies aimed at evaluating the pharmacological activity or efficacy of some homeopathic remedies under potentially reproducible conditions. However, in addition to some contradictory results, these studies have also highlighted a series of methodological difficulties.The present study was designed to explore the possibility to test in a controlled way the effects of homeopathic remedies on two known experimental models of acute inflammation in the rat. To this aim, the study considered six different remedies indicated by homeopathic practice for this type of symptom in two experimental edema models (carrageenan- and autologous blood-induced edema), using two treatment administration routes (sub-plantar injection and oral administration). In a first phase, the different remedies were tested in the four experimental conditions, following a single-blind (measurement) procedure. In a second phase, some of the remedies (in the same and in different dilutions) were tested by oral administration in the carrageenan-induced edema, under double-blind (treatment administration and measurement) and fully randomized conditions. Seven-hundred-twenty male Sprague Dawley rats weighing 170-180 g were used. Six homeopathic remedies (Arnica montana D4, Apis mellifica D4, D30, Atropa belladonna D4, Hamamelis virginiana D4, Lachesis D6, D30, Phosphorus D6, D30), saline and indomethacin were tested. Edema was measured using a water-based plethysmometer, before and at different times after edema induction. Data were analyzed by ANOVA and Student t test. In the first phase of experiments, some statistically significant

The Traditional Medicine and Modern Medicine from Natural Products.

PubMed

Yuan, Haidan; Ma, Qianqian; Ye, Li; Piao, Guangchun

2016-04-29

Natural products and traditional medicines are of great importance. Such forms of medicine as traditional Chinese medicine, Ayurveda, Kampo, traditional Korean medicine, and Unani have been practiced in some areas of the world and have blossomed into orderly-regulated systems of medicine. This study aims to review the literature on the relationship among natural products, traditional medicines, and modern medicine, and to explore the possible concepts and methodologies from natural products and traditional medicines to further develop drug discovery. The unique characteristics of theory, application, current role or status, and modern research of eight kinds of traditional medicine systems are summarized in this study. Although only a tiny fraction of the existing plant species have been scientifically researched for bioactivities since 1805, when the first pharmacologically-active compound morphine was isolated from opium, natural products and traditional medicines have already made fruitful contributions for modern medicine. When used to develop new drugs, natural products and traditional medicines have their incomparable advantages, such as abundant clinical experiences, and their unique diversity of chemical structures and biological activities.

Efficacy of homeopathically potentized antimony on blood coagulation. A randomized placebo controlled crossover trial.

PubMed

Heusser, Peter; Berger, Sarah; Stutz, Monika; Hüsler, André; Haeberli, André; Wolf, Ursula

2009-02-01

Homeopathically potentized antimony 6x is traditionally used in anthroposophic medicine for an alleged pro-coagulatory effect in bleeding disorders. However, the scientific evidence base is yet insufficient. Results of a previous in vitro study suggested a slight increase of maximal clot firmness (MCF) and a tendency towards a shorter clotting time (CT). The objective of this study was to investigate the pro-coagulatory effects of antimony in vivo, and possible unexpected or adverse events. A randomized placebo controlled double blind crossover study was carried out in 30 healthy volunteers (15 males, 15 females). Each participant received intravenously 10 ml of antimony 6x and placebo in a randomized order at an interval of 1 month. Thrombelastography (TEG) was carried out immediately before and 30 and 60 min after the injection. Statistically significant pro-coagulatory effects were observed 30 min after injection for CT in men (p = 0.0306), and for MCF in men and women combined (p = 0.0476). The effect of antimony was significantly larger on test day 1 than on test day 2, whereas the effect of placebo was similar on both test days. No unexpected adverse or adverse events causally related to antimony were observed. This study adds evidence to the hypothesis that homeopathically potentized antimony may be efficacious in vivo. The consistency of the results with previous in vitro results indicates an effect on MCF and CT. The in vivo application of antimony 6x is safe. Copyright (c) 2009 S. Karger AG, Basel.

Integrative Nanomedicine: Treating Cancer With Nanoscale Natural Products

PubMed Central

Sarter, Barbara; Koithan, Mary; Banerji, Prasanta; Banerji, Pratip; Jain, Shamini; Ives, John

2014-01-01

Finding safer and more effective treatments for specific cancers remains a significant challenge for integrative clinicians and researchers worldwide. One emerging strategy is the use of nanostructured forms of drugs, vaccines, traditional animal venoms, herbs, and nutraceutical agents in cancer treatment. The recent discovery of nanoparticles in traditional homeopathic medicines adds another point of convergence between modern nanomedicine and alternative interventional strategies. A way in which homeopathic remedies could initiate anticancer effects includes cell-to-cell signaling actions of both exogenous and endogenous (exosome) nanoparticles. The result can be a cascade of modulatory biological events with antiproliferative and pro-apoptotic effects. The Banerji Protocols reflect a multigenerational clinical system developed by homeopathic physicians in India who have treated thousands of patients with cancer. A number of homeopathic remedy sources from the Banerji Protocols (eg, Calcarea phosphorica; Carcinosin—tumor-derived breast cancer tissue prepared homeopathically) overlap those already under study in nonhomeopathic nanoparticle and nanovesicle tumor exosome cancer vaccine research. Past research on antineoplastic effects of nano forms of botanical extracts such as Phytolacca, Gelsemium, Hydrastis, Thuja, and Ruta as well as on homeopathic remedy potencies made from the same types of source materials suggests other important overlaps. The replicated finding of silica, silicon, and nano-silica release from agitation of liquids in glassware adds a proven nonspecific activator and amplifier of immunological effects. Taken together, the nanoparticulate research data and the Banerji Protocols for homeopathic remedies in cancer suggest a way forward for generating advances in cancer treatment with natural product–derived nanomedicines. PMID:24753994

A placebo controlled clinical trial investigating the efficacy of a homeopathic after-bite gel in reducing mosquito bite induced erythema.

PubMed

Hill, N; Stam, C; Tuinder, S; van Haselen, R A

1995-01-01

A randomised, placebo controlled clinical trial was conducted to examine the efficacy of a homeopathic after-bite gel in the symptomatic relief of mosquito bites. Sixty eight healthy volunteers were bitten under laboratory conditions by Aedes aegypti mosquitoes at three spots, on the ventral aspect of the forearm. One bite was treated with the homeopathic after-bite gel, another bite with a placebo gel which was identical in appearance and smell to the homeopathic after-bite gel, and the third bite remained untreated. Immediately after the bites and 1, 3, 6, 26 and 31 hours post-bite, the length and width of the erythema were measured with a calliper, and photographs were taken of the bite sites from which the size of the erythema was subsequently determined. This was followed by assessment of the extent of itching with a verbal analogue scale, and finally treatment took place. For each spot the total erythema was calculated as the area under the plotted curve of the erythema at different time points (mm2*h) and the total sum of the itch scores was determined. For the bites treated with the homeopathic after-bite gel the median total erythema was 10.500 mm2*h. For the spots treated with the placebo gel and the untreated spots the median total erythema was 12.900 mm2*h and 13.300 mm2*h, respectively. The difference between the spots treated with the homeopathic after-bite gel and the untreated spots came close to significance (two-tailed P = 0.06), which was not the case for the difference between the spots treated with the homeopathic after-bite gel and the spots treated with placebo gel (P = 0.13). After pooling the data of a very similar previous pilot study and the present study (ntotal = 83), the homeopathic after-bite gel was significantly superior to no treatment (two-tailed P = 0.003) as well as to placebo gel (two-tailed P = 0.03). Comparing itching after the three treatments, no significant differences could be demonstrated. The extent of itching was

The role of Abraham Lincoln in securing a charter for a homeopathic medical college.

PubMed

Spiegel, Allen D; Kavaler, Florence

2002-10-01

In 1854, Abraham Lincoln was retained to prepare a state legislative proposal to charter a homeopathic medical college in Chicago. This was a complex task in view of the deep-seated animosity between allopathic or orthodox medical practitioners and irregular healers. Homeopathy was regarded as a cult by the nascent American Medical Association. In addition, the poor reputation of medical education in the United States in general, further complicated the project. Lincoln and influential individuals in Illinois lobbied legislators and succeeded in securing the charter. Subsequently, the Hahnemann Homeopathic Medical College accepted its first class in 1860 and with its successors remained in existence for almost sixty-five years.

Homeopathic Treatment of Vitiligo: A Report of Fourteen Cases.

PubMed

Mahesh, Seema; Mallappa, Mahesh; Tsintzas, Dionysios; Vithoulkas, George

2017-12-02

BACKGROUND Vitiligo, also known as leukoderma, is an autoimmune skin condition that results in the loss of melanin pigment. Vitiligo is not a rare condition but is difficult to treat and is associated with psychological distress. CASE REPORT A series of 14 cases of vitiligo are presented that were treated with individualized homeopathic remedies that were based on plant, animal, or mineral compounds. There were 13 women and one man in the case series, with a mean age 29.8 years, and a mean follow-up from treatment of 58 months. The mean time between the onset of the appearance of vitiligo and the first consultation at our clinic was 96 months. Homeopathic treatment for patients is holistic and was performed on an individualized basis as described in this case series. Photographic images of the skin are presented before and after treatment. CONCLUSIONS In 14 patients with vitiligo treated with individualized homeopathy, the best results were achieved in the patients who were treated in the early stages of the disease. We believe that homeopathy may be effective in the early stages of vitiligo, but large controlled clinical studies are needed in this area.

The role of the Therapeutic Goods Administration and the Medicine and Medical Devices Safety Authority in evaluating complementary and alternative medicines in Australia and New Zealand.

PubMed

Ghosh, Dilip; Skinner, Margot; Ferguson, Lynnette R

2006-04-03

Currently, the regulation of complementary and alternative medicines and related health claims in Australia and New Zealand is managed in a number of ways. Complementary medicines, including herbal, minerals, nutritional/dietary supplements, aromatherapy oils and homeopathic medicines are regulated under therapeutic goods/products legislation. The Therapeutic Goods Administration (TGA), a division of the Commonwealth Department of Health and Ageing is responsible for administering the provisions of the legislation in Australia. The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) administers the provision of legislation in New Zealand. In December 2003 the Australian and New Zealand governments signed a Treaty to establish a single, bi-national agency to regulate therapeutic products, including medical devices prescription, over-the-counter and complementary medicines. A single agency will replace the Australian TGA and the New Zealand Medsafe. The role of the new agency will be to safeguard public health through regulation of the quality, safety and efficacy or performance of therapeutic products in both Australia and New Zealand. The major activities of the new joint Australia New Zealand therapeutic products agency are in product licensing, specifying labelling standards and setting the advertising scheme, together with determining the risk classes of medicines and creating an expanded list of ingredients permitted in Class I medicines. A new, expanded definition of complementary medicines is proposed and this definition is currently under consultation. Related Australian and New Zealand legislation is being developed to implement the joint scheme. Once this legislation is passed, the Treaty will come into force and the new joint regulatory scheme will begin. The agency is expected to commence operation no later than 1 July 2006 and will result in a single agency to regulate complementary and alternative medicines.

Assays of homeopathic remedies in rodent behavioural and psychopathological models.

PubMed

Bellavite, Paolo; Magnani, Paolo; Marzotto, Marta; Conforti, Anita

2009-10-01

The first part of this paper reviews the effects of homeopathic remedies on several models of anxiety-like behaviours developed and described in rodents. The existing literature in this field comprises some fifteen exploratory studies, often published in non-indexed and non-peer-reviewed journals. Only a few results have been confirmed by multiple laboratories, and concern Ignatia, Gelsemium, Chamomilla (in homeopathic dilutions/potencies). Nevertheless, there are some interesting results pointing to the possible efficacy of other remedies, and confirming a statistically significant effect of high dilutions of neurotrophic molecules and antibodies. In the second part of this paper we report some recent results obtained in our laboratory, testing Aconitum, Nux vomica, Belladonna, Argentum nitricum, Tabacum (all 5CH potency) and Gelsemium (5, 7, 9 and 30CH potencies) on mice using ethological models of behaviour. The test was performed using coded drugs and controls in double blind (operations and calculations). After an initial screening that showed all the tested remedies (except for Belladonna) to have some effects on the behavioural parameters (light-dark test and open-field test), but with high experimental variability, we focused our study on Gelsemium, and carried out two complete series of experiments. The results showed that Gelsemium had several effects on the exploratory behaviour of mice, which in some models were highly statistically significant (p < 0.001), in all the dilutions/dynamizations used, but with complex differences according to the experimental conditions and test performed. Finally, some methodological issues of animal research in this field of homeopathy are discussed. The "Gelsemium model" - encompassing experimental studies in vitro and in vivo from different laboratories and with different methods, including significant effects of its major active principle gelsemine - may play a pivotal rule for investigations on other homeopathic

Health insurance and use of alternative medicine in Mexico

PubMed Central

van Gameren, Edwin

2014-01-01

Objectives I analyze the effect of coverage by health insurance on the use of alternative medicine such as folk healers and homeopaths, in particular if it complements or substitutes conventional services. Methods Panel data from the Mexican Health and Aging Study (MHAS) is used to estimate bivariate probit models in order to explain the use of alternative medicine while allowing the determinant of interest, access to health insurance, to be an endogenous factor. Results The findings indicate that households with insurance coverage less often use alternative medicine, and that the effect is much stronger among poor than among rich households. Conclusions Poor households substitute away from traditional medicine towards conventional medicine. PMID:20546965

Physicochemical Investigations of Homeopathic Preparations: A Systematic Review and Bibliometric Analysis-Part 1.

PubMed

Klein, Sabine D; Würtenberger, Sandra; Wolf, Ursula; Baumgartner, Stephan; Tournier, Alexander

2018-05-01

The last systematic review of physicochemical research performed on homeopathic preparations was published in 2003. The aim of the study is to update and expand the current state of knowledge in the area of physicochemical properties of homeopathic preparations. In part 1 of the study, we aim to present an overview of the literature with respect to publication quality and methods used. In part 2, we aim to identify the most interesting experimental techniques. With this, we aim to be in a position to generate meaningful hypotheses regarding a possible mode of action of homeopathic preparations. A two-step procedure was adopted: (1) an extensive literature search, followed by a bibliometric and quality analysis on the level of publications and (2) a thorough qualitative analysis of the individual physicochemical investigations found. In this publication, we report on step (1). We searched major scientific databases to find publications reporting physicochemical investigations of homeopathy from its origin to the end of 2015. Publications were assessed using a scoring scheme, the Manuscript Information Score (MIS). Information regarding country of origin of the research and experimental techniques used was extracted. We identified 183 publications (compared to 44 in the last review), 122 of which had an MIS ≥5. The rate of publication in the field was ∼2 per year from the 1970s until 2000. Afterward, it increased to over 5.5 publications per year. The quality of publications was seen to increase sharply from 2000 onward, whereas before 2000, only 12 (13%) publications were rated as "high quality" (MIS ≥7.5); 44 (48%) publications were rated as "high quality" from 2000 onward. Countries with most publications were Germany (n = 42, 23%), France (n = 29, 16%), India (n = 27, 15%), and Italy (n = 26, 14%). Techniques most frequently used were electrical impedance (26%), analytical methods (20%), spectroscopy (20%), and nuclear magnetic resonance (19

Physicochemical Investigations of Homeopathic Preparations: A Systematic Review and Bibliometric Analysis—Part 1

PubMed Central

Klein, Sabine D.; Würtenberger, Sandra; Wolf, Ursula; Baumgartner, Stephan

2018-01-01

Abstract Objectives: The last systematic review of physicochemical research performed on homeopathic preparations was published in 2003. The aim of the study is to update and expand the current state of knowledge in the area of physicochemical properties of homeopathic preparations. In part 1 of the study, we aim to present an overview of the literature with respect to publication quality and methods used. In part 2, we aim to identify the most interesting experimental techniques. With this, we aim to be in a position to generate meaningful hypotheses regarding a possible mode of action of homeopathic preparations. Methods: A two-step procedure was adopted: (1) an extensive literature search, followed by a bibliometric and quality analysis on the level of publications and (2) a thorough qualitative analysis of the individual physicochemical investigations found. In this publication, we report on step (1). We searched major scientific databases to find publications reporting physicochemical investigations of homeopathy from its origin to the end of 2015. Publications were assessed using a scoring scheme, the Manuscript Information Score (MIS). Information regarding country of origin of the research and experimental techniques used was extracted. Results: We identified 183 publications (compared to 44 in the last review), 122 of which had an MIS ≥5. The rate of publication in the field was ∼2 per year from the 1970s until 2000. Afterward, it increased to over 5.5 publications per year. The quality of publications was seen to increase sharply from 2000 onward, whereas before 2000, only 12 (13%) publications were rated as “high quality” (MIS ≥7.5); 44 (48%) publications were rated as “high quality” from 2000 onward. Countries with most publications were Germany (n = 42, 23%), France (n = 29, 16%), India (n = 27, 15%), and Italy (n = 26, 14%). Techniques most frequently used were electrical impedance (26%), analytical methods (20

Performing 'pragmatic holism': Professionalisation and the holistic discourse of non-medically qualified acupuncturists and homeopaths in the United Kingdom.

PubMed

Givati, Assaf

2015-01-01

Complementary and alternative medicine practitioners have often utilised 'holism' as a key identification mark of their practice, distancing themselves from 'the reductionist biomedicine'. However, the past couple of decades have witnessed increased engagement of several complementary and alternative medicines in professionalisation, which includes a degree of biomedical alignment while 'reducing' holistic claims in order to provide practice with a 'credible outlook' and move closer to the mainstream, a development which challenges the role of holism in complementary and alternative medicine practices. This article explores the strategies by which two groups of complementary and alternative medicine practitioners, namely, non-medically qualified acupuncturists and homeopaths in the United Kingdom, pragmatically accommodate holistic notions as a professional resource, a process of negotiation between maintaining their holistic premise, on the one hand, and the drive to professionalise and enhance their societal status, on the other. Based on in-depth interviews with non-medically qualified acupuncture and homeopathy practitioners and school principals, textual analysis of practitioners' web sites and observation of practice, the findings demonstrate the dynamic approach to 'holism' in complementary and alternative medicine practice. This discourse, through which practitioners use a range of strategies in order to 'narrow' or 'expand' their holistic expression, can be described as 'pragmatic holism', by which they try to make gains from the formalisation/standardisation processes, without losing the therapies' holistic outlook and appeal. © The Author(s) 2014.

Evaluation of homeopathic Arnica montana for ecchymosis after upper blepharoplasty: a placebo-controlled, randomized, double-blind study.

PubMed

Kotlus, Brett S; Heringer, Dustin M; Dryden, Robert M

2010-01-01

Ecchymosis is commonly encountered after upper eyelid blepharoplasty. The use of homeopathic preparations of Arnica montana, a flowering herb, has been advocated by physicians, patients, and manufacturers for reduction of postsurgical ecchymosis. The authors evaluate its efficacy after upper eyelid blepharoplasty. A prospective, placebo-controlled, double-blind study was performed in which patients were randomly assigned to the administration of homeopathic A. montana or placebo concurrent with unilateral upper eyelid blepharoplasty followed by contralateral treatment at least 1 month later. Ecchymosis was evaluated at days 3 and 7 by rank order of severity and measurement of surface area of observable ecchymosis. There was no statistically significant difference in area of ecchymosis or rank order of ecchymosis severity for days 3 and 7 after treatment with A. montana versus placebo. Additionally, there was no difference in ease of recovery per patient report, and there was no difference in the rate of ecchymosis resolution. The authors find no evidence that homeopathic A. montana, as used in this study, is beneficial in the reduction or the resolution of ecchymosis after upper eyelid blepharoplasty.

Homeopathy as Boundary Object and Distributed Therapeutic Agency. A Discussion on the Homeopathic Placebo Response.

PubMed

Rughiniş, Cosima; Ciocănel, Alexandra; Vasile, Sorina

2017-09-27

We discuss homeopathy's placebo effect as the result of a distributed therapeutic agency involving humans, objects, and texts. Homeopathy has been involved in controversies for centuries, and the dispute whether it is therapy or quackery is as lively as ever. Still, homeopathy has retained significant popularity and acceptance within the medical establishment. We bracket the issue of biochemical effectiveness of homeopathic remedies as we only discuss homeopathy's potential to elicit a placebo response within its therapeutic alliance, in virtue of its social, symbolic, and material features. The review is based on literature discussing homeopathic effectiveness, including historical, biographical, sociological, and epistemological perspectives. We build upon research that clarifies the therapeutic relationship, examining its activities and meanings for practitioners and patients. Previous analyses discussing homeopathy's placebo effect stress the importance of the individualized consultation that functions as psychotherapy and generates empathy and hope. We enlarge the discussion, highlighting homeopathy's distributed therapeutic agency across humans, texts, and materials. The historical evolution of homeopathy in relation to biomedicine and science is important to understand its institutional integration into mainstream medicine and its appeal to scientifically minded doctors. Anecdotes of healing and the message of no-harm encourage patients to try homeopathy and hope for the best. The esthetics and ritual of remedies, coupled with computers' scientific legitimacy and time-saving power constitute a material infrastructure of therapeutic persuasion. Through its relation with biomedicine, its doctrine, consultation design, and treatment rituals, homeopathy offers a powerful medium to elicit a placebo response in a therapeutic alliance. By virtue of its proximity and radical difference from the scientific and biomedical enterprises, its material and textual

High-field 1H T1 and T2 NMR relaxation time measurements of H2O in homeopathic preparations of quartz, sulfur, and copper sulfate

NASA Astrophysics Data System (ADS)

Baumgartner, Stephan; Wolf, Martin; Skrabal, Peter; Bangerter, Felix; Heusser, Peter; Thurneysen, André; Wolf, Ursula

2009-09-01

Quantitative meta-analyses of randomized clinical trials investigating the specific therapeutic efficacy of homeopathic remedies yielded statistically significant differences compared to placebo. Since the remedies used contained mostly only very low concentrations of pharmacologically active compounds, these effects cannot be accounted for within the framework of current pharmacology. Theories to explain clinical effects of homeopathic remedies are partially based upon changes in diluent structure. To investigate the latter, we measured for the first time high-field (600/500 MHz) 1H T1 and T2 nuclear magnetic resonance relaxation times of H2O in homeopathic preparations with concurrent contamination control by inductively coupled plasma mass spectrometry (ICP-MS). Homeopathic preparations of quartz (10 c-30 c, n = 21, corresponding to iterative dilutions of 100-10-100-30), sulfur (13 x-30 x, n = 18, 10-13-10-30), and copper sulfate (11 c-30 c, n = 20, 100-11-100-30) were compared to n = 10 independent controls each (analogously agitated dilution medium) in randomized and blinded experiments. In none of the samples, the concentration of any element analyzed by ICP-MS exceeded 10 ppb. In the first measurement series (600 MHz), there was a significant increase in T1 for all samples as a function of time, and there were no significant differences between homeopathic potencies and controls. In the second measurement series (500 MHz) 1 year after preparation, we observed statistically significant increased T1 relaxation times for homeopathic sulfur preparations compared to controls. Fifteen out of 18 correlations between sample triplicates were higher for controls than for homeopathic preparations. No conclusive explanation for these phenomena can be given at present. Possible hypotheses involve differential leaching from the measurement vessel walls or a change in water molecule dynamics, i.e., in rotational correlation time and/or diffusion. Homeopathic preparations

Effect of homeopathic Arnica montana on bruising in face-lifts: results of a randomized, double-blind, placebo-controlled clinical trial.

PubMed

Seeley, Brook M; Denton, Andrew B; Ahn, Min S; Maas, Corey S

2006-01-01

To design a model for performing reproducible, objective analyses of skin color changes and to apply this model to evaluate the efficacy of homeopathic Arnica montana as an antiecchymotic agent when taken perioperatively. Twenty-nine patients undergoing rhytidectomy at a tertiary care center were treated perioperatively with either homeopathic A. montana or placebo in a double-blind fashion. Postoperative photographs were analyzed using a novel computer model for color changes, and subjective assessments of postoperative ecchymosis were obtained. No subjective differences were noted between the treatment group and the control group, either by the patients or by the professional staff. No objective difference in the degree of color change was found. Patients receiving homeopathic A. montana were found to have a smaller area of ecchymosis on postoperative days 1, 5, 7, and 10. These differences were statistically significant (P<.05) only on postoperative days 1 (P<.005) and 7 (P<.001). This computer model provides an efficient, objective, and reproducible means with which to assess perioperative color changes, both in terms of area and degree. Patients taking perioperative homeopathic A. montana exhibited less ecchymosis, and that difference was statistically significant (P<.05) on 2 of the 4 postoperative data points evaluated.

Lack of efficacy of homeopathic therapy against post-calving clinical mastitis in dairy herds in the Waikato region of New Zealand.

PubMed

Williamson, J H; Lacy-Hulbert, S J

2014-01-01

To compare clinical and bacteriological cure rates of clinical mastitis following treatment with either antimicrobials or homeopathic preparations. Seven spring-calving herds from the Waikato region of New Zealand were used to source cases of clinical mastitis (n = 263 glands) during the first 90 days following calving. Duplicate milk samples were collected for bacteriology from each clinically infected gland at diagnosis and 25 (SD 5.3) days after initial treatment. Affected glands were treated with either an antimicrobial formulation or a homeopathic remedy. Generalised linear models with binomial error distribution and logit link were used to analyse the proportion of cows that were clinical treatment cures and the proportion of glands that were classified as bacteriological cures, based on initial and post-treatment milk samples. Mean cumulative incidence of clinical mastitis was 7% (range 2-13% across herds) of cows. Streptococcus uberis was the most common pathogen isolated from culture-positive samples from affected glands (140/209; 67%). The clinical cure rate was higher for cows treated with antimicrobials (107/113; 95%) than for cows treated with homeopathic remedies (72/114; 63%) (p < 0.001) based on the observance of clinical signs following initial treatment. Across all pathogen types bacteriological cure rate at gland level was higher for those cows treated with antimicrobials (75/102; 74%) than for those treated with a homeopathic preparation (39/107; 36%) (p < 0.001). Using herds located in the Waikato region of New Zealand, homeopathic remedies had significantly lower clinical and bacteriological cure rates compared with antimicrobials when used to treat post-calving clinical mastitis where S. uberis was the most common pathogen. The proportion of cows that needed retreatment was significantly higher for the homeopathic treated cows. This, combined with lower bacteriological cure rates, has implications for duration of infection

Homeopathic Treatment of Vitiligo: A Report of Fourteen Cases

PubMed Central

Mahesh, Seema; Mallappa, Mahesh; Tsintzas, Dionysios; Vithoulkas, George

2017-01-01

Case series Patient: — Final Diagnosis: — Symptoms: Skin lesions Medication: — Clinical Procedure: — Specialty: Dermatology Objective: Unusual or unexpected effect of treatment Background: Vitiligo, also known as leukoderma, is an autoimmune skin condition that results in the loss of melanin pigment. Vitiligo is not a rare condition but is difficult to treat and is associated with psychological distress. Case Reports: A series of 14 cases of vitiligo are presented that were treated with individualized homeopathic remedies that were based on plant, animal, or mineral compounds. There were 13 women and one man in the case series, with a mean age 29.8 years, and a mean follow-up from treatment of 58 months. The mean time between the onset of the appearance of vitiligo and the first consultation at our clinic was 96 months. Homeopathic treatment for patients is holistic and was performed on an individualized basis as described in this case series. Photographic images of the skin are presented before and after treatment. Conclusions: In 14 patients with vitiligo treated with individualized homeopathy, the best results were achieved in the patients who were treated in the early stages of the disease. We believe that homeopathy may be effective in the early stages of vitiligo, but large controlled clinical studies are needed in this area. PMID:29196612

Homeopathy in France in 2011-2012 according to reimbursements in the French national health insurance database (SNIIRAM).

PubMed

Piolot, Michel; Fagot, Jean-Paul; Rivière, Sébastien; Fagot-Campagna, Anne; Debeugny, Gonzague; Couzigou, Patrice; Alla, François

2015-08-01

The use of homeopathic medicine is poorly described and the frequency of combined allopathic and homeopathic prescriptions is unknown. To analyse data on medicines, prescribers and patients for homeopathic prescriptions that are reimbursed by French national health insurance. The French national health insurance databases (SNIIRAM) were used to analyse prescriptions of reimbursed homeopathic drugs or preparations in the overall French population, during the period July 2011-June 2012. A total of 6,705,420 patients received at least one reimbursement for a homeopathic preparation during the 12-month period, i.e. 10.2% of the overall population, with a predominance in females (68%) and a peak frequency observed in children aged 0-4 years (18%). About one third of patients had only one reimbursement, and one half of patients had three or more reimbursements. A total of 120,110 healthcare professionals (HCPs) prescribed at least one homeopathic drug or preparation. They represented 43.5% of the overall population of HCPs, nearly 95% of general practitioners, dermatologists and pediatricians, and 75% of midwives. Homeopathy accounted for 5% of the total number of drug units prescribed by HCPs. Allopathic medicines were coprescribed with 55% of homeopathic prescriptions. Many HCPs occasionally prescribe reimbursed homeopathic preparations, representing however a small percentage of reimbursements compared to allopathic medicines. About 10% of the French population, particularly young children and women, received at least one homeopathic preparation during the year. In more than one half of cases, reimbursed homeopathic preparations are prescribed in combination with allopathic medicines. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery

PubMed Central

Stevinson, C; Devaraj, V S; Fountain-Barber, A; Hawkins, S; Ernst, E

2003-01-01

Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery. PMID:12562974

Homeopathic arnica for prevention of pain and bruising: randomized placebo-controlled trial in hand surgery.

PubMed

Stevinson, C; Devaraj, V S; Fountain-Barber, A; Hawkins, S; Ernst, E

2003-02-01

Homeopathic arnica is widely believed to control bruising, reduce swelling and promote recovery after local trauma; many patients therefore take it perioperatively. To determine whether this treatment has any effect, we conducted a double-blind, placebo-controlled, randomized trial with three parallel arms. 64 adults undergoing elective surgery for carpal tunnel syndrome were randomized to take three tablets daily of homeopathic arnica 30C or 6C or placebo for seven days before surgery and fourteen days after surgery. Primary outcome measures were pain (short form McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). 62 patients could be included in the intention-to-treat analysis. There were no group differences on the primary outcome measures of pain (P=0.79) and bruising (P=0.45) at day four. Swelling and use of analgesic medication also did not differ between arnica and placebo groups. Adverse events were reported by 2 patients in the arnica 6C group, 3 in the placebo group and 4 in the arnica 30C group. The results of this trial do not suggest that homeopathic arnica has an advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery.

A model for homeopathic remedy effects: low dose nanoparticles, allostatic cross-adaptation, and time-dependent sensitization in a complex adaptive system

PubMed Central

2012-01-01

Background This paper proposes a novel model for homeopathic remedy action on living systems. Research indicates that homeopathic remedies (a) contain measurable source and silica nanoparticles heterogeneously dispersed in colloidal solution; (b) act by modulating biological function of the allostatic stress response network (c) evoke biphasic actions on living systems via organism-dependent adaptive and endogenously amplified effects; (d) improve systemic resilience. Discussion The proposed active components of homeopathic remedies are nanoparticles of source substance in water-based colloidal solution, not bulk-form drugs. Nanoparticles have unique biological and physico-chemical properties, including increased catalytic reactivity, protein and DNA adsorption, bioavailability, dose-sparing, electromagnetic, and quantum effects different from bulk-form materials. Trituration and/or liquid succussions during classical remedy preparation create “top-down” nanostructures. Plants can biosynthesize remedy-templated silica nanostructures. Nanoparticles stimulate hormesis, a beneficial low-dose adaptive response. Homeopathic remedies prescribed in low doses spaced intermittently over time act as biological signals that stimulate the organism’s allostatic biological stress response network, evoking nonlinear modulatory, self-organizing change. Potential mechanisms include time-dependent sensitization (TDS), a type of adaptive plasticity/metaplasticity involving progressive amplification of host responses, which reverse direction and oscillate at physiological limits. To mobilize hormesis and TDS, the remedy must be appraised as a salient, but low level, novel threat, stressor, or homeostatic disruption for the whole organism. Silica nanoparticles adsorb remedy source and amplify effects. Properly-timed remedy dosing elicits disease-primed compensatory reversal in direction of maladaptive dynamics of the allostatic network, thus promoting resilience and recovery from

A model for homeopathic remedy effects: low dose nanoparticles, allostatic cross-adaptation, and time-dependent sensitization in a complex adaptive system.

PubMed

Bell, Iris R; Koithan, Mary

2012-10-22

This paper proposes a novel model for homeopathic remedy action on living systems. Research indicates that homeopathic remedies (a) contain measurable source and silica nanoparticles heterogeneously dispersed in colloidal solution; (b) act by modulating biological function of the allostatic stress response network (c) evoke biphasic actions on living systems via organism-dependent adaptive and endogenously amplified effects; (d) improve systemic resilience. The proposed active components of homeopathic remedies are nanoparticles of source substance in water-based colloidal solution, not bulk-form drugs. Nanoparticles have unique biological and physico-chemical properties, including increased catalytic reactivity, protein and DNA adsorption, bioavailability, dose-sparing, electromagnetic, and quantum effects different from bulk-form materials. Trituration and/or liquid succussions during classical remedy preparation create "top-down" nanostructures. Plants can biosynthesize remedy-templated silica nanostructures. Nanoparticles stimulate hormesis, a beneficial low-dose adaptive response. Homeopathic remedies prescribed in low doses spaced intermittently over time act as biological signals that stimulate the organism's allostatic biological stress response network, evoking nonlinear modulatory, self-organizing change. Potential mechanisms include time-dependent sensitization (TDS), a type of adaptive plasticity/metaplasticity involving progressive amplification of host responses, which reverse direction and oscillate at physiological limits. To mobilize hormesis and TDS, the remedy must be appraised as a salient, but low level, novel threat, stressor, or homeostatic disruption for the whole organism. Silica nanoparticles adsorb remedy source and amplify effects. Properly-timed remedy dosing elicits disease-primed compensatory reversal in direction of maladaptive dynamics of the allostatic network, thus promoting resilience and recovery from disease. Homeopathic

Effectiveness of Homeopathic Medicines as Add-on to Institutional Management Protocol for Acute Encephalitis Syndrome in Children: An Open-Label Randomized Placebo-Controlled Trial.

PubMed

Oberai, Praveen; Varanasi, Roja; Padmanabhan, Maya; Upadhyaya, Alok; Singh, Supriya; Singh, Samarendra Pratap; Vikram, Deepika; Khan, Tariq; Prasad, Ramesh; Gupta, A K; Singh, J R; Manchanda, Raj K

2018-06-05

 Acute encephalitis syndrome (AES) is endemic to certain parts of India, with limited treatment options. In our initial exploratory comparative observational study of 151 patients with AES, there was significantly reduced mortality with adjunctive homeopathy compared to institutional management protocol (IMP). The present randomized placebo-controlled trial brings more statistical rigor to this research program.  This study was conducted at a pediatric unit from 2013 to 2015. Children aged > 6 months and ≤ 18 years and receiving IMP were randomized to receive adjunctive homeopathy ( n  = 325) or placebo as control ( n  = 323). The primary effectiveness analysis was based on Glasgow Outcome Scale (GOS). Morbidity was assessed using the Liverpool Outcome Score for Assessing Children at Follow-up. Analysis was by intention to treat.  A total of 612 children were analyzed (Homeopathy [H] = 304; Control [C] = 308). The primary outcome, GOS, differed significantly between H and C groups. There was 14.8% death/neuro-vegetative state in the H group compared to 29.8% in the C group. Relative risk was 0.49 (95% confidence interval [CI]: 0.36 to 0.68), with absolute risk reduction of 15.0% (95% CI: 8.6 to 21.6%). Number needed to treat to prevent one additional death/neuro-vegetative state was 6.6 (95% CI: 4.6 to 11.6). Proportional-odds analysis also revealed a greater effect in the H group: odds ratio, 0.40 (95% CI: 0.27 to 0.60). The most frequently used medicines were Belladonna ( n  = 116), Stramonium ( n  = 33), Arsenicum album ( n  = 25), Sulfur ( n  = 18), Opium ( n  = 17), and Nux vomica ( n  = 10).  Adjunctive homeopathic medicines may improve clinical outcomes associated with AES. Further randomized and controlled studies, using double-blinded trial design, are recommended to discover if the current findings may be corroborated. The Faculty of Homeopathy.

Effects of homeopathic preparations on human prostate cancer growth in cellular and animal models.

PubMed

MacLaughlin, Brian W; Gutsmuths, Babett; Pretner, Ewald; Jonas, Wayne B; Ives, John; Kulawardane, Don Victor; Amri, Hakima

2006-12-01

The use of dietary supplements for various ailments enjoys unprecedented popularity. As part of this trend, Sabal serrulata (saw palmetto) constitutes the complementary treatment of choice with regard to prostate health. In homeopathy, Sabal serrulata is commonly prescribed for prostate problems ranging from benign prostatic hyperplasia to prostate cancer. The authors' work assessed the antiproliferative effects of homeopathic preparations of Sabal serrulata, Thuja occidentalis, and Conium maculatum, in vivo, on nude mouse xenografts, and in vitro, on PC-3 and DU-145 human prostate cancer as well as MDA-MB-231 human breast cancer cell lines. Treatment with Sabal serrulata in vitro resulted in a 33% decrease of PC-3 cell proliferation at 72 hours and a 23% reduction of DU-145 cell proliferation at 24 hours (P<.01). The difference in reduction is likely due to the specific doubling time of each cell line. No effect was observed on MDA-MB-231 human breast cancer cells. Thuja occidentalis and Conium maculatum did not have any effect on human prostate cancer cell proliferation. In vivo, prostate tumor xenograft size was significantly reduced in Sabal serrulata-treated mice compared to untreated controls (P=.012). No effect was observed on breast tumor growth. Our study clearly demonstrates a biologic response to homeopathic treatment as manifested by cell proliferation and tumor growth. This biologic effect was (i)significantly stronger to Sabal serrulata than to controls and (ii)specific to human prostate cancer. Sabal serrulata should thus be further investigated as a specific homeopathic remedy for prostate pathology.

Health Care Utilization Among Complementary and Alternative Medicine Users in a Large Military Cohort

DTIC Science & Technology

2011-04-11

the Naval Health Research Center (protocol NHRC.2000.0007). Data Sources In addition to our longitudinal survey instrument , other data sources...megavitamin therapy, homeopathic remedies, hypnosis , massage therapy, relaxation, and spiritual healing. For the purposes of these analyses...acupuncture, biofeedback, chiropractic care, energy healing, folk medicine, hypnosis , and massage therapy were grouped together as practitioner-assisted

Physiotherapy and a Homeopathic Complex for Chronic Low-back Pain Due to Osteoarthritis: A Randomized, Controlled Pilot Study.

PubMed

Morris, Mary; Pellow, Janice; Solomon, Elizabeth Margaret; Tsele-Tebakang, Tebogo

2016-01-01

Osteoarthritis (OA) is a common cause of chronic low-back pain (CLBP) and can be managed with drug therapy and physiotherapy. Homeopathic remedies may assist managing OA; however, research that supports their effectiveness is limited. The study aimed to investigate the efficacy of a homeopathic complex in combination with physiotherapy in treating CLBP due to OA. The study was a 6-wk, randomized, double-blind, placebo-controlled pilot. The study took place in a private physiotherapy practice in Gauteng, South Africa. The participants were 30 males and females, aged 45-75 y, who were receiving physiotherapy treatment for OA of the lumbar spine from a therapist in private practice. The intervention and control groups both received standard physiotherapy treatment-massage, thermal therapy, and joint mobilization-every 2 wk. In addition, the treatment group received a homeopathic complex-6cH each of Arnica montana, Bryonia alba, Causticum, Kalmia latifolia, Rhus toxicodendron, and Calcarea fluorica. The control group a received a placebo. The primary measure was a visual analogue scale (VAS) for pain. Secondary outcome measures included the Oswestry Disability Index (ODI), an evaluation of each patient's range of motion (ROM) of the lumbar spine, and a determination of each patient's need for pain medication. Intergroup analysis revealed that the treatment group significantly outperformed the control group with regard to pain, daily functioning, and ROM. No difference existed between the groups, however, in the need for conventional pain medication. The study was too small to be conclusive, but results suggest the homeopathic complex, together with physiotherapy, can significantly improve symptoms associated with CLBP due to OA.

Prevention of poison ivy dermatitis with oral homeopathic Rhus toxicodendron.

PubMed

Signore, Robert Joseph

2017-01-15

Acute allergic contact dermatitis to poison ivy is acommon and miserable dermatosis which affectsmillions of Americans each year. Preventativemeasures, such as avoidance, protective clothing,barrier creams, soaps, and solvents often fail despiteour patients' best attempts. Severe allergic reactionsto poison ivy are a significant source of decreasedemployee productivity owing to inability to work anda major health care expenditure. Patients may haveto leave their jobs and discontinue favorite outdoorrecreational activities as a result of severe urushiolsensitivity. Thus, a simple and effective method ofpreventing poison ivy dermatitis would be of greatbenefit to clinical dermatologists and their patients.Complementary and alternative medical practitionerscommonly prescribe homeopathic poison ivyproducts by mouth for the prevention of poisonivy dermatitis. Yet, conventional dermatologists aremostly unaware of this little known clinical pearl. Theauthor discusses two open studies and anecdotalexperience with administration of homeopathicpoison ivy in the prevention of acute allergic contactdermatitis related to poison ivy exposure. Potentialadvantages could include patient acceptability,ease of administration, affordability, and availability.Randomized clinical trials are needed to furtherevaluate the safety and efficacy of this interesting andpromising clinical tip.

[Innovative medicinal products: the new criteria of the Italian Medicines Agency.

PubMed

Mammarella, Federica; Tafuri, Giovanni

2018-05-01

The Italian Medicines Agency (AIFA), which has the dual function of a regulatory and a reimbursement authority, has recently established new criteria to define innovative medicinal products. Indeed, the decision making process to grant the innovative status is based on the evaluation of the unmet medical need, the added therapeutic value compared to existing therapeutic options and the overall quality of clinical evidence, which is assessed based on the GRADE system. Following this evaluation, if a medicinal product is granted the status of "full innovativeness" for a specific therapeutic indication, its manufacturer can access dedicated yearly funds amounting to 500 million Euros each, depending on the type of medicine (one fund for oncology, the other for all other innovative medicinal products). Alternatively, the product can be granted the status of "conditional innovativeness" which allows immediate access to all Regional formularies, with no additional re-assessments at the local level. The third possible outcome is that no innovativeness is recognized. Starting from January 2018, a full report explaining the rationale for the Agency Committee's decision is made publicly available on the AIFA's website.

Health Care Utilization Among Complementary and Alternative Medicine Users in a Large Military Cohort

DTIC Science & Technology

2011-01-01

Sources In addition to our longitudinal survey instrument , other data sources include the Standard Inpatient Data Record (SIDR), which is an...therapy, high-dose megavita- min therapy, homeopathic remedies, hypnosis , massage therapy, relaxation, and spiritual healing. For the pur- poses of these...analyses, acupuncture, biofeedback, chiro- practic care, energy healing, folk medicine, hypnosis , and massage therapy were grouped together as practi

Can Homeopathic Arsenic Remedy Combat Arsenic Poisoning in Humans Exposed to Groundwater Arsenic Contamination?: A Preliminary Report on First Human Trial

PubMed Central

2005-01-01

Groundwater arsenic (As) has affected millions of people globally distributed over 20 countries. In parts of West Bengal (India) and Bangladesh alone, over 100 million people are at risk, but supply of As-free water is grossly inadequate. Attempts to remove As by using orthodox medicines have mostly been unsuccessful. A potentized homeopathic remedy, Arsenicum Album-30, was administered to a group of As affected people and thereafter the As contents in their urine and blood were periodically determined. The activities of various toxicity marker enzymes and compounds in the blood, namely aspartate amino transferase, alanine amino transferase, acid phosphatase, alkaline phosphatase, lipid peroxidation and reduced glutathione, were also periodically monitored up to 3 months. The results are highly encouraging and suggest that the drug can alleviate As poisoning in humans. PMID:16322812

Effects of homeopathic medications Eupatorium perfoliatum and Arsenicum album on parasitemia of Plasmodium berghei-infected mice.

PubMed

Lira-Salazar, G; Marines-Montiel, E; Torres-Monzón, J; Hernández-Hernández, F; Salas-Benito, J S

2006-10-01

Malaria is one of the most important parasitic diseases in the world and a major public health problem because of emerging drug-resistant strains of Plasmodium. A number of synthetic and natural compounds are now being analysed to develop more effective antimalarial drugs. We investigated the effect of homeopathic preparations of Eupatorium perfoliatum and Arsenicum album on parasitemia using a rodent malaria model. We found significant inhibitory effect on parasite multiplication with both medications with a level of 60% for Eupatorium perfoliatum at a 30 CH potency. Arsenicum album 0/6 gave 70% inhibition but this was less stable than Eupatorium perfoliatum. The number of schizonts was higher in animals treated with homeopathic medications. Although the mechanism of action is unknown, these agents would be good candidates as alternative or complementary medications in the treatment of malaria.

Medicinal Product Regulation: Portugal׳s Framework.

PubMed

Herdeiro, Maria Teresa; Bastos, Paulo D; Teixeira-Rodrigues, António; Roque, Fátima

2016-09-01

The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety. The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances. Copyright © 2016 Elsevier HS Journals, Inc. All rights reserved.

The medicinal use of chocolate in early North America.

PubMed

Pucciarelli, Deanna L; Grivetti, Louis E

2008-10-01

The medicinal use of chocolate has a long history in North America dating back to the 16th century. From Mesoamerican Codices and European Treatises scholars have determined that for hundreds of years the beverage called chocolate was administered to the sick and prescribed homeopathically to prevent illness. Yet, little scholarship exists that focuses on medicinal chocolate usage in early North America (18th-19th century). This paper examines medical practices during this era and associated medicinal norms with special attention given to chocolate/cocoa usage. Given the current scientific attention on the relationship between dark chocolate consumption and heart disease attenuation it is timely to investigate and chronicle America's medical forebears' understanding of, and practices related to, the medicinal use of chocolate. Indeed, there is a significant amount of literature to suggest that chocolate was used for wellness and to treat illness.

Immunology and Homeopathy. 3. Experimental Studies on Animal Models

PubMed Central

Bellavite, Paolo; Ortolani, Riccardo; Conforti, Anita

2006-01-01

A search of the literature and the experiments carried out by the authors of this review show that there are a number of animal models where the effect of homeopathic dilutions or the principles of homeopathic medicine have been tested. The results relate to the immunostimulation by ultralow doses of antigens, the immunological models of the ‘simile’, the regulation of acute or chronic inflammatory processes and the use of homeopathic medicines in farming. The models utilized by different research groups are extremely etherogeneous and differ as the test medicines, the dilutions and the outcomes are concerned. Some experimental lines, particularly those utilizing mice models of immunomodulation and anti-inflammatory effects of homeopathic complex formulations, give support to a real effect of homeopathic high dilutions in animals, but often these data are of preliminary nature and have not been independently replicated. The evidence emerging from animal models is supporting the traditional ‘simile’ rule, according to which ultralow doses of compounds, that in high doses are pathogenic, may have paradoxically a protective or curative effect. Despite a few encouraging observational studies, the effectiveness of the homeopathic prevention or therapy of infections in veterinary medicine is not sufficiently supported by randomized and controlled trials. PMID:16786046

Research Productivity of Sports Medicine Fellowship Faculty.

PubMed

Cvetanovich, Gregory L; Saltzman, Bryan M; Chalmers, Peter N; Frank, Rachel M; Cole, Brian J; Bach, Bernard R

2016-12-01

Research productivity is considered an important factor in academic advancement in sports medicine. No study to date has evaluated academic productivity and correlates of academic rank for sports medicine fellowship faculty. To describe the academic productivity of American Orthopaedic Society for Sports Medicine (AOSSM) fellowship program faculty and to determine the association between academic productivity, fellowship characteristics, and academic rank. Descriptive epidemiology study. Characteristics of orthopaedic sports medicine fellowship programs were obtained from the AOSSM and program websites. Metrics of academic productivity (Hirsch index [ h index], I-10 index, publications, citations, and number of publications in several journals) were obtained from Scopus. Statistical analyses were conducted to determine whether academic productivity differs with fellowship attributes and academic rank. A total of 90 AOSSM sports medicine fellowship programs with 610 associated faculty members were identified. Faculty were predominantly male (94%), at academic medical centers (74%), members of AOSSM (71%), and sports medicine-fellowship trained (84%). Faculty had a median of 18 (range, 0-684) publications overall, including a median of 3 (range, 0-161) publications since 2012. All measures of academic productivity were significantly higher among faculty employed at academic medical centers compared with those not employed at academic centers ( P < .05 in all cases). On multivariate ordinal regression analysis, the best correlates of higher academic rank were higher cumulative h index (1.22; P < .001) and longer time in practice since fellowship (1.14; P < .001), which predicted 63.8% of the variance in academic rank. Fellowships with a larger number of fellows had more publications and citations per faculty member, higher faculty cumulative h index, and more publications in the American Journal of Sports Medicine and Arthroscopy per faculty member ( P < .017

Editorial for Special Issue on Herbal Medicines and Natural Products.

PubMed

Zhou, Zhi-Wei; Zhou, Shu-Feng

2015-11-16

Herbal medicines and natural products have been the most productive source of drug development and there is a large line of evidence on the applications of herbal medicines and natural products for the management of body function and the treatment of aliments. The multiple bioactive components in herbal medicines and natural products can explain the multiple targets effect in their medical applications. The increasing usage of state-of-art computational, molecular biological, and analytical chemistry techniques will promote the exploration of the pharmacological effect of previously inaccessible sources of herbal medicines and natural products. Notably, with the increasing reports on the safety issues regarding the medical use of herbal medicines and natural products, the awareness of pharmacovigilance in herbal medicines and natural products needs to be strengthened. To prevent the adverse drug reactions related to herbal medicines and natural products, physicians need to be aware of potential risks and alert patients in the use of herbal medicines and natural products.

Effects of Homeopathic Arsenicum Album, Nosode, and Gibberellic Acid Preparations on the Growth Rate of Arsenic-Impaired Duckweed (Lemna gibba L.)

PubMed Central

Jäger, Tim; Scherr, Claudia; Simon, Meinhard; Heusser, Peter; Baumgartner, Stephan

2010-01-01

This study evaluated the effects of homeopathically potentized Arsenicum album, nosode, and gibberellic acid in a bioassay with arsenic-stressed duckweed (Lemna gibba L.). The test substances were applied in nine potency levels (17x, 18x, 21x–24x, 28x, 30x, 33x) and compared with controls (unsuccussed and succussed water) regarding their influence on the plant’s growth rate. Duckweed was stressed with arsenic(V) for 48 h. Afterwards, plants grew in either potentized substances or water controls for 6 days. Growth rates of frond (leaf) area and frond number were determined with a computerized image analysis system for different time intervals (days 0–2, 2–6, 0–6). Five independent experiments were evaluated for each test substance. Additionally, five water control experiments were analyzed to investigate the stability of the experimental setup (systematic negative control experiments). All experiments were randomized and blinded. The test system exhibited a low coefficient of variation (≈1%). Unsuccussed and succussed water did not result in any significant differences in duckweed growth rate. Data from the control and treatment groups were pooled to increase statistical power. Growth rates for days 0–2 were not influenced by any homeopathic preparation. Growth rates for days 2–6 increased after application of potentized Arsenicum album regarding both frond area (p < 0.001) and frond number (p < 0.001), and by application of potentized nosode (frond area growth rate only, p < 0.01). Potencies of gibberellic acid did not influence duckweed growth rate. The systematic negative control experiments did not yield any significant effects. Thus, false-positive results can be excluded with high certainty. To conclude, the test system with L. gibba impaired by arsenic(V) was stable and reliable. It yielded evidence for specific effects of homeopathic Arsenicum album preparations and it will provide a valuable tool for future experiments that aim at revealing

Individualized homeopathy in a group of Egyptian asthmatic children.

PubMed

Shafei, Heba Farid; AbdelDayem, Soha Mahmoud; Mohamed, Nagwa Hassan

2012-10-01

To evaluate homeopathy as an adjunctive treatment for bronchial asthma in children. In a prospective observational longitudinal study the effects of individualised homeopathic medicines were assessed in 30 children with asthma as an adjunct to conventional treatment. The main outcome measures were frequency of attacks, use of medication, night awakening and spirometry at baseline and at follow-up till 6 months. There were clinically relevant and statistically significant changes in those measuring severity, indicating relative improvements after 3 months and absolute improvements after 6 months of treatment by homeopathic medicines. This study provides evidence that homeopathic medicines, as prescribed by experienced homeopathic practitioners, improve severity of asthma in children. Controlled studies should be conducted. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Morphometry of white muscle fibers and performance of Nile tilapia (Oreochromis niloticus) fingerlings treated with methyltestosterone or a homeopathic complex.

PubMed

Júnior, R P; Vargas, L; Valentim-Zabott, M; Ribeiro, R P; da Silva, A V; Otutumi, L K

2012-07-01

Nile tilapia (Oreochromis niloticus), are widely used in fish farming, hormonal treatments are used to increase productivity. Studies of the characteristics of the fiber types are important in species that have well developed muscle mass, such as Nile tilapia. A total of 4800 post-larval fish were randomly assigned by tank to receive one of three treatments: Control (30°GL alcohol), Homeopathic complex (Homeopatila RS) or Hormone (17-α-methyltestosterone) supplemented in the feed for 28 days. Survival and morphological parameters were measured at day 45. At day 45, the survival rates were 54.1% (Control), 87.8% (Homeopathy), 50.3% (Hormone). The mean final weight for Homeopathy was statistically significantly lower (1.07 g) than the other two groups: Control (1.81 g) and Hormone (2.04 g). Mean total lengths were Control (4.75 cm), Hormone (4.49 cm), statistically significantly different from Homeopathy (3.83 cm). Average partial length, trunk length, height and body width were significantly lower for Homeopathy than Control or Hormone (p<0.05) Homeopathy treated fish had significantly greater muscle fiber diameter than the other two groups. Fish treated with the homeopathic complex had improved survival and muscle fiber hypertrophy, but were smaller (probably related to increased survival and overcrowding) compared to fingerlings treated with synthetic hormone or control. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Physician practicing preferences for conventional or homeopathic medicines in elderly subjects with musculoskeletal disorders in the EPI3-MSD cohort.

PubMed

Danno, Karine; Joubert, Clementine; Duru, Gerard; Vetel, Jean-Marie

2014-01-01

Musculoskeletal pain is common in elderly persons. Analgesic use is high in the elderly and may involve unacceptable risk in individuals with chronic pain. Our aim was to compare the socio-demographic characteristics of elderly subjects with musculoskeletal disorders (MSD) and to assess medication use and clinical evolution of musculoskeletal pain according to physician prescribing preference: homeopathy (Ho) group, conventional medicine (CM) group, or mixed prescription (MX) group. The EPI3 study was a 1 year observational survey carried out among general practitioners in France between March 2007 and July 2008. This sub-analysis was carried out on elderly subjects aged ≥70 years from the original EPI3 cohort. Socio-demographic data were collected at inclusion using a self-administered patient questionnaire and medical data were recorded for each patient. Quality of life was measured using the Short Form-12 questionnaire. Patients completed a structured telephone interview on their functional status (evaluated with the QuickDash questionnaire, EIFEL scale or Lequesne index) within 72 hours of inclusion. This telephone interview was repeated at 1, 3, and 12 months. Drug exposure was also assessed during these interviews. 146 patients (mean age ± standard deviation: 75.8±4.8 years) were analyzed (80.1% female, 74.7% MSD of the spine or lower limbs, 64.4% chronic MSD). Patients in the CM and MX groups were 3.7 times or 2.5 times more likely (odds ratio [OR] =3.71, 95% confidence interval [CI]: 1.12-12.30; OR =2.52, 95% CI: 1.05-6.05; respectively) to have used non-steroidal anti-inflammatory drugs (NSAIDs) than those in the Ho group. In contrast, analgesic use was comparable in the three groups (OR =1.06 [CM versus Ho], 95% CI: 0.09-12.11; OR =0.34 [MX versus Ho], 95% CI: 0.07-1.57). Overall functional score evolution was similar in the three groups over time (P=0.16). NSAID use was significantly higher in elderly MSD patients consulting a conventional practice

Regulatory and clinical aspects of psychotropic medicinal products bioequivalence.

PubMed

Bałkowiec-Iskra, Ewa; Cessak, Grzegorz; Kuzawińska, Olga; Sejbuk-Rozbicka, Katarzyna; Rokita, Konrad; Mirowska-Guzel, Dagmara

2015-07-01

Introduction of generic medicinal products to the market has increased access to modern therapies but also enabled significant reduction in their cost, leading to containment of public expenditures on medicinal products reimbursement. The critical assessment of bioequivalence of any reference medicinal product and its counterpart is based on comparison of their rate and extent of absorption. It is assumed that two medicinal products are bioequivalent when their rate and extent of absorption do not show significant differences when administered at the same dose under similar experimental conditions. Bioequivalent medicinal products are declared to be also therapeutically equivalent and can be used interchangeably. However, despite regulatory declaration, switching from reference to generic drugs is often associated with concerns of healthcare providers about decreased treatment effectiveness or occurrence of adverse drug reactions. The aim of this article is to provide a description of rules that guide registration of generic medicinal products in the European Union and to analyze specific examples from the scientific literature concerning therapeutic equivalence of reference and generic antidepressant and antipsychotic medicinal products. Copyright © 2015 Elsevier B.V. and ECNP. All rights reserved.

A Homeopathic Arnica Patch for the Relief of Cellulitis-derived Pain and Numbness in the Hand.

PubMed

Barkey, Elisabeth; Kaszkin-Bettag, Marietta

2012-05-01

Arnica montana, belonging to the Compositae family, is a plant with a longstanding tradition of relieving pain and/or inflammation in muscles and joints and may thus represent an alternative to nonsteroidal antiinflammatory drugs, which are often ineffective or lead to a number of adverse effects. A homeopathic arnica patch (3X dilution according to the Homeopathic Pharmacopoeia of the United States) was developed to alleviate pain symptoms in the back and neck muscles and joints. The present case report describes the treatment outcome after administration of the arnica patch in a 55-year-old female patient with pain in the right hand and numbness in the fourth finger after cellulitis in the palmar area. The cellulitis was treated with antibiotics, but pain symptoms remained at 7 points on a 0-to-10-point visual analog scale (VAS) for pain despite intake of oral ibuprofen and oral and topical application of an arnica-containing complex homeopathic ointment. Ten arnica patches were dispensed to the patient. She cut the patch into strips to cover all painful areas of the hand and applied them at night. After 3 days, she reported a substantial decrease in pain symptoms (VAS = 1) and a marked decrease in numbness and in the size of a tender nodule on the third metacarpal area. Moreover, the patient was able to sleep through the night without being awakened by the pain. The symptoms declined further during the next 2 days. This case demonstrates that after a relatively short period of time, the administration of the arnica patch on the hand provided a marked reduction of pain and recovery of functionality of the hand.

A double-blind placebo-controlled study into the efficacy of a homeopathic remedy for fear of firework noises in the dog (Canis familiaris).

PubMed

Cracknell, Nina R; Mills, Daniel S

2008-07-01

Seventy-five dogs that showed a fear response to fireworks participated in a double-blinded, placebo-controlled clinical trial to assess the efficacy of a homeopathic remedy for the alleviation of their behavioural signs. Dogs were randomly assigned to one of two treatments; the homeopathic treatment or the placebo treatment. At the baseline assessments the owners identified the behavioural signs of fear that their dogs normally displayed in response to fireworks, rated their frequency and intensity, and assessed the global severity of their dog's responses. These measures were repeated at the final assessment and owners also completed weekly diaries for the length of the trial. There were significant improvements in the owners' rating of 14/15 behavioural signs of fear in the placebo treatment group and all 15 behavioural signs in the homeopathic treatment group. Both treatment groups also showed significant improvement in the owners' rating of the global severity of their dog's responses. However, there was no significant difference in the response seen between the two treatment groups.

A comparative consecutive case series of 20 children with a diagnosis of ADHD receiving homeopathic treatment, compared with 10 children receiving usual care.

PubMed

Fibert, Philippa; Relton, Clare; Heirs, Morag; Bowden, Deborah

2016-05-01

20 consecutively enrolled children age 5-16 with Attention Deficit Hyperactivity Disorder (ADHD) received treatment by a homeopath (8 consultations and individualized remedies) for one year. Ten subsequently enrolled children received similar time and attention for 4 months. The study explored optimum treatment protocols; the effectiveness, deliverability and acceptability of treatment; and the feasibility of outcome measurement and recruitment. Parents completed Conners' Parent Rating Scale, Revised Long Version ( L) every 4 months, from which DSMIV total scores were extracted; and Measure Your Own Medical Outcome Profile (MYMOP) every consultation. An interaction between time (baseline/4 months) and group (treatment/non-treatment) was found .756 F (1,28)=9.06, p=0.005. The intervention was associated with statistically significant improvements in treated children over the year: L (t (18)=4.529, p≤0.000); MYMOP (t (18)=6.938, p≤0.000). Mean DSMIV total t scores decreased at each time point: baseline: 85 (SD 5.1); 4 months 76.2 (SD 10.9); and 12 months 71.5 (SD 12.77). Recruitment of control participants was problematic. Recruitment to treatment was feasible via ADHD support groups, charities, police support agencies and social services, not schools or NHS services. Attending appointments was problematic for some participants, but home visits did not improve uptake. The best venue was a familiar clinic. Some participants took medicines inappropriately, but generally taking homeopathic remedies was acceptable and well implemented. L (80 items) was problematic for some parents. MYMOP was preferred by parents but not acceptable to stakeholders. In this small consecutive sample the intervention was associated with improvements in criminality, anger and children with a concomitant diagnosis of Autism Spectrum Disorder ASD. Treatment by a homeopath was associated with sustained, increasing improvements and the intervention was acceptable to participants. More

Advice offered by practitioners of complementary/ alternative medicine: an important ethical issue.

PubMed

Ernst, E

2009-12-01

The current popularity of complementary/alternative medicine (CAM) generates many challenges to medical ethics. The one discussed here is the advice offered by CAM practitioners. Using selected examples, the author tries to demonstrate that some of the advice issued through the popular media or provided by acupuncturists, chiropractors, herbalists, homeopaths, pharmacists, and doctors is misleading or dangerous. This, the author argues, can impinge on the main principle of medical ethics: beneficence, nonmaleficence, and autonomy. We should work toward correcting this deplorable situation.

A Homeopathic Arnica Patch for the Relief of Cellulitis-derived Pain and Numbness in the Hand

PubMed Central

Kaszkin-Bettag, Marietta

2012-01-01

Objectives: Arnica montana, belonging to the Compositae family, is a plant with a longstanding tradition of relieving pain and/or inflammation in muscles and joints and may thus represent an alternative to nonsteroidal antiinflammatory drugs, which are often ineffective or lead to a number of adverse effects. A homeopathic arnica patch (3X dilution according to the Homeopathic Pharmacopoeia of the United States) was developed to alleviate pain symptoms in the back and neck muscles and joints. Case Presentation: The present case report describes the treatment outcome after administration of the arnica patch in a 55-year-old female patient with pain in the right hand and numbness in the fourth finger after cellulitis in the palmar area. The cellulitis was treated with antibiotics, but pain symptoms remained at 7 points on a 0-to-10–point visual analog scale (VAS) for pain despite intake of oral ibuprofen and oral and topical application of an arnica-containing complex homeopathic ointment. Ten arnica patches were dispensed to the patient. She cut the patch into strips to cover all painful areas of the hand and applied them at night. After 3 days, she reported a substantial decrease in pain symptoms (VAS = 1) and a marked decrease in numbness and in the size of a tender nodule on the third metacarpal area. Moreover, the patient was able to sleep through the night without being awakened by the pain. The symptoms declined further during the next 2 days. Conclusion: This case demonstrates that after a relatively short period of time, the administration of the arnica patch on the hand provided a marked reduction of pain and recovery of functionality of the hand. PMID:24278813

CAM use in pediatric neurology: an exploration of concurrent use with conventional medicine.

PubMed

Galicia-Connolly, Elaine; Adams, Denise; Bateman, Justin; Dagenais, Simon; Clifford, Tammy; Baydala, Lola; King, W James; Vohra, Sunita

2014-01-01

Previous studies have found that up to 60% of children with neurologic conditions have tried complementary and alternative medicine (CAM). To assess the use of CAM among patients presenting to neurology clinics at two academic centers in Canada. A survey instrument was developed to inquire about use of CAM products and therapies, including reasons for use, perceived helpfulness, and concurrent use with conventional medicine, and administered to patients or their parents/guardians at the Stollery Children's Hospital in Edmonton and the Children's Hospital of Eastern Ontario (CHEO) in Ottawa. Overall CAM use at the Stollery was 78%, compared to 48% at CHEO. The most common CAM products used were multi-vitamins (84%), vitamin C (37%), homeopathic remedies (24%), and fish oil/omega 3 s (22%). The most common CAM practices used were massage (47%), chiropractic (37%), faith healing (18%), aromatherapy (16%), homeopathy (16%), and relaxation (16%). Many patients used CAM products at the same time as conventional medicine but just over half (57%) discussed this concurrent use with their physician. CAM use is common in pediatric neurology patients and most respondents felt that it was helpful, with few or no harms associated. However, this use is often undisclosed, increasing possibility of interactions with conventional drugs. We urge clinicians to inquire about CAM use during routine history taking at every patient visit. Parents would clearly like more information about CAM from their specialty clinics; such information would be easier to share if more primary data were available about the safety and effectiveness of commonly used therapies.

CAM Use in Pediatric Neurology: An Exploration of Concurrent Use with Conventional Medicine

PubMed Central

Galicia-Connolly, Elaine; Adams, Denise; Bateman, Justin; Dagenais, Simon; Clifford, Tammy; Baydala, Lola; King, W. James; Vohra, Sunita

2014-01-01

Background Previous studies have found that up to 60% of children with neurologic conditions have tried complementary and alternative medicine (CAM). Objective To assess the use of CAM among patients presenting to neurology clinics at two academic centers in Canada. Methods A survey instrument was developed to inquire about use of CAM products and therapies, including reasons for use, perceived helpfulness, and concurrent use with conventional medicine, and administered to patients or their parents/guardians at the Stollery Children's Hospital in Edmonton and the Children's Hospital of Eastern Ontario (CHEO) in Ottawa. Results Overall CAM use at the Stollery was 78%, compared to 48% at CHEO. The most common CAM products used were multi-vitamins (84%), vitamin C (37%), homeopathic remedies (24%), and fish oil/omega 3 s (22%). The most common CAM practices used were massage (47%), chiropractic (37%), faith healing (18%), aromatherapy (16%), homeopathy (16%), and relaxation (16%). Many patients used CAM products at the same time as conventional medicine but just over half (57%) discussed this concurrent use with their physician. Conclusion CAM use is common in pediatric neurology patients and most respondents felt that it was helpful, with few or no harms associated. However, this use is often undisclosed, increasing possibility of interactions with conventional drugs. We urge clinicians to inquire about CAM use during routine history taking at every patient visit. Parents would clearly like more information about CAM from their specialty clinics; such information would be easier to share if more primary data were available about the safety and effectiveness of commonly used therapies. PMID:24736474

Effects of herbal medicinal formulas on suppressing viral replication and modulating immune responses.

PubMed

Liao, Hui-Fen; Lu, Min-Chi; Chang, Hon-Chou; Wei, Cheng-Chung; Kao, Chih-Hsiung; Chen, Zong-Huei; Huang, Chin-Chin; Li, Ching

2010-01-01

The Chinese medicinal herbs Radix Isatidis and Viola yedoensis Makino have been suggested to possess antiviral activity. This study tests whether these and other Chinese and Western herbal medicinal formulas can modulate the immune functions involving virus-suppression in BALB/c mouse. We first confirmed the extract from Viola yedoensis Makino, but not from Radix Isatidis, the traditional Chinese medicine (TCM) formula Chui-Uren-Chien (CUC), or a Western homeopathic medicinal drink Método Canova, could inhibit the replications of herpes simplex virus-1 and enterovirus 71 in the human neuroblastoma SK-N-SH cell line. Subsequently, the same herbal extracts and drink underwent toxicity and immunomodulatory tests on mice of 5-7 weeks old. After 8 weeks of feeding different herbal medicinal formulas, no hepatic or renal toxicity was noted in any tested animal; whereas among the immune function evaluations, only the mice treated with CUC extract were found to be associated with significant increases (p < 0.05) in both the level of plasma IgG and the percentage of monocyte in blood mononuclear cells as well as the activation of macrophage Raw264.7 cells for nitric oxide production, suggesting its role in modulating the non-specific immune response. Analyses using protein arrays showed CUC was the most potent herbal medicinal formula eliciting fluctuations in plasma cytokine and chemokine concentrations. Taking all experimental data together, we conclude Chui-Uren-Chien possesses immunomodulatory capability in mouse, but none of the herbal medicinal formulas tested here are involved in strengthening antiviral immunity.

Utility of Nutraceutical Products Marketed for Cognitive and Memory Enhancement

PubMed Central

McDougall, Graham J.; Austin-Wells, Vonnette; Zimmerman, Teena

2008-01-01

This article identifies a convenience sample of 14 memory-enhancing herbal products that were found to be available commercially, examines their active ingredients, states their claims, and evaluates the available evidence to determine their efficacy. The analyses identified four problematic areas. First, a majority of the products use cognitive terminology, which leads consumers to anticipate an intended cognitive benefit. Second, some ingredients are completely homeopathic and contain components not known outside of the homeopathic field. Third, the evidence of treatment efficacy is often contradictory, because products are recommended for purposes other than cognitive or memory loss. Finally, the manufacturers of the product have usually conducted the research on individual products. Until more research is available, it is suggested that holistic nursing professionals exercise caution in recommending nutraceuticals to their patients/clients for the use of cognitive improvement or memory enhancement. PMID:16251490

Homeopathic and conventional treatment for acute respiratory and ear complaints: A comparative study on outcome in the primary care setting

PubMed Central

Haidvogl, Max; Riley, David S; Heger, Marianne; Brien, Sara; Jong, Miek; Fischer, Michael; Lewith, George T; Jansen, Gerard; Thurneysen, André E

2007-01-01

Background The aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting. Methods The study was designed as an international, multi-centre, comparative cohort study of non-randomised design. Patients, presenting themselves with at least one chief complaint: acute (≤ 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment. Therapy outcome was measured by using the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' in each treatment group. The primary outcome criterion was the response rate after 14 days of therapy. Results Data of 1,577 patients were evaluated in the full analysis set of which 857 received homeopathic (H) and 720 conventional (C) treatment. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovery or major improvement (H: 86.9%; C: 86.0%; p = 0.0003 for non-inferiority testing). In the per-protocol set (H: 576 and C: 540 patients) similar results were obtained (H: 87.7%; C: 86.9%; p = 0.0019). Further subgroup analysis of the full analysis set showed no differences of response rates after 14 days in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) in children and 0.92 (0.63–1.34) in adults. Adjustments for demographic differences at baseline did not significantly alter the OR. The response rates after 7 and 28 days also showed no significant differences between both treatment groups. However, onset of improvement within the first 7 days after treatment was significantly faster upon homeopathic treatment both

Complementary and alternative medicine use by pediatric specialty outpatients.

PubMed

Adams, Denise; Dagenais, Simon; Clifford, Tammy; Baydala, Lola; King, W James; Hervas-Malo, Marilou; Moher, David; Vohra, Sunita

2013-02-01

Complementary and alternative medicine (CAM) use is high among children and youth with chronic illnesses. The objective of this study was to assess the prevalence and patterns of CAM use in 10 subspecialty clinics in Canada and to compare CAM use between 2 geographically diverse locations. This survey was carried out at 1 Children's Hospital in western Canada (Edmonton) and 1 Children's Hospital in central Canada (Ottawa). Questionnaires were completed by parents in either French or English. Although demographic characteristics of the 2 populations were similar, CAM use at the western hospital was 71% (n = 704) compared with 42% (n = 222) at the central hospital (P < .0001). Most respondents agreed or strongly agreed that they feel comfortable discussing CAM in their clinic. The most common CAM products currently used were multivitamins/minerals, herbal products, and homeopathic remedies. The most common CAM practices currently used were massage, chiropractic, relaxation, and aromatherapy. Eighty adverse effects were reported, and 55 (68.8%) of these were self-assessed as minor. Results of this study indicate that CAM use is high among pediatric specialty clinic outpatients and is much greater in the western than in the central hospital. Most respondents felt that their CAM use was helpful with few or no harms associated. Many patients, using CAM alongside their conventional medicines, are still not discussing their CAM use with their physicians and are increasing the likelihood for potential interactions and preventable harms.

Physician practicing preferences for conventional or homeopathic medicines in elderly subjects with musculoskeletal disorders in the EPI3-MSD cohort

PubMed Central

Danno, Karine; Joubert, Clementine; Duru, Gerard; Vetel, Jean-Marie

2014-01-01

Background Musculoskeletal pain is common in elderly persons. Analgesic use is high in the elderly and may involve unacceptable risk in individuals with chronic pain. Our aim was to compare the socio-demographic characteristics of elderly subjects with musculoskeletal disorders (MSD) and to assess medication use and clinical evolution of musculoskeletal pain according to physician prescribing preference: homeopathy (Ho) group, conventional medicine (CM) group, or mixed prescription (MX) group. Methods The EPI3 study was a 1 year observational survey carried out among general practitioners in France between March 2007 and July 2008. This sub-analysis was carried out on elderly subjects aged ≥70 years from the original EPI3 cohort. Socio-demographic data were collected at inclusion using a self-administered patient questionnaire and medical data were recorded for each patient. Quality of life was measured using the Short Form-12 questionnaire. Patients completed a structured telephone interview on their functional status (evaluated with the QuickDash questionnaire, EIFEL scale or Lequesne index) within 72 hours of inclusion. This telephone interview was repeated at 1, 3, and 12 months. Drug exposure was also assessed during these interviews. Results 146 patients (mean age ± standard deviation: 75.8±4.8 years) were analyzed (80.1% female, 74.7% MSD of the spine or lower limbs, 64.4% chronic MSD). Patients in the CM and MX groups were 3.7 times or 2.5 times more likely (odds ratio [OR] =3.71, 95% confidence interval [CI]: 1.12–12.30; OR =2.52, 95% CI: 1.05–6.05; respectively) to have used non-steroidal anti-inflammatory drugs (NSAIDs) than those in the Ho group. In contrast, analgesic use was comparable in the three groups (OR =1.06 [CM versus Ho], 95% CI: 0.09–12.11; OR =0.34 [MX versus Ho], 95% CI: 0.07–1.57). Overall functional score evolution was similar in the three groups over time (P=0.16). Conclusion NSAID use was significantly higher in elderly MSD

Use of herbal medicinal products among children and adolescents in Germany

PubMed Central

2014-01-01

Background Germany is a country with a high use of herbal medicinal products. Population-based data on the use of herbal medicinal products among children are lacking. The aim of this study is to investigate the prevalence, patterns and determinants of herbal medicine use among children and adolescents in Germany. Methods As data base served the German Health Interview and Examination Survey for Children and Adolescents (KiGGS), a representative population based survey conducted 2003–2006 by the Robert Koch Institute. 17,450 boys and girls aged 0–17 years provided information on drug use in the preceding seven days. Herbal medicinal products were defined according to the European and German drug laws. SPSS Complex Sample method was used to estimate prevalence rates and factors associated with herbal medicine use. Results The prevalence rate of herbal medicinal product use amounts to 5.8% (95% confidence interval 5.3-6.3%). Use of herbal medicine declines along with increasing age and shows no difference between boys and girls in younger age groups. Teenage girls are more likely to use herbal medicines than teenage boys. Two thirds of herbal medicines are used for the treatment of coughs and colds; nearly half of herbal medicines are prescribed by medical doctors. Determinants of herbal medicinal product use are younger age, residing in South Germany, having a poor health status, having no immigration background and coming from a higher social class family. Children’s and parents-related health behavior is not found to be associated with herbal medicine use after adjusting for social class. Conclusions Use of herbal medicinal products among children and adolescents between the ages of 0 and 17 years in Germany is widely spread and shows relatively higher rates compared to international data. This study provides a reference on the use of herbal medicinal products for policy-makers, health professionals and parents. Further studies are needed to investigate the

'Homeopathy': untangling the debate.

PubMed

Relton, Clare; O'Cathain, Alicia; Thomas, Kate J

2008-07-01

There are active public campaigns both for and against homeopathy, and its continuing availability in the NHS is debated in the medical, scientific and popular press. However, there is a lack of clarity in key terms used in the debate, and in how the evidence base of homeopathy is described and interpreted. The term 'homeopathy' is used with several different meanings including: the therapeutic system, homeopathic medicine, treatment by a homeopath, and the principles of 'homeopathy'. Conclusions drawn from one of these aspects are often inappropriately applied to another aspect. In interpreting the homeopathy evidence it is important to understand that the existing clinical experimental (randomised controlled trial) evidence base provides evidence as to the efficacy of homeopathic medicines, but not the effectiveness of treatment by a homeopath. The observational evidence base provides evidence as to the effectiveness of treatment by a homeopath. We make four recommendations to promote clarity in the reporting, design and interpretation of homeopathy research.

Can Additional Homeopathic Treatment Save Costs? A Retrospective Cost-Analysis Based on 44500 Insured Persons

PubMed Central

Ostermann, Julia K.; Reinhold, Thomas; Witt, Claudia M.

2015-01-01

Objectives The aim of this study was to compare the health care costs for patients using additional homeopathic treatment (homeopathy group) with the costs for those receiving usual care (control group). Methods Cost data provided by a large German statutory health insurance company were retrospectively analysed from the societal perspective (primary outcome) and from the statutory health insurance perspective. Patients in both groups were matched using a propensity score matching procedure based on socio-demographic variables as well as costs, number of hospital stays and sick leave days in the previous 12 months. Total cumulative costs over 18 months were compared between the groups with an analysis of covariance (adjusted for baseline costs) across diagnoses and for six specific diagnoses (depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache). Results Data from 44,550 patients (67.3% females) were available for analysis. From the societal perspective, total costs after 18 months were higher in the homeopathy group (adj. mean: EUR 7,207.72 [95% CI 7,001.14–7,414.29]) than in the control group (EUR 5,857.56 [5,650.98–6,064.13]; p<0.0001) with the largest differences between groups for productivity loss (homeopathy EUR 3,698.00 [3,586.48–3,809.53] vs. control EUR 3,092.84 [2,981.31–3,204.37]) and outpatient care costs (homeopathy EUR 1,088.25 [1,073.90–1,102.59] vs. control EUR 867.87 [853.52–882.21]). Group differences decreased over time. For all diagnoses, costs were higher in the homeopathy group than in the control group, although this difference was not always statistically significant. Conclusion Compared with usual care, additional homeopathic treatment was associated with significantly higher costs. These analyses did not confirm previously observed cost savings resulting from the use of homeopathy in the health care system. PMID:26230412

PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.

PubMed

Krause, Stephan O

2015-01-01

This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages. This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system. © PDA, Inc. 2015.

[The agent Latrodectus and canine paecilomycotic eclampsia as a laboratory model in the survey of treatment for mycoses and parasitic diseases].

PubMed

Gasparian, E R; Streliaeva, A V; Chebyshev, N V; Sagieva, A T; Polzikov, V V; Lazareva, N B; Kurilov, D V; Zuev, S S; Shcheglova, T A; Sadykov, V M

2012-01-01

The extragent used to prepare a Latrodectus mactans hydrocarbon extract is a multicomponent system composed of alkanes, alkenes, and arenes. More than 100 compounds were identified in the hydrocarbon extract (petroleum). The petroleum matrix of Latrodectus mactans was first obtained to manufacture homeopathic remedies. The authors could prepare the first Russian homeopathic medicine from Latrodectus mactans, which proved to be effective in treating canine eclampsia. Canine experiments provide a rationale for the authors' choice as the only homeopathic remedy among thousand known drugs to treat female eclampsia. It is Latrodectus mactans that is in the list of homeopathic medicines permitted for use in accordance with Order No. 335 (Supplement 2) of the Ministry of Health and Medical Industry of Russia, issued on November 29, 1995. It is manufactured from Latrodectus mactans living in the USA.

The mathematics of dilution.

PubMed

Chatterjee, Barun Kumar

2014-04-01

The major objection to homeopathic medicine is that the doses of medicine prescribed in some cases are too dilute for any active ingredient to be present. The medicines would hence be rendered inactive, necessitating novel explanations for the action. A further examination of dilution in the light of the Langmuir equation shows that homeopathic medicines may not be as dilute as a simplistic application of Avogadro's Principle suggests, due to surface effects. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

[René Allendy and the medicine of the imponderables].

PubMed

Hochmann, J

1993-01-01

René Allendy was one of the first French psychoanalysts. He was also a homeopath. A text by him on the "medicine of the imponderables" demonstrates his proximity to esoteric theories. The objective of this article is to illustrate a cultural misunderstanding at the time of the introduction of psychoanalysis in France, when it met up with a Gnostic and Illuminist heritage that was still very much alive. This initial confusion between the Freudian approach, which was in keeping with the thinking of the Lumières, and a certain obscurantism, explains perhaps some of the resistance as well as some of the subsequent deviations of psychoanalysis in France.

Comparison of homeopathic globules prepared from high and ultra-high dilutions of various starting materials by ultraviolet light spectroscopy.

PubMed

Klein, Sabine D; Wolf, Ursula

2016-02-01

Homeopathic globules are commonly used in clinical practice, while research focuses on liquid potencies. Sequential dilution and succussion in their production process has been proposed to change the physico-chemical properties of the solvent(s). It has been reported that aqueous potencies of various starting materials showed significant differences in ultraviolet light transmission compared to controls and between different dilution levels. The aim of the present study was to repeat and expand these experiments to homeopathic globules. Globules were specially produced for this study by Spagyros AG (Gümligen, Switzerland) from 6 starting materials (Aconitum napellus, Atropa belladonna, phosphorus, sulfur, Apis mellifica, quartz) and for 6 dilution levels (6x, 12x, 30c, 200c, 200CF (centesimal discontinuous fluxion), 10,000CF). Native globules and globules impregnated with solvents were used as controls. Globules were dissolved in ultrapure water, and absorbance in the ultraviolet range was measured. The average absorbance from 200 to 340nm was calculated and corrected for differences between measurement days and instrumental drift. Statistically significant differences were found for A. napellus, sulfur, and A. mellifica when normalized average absorbance of the various dilution levels from the same starting material (including control and solvent control globules) was compared. Additionally, absorbance within dilution levels was compared among the various starting materials. Statistically significant differences were found among 30c, 200c and 200CF dilutions. This study has expanded previous findings from aqueous potencies to globules and may indicate that characteristics of aqueous high dilutions may be preserved and detectable in dissolved globules. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Regulation of Cell and Gene Therapy Medicinal Products in Taiwan.

PubMed

Lin, Yi-Chu; Wang, Po-Yu; Tsai, Shih-Chih; Lin, Chien-Liang; Tai, Hsuen-Yung; Lo, Chi-Fang; Wu, Shiow-Ing; Chiang, Yu-Mei; Liu, Li-Ling

2015-01-01

Owing to the rapid and mature development of emerging biotechnology in the fields of cell culture, cell preservation, and recombinant DNA technology, more and more cell or gene medicinal therapy products have been approved for marketing, to treat serious diseases which have been challenging to treat with current medical practice or medicine. This chapter will briefly introduce the Taiwan Food and Drug Administration (TFDA) and elaborate regulation of cell and gene therapy medicinal products in Taiwan, including regulatory history evolution, current regulatory framework, application and review procedures, and relevant jurisdictional issues. Under the promise of quality, safety, and efficacy of medicinal products, it is expected the regulation and environment will be more flexible, streamlining the process of the marketing approval of new emerging cell or gene therapy medicinal products and providing diverse treatment options for physicians and patients.

How healthy are chronically ill patients after eight years of homeopathic treatment?--Results from a long term observational study.

PubMed

Witt, Claudia M; Lüdtke, Rainer; Mengler, Nils; Willich, Stefan N

2008-12-17

Homeopathy is a highly debated but often used medical treatment. With this cohort study we aimed to evaluate health status changes under homeopathic treatment in routine care. Here we extend former results, now presenting data of an 8-year follow-up. In a prospective, multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: The patients' perceived change in complaint severity (numeric rating scales from 0 = no complaint to 10 = maximal severity) and quality of life as measured by the SF-36 at baseline, and after 2 and 8 years. A total of 3,709 patients were studied, 73% (2,722 adults, 72.8% female, age at baseline 41.0 +/- 12.3; 819 children, 48.4% female, age 6.5 +/- 4.0) contributed data to the 8-year follow-up. The most frequent diagnoses were allergic rhinitis and headache in adults, and atopic dermatitis and multiple recurrent infections in children. Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years (adults from 6.2 +/- 1.7 to 2.9 +/- 2.2 and 2.7 +/- 2.1; children from 6.1 +/- 1.8 to 2.1 +/- 2.0 and 1.7 +/- 1.9). Physical and mental quality of life sores also increased considerably. Younger age, female gender and more severe disease at baseline were factors predictive of better therapeutic success. Patients who seek homeopathic treatment are likely to improve considerably. These effects persist for as long as 8 years.

Treatment with at Homeopathic Complex Medication Modulates Mononuclear Bone Marrow Cell Differentiation

PubMed Central

Cesar, Beatriz; Abud, Ana Paula R.; de Oliveira, Carolina C.; Cardoso, Francolino; Bernardi, Raffaello Popa Di; Guimarães, Fernando S. F.; Gabardo, Juarez; de Freitas Buchi, Dorly

2011-01-01

A homeopathic complex medication (HCM), with immunomodulatory properties, is recommended for patients with depressed immune systems. Previous studies demonstrated that the medication induces an increase in leukocyte number. The bone marrow microenvironment is composed of growth factors, stromal cells, an extracellular matrix and progenitor cells that differentiate into mature blood cells. Mice were our biological model used in this research. We now report in vivo immunophenotyping of total bone marrow cells and ex vivo effects of the medication on mononuclear cell differentiation at different times. Cells were examined by light microscopy and cytokine levels were measured in vitro. After in vivo treatment with HCM, a pool of cells from the new marrow microenvironment was analyzed by flow cytometry to detect any trend in cell alteration. The results showed decreases, mainly, in CD11b and TER-119 markers compared with controls. Mononuclear cells were used to analyze the effects of ex vivo HCM treatment and the number of cells showing ring nuclei, niche cells and activated macrophages increased in culture, even in the absence of macrophage colony-stimulating factor. Cytokines favoring stromal cell survival and differentiation in culture were induced in vitro. Thus, we observe that HCM is immunomodulatory, either alone or in association with other products. PMID:19736221

[Testing of medicinal products produced from pooled plasma].

PubMed

Unkelbach, U; Hunfeld, A; Breitner-Ruddock, S

2014-10-01

Medicinal products produced from human plasma fall under the administrative batch release procedure of the competent authority. In Germany, this has been carried out since 1995 by the Paul Ehrlich Institute (PEI), the responsible state control agency for blood products. Medicinal products released for the European and national market are tested for quality, efficacy and safety. Experimental testing of the final product and the starting materials, the plasma pools, as well as control of the production documentation guarantee a constantly high product safety. In the 28,000 batches tested since the beginning of the state controlled batch release testing of these blood products at the PEI, there has been no transmission of infectious viruses (HIV, HBV and HCV) to any patient. The batch release has made a contribution to the improvement of product quality. This procedure is still an important tool to ensure safety of blood products. The PEI is integrated in the batch release network of the European Directorate for the Quality of Medicines & Health Care (EDQM) in Strasbourg. Regulations and guidelines for official control authority batch release (OCABR) ensure harmonized procedures for mutual recognition of batch release on the European level. The EU certificates and German national certificates are requested and accepted in over 70 countries worldwide. Experimental testing in the EU and the requisite certificates have developed into a seal of quality for the world market.

Is Patent "Evergreening" Restricting Access to Medicine/Device Combination Products?

PubMed

Beall, Reed F; Nickerson, Jason W; Kaplan, Warren A; Attaran, Amir

2016-01-01

Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as "evergreening", can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market. We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration's Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product's device patents and medicine patents. Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3-15.2 years). Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes "evergreening" depends on whether these incremental innovations and the years of extra patent protection they confer are proportionately matched by therapeutic

Regulatory structures for gene therapy medicinal products in the European Union.

PubMed

Klug, Bettina; Celis, Patrick; Carr, Melanie; Reinhardt, Jens

2012-01-01

Taking into account the complexity and technical specificity of advanced therapy medicinal products: (gene and cell therapy medicinal products and tissue engineered products), a dedicated European regulatory framework was needed. Regulation (EC) No. 1394/2007, the "ATMP Regulation" provides tailored regulatory principles for the evaluation and authorization of these innovative medicines. The majority of gene or cell therapy product development is carried out by academia, hospitals, and small- and medium-sized enterprises (SMEs). Thus, acknowledging the particular needs of these types of sponsors, the legislation also provides incentives for product development tailored to them. The European Medicines Agency (EMA) and, in particular, its Committee for Advanced Therapies (CAT) provide a variety of opportunities for early interaction with developers of ATMPs to enable them to have early regulatory and scientific input. An important tool to promote innovation and the development of new medicinal products by micro-, small-, and medium-sized enterprises is the EMA's SME initiative launched in December 2005 to offer financial and administrative assistance to smaller companies. The European legislation also foresees the involvement of stakeholders, such as patient organizations, in the development of new medicines. Considering that gene therapy medicinal products are developed in many cases for treatment of rare diseases often of monogenic origin, the involvement of patient organizations, which focus on rare diseases and genetic and congenital disorders, is fruitful. Two such organizations are represented in the CAT. Research networks play another important role in the development of gene therapy medicinal products. The European Commission is funding such networks through the EU Sixth Framework Program. Copyright © 2012 Elsevier Inc. All rights reserved.

Comparison of veterinary drugs and veterinary homeopathy: part 2

PubMed Central

Lees, P.; Pelligand, L.; Whiting, M.; Chambers, D.; Toutain, P-L.; Whitehead, M. L.

2017-01-01

Part 2 of this narrative review outlines the theoretical and practical bases for assessing the efficacy and effectiveness of conventional medicines and homeopathic products. Known and postulated mechanisms of action are critically reviewed. The evidence for clinical efficacy of products in both categories, in the form of practitioner experience, meta-analysis and systematic reviews of clinical trial results, is discussed. The review also addresses problems and pitfalls in assessing data, and the ethical and negative aspects of pharmacology and homeopathy in veterinary medicine. PMID:28821700

How healthy are chronically ill patients after eight years of homeopathic treatment? – Results from a long term observational study

PubMed Central

Witt, Claudia M; Lüdtke, Rainer; Mengler, Nils; Willich, Stefan N

2008-01-01

Background Homeopathy is a highly debated but often used medical treatment. With this cohort study we aimed to evaluate health status changes under homeopathic treatment in routine care. Here we extend former results, now presenting data of an 8-year follow-up. Methods In a prospective, multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: The patients' perceived change in complaint severity (numeric rating scales from 0 = no complaint to 10 = maximal severity) and quality of life as measured by the SF-36 at baseline, and after 2 and 8 years. Results A total of 3,709 patients were studied, 73% (2,722 adults, 72.8% female, age at baseline 41.0 ± 12.3; 819 children, 48.4% female, age 6.5 ± 4.0) contributed data to the 8-year follow-up. The most frequent diagnoses were allergic rhinitis and headache in adults, and atopic dermatitis and multiple recurrent infections in children. Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years (adults from 6.2 ± 1.7 to 2.9 ± 2.2 and 2.7 ± 2.1; children from 6.1 ± 1.8 to 2.1 ± 2.0 and 1.7 ± 1.9). Physical and mental quality of life sores also increased considerably. Younger age, female gender and more severe disease at baseline were factors predictive of better therapeutic success. Conclusion Patients who seek homeopathic treatment are likely to improve considerably. These effects persist for as long as 8 years. PMID:19091085

Quality of natural product clinical trials: a comparison of those published in alternative medicine versus conventional medicine journals.

PubMed

Cochrane, Zara Risoldi; Gregory, Philip; Wilson, Amy

2011-06-01

To compare the quality of natural product clinical trials published in alternative medicine journals versus those published in conventional medicine journals. Systematic search and review of the literature. Randomized controlled trials of natural products were included if they were published in English between 2003 and 2008. Articles were categorized by their journal of publication (alternative medicine versus conventional medicine). Two independent reviewers evaluated study quality using guidelines from the Cochrane Collaboration. The results with respect to the primary outcome (positive or negative) were also assessed. Thirty articles were evaluated, 15 published in alternative medicine journals and 15 in conventional medicine journals. Of articles published in alternative medicine journals, 33.33% (n = 5) were considered low quality, and none were considered high quality. Of articles published in conventional medicine journals, 26.67% (n = 4) were considered low quality and 6.67% (n = 1) were considered high quality. Two thirds of all trials reviewed were of unclear quality, due to inadequate reporting of information relating to the study's methodology. Similar proportions of positive and negative primary outcomes were found in alternative and conventional medicine journals, and low-quality articles were not more likely to report a positive primary outcome (Fisher's exact test, two-tailed p = .287). The quality of natural product randomized controlled trials was similar among alternative and conventional medicine journals. Efforts should be made to improve the reporting of natural product clinical trials for accurate determinations of study quality to be possible.

[Changes in physico-chemical parameters of homeopathic remedies ferrum metallicum CH6 and ferrum metallicum CH30 after exposure to high frequency electromagnetic radiation of low intensity].

PubMed

Mendez, N M

2005-01-01

It is considered the microwaves electromagnetic radiation do not affect the materials, alive or not, when used in low power. In high power, the interaction effects would be the material warming (thermal effect). However, in the last years, the studies about electromagnetic radiation with low power (non thermal effect) in the human being have been increasing. It was found out the electromagnetic radiation, even with low power, can affect the living organisms and biosubstratum. In the present work the influence of electromagnetic radiation (2.45 GHz 500 W/cm2), on physical and chemical parameters of the homeopathic pharmaceutics products in shown.

Complementary and Alternative Medicine: A Cross-Sectional Observational Study in Pediatric Inpatients

PubMed Central

Dhankar, Mukesh

2018-01-01

The aim was to study the prevalence of complementary and alternative medicine use in acutely sick hospitalized children and factors associated with it. This is a cross-sectional, hospital-based study in a tertiary care center of Delhi, India. Children admitted to a pediatric unit during the study period were assessed using a specially designed questionnaire. Out of the total 887 admitted children, 161 (18.1%) were using complementary and alternate medicine in one form or another. Of these, 113 (70.2%) were using complementary and alternate medicine for the current illness directly leading to admission and the remaining 48 (29.8%) had used complementary and alternate medicine in past. The common complementary and alternate medicine use observed in our study was combined ayurveda and spiritual approach (25.5%), ayurveda (24.8%), spiritual (21.7%), homeopathic (13%), and 47.2% of children were using spiritual approach in form of Jhada (tying piece of cloth on arm or leg or keeping a knife by the side of child). The significant factors associated with complementary and alternate medicine use were younger age, female gender, and father being employed. Complementary and alternate medicine is commonly used even in acutely sick children. PMID:29616560

[Research strategies for feed additives and veterinary medicines from side products of Chinese medicine resources industrialization].

PubMed

Zhao, Ming; Duan, Jin-Ao; Zhang, Sen; Guo, Sheng; Su, Shu-Lan; Wu, Qi-Nan; Tang, Yu-Ping; Zeng, Jian-Guo

2017-09-01

The global antimicrobial resistance has been a big challenge to the human health for years. It has to make balance between the safety of animal products and the use of antimicrobials in animal husbandry. Any methods that can minimize or even phase out the use of antimicrobials in animal husbandry should be encouraged. We herein describe the research strategies for feed additives and veterinary medicines from the side products of Chinese medicine resources industrialization. Killing two birds with one stone-besides the major purposes, the rational utilization of non-medicinal parts and wastes of industrialization of Chinese herbal medicines is also achieved under the proposed strategies. Copyright© by the Chinese Pharmaceutical Association.

EMEA and Gene Therapy Medicinal Products Development in the European Union

PubMed Central

2003-01-01

The evaluation of quality, safety, and efficacy of medicinal products by the European Medicines Evaluation Agency (EMEA) via the centralized procedure is the only available regulatory procedure for obtaining marketing authorization for gene therapy (GT) medicinal products in the European Union. The responsibility for the authorization of clinical trials remains with the national competent authorities (NCA) acting in a harmonized framework from the scientific viewpoint. With the entry into force of a new directive on good clinical practice implementation in clinical trials as of 1 May 2004, procedural aspects will also be harmonized at EU level. Scientifically sound development of medicinal products is the key for the successful registration of dossiers and for contributing to the promotion and protection of public health. The objective of this paper is to introduce the EMEA regulatory processes and scientific activities relevant to GT medicinal products. PMID:12686717

[Safety monitoring of cell-based medicinal products (CBMPs)].

PubMed

Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

2015-11-01

Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

Reproducibility of effects of homeopathically potentised gibberellic acid on the growth of Lemna gibba L. in a randomised and blinded bioassay.

PubMed

Majewsky, Vera; Scherr, Claudia; Arlt, Sebastian Patrick; Kiener, Jonas; Frrokaj, Kristina; Schindler, Tobias; Klocke, Peter; Baumgartner, Stephan

2014-04-01

Reproducibility of basic research investigations in homeopathy is challenging. This study investigated if formerly observed effects of homeopathically potentised gibberellic acid (GA3) on growth of duckweed (Lemna gibba L.) were reproducible. Duckweed was grown in potencies (14x-30x) of GA3 and one time succussed and unsuccussed water controls. Outcome parameter area-related growth rate was determined by a computerised image analysis system. Three series including five independent blinded and randomised potency experiments (PE) each were carried out. System stability was controlled by three series of five systematic negative control (SNC) experiments. Gibbosity (a specific growth state of L. gibba) was investigated as possibly essential factor for reactivity of L. gibba towards potentised GA3 in one series of potency and SNC experiments, respectively. Only in the third series with gibbous L. gibba L. we observed a significant effect (p = 0.009, F-test) of the homeopathic treatment. However, growth rate increased in contrast to the former study, and most biologically active potency levels differed. Variability in PE was lower than in SNC experiments. The stability of the experimental system was verified by the SNC experiments. Gibbosity seems to be a necessary condition for reactivity of L. gibba to potentised GA3. Further still unknown conditions seem to govern effect direction and the pattern of active and inactive potency levels. When designing new reproducibility studies, the physiological state of the test organism must be considered. Variability might be an interesting parameter to investigate effects of homeopathic remedies in basic research. Copyright © 2014 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Regulation of Clinical Trials with Advanced Therapy Medicinal Products in Germany.

PubMed

Renner, Matthias; Anliker, Brigitte; Sanzenbacher, Ralf; Schuele, Silke

2015-01-01

In the European Union, clinical trials for Advanced Therapy Medicinal Products are regulated at the national level, in contrast to the situation for a Marketing Authorisation Application, in which a centralised procedure is foreseen for these medicinal products. Although based on a common understanding regarding the regulatory requirement to be fulfilled before conduct of a clinical trial with an Advanced Therapy Investigational Medicinal Product, the procedures and partly the scientific requirements for approval of a clinical trial application differ between the European Union Member States. This chapter will thus give an overview about the path to be followed for a clinical trial application and the subsequent approval process for an Advanced Therapy Investigational Medicinal Product in Germany and will describe the role of the stakeholders that are involved. In addition, important aspects of manufacturing, quality control and non-clinical testing of Advanced Therapy Medicinal Products in the clinical development phase are discussed. Finally, current and future approaches for harmonisation of clinical trial authorisation between European Union Member States are summarised.

[Review on community herbal monographs for traditional herbal medicinal products].

PubMed

Zou, Wenjun; Qu, Liping; Ye, Zuguang; Ji, Jianxin; Li, Bogang

2011-12-01

This article discusses the characteristics of cmmunity herbal monographs for traditional herbal medicinal products and its establishment procedure. It also reviews the new development of cmmunity traditional herbal monographs. The purpose is to clarify the relationship between cmmunity herbal monographs and simplified registration for traditional herbal medicinal product in European Union and provide reference to the registration of taditional Chinese mdicinal products in Europe.

An exploratory study on scientific investigations in homeopathy using medical analyzer.

PubMed

Mishra, Nirupama; Muraleedharan, K Charan; Paranjpe, Akalpita Sriniwas; Munta, Devendra Kumar; Singh, Hari; Nayak, Chaturbhuja

2011-08-01

The action of homeopathic medicines, in ultra-high dilution, is not directly observable. An attempt was made to explore autonomic response of selective homeopathic medicines, in healthy persons, using Medical Analyzer System (Electronics Division, Bhabha Atomic Research Centre, Mumbai, India). The objective of the study was to observe the action of homeopathic medicines on physiologic variability of heart rate and blood flow. Pre- and postinterventional variability spectra of heart rate and blood flow of 77 subjects were recorded with the Medical Analyzer System, administering homeopathic preparations of Aconitum napellus (6c, 10M), Arsenicum album (200c, 1M), Gelsemium sempervirens (200c, 1M), Phosphorus (200c, 1M), Pulsatilla nigricans (200c) and Sulphur (200c, 1M) versus placebo control. The amplitude of the peaks viz. low-frequency, medium-frequency, and high-frequency was measured for postintervention analysis. An increase in the amplitude of any valid peak by 100% or a decrease by 50% was considered as significant change. Aconitum napellus produced a response in heart rate variability (HRV) with 30c potency and in blood flow variability with 1M potency. Sulphur 200c and 1M, Gelsemium 200c and Pulsatilla 200c, produced a 62.5% response in HRV against the placebo response of 16.6%. Gelsemium, Phosphorus, and Sulphur produced a response in blood flow variability with a 1M potency, similar to the response of Aconitum napellus 1M. These data suggest that it is possible to record the response of homeopathic medicines on physiologic parameters of the autonomic nervous system.

Treatment of Postoperative Sore Throat With the Aid of the Homeopathic Remedy Arnica montana: A Report of Two Cases.

PubMed

Tsintzas, Dionysis; Vithoulkas, George

2017-10-01

We present 2 cases of severe postoperative sore throat, hoarseness, aphonia, and dysphagia, after a laryngeal mask insertion, who were treated successfully with the homeopathic remedy Arnica montana. Three doses of Arnica montana 200CH were given to the patients over 36 hours. Although the symptoms were very intense, the remedy was very effective and cleared most of the symptoms in 48 hours.

Submerged cultivation of medicinal mushrooms: bioprocesses and products (review).

PubMed

Elisashvili, Vladimir

2012-01-01

Medicinal mushrooms belonging to higher Basidiomycetes are an immensely rich yet largely untapped resource of useful, easily accessible, natural compounds with various biological activities that may promote human well-being. The medicinal properties are found in various cellular components and secondary metabolites (polysaccharides, proteins and their complexes, phenolic compounds, polyketides, triterpenoids, steroids, alkaloids, nucleotides, etc.), which have been isolated and identified from the fruiting bodies, culture mycelium, and culture broth of mushrooms. Some of these compounds have cholesterol-lowering, anti-diabetic, antioxidant, antitumor, immunomodulating, antimicrobial, and antiviral activities ready for industrial trials and further commercialization, while others are in various stages of development. Recently, the submerged cultivation of medicinal mushrooms has received a great deal of attention as a promising and reproducible alternative for the efficient production of mushroom mycelium and metabolites. Submerged cultivation of mushrooms has significant industrial potential, but its success on a commercial scale depends on increasing product yields and development of novel production systems that address the problems associated with this technique of mushroom cultivation. In spite of many researchers' efforts for the production of bioactive metabolites by mushrooms, the physiological and engineering aspects of submerged cultures are still far from being thoroughly studied. The vast majority of studies have focused on polysaccharide and ganoderic acid production in submerged cultivation of medicinal mushrooms, and very little has been written so far on the antioxidant and hemagglutinating activity of submerged mushroom cultures. The purpose of this review is to provide an update of the present state of the art and future prospects of submerged cultivation of medicinal mushrooms to produce mycelium and bioactive metabolites, and to make a

Fighting trafficking of falsified and substandard medicinal products in Russia.

PubMed

Fayzrakhmanov, N F

2015-01-01

The trafficking of falsified and substandard medicinal products is a global socio-economic problem, which poses a serious threat to economy and health of populations of most countries, including the Russian Federation. To identify the main achievements and challenges in the fight against trafficking of falsified and substandard medicinal products in the Russian Federation, to formulate possible solutions to these problems. The study of criminal cases and statistical information about the level of crime in the Russian Federation; legal analysis of regulatory legal acts in the sphere of criminal law and turnover of medicinal products; review of scientific and practical publications. The problem of trafficking of falsified and substandard medicinal products in the Russian Federation was publicly discussed in the late 1990s - early 2000-ies, first in the media and special editions, later this phenomenon was the subject of extensive discussions at international conferences, in public authorities and public circles. However, the most significant results in tackling this problem were achieved only in the last 5 years.Thus, in 2010, the Russian Federation first joined the annual international police operation under the code name Pangaea, held since 2008 on the initiative of Interpol and the Medicines and Healthcare products Regulatory Agency of the World Health Organization (MHRA WHO). From year to year, the special operation Pangea unites the efforts of many countries from different continents and aims to eliminate transnational criminal groups operating through a global network the Internet. In 2010, as a result of large-scale international inspections 1 200 Internet sites were revealed, through which the fake medicines were spread and 10,000 boxes of medicines were seized, making more than a million falsified tablets in the amount of 2.6 million USA dollars. In 2011, in a special operation Pangea IV was attended by 165 different organizations from 81 countries

Systems Approaches: A Global and Historical Perspective on Integrative Medicine

PubMed Central

2012-01-01

The globalization of healing systems is a dance of cultural awareness and cultural dominance that has arisen throughout history. With the development of greater communication and interest in whole-systems approaches to healing, the opportunity for the development of a global perspective on healing has emerged with new life force. The birth of integrative holistic healing systems in the West, such as naturopathic, homeopathic, anthroposophic, integral and functional medicine, and others, echoes the ocean of wisdom present in traditional healing systems, such as traditional Chinese medicine (TCM) and Ayurveda. In working to integrate the lessons from these systems, we see the inextricable link between man and the natural world, we work to understand the root cause of disease, we focus on the whole person to return balance, and we use empiric observation in large populations over time to grasp the interrelationships inherent in the whole-systems view of illness and wellness. PMID:24278794

Public expenditure for plasma-derived and recombinant medicinal products in Italy.

PubMed

Lanzoni, Monica; Candura, Fabio; Calizzani, Gabriele; Biffoli, Claudia; Grazzini, Giuliano

2013-09-01

In Italy, the supply of plasma-derived medicinal products funded by the National Health Service can be through public healthcare facilities, accredited pharmacies or toll fractionation agreements between Regions and the manufacturer. Pharmaceutical public expenditure includes the supply related to the first two channels and costs can significantly vary because of channel-specific price reductions. This paper describes 2011 public expenditure for plasma-derived medicinal products purchased on the market, as well as the cost analysis per active substance. Analysis of the usage of plasma-derived medicinal products and of the related expenditure in public facilities has been carried out using medicinal product traceability data. The analysis related to the accredited pharmacies channel has been carried out using quantities for every medicinal package recorded by Pharmacy Associations and applying reference prices in force on March 1(st), 2012 as well as discounts for the accredited pharmaceutical expenditure imposed by law. At national and regional level, total and total per capita expenditures on plasma-derived medicinal products by market channel and funded by the National Health Service are shown. Analysis was conducted considering the active substances in three groups: substances included in toll fractionation agreements, recombinant coagulation factors, and other substances not included in toll fractionation agreements. In 2011, the national expenditure estimate for plasma-derived and recombinant medicinal product acquisition on the market was about € 535 million. The purchased volumes and mean purchased prices per unit of each substance have a significant influence on the observed regional variability of the pharmaceutical public expenditure. A strategy of regional comparison aimed at both sharing a national range of reference for purchase prices and evaluating modalities for centralised purchasing is desirable.

Comparison of veterinary drugs and veterinary homeopathy: part 1

PubMed Central

Lees, P.; Pelligand, L.; Whiting, M.; Chambers, D.; Toutain, P-L.; Whitehead, M. L.

2017-01-01

For many years after its invention around 1796, homeopathy was widely used in people and later in animals. Over the intervening period (1796-2016) pharmacology emerged as a science from Materia Medica (medicinal materials) to become the mainstay of veterinary therapeutics. There remains today a much smaller, but significant, use of homeopathy by veterinary surgeons. Homeopathic products are sometimes administered when conventional drug therapies have not succeeded, but are also used as alternatives to scientifically based therapies and licensed products. The principles underlying the veterinary use of drug-based and homeopathic products are polar opposites; this provides the basis for comparison between them. This two-part review compares and contrasts the two treatment forms in respect of history, constituents, methods of preparation, known or postulated mechanisms underlying responses, the legal basis for use and scientific credibility in the 21st century. Part 1 begins with a consideration of why therapeutic products actually work or appear to do so. PMID:28801498

Comparison of veterinary drugs and veterinary homeopathy: part 1.

PubMed

Lees, P; Pelligand, L; Whiting, M; Chambers, D; Toutain, P-L; Whitehead, M L

2017-08-12

For many years after its invention around 1796, homeopathy was widely used in people and later in animals. Over the intervening period (1796-2016) pharmacology emerged as a science from Materia Medica (medicinal materials) to become the mainstay of veterinary therapeutics. There remains today a much smaller, but significant, use of homeopathy by veterinary surgeons. Homeopathic products are sometimes administered when conventional drug therapies have not succeeded, but are also used as alternatives to scientifically based therapies and licensed products. The principles underlying the veterinary use of drug-based and homeopathic products are polar opposites; this provides the basis for comparison between them. This two-part review compares and contrasts the two treatment forms in respect of history, constituents, methods of preparation, known or postulated mechanisms underlying responses, the legal basis for use and scientific credibility in the 21st century. Part 1 begins with a consideration of why therapeutic products actually work or appear to do so. British Veterinary Association.

Complementary and Alternative Medicines Use during Pregnancy: A Systematic Review of Pregnant Women and Healthcare Professional Views and Experiences

PubMed Central

Pallivalappila, Abdul Rouf; Stewart, Derek; Shetty, Ashalatha; Pande, Binita; McLay, James S.

2013-01-01

Aims. To undertake a systematic review of the recent (2008–2013) primary literature, describing views and experiences of CAM use during pregnancy by women and healthcare professionals. Method. Medline, Cumulative Index to Nursing and Allied Health Literature, Cochrane Database of Systematic Review Library and Allied, and Complementary Medicine Database were searched. Studies reporting systemic CAM products (homeopathic preparations, herbal medicines, Vitamins and minerals, homeopathy, and special diets) alone or in combination with other nonsystemic CAM modalities (e.g., acupuncture) were included. Results. Database searches retrieved 2,549 citations. Removal of duplicates followed by review of titles and abstracts yielded 32 relevant studies. Twenty-two reported the perspectives of women and their CAM use during pregnancy, while 10 focused on healthcare professionals. The majority of studies had significant flaws in study design and reporting, including a lack of appropriate definitions of CAM and associated modalities, absence of detailed checklists provided to participants, the use of convenience sampling, and a general lack of scientific robustness in terms of data validity and reliability. Conclusion. To permit generalisability of study findings, there is an urgent need to expand the evidence base assessing CAMs use during pregnancy using appropriately designed studies. PMID:24194778

Treatment of Postoperative Sore Throat With the Aid of the Homeopathic Remedy Arnica montana: A Report of Two Cases

PubMed Central

Tsintzas, Dionysis; Vithoulkas, George

2017-01-01

We present 2 cases of severe postoperative sore throat, hoarseness, aphonia, and dysphagia, after a laryngeal mask insertion, who were treated successfully with the homeopathic remedy Arnica montana. Three doses of Arnica montana 200CH were given to the patients over 36 hours. Although the symptoms were very intense, the remedy was very effective and cleared most of the symptoms in 48 hours. PMID:29228804

M1 homeopathic complex trigger effective responses against Leishmania (L) amazonensis in vivo and in vitro.

PubMed

Nascimento, Katia Fialho; de Santana, Fabiana Rodrigues; da Costa, Cleber Rafael Vieira; Kaplum, Vanessa; Volpato, Helito; Nakamura, Celso Vaturo; Bonamin, Leoni Villano; de Freitas Buchi, Dorly

2017-11-01

Leishmaniasis is a term referring to a range of clinical conditions caused by protozoan parasites of the genus Leishmania, Trypanosomatidae family, Kinetoplastida order that is transmitted by the bite of certain species of mosquitoes Phlebotominae subfamily. These parasites infect hosts wild and domestic mammals, considered as natural reservoirs and can also infect humans. Leishmania are obligate intramacrophage protozoa that have exclusively intracellular life style. This suggests that the amastigotes possess mechanisms to avoid killing by host cells. Cutaneous leishmaniasis, the most common form of the disease, causes ulcers on exposed parts of the body, leading to disfigurement, permanent scars, and stigma and in some cases disability. Many studies concluded that the cytokines profile and immune system of host have fundamental role in humans and animals natural self-healing. Conventional treatments are far from ideals and the search for new therapeutic alternatives is considered a strategic priority line of research by the World Health Organization. A promising approach in the field of basic research in homeopathy is the treatment of experimental infections with homeopathic drugs prepared from natural substances associations highly diluted, which comprise a combination of several different compounds considered as useful for a symptom or disease. Therefore, this study aimed to evaluate the effect of M1, a complex homeopathic product, in macrophage-Leishmania interaction in vitro and in vivo. It was used RAW cells lineage and BALB/c mice as a host for the promastigotes of L. amazonensis (WHOM/BR/75/Josefa). Several biochemical and morphological parameters were determined. Together, the harmonic results obtained in this study indicate that, in general, the highly diluted products trigger rapid and effective responses by living organisms, cells and mice, against Leishmania, by altering cytokines profile, by NO increasing (p<0.05), by decreasing parasitic load (p<0

75 FR 65293 - Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-22

...] Draft Guidelines on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for... Requirements for the Registration of Veterinary Medicinal Products (VICH) has developed a draft guideline titled ``Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data...

High sensitivity 1H-NMR spectroscopy of homeopathic remedies made in water

PubMed Central

Anick, David J

2004-01-01

Background The efficacy of homeopathy is controversial. Homeopathic remedies are made via iterated shaking and dilution, in ethanol or in water, from a starting substance. Remedies of potency 12 C or higher are ultra-dilute (UD), i.e. contain zero molecules of the starting material. Various hypotheses have been advanced to explain how a UD remedy might be different from unprepared solvent. One such hypothesis posits that a remedy contains stable clusters, i.e. localized regions where one or more hydrogen bonds remain fixed on a long time scale. High sensitivity proton nuclear magnetic resonance spectroscopy has not previously been used to look for evidence of differences between UD remedies and controls. Methods Homeopathic remedies made in water were studied via high sensitivity proton nuclear magnetic resonance spectroscopy. A total of 57 remedy samples representing six starting materials and spanning a variety of potencies from 6 C to 10 M were tested along with 46 controls. Results By presaturating on the water peak, signals could be reliably detected that represented H-containing species at concentrations as low as 5 μM. There were 35 positions where a discrete signal was seen in one or more of the 103 spectra, which should theoretically have been absent from the spectrum of pure water. Of these 35, fifteen were identified as machine-generated artifacts, eight were identified as trace levels of organic contaminants, and twelve were unexplained. Of the unexplained signals, six were seen in just one spectrum each. None of the artifacts or unexplained signals occurred more frequently in remedies than in controls, using a p < .05 cutoff. Some commercially prepared samples were found to contain traces of one or more of these small organic molecules: ethanol, acetate, formate, methanol, and acetone. Conclusion No discrete signals suggesting a difference between remedies and controls were seen, via high sensitivity 1H-NMR spectroscopy. The results failed to support

A short history of the development of homeopathy in India.

PubMed

Ghosh, Ajoy Kumar

2010-04-01

Homeopathy was introduced in India the early 19th century. It flourished in Bengal at first, and then spread all over India. In the beginning, the system was extensively practised by amateurs in the civil and military services and others. Mahendra Lal Sircar was the first Indian who became a homeopathic physician. A number of allopathic doctors started homeopathic practice following Sircar's lead. The 'Calcutta Homeopathic Medical College', the first homeopathic medical college was established in 1881. This institution took on a major role in popularising homeopathy in India. In 1973, the Government of India recognised homeopathy as one of the national systems of medicine and set up the Central Council of Homeopathy (CCH) to regulate its education and practice. Now, only qualified registered homeopaths can practice homeopathy in India. At present, in India, homeopathy is the third most popular method of medical treatment after allopathy and Ayurveda. There are over 200,000 registered homeopathic doctors currently, with approximately 12,000 more being added every year.

Homeopathic Treatment of Overweight and Obesity in Pregnant Women With Mental Disorders: A Double-blind, Controlled Clinical Trial.

PubMed

Vilhena, Edgard Costa de; Castilho, Euclides Ayres de

2016-10-01

Context • Worldwide, 35 million people suffer from obesity. Mental disorders have been associated with being overweight or obese. Considerable evidence has shown a correlation between stress and the use of homeopathy and stress and obesity. However, few studies have examined the relationship between weight loss and homeopathic treatment of obesity. Objective • The study intended to evaluate the efficacy of a homeopathic treatment in preventing excessive weight gain during pregnancy in overweight or obese women who were suspected of having a common mental disorder. Design • The study was a randomized, controlled, double-blinded clinical trial. Setting • The study took place at the Center for the Social Support of Motherhood (São Paulo, Brazil). Participants • Participants were pregnant women who were enrolled at the center. Intervention • For the homeopathic group, 9 drugs were preselected, including (1) Pulsatilla nigricans, (2) Sepia succus, (3) Lycopodium clavatum, (4) sulphur, (5) Lachesis trigonocephalus, (6) Nux vomica, (7) Calcarea carbonica, (8) phosphorus; and (9) Conium maculatum. From those 9 drugs, 1 was prioritized for administration for each participant. After the first appointment, a reselection or selection of a new, more appropriate drug occurred, using the list of preselected drugs. The dosage was 6 drops orally 2 ×/d, in the morning and at night, on 4 consecutive days each wk, with an interval of 3 d between doses, up until the next appointment medical appointment. The control group received the equivalent placebo drug. Both groups also received a diet orientation. Outcome Measures • We evaluated pregnant women who were overweight or had class 1 or 2 obesity and were suspected of having a common mental disorder, with no concomitant diseases, in 2 groups: those receiving a placebo (control group, n = 72); and those receiving homeopathic treatment (homeopathy group, n = 62). Weight change during pregnancy was defined as the

Effect of homeopathic preparations of Syzygium jambolanum and Cephalandra indica on gastrocnemius muscle of high fat and high fructose-induced type-2 diabetic rats.

PubMed

Sampath, Sathish; Narasimhan, Akilavalli; Chinta, Raveendar; Nair, K R Janardanan; Khurana, Anil; Nayak, Debadatta; Kumar, Alok; Karundevi, Balasubramanian

2013-07-01

Homeopathy is a holistic method of treatment that uses microdoses of natural substances originating from plants, minerals, or animal parts. Syzygium jambolanum and Cephalandra indica are used in homeopathy for treatment of type-2 diabetes. However, the molecular mechanisms responsible for such effects are not known. Homeopathic preparations of S. jambolanum and C. indica in mother tincture, 6c and 30c were used to examine the molecular mechanism of antidiabetic effects in the skeletal muscle of rats with high fat and fructose-induced type-2 diabetes mellitus. After 30 days treatment, fasting blood glucose, serum insulin and insulin signaling molecules in the skeletal muscle (gastrocnemius) were measured. Diabetic rats showed a significant decrease in serum insulin and lipid profile as well as low levels of insulin receptor (IR), v-akt murine thymoma viral oncogene homolog (Akt), p-Akt(ser473) and glucose transporter-4 (GLUT4) protein expression (p < 0.05) with a significant increase in fasting blood glucose level (p < 0.05) compared to the control group. Treatment with homeopathic remedies significantly increased the serum insulin and expression of these proteins (p < 0.05) with a significant decrease in fasting blood glucose (p < 0.05) compared to diabetic rats. In the present study homeopathic preparations of S. jambolanum and C. indica, including ultramolecular dilutions exhibit antidiabetic effects, improving insulin action through activation of insulin signaling molecules in skeletal muscle of type-2 diabetic rats. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Products Successfully to the Market - Report from the CAT-DGTI-GSCN Workshop at the DGTI Annual Meeting 2014.

PubMed

Celis, Patrick; Ferry, Nicolas; Hystad, Marit; Schüßler-Lenz, Martina; Doevendans, Pieter A; Flory, Egbert; Beuneu, Claire; Reischl, Ilona; Salmikangas, Paula

2015-05-01

On September 11, 2014, a workshop entitled 'Advanced Therapy Medicinal Products: How to Bring Cell-Based Medicinal Product Successfully to the Market' was held at the 47th annual meeting of the German Society for Transfusion Medicine and Immunohematology (DGTI), co-organised by the European Medicines Agency (EMA) and the DGTI in collaboration with the German Stem Cell Network (GSCN). The workshop brought together over 160 participants from academia, hospitals, small- or medium-sized enterprise developers and regulators. At the workshop, speakers from EMA, the Committee for Advanced Therapies (CAT), industry and academia addressed the regulatory aspects of development and authorisation of advanced therapy medicinal products (ATMPs), classification of ATMPs and considerations on cell-based therapies for cardiac repair. The open forum discussion session allowed for a direct interaction between ATMP developers and the speakers from EMA and CAT.

Cameroonian Medicinal Plants: Pharmacology and Derived Natural Products

PubMed Central

Kuete, Victor; Efferth, Thomas

2010-01-01

Many developing countries including Cameroon have mortality patterns that reflect high levels of infectious diseases and the risk of death during pregnancy and childbirth, in addition to cancers, cardiovascular diseases and chronic respiratory diseases that account for most deaths in the developed world. Several medicinal plants are used traditionally for their treatment. In this review, plants used in Cameroonian traditional medicine with evidence for the activities of their crude extracts and/or derived products have been discussed. A considerable number of plant extracts and isolated compounds possess significant antimicrobial, anti-parasitic including antimalarial, anti-proliferative, anti-inflammatory, anti-diabetes, and antioxidant effects. Most of the biologically active compounds belong to terpenoids, phenolics, and alkaloids. Terpenoids from Cameroonian plants showed best activities as anti-parasitic, but rather poor antimicrobial effects. The best antimicrobial, anti-proliferative, and antioxidant compounds were phenolics. In conclusion, many medicinal plants traditionally used in Cameroon to treat various ailments displayed good activities in vitro. This explains the endeavor of Cameroonian research institutes in drug discovery from indigenous medicinal plants. However, much work is still to be done to standardize methodologies and to study the mechanisms of action of isolated natural products. PMID:21833168

Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial.

PubMed

Macías-Cortés, Emma del Carmen; Aguilar-Faisal, Leopoldo; Asbun-Bojalil, Juan

2013-04-23

The perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depressive symptoms. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression. In classical homeopathy, an individually selected homeopathic remedy is prescribed after a complete case history of the patient. The aim of this study is to assess the efficacy and safety of the homeopathic individualized treatment versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. A randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a six-week follow-up study was designed. The study will be conducted in a public research hospital in Mexico City (Juárez de México Hospital) in the outpatient service of homeopathy. One hundred eighty nine peri- and postmenopausal women diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (moderate to severe intensity) will be included. The primary outcome is change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression after the fourth and sixth week of treatment. Secondary outcomes are: Beck Depression Inventory change in mean score, Greene's Scale change in mean score, response and remission rates and safety. Efficacy data will be analyzed in the intention-to-treat population. To determine differences in the primary and secondary outcomes among groups at baseline and weeks four and six, data will be analyzed by analysis of variance for independent measures with the Bonferroni post-hoc test. This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic individualized treatment using C-potencies versus placebo or

Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial

PubMed Central

2013-01-01

Background The perimenopausal period refers to the interval when women’s menstrual cycles become irregular and is characterized by an increased risk of depressive symptoms. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression. In classical homeopathy, an individually selected homeopathic remedy is prescribed after a complete case history of the patient. The aim of this study is to assess the efficacy and safety of the homeopathic individualized treatment versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. Methods/design A randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a six-week follow-up study was designed. The study will be conducted in a public research hospital in Mexico City (Juárez de México Hospital) in the outpatient service of homeopathy. One hundred eighty nine peri- and postmenopausal women diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (moderate to severe intensity) will be included. The primary outcome is change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression after the fourth and sixth week of treatment. Secondary outcomes are: Beck Depression Inventory change in mean score, Greene’s Scale change in mean score, response and remission rates and safety. Efficacy data will be analyzed in the intention-to-treat population. To determine differences in the primary and secondary outcomes among groups at baseline and weeks four and six, data will be analyzed by analysis of variance for independent measures with the Bonferroni post-hoc test. Discussion This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic individualized treatment

Is Patent “Evergreening” Restricting Access to Medicine/Device Combination Products?

PubMed Central

Beall, Reed F.; Nickerson, Jason W.; Kaplan, Warren A.; Attaran, Amir

2016-01-01

Background Not all new drug products are truly new. Some are the result of marginal innovation and incremental patenting of existing products, but in such a way that confers no major therapeutic improvement. This phenomenon, pejoratively known as “evergreening”, can allow manufacturers to preserve market exclusivity, but without significantly bettering the standard of care. Other studies speculate that evergreening is especially problematic for medicine/device combination products, because patents on the device component may outlast expired patents on the medicine component, and thereby keep competing, possibly less-expensive generic products off the market. Materials and Methods We focused on four common conditions that are often treated by medicine/device product combinations: asthma and chronic obstructive pulmonary disease (COPD), diabetes, and severe allergic reactions. The patent data for a sample of such products (n = 49) for treating these conditions was extracted from the United States Food and Drug Administration’s Orange Book. Additional patent-related data (abstracts, claims, etc) were retrieved using LexisNexis TotalPatent. Comparisons were then made between each product’s device patents and medicine patents. Results Unexpired device patents exist for 90 percent of the 49 medicine/device product combinations studied, and were the only sort of unexpired patent for 14 products. Overall, 55 percent of the 235 patents found by our study were device patents. Comparing the last-to-expire device patent to that of the last-to-expire active ingredient patent, the median additional years of patent protection afforded by device patents was 4.7 years (range: 1.3–15.2 years). Conclusion Incremental, patentable innovation in devices to extend the overall patent protection of medicine/device product combinations is very common. Whether this constitutes “evergreening” depends on whether these incremental innovations and the years of extra patent

Readability assessment of package inserts of biological medicinal products from the European medicines agency website.

PubMed

Piñero-López, Ma Ángeles; Modamio, Pilar; Lastra, Cecilia F; Mariño, Eduardo L

2014-07-01

Package inserts that accompany medicines are a common source of information aimed at patients and should match patient abilities in terms of readability. Our objective was to determine the degree of readability of the package inserts for biological medicinal products commercially available in 2007 and compare them with the readability of the same package inserts in 2010. A total of 33 package inserts were selected and classified into five groups according to the type of medicine: monoclonal antibody-based products, cytokines, therapeutic enzymes, recombinant blood factors and other blood-related products, and recombinant hormones. The package inserts were downloaded from the European Medicines Agency website in 2007 and 2010. Readability was evaluated for the entire text of five of the six sections of the package inserts and for the 'Annex' when there was one. Three readability formulas were used: SMOG (Simple Measure of Gobbledygook) grade, Flesh-Kincaid grade level, and Szigriszt's perspicuity index. No significant differences were found between the readability results for the 2007 package inserts and those from 2010 according to any of the three readability indices studied (p>0.05). However, there were significant differences (p<0.05) between the readability scores of the sections of the package inserts in both 2007 and 2010. The readability of the package inserts was above the recommended sixth grade reading level (ages 11-12) and may lead to difficulties of understanding for people with limited literacy. All the sections should be easy to read and, therefore, the readability of the medicine package inserts studied should be improved.

Homeopathy in the treatment of tubercular lymphadenitis (TBLN)--an Indian experience.

PubMed

Chand, S Kusum; Manchanda, R K; Batra, Sudhir; Mittal, Renu

2011-07-01

Tuberculosis (TB) has been known since antiquity. In spite of effective antibiotic treatment, it is still a major worldwide public health problem. Endogenous factors are important in the development of active disease. Homeopathic medicines have the potential for immune-modulation and hence to influence endogenous factors in disease. In India, patients with tubercular lymphadenitis (TBLN) often consult homeopaths but such cases are seldom documented. The objective of the present study is to document such experience. A retrospective exploratory study of 25 positively diagnosed cases of TBLN has lead to the development of a homeopathic regime consisting of a patient specific constitutional medicine, one disease specific biotherapy (Tuberculinum) and Silicea 6x as supportive medicine. Homeopathy can be used as a complement to conventional anti tubercular treatment (ATT) with beneficial results. Further validation in controlled trials with immunological markers is required. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

[Application of risk-based approach for determination of critical factors in technology transfer of production of medicinal products].

PubMed

Beregovykh, V V; Spitskiy, O R

2014-01-01

Risk-based approach is used for examination of impact of different factors on quality of medicinal products in technology transfer. A general diagram is offered for risk analysis execution in technology transfer from pharmaceutical development to production. When transferring technology to full- scale commercial production it is necessary to investigate and simulate production process application beforehand in new real conditions. The manufacturing process is the core factorfor risk analysis having the most impact on quality attributes of a medicinal product. Further importantfactors are linked to materials and products to be handled and manufacturing environmental conditions such as premises, equipment and personnel. Usage of risk-based approach in designing of multipurpose production facility of medicinal products is shown where quantitative risk analysis tool RAMM (Risk Analysis and Mitigation Matrix) was applied.

Complementary and alternative medicine for pediatric otitis media.

PubMed

Levi, Jessica R; Brody, Robert M; McKee-Cole, Katie; Pribitkin, Edmund; O'Reilly, Robert

2013-06-01

To review the literature involving complementary and alternative medicine (CAM) for pediatric otitis media. Multiple modalities are discussed, including prevention involving breastfeeding, nutrition, and vaccination; symptomatic treatment involving homeopathy, natural health products, and probiotics; manual manipulations involving osteopathy and chiropractics; and traditional Chinese and Japanese medicine. The information presented will assist physicians in advising patients on their decision-making during the early stages of otitis media when antibiotics and surgery are not yet indicated. A systematic literature search was conducted through January 2012 in PubMed using MESH term "otitis media" in conjunction with "complementary therapies," "homeopathy," "manipulation, osteopathic," "manipulation, chiropractic," "acupuncture therapy," "probiotics," "naturopathy," and "xylitol." Theses searches yielded 163 unique results. Abstracts and titles were evaluated for relevance. Case reports, case series, randomized controlled trials, and basic science research were included. Publications not relevant to the discussion of alternative medicine in otitis media were excluded. Bibliographies were checked for further publications. Thirty-six unique publications were reviewed. Of all therapies in complementary and alternative medicine, only xylitol has been studied in well-designed, randomized, blinded trials; it is likely effective, but compliance limits its applicability. Management of acute otitis media begins with watchful waiting. Herbal eardrops may help relieve symptoms. Homeopathic treatments may help decrease pain and lead to faster resolution. Prevention should be emphasized with elimination of risk factors, such as second hand smoke and bottle-feeding, as well as maintaining nutrition and vaccinations. Vitamin supplementation may be helpful. Probiotics and xylitol may be beneficial as well. Traditional Chinese/Japanese therapies show promising results but remain

Like cures like: a neuroimmunological model based on electromagnetic resonance.

PubMed

Shahabi, Shahram; Kasariyans, Aditya; Noorbakhsh, Farshid

2013-12-01

Recent investigations have pointed to the production of characteristic electromagnetic (EM) waves in highly diluted sterile filtrates of different microorganisms and their associated DNA molecules. Analysis of these diluted solutions that are prepared using methods almost identical to the way that homeopathic medicines are prepared has pointed to the existence of nanostructures capable of emitting EM waves. Combining these results with findings that point to the interaction of EM waves with sensory nerves with subsequent activation of homeostatic efferent pathways, we propose a model to describe mechanisms underlying the effects of homeopathic remedies. THE MODEL: Living cells and tissues are capable of generating EM waves in their physiological conditions. When a cell deviates from its physiological state, in addition to normal EM emissions, it starts to produce EM waves with altered characteristics. According to our model, the main cause of the therapeutic effects of homeopathic remedies is the occurrence of resonance between the non-physiological EM waves of the patient and extremely low-frequency EM waves produced by nanostructures present in the homeopathic remedy. Resonance occurs if the frequency and amplitude characteristics of the patient's non-physiological EM waves and those produced by nanostructures of the applied homeopathic remedy are similar. Once resonance occurs, stimulation of the patient's sensory neurons, which are sensitized due to inflammation of any origin, leads to triggering of different regulatory mechanisms, including the activation of descending antinociceptive and/or cholinergic anti-inflammatory pathways, which leads to the restoration of homeostasis.

The legal framework governing the quality of (traditional) herbal medicinal products in the European Union.

PubMed

Kroes, Burt H

2014-12-02

In the European Union a complex regulatory framework is in place for the regulation of (traditional) herbal medicinal products. It is based on the principle that a marketing authorisation granted by the competent authorities is required for placing medicinal products on the market. The requirements and procedures for acquiring such a marketing authorisation are laid down in regulations, directives and scientific guidelines. This paper gives an overview of the quality requirements for (traditional) herbal medicinal products that are contained in European pharmaceutical legislation. Pharmaceutical quality of medicinal product is the basis for ensuring safe and effective medicines. The basic principles governing the assurance of the quality of medicinal products in the European Union are primarily defined in the amended Directive 2001/83/EC and Directive 2003/63/EC. Quality requirements of herbal medicinal products are also laid down in scientific guidelines. Scientific guidelines provide a basis for practical harmonisation of how the competent authorities of EU Member States interpret and apply the detailed requirements for the demonstration of quality laid down in regulations and directives. Detailed quality requirements for herbal medicinal products on the European market are contained in European Union (EU) pharmaceutical legislation. They include a system of manufacturing authorisations which ensures that all herbal medicinal products on the European market are manufactured/imported only by authorised manufacturers, whose activities are regularly inspected by the competent authorities. Additionally, as starting materials only active substances are allowed which have been manufactured in accordance with the GMP for starting materials as adopted by the Community. The European regulatory framework encompasses specific requirements for herbal medicinal products. These requirements are independent from the legal status. Thus, the same quality standards equally apply

Effects of the homeopathic remedy arnica on attenuating symptoms of exercise-induced muscle soreness

PubMed Central

Plezbert, Julie A.; Burke, Jeanmarie R.

2005-01-01

Abstract Objective To evaluate the clinical efficacy of Arnica at a high potency (200c), on moderating delayed onset muscle soreness and accompanying symptoms of muscle dysfunction. Methods Twenty subjects completed a maximal eccentric exercise protocol with the non-dominate elbow flexors to induce delayed onset muscle soreness. Either Arnica or placebo tablets were administered in a random, double- blinded fashion immediately after exercise and at 24 hours and 72 hours after exercise. Before exercise, immediately post-exercise, and at 24, 48, 72, and 96 hours post-exercise, assessments of delayed onset muscle soreness and muscle function included: 1) muscle soreness and functional impairment; 2) maximum voluntary contraction torque; 3) muscle swelling; and 4) range of motion tests to document spontaneous muscle shortening and muscle shortening ability. Blood samples drawn before exercise and at 24, 48, and 96 hours after exercise were used to measure muscle enzymes as indirect indices of muscle damage. Results Regardless of the intervention, the extent of delayed onset muscle soreness and elevations in muscle enzymes were similar on the days following the eccentric exercise protocol. The post-exercise time profiles of decreases in maximum voluntary contraction torque and muscle shortening ability and increases in muscle swelling and spontaneous muscle shortening were similar for each treatment intervention. Conclusions The results of this study did not substantiate the clinical efficacy of Arnica at a high potency on moderating delayed onset muscle soreness and accompanying symptoms of muscle dysfunction. Despite the findings of this study, future investigations on the clinical efficacy of homeopathic interventions should consider incorporating research strategies that emphasize differential therapeutics for each patient rather than treating a specific disease or symptom complex, such as DOMS, with a single homeopathic remedy. PMID:19674657

Community pharmacist's responsibilities with regards to traditional medicine/complementary medicine products: A systematic literature review.

PubMed

Ung, Carolina Oi Lam; Harnett, Joanna; Hu, Hao

The use of Traditional Medicine/Complementary Medicine (TM/CM) products has gained popularity in many countries. There is a growing body of evidence to support that concomitant use of TM/CM products with certain pharmaceutical medicines may adversely affect treatment outcomes. There is a general consensus that pharmacists have a role to play in the safe and appropriate use of these products. However, the extent of their involvement and responsibilities are not yet defined. Clear guidelines that inform their duty of care are essential for pharmacists to establish their role in the management of TM/CM product use. The purpose of this study was to determine pharmacist's responsibilities with regards to TM/CM products that have been discussed in the literature since 2000. A literature search in 3 electronic databases (Web of Science, Science Direct and PubMed) was used to extract publications from 2000 to 2015 that related pharmacist to TM/CM products. Out of the 2859 publications extracted for abstract review, 171 documents were selected for full text assessment. 41 publications which reported findings from exploratory studies or discussed pharmacists' responsibilities towards TM/CM products were selected for inclusion in this study. Seven major responsibilities were frequently discussed in the literature: (1) to acknowledge the use; (2) to be knowledgeable about the TM/CM products; (3) to ensure safe use of TM/CM products; (4) to document the use of TM/CM products; (5) to report ADRs related to TM/CM products; (6) to educate about TM/CM products; and (7) to collaborate with other health care professionals. Various forms and levels of pharmacists' responsibilities with TM/CM products have been mentioned in the literature. Subsequent work towards a common consensus must take into account three influential factors strategically: the scope of TM/CM products, objectives of pharmacists' involvement and the perspectives of key stakeholders. Copyright © 2016 Elsevier Inc

Spontaneously Reported Adverse Reactions for Herbal Medicinal Products and Natural Remedies in Sweden 2007-15: Report from the Medical Products Agency.

PubMed

Svedlund, Erika; Larsson, Maria; Hägerkvist, Robert

2017-06-01

In relation to the extensive use of herbal medicinal products in self-care, the safety information is limited and there is a need for improvement. This study describes spontaneously reported adverse reactions related to herbal medicinal products and natural remedies in Sweden. To evaluate the characteristics and frequency of adverse events recorded by the Swedish Medical Products Agency, where herbal medicinal products and natural remedies were suspected as causative agents. Adverse drug reactions reported to the Swedish Medical Product Agency during 2007-15 related to approved herbal medicinal products or natural remedies were included and analysed in the retrospective study. Reports had been assessed for causality when they were lodged and only reports that had been assessed as at least possible were included in the study. In total, 116 reports (concerning 259 adverse reactions) related to herbal medicinal products or natural remedies were found in the Swedish national pharmacovigilance database. The active ingredients most frequently suspected during the study period were black cohosh rhizome (15 reports), purple coneflower herb (14 reports) and a combination of extracts of pollen (13 reports). Adverse reactions related to skin and subcutaneous tissue were the most commonly reported reactions. No previously unknown safety problems have been discovered in the present study. This finding could be explained by a thorough pre-approval assessment of medicinal products and the fact that most herbal preparations in medicinal products have been in clinical use for many years (for traditional herbal medicinal products, the requirements are ≥30 years), i.e. adverse reactions are acknowledged and assessed before approval.

Selected non-timber forest products with medicinal applications from Jilin Province in China

Treesearch

Yao Ge Huang; Branka Barl; Gerald Ivanochko

2001-01-01

This paper provides a brief account of the distribution, production, and use of some non-timber forest products such as medicinal plants, medicinal and nutraceutical mushrooms, pharmaceutical insects, and "wild" vegetables in Jilin Province, China. All materials featured in this paper are used in Traditional Chinese Medicine (TCM) inside and outside of China...

Homeopathy ‘for Mexicans’: Medical Popularisation, Commercial Endeavours, and Patients’ Choice in the Mexican Medical Marketplace, 1853–1872

PubMed Central

Hernández Berrones, Jethro

2017-01-01

This paper focuses on homeopaths’ strategies to popularise homeopathy from 1850 to 1870. I argue that homeopaths created a space for homeopathy in Mexico City in the mid-nineteenth century by facilitating patients’ access to medical knowledge, consultation and practice. In this period, when national and international armed conflicts limited the diffusion and regulation of academic medicine, homeopaths popularised homeopathy by framing it as a life-enhancing therapy with tools that responded to patients’ needs. Patients’ preference for homeopathy evolved into commercial endeavours that promoted the practice of homeopathy through the use of domestic manuals. Using rare publications and archival records, I analyse the popularisation of homeopathy in Ramón Comellas’s homeopathic manual, the commercialisation of Julián González’s family guides, and patients’ and doctors’ reception of homeopathy. I show that narratives of conversion to homeopathy relied on the different experiences of patients and trained doctors, and that patients’ positive experience with homeopathy weighed more than the doctors’ efforts to explain to the public how academic medicine worked. The fact that homeopaths and patients used a shared language to describe disease experiences framed the possibility of a horizontal transmission of medical knowledge, opening up the possibility for patients to become practitioners. By relying on the long tradition of domestic medicine in Mexico, the popularisation of homeopathy disrupted the professional boundaries that academic physicians had begun to build, making homeopaths the largest group that challenged the emergent medical academic culture and its diffusion in Mexico in the nineteenth century. PMID:28901873

Top-10 list of herbal and supplemental medicines used by cosmetic patients: what the plastic surgeon needs to know.

PubMed

Heller, Justin; Gabbay, Joubin S; Ghadjar, Kiu; Jourabchi, Mickel; O'Hara, Catherine; Heller, Misha; Bradley, James P

2006-02-01

Widespread use of herbal medications/supplements among the presurgical population may have a negative effect on perioperative patient care. Thus, the authors' goal was to identify the prevalence of such use in a cosmetic surgery patient population compared with use among the general public; to assess physician awareness of proper management of these herbal medications/supplements; and to review the literature to provide rational strategies for managing perioperative patients taking these remedies. To assess patient (n = 100) and general public (n = 100) usage rates, open-ended lists of (1) the most common herbal medications/supplements and (2) homeopathic treatments were compiled. Board-certified plastic surgeons (n = 20) were then given the same list of herbs/supplements and surveyed on their awareness of these treatments and perioperative side effects. The usage rate for cosmetic versus public surveys for herbal medicines/supplements was 55 percent versus 24 percent (p < 0.001), with 35 percent versus 8 percent (p < 0.001) engaging in homeopathic practices, respectively. Cosmetic patients' top four herbal/supplements of usage were chondroitin (18 percent), ephedra (18 percent), echinacea (14 percent), and glucosamine (10 percent). The top four used by the general public were echinacea (8 percent), garlic (6 percent), ginseng (4 percent), and ginger (4 percent). The physician survey demonstrated awareness of 54 percent of the listed supplements/herbal medicines, 85 percent of which were not suggested to be discontinued preoperatively, with only ephedra achieving 100 percent physician discontinuation preoperatively. Herbal medicines and supplements displayed greater prevalence in the cosmetic surgery population than in the population at large. Furthermore, side effects and potential complications warrant addressing these remedies as pharmaceuticals rather than as safe and "natural." Thus, a descriptive "top-10" list with perioperative recommendations was compiled

Recent Advances in Developing Insect Natural Products as Potential Modern Day Medicines

PubMed Central

Ratcliffe, Norman; Azambuja, Patricia; Mello, Cicero Brasileiro

2014-01-01

Except for honey as food, and silk for clothing and pollination of plants, people give little thought to the benefits of insects in their lives. This overview briefly describes significant recent advances in developing insect natural products as potential new medicinal drugs. This is an exciting and rapidly expanding new field since insects are hugely variable and have utilised an enormous range of natural products to survive environmental perturbations for 100s of millions of years. There is thus a treasure chest of untapped resources waiting to be discovered. Insects products, such as silk and honey, have already been utilised for thousands of years, and extracts of insects have been produced for use in Folk Medicine around the world, but only with the development of modern molecular and biochemical techniques has it become feasible to manipulate and bioengineer insect natural products into modern medicines. Utilising knowledge gleaned from Insect Folk Medicines, this review describes modern research into bioengineering honey and venom from bees, silk, cantharidin, antimicrobial peptides, and maggot secretions and anticoagulants from blood-sucking insects into medicines. Problems and solutions encountered in these endeavours are described and indicate that the future is bright for new insect derived pharmaceuticals treatments and medicines. PMID:24883072

A homeopathic remedy from arnica, marigold, St. John's wort and comfrey accelerates in vitro wound scratch closure of NIH 3T3 fibroblasts.

PubMed

Hostanska, Katarina; Rostock, Matthias; Melzer, Joerg; Baumgartner, Stephan; Saller, Reinhard

2012-07-18

Drugs of plant origin such as Arnica montana, Calendula officinalis or Hypericum perforatum have been frequently used to promote wound healing. While their effect on wound healing using preparations at pharmacological concentrations was supported by several in vitro and clinical studies, investigations of herbal homeopathic remedies on wound healing process are rare. The objective of this study was to investigate the effect of a commercial low potency homeopathic remedy Similasan® Arnica plus Spray on wound closure in a controlled, blind trial in vitro. We investigated the effect of an ethanolic preparation composed of equal parts of Arnica montana 4x, Calendula officinalis 4x, Hypericum perforatum 4x and Symphytum officinale 6x (0712-2), its succussed hydroalcoholic solvent (0712-1) and unsuccussed solvent (0712-3) on NIH 3T3 fibroblasts. Cell viability was determined by WST-1 assay, cell growth using BrdU uptake, cell migration by chemotaxis assay and wound closure by CytoSelect ™Wound Healing Assay Kit which generated a defined "wound field". All assays were performed in three independent controlled experiments. None of the three substances affected cell viability and none showed a stimulating effect on cell proliferation. Preparation (0712-2) exerted a stimulating effect on fibroblast migration (31.9%) vs 14.7% with succussed solvent (0712-1) at 1:100 dilutions (p < 0.001). Unsuccussed solvent (0712-3) had no influence on cell migration (6.3%; p > 0.05). Preparation (0712-2) at a dilution of 1:100 promoted in vitro wound closure by 59.5% and differed significantly (p < 0.001) from succussed solvent (0712-1), which caused 22.1% wound closure. Results of this study showed that the low potency homeopathic remedy (0712-2) exerted in vitro wound closure potential in NIH 3T3 fibroblasts. This effect resulted from stimulation of fibroblasts motility rather than of their mitosis.

Effectiveness of the homeopathic preparation Zeel compared with carprofen in dogs with osteoarthritis.

PubMed

Neumann, Stephan; Stolt, Pelle; Braun, Gabriele; Hellmann, Klaus; Reinhart, Erich

2011-01-01

The authors compared the symptomatic effectiveness of a complex homeopathic preparation Zeel (1-3 tablets orally per day depending on body weight) to carprofen (4 mg/kg body weight) in dogs (n=68) aged >1 yr diagnosed with osteoarthritis in a multicenter, prospective, observational open-label cohort study in 12 German veterinary clinics. The active treatment period was 56 days. Symptomatic effectiveness, lameness, stiffness of movements, and pain on palpation were evaluated by treating veterinarians and owners. Clinical signs of osteoarthritis improved significantly (P<0.05) at all time points (days 1, 28, and 56) with both therapies. At the end of the treatment period, effectiveness was comparable in both groups. Both treatment regimens were well tolerated with only three treatment-related adverse events, all in the carprofen group.

Sustainable Utilization of Traditional Chinese Medicine Resources: Systematic Evaluation on Different Production Modes

PubMed Central

Li, Xiwen; Chen, Yuning; Yang, Qing; Wang, Yitao

2015-01-01

The usage amount of medicinal plant rapidly increased along with the development of traditional Chinese medicine industry. The higher market demand and the shortage of wild herbal resources enforce us to carry out large-scale introduction and cultivation. Herbal cultivation can ease current contradiction between medicinal resources supply and demand while they bring new problems such as pesticide residues and plant disease and pests. Researchers have recently placed high hopes on the application of natural fostering, a new method incorporated herbal production and diversity protecting practically, which can solve the problems brought by artificial cultivation. However no modes can solve all problems existing in current herbal production. This study evaluated different production modes including cultivation, natural fostering, and wild collection to guide the traditional Chinese medicine production for sustainable utilization of herbal resources. PMID:26074987

Antiviral Natural Products and Herbal Medicines

PubMed Central

Lin, Liang-Tzung; Hsu, Wen-Chan; Lin, Chun-Ching

2014-01-01

Viral infections play an important role in human diseases, and recent outbreaks in the advent of globalization and ease of travel have underscored their prevention as a critical issue in safeguarding public health. Despite the progress made in immunization and drug development, many viruses lack preventive vaccines and efficient antiviral therapies, which are often beset by the generation of viral escape mutants. Thus, identifying novel antiviral drugs is of critical importance and natural products are an excellent source for such discoveries. In this mini-review, we summarize the antiviral effects reported for several natural products and herbal medicines. PMID:24872930

Inhibition of peripheral blood neutrophil oxidative burst in periodontitis patients with a homeopathic medication Traumeel S

PubMed Central

žilinskas, Juozas; žekonis, Jonas; žekonis, Gediminas; Šadzevičienė, Renata; Sapragonienė, Marija; Navickaitė, Justina; Barzdžiukaitė, Ingrida

2011-01-01

Summary Background The anti-inflammatory effects of a homeopathic remedy, Traumeel S, have been observed in experimental and clinical studies; however, its antioxidant properties have not been elucidated. The aim of the present study was to evaluate the antioxidant effects of Traumeel S on peripheral blood neutrophils in patients with periodontitis. Material/Methods The study was performed using venous blood of 22 individuals with chronic periodontitis and 21 healthy subjects. The antioxidant effects of Traumeel S on the production of reactive oxygen species by unstimulated and stimulated with unopsonized E. coli neutrophils were investigated using luminol- and lucigenin-dependent chemiluminescence (CL). Results Polymorphonuclear leukocytes of periodontitis patients produced higher levels (p<0.01) of light output of lucigenin-dependent chemiluminescence and significantly reduced (p<0.01) light output of luminol-dependent chemiluminescence than analogous cells of healthy subjects. Highly diluted (10−4 of the stem solution) Traumeel S significantly (by approximately 50%) reduced superoxide-induced oxidation of lucigenin by unstimulated and stimulated with unopsonized E. coli polymorphonuclear leukocytes of periodontitis patients and had a tendency to intensify luminol-dependent chemiluminescence. Preincubation of the unstimulated and stimulated with unopsonized E. coli polymorphonuclear leukocytes of healthy subjects with Traumeel S exerts no inhibitory action on the luminol- and lucigenin-dependent chemiluminescence of the above-mentioned cells. Conclusions This study indicates that Traumeel S may significantly reduce production of superoxide anion by unstimulated and stimulated peripheral blood polymorphonuclear neutrophils of periodontitis patients. PMID:21525811

Medicinal and commercial uses of ostrich products in Tanzania.

PubMed

Magige, Flora; Røskaft, Eivin

2017-08-23

Traditional communities have been utilizing animal products for numerous purposes and have for a long time contributed to the accumulation of world knowledge. Local people in Tanzania and elsewhere in Africa, have been using birds including ostriches as pets or their products such as meat, eggs as food; their body parts such as feathers, bones and hide for ornaments but more importantly have used such products in traditional medicine and rituals. Nevertheless, there is a general lack of information about the differences that exist between local people with different cultures, and the best use of such products to improve their livelihoods. This study aimed to determine the use of ostrich products among people residing around Serengeti National Park and explore the potential of improving livelihoods through game ranching. Use of the products was compared between that of agriculturalists with long hunting traditions in the Serengeti District to the west of Serengeti National Park (SNP) and the largely pastoral community in the Ngorongoro District to the east by using semistructured questionnaires in June 2006. A total of 115 respondents were interviewed, and the majority (74.5%) in the Serengeti district admitted that ostriches were mainly hunted for their products by snares, while in the Ngorongoro district, 98.2% of the respondents said that villagers only gathered products such as feathers and eggs. Ostriches were hunted for food, ornamentation, medical and economic purposes, and eggs and oil, which are believed to have medicinal properties, were used for the treatment of various ailments, including asthma. This indigenous knowledge of the medicinal value of ostrich products must be integrated with scientific knowledge to prove the supposed medical efficacy of the products. Ostrich products also had market value and were thus sold to the villagers. Since it has been found that ostrich products are commercially used, legal establishment of markets through game

Turning Regenerative Medicine Breakthrough Ideas and Innovations into Commercial Products.

PubMed

Bayon, Yves; Vertès, Alain A; Ronfard, Vincent; Culme-Seymour, Emily; Mason, Chris; Stroemer, Paul; Najimi, Mustapha; Sokal, Etienne; Wilson, Clayton; Barone, Joe; Aras, Rahul; Chiesi, Andrea

2015-12-01

The TERMIS-Europe (EU) Industry committee intended to address the two main critical issues in the clinical/commercial translation of Advanced Therapeutic Medicine Products (ATMP): (1) entrepreneurial exploitation of breakthrough ideas and innovations, and (2) regulatory market approval. Since January 2012, more than 12,000 publications related to regenerative medicine and tissue engineering have been accepted for publications, reflecting the intense academic research activity in this field. The TERMIS-EU 2014 Industry Symposium provided a reflection on the management of innovation and technological breakthroughs in biotechnology first proposed to contextualize the key development milestones and constraints of allocation of financial resources, in the development life-cycle of radical innovation projects. This was illustrated with the biofuels story, sharing similarities with regenerative medicine. The transition was then ensured by an overview of the key identified challenges facing the commercialization of cell therapy products as ATMP examples. Real cases and testimonies were then provided by a palette of medical technologies and regenerative medicine companies from their commercial development of cell and gene therapy products. Although the commercial development of ATMP is still at the proof-of-concept stage due to technology risks, changing policies, changing markets, and management changes, the sector is highly dynamic with a number of explored therapeutic approaches, developed by using a large diversity of business models, both proposed by the experience, pitfalls, and successes of regenerative medicine pioneers, and adapted to the constraint resource allocation and environment in radical innovation projects.

[Transgenic plants as medicine production systems].

PubMed

Okada, Y

1997-10-01

Transgenic plants are emerging as an important system for the expression of many recombinant proteins, especially those intended for therapeutic purpose. The production of foreign proteins in plants has several advantages. In terms of required equipment and cost, mass production in plants is far easier to achieve than techniques involving animal cells. Successful production of several proteins in plants, including human serum albumin, haemoglobin, monoclonal antibodies, viral antigens (vaccines), enkephalin, and trichosanthin, has been reported. Particularly, the demonstration that vaccine antigens can be produced in plants in their native, immunogenic forms opens exciting possibilities for the "bio-farming" of vaccines. If the antigens are orally active, food-based "edible vaccines" could allow economical production. In this review, I will discuss the progress that has been made by several groups in what is now an expanding area of medicine research that utilizes transgenic plants.

Observational study on the dispensing of cough syrups to children with acute cough by community pharmacists in France.

PubMed

Allaert, François-André; Villet, Stéphanie; Vincent, Stéphane; Sauve, Laurent

2018-04-01

Over-the-counter medicines may be proposed by pharmacists for children with acute cough. Study objectives were to describe the sociodemographic profile of children who were proposed a cough syrup by a pharmacist, the nature of the cough and type(s) of cough syrup proposed and to assess the evolution of the cough, tolerance and satisfaction with treatment. Observational, prospective, longitudinal, multicentre study with 157 pharmacies in France. Children who were proposed a cough syrup by a pharmacist were recruited. Questionnaires were completed by the pharmacists and/or parents at inclusion and by the parents after 5 days of treatment. Four hundred fourteen children were included (mean age: 6.0±2.9 years); 45.9% had a dry and 43.3% a productive cough. 30.4% were proposed an allopathic antitussive syrup, 28.3% an allopathic expectorant syrup and 23.7% a homeopathic syrup. Children with a dry cough were more likely to be given an allopathic antitussive (55.2%) or homeopathic (28.2%) syrup. Children with a productive cough or cough of several days duration were more likely to be given an allopathic expectorant syrup (70.1%). Cough disappearance was more frequent with homeopathic syrups compared to allopathic expectorants (P=0.002), or allopathic antitussives (P=0.042). Adverse events were most common with allopathic antitussive syrups (18.7%) (P<0.001). Two-thirds of parents were satisfied with the treatment their child received. Pharmacists play an important role in the management of acute cough in children. Homeopathic cough syrups may have an interest in terms of public health.

Assessing patients' preferences for characteristics associated with homeopathic and conventional treatment of asthma: a conjoint analysis study

PubMed Central

Ratcliffe, J; Van Haselen, R; Buxton, M; Hardy, K; Colehan, J; Partridge, M

2002-01-01

Background: A study was undertaken to investigate the preferences of patients with asthma for attributes or characteristics associated with treatment for their asthma and to investigate the extent to which such preferences may differ between patient subgroups. Methods: The economic technique of conjoint analysis (CA) was used to investigate patients' strength of preference for several key attributes associated with services for the treatment of asthma. A CA questionnaire was administered to two groups of asthma outpatients aged 18 years or older, 150 receiving conventional treatment at Whipps Cross Hospital (WC) and 150 receiving homeopathic treatment at the Royal London Homoeopathic Hospital (RL). Results: An overall response rate of 47% (n=142) was achieved. Statistically significant attributes in influencing preferences for both the WC and RL respondents were (1) the extent to which the doctor gave sufficient time to listen to what the patient has to say, (2) the extent to which the treatment seemed to relieve symptoms, and (3) the travel costs of attending for an asthma consultation. The extent to which the doctor treated the patient as a whole person was also a statistically significant attribute for the RL respondents. Conclusions: This study has shown that aspects associated with the process of delivery of asthma services are important to patients in addition to treatment outcomes. The homeopathic respondents expressed stronger preferences for the doctor to treat them as a whole person than the patients receiving conventional treatment. Overall, the preferences for the attributes included in the study were similar for both groups. PMID:12037224

Quality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human Use.

PubMed

Cilia, Mark; Ruiz, Sol; Richardson, Peter; Salmonson, Tomas; Serracino-Inglott, Anthony; Wirth, Francesca; Borg, John Joseph

2018-02-01

The aim of this study was to identify trends in deficiencies raised during the EU evaluation of the quality part of dossiers for marketing authorisation applications of biosimilar medicinal products. All adopted day 120 list of questions on the quality module of 22 marketing authorisation applications for biosimilars submitted to the European Medicines Agency and concluded by the end of October 2015 was analysed. Frequencies of common deficiencies identified were calculated and summarised descriptions included. Frequencies and trends on quality deficiencies were recorded and presented for 22 biosimilar applications. Thirty-two 'major objections' for 9 products were identified from 14 marketing authorisation applications with 15 raised for drug substance and 17 for drug product. In addition, 547 'other concerns' for drug substance and 495 for drug product were also adopted. The frequencies and trends of the identified deficiencies together with their impact were discussed from a regulatory perspective and how these impact key manufacturing processes and key materials used in the production of biosimilars. This study provides an insight to the regulatory challenges prospective companies need to consider when developing biosimilars; it also helps elucidate common pitfalls in the development and production of biosimilars and in the submission of dossiers for their marketing authorisations. The results are expected to be of interest to pharmaceutical companies but also to regulators to obtain consistent information on medicinal products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

[Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

PubMed

Kuhlmann-Gottke, Johanna; Duchow, Karin

2015-11-01

At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

Study of Scientific Production of Community Medicines' Department Indexed in ISI Citation Databases.

PubMed

Khademloo, Mohammad; Khaseh, Ali Akbar; Siamian, Hasan; Aligolbandi, Kobra; Latifi, Mahsoomeh; Yaminfirooz, Mousa

2016-10-01

In the scientometric, the main criterion in determining the scientific position and ranking of the scientific centers, particularly the universities, is the rate of scientific production and innovation, and in all participations in the global scientific development. One of the subjects more involved in repeatedly dealt with science and technology and effective on the improvement of health is medical science fields. In this research using scientometric and citation analysis, we studied the rate of scientific productions in the field of community medicine, which is the numbers of articles published and indexed in ISI database from 2000 to 2010. This study is scientometric using the survey and analytical citation. The study samples included all of the articles in the ISI database from 2000 to 2010. For the data collection, the advance method of searching was used at the ISI database. The ISI analyses software and descriptive statistics were used for data analysis. Results showed that among the five top universities in producing documents, Tehran University of Medical Sciences with 88 (22.22%) documents are allocated to the first rank of scientific products. M. Askarian with 36 (90/9%) published documents; most of the scientific outputs in Community medicine, in the international arena is the most active author in this field. In collaboration with other writers, Iranian departments of Community Medicine with 27 published articles have the greatest participation with scholars of English authors. In the process of scientific outputs, the results showed that the scientific process was in its lowest in the years 2000 to 2004, and while the department of Community medicine in 2009 allocated most of the production process to itself. Iranian Journal of Public Health and Saudi Medical Journal each of them had 16 articles which had most participation rate in the publishing of community medicine's department. On the type of carrier, community medicine's department by

[Aconite in homeopathic relief of post-operative pain and agitation in children].

PubMed

Alibeu, J P; Jobert, J

1990-01-01

Despite the use of modern analgesic methods and an improved use of narcotics, the combination pain-agitation sometimes persists in the recovery-room. Aconit seems to be an appropriate homeopathic treatment in this case. To prescribe it, the following conditions must be combined: violence and suddeness of the stress bringing about intense and anguish. The study included 50 children with such symptoms; it was carried out double-blind, the children being given either placebo or Aconit. Aconit proved to be effective for children's postoperative agitation with 95% good results. It is usually stated in such studies that the placebo effect is high and may reach rates higher than 30%. Aconit is an amazing cure when well prescribed, as much for the speediness of its action as for its efficiency. This remedy has a place in the recovery-room and should be in every physician's emergency case. The fundamental research could specify how the remedy works and may be discover other molecules effective for stress.

Evolution of European Union legislation of herbal medicinal products and its transposition to national legislation in 1965-2007: case Finland.

PubMed

Koski, Sari M; Laitinen-Parkkonen, Pirjo; Airaksinen, Marja

2015-01-01

The study aim was to explore the progress of legislation relating to herbal medicinal products in the European Union and compare it with the corresponding progress of the legislation in Finland in 1965-2007. The study was carried out using content analysis. Data were searched from publicly available European Union directives and national acts. All definitions and safety-related requirements for herbal medicinal products were identified. The transposition of safety-related requirements into the national legislation was studied. Medicinal products from plant origins have been part of the European Union legislation since 1965. Most plant-based products have not initially been regarded as medicinal products but rather as some kind of medicine-like products. The official definition of herbal medicinal products was introduced in Directive 2004/24/EC and implemented into the Finnish legislation with the terminology to recognise herbal medicinal products as part of medicinal products. The current safety-related requirements of medicinal products concern analogously herbal medicinal products. Herbal medicinal products have had different definitions in pharmaceutical legislation over the study period in the European Union and Finland. The current definition places herbal medicinal products more clearly under the medicinal products' legislation. Safety-related requirements are now practically identical for all medicinal products. Transposition of the European Union legislation into the national legislation in Finland is apparent. Copyright © 2013 John Wiley & Sons, Ltd.

PRICING, REIMBURSEMENT, AND HEALTH TECHNOLOGY ASSESSMENT OF MEDICINAL PRODUCTS IN BULGARIA.

PubMed

Benisheva-Dimitrova, Tatyana; Sidjimova, Dobriana; Cherneva, Daniela; Kralimarkov, Nikolay

2017-01-01

The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000-15 and health technology assessment (HTA) role in these processes. The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis. Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013-14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses. Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.

A potentized homeopathic drug, Arsenicum Album 200, can ameliorate genotoxicity induced by repeated injections of arsenic trioxide in mice.

PubMed

Banerjee, P; Biswas, S J; Belon, P; Khuda-Bukhsh, A R

2007-09-01

Groundwater arsenic contamination has become a menacing global problem. No drug is available until now to combat chronic arsenic poisoning. To examine if a potentized homeopathic remedy, Arsenicum Album-200, can effectively combat chronic arsenic toxicity induced by repeated injections of Arsenic trioxide in mice, the following experimental design was adopted. Mice (Mus musculus) were injected subcutaneously with 0.016% arsenic trioxide at the rate of 1 ml/100 g body weight, at an interval of 7 days until they were killed at day 30, 60, 90 or 120 and were divided into three groups: (i) one receiving a daily dose of Arsenicum Album-200 through oral administration, (ii) one receiving the same dose of diluted succussed alcohol (Alcohol-200) and (iii) another receiving neither drug, nor succussed alcohol. The remedy or the placebo, as the case may be, was fed from the next day onwards after injection until the day before the next injection, and the cycle was repeated until the mice were killed. Two other control groups were also maintained: one receiving only normal diet, and the other receiving normal diet and succussed alcohol. Several toxicity assays, such as cytogenetical (chromosome aberrations, micronuclei, mitotic index, sperm head anomaly) and biochemical (acid and alkaline phosphatases, lipid peroxidation), were periodically made. Compared with controls, the drug fed mice showed reduced toxicity at statistically significant levels in respect of all the parameters studied, thereby indicating protective potentials of the homeopathic drug against chronic arsenic poisoning.

HEAVY METAL CONTENT OF AYURVEDIC HERBAL MEDICINE PRODUCTS

EPA Science Inventory

Case reports of individuals taking Ayurvedic herbal medicine products (HMPs) suggest that they may contain lead, mercury, and/or arsenic. We analyzed the heavy metal content of Ayurvedic HMPs manufactured in India and Pakistan, available in South Asian grocery stores in the Bost...

Local production of pharmaceuticals in Africa and access to essential medicines: 'urban bias’ in access to imported medicines in Tanzania and its policy implications

PubMed Central

2014-01-01

Background International policy towards access to essential medicines in Africa has focused until recently on international procurement of large volumes of medicines, mainly from Indian manufacturers, and their import and distribution. This emphasis is now being challenged by renewed policy interest in the potential benefits of local pharmaceutical production and supply. However, there is a shortage of evidence on the role of locally produced medicines in African markets, and on potential benefits of local production for access to medicines. This article contributes to filling that gap. Methods This article uses WHO/HAI data from Tanzania for 2006 and 2009 on prices and sources of a set of tracer essential medicines. It employs innovative graphical methods of analysis alongside conventional statistical testing. Results Medicines produced in Tanzania were equally likely to be found in rural and in urban areas. Imported medicines, especially those imported from countries other than Kenya (mainly from India) displayed 'urban bias’: that is, they were significantly more likely to be available in urban than in rural areas. This finding holds across the range of sample medicines studied, and cannot be explained by price differences alone. While different private distribution networks for essential medicines may provide part of the explanation, this cannot explain why the urban bias in availability of imported medicines is also found in the public sector. Conclusions The findings suggest that enhanced local production may improve rural access to medicines. The potential benefits of local production and scope for their improvement are an important field for further research, and indicate a key policy area in which economic development and health care objectives may reinforce each other. PMID:24612518

Local production of pharmaceuticals in Africa and access to essential medicines: 'urban bias' in access to imported medicines in Tanzania and its policy implications.

PubMed

Mujinja, Phares G M; Mackintosh, Maureen; Justin-Temu, Mary; Wuyts, Marc

2014-03-10

International policy towards access to essential medicines in Africa has focused until recently on international procurement of large volumes of medicines, mainly from Indian manufacturers, and their import and distribution. This emphasis is now being challenged by renewed policy interest in the potential benefits of local pharmaceutical production and supply. However, there is a shortage of evidence on the role of locally produced medicines in African markets, and on potential benefits of local production for access to medicines. This article contributes to filling that gap. This article uses WHO/HAI data from Tanzania for 2006 and 2009 on prices and sources of a set of tracer essential medicines. It employs innovative graphical methods of analysis alongside conventional statistical testing. Medicines produced in Tanzania were equally likely to be found in rural and in urban areas. Imported medicines, especially those imported from countries other than Kenya (mainly from India) displayed 'urban bias': that is, they were significantly more likely to be available in urban than in rural areas. This finding holds across the range of sample medicines studied, and cannot be explained by price differences alone. While different private distribution networks for essential medicines may provide part of the explanation, this cannot explain why the urban bias in availability of imported medicines is also found in the public sector. The findings suggest that enhanced local production may improve rural access to medicines. The potential benefits of local production and scope for their improvement are an important field for further research, and indicate a key policy area in which economic development and health care objectives may reinforce each other.

The defining role of structure (including epitaxy) in the plausibility of homeopathy.

PubMed

Rao, Manju Lata; Roy, Rustum; Bell, Iris R; Hoover, Richard

2007-07-01

The key stumbling block to serious consideration of homeopathy is the presumed "implausibility" of biological activity for homeopathic medicines in which the source material is diluted past Avogadro's number of molecules. Such an argument relies heavily on the assumptions of elementary chemistry (and biochemistry), in which the material composition of a solution, (dilution factors and ligand-receptor interactions), is the essential consideration. In contrast, materials science focuses on the three-dimensional complex network structure of the condensed phase of water itself, rather than the original solute molecules. The nanoheterogenous structure of water can be determined by interactive phenomena such as epitaxy (the transmission of structural information from the surface of one material to another without the transfer of any matter), temperature-pressure processes during succussion, and formation of colloidal nanobubbles containing gaseous inclusions of oxygen, nitrogen, carbon dioxide, and possibly the remedy source material. Preliminary data obtained using Raman and Ultra-Violet-Visible (UV-VIS) spectroscopy illustrate the ability to distinguish two different homeopathic medicines (Nux vomica and Natrum muriaticum) from one another and to differentiate, within a given medicine, the 6c, 12c, and 30c potencies. Materials science concepts and experimental tools offer a new approach to contemporary science, for making significant advances in the basic science studies of homeopathic medicines.

[Analysis of difficult problems on European Union laws and regulations of traditional herbal medicinal products].

PubMed

Qu, Li-Ping; Zhang, Xiao-Qun; Xiong, Yan; Wang, Yi-Tao; Zou, Wen-Jun

2017-10-01

Registration of Chinese patent medicine in European Union (EU) is of great significance to the internationalization of traditional Chinese medicine as EU market acts as an important position in the global botanical market. In retrospect, the domestic studies on EU regulations of traditional herbal medicinal products have been conducted for more than 10 years, but there is still some cognitive bias and lack of research. In this paper, a review of the relevant research progress and the main misunderstanding problems about Directive 2004/24/EC, like the centralized and decentralized supervision system of traditional herbal medicinal products in the EU, marketing authorization procedures for traditional herbal medicinal products, Community Herbal Monograph and List Entries, would be systematically analyzed, so as to provide reference for the registration of Chinese patent medicine in EU. Copyright© by the Chinese Pharmaceutical Association.

Prevalence of homeopathy use by the general population worldwide: a systematic review.

PubMed

Relton, Clare; Cooper, Katy; Viksveen, Petter; Fibert, Philippa; Thomas, Kate

2017-05-01

To systematically review surveys of 12-month prevalence of homeopathy use by the general population worldwide. Studies were identified via database searches to October 2015. Study quality was assessed using a six-item tool. All estimates were in the context of a survey which also reported prevalence of any complementary and alternative medicine use. A total of 36 surveys were included. Of these, 67% met four of six quality criteria. Twelve-month prevalence of treatment by a homeopath was reported in 24 surveys of adults (median 1.5%, range 0.2-8.2%). Estimates for children were similar to those for adults. Rates in the USA, UK, Australia and Canada all ranged from 0.2% to 2.9% and remained stable over the years surveyed (1986-2012). Twelve-month prevalence of all use of homeopathy (purchase of over-the-counter homeopathic medicines and treatment by a homeopath) was reported in 10 surveys of adults (median 3.9%, range 0.7-9.8%) while a further 11 surveys which did not define the type of homeopathy use reported similar data. Rates in the USA and Australia ranged from 1.7% to 4.4% and remained stable over the years surveyed. The highest use was reported by a survey in Switzerland where homeopathy is covered by mandatory health insurance. This review summarises 12-month prevalence of homeopathy use from surveys conducted in eleven countries (USA, UK, Australia, Israel, Canada, Switzerland, Norway, Germany, South Korea, Japan and Singapore). Each year a small but significant percentage of these general populations use homeopathy. This includes visits to homeopaths as well as purchase of over-the-counter homeopathic medicines. Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Attitude and practice of patients and doctors towards complementary and alternative medicine.

PubMed

Junaid, Rabyyan; Abaas, Mustafa; Fatima, Batool; Anis, Irma; Hussain, Mehwish

2012-08-01

To determine the attitude towards complementary and alternative medicine among the doctors and patients. The study was carried out at Civil Hospital Karachi and Liaquat National University Hospital, Karachi during April to September 2010. Two sets of questionnaires were developed separately for doctors and patients. Each set consisted of queries regarding demographic data of patients and doctors. The questionnaire for the patients contained questions reflecting the general attitude, mode of complimentary and alternative medicine usage, disease referred and the underlined reasons behind pricking the options. The questionnaires for doctors in general laid focus on the personal opinion about the practice not only for their own use, but also related to their concern towards those patients who used complimentary and alternative medicine. Predictive analysis software statistics 18 was used for statistical analysis. Of the patients, 237 (59.3%) used complimentary and alternative medicine. Herbal medicine followed by homeopathic medicine were the most commonly used therapies. Fever and cough were the most common diseases for which patients used the options. The preference was mainly based on inter-personal communications, reliance on complimentary and alternative medicine, and financial restriction. Concealing from the doctors was common in patients. Only 62 (34.4%) out of 180 doctors used complimentary and alternative medicine themselves. Refusal by other doctors was because they considered the option ineffective, obsolete and unsatisfactory. About half of the doctors forbade the patients to use such therapies, but 31% (n=73) patients ignored the doctor's advice. The use of complimentary and alternative medicine is highly prevalent in our society by patients irrespective of their social class. Preference for such therapies, on the other hand, is quite low among medical doctors as they consider allopathic medicine to be effective.

Response to Individualized Homeopathic Treatment for Depression in Climacteric Women with History of Domestic Violence, Marital Dissatisfaction or Sexual Abuse: Results from the HOMDEP-MENOP Study.

PubMed

Macías-Cortés, Emma Del Carmen; Llanes-González, Lidia; Aguilar-Faisal, Leopoldo; Asbun-Bojalil, Juan

2018-06-05

 Although individualized homeopathic treatment is effective for depression in climacteric women, there is a lack of well-designed studies of its efficacy for depression in battered women or in post-traumatic stress disorder. The aim of this study was to assess the association between individualized homeopathic treatment or fluoxetine and response to depression treatment in climacteric women with high levels of domestic violence, sexual abuse or marital dissatisfaction.  One hundred and thirty-three Mexican climacteric women with moderate-to-severe depression enrolled in the HOMDEP-MENOP Study (a randomized, placebo-controlled, double-blind, double-dummy, three-arm trial, with a 6-week follow-up study) were evaluated. Domestic violence, marital dissatisfaction and sexual abuse were assessed at baseline. Response to depression treatment was defined by a decrease of 50% or more from baseline score of Hamilton scale. Association between domestic violence, sexual abuse, and marital dissatisfaction and response to depression treatment was analyzed with bivariate analysis in the three groups. Odds ratio (OR) and 95% confidence interval (CI) were calculated.  Homeopathy versus placebo had a statistically significant association with response to depression treatment after adjusting for sexual abuse (OR [95% CI]: 11.07 [3.22 to 37.96]), domestic violence (OR [95% CI]: 10.30 [3.24 to 32.76]) and marital dissatisfaction (OR [95% CI]: 8.61 [2.85 to 25.99]).  Individualized homeopathic treatment is associated with response to depression treatment in climacteric women with high levels of domestic violence, sexual abuse or marital dissatisfaction. Further studies should be conducted to evaluate its efficacy specifically for post-traumatic stress disorder in battered women. CLINICALTRIALS. NCT01635218,:  URL: http://clinicaltrials.gov/ct2/show/NCT01635218?term=depression+homeopathy&rank=1. The Faculty of Homeopathy.

The effect of the homeopathic remedies Arnica montana and Bellis perennis on mild postpartum bleeding--a randomized, double-blind, placebo-controlled study--preliminary results.

PubMed

Oberbaum, Menachem; Galoyan, Narine; Lerner-Geva, Liat; Singer, Shepherd Roee; Grisaru, Sorina; Shashar, David; Samueloff, Arnon

2005-06-01

To evaluate the effect of Arnica Montana and Bellis perennis on postpartum blood loss. Double blind, placebo-controlled, randomized, clinical trial. Department of Gynecology, Shaare Zedek Medical Center, Jerusalem. Forty parturients were randomized to one of three groups: Arnica montana C6 and Bellis perennis C6 (n=14), Arnica montana C30 and Bellis perennis C30 (n=14), or double placebo (n=12). After 48 h the Arnica/placebo was halted, and patients continued the Bellis/placebo until cessation of lochia. Hemoglobin levels (Hb) at 48 and 72 h postpartum. At 72 h postpartum, mean Hb levels remained similar after treatment with homeopathic remedies (12.7 versus 12.4) as compared to a significant decrease in Hb levels in the placebo group (12.7 versus 11.6; p<0.05), in spite of less favorable initial characteristics of the treatment group. The mean difference in Hb levels at 72 h postpartum was -0.29 (95% CI -1.09; 0.52) in the treatment group and -1.18 (95% CI -1.82; -0.54) in the placebo group (p<0.05). Treatment with homeopathic Arnica montana and Bellis perennis may reduce postpartum blood loss, as compared with placebo.

Material science as basis for nuclear medicine: Holmium irradiation for radioisotopes production

NASA Astrophysics Data System (ADS)

Usman, Ahmed Rufai; Khandaker, Mayeen Uddin; Haba, Hiromitsu; Otuka, Naohiko

2018-05-01

Material Science, being an interdisciplinary field, plays important roles in nuclear science. These applications are seen in weaponry, armoured vehicles, accelerator structure and development, semiconductor detectors, nuclear medicine and many more. Present study presents the applications of some metals in nuclear medicine (radioisotope production). The charged-particle-induced nuclear reactions by using cyclotrons or accelerators have become a very vital feature of the modern nuclear medicine. Realising the importance of excitation functions for the efficient production of medical radionuclides, some very high purity holmium metals are generally prepared or purchased for bombardment in nuclear accelerators. In the present work, various methods to obtain pure holmium for radioisotope production have been discussed while also presenting details of our present studies. From the experimental work of the present studies, some very high purity holmium foils have been used in the work for a comprehensive study of residual radionuclides production cross-sections. The study was performed using a stacked-foil activation technique combined with γ-ray spectrometry. The stack was bombarded with 50.4 MeV alpha particle beam from AVF cyclotron of RI Beam Factory, Nishina Centre for Accelerator-Based Science, RIKEN, Japan. The work produced thulium radionuclides useful in nuclear medicine.

Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations.

PubMed

Lehmann, Birka

2008-12-08

Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective.The same approach may not always be applied to medicinal products used to treat children.Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions.The Regulation (EC) No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children.The Regulation is addressed to: 1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population. 2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use. 3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate. The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD), for the European Union (EU). The CTD establishes specific provisions regarding conduct of clinical trials, including multi

Regulation (EC) No 1901/2006 on medicinal products for paediatric use & clinical research in vulnerable populations

PubMed Central

Lehmann, Birka

2008-01-01

Before any medicinal product is authorised for use in adults, it must undergo extensive pharmaceutical consistency and stability tests, toxicological tests and clinical trials to ensure that it is of high quality, safe and effective. The same approach may not always be applied to medicinal products used to treat children. Studies showed that over 50% of the medicinal products used in children may not have been tested for use in this age group. The absence of suitable authorised medicinal products to treat conditions in children results from the fact that pharmaceutical companies do not adapt medicinal products to the needs of the paediatric population. This leaves health care professionals with no alternative other than to use medicinal products "off-label" and to use unauthorised products with the associated risks of inefficacy and/or adverse reactions. The Regulation (EC) No 1901/2006 sets up a system of requirements, rewards and incentives, together with horizontal measures, to ensure that medicinal products are researched, developed and authorised to meet the therapeutic needs of children. The Regulation is addressed to: 1. The pharmaceutical industry by setting out the legal framework for receiving rewards and incentives by conducting clinical trials in the paediatric population. 2. The Member States to set out to support research into, and the development and availability of, medicinal products for paediatric use. 3. The Community as funds for research into medicinal products for the paediatric population shall be provided for in the Community budget in order to support studies relating to medicinal products or active substances not covered by a patent or a supplementary protection certificate. The legal framework for conducting clinical trials, including children/minors, is set up in Directive 2001/20/EC, the Clinical Trials Directive (CTD), for the European Union (EU). The CTD establishes specific provisions regarding conduct of clinical trials, including

A homeopathic remedy from arnica, marigold, St. John’s wort and comfrey accelerates in vitro wound scratch closure of NIH 3T3 fibroblasts

PubMed Central

2012-01-01

Background Drugs of plant origin such as Arnica montana, Calendula officinalis or Hypericum perforatum have been frequently used to promote wound healing. While their effect on wound healing using preparations at pharmacological concentrations was supported by several in vitro and clinical studies, investigations of herbal homeopathic remedies on wound healing process are rare. The objective of this study was to investigate the effect of a commercial low potency homeopathic remedy Similasan® Arnica plus Spray on wound closure in a controlled, blind trial in vitro. Methods We investigated the effect of an ethanolic preparation composed of equal parts of Arnica montana 4x, Calendula officinalis 4x, Hypericum perforatum 4x and Symphytum officinale 6x (0712–2), its succussed hydroalcoholic solvent (0712–1) and unsuccussed solvent (0712–3) on NIH 3T3 fibroblasts. Cell viability was determined by WST-1 assay, cell growth using BrdU uptake, cell migration by chemotaxis assay and wound closure by CytoSelect ™Wound Healing Assay Kit which generated a defined “wound field”. All assays were performed in three independent controlled experiments. Results None of the three substances affected cell viability and none showed a stimulating effect on cell proliferation. Preparation (0712–2) exerted a stimulating effect on fibroblast migration (31.9%) vs 14.7% with succussed solvent (0712–1) at 1:100 dilutions (p < 0.001). Unsuccussed solvent (0712–3) had no influence on cell migration (6.3%; p > 0.05). Preparation (0712–2) at a dilution of 1:100 promoted in vitro wound closure by 59.5% and differed significantly (p < 0.001) from succussed solvent (0712–1), which caused 22.1% wound closure. Conclusion Results of this study showed that the low potency homeopathic remedy (0712–2) exerted in vitro wound closure potential in NIH 3T3 fibroblasts. This effect resulted from stimulation of fibroblasts motility rather than of their mitosis. PMID:22809174

Clinical verification in homeopathy and allergic conditions.

PubMed

Van Wassenhoven, Michel

2013-01-01

The literature on clinical research in allergic conditions treated with homeopathy includes a meta-analysis of randomised controlled trials (RCT) for hay fever with positive conclusions and two positive RCTs in asthma. Cohort surveys using validated Quality of Life questionnaires have shown improvement in asthma in children, general allergic conditions and skin diseases. Economic surveys have shown positive results in eczema, allergy, seasonal allergic rhinitis, asthma, food allergy and chronic allergic rhinitis. This paper reports clinical verification of homeopathic symptoms in all patients and especially in various allergic conditions in my own primary care practice. For preventive treatments in hay fever patients, Arsenicum album was the most effective homeopathic medicine followed by Nux vomica, Pulsatilla pratensis, Gelsemium, Sarsaparilla, Silicea and Natrum muriaticum. For asthma patients, Arsenicum iodatum appeared most effective, followed by Lachesis, Calcarea arsenicosa, Carbo vegetabilis and Silicea. For eczema and urticaria, Mezereum was most effective, followed by Lycopodium, Sepia, Arsenicum iodatum, Calcarea carbonica and Psorinum. The choice of homeopathic medicine depends on the presence of other associated symptoms and 'constitutional' features. Repertories should be updated by including results of such clinical verifications of homeopathic prescribing symptoms. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Industry perceptions of barriers to commercialization of regenerative medicine products in the UK.

PubMed

Plagnol, Anke C; Rowley, Emma; Martin, Paul; Livesey, Finbarr

2009-07-01

Regenerative medicine is an emerging field with the potential to provide widespread improvement in healthcare and patient wellbeing via the delivery of therapies that can restore, regenerate or repair damaged tissue. As an industry, it could significantly contribute to economic growth if products are successfully commercialized. However, to date, relatively few products have reached the market owing to a variety of barriers, including a lack of funding and regulatory hurdles. The present study analyzes industry perceptions of the barriers to commercialization that currently impede the success of the regenerative medicine industry in the UK. The analysis is based on 20 interviews with leading industrialists in the field. The study revealed that scientific research in regenerative medicine is thriving in the UK. Unfortunately, lack of access to capital, regulatory hurdles, lack of clinical evidence leading to problems with reimbursement, as well as the culture of the NHS do not provide a good environment for the commercialization of regenerative medicine products. Policy interventions, including increased translational government funding, a change in NHS and NICE organization and policies, and regulatory clarity, would likely improve the general outcomes for the regenerative medicine industry in the UK.

Effect of the oral administration homeopathic Arnica montana on mitochondrial oxidative stress.

PubMed

de Camargo, Ronaldo Antônio; da Costa, Ellen Dias; Catisti, Rosana

2013-01-01

To analyze the effect of homeopathic Arnica on mitochondrial oxidative stress induced by Ca(2+) plus inorganic phosphate and/or Fe(2+)-citrate-mediated lipid peroxidation through changes in oxygen consumption rates. Mitochondria were isolated by differential centrifugation from the livers of adult male Wistar rats which had been treated with Arnica montana 6cH, 12cH, 30cH or succussed 30% ethanol (control) for 21 days. In the presence of antimycin-A, electron transport chain inhibitor, as evidenced by antimycin-A insensitive O(2) consumption, Arnica inhibited lipid peroxidation of mitochondrial membranes. In oxidative stress conditions, in the presence of Ca(2+) and inorganic phosphate, animals receiving Arnica 30cH had a significant decrease in mitochondrial O(2) consumption compared to control animals. When administrated orally, Arnica 30cH protects against hepatic mitochondrial membrane permeabilization induced by Ca(2+) and/or Fe(2+)-citrate-mediated lipid peroxidation and fragmentation of proteins due to the attack by reactive oxygen species. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

[Investigation on production process quality control of traditional Chinese medicine--Banlangen granule as an example].

PubMed

Tan, Manrong; Yan, Dan; Qiu, Lingling; Chen, Longhu; Yan, Yan; Jin, Cheng; Li, Hanbing; Xiao, Xiaohe

2012-04-01

For the quality management system of herbal medicines, intermediate and finished products it exists the " short board" effect of methodologies. Based on the concept of process control, new strategies and new methods of the production process quality control had been established with the consideration of the actual production of traditional Chinese medicine an the characteristics of Chinese medicine. Taking Banlangen granule as a practice example, which was effective and widespread application, character identification, determination of index components, chemical fingerprint and biometrics technology were sequentially used respectively to assess the quality of Banlangen herbal medicines, intermediate (water extraction and alcohol precipitation) and finished product. With the transfer rate of chemical information and biological potency as indicators, the effectiveness and transmission of the above different assessments and control methods had been researched. And ultimately, the process quality control methods of Banlangen granule, which were based on chemical composition analysis-biometric analysis, had been set up. It can not only validly solute the current status that there were many manufacturers varying quality of Banlangen granule, but also ensure and enhance its clinical efficacy. Furthermore it provided a foundation for the construction of the quality control of traditional Chinese medicine production process.

Where is industry getting it wrong? A review of quality concerns raised at Day 120 by the Committee For Medicinal Products for Human Use during European Centralised Marketing Authorisation Submissions for Chemical Entity Medicinal Products.

PubMed

Borg, John Joseph; Robert, Jean-Louis; Wade, George; Aislaitner, George; Pirozynski, Michal; Abadie, Eric; Salmonson, Tomas; Vella Bonanno, Patricia

2009-01-01

The aim of this study was to identify common trends in the deficiencies identified in the quality part of the dossier during the evaluation of marketing authorisation applications for medicinal products for human use submitted through the EU's centralised procedure. We analysed all the adopted Day 120 list of questions on the quality module of 52 marketing authorisation applications for chemical entity medicinal products submitted to the European Medicines Agency and evaluated by the Committee for Medicinal Products for Human Use (CHMP), during 12 consecutive plenary meetings held in 2007 and 2008. Subsequently we calculated the frequency of common deficiencies identified across these applications. Frequencies and trends on quality deficiencies have been recorded and presented for 52 marketing authorisation applications. 32 "Major Objections" originated from 13 marketing authorisation applications. 13 concerned were raised regarding drug substances and 19 for drug products. Furthermore, 905 concerns on drug substance and 1,054 on drug product were also adopted. The impact of the frequencies and trends in quality deficiencies that were identified are discussed from a regulatory point of view. It is expected that the results of this study will not only be of interest to pharmaceutical companies but will also aid regulators' in obtaining consistent information on drug products based on transparent rules safeguarding the necessary pharmaceutical quality of medicinal products.

Elements of effective communication--rediscoveries from homeopathy.

PubMed

Hartog, Christiane S

2009-11-01

Patients are increasingly attracted to homeopathy despite the unproven effectiveness of homeopathic remedies. Clinical benefit of homeopathy may be due to communication. This review aims to identify and assess effective communication patterns in homeopathy. Narrative review and synthesis of published communication patterns, patient narratives and the author's professional experience as a homeopathic practitioner. In the biomedical model, where the focus is on disease, communication is physician-centered with early redirection of patients' concerns, and associated with reduced compliance, increasing risk of malpractice claims and low professional fulfillment. The biopsychosocial and the developing integrative medicine models are based on biomedicine but aim to include the whole person. Patient-centeredness is a behavior that elicits, respects and incorporates patients' wishes, allows active patient participation and is related to improved outcomes. The homeopathic model is based on holism and comprehension of the totality of the patient and uses patient-centered communication with a high degree of physician co-operation, empathy, hopefulness, enablement and narrative competence, all of which can improve outcomes. Both biopsychosocial and homeopathic models rely on patient-centered communication. Regardless of conceptual differences, they overlap in their common respect for the totality and individuality of the patient. The study of the homeopathic model shows that respect for the whole person is a basic requirement to entrench patient-centeredness more firmly in medicine. Medical education should include values such as individual coping strategies, the benefits of a sound and healthy life-style and the necessity of hope and enablement. Health care should be redesigned to honor physicians who practice these values.

Functional Medicine Approach to Traumatic Brain Injury.

PubMed

Richer, Alice C

2017-08-01

Background: The U.S. military has seen dramatic increases in traumatic brain injuries (TBIs) among military personnel due to the nature of modern-day conflicts. Conventional TBI treatment for secondary brain injuries has suboptimal success rates, and patients, families, and healthcare professionals are increasingly turning to alternative medicine treatments. Objective: Effective treatments for the secondary injury cascades that occur after an initial brain trauma are unclear at this time. The goal of successful treatment options for secondary TBI injuries is to reduce oxidative stress, excitotoxicity, and inflammation while supporting mitochondrial functions and repair of membranes, synapses, and axons. Intervention: A new paradigm of medical care, known as functional medicine, is increasing in popularity and acceptance. Functional medicine combines conventional treatment methods with complementary, genetic, holistic, and nutritional therapies. The approach is to assess the patient as a whole person, taking into account the interconnectedness of the body and its unique reaction to disease, injury, and illness while working to restore balance and optimal health. Functional medicine treatment recommendations often include the use of acupuncture, Ayurveda, chiropractic manipulation, detoxification programs, herbal and homeopathic supplements, specialized diets, massage, meditation and mindfulness practices, neurobiofeedback, nutritional supplements, t'ai chi , and yoga. At present, some of these alternative treatments appear to be beneficial, but more research is needed to validate reported outcomes. Conclusions: Few clinical studies validate the effectiveness of alternative therapies for TBIs. However, further clinical trials and empirical studies warrant further investigation based on some reported positive results from research studies, case histories, anecdotal evidence, and widespread popularity of some approaches. To date, only nutritional therapies and

Functional Medicine Approach to Traumatic Brain Injury

PubMed Central

2017-01-01

Abstract Background: The U.S. military has seen dramatic increases in traumatic brain injuries (TBIs) among military personnel due to the nature of modern-day conflicts. Conventional TBI treatment for secondary brain injuries has suboptimal success rates, and patients, families, and healthcare professionals are increasingly turning to alternative medicine treatments. Objective: Effective treatments for the secondary injury cascades that occur after an initial brain trauma are unclear at this time. The goal of successful treatment options for secondary TBI injuries is to reduce oxidative stress, excitotoxicity, and inflammation while supporting mitochondrial functions and repair of membranes, synapses, and axons. Intervention: A new paradigm of medical care, known as functional medicine, is increasing in popularity and acceptance. Functional medicine combines conventional treatment methods with complementary, genetic, holistic, and nutritional therapies. The approach is to assess the patient as a whole person, taking into account the interconnectedness of the body and its unique reaction to disease, injury, and illness while working to restore balance and optimal health. Functional medicine treatment recommendations often include the use of acupuncture, Ayurveda, chiropractic manipulation, detoxification programs, herbal and homeopathic supplements, specialized diets, massage, meditation and mindfulness practices, neurobiofeedback, nutritional supplements, t'ai chi, and yoga. At present, some of these alternative treatments appear to be beneficial, but more research is needed to validate reported outcomes. Conclusions: Few clinical studies validate the effectiveness of alternative therapies for TBIs. However, further clinical trials and empirical studies warrant further investigation based on some reported positive results from research studies, case histories, anecdotal evidence, and widespread popularity of some approaches. To date, only nutritional therapies and

[Scientific advice by the national and European approval authorities concerning advanced therapy medicinal products].

PubMed

Jost, Nils; Schüssler-Lenz, Martina; Ziegele, Bettina; Reinhardt, Jens

2015-11-01

The aim of scientific advice is to support pharmaceutical developers in regulatory and scientific questions, thus facilitating the development of safe and efficacious new medicinal products. Recent years have shown that the development of advanced therapy medicinal products (ATMPs) in particular needs a high degree of regulatory support. On one hand, this is related to the complexity and heterogeneity of this group of medicinal products and on the other hand due to the fact that mainly academic research institutions and small- and medium-sized enterprises (SMEs) are developing ATMPs. These often have limited regulatory experience and resources. In 2009 the Paul-Ehrlich-Institut (PEI) initiated the Innovation Office as a contact point for applicants developing ATMPs. The mandate of the Innovation Office is to provide support on regulatory questions and to coordinate national scientific advice meetings concerning ATMPs for every phase in drug development and especially with view to the preparation of clinical trial applications. On the European level, the Scientific Advice Working Party (SAWP) of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicinal Agency (EMA) offers scientific advice. This article describes the concepts of national and EMA scientific advice concerning ATMPs and summarizes the experience of the last six years.

A short guide to peer-reviewed, MEDLINE-indexed complementary and alternative medicine journals.

PubMed

Morgan, Sherry; Littman, Lynn; Palmer, Christina; Singh, Gurneet; LaRiccia, Patrick J

2012-01-01

Complementary and alternative medicine (CAM) comprises a multitude of disciplines, for example, acupuncture, ayurvedic medicine, biofeedback, herbal medicine, and homeopathic medicine. While research on CAM interventions has increased and the CAM literature has proliferated since the mid-1990s, a number of our colleagues have expressed difficulties in deciding where to publish CAM articles. In response, we created a short guide to peer-reviewed MEDLINE-indexed journals that publish CAM articles. We examined numerous English-language sources to identify titles that met our criteria, whether specific to or overlapping CAM. A few of the resources in which we found the journal titles that we included are Alternative Medicine Foundation, American Holistic Nurses Association, CINAHL/Nursing Database, Journal Citation Reports database, MEDLINE, PubMed, and Research Council for Complementary Medicine. We organized the 69 selected titles for easy use by creating 2 user-friendly tables, one listing titles in alphabetical order and one listing them in topical categories. A few examples of the topical categories are Acupuncture, CAM (general), Chinese Medicine, Herbal/Plant/Phytotherapy, Neuroscience/Psychology, Nursing/Clinical Care. Our study is the first to list general CAM journals, specialty CAM journals, and overlapping mainstream journals that are peer reviewed, in English, and indexed in MEDLINE. Our goal was to assist both authors seeking publication and mainstream journal editors who receive an overabundance of publishable articles but must recommend that authors seek publication elsewhere due to space and priority issues. Publishing in journals indexed by and included in MEDLINE (or PubMed) ensures that citations to articles will be found easily. Copyright © 2012 Lippincott Williams & Wilkins.

Medicinal plants used for traditional veterinary in the Sierras de Córdoba (Argentina): An ethnobotanical comparison with human medicinal uses

PubMed Central

2011-01-01

with a vast repertoire of plant pharmacopoeia, the therapies also involve religious or ritualistic practices and other popular remedies that evidence the influence of traditional Hispanic-European knowledge. Although the traditional veterinary knowledge seems to be similar or else is inlcuded in the local human ethnomedicine, sharing a common group of plants, it has distinct traits originated by a constant assessment of new applications specifically destined to the treatment of animals. Conclusions Veterinary medicine is a fountain of relevant vernacular knowledge, a permanent source for testing new applications with valuable ethnobotanical interest. Knowledge on medicinal applications of native plants will allow future validations and tests for new homeopathic or phytotherapeutic preparations. PMID:21816043

Medicinal and dietary supplements: specialty forest products with a long tradition

Treesearch

James L. Chamberlain; A.L. Hammett

1999-01-01

Over the last five years forest products other than timber-based products have received a great deal of attention. The markets for medicinal plants that are collected from the forests are growing rapidly. Some reports suggest this segment of the non-timber forest products industry is expanding faster than the timber-based industry. Plants used for their therapeutic...

Pharmaceutical counseling: Between evidence-based medicine and profits.

PubMed

Egorova, S N; Akhmetova, T

2015-01-01

pharmaceutical counseling standards: Article 1.1 "Code of Ethics of the pharmaceutical worker of Russia" states: "The main task of the professional activity of the pharmaceutical worker - protection of human health", Article 1.3 states that a pharmaceutical worker must take professional decisions solely in the interests of a patient [1]. However, the pharmacy is a trade organization, thus as a retailer the pharmacy is directly interested in making profits and increasing sales of pharmaceutical products, including non-prescription medicines. Moreover, while the clinical medicine is monitored for unjustified prescribing and measures are being taken to prevent polypharmacy, for a pharmacist the growing sales of over-the-counter drugs, active promotion of dietary supplements, homeopathic medicines, medical devices, and, consequently, an increase of financial indicators (particularly "average purchase size") - all are characteristics of success [2].Rational use of over-the-counter medicines requires introduction of pharmaceutical counseling standards (pharmaceutical care) according to symptoms - major reasons to visit a pharmacy as part of responsible self-medication (cold, sore throat, headache, diarrhea, etc.). Standards of pharmaceutical counseling should be objective, reliable and up-to-date and contain recommendations for the rational use of over-the-counter drugs as well as indications requiring treatment to the doctor. Standardization of pharmaceutical counseling in terms of Evidence-based Pharmacy would enhance the efficiency, safety and cost-effectiveness of over-the-counter medicines.Currently, the lack of clinical component in the higher pharmaceutical education and the lack of approved standards of pharmaceutical counseling lead to the introduction of cross-selling technologies (which are broadly applied in other areas of trade, for example, the offer of a boot-polish during the sale of shoes) to the pharmaceutical practice [2, 3]. However, drugs belong to a special group

Immunology and Homeopathy. 5. The Rationale of the ‘Simile’

PubMed Central

Ortolani, Riccardo; Pontarollo, Francesco; Pitari, Giuseppina; Conforti, Anita

2007-01-01

The foundation of homeopathic medicine is the ‘Similia Principle’, also known as the ‘Principle of Similarity’ or also as the ‘Simile’, which reflects the inversion of pharmacological effects in healthy subjects as compared with sick ones. This article describes the inversion of effects, a widespread medical phenomenon, through three possible mechanisms: non-linearity of dose–response relationship, different initial pathophysiological states of the organism, and pharmacodynamics of body response to the medicine. Based on the systemic networks which play an important role in response to stress, a unitary and general model is designed: homeopathic medicines could interact with sensitive (primed) regulation systems through complex information, which simulate the disorders of natural disease. Reorganization of regulation systems, through a coherent response to the medicine, could pave the way to the healing of the cellular, tissue and neuro-immuno-endocrine homeodynamics. Preliminary evidence is suggesting that even ultra-low doses and high-dilutions of drugs may incorporate structural or frequency information and interact with chaotic dynamics and physical-electromagnetic levels of regulation. From the clinical standpoint, the ‘simile’ can be regarded as a heuristic principle, according to which the detailed knowledge of pathogenic effects of drugs, associated with careful analysis of signs and symptoms of the ill subject, could assist in identifying homeopathic remedies with high grade of specificity for the individual case. PMID:17549232

Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications.

PubMed

Riboh, Jonathan C; Saltzman, Bryan M; Yanke, Adam B; Cole, Brian J

2016-09-01

Amniotic membrane (AM)-derived products have been successfully used in ophthalmology, plastic surgery, and wound care, but little is known about their potential applications in orthopaedic sports medicine. To provide an updated review of the basic science and preclinical and clinical data supporting the use of AM-derived products and to review their current applications in sports medicine. Systematic review. A systematic search of the literature was conducted using the Medline, EMBASE, and Cochrane databases. The search term amniotic membrane was used alone and in conjunction with stem cell, orthopaedic, tissue engineering, scaffold, and sports medicine. The search identified 6870 articles, 80 of which, after screening of the titles and abstracts, were considered relevant to this study. Fifty-five articles described the anatomy, basic science, and nonorthopaedic applications of AM-derived products. Twenty-five articles described preclinical and clinical trials of AM-derived products for orthopaedic sports medicine. Because the level of evidence obtained from this search was not adequate for systematic review or meta-analysis, a current concepts review on the anatomy, physiology, and clinical uses of AM-derived products is presented. Amniotic membranes have many promising applications in sports medicine. They are a source of pluripotent cells, highly organized collagen, antifibrotic and anti-inflammatory cytokines, immunomodulators, and matrix proteins. These properties may make it beneficial when applied as tissue engineering scaffolds, improving tissue organization in healing, and treatment of the arthritic joint. The current body of evidence in sports medicine is heavily biased toward in vitro and animal studies, with little to no human clinical data. Nonetheless, 14 companies or distributors offer commercial AM products. The preparation and formulation of these products alter their biological and mechanical properties, and a thorough understanding of these

[Homeopathy in cancer patients: What does the "best" evidence tell us?

PubMed

de Nonneville, Alexandre; Gonçalves, Anthony

2018-04-01

Homeopathic medicines are used by many patients with cancer, usually alongside conventional treatment. A recent report by the European Academies' Science Advisory Council concluded that "that there are no robust and reproducible evidence that homeopathy is effective". This literature review aims to make the analysis of published controlled randomized trials involving homeopathic treatment in the field of oncology. Copyright © 2018 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

Homeopathic prescribing for chronic and acute periodontal conditions in 3 dental practices in the UK.

PubMed

Farrer, S; Baitson, E S; Gedah, L; Norman, C; Darby, P; Mathie, R T

2013-10-01

This investigation extends our previous dental data collection pilot study with the following main aims: to gain insight into the periodontal complaints that dentists in the UK treat using individualised homeopathic prescription; to record patient-assessed change in severity of treated complaint (acute or chronic); to determine periodontal pocket depth (PPD). Three dentists recorded data systematically at 249 homeopathic appointments in 51 patients over a period of 18 months. A spreadsheet enabled the data collection of the following records: date of appointment; anonymised patient identity; main periodontal problem treated; whether the condition was acute or chronic; patient-assessed clinical outcome on a 7-point Likert scale, ranging from -3 to +3, to compare the first and any subsequent appointments; whether any interventional dental surgery (IDS) had been carried out; clinician-assessed PPD measurements. At least one follow-up (FU) appointment was reported for each of 46 patients (22 chronic [6 with IDS, 16 without IDS]; 24 acute [10 with IDS, 14 without IDS]). In chronic cases, strongly positive outcomes (score of +2 or +3) were reported by 2 (33.3%) of 6 IDS patients and by 1 (6.3%) of 16 non-IDS patients. In acute cases, strongly positive outcomes were reported by 7 (70%) of 10 IDS patients and by 8 (57.2%) of 14 non-IDS patients (no statistically significant difference between sub-groups). The FU conditions most frequently treated with homeopathy were chronic periodontitis (19 patients) and acute periodontal abscess (11 patients). Analysis of PPD data was not feasible due to the small numbers of patients involved. Limited insight has been gained into the periodontal complaints treated by homeopathy in the UK. Due to small sample size and equivocal results, the interpretation of the patient-reported outcomes data is unclear. Positive findings obtained in the acute treatment setting suggest that this may be a promising area for research in periodontal

Journeys in The Country of The Blind: Entanglement Theory and The Effects of Blinding on Trials of Homeopathy and Homeopathic Provings

PubMed Central

2007-01-01

The idea of quantum entanglement is borrowed from physics and developed into an algebraic argument to explain how double-blinding randomized controlled trials could lead to failure to provide unequivocal evidence for the efficacy of homeopathy, and inability to distinguish proving and placebo groups in homeopathic pathogenic trials. By analogy with the famous double-slit experiment of quantum physics, and more modern notions of quantum information processing, these failings are understood as blinding causing information loss resulting from a kind of quantum superposition between the remedy and placebo. PMID:17342236

Does the development of new medicinal products in the European Union address global and regional health concerns?

PubMed Central

2010-01-01

Background Since 1995, approval for many new medicinal products has been obtained through a centralized procedure in the European Union. In recent years, the use of summary measures of population health has become widespread. We investigated whether efforts to develop innovative medicines are focusing on the most relevant conditions from a global public health perspective. Methods We reviewed the information on new medicinal products approved by centralized procedure from 1995 to 2009, information that is available to the public in the European Commission Register of medicinal products and the European Public Assessment Reports from the European Medicines Agency. Morbidity and mortality data were included for each disease group, according to the Global Burden of Disease project. We evaluated the association between authorized medicinal products and burden of disease measures based on disability-adjusted life years (DALYs) in the European Union and worldwide. Results We considered 520 marketing authorizations for medicinal products and 338 active ingredients. New authorizations were seen to increase over the period analyzed. There was a positive, high correlation between DALYs and new medicinal product development (ρ = 0.619, p = 0.005) in the European Union, and a moderate correlation for middle-low-income countries (ρ = 0.497, p = 0.030) and worldwide (ρ = 0.490, p = 0.033). The most neglected conditions at the European level (based on their attributable health losses) were neuropsychiatric diseases, cardiovascular diseases, respiratory diseases, sense organ conditions, and digestive diseases, while globally, they were perinatal conditions, respiratory infections, sense organ conditions, respiratory diseases, and digestive diseases. Conclusions We find that the development of new medicinal products is higher for some diseases than others. Pharmaceutical industry leaders and policymakers are invited to consider the implications of this imbalance by establishing

[Development of guidance for the approval process of brand-new medical products and regenerative medicine products].

PubMed

Niimi, Shingo

2015-01-01

Ministry of Health, Labour and Weltare has been conducting development of guidance for the approval process of brand-new medical products/development of guidance for medical devices in collaboration with Ministry of Economy, Trade and Industry as part of measures to promote practical use of brand-new medical products since 2005. The objective of this project is to expedite the processes from developmental process of medical devices to approval review and to introduce the medical devices to medical front quickly.. Ministry of Health, Labour and Welfare side has been making guidance for the guide in approval process of brand-new medical products and regeneration medicine products to aim at acceleration and facilitation of development and approval process of innovative medical products. Twenty-two of the guidance have been issued as director of the evaluation and licensing division. The evaluation index about safety and efficacy required for medical devices and regenerative medicine products in progress were put together in these guidance and useful for medical devices developer to understand the point at the approved review. Therefore, I think that the evaluation index could also contribute to the efficient product development. The guidance about implantable artificial heart is issued as the representative example which was useful in the approved review.

Herbal medicine for low back pain.

PubMed

Gagnier, J J; van Tulder, M; Berman, B; Bombardier, C

2006-04-19

placebo for short-term improvements in pain and rescue medication. An additional trial demonstrated relative equivalence to 12.5 mg per day of rofecoxib. Three low quality trials on Capsicum Frutescens (Cayenne), examining various topical preparations, found moderate evidence that Capsicum Frutescens produced more favourable results than placebo and one trial found equivalence to a homeopathic ointment. Harpagophytum Procumbens, Salix Alba and Capsicum Frutescens seem to reduce pain more than placebo. Additional trials testing these herbal medicines against standard treatments are needed. The quality of reporting in these trials was generally poor. Trialists should refer to the CONSORT statement extension for reporting trials of herbal medicine interventions.

The use of animal models in homeopathic research--a review of 2010-2014 PubMed indexed papers.

PubMed

Bonamin, Leoni Villano; Cardoso, Thayná Neves; de Carvalho, Aloísio Cunha; Amaral, Juliana Gimenez

2015-10-01

In the 1990s, a study was performed on the effects of highly diluted thyroxine on frog metamorphosis. This model represented one of the most discussed examples of the biological effects of high dilutions over the next two decades. In 2010, another critical conceptual review of the use of animal models in homeopathy and high-dilution research was published. The main contribution of these studies was the elucidation of the biological features and phenomenology of the effects of high dilutions on living systems, representing an important step forward in our understanding of the mechanisms of action of homeopathic medicines. We performed a further review of this line of investigation using the same methods. Fifty-three articles that were indexed in the PubMed database and used 12 different animal species were systematically evaluated. Only a fraction of the studies (29/53) reported herein were performed with "ultra high" dilutions. The other studies were performed with dilutions in ranges below 10(-23) (14/53 articles) or commercial complexes (10/53 articles). Only two articles reported negative results; both used in vivo protocols to test commercial complexes, one in fish and one in bees. The quality of the employed techniques improved in 2010-2014 compared with the studies that were reviewed previously in 2010, with the inclusion of more ethically refined protocols, including in vitro primary cell cultures and ex vivo studies (10/53 articles), often with three or more replicates and analyses of epigenetic mechanisms that were previously unknown in 2010. In our updated review of the past 5 years, we found further demonstrations of the biological effects of homeopathy using more refined animal models and in vitro techniques. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

[Establishment of design space for production process of traditional Chinese medicine preparation].

PubMed

Xu, Bing; Shi, Xin-Yuan; Qiao, Yan-Jiang; Wu, Zhi-Sheng; Lin, Zhao-Zhou

2013-03-01

The philosophy of quality by design (QbD) is now leading the changes in the drug manufacturing mode from the conventional test-based approach to the science and risk based approach focusing on the detailed research and understanding of the production process. Along with the constant deepening of the understanding of the manufacturing process, the design space will be determined, and the emphasis of quality control will be shifted from the quality standards to the design space. Therefore, the establishment of the design space is core step in the implementation of QbD, and it is of great importance to study the methods for building the design space. This essay proposes the concept of design space for the production process of traditional Chinese medicine (TCM) preparations, gives a systematic introduction of the concept of the design space, analyzes the feasibility and significance to build the design space in the production process of traditional Chinese medicine preparations, and proposes study approaches on the basis of examples that comply with the characteristics of traditional Chinese medicine preparations, as well as future study orientations.

Prevalence and likelihood ratio of symptoms in patients with good therapeutic response to Lycopodium clavatum. A retrospective study.

PubMed

Eizayaga, José Enrique; Pozzi, María Isabel; Canan, María Clara; Saravia, Laura

2016-02-01

Assessment of the likelihood ratio (LR) of symptoms has been proposed as a rational means for detecting indicators to homeopathic medicines. To investigate the prevalence and LR of symptoms commonly attributed to the homeopathic medicine Lycopodium clavatum (Lyc). Secondarily, to answer the question if experienced homeopaths could intuitively infer which the main symptoms of this medicine are. The presence of 35 selected symptoms, prescribed medicines and therapeutic response were assessed retrospectively. The symptoms' prevalence in the Lyc responding population and the LR of the symptoms compared to their prevalence in the remainder of the population were calculated. Two hundred and two Lyc and 550 non Lyc cases (total 752) were included for analysis. Twenty-two symptoms were confirmed as pertaining to Lyc's semiology (prevalence %; LR): contemptuous (3.3; 6.7), urinary stones history (2.7; 5.4), egotism (5.6; 3.6), dictatorial (33.3; 3.4), haughty (8.7; 3.3), sleeps on abdomen (3.3; 3.3), intolerance to clothing in abdomen (12.0; 3.1), reproaches (4.0; 3.0), helplessness (24.0; 2.7), fear of failure (10.7; 2.6), irritability on waking in the morning (16.7; 2.5), constipation alternating with diarrhea (8.7; 2.5), intolerant to contradiction (59.3; 2.3), want of self confidence (30.0; 2.4), abdominal distension after eating (23.3; 2.1); ailments from anticipation (32.0; 1.9), irritability before menses (23.3; 1.8), conscientious (26.0; 1.6), desire of sweets (52.0; 1.6), desire of chocolate (16.7; 1.6), lack of vital heat (41.3; 1.3), and flatterer (1.3; ∞). Surveyed homeopaths' intuitive inferences correlated well with symptoms' prevalence but not with their LR. Lycopodium's main symptoms are well known by homeopaths, but their knowledge correlates well with the symptoms' prevalence and not with their LR. Retrospective assessment of prevalence and LR of symptoms in good responders might be a means for better selection of symptoms for prospective studies

The expanding role of the clinical haematologist in the new world of advanced therapy medicinal products.

PubMed

Lowdell, Mark W; Thomas, Amy

2017-01-01

Advanced therapy medicinal products (ATMPs) represent the current pinnacle of 'patient-specific medicines' and will change the nature of medicine in the near future. They fall into three categories; somatic cell-therapy products, gene therapy products and cells or tissues for regenerative medicine, which are termed 'tissue engineered' products. The term also incorporates 'combination products' where a human cell or tissue is combined with a medical device. Plainly, many of these new medicines share similarities with conventional haematological stem cell transplant products and donor lymphocyte infusions as well as solid organ grafts and yet ATMPs are regulated as medicines and their development has remained predominantly in academic settings and within specialist centres. However, with the advent of commercialisation of dendritic cell vaccines, chimeric antigen receptor (CAR)-T cells and genetically modified autologous haematopoietic stem cells to cure single gene-defects in β-thalassaemia and haemophilia, the widespread availability of these therapies needs to be accommodated. Uniquely to ATMPs, the patient or an allogeneic donor is regularly part of the manufacturing process. All of the examples given above require procurement of blood, bone marrow or an apheresate from a patient as a starting material for manufacture. This can only occur in a clinical facility licensed for the procurement of human cells for therapeutic use and this is likely to fall to haematology departments, either as stem cell transplant programmes or as blood transfusion departments, to provide under a contract with the company that will manufacture and supply the final medicine. The resource implications associated with this can impact on all haematology departments, not just stem cell transplant units, and should not be under-estimated. © 2016 John Wiley & Sons Ltd.

Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.

PubMed

Salmikangas, Paula; Menezes-Ferreira, Margarida; Reischl, Ilona; Tsiftsoglou, Asterios; Kyselovic, Jan; Borg, John Joseph; Ruiz, Sol; Flory, Egbert; Trouvin, Jean-Hugues; Celis, Patrick; Ancans, Janis; Timon, Marcos; Pante, Guido; Sladowski, Dariusz; Lipnik-Stangelj, Metoda; Schneider, Christian K

2015-01-01

During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development should be built around a well-controlled manufacturing process and a qualified product to guarantee reproducible data from nonclinical and clinical studies.

Homeopathy--between tradition and modern science: remedies as carriers of significance.

PubMed

Almirantis, Yannis

2013-04-01

The healing potential and description of homeopathic remedies, as determined in homeopathic pathogenic trials (HPTs) and verified by medical experience, are often found to be meaningfully connected with the symbolic content attributed to the original materials (tinctures, metals etc) through tradition or modern semantics. Such a connection is incompatible with a biomolecular mechanistic explanation of the healing action of remedies. The physiological effects of crude substances are often similar to the symptoms of illnesses cured by the corresponding homeopathic remedy. This is considered a manifestation of the similia principle. Evidence is brought here that in several cases the inverse situation occurs, with the healing properties of the crude substance and those of its homeopathic preparation partially coinciding, the remedy usually having broader healing properties. The existence of these two possibilities in the relationship of medicinal actions of remedy and the crude substance, offers evidence in favor of a direct involvement of the level of significances in the mechanism underlying the homeopathic phenomenon. Finally, an experimental methodology is proposed, which may bring the result of double-blind randomized studies for homeopathic remedies closer to the reported performance of homeopathy in real life medical practice. If successful, this method would be a further indication of a non-local, significance-related interpretation of homeopathy. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

[The use of medicinal products "off-label use" in the pediatric population--the border risk, or reasonable diligence?].

PubMed

Zajdel, Justyna

2011-01-01

Any medicinal product marketed in the country has its registration, under which are strictly defined indications and the extent to which a product can be used. It is of significance that the use of the product which is registered in the given range produces an effect similar to or identical to that effect, which is obtained after applying the product having a registration in a given indication. Relied on to justify the use of a medicinal product or medical product "off-label use" in Poland, there is also the fact that the same product has a registration in a particular indication in another EU member state or outside the Community. It is worth noting that the medicinal product may be used in therapeutic management of omitting or reducing the principles resulting from the SPC. However, this applies only to cases where the use of the medicinal product "off-label use" dictated by the necessity of saving life or health of the patient, and the previous ways and methods of treatment with the use of registered medicines have proved ineffective or insufficient to achieve the desired therapeutic effect.

Dietary Supplements in Children.

PubMed

Smolinske, Susan C

2017-12-01

High-quality systematic reviews of use of herbal or homeopathic remedies in children often suffer from design flaws, such as not following PRISMA guidelines, inconsistent outcome measurements, and paucity of high-quality studies. Herbal remedies have modest demonstrated benefits with insufficient evidence to recommend any particular supplement. Homeopathic remedies have no role in treatment of pediatric conditions, and have been associated with great harm in infants given homeopathic teething products. Two types of herbal supplements are associated with high risk in adolescents, energy drinks and adulterated weight-loss products. Parents should be counseled about risks of these products. Copyright © 2017 Elsevier Inc. All rights reserved.

Homeopathy for treatment of irritable bowel syndrome.

PubMed

Peckham, Emily J; Nelson, E Andrea; Greenhalgh, Joanne; Cooper, Katy; Roberts, E Rachel; Agrawal, Anurag

2013-11-13

Irritable bowel syndrome (IBS) is a common, chronic disorder that leads to decreased health-related quality of life and work productivity. Evidence-based treatment guidelines have not been able to give guidance on the effects of homeopathic treatment for IBS because no systematic reviews have been carried out to assess the effectiveness of homeopathic treatment for IBS. Two types of homeopathic treatment were evaluated in this systematic review. In clinical homeopathy a specific remedy is prescribed for a specific condition. This differs from individualised homeopathic treatment, where a homeopathic remedy based on a person's individual symptoms is prescribed after a detailed consultation. To assess the effectiveness and safety of homeopathic treatment for treating IBS. We searched MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Allied and Complementary Medicine Database (AMED), Cochrane IBD/FBD Group Specialised Register, Cochrane Complementary Medicine Field Specialised Register and the database of the Homeopathic Library (Hom-inform) from inception to February 2013. Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care, in adults with IBS were considered for inclusion. Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS. The overall quality of the evidence supporting this outcome was assessed using the GRADE criteria. We calculated the mean difference (MD) and 95% confidence interval (CI) for continuous outcomes and the risk ratio (RR) and 95% CI for dichotomous outcomes. Three RCTs (213 participants) were included. No cohort or case-control studies were identified. Two studies published in 1976 and 1979 compared clinical homeopathy (homeopathic remedy) to placebo for constipation-predominant IBS

The remote supervisory and controlling experiment system of traditional Chinese medicine production based on Fieldbus

NASA Astrophysics Data System (ADS)

Zhan, Jinliang; Lu, Pei

2006-11-01

Since the quality of traditional Chinese medicine products are affected by raw material, machining and many other factors, it is difficult for traditional Chinese medicine production process especially the extracting process to ensure the steady and homogeneous quality. At the same time, there exist some quality control blind spots due to lacking on-line quality detection means. But if infrared spectrum analysis technology was used in traditional Chinese medicine production process on the basis of off-line analysis to real-time detect the quality of semi-manufactured goods and to be assisted by advanced automatic control technique, the steady and homogeneous quality can be obtained. It can be seen that the on-line detection of extracting process plays an important role in the development of Chinese patent medicines industry. In this paper, the design and implement of a traditional Chinese medicine extracting process monitoring experiment system which is based on PROFIBUS-DP field bus, OPC, and Internet technology is introduced. The system integrates intelligence node which gathering data, superior sub-system which achieving figure configuration and remote supervisory, during the process of traditional Chinese medicine production, monitors the temperature parameter, pressure parameter, quality parameter etc. And it can be controlled by the remote nodes in the VPN (Visual Private Network). Experiment and application do have proved that the system can reach the anticipation effect fully, and with the merits of operational stability, real-time, reliable, convenient and simple manipulation and so on.

Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.

PubMed

Salmikangas, Paula; Schuessler-Lenz, Martina; Ruiz, Sol; Celis, Patrick; Reischl, Ilona; Menezes-Ferreira, Margarida; Flory, Egbert; Renner, Matthias; Ferry, Nicolas

2015-01-01

With the release of Regulation 1394/2007, a new framework for gene and cell therapy medicinal products and tissue-engineered products was established in the European Union. For all three product classes, called advanced therapy medicinal products, a centralised marketing authorisation became mandatory. The European Medicines Agency (EMA) together with its Committee for Advanced Therapies, Committee for Human Medicinal Products and the network of national agencies is responsible for scientific evaluation of the marketing authorisation applications. For a new application, data and information relating to manufacturing processes and quality control of the active substance and the final product have to be submitted for evaluation together with data from non-clinical and clinical safety and efficacy studies. Technical requirements for ATMPs are defined in the legislation, and guidance for different products is available through several EMA/CAT guidelines. Due to the diversity of ATMPs, a tailored approach for regulating these products is considered necessary. Thus, a risk-based approach has been introduced for ATMPs allowing flexibility for the regulatory requirements. Since the regulatory framework for ATMPs was established, five products have been licenced in the European Union. However, the pipeline of new ATMPs is much bigger, as seen from the significant numbers of different products discussed by the CAT in scientific advice and classification procedures. In 2013, a public consultation on the ATMP Regulation was conducted by the European Commission, and the results were published in 2014. The report proposes several improvements for the current framework and established procedures for the regulation of ATMPs.

Individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP study): a randomized, double-dummy, double-blind, placebo-controlled trial.

PubMed

Macías-Cortés, Emma Del Carmen; Llanes-González, Lidia; Aguilar-Faisal, Leopoldo; Asbun-Bojalil, Juan

2015-01-01

Perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression. A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test). After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale. Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo in response definition only. Homeopathy, but

Individualized Homeopathic Treatment and Fluoxetine for Moderate to Severe Depression in Peri- and Postmenopausal Women (HOMDEP-MENOP Study): A Randomized, Double-Dummy, Double-Blind, Placebo-Controlled Trial

PubMed Central

Macías-Cortés, Emma del Carmen; Llanes-González, Lidia; Aguilar-Faisal, Leopoldo; Asbun-Bojalil, Juan

2015-01-01

Background Perimenopausal period refers to the interval when women's menstrual cycles become irregular and is characterized by an increased risk of depression. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. The aim of this study was to assess efficacy and safety of individualized homeopathic treatment versus placebo and fluoxetine versus placebo in peri- and postmenopausal women with moderate to severe depression. Methods/Design A randomized, placebo-controlled, double-blind, double-dummy, superiority, three-arm trial with a 6 week follow-up study was conducted. The study was performed in a public research hospital in Mexico City in the outpatient service of homeopathy. One hundred thirty-three peri- and postmenopausal women diagnosed with major depression according to DSM-IV (moderate to severe intensity) were included. The outcomes were: change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression, Beck Depression Inventory and Greene Scale, after 6 weeks of treatment, response and remission rates, and safety. Efficacy data were analyzed in the intention-to-treat population (ANOVA with Bonferroni post-hoc test). Results After a 6-week treatment, homeopathic group was more effective than placebo by 5 points in Hamilton Scale. Response rate was 54.5% and remission rate, 15.9%. There was a significant difference among groups in response rate definition only, but not in remission rate. Fluoxetine-placebo difference was 3.2 points. No differences were observed among groups in the Beck Depression Inventory. Homeopathic group was superior to placebo in Greene Climacteric Scale (8.6 points). Fluoxetine was not different from placebo in Greene Climacteric Scale. Conclusion Homeopathy and fluoxetine are effective and safe antidepressants for climacteric women. Homeopathy and fluoxetine were significantly different from placebo

Estimated costs of production and potential prices for the WHO Essential Medicines List

PubMed Central

Hill, Andrew M; Barber, Melissa J

2018-01-01

Introduction There are persistent gaps in access to affordable medicines. The WHO Model List of Essential Medicines (EML) includes medicines considered necessary for functional health systems. Methods A generic price estimation formula was developed by reviewing published analyses of cost of production for medicines and assuming manufacture in India, which included costs of formulation, packaging, taxation and a 10% profit margin. Data on per-kilogram prices of active pharmaceutical ingredient exported from India were retrieved from an online database. Estimated prices were compared with the lowest globally available prices for HIV/AIDS, tuberculosis (TB) and malaria medicines, and current prices in the UK, South Africa and India. Results The estimation formula had good predictive accuracy for HIV/AIDS, TB and malaria medicines. Estimated generic prices ranged from US$0.01 to US$1.45 per unit, with most in the lower end of this range. Lowest available prices were greater than estimated generic prices for 214/277 (77%) comparable items in the UK, 142/212 (67%) in South Africa and 118/298 (40%) in India. Lowest available prices were more than three times above estimated generic price for 47% of cases compared in the UK and 22% in South Africa. Conclusion A wide range of medicines in the EML can be profitably manufactured at very low cost. Most EML medicines are sold in the UK and South Africa at prices significantly higher than those estimated from production costs. Generic price estimation and international price comparisons could empower government price negotiations and support cost-effectiveness calculations. PMID:29564159

Reporting Experiments in Homeopathic Basic Research (REHBaR).

PubMed

Stock-Schröer, Beate

2015-10-01

The aim of this study was to develop a criteria catalogue serving as a guideline for authors to improve quality of Reporting Experiments in Homeopathic Basic Research (REHBaR). Main focus was in the field of biochemical and biological experiments. So far, there was no guideline for scientists and authors available, unlike criteria catalogues common in clinical research. A Delphi Process was conducted among experts who published experimental work within the last five years in this field. The process included a total of five rounds, three rounds of adjusting and phrasing plus two consensus conferences. A checklist of 23 items was achieved, augmented with detailed examples how to handle each item while compiling a publication. Background, objectives and possible hypotheses are necessary to be given in the part 'introduction'. The section 'materials and methods' is the most important part, where a detailed description of chosen controls, object of investigation, experimental setup, replication, parameters, intervention, allocation, blinding, and statistical methods is mandatory. In the 'results' section sufficient details on analysed data, descriptive as well as inferential are needed. Moreover, authors should discuss their results and interpret them in the context of current evidence. REHBaR was compiled for authors when preparing their manuscripts, and to be used by scientific journals in the reviewing process. Reporting experiments in basic research in homeopathy is an important issue to state the quality and validity of gained results. A guideline for REHBaR seemed to be the first step to come to a commitment what information is necessary to be given in a paper. More than that, the catalogue can serve as a statement what the standards in good basic research should be. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Quality transitivity and traceability system of herbal medicine products based on quality markers.

PubMed

Liu, Changxiao; Guo, De-An; Liu, Liang

2018-05-15

Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

Sustainability of a public system for plasma collection, contract fractionation and plasma-derived medicinal product manufacturing

PubMed Central

Grazzini, Giuliano; Ceccarelli, Anna; Calteri, Deanna; Catalano, Liviana; Calizzani, Gabriele; Cicchetti, Americo

2013-01-01

Background In Italy, the financial reimbursement for labile blood components exchanged between Regions is regulated by national tariffs defined in 1991 and updated in 1993–2003. Over the last five years, the need for establishing standard costs of healthcare services has arisen critically. In this perspective, the present study is aimed at defining both the costs of production of blood components and the related prices, as well as the prices of plasma-derived medicinal products obtained by national plasma, to be used for interregional financial reimbursement. Materials and methods In order to analyse the costs of production of blood components, 12 out 318 blood establishments were selected in 8 Italian Regions. For each step of the production process, driving costs were identified and production costs were. To define the costs of plasma-derived medicinal products obtained by national plasma, industrial costs currently sustained by National Health Service for contract fractionation were taken into account. Results The production costs of plasma-derived medicinal products obtained from national plasma showed a huge variability among blood establishments, which was much lower after standardization. The new suggested plasma tariffs were quite similar to those currently in force. Comparing the overall costs theoretically sustained by the National Health Service for plasma-derived medicinal products obtained from national plasma to current commercial costs, demonstrates that the national blood system could gain a 10% cost saving if it were able to produce plasma for fractionation within the standard costs defined in this study. Discussion Achieving national self-sufficiency through the production of plasma-derived medicinal products from national plasma, is a strategic goal of the National Health Service which must comply not only with quality, safety and availability requirements but also with the increasingly pressing need for economic sustainability. PMID:24333307

Sustainability of a public system for plasma collection, contract fractionation and plasma-derived medicinal product manufacturing.

PubMed

Grazzini, Giuliano; Ceccarelli, Anna; Calteri, Deanna; Catalano, Liviana; Calizzani, Gabriele; Cicchetti, Americo

2013-09-01

In Italy, the financial reimbursement for labile blood components exchanged between Regions is regulated by national tariffs defined in 1991 and updated in 1993-2003. Over the last five years, the need for establishing standard costs of healthcare services has arisen critically. In this perspective, the present study is aimed at defining both the costs of production of blood components and the related prices, as well as the prices of plasma-derived medicinal products obtained by national plasma, to be used for interregional financial reimbursement. In order to analyse the costs of production of blood components, 12 out 318 blood establishments were selected in 8 Italian Regions. For each step of the production process, driving costs were identified and production costs were. To define the costs of plasma-derived medicinal products obtained by national plasma, industrial costs currently sustained by National Health Service for contract fractionation were taken into account. The production costs of plasma-derived medicinal products obtained from national plasma showed a huge variability among blood establishments, which was much lower after standardization. The new suggested plasma tariffs were quite similar to those currently in force. Comparing the overall costs theoretically sustained by the National Health Service for plasma-derived medicinal products obtained from national plasma to current commercial costs, demonstrates that the national blood system could gain a 10% cost saving if it were able to produce plasma for fractionation within the standard costs defined in this study. Achieving national self-sufficiency through the production of plasma-derived medicinal products from national plasma, is a strategic goal of the National Health Service which must comply not only with quality, safety and availability requirements but also with the increasingly pressing need for economic sustainability.

Optimization of yeast-based production of medicinal protoberberine alkaloids.

PubMed

Galanie, Stephanie; Smolke, Christina D

2015-09-16

Protoberberine alkaloids are bioactive molecules abundant in plant preparations for traditional medicines. Yeast engineered to express biosynthetic pathways for fermentative production of these compounds will further enable investigation of the medicinal properties of these molecules and development of alkaloid-based drugs with improved efficacy and safety. Here, we describe the optimization of a biosynthetic pathway in Saccharomyces cerevisiae for conversion of rac-norlaudanosoline to the protoberberine alkaloid (S)-canadine. This yeast strain is engineered to express seven heterologous enzymes, resulting in protoberberine alkaloid production from a simple benzylisoquinoline alkaloid precursor. The seven enzymes include three membrane-bound enzymes: the flavin-dependent oxidase berberine bridge enzyme, the cytochrome P450 canadine synthase, and a cytochrome P450 reductase. A number of strategies were implemented to improve flux through the pathway, including enzyme variant screening, genetic copy number variation, and culture optimization, that led to an over 70-fold increase in canadine titer up to 1.8 mg/L. Increased canadine titers enable extension of the pathway to produce berberine, a major constituent of several traditional medicines, for the first time in a microbial host. We also demonstrate that this strain is viable at pilot scale. By applying metabolic engineering and synthetic biology strategies for increased conversion of simple benzylisoquinoline alkaloids to complex protoberberine alkaloids, this work will facilitate chemoenzymatic synthesis or de novo biosynthesis of these and other high-value compounds using a microbial cell factory.

Alternative medicine: an ethnographic study of how practitioners of Indian medical systems manage TB in Mumbai.

PubMed

McDowell, Andrew; Pai, Madhukar

2016-03-01

Mumbai is a hot spot for drug-resistant TB, and private practitioners trained in AYUSH systems (Ayurveda, yoga, Unani, Siddha and homeopathy) are major healthcare providers. It is important to understand how AYUSH practitioners manage patients with TB or presumptive TB. We conducted semi-structured interviews of 175 Mumbai slum-based practitioners holding degrees in Ayurveda, homeopathy and Unani. Most providers gave multiple interviews. We observed 10 providers in clinical interactions, documenting: clinical examinations, symptoms, history taking, prescriptions and diagnostic tests. No practitioners exclusively used his or her system of training. The practice of biomedicine is frequent, with practitioners often using biomedical disease categories and diagnostics. The use of homeopathy was rare (only 4% of consultations with homeopaths resulted in homeopathic remedies) and Ayurveda rarer (3% of consultations). For TB, all mentioned chest x-ray while 31 (17.7%) mentioned sputum smear as a TB test. One hundred and sixty-four practitioners (93.7%) reported referring TB patients to a public hospital or chest physician. Eleven practitioners (6.3%) reported treating patients with TB. Nine (5.1%) reported treating patients with drug-susceptible TB with at least one second-line drug. Important sources of health care in Mumbai's slums, AYUSH physicians frequently use biomedical therapies and most refer patients with TB to chest physicians or the public sector. They are integral to TB care and control. © The Author 2016. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Use of complementary and alternative medicine in Israel: 2000 vs. 1993.

PubMed

Shmueli, Amir; Shuval, Judith

2004-01-01

Complementary and alternative medical care has gained increasing popularity in western societies in recent years. To provide a cross-sectional and temporal (2000 vs. 1993) analysis of the use of complementary and alternative medicine in Israel. The subjects studied represented the Israeli Jewish urban population aged 45-75 years. Full sit-down interviews were conducted with 2,003 respondents in 1993 and 2,505 respondents in 2000. For 1993, 6% of the population reported on consultations with CAM providers during the previous year. For 2000, that proportion increased to 10%. Being a woman, having higher education, enjoying better economic status, being younger, living in a big city, and being dissatisfied with specialists' care were all positively related to the use of non-conventional medicine, particularly in 2000. In both years, more than 50% of the consultations were with acupuncturists and homeopaths. However, chiropractors have doubled their market shares, and lower back pain became the leading problem for which care was sought. The main reason for consulting CAM was a reluctance to use too many drugs or to undergo an invasive procedure. However, a significant proportion of the users continue to use conventional medicine concurrently. Seventy-five percent in 2000 and 60% in 1993 reported that the treatment helped. Between 1993 and 2000, CAM in Israel changed from an infant industry into a mainstream medical commodity, reflected in both prevalence and different patterns of consumption.

[Interpretation of the concept of 'medicinal product' in relation to herb- and cannabinoid-based products].

PubMed

Zsigmond, Ferge

2014-11-30

On 10th of July 2014 the European Court of Justice made in his decisions in relation to the cases D. (C-358/13) and G. (C-181/14) an interpretation, that the concept of 'medicinal product' according to the law of the European Union does not include the materials, which are - as not covering substances, such as those at issue in the main proceedings, which produce effects that merely modify physiological functions but which are not such as to have any beneficial effects, either immediately or in the long term, on human health, are consumed solely to induce a state of intoxication and are, as such, harmful to human health. The Court made his interpretation after the request for preliminary ruling from the Bundesgerichtshof (the High Court of Justice in Germany). The Court had to decide in two criminal procedures, whether for the retail of mixtures including syntetic canabinoids, such as complements of marihuana, due the fact that they are "unsafe medicinal products", a criminal proceeding can be initiated or not. The Ordinary Courts had two persons (D. and G.) for selling the unsafe medicinal products sentenced to one year and nine months imprisonment, and suspension (D.), and sentenced (G.) to four years and six months imprisonment and fined with a charge of two hundred thousand Euro. The retail of herb mixtures containing, inter alia, synthetic cannabinoids, did not fall under the German law on narcotic drugs at the material time, resulting that the German Authorities could not initiate a criminal procedure.

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

PubMed

Nayak, Chaturbhuja; Singh, Vikram; Singh, V P; Oberai, Praveen; Roja, Varanasi; Shitanshu, Shashi Shekhar; Sinha, M N; Deewan, Deepti; Lakhera, B C; Ramteke, Sunil; Kaushik, Subhash; Sarkar, Sarabjit; Mandal, N R; Mohanan, P G; Singh, J R; Biswas, Sabyasachi; Mathew, Georgekutty

2012-04-01

The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS). 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. 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. Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation. Copyright © 2012 Elsevier Ltd. All rights reserved.

Adverse effects of homeopathy, what do we know? A systematic review and meta-analysis of randomized controlled trials.

PubMed

Stub, Trine; Musial, Frauke; Kristoffersen, Agnete A; Alræk, Terje; Liu, Jianping

2016-06-01

Homeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients' symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed. Sixteen electronic databases were searched for Randomized Controlled Trials (RCTs). The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055 participants were included. A subtotal of 39 studies was included in the additional meta-analysis. A total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86-1.14, I(2)=54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade 2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high. Adverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine

Innovation, productivity, and pricing: Capturing value from precision medicine technology in Canada.

PubMed

Emery, J C Herbert; Zwicker, Jennifer D

2017-07-01

For new technology and innovation such as precision medicine to become part of the solution for the fiscal sustainability of Canadian Medicare, decision-makers need to change how services are priced rather than trying to restrain emerging technologies like precision medicine for short-term cost savings. If provincial public payers shift their thinking to be public purchasers, value considerations would direct reform of the reimbursement system to have prices that adjust with technologically driven productivity gains. This strategic shift in thinking is necessary if Canadians are to benefit from the promised benefits of innovations like precision medicine.

Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

PubMed

Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

2017-12-05

The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

PubMed

Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

2010-01-01

The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

[The amazing career of a homeopath, philanthropist, Fourierist, Benoît-Jules Mure. (1809-1858)].

PubMed

Ségal, Alain; Trépardoux, Francis

2005-01-01

The authors evoke the difficulty of dealing with the life and work of Benoît-Jules Mure who was a homeopathic scientist and a keen specialist on propaganda. He was also an adept of Charles Fourier and he used almost his fortune to the spreading of homeopathy and at time, the improvement of social life. Thus he tried to settle humanitarian colonies in Brazil and later in Egypt, Nubian and Sudan in order to improve their fashion of life. He was hit by tuberculosis which led him discover homeopathy and by his strength of character lie led the idea of his mission in favour of his convictions. He was very angry with the official medical organisation and at last he never has been recognized as a médical doctor. The authors underline that his life and his work have probably left some definite marks in the South America let alone the birth of Socialism.

Worldwide withdrawal of medicinal products because of adverse drug reactions: a systematic review and analysis.

PubMed

Onakpoya, Igho J; Heneghan, Carl J; Aronson, Jeffrey K

2016-07-01

We have systematically identified medicinal products withdrawn worldwide because of adverse drug reactions, assessed the level of evidence used for making the withdrawal decisions, and explored the patterns of withdrawals over time. We searched PubMed, the WHO database of withdrawn products, and selected texts. We included products that were withdrawn after launch from 1950 onwards, excluding non-human and over-the-counter medicines. We assessed the levels of evidence on which withdrawals were based using the Oxford Center for Evidence Based Medicine Levels of Evidence. Of 353 medicinal products withdrawn from any country, only 40 were withdrawn worldwide. Anecdotal reports were cited as evidence for withdrawal in 30 (75%) and deaths occurred in 27 (68%). Hepatic, cardiac, and nervous system toxicity accounted for over 60% of withdrawals. In 28 cases, the first withdrawal was initiated by the manufacturer. The median interval between the first report of an adverse drug reaction that led to withdrawal and the first withdrawal was 1 year (range 0-43 years). Worldwide withdrawals occurred within 1 year after the first withdrawal in any country. In conclusion, the time it takes for drugs to be withdrawn worldwide after reports of adverse drug reactions has shortened over time. However, there are inconsistencies in current withdrawal procedures when adverse drug reactions are suspected. A uniform method for establishing worldwide withdrawal of approved medicinal products when adverse drug reactions are suspected should be developed, to facilitate global withdrawals. Rapid synthesis of the evidence on harms should be a priority when serious adverse reactions are suspected.

Effects of a dragonfly (Anax i.) homeopathic remedy on learning, memory and cell morphology in mice.

PubMed

Mutlu, Oguz; Ulak, Guner; Kokturk, Sibel; Komsuoglu Celikyurt, Ipek; Tanyeri, Pelin; Akar, Furuzan; Erden, Faruk

2016-02-01

Homeopathy is a form of alternative medicine in which uses highly diluted preparations that are believed to cause healthy people to exhibit symptoms similar to those exhibited by patients. The aim of this study was to investigate the effects of dragonfly (Anax imperator, Anax i.) on learning and memory in naive mice using the Morris water maze (MWM) test; moreover, the effects of dragonfly on MK-801-induced cognitive dysfunction were evaluated. Male balb-c mice were treated with dragonfly (30C and 200C) or MK-801 (0.2 mg/kg) alone or concurrently (n = 10). Dragonfly (D) and MK-801 were administered subchronically for 6 days intraperitoneally 60 min and 30 min, respectively, before the daily performance of the MWM test. This study revealed that in the familiarization session and first session of the MWM test, Anax i. D30 significantly decreased escape latency compared to the control group, although MK-801, D30 and D200 significantly increased escape latency at the end of five acquisition sessions. Anax i. combined with dizocilpine maleate (MK-801) also significantly decreased escape latency in the familiarization session and first session of the MWM test, although this combination increased escape latency compared to the MK-801 alone group at the end of the test. Time spent in escape platform's quadrant in the probe trial significantly decreased while mean distance to platform significantly increased in MK-801, D30 and D200 groups. In the MWM test, Anax i. combined with MK-801 significantly decreased speed of the animals compared to the MK-801 alone group. General cell morphology was disturbed in the MK-801 group while D30 and D200 seemed to improve cell damage in the MK-801 group. These results suggest that the homeopathic Anax i. can impair learning acquisition and reference memory, and it has beneficial effects on disturbed cell morphology. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Homeopathy for Depression - DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study

PubMed Central

2011-01-01

Background Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history. Methods/Design A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode) by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history. Discussion For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an attempt to deal with the

Bar-HRM for Authentication of Plant-Based Medicines: Evaluation of Three Medicinal Products Derived from Acanthaceae Species

PubMed Central

Osathanunkul, Maslin; Madesis, Panagiotis; de Boer, Hugo

2015-01-01

Medicinal plants are used as a popular alternative to synthetic drugs, both in developed and developing countries. The economic importance of the herbal and natural supplement industry is increasing every year. As the herbal industry grows, consumer safety is one issue that cannot be overlooked. Herbal products in Thai local markets are commonly sold without packaging or labels. Plant powders are stored in large bags or boxes, and therefore buying local herbal products poses a high risk of acquiring counterfeited, substituted and/or adulterated products. Due to these issues, a reliable method to authenticate products is needed. Here DNA barcoding was used in combination with High Resolution Melting analysis (Bar-HRM) to authenticate three medicinal Acanthaceae species (Acanthus ebracteatus, Andrographis paniculata and Rhinacanthus nasutus) commonly used in Thailand. The rbcL barcode was selected for use in primers design for HRM analysis to produce standard melting profiles of the selected species. Melting data from the HRM assay using the designed rbcL primers showed that the three chosen species could be distinguished from each other. HRM curves of all fifteen test samples indicated that three of tested products did not contain the indicated species. Two closely related species (A. paniculata and R. nasutus), which have a high level of morphological similarity, were interchanged with one another in three tested products. Incorrect information on packaging and labels of the tested herbal products was the cause of the results shown here. Morphological similarity among the species of interest also hindered the collection process. The Bar-HRM method developed here proved useful in aiding in the identification and authentication of herbal species in processed samples. In the future, species authentication through Bar-HRM could be used to promote consumer trust, as well as raising the quality of herbal products. PMID:26011474

Bar-HRM for Authentication of Plant-Based Medicines: Evaluation of Three Medicinal Products Derived from Acanthaceae Species.

PubMed

Osathanunkul, Maslin; Madesis, Panagiotis; de Boer, Hugo

2015-01-01

Medicinal plants are used as a popular alternative to synthetic drugs, both in developed and developing countries. The economic importance of the herbal and natural supplement industry is increasing every year. As the herbal industry grows, consumer safety is one issue that cannot be overlooked. Herbal products in Thai local markets are commonly sold without packaging or labels. Plant powders are stored in large bags or boxes, and therefore buying local herbal products poses a high risk of acquiring counterfeited, substituted and/or adulterated products. Due to these issues, a reliable method to authenticate products is needed. Here DNA barcoding was used in combination with High Resolution Melting analysis (Bar-HRM) to authenticate three medicinal Acanthaceae species (Acanthus ebracteatus, Andrographis paniculata and Rhinacanthus nasutus) commonly used in Thailand. The rbcL barcode was selected for use in primers design for HRM analysis to produce standard melting profiles of the selected species. Melting data from the HRM assay using the designed rbcL primers showed that the three chosen species could be distinguished from each other. HRM curves of all fifteen test samples indicated that three of tested products did not contain the indicated species. Two closely related species (A. paniculata and R. nasutus), which have a high level of morphological similarity, were interchanged with one another in three tested products. Incorrect information on packaging and labels of the tested herbal products was the cause of the results shown here. Morphological similarity among the species of interest also hindered the collection process. The Bar-HRM method developed here proved useful in aiding in the identification and authentication of herbal species in processed samples. In the future, species authentication through Bar-HRM could be used to promote consumer trust, as well as raising the quality of herbal products.

Navigating through orphan medicinal product regulations in EU and US--similarities and differences.

PubMed

Tiwari, Jyoti

2015-02-01

Rare diseases as the name suggests are the diseases which occur in a very small population due to which the development of medicinal products for these diseases is sidelined as it is anticipated that the cost of development will never be recovered from the sales. It has been estimated by National Institute of Health (NIH) that globally around 7000 rare diseases are there, many of which are of genetic origin. This paper aims to analyze the basic similarities and differences between the rules and regulations put forth by regulatory agencies of US and EU for development of medicinal products for rare diseases, also called orphan medicinal products. The basic purpose was to carve out the loopholes as well as positive aspects of each of these acts and regulations so as to have a clear understanding on the subject. It was to understand that how these legal instruments have stimulated the growth of the drug products for rare diseases and what other things can be done in order to achieve a better impact. This article also provides an overview of the various incentives offered as well as challenges and hurdles faced by each of these regulatory agencies while implementing these regulations. Copyright © 2014 Elsevier Inc. All rights reserved.

Studies on saponin production in tropical medicinal plants Maesa argentea and Maesa lanceolata

NASA Astrophysics Data System (ADS)

Faizal, Ahmad; Geelen, Danny

2015-09-01

The continuous need for new compounds with important medicinal activities has lead to the identification and characterization of various plant-derived natural products. As a part of this program, we studied the saponin production from two tropical medicinal plants Maesa argentea and M. lanceolata and evaluated several treatments to enhance their saponin production. In this experiment, we present the analyses of saponin production from greenhouse grown plants by means of TLC and HPLC-MS. We observed that the content of saponin from these plants varied depending on organ and physiological age of the plants. In addition, the impact of elicitors on saponin accumulation on in vitro grown plants was analyzed using TLC. The production of saponin was very stable and not affected by treatment with methyl jasmonate, and salicylic acid. In conclusion, Maesa saponins are constitutively produced in plants and the level of these compounds in plants is mainly affected by the developmental or physiological stage.

Application of plant cell and tissue culture for the production of phytochemicals in medicinal plants.

PubMed

Pant, Bijaya

2014-01-01

Approximately 80% of the world inhabitants depend on the medicinal plants in the form of traditional formulations for their primary health care system well as in the treatment of a number of diseases since the ancient time. Many commercially used drugs have come from the information of indigenous knowledge of plants and their folk uses. Linking of the indigenous knowledge of medicinal plants to modern research activities provides a new reliable approach, for the discovery of novel drugs much more effectively than with random collection. Increase in population and increasing demand of plant products along with illegal trade are causing depletion of medicinal plants and many are threatened in natural habitat. Plant tissue culture technique has proved potential alternative for the production of desirable bioactive components from plants, to produce the enough amounts of plant material that is needed and for the conservation of threatened species. Different plant tissue culture systems have been extensively studied to improve and enhance the production of plant chemicals in various medicinal plants.

Short-term effects of repeated olfactory administration of homeopathic sulphur or pulsatilla on electroencephalographic alpha power in healthy young adults.

PubMed

Bell, Iris R; Brooks, Audrey J; Howerter, Amy; Jackson, Nicholas; Schwartz, Gary E

2011-10-01

Homeopathic pathogenetic trials usually rely on symptom self report measures. Adding objective biomarkers could enhance detection of subtle initial remedy effects. The present feasibility study examined electroencephalographic (EEG) effects of repeated olfactory administration of two polycrest remedies. College student volunteers (ages 18-30, both sexes) from an introductory psychology course were screened for good health and relatively elevated Sulphur or Pulsatilla symptom scores on the Homeopathic Constitutional Type Questionnaire (CTQ). Subjects underwent a series of 3 once-weekly double-blind sessions during which they repeatedly sniffed the remedy matched to their CTQ type and solvent controls. Each remedy was given in a 6c, 12c, and 30c potency, one potency per week, in randomly assigned order. Solvent controls included both plain distilled water and a water-ethanol (95%) solution. All sniff test solutions were further diluted just prior to laboratory sessions (0.5 ml test solution in 150 ml distilled water). Within a session, remedies and control solvents were administered via 2-s sniffs (8 sniffs of each of 4 different succussion levels for the potency in randomized order). Primary outcome variable was relative EEG power (alpha 1 8-10 Hz; alpha 2 10-12 Hz) averaged over 19 electrode sites, including all succussions for a given potency. Mixed-effect models revealed significant main effects for remedy type (Sulphur >Pulsatilla) in both alpha bands, controlling for gender, baseline resting EEG alpha, and solvent control responses. Additional analyses showed significant nonlinear interactions between dilution and time (weekly session) in alpha 2 for both remedies and alpha 1 for Sulphur. EEG alpha offers an objective biomarker of remedy effects for future studies and potential method for distinguishing time-dependent effects of specific remedies and remedy potencies from one another. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd

Short-Term Effects of Repeated Olfactory Administration of Homeopathic Sulphur or Pulsatilla on Electroencephalographic Alpha Power in Healthy Young Adults

PubMed Central

Bell, Iris R.; Brooks, Audrey J.; Howerter, Amy; Jackson, Nicholas; Schwartz, Gary E.

2011-01-01

Introduction Homeopathic pathogenetic trials usually rely on symptom self report measures. Adding objective biomarkers could enhance detection of subtle initial remedy effects. The present feasibility study examined electroencephalographic (EEG) effects of repeated olfactory administration of two polycrest remedies. Methods College student volunteers (ages 18–30, both sexes) from an introductory psychology course were screened for good health and relatively elevated Sulphur OR Pulsatilla symptom scores on the Homeopathic Constitutional Type Questionnaire. Subjects underwent a series of 3 once-weekly double-blind sessions during which they repeatedly sniffed the remedy matched to their CTQ type and solvent controls. Each remedy was given in a 6c, 12c, and 30c potency, one potency per week, in randomly assigned order. Solvent controls included both plain distilled water and a water-ethanol (95%) solution. All sniff test solutions were further diluted just prior to laboratory sessions (0.5 ml test solution in 150 ml distilled water). Within a session, remedies and control solvents were administered via 2-second sniffs (8 sniffs of each of 4 different succussion levels for the potency in randomized order). Primary outcome variable was relative EEG power (alpha 1 8–10 hertz; alpha 2 10–12 hertz) averaged over 19 electrode sites, including all succussions for a given potency. Results Mixed-effect models revealed significant main effects for remedy type (Sulphur>Pulsatilla) in both alpha bands, controlling for gender, baseline resting EEG alpha, and solvent control responses. Additional analyses showed significant non-linear interactions between dilution and time (weekly session) in alpha 2 for both remedies and alpha 1 for Sulphur. Conclusion EEG alpha offers an objective biomarker of remedy effects for future studies and potential method for distinguishing time-dependent effects of specific remedies and remedy potencies from one another. PMID:21962194

Animal-derived natural products of Sowa Rigpa medicine: Their pharmacopoeial description, current utilization and zoological identification.

PubMed

Yeshi, Karma; Morisco, Paolo; Wangchuk, Phurpa

2017-07-31

The Bhutanese Sowa Rigpa medicine (BSM) uses animal parts in the preparation of numerous polyingredient traditional remedies. Our study reports the taxonomical identification of medicinal animals and the description of traditional uses in English medical terminologies. To taxonomically identify the medicinal animals and their derived natural products used as a zootherapeutic agents in BSM. First, the traditional textbooks were reviewed to generate a list of animal products described as ingredients. Second, animal parts that are currently used in Bhutan were identified. Third, the ethnopharmacological uses of each animal ingredients were translated into English medical terminologies by consulting Traditional Physicians, clinical assistants, pharmacognosists, and pharmacists in Bhutan. Fourth, the animal parts were taxonomically identified and their Latin names were confirmed by crosschecking them with online animal databases and relevant scientific literature. The study found 73 natural products belonging to 29 categories derived from 45 medicinal animals (36 vertebrates and 9 invertebrates), comprising of 9 taxonomic categories and 30 zoological families. Out of 116 formulations currently produced, 87 of them contain one or more extracts and products obtained from 13 medicinal animals to treat more than 124 traditionally classified illnesses. Only five animal ingredients were found available in Bhutan and rest of the animal parts are being imported from India. Out of 73 natural products described in the traditional textbooks, only 13 of them (some omitted and few substituted by plants) are currently included in 87 formulations of BSM. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

A morphometric and molecular study of the apoptosis observed on tadpoles' tail explants under the exposition of triiodothyronine in different homeopathic dilutions.

PubMed

Guedes, José Roberto Pereira; Carrasco, Solange; Ferreira, Cláudia M; Bonamin, Leoni V; Goldenstein-Schainberg, Cláudia; Martins, Vanessa; Capelozzi, Vera L

2016-08-01

As a therapeutic system, homeopathy is supported by: i) similitude and experimentation in healthy individuals, ii) potentization. A challenge for researchers consists in looking for signals in water (or vehicle) to explain the storage of information in extremely high dilutions and the transfer of such information to the living systems. Anuran amphibian metamorphosis is controlled by thyroid hormones (TH), including the resorption of the tadpole tail. Apoptosis is a genetically regulated form of cell death that can be triggered by various extracellular and intracellular stimuli resulting in coordinated activation of a family of cysteine proteases called caspases. This study was blind and randomized. It performed in three stages: I) the identification of the most effective T3 homeopathic dilution to induce apoptotic reactions in Rana (Lithobates) catesbeianus tadpole tail explants stimulated by T3 in substantial, II) study of different controls and III) detection in explants under the action of the most effective dilution of T3, as established in Stage I. There was no statistically significant difference between tail macroscopic dimensions between the groups. T3 10cH decreased the expression of caspase 3/7 mRNA, in explants treated with T3 20 nM. The present experiment is in agreement with the hypothesis that T3, at a 10cH homeopathic dilution, changes the metamorphosis molecular network. Copyright © 2016 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

FDA and NIST collaboration on standards development activities supporting innovation and translation of regenerative medicine products.

PubMed

Arcidiacono, Judith A; Bauer, Steven R; Kaplan, David S; Allocca, Clare M; Sarkar, Sumona; Lin-Gibson, Sheng

2018-06-01

The development of standards for the field of regenerative medicine has been noted as a high priority by several road-mapping activities. Additionally, the U.S. Congress recognizes the importance of standards in the 21st Century Cure Act. Standards will help to accelerate and streamline cell and gene therapy product development, ensure the quality and consistency of processes and products, and facilitate their regulatory approval. Although there is general agreement for the need of additional standards for regenerative medicine products, a shared understanding of standards is required for real progress toward the development of standards to advance regenerative medicine. Here, we describe the roles of standards in regenerative medicine as well as the process for standards development and the interactions of different entities in the standards development process. Highlighted are recent coordinated efforts between the U.S. Food and Drug Administration and the National Institute of Standards and Technology to facilitate standards development and foster science that underpins standards development. Published by Elsevier Inc.

[Some engineering problems on developing production industry of modern traditional Chinese medicine].

PubMed

Qu, Hai-bin; Cheng, Yi-yu; Wang, Yue-sheng

2003-10-01

Based on the review of some engineering problems on developing modern production industry of Traditional Chinese Medicine (TCM), the differences of TCM production industry between China and abroad were pointed out. Accelerating the application and extension of high-tech and computer integrated manufacturing system (CIMS) were suggested to promote the technology advancement of TCM industry.

Communication in production animal medicine: modelling a complex interaction with the example of dairy herd health medicine

PubMed Central

2011-01-01

Background The importance of communication skills in veterinary medicine is increasingly recognised. Appropriate communication skills towards the client are of utmost importance in both companion animal practice and production animal field and consultancy work. The need for building a relationship with the client, alongside developing a structure for the consultation is widely recognised and applies to both types of veterinary practice. Results Veterinary advisory practice in production animal medicine is, however, characterised by a more complex communication on different levels. While the person-orientated communication is a permanent process between veterinarian and client with a rather personal perspective and defines the roles of interaction, the problem-orientated communication deals with emerging difficulties; the objective is to solve an acute health problem. The solution - orientated communication is a form of communication in which both veterinarian and client address longstanding situations or problems with the objective to improve herd health and subsequently productivity performance. All three forms of communication overlap. Conclusions Based on this model, it appears useful for a veterinary practice to offer both a curative and an advisory service, but to keep these two separated when deemed appropriate. In veterinary education, the strategies and techniques necessary for solution orientated communication should be included in the teaching of communication skills. PMID:21777495

Communication in production animal medicine: modelling a complex interaction with the example of dairy herd health medicine.

PubMed

Kleen, Joachim L; Atkinson, Owen; Noordhuizen, Jos Ptm

2011-07-20

The importance of communication skills in veterinary medicine is increasingly recognised. Appropriate communication skills towards the client are of utmost importance in both companion animal practice and production animal field and consultancy work. The need for building a relationship with the client, alongside developing a structure for the consultation is widely recognised and applies to both types of veterinary practice. Veterinary advisory practice in production animal medicine is, however, characterised by a more complex communication on different levels. While the person-orientated communication is a permanent process between veterinarian and client with a rather personal perspective and defines the roles of interaction, the problem-orientated communication deals with emerging difficulties; the objective is to solve an acute health problem. The solution - orientated communication is a form of communication in which both veterinarian and client address longstanding situations or problems with the objective to improve herd health and subsequently productivity performance. All three forms of communication overlap. Based on this model, it appears useful for a veterinary practice to offer both a curative and an advisory service, but to keep these two separated when deemed appropriate. In veterinary education, the strategies and techniques necessary for solution orientated communication should be included in the teaching of communication skills.

Medicinal plants and natural products in amelioration of arsenic toxicity: a short review.

PubMed

Bhattacharya, Sanjib

2017-12-01

Chronic arsenic toxicity (arsenicosis) is considered a serious public health menace worldwide, as there is no specific, safe, and efficacious therapeutic management of arsenicosis. To collate the studies on medicinal plants and natural products with arsenic toxicity ameliorative effect, active pre-clinically and/or clinically. Literature survey was carried out by using Google, Scholar Google and Pub-Med. Only the scientific journal articles found on the internet for last two decades were considered. Minerals and semi-synthetic or synthetic analogs of natural products were excluded. Literature study revealed that 34 medicinal plants and 14 natural products exhibited significant protection from arsenic toxicity, mostly in preclinical trials and a few in clinical studies. This research could lead to development of a potentially useful agent in clinical management of arsenicosis in humans.

Legal requirements for the quality of herbal substances and herbal preparations for the manufacturing of herbal medicinal products in the European union.

PubMed

Vlietinck, Arnold; Pieters, Luc; Apers, Sandra

2009-06-01

In the European Union (EU) herbal medicinal products have become increasingly important. This is, for instance, underlined by the recent introduction of a simplified procedure in the Member States of the EU allowing the registration of herbal medicinal products which fulfill the criteria of a traditional herbal medicinal product, i.e., sufficient evidence of its medicinal use throughout a period of at least 30 years for products in the EU and at least 15 years within the EU and 15 years elsewhere for products outside the EU. With regard to the manufacturing of these products and their quality, applications of traditional herbal medicinal products have to fulfil the same requirements as applications for a marketing authorization. The quality of herbal substances as well as herbal preparations will be determined by the availability of modern science-based public monographs in the European Pharmacopoeia and their equivalents developed by the pharmaceutical industry. The standards put forward in these monographs must allow us not only to define the quality of these products, but also to eliminate dangerous counterfeit, substandard, adulterated and contaminated (traditional) herbal medicinal products. The usefulness of these monographs to implement the criteria on quality and specifications put forward for these products in the different guidelines of the European Medicines Agency (EMEA) is discussed.

Oral hygiene products and acidic medicines.

PubMed

Hellwig, E; Lussi, A

2006-01-01

Acidic or EDTA-containing oral hygiene products and acidic medicines have the potential to soften dental hard tissues. The low pH of oral care products increases the chemical stability of some fluoride compounds, favors the incorporation of fluoride ions in the lattice of hydroxyapatite and the precipitation of calcium fluoride on the tooth surface. This layer has some protective effect against an erosive attack. However, when the pH is too low or when no fluoride is present these protecting effects are replaced by direct softening of the tooth surface. Xerostomia or oral dryness can occur as a consequence of medication such as tranquilizers, anti-histamines, anti-emetics and anti-parkinsonian medicaments or of salivary gland dysfunction e.g. due to radiotherapy of the oral cavity and the head and neck region. Above all, these patients should be aware of the potential demineralization effects of oral hygiene products with low pH and high titratable acids. Acetyl salicylic acid taken regularly in the form of multiple chewable tablets or in the form of headache powder as well chewing hydrochloric acids tablets for treatment of stomach disorders can cause erosion. There is most probably no direct association between asthmatic drugs and erosion on the population level. Consumers, patients and health professionals should be aware of the potential of tooth damage not only by oral hygiene products and salivary substitutes but also by chewable and effervescent tablets. Additionally, it can be assumed that patients suffering from xerostomia should be aware of the potential effects of oral hygiene products with low pH and high titratable acids.

Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe

PubMed Central

Farkas, Andreas M.; Mariz, Segundo; Stoyanova-Beninska, Violeta; Celis, Patrick; Vamvakas, Spiros; Larsson, Kristina; Sepodes, Bruno

2017-01-01

In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs). We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regulation have been submitted for orphan designation. Prior to its introduction in 2008, 4.5% of the products submitted for orphan designation met these criteria. This percentage went up to 15% after 2008. We analyzed several parameters associated with active ATMP ODDs focusing on sponsor type and EU-Member State origin, therapeutic area targeted, and ATMP classification [i.e., somatic cell therapy medicinal product, tissue-engineered product (TEP), or gene therapy medicinal product (GTMP)] and the use of regulatory services linked to incentives such as the use of protocol assistance (PA) and other Committees [Committee for Advanced Therapies (CAT) and the Pediatric Committee]. The aim here was to gain insight on the use of different services. The UK submits the largest number of ATMPs for ODD representing ~30% of the total to date. Few submissions have been received from central and Eastern European Member States as well as some of the larger Member States such as Germany (3.6%). ATMPs ODDs were primarily GTMPs (48.7%) and SCTMPs (43.3%). TEPs only represented 8% of all submissions for this medicinal class. This is different from non-ODDs ATMPs where GTMPs make only 20% of ATMPs. A total of 11.7% of ATMP ODDs had received formal CAT classification. A total of 29.8% of all orphan drug (OD) ATMPs requested PA. A total of 71.8% did not have an agreed pediatric investigation plan (PIP). Four products (Glybera one PA; Zalmoxis two; Holoclar one; Strimvelis three) have received a marketing authorization (MAA) and a 10-year market exclusivity. Strimvelis also completed their PIP

Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe.

PubMed

Farkas, Andreas M; Mariz, Segundo; Stoyanova-Beninska, Violeta; Celis, Patrick; Vamvakas, Spiros; Larsson, Kristina; Sepodes, Bruno

2017-01-01

In 2008, the European Union introduced the Advanced Medicines Regulation aiming to improve regulation of advanced therapy medicinal products (ATMPs). We applied the ATMPs classification definitions in this Regulation to understand the link of this emerging group of medicinal products and the use of the Orphan Regulation. A total of 185 products that can be classified as ATMPs based on this Regulation have been submitted for orphan designation. Prior to its introduction in 2008, 4.5% of the products submitted for orphan designation met these criteria. This percentage went up to 15% after 2008. We analyzed several parameters associated with active ATMP ODDs focusing on sponsor type and EU-Member State origin, therapeutic area targeted, and ATMP classification [i.e., somatic cell therapy medicinal product, tissue-engineered product (TEP), or gene therapy medicinal product (GTMP)] and the use of regulatory services linked to incentives such as the use of protocol assistance (PA) and other Committees [Committee for Advanced Therapies (CAT) and the Pediatric Committee]. The aim here was to gain insight on the use of different services. The UK submits the largest number of ATMPs for ODD representing ~30% of the total to date. Few submissions have been received from central and Eastern European Member States as well as some of the larger Member States such as Germany (3.6%). ATMPs ODDs were primarily GTMPs (48.7%) and SCTMPs (43.3%). TEPs only represented 8% of all submissions for this medicinal class. This is different from non-ODDs ATMPs where GTMPs make only 20% of ATMPs. A total of 11.7% of ATMP ODDs had received formal CAT classification. A total of 29.8% of all orphan drug (OD) ATMPs requested PA. A total of 71.8% did not have an agreed pediatric investigation plan (PIP). Four products (Glybera one PA; Zalmoxis two; Holoclar one; Strimvelis three) have received a marketing authorization (MAA) and a 10-year market exclusivity. Strimvelis also completed their PIP

75 FR 61504 - Global Implementation of the Veterinary Medicinal Products Guidelines

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-05

... countries to allocate appropriate human and financial resources to veterinary services and laboratories to... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0497] Global Implementation of the Veterinary Medicinal Products Guidelines AGENCY: Food and Drug...

Evidences of Herbal Medicine-Derived Natural Products Effects in Inflammatory Lung Diseases.

PubMed

Santana, Fernanda Paula R; Pinheiro, Nathalia M; Mernak, Márcia Isabel B; Righetti, Renato F; Martins, Mílton A; Lago, João H G; Lopes, Fernanda D T Q Dos Santos; Tibério, Iolanda F L C; Prado, Carla M

2016-01-01

Pulmonary inflammation is a hallmark of many respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD), and acute respiratory syndrome distress (ARDS). Most of these diseases are treated with anti-inflammatory therapy in order to prevent or to reduce the pulmonary inflammation. Herbal medicine-derived natural products have been used in folk medicine and scientific studies to evaluate the value of these compounds have grown in recent years. Many substances derived from plants have the biological effects in vitro and in vivo, such as flavonoids, alkaloids, and terpenoids. Among the biological activities of natural products derived from plants can be pointed out the anti-inflammatory, antiviral, antiplatelet, antitumor anti-allergic activities, and antioxidant. Although many reports have evaluated the effects of these compounds in experimental models, studies evaluating clinical trials are scarce in the literature. This review aims to emphasize the effects of these different natural products in pulmonary diseases in experimental models and in humans and pointing out some possible mechanisms of action.

[Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].

PubMed

Sato, Yoji

2014-01-01

In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the revisions to the Pharmaceutical Affairs Act, which was also renamed as the Therapeutic Products Act (TPA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the TPA, a product derived from processing cells is categorized as a subgroup of "regenerative medicine, cellular therapy and gene therapy products" (RCGPs), products distinct from pharmaceuticals and medical devices, allowing RCGPs to obtain a conditional and time- limited marketing authorization much earlier than that under the conventional system. To foster not only RCGPs, but also innovative pharmaceuticals and medical devices, the Ministry of Health, Labour and Welfare recently launched Translational Research Program for Innovative Pharmaceuticals, Medical Devices and RCGPs. This mini-review introduces contributions of the National Institute of Health Sciences (NIHS) to research projects on RCGPs in the Program.

Are agricultural and natural sources of bio-products important for modern regenerative medicine? A review.

PubMed

Nowacki, Maciej; Nowacka, Katarzyna; Kloskowski, Tomasz; Pokrywczyńska, Marta; Tyloch, Dominik; Rasmus, Marta; Warda, Karolina; Drewa, Tomasz

2017-05-11

[b] Abstract Introduction and objectives[/b]. As tissue engineering and regenerative medicine have continued to evolve within the field of biomedicine, the fundamental importance of bio-products has become increasingly apparent. This true not only in cases where they are derived directly from the natural environment, but also when animals and plants are specially bred and cultivated for their production. [b]Objective.[/b] The study aims to present and assess the global influence and importance of selected bio-products in current regenerative medicine via a broad review of the existing literature. In particular, attention is paid to the matrices, substances and grafts created from plants and animals which could potentially be used in experimental and clinical regeneration, or in reconstructive procedures. [b]Summary.[/b] Evolving trends in agriculture are likely to play a key role in the future development of a number of systemic and local medical procedures within tissue engineering and regenerative medicine. This is in addition to the use of bio-products derived from the natural environment which are found to deliver positive results in the treatment of prospective patients.

Medicinal and other products and human and animal transmissible spongiform encephalopathies: memorandum from a WHO meeting.

PubMed Central

1997-01-01

The report in March 1996 of 10 human cases of a novel from of Creutzfeldt-Jakob disease in the United Kingdom, and its possible link to the agent that causes bovine spongiform encephalopathy (BSE), raises many questions about the safety of animal-derived products and by-products entering the food chain or being used in medicine. This Memorandum updates the preventive measures put forward in 1991 to minimize the risks associated with the use of bovine-derived materials in medicinal products and medical devices. PMID:9509622

Consumer and health literacy: The need to better design tobacco-cessation product packaging, labels, and inserts.

PubMed

Weiss, Stephanie M; Smith-Simone, Stephanie Y

2010-03-01

Tobacco-cessation product packaging and instruction materials may not be appropriate for some smokers and may contribute to the underuse and misuse of evidence-based treatments. The dual goals of this project are to analyze literacy levels of Food and Drug Administration (FDA)-approved and non-approved tobacco-cessation product packaging, directions, and claims, and to identify and categorize claims found on product packaging. The Campaign for Tobacco Free Kids (CTFK) maintains the Quitting and Reducing Tobacco Use Inventory of Products (QuiTIP) database, which catalogs products marketed and sold to consumers to reduce or quit use of tobacco products. It also includes all medications approved by the FDA for tobacco cessation as well as a sample of non-approved products such as homeopathic, herbal, nutritional, or dietary supplements commonly marketed as either cessation aids or alternative tobacco/nicotine products. This paper assesses the reading levels required to understand product packaging, labeling, and instructions using the Simple Measure of Gobbledygook (SMOG) and identifies claims on the product package labels using standard qualitative methods. Key findings show that the average reading levels needed to understand instructions for both FDA-approved and non-approved cessation products are above the reading levels recommended to ensure maximum comprehension. Improving the packaging and directions of evidence-based tobacco-cessation products so that they are preferably at or below a fifth-grade reading level, along with using consumer-based design principles to develop packaging, may help smokers take advantage of and correctly use products that will greatly increase their chances of successful quitting. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Bluegenics: Bioactive Natural Products of Medicinal Relevance and Approaches to Their Diversification.

PubMed

Zarins-Tutt, Joseph S; Abraham, Emily R; Bailey, Christopher S; Goss, Rebecca J M

Nature provides a valuable resource of medicinally relevant compounds, with many antimicrobial and antitumor agents entering clinical trials being derived from natural products. The generation of analogues of these bioactive natural products is important in order to gain a greater understanding of structure activity relationships; probing the mechanism of action, as well as to optimise the natural product's bioactivity and bioavailability. This chapter critically examines different approaches to generating natural products and their analogues, exploring the way in which synthetic and biosynthetic approaches may be blended together to enable expeditious access to new designer natural products.

Application of Traditional Chinese Herbal Medicine By-products as Dietary Feed Supplements and Antibiotic Replacements in Animal Production.

PubMed

Abdallah, Abedin; Zhang, Pei; Zhong, Qingzhen; Sun, Zewei

2018-05-22

Misuse of synthetic antibiotics in livestock leads to the transfer of antibiotic resistant pathogens into humans and deposits toxic residues in meat and milk. There is therefore an urgent need for safe and viable alternative approaches to improve the nutrition and wellbeing of farm animals. An alternative source that has been widely exploited is traditional Chinese herbal medicine (TCHM). These herbal medicines are an important part of the healthcare system in many Asian countries. Such herbs contain several but less toxic bioactive compounds which are generally regarded biodegradable. Recently, advances in knowledge on the importance of TCHM have led to a rapid increase in its production and hence, increasing the amount of by-products generated. Such by-products have become a serious environmental challenge because producers regard them as industrial waste and discard them directly. Incorporating TCHM by-products as feed additives to improve animal health and nutrition has been proposed because they contain high amounts of bioactive compounds which confer several health benefits to animals. TCHM by-products as feed additives apart from being a good alternative for synthetic antibiotics could also minimize the current environmental challenges associated with its disposal. This review summarizes scientific findings on the bioactive compounds in TCHM and TCHM by-products, discusses functional dietary patterns and outlines challenges that may hinder full utilization of TCHM by-products in animal production. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Randomized controlled pilot study to compare Homeopathy and Conventional therapy in Acute Otitis Media.

PubMed

Sinha, M N; Siddiqui, V A; Nayak, C; Singh, Vikram; Dixit, Rupali; Dewan, Deepti; Mishra, Alok

2012-01-01

To compare the effectiveness of Homeopathy and Conventional therapy in Acute Otitis Media (AOM). A randomized placebo-controlled parallel group pilot study of homeopathic vs conventional treatment for AOM was conducted in Jaipur, India. Patients were randomized by a computer generated random number list to receive either individualized homeopathic medicines in fifty millesimal (LM) potencies, or conventional treatment including analgesics, antipyretics and anti-inflammatory drugs. Patients who did not improve were prescribed antibiotics at the 3rd day. Outcomes were assessed by the Acute Otitis Media-Severity of Symptoms (AOM-SOS) Scale and Tympanic Membrane Examination over 21 days. 81 patients were included, 80 completed follow-up: 41 for conventional and 40 for homeopathic treatment. In the Conventional group, all 40 (100%) patients were cured, in the Homeopathy group, 38 (95%) patients were cured while 02 (5%) patients were lost to the last two follow-up. By the 3rd day of treatment, 4 patients were cured in Homeopathy group but in Conventional group only one patient was cured. In the Conventional group antibiotics were prescribed in 39 (97.5%), no antibiotics were required in the Homeopathy group. 85% of patients were prescribed six homeopathic medicines. Individualized homeopathy is an effective conventional treatment in AOM, there were no significant differences between groups in the main outcome. Symptomatic improvement was quicker in the Homeopathy group, and there was a large difference in antibiotic requirements, favouring homeopathy. Further work on a larger scale should be conducted. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

Translating cell-based regenerative medicines from research to successful products: challenges and solutions.

PubMed

Bayon, Yves; Vertès, Alain A; Ronfard, Vincent; Egloff, Matthieu; Snykers, Sarah; Salinas, Gabriella Franco; Thomas, Robert; Girling, Alan; Lilford, Richard; Clermont, Gaelle; Kemp, Paul

2014-08-01

The Tissue Engineering & Regenerative Medicine International Society-Europe (TERMIS-EU) Industry Committee as well as its TERMIS-Americas (AM) counterpart intend to address the specific challenges and needs facing the industry in translating academic research into commercial products. Over the last 3 years, the TERMIS-EU Industry Committee has worked with commercial bodies to deliver programs that encourage academics to liaise with industry in proactive collaborations. The TERMIS-EU 2013 Industry Symposium aimed to build on this commercial agenda by focusing on two topics: Operations Management (How to move a process into the good manufacturing practice [GMP] environment) and Clinical Translation (Moving a GMP process into robust trials). These topics were introduced by providing the synergistic business perspective of partnering between the multiple regenerative medicine stakeholders, throughout the life cycle of product development. Seven industry leaders were invited to share their experience, expertise, and strategies. Due to the complex nature of regenerative medicine products, partnering for their successful commercial development seems inevitable to overcome all obstacles by sharing experiences and expertise of all stakeholders. When ideally implemented, the "innovation quotient" of a virtual team resulting from the combination of internal and external project teams can be maximized through maximizing the three main dimensions: core competences, technology portfolio, and alliance management.

Homeopathic Arnica montana for post-tonsillectomy analgesia: a randomised placebo control trial.

PubMed

Robertson, A; Suryanarayanan, R; Banerjee, A

2007-01-01

To evaluate the efficacy of Homeopathic Arnica in reducing the morbidity following tonsillectomy. Randomised double blind, placebo controlled trial at a tertiary referral centre. 190 patients over the age of 18 undergoing tonsillectomy were randomised into intervention and control groups receiving either Arnica 30c or identical placebo, 2 tablets 6 times in the first post-operative day and then 2 tablets twice a day for the next 7 days. The primary outcome measure was the change in pain scores (visual analogue scale) recorded by the patient on a questionnaire over 14 days post-operatively; Secondary outcome measures were: analgesia consumption, visits to the GP or hospital, antibiotic usage, the day on which their swallowing returned to normal and the day on which they returned to work. 111 (58.4%) completed questionnaires were available for analysis. The Arnica group had a significantly larger drop in pain score from day 1 to day 14 (28.3) compared to the placebo group (23.8) with p < 0.05. The two groups did not differ significantly on analgesic consumption or any of the other secondary outcome measures (number of post-operative visits to GP, use of antibiotics and secondary haemorrhage readmissions). The results of this trial suggest that Arnica montana given after tonsillectomy provides a small, but statistically significant, decrease in pain scores compared to placebo.

Restrictions on the reimbursement policy with regard to retail marketing of medicinal products in Poland.

PubMed

Zimmermann, Agnieszka

2013-01-01

On January 1, 2012, the law of 12 May 2011 on the reimbursement of medicines, food products of special nutritional purpose and medicinal products, intended to tighten up the reimbursement system, came into force in Poland. The new legislative act has significantly altered the previous principles of retail marketing of products subject to publicly financed reimbursement. First of all, the prices of reimbursed products have been unified through the introduction of fixed margins and prices and a ban--completely unknown until now--on using free market sales practices. These regulations are intended to lead to the abolition of price competition and its replacement with competition as to the quality of services provided by pharmacies. At the same time, entities engaged in retail marketing of medicinal products have been imposed a number of new obligations and highly repressive penalties for failure to fulfill them. The paper analyzes the legislative changes and points out the consequences, both those which can already be seen and the predictable ones. The assumed priority and criterion of evaluation of the reimbursement policy in question is its impact on the functioning of pharmacies which, according to the premises of Polish pharmaceutical law, should play the role of public health protection institutions.

A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs)

PubMed Central

Jones, David R; McBlane, James W; McNaughton, Graham; Rajakumaraswamy, Nishanthan; Wydenbach, Kirsty

2013-01-01

The safety of trial subjects is the tenet that guides the regulatory assessment of a Clinical Trial Authorization application and applies equally to trials involving small molecules and those with biological/biotechnological products, including Advanced Therapy Medicinal Products. The objective of a regulator is to ensure that the potential risk faced by a trial subject is outweighed by the potential benefit to them from taking part in the trial. The focus of the application review is to assess whether risks have been identified and appropriate steps taken to alleviate these as much as possible. Other factors are also taken into account during a review, such as regulatory requirements, and emerging non-clinical and clinical data from other trials on the same or similar products. This paper examines the regulatory review process of a Clinical Trial Authorization application from the perspectives of Quality, Non-Clinical and Clinical Regulatory Assessors at the Medicines and Healthcare products Regulatory Agency. It should be noted that each perspective has highlighted specific issues from their individual competence and that these can be different between the disciplines. PMID:23216470

Underestimating the toxicological challenges associated with the use of herbal medicinal products in developing countries.

PubMed

Neergheen-Bhujun, Vidushi S

2013-01-01

Various reports suggest a high contemporaneous prevalence of herb-drug use in both developed and developing countries. The World Health Organisation indicates that 80% of the Asian and African populations rely on traditional medicine as the primary method for their health care needs. Since time immemorial and despite the beneficial and traditional roles of herbs in different communities, the toxicity and herb-drug interactions that emanate from this practice have led to severe adverse effects and fatalities. As a result of the perception that herbal medicinal products have low risk, consumers usually disregard any association between their use and any adverse reactions hence leading to underreporting of adverse reactions. This is particularly common in developing countries and has led to a paucity of scientific data regarding the toxicity and interactions of locally used traditional herbal medicine. Other factors like general lack of compositional and toxicological information of herbs and poor quality of adverse reaction case reports present hurdles which are highly underestimated by the population in the developing world. This review paper addresses these toxicological challenges and calls for natural health product regulations as well as for protocols and guidance documents on safety and toxicity testing of herbal medicinal products.

Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market.

PubMed

Sillo, Hiiti B; Masota, Nelson E; Kisoma, Sunday; Rago, Lembit; Mgoyela, Veronica; Kaale, Eliangiringa A

2018-01-01

Availability of correct and adequate information about medicines is an important aspect in ensuring rational use of medicines and hence facilitating safety and expected efficacy of medicines during therapy. Package inserts have proven to be a good source of information to the prescribers and patients whereby they have been useful in highlighting important information pertaining proper use and handling of the medicines. The present study was aimed at establishing the extent to which package inserts of medicines circulating on the markets of the East African Community (EAC) Partner States conform to medicines information requirements as established in the harmonized guidelines as well as national guidelines. A total of 99 package inserts from six (6) types of medicines namely Albendazole, Artemether/Lumefantrine (ALu), Ciprofloxacin, Paracetamol, Amoxicillin and Metronidazole were purposefully collected from three EAC Partner States: Kenya, Tanzania and Uganda. The medicines were selected based on their indications as first line treatments, high rates of utilization within the medicines supply system and their positions in treatment of diseases of public importance across EAC Partner States. The inserts were evaluated on the availability of information regarding fifteen (15) parameters as extracted from the EAC harmonized guidelines for registration of medicines. Moreover, comparisons were made between the percentage conformity of the branded versus generic products, markets from which the samples were collected, origin of the manufacturer and type of medicine. Majority (93.9-100%) of the medicines' package inserts highly conformed to the inclusion of the information regarding the description and composition of the medications, indications, dosage and methods of administration, warnings and precautions, contraindications and storage conditions. However, the information on handling and disposal, container package description, excipients used, clinical pharmacology of

Recent progress of research on medicinal mushrooms, foods, and other herbal products used in traditional Chinese medicine

PubMed Central

Lee, Kuo-Hsiung; Morris-Natschke, Susan L.; Yang, Xiaoming; Huang, Rong; Zhou, Ting; Wu, Shou-Fang; Shi, Qian; Itokawa, Hideji

2012-01-01

This article will review selected herbal products used in traditional Chinese medicine, including medicinal mushrooms (巴西蘑菇 bā xī mó gū; Agaricus blazei, 雲芝 yún zhī; Coriolus versicolor, 靈芝 líng zhī; Ganoderma lucidum, 香蕈 xiāng xùn; shiitake, Lentinus edodes, 牛樟芝 niú zhāng zhī; Taiwanofungus camphoratus), Cordyceps (冬蟲夏草 dōng chóng xià cǎo), pomegranate (石榴 shí liú; Granati Fructus), green tea (綠茶 lǜ chá; Theae Folium Non Fermentatum), garlic (大蒜 dà suàn; Allii Sativi Bulbus), turmeric (薑黃 jiāng huáng; Curcumae Longae Rhizoma), and Artemisiae Annuae Herba (青蒿 qīng hāo; sweet wormwood). Many of the discussed herbal products have gained popularity in their uses as dietary supplements for health benefits. The review will focus on the active constituents of the herbs and their bioactivities, with emphasis on the most recent progress in research for the period of 2003 to 2011. PMID:24716120

[The role of German official medicines control laboratories in combating counterfeit medicines].

PubMed

Wiegard, Andrea; Heuermann, Matthias

2017-11-01

An official medicines control laboratory (OMCL) provides an important contribution to combat counterfeit and illegal medicines. The OMCL supports the competent authorities in controlling the quality of authorised medicinal products in the legal supply chain. For detecting counterfeit medicines in the legal supply chain, a risk-based approach in choice of products is conducted. Furthermore, the OMCL analyses suspicious medicines from the illegal supply chain for any other authority. The chemical analysis of a suspicious sample is needed to identify such a sample as a counterfeit medicine. The analytical results are fundamental for the evaluation of the legal status of the product and for the assessment of it's inherent hazard to public health. The global market of illegal medicines is rapidly changing. Therefore a good national and international working liaison and co-operation between laboratories and authorities is obligatory to protect public health. The OMCL provides important knowledge of new trends in counterfeit and illegal medicines. Hence, it is an essential part in surveillance of medicinal products. The efficient networking enables prompt official interventions. Thus, risks for the public health by substandard medicines were reduced. Beside the chemical analysis, the OMCL can help to raise public awareness about counterfeit and illegal medicines. In Germany, the risk of counterfeit medicines reaching patients through the legal supply chain is still low, but the possibility cannot be ignored.

Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices

PubMed Central

Tomić, Siniša; Filipović Sučić, Anita; Plazonić, Ana; Truban Žulj, Rajka; Macolić Šarinić, Viola; Čudina, Branka; Ilić Martinac, Adrijana

2010-01-01

Aim To present the activities of the Agency for Medicinal Products and Medical Devices in the first 5 years of its existence and to define its future challenges. Methods Main activities within the scope of the Agency as a regulatory authority were retrospectively analyzed for the period from 2004-2008. Data were collected from the Agency’s database and analyzed by descriptive statistics. Results The number of issued medicine authorizations rose from 240 in 2004 to 580 in 2008. The greatest number of new chemical and biological entities was approved in 2005. The greatest number of regular quality controls (n = 5833) and special quality controls was performed in 2008 (n = 589), while the greatest number of off-shelf quality controls (n = 132) was performed in 2007. The greatest number of medicine labeling irregularities was found in 2007 (n = 19) and of quality irregularities in 2004 (n = 9). The greatest number of adverse reactions was reported in 2008 (n = 1393). The number of registered medical devices rose from 213 in 2004 to 565 in 2008. Conclusion Over its 5 years of existence, the Agency has successfully coped with the constant increase in workload. In the future, as Croatia enters the European Union, the Agency will have to face the challenge of joining the integrated European regulatory framework. PMID:20401952

Herbal medicine IMOD suppresses LPS-induced production of proinflammatory cytokines in human dendritic cells

PubMed Central

Mirzaee, Saeedeh; Drewniak, Agata; Sarrami-Forooshani, Ramin; Kaptein, Tanja M.; Gharibdoost, Farhad; Geijtenbeek, Teunis B. H.

2015-01-01

Traditional medicines that stimulate or modulate the immune system can be used as innovative approaches to treat immunological diseases. The herbal medicine IMOD has been shown to strongly modulate immune responses in several animal studies as well as in clinical trials. However, little is known about the mechanisms of IMOD to modulate immunity. Here we have investigated whether IMOD modulates the immunological function of human dendritic cells (DCs). IMOD alone did not induce DC maturation nor production of cytokines. Notably, IMOD decreased the production of pro-inflammatory cytokines IL-6, IL-12 p70, and TNFα by LPS-activated DCs at both mRNA and protein levels in a dose dependent manner. In contrast, treatment with IMOD did not affect LPS induced-production of the anti-inflammatory cytokine IL-10. Furthermore, IMOD inhibited T cell activation/proliferation by LPS-treated DCs and skewed T-cells responses toward the T helper type 2 polarization. These data strongly indicate that IMOD has a potent immunomodulatory ability that affects TLR signaling and thereby modulates DC function. Insight into the immunomodulatory effect of herbal medicine IMOD may provide innovative strategies to affect the immune system and to help combat various diseases. PMID:25870561

Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jordan, Scott A., E-mail: scott.jordan@hc-sc.gc.c; Cunningham, David G.; Marles, Robin J.

Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantitymore » and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.« less

A Not-So-Gentle Refutation of the Defence of Homeopathy.

PubMed

Zawiła-Niedźwiecki, Jakub; Olender, Jacek

2016-03-01

In a recent paper, Levy, Gadd, Kerridge, and Komesaroff attempt to defend the ethicality of homeopathy by attacking the utilitarian ethical framework as a basis for medical ethics and by introducing a distinction between evidence-based medicine and modern science. This paper demonstrates that their argumentation is not only insufficient to achieve that goal but also incorrect. Utilitarianism is not required to show that homeopathic practice is unethical; indeed, any normative basis of medical ethics will make it unethical, as a defence of homeopathic practice requires the rejection of modern natural sciences, which are an integral part of medical ethics systems. This paper also points out that evidence-based medicine lies at the very core of modern science. Particular arguments made by Levy et al. within the principlist medical ethics normative system are also shown to be wrong.

[The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises].

PubMed

Berger, A; Schüle, S; Flory, E

2011-07-01

Advanced therapy medicinal products (ATMPs) are gene therapy, cell therapy, and tissue engineered products. To gain access to the market within the European Union, ATMPs must be authorized by the European Commission (EC). Especially for small and medium-sized enterprises (SMEs), the European centralized procedure of marketing authorization that is conducted by the European Medicines Agency (EMA) constitutes a major challenge, because SMEs often have little experience with regulatory procedures and many have limited financial possibilities. To tackle these challenges, a certification procedure exclusively for SMEs and their ATMP development was introduced by the EC. Independently from a marketing authorization application, development and/or production processes can be certified. An issued certificate demonstrates that the respective process meets the current regulatory and scientific requirements of the EMA, representing a valuable milestone for putative investors and licensees. This article highlights the background, the detailed procedure, the minimum requirements, as well as the costs of certification, while giving further noteworthy guidance for interested parties.

[Advertising and Zeitgeist. The advertising of Schwabe Pharmaceuticals].

PubMed

Hofmann, Cornelia; Riha, Ortrun

2015-01-01

This contribution explores the advertisements for homeopathic products in magazines in the first half of the twentieth century, focusing on the period between 1933 and 1945 and based on the example of the pharmaceutical company Dr Willmar Schwabe. In the first half of the twentieth century, Schwabe Pharmaceuticals was market leader for homeopathic and other complementary medical products (phytotherapy, biochemicals). The example chosen as well as the time frame complement the existing research. We searched three German publications (the homeopathy journal Leipziger Populäre Zeitschrift für Homöopathie, the medical weekly Münchner Medizinische Wochenschrift and the pharma magazine Pharmazeutische Zeitung) and collected target-group-specific results for laypersons, physicians and pharmacists. Analysis of the images and texts in the selected advertisements often reflected the historical background and the respective health policies (wartime requirements, times of need, "Neue Deutsche Heilkunde"). The history of this traditional company was seen as an important point in advertising, as were the recognisability of the brand through the company logo, the emphasis on the high quality of their products and the reference to the company's own research activities. We furthermore found the kind of argumentation that is typical of natural medicine (naturalness, the power of the sun, prominent representatives). Schwabe met the expectations of its clients, who were interested in complementary medicine, whilst pursuing an approach to homeopathy that was compatible with natural science, and it presented itself as a modern, scientifically oriented enterprise. The company did not lose credibility as a result, but increased its clientele by expanding to include the whole naturopathic market.

Medicinal Herbs Affecting Gray Hair in Iranian Traditional Medicine.

PubMed

Rameshk, Maryam; Khandani, Shahram Kalantari; Raeiszadeh, Mahboobeh

2016-05-01

The presence of hair plays an important role in people's overall physical appearance and self-perception. As a result of increased life expectancy, the desire to look youthful plays a bigger role than ever.The use of medicinal plants is as old as mankind and the market will face many new products containing natural oils and herbs in coming years. In traditional Iranian medicine, many plants and herbal formulations are reported for hair growth as well as the improvement in hair quality. The aim of this article is to introduce effective medicinal plants in traditional Iranian medicine to prevent gray hair and advocate them as the new products. The present investigation is an overview study and has been codified by library search in the main sources of traditional Iranian medicine. In traditional Iranian medicine, three types of formulations are proposed to prevent gray hair, namely (i) treatment compounds, (ii) preventive compounds, and (iii) hair dyes to color gray hairs. Our search showed that the main parts of a plant that is used in the treatment and preventive compounds are seeds and fruits. These are primarily in the form of topical oil or oral compound (electuary). The majority of plant parts used in hair dyes is from the fruit and/or leaves. Natural products are highly popular and the use of plant extracts in formulations is on the rise. This is because synthetic based product may cause health hazards with several side effects. Considering the increased popularity of herbal drugs in hair care, it is worthwhile to conduct systemic investigation on the production and efficacy of these drugs. We trust that our investigation would encourage the use of traditional Iranian medicine in future hair care products.

A prospective multi-centric open clinical trial of homeopathy in diabetic distal symmetric polyneuropathy.

PubMed

Nayak, Chaturbhuja; Oberai, Praveen; Varanasi, Roja; Baig, Hafeezullah; Ch, Raveender; Reddy, G R C; Devi, Pratima; S, Bhubaneshwari; Singh, Vikram; Singh, V P; Singh, Hari; Shitanshu, Shashi Shekhar

2013-04-01

To evaluate homeopathic treatment in the management of diabetic distal symmetric polyneuropathy. A prospective multi-centric clinical observational study was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) (India) at its five institutes/units. Patients suffering from diabetes mellitus (DM) and presenting with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were evaluated by the diabetic distal symmetric polyneuropathy symptom score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months. Out of 336 patients (167 males and 169 females) enrolled in the study, 247 patients (123 males and 124 females) were analyzed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis.). A statistically significant improvement in DDSPSS total score (p = 0.0001) was found at 12 months from baseline. Most objective measures did not show significant improvement. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the medicines most frequently prescribed. Adverse event of hypoglycaemia was observed in one patient only. This study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the quality of life (QOL) assessment. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

The Brazilian market of herbal medicinal products and the impacts of the new legislation on traditional medicines.

PubMed

Carvalho, Ana Cecília Bezerra; Lana, Túlio Nader; Perfeito, João Paulo Silvério; Silveira, Dâmaris

2018-02-15

the herbal medicinal products (HMP) market is expanding in the world, an expansion that has not occurred in Brazil when considering the number of licensed products. Despite being a megadiverse country, the number of HMP licensed in Brazil is small, and the number of HMP obtained from native species is even smaller. A new legislation for herbal products licensing, which divides the products into two categories, Herbal Medicine (HM) and Traditional Herbal Product (THP) was launched in Brazil focusing on traditional use, as well as a law regulating the use of biodiversity and traditional knowledge. to evaluate the situation of HMP licensed in Brazil and to make a comparison with the data obtained in 2008 and 2011, discussing the evolution of the licensed products and the possible impacts of the new legislation. a survey was carried out in the Brazilian Health Regulatory Agency (Anvisa) database to verify the HMP licensed in Brazil in September 2016. The data obtained were compared with two surveys previously published. There are 332 single, and 27 combined HM, totaling 359 HM licensed in Brazil. There is no THP notified in Anvisa's system yet. There are 214 HM classified as nonprescription (OTC), while 145 are sold under prescription, one of them with prescription retention. There are 101 plant species licensed as active in HM in Brazil, 39 of which are native, adapted or cultivated. The most licensed plant species is Mikania glomerata Spreng., with 25 HM licensed. The article includes tables with plant species that have derivatives licensed as simple and combined HM, their therapeutic classification, the native plant species indication and the distribution of the companies by Brazilian regions. There are few licensed HM in Brazil, and this number has been decreasing in recent years. It is expected that the data obtained, together with the changes promoted in sanitary and environmental rules, will help to develop and regulate HMP chain in Brazil. Copyright © 2017

Influence of Clinical Experience and Productivity on Emergency Medicine Faculty Teaching Scores

PubMed Central

Clyne, Brian; Smith, Jessica L.; Napoli, Anthony M.

2012-01-01

Background Commonly cited barriers to effective teaching in emergency medicine include lack of time, competing demands for patient care, and a lack of formal teaching experience. Teaching may be negatively affected by demands for increased clinical productivity, or positively influenced by clinical experience. Objective To examine the association between faculty teaching scores and clinical productivity, years of clinical experience, and amount of clinical contact with resident physicians. Methods We conducted a retrospective, observational study with existing data on full-time faculty at a high-volume, urban emergency medicine residency training program for academic year 2008–2009. Residents rated faculty on 9 domains of teaching, including willingness to teach, enthusiasm for teaching, medical knowledge, preparation, and communication. Clinical productivity data for relative value units per hour and number of patients per hour, years of clinical experience, and annual clinical hours were obtained from existing databases. Results For the 25 core faculty members included in the study, there was no relationship between faculty teaching scores and clinical productivity measures (relative value units per hour: r2  =  0.01, P  =  .96, patients per hour: r2  =  0.00, P  =  .76), or between teaching scores and total clinical hours with residents (r2  =  0.07, P  =  .19). There was a significant negative relationship between years of experience and teaching scores (r2  =  0.27, P < .01). Conclusions Our study demonstrated that teaching scores for core emergency medicine faculty did not correlate with clinical productivity or amount of clinical contact with residents. Teaching scores were inversely related to number of years of clinical experience, with more experienced faculty earning the lowest teaching scores. Further study is necessary to determine if there are clinical measures that identify good educators

Progression of emergency medicine resident productivity.

PubMed

Brennan, Daniel F; Silvestri, Salvatore; Sun, Joanne Y; Papa, Linda

2007-09-01

To evaluate the progression in productivity of emergency medicine (EM) residents by postgraduate year, as measured by hourly work in relative value units (RVUs). This retrospective study was conducted at an Accreditation Council for Graduate Medical Education (ACGME)-accredited EM residency with a postgraduate year (PGY) 1-2-3 configuration. A query of an electronic billing database composed of more than 230,000 visits from academic years July 2003 to December 2006, representing at least four classes at each PGY level, was conducted. The main outcome was change in productivity in RVUs generated per hour, compared by resident PGY level. This measure encompasses not only volume of patients seen but also patient acuity in terms of evaluation and management services and procedures provided and supported by documentation adequate for coding. Descriptive statistics and Tukey's test were used for data analysis. Over the three-year study period, 70 EM residents were assessed at various levels of training. Productivity, as measured by mean RVUs generated per hour, was 2.51 (95% confidence interval [CI] = 2.20 to 2.82) for PGY-1 residents, 3.51 (95% CI = 3.12 to 3.90) for PGY-2 residents, and 3.61 (95% CI = 3.41 to 3.80) for PGY-3 residents (p < 0.001). Patient acuity (RVUs generated per patient) increased 5%-8% with each PGY progression: 3.05 (95% CI = 2.96 to 3.13) for PGY-1, 3.20 (95% CI = 3.09 to 3.31) for PGY-2, and 3.46 (95% CI = 3.42 to 3.50) for PGY-3 (p < 0.001). There was a statistically significant increase in productivity (p < 0.001) and acuity (p = 0.03) from PGY-1 to PGY-2, with acuity also increasing between PGY-2 and PGY-3 (p < 0.001). Hourly work productivity and acuity increased with experience within this ACGME-accredited EM residency. The progression in workload and acuity by PGY is measurable and commensurate with the graduated level of responsibility desired in an EM program.

Quality evaluation of medicinal products and health foods containing chaste berry (Vitex agnus-castus) in Japanese, European and American markets.

PubMed

Fukahori, Masahiro; Kobayashi, Shojiro; Naraki, Yoko; Sasaki, Takahiro; Oka, Hideki; Seki, Masaharu; Masada-Atsumi, Sayaka; Hakamatsuka, Takashi; Goda, Yukihiro

2014-01-01

The aim of present study was to evaluate the qualities of chaste berry (fruit of Vitex agnus-castus L.) preparations using HPLC fingerprint analysis. Seven medicinal products 1 from Japan and 6 from Europe, and 17 health foods, 6 from Japan and 11 from the United States were analyzed. HPLC profile and 26 authentic peaks were compared medicinal products and health foods. Whereas medicinal products had similar HPLC profiles, health foods had various profiles and each peak was also greatly different. The measured amounts of two markers in 5 traditional medicinal products, agnuside and casticin specified in the European Pharmacopoeia (EP), the U.S. Pharmacopoeia (USP) or the WHO monographs of chaste berry, were much lower than those in 2 medicinal products defined as "well-established use" by the European Medicines Agency. The amounts of two markers for 17 health foods differed in a great deal from 14-5054% and 3-1272%, respectively. Furthermore the amount ratios of two markers, agnuside/casticin, in about half of the health foods were remarkably larger than the standard crude drug and the ratios were closer to one of the related Chinese herbs, Vitex negundo L. It is concluded that a combination of HPLC fingerprints and the amount ratios of the marker compounds of chaste berry preparations serves as a useful tool to evaluate the qualities of these preparations.

Search for bioactive natural products from medicinal plants of Bangladesh.

PubMed

Ahmed, Firoj; Sadhu, Samir Kumar; Ishibashi, Masami

2010-10-01

In our continuous search for bioactive natural products from natural resources, we explored medicinal plants of Bangladesh, targeting cancer-related tumor necrosis factor-related apoptosis-inducing ligand-signaling pathway, along with some other biological activities such as prostaglandin inhibitory activity, 1,1-diphenyl-2-picrylhydrazyl free-radical-scavenging activity, and cell growth inhibitory activity. Along with this, we describe a short field study on Sundarbans mangrove forests, Bangladesh, in the review.

Non-timber forest products marketing systems and market players in southwest Virginia: crafts, medicinal and herbal, and specialty wood products

Treesearch

S.M. Greene; A.L. Hammett; S. Kant

2000-01-01

Non-timber forest products (NTFPs) are important in rural southwest Virginia as a source of household income. Marketing system of crafts, medicinal and herbal, and specialty wood products are studied using exploratory and qualitative research methods. Fifty market players at various levels in marketing chains are interviewed to get the information on elements of...

A retrospective cost-analysis of additional homeopathic treatment in Germany: Long-term economic outcomes

PubMed Central

Ostermann, Julia K.; Witt, Claudia M.; Reinhold, Thomas

2017-01-01

Objectives This study aimed to provide a long-term cost comparison of patients using additional homeopathic treatment (homeopathy group) with patients using usual care (control group) over an observation period of 33 months. Methods Health claims data from a large statutory health insurance company were analysed from both the societal perspective (primary outcome) and from the statutory health insurance perspective (secondary outcome). To compare costs between patient groups, homeopathy and control patients were matched in a 1:1 ratio using propensity scores. Predictor variables for the propensity scores included health care costs and both medical and demographic variables. Health care costs were analysed using an analysis of covariance, adjusted for baseline costs, between groups both across diagnoses and for specific diagnoses over a period of 33 months. Specific diagnoses included depression, migraine, allergic rhinitis, asthma, atopic dermatitis, and headache. Results Data from 21,939 patients in the homeopathy group (67.4% females) and 21,861 patients in the control group (67.2% females) were analysed. Health care costs over the 33 months were 12,414 EUR [95% CI 12,022–12,805] in the homeopathy group and 10,428 EUR [95% CI 10,036–10,820] in the control group (p<0.0001). The largest cost differences were attributed to productivity losses (homeopathy: EUR 6,289 [6,118–6,460]; control: EUR 5,498 [5,326–5,670], p<0.0001) and outpatient costs (homeopathy: EUR 1,794 [1,770–1,818]; control: EUR 1,438 [1,414–1,462], p<0.0001). Although the costs of the two groups converged over time, cost differences remained over the full 33 months. For all diagnoses, homeopathy patients generated higher costs than control patients. Conclusion The analysis showed that even when following-up over 33 months, there were still cost differences between groups, with higher costs in the homeopathy group. PMID:28915242

New European commission regulation on variations to the terms of marketing authorization for medicinal products and its impact on Croatian legislation.

PubMed

Martinac, Adrijana Ilić; Tomić, Sinisa; Simicić, Mirna

2010-09-01

Variations introduced to medicinal product documentation must not affect the quality, efficacy, and safety of the product. Croatian Medicinal Products Act and accompanying ordinances are largely aligned with the EU regulations. The EU has now tried to simplify the issue of variations with a new Regulation, creating differences in the definition of and approach to resolving certain types of variations between Croatia and the EU. These differences could hinder the approval procedure for variations in Croatia, particularly for medicines already approved in the EU. Amending the Croatian Ordinance on medicines already authorised in the EU would be one way of maintaining the efficiency of the Croatian regulatory system.

Traditional Indian medicine and homeopathy for HIV/AIDS: a review of the literature

PubMed Central

Fritts, M; Crawford, CC; Quibell, D; Gupta, A; Jonas, WB; Coulter, I; Andrade, SA

2008-01-01

Background Allopathic practitioners in India are outnumbered by practitioners of traditional Indian medicine and homeopathy (TIMH), which is used by up to two-thirds of its population to help meet primary health care needs, particularly in rural areas. India has an estimated 2.5 million HIV infected persons. However, little is known about TIMH use, safety or efficacy in HIV/AIDS management in India, which has one of the largest indigenous medical systems in the world. The purpose of this review was to assess the quality of peer-reviewed, published literature on TIMH for HIV/AIDS care and treatment. Results Of 206 original articles reviewed, 21 laboratory studies, 17 clinical studies, and 6 previous reviews of the literature were identified that covered at least one system of TIMH, which includes Ayurveda, Unani medicine, Siddha medicine, homeopathy, yoga and naturopathy. Most studies examined either Ayurvedic or homeopathic treatments. Only 4 of these studies were randomized controlled trials, and only 10 were published in MEDLINE-indexed journals. Overall, the studies reported positive effects and even "cure" and reversal of HIV infection, but frequent methodological flaws call into question their internal and external validity. Common reasons for poor quality included small sample sizes, high drop-out rates, design flaws such as selection of inappropriate or weak outcome measures, flaws in statistical analysis, and reporting flaws such as lack of details on products and their standardization, poor or no description of randomization, and incomplete reporting of study results. Conclusion This review exposes a broad gap between the widespread use of TIMH therapies for HIV/AIDS, and the dearth of high-quality data supporting their effectiveness and safety. In light of the suboptimal effectiveness of vaccines, barrier methods and behavior change strategies for prevention of HIV infection and the cost and side effects of antiretroviral therapy (ART) for its treatment

Computer aided design of medicinal products based on interactive chemical/herbal ingredients - An R&D approach

NASA Astrophysics Data System (ADS)

Siontorou, Christina G.

2012-12-01

Herbal products have gained increasing popularity in the last decades, and are now broadly used to treat illness and improve health. Notwithstanding the public opinion, both, safety and efficacy, are major sources of dispute among the scientific community, mainly due to lack of (or scarcity or scattered) conclusive data linking a herbal constituent to pharmacological action in vivo, in a way that benefit overrides risk. This paper presents a methodological framework for addressing natural medicine in a systematic and holistic way with a view to providing medicinal products based on interactive chemical/herbal ingredients.

Latin American Social Medicine and Global Social Medicine

PubMed Central

Yamada, Seiji

2003-01-01

A fundamental change in the theory underlying public health and medicine is needed. Latin American social medicine (LASM), originating in a region of the world that has been subjected to colonial and postcolonial influence, will be part of this change. To the extent that the social production of disease among people in other regions is a consequence of various large-scale forms of domination, LASM offers a relevant analysis, models of resistance, and exemplars of social medicine in practice. I draw upon LASM to examine the social production of disease in the Marshall Islands and Iraq. I suggest a basis for a global social medicine in the shared experience of suffering and describe implications for public health theory and practice. PMID:14652319

Degree of Response to Homeopathic Potencies Correlates with Dipole Moment Size in Molecular Detectors: Implications for Understanding the Fundamental Nature of Serially Diluted and Succussed Solutions.

PubMed

Cartwright, Steven J

2018-02-01

 The use of solvatochromic dyes to investigate homeopathic potencies holds out the promise of understanding the nature of serially succussed and diluted solutions at a fundamental physicochemical level. Recent studies have shown that a range of different dyes interact with potencies and, moreover, the nature of the interaction is beginning to allow certain specific characteristics of potencies to be delineated.  The study reported in this article takes previous investigations further and aims to understand more about the nature of the interaction between potencies and solvatochromic dyes. To this end, the UV-visible spectra of a wide range of potential detectors of potencies have been examined using methodologies previously described.  Results presented demonstrate that solvatochromic dyes are a sub-group of a larger class of compounds capable of demonstrating interactions with potencies. In particular, amino acids containing an aromatic bridge also show marked optical changes in the presence of potencies. Several specific features of molecular detectors can now be shown to be necessary for significant interactions with homeopathic potencies. These include systems with a large dipole moment, electron delocalisation, polarizability and molecular rigidity.  Analysis of the optical changes occurring on interaction with potencies suggests that in all cases potencies increase the polarity of molecular detectors to a degree that correlates with the size of the compound's permanent or ground dipole moment. These results can be explained by inferring that potencies themselves have polarity. Possible candidates for the identity of potencies, based on these and previously reported results, are discussed. The Faculty of Homeopathy.

Herbal medicine for low back pain: a Cochrane review.

PubMed

Gagnier, Joel J; van Tulder, Maurits W; Berman, Brian; Bombardier, Claire

2007-01-01

Salix alba (White willow bark) found moderate evidence for short-term improvements in pain and rescue medication for daily doses standardized to 120 mg or 240 mg salicin with an additional trial demonstrating relative equivalence to 12.5 mg per day of rofecoxib. Three low-quality trials using Capsicum frutescens (Cayenne) using various topical preparations found moderate evidence for favorable results against placebo and one trial found equivalence to a homeopathic ointment. Harpagophytum procumbens, Salix alba, and Capsicum frutescens seem to reduce pain more than placebo. Additional trials testing these herbal medicines against standard treatments will clarify their equivalence in terms of efficacy. The quality of reporting in these trials was generally poor; thus, trialists should refer to the CONSORT statement in reporting clinical trials of herbal medicines.

Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA.

PubMed

Kondo, Hideyuki; Shibatsuji, Masayoshi; Yasuda, Naoyuki

2018-01-01

Micro-, small-, and medium-sized enterprises (SMEs) have been considered as key players who can bring innovative medicinal products and/or technologies into the field. However, they may need much regulatory/scientific supports to provide their products, technologies, or services to the market in a timely way. Both the Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA), regulatory authorities for medicinal products in Japan and the EU, respectively, have prepared supportive measures for SMEs from the early phase of product/technology development to the postmarketing phase. With respect to supports for SMEs, both agencies have provided similar SME-specific supportive activities, including routine administrative assistance, consultations about product development strategy from an early phase, as well as specific regulatory/scientific issues and fee incentives. In addition, there is a system to register SME status in the EU, which can be a tool for regulators to know how much potential SME-driven activities have and with whom they should communicate to provide necessary supports. Furthermore, as new technologies and novel products from SMEs are not limited to the region where they are developed, close communication about these topics between the PMDA and the EMA will contribute to advancing patients' access to necessary medicinal products.

Giving information on medicinal products to the general public--in search of a definition to safeguard the patient.

PubMed

Faeh, Andrea

2014-04-01

Information on medicinal products is vital for enabling patients to give informed consent to the use of a specific product. Within the European Union (EU) the debate about how much information about prescription-only medicinal products should be made available to patients has gone on for the past five years with no definite conclusion yet. This contribution assesses the current legislation and the ongoing debate in order to identify the challenges and the prospect of new legislation, and consider its potential implications for the scope for advertising and for patient safety.

Restrictions on the conduct of advertising of medicinal products in Poland and their violations.

PubMed

Czerw, Aleksandra; Marek, Ewelina Maria

2013-01-01

Similarly to other European countries, the Polish pharmaceutical market is in the phase of maturity characterized by limited speed of increase in sales. In connection with escalation of the competitive struggle, being the result of globalization and development of enterprises producing generic medications, the most important aim for pharmaceutical companies has been to maintain profitability on the right level. To perform this task, companies producing medications have to carry out proper marketing actions. The marketing elements include, apart from the product, the price and the distribution, also promotion which is inextricably linked with advertising. It is a special type of information message that aims at evoking a specific consumer's attitude and belief. Advertising of medicinal products is subject to detailed legislative and non-legislative regulations. The aim of the article is to present legal regulations within the scope of advertising of medicinal products and violations of these regulations based on example decisions of the Main Pharmaceutical Inspector issued in the years 2008-2010. Abundant rulings of the Main Pharmaceutical Inspector prove that both advertisements addressed to public attention and those addressed to specialists often diverge from the criteria determined by the Pharmaceutical Law. In the face of still increasing violations of the provisions of the Pharmaceutical Law act, it seems that introducing a ban on advertising or any possible financial sanctions is not a sufficient punishment for advertisers. Thus, an introduction of other, more rigorous legal regulations as a deterrent for those involved in illegal advertising of medicinal products ought to be considered.

[Scientific production in clinical medicine and international collaboration networks in South American countries].

PubMed

Huamaní, Charles; González A, Gregorio; Curioso, Walter H; Pacheco-Romero, José

2012-04-01

International collaboration is increasingly used in biomedical research. To describe the characteristics of scientific production in Latin America and the main international collaboration networks for the period 2000 to 2009. Search for papers generated in Latin American countries in the Clinical Medicine database of ISI Web of Knowledge v.4.10 - Current Contents Connect. The country of origin of the corresponding author was considered the producing country of the paper. International collaboration was analyzed calculating the number of countries that contributed to the generation of a particular paper. Collaboration networks were graphed to determine the centrality of each network. Twelve Latin American countries participated in the production of 253,362 papers. The corresponding author was South American in 79% of these papers. Sixteen percent of papers were on clinical medicine and 36% of these were carried out in collaboration. Brazil had the highest production (22,442 papers) and the lower percentage of international collaboration (31%). North America accounts for 63% of collaborating countries. Only 8% of collaboration is between South American countries. Brazil has the highest tendency to collaborate with other South American countries. Brazil is the South American country with the highest scientific production and indicators of centrality in South America. The most common collaboration networks are with North American countries.

Women's attitudes towards the use of complementary and alternative medicine products during pregnancy.

PubMed

Frawley, J; Sibbritt, D; Broom, A; Gallois, C; Steel, A; Adams, J

2016-05-01

The aim of this study was to analyse women's attitudes towards the use of complementary and alternative medicine (CAM) products during pregnancy. The study sample was obtained via the Australian Longitudinal Study on Women's Health or ALSWH. A response rate of 79.2% (n = 1,835) was attained. Women who use herbal medicines (34.5%, n = 588) view CAM as a preventative measure, are looking for something holistic and are concerned about evidence of clinical efficacy when considering the use of these products during pregnancy. Women who use aromatherapy (17.4%, n = 319) and homoeopathy (13.3%, n = 244) want more personal control over their body and are concerned more about their own personal experience of the efficacy of CAM than clinical evidence of efficacy. As CAM use in pregnancy appears to be increasingly commonplace, insights into women's attitudes towards CAM are valuable for maternity healthcare providers.

Probiotics, fibre and herbal medicinal products for functional and inflammatory bowel disorders

PubMed Central

Ianiro, Gianluca; Pecere, Silvia; Bibbò, Stefano; Cammarota, Giovanni

2016-01-01

Functional bowel disorders (FBD), mainly irritable bowel syndrome (IBS) and functional constipation (FC, also called chronic idiopathic constipation), are very common worldwide. Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, although less common, has a strong impact on patients' quality of life, as well as being highly expensive for our healthcare. A definite cure for those disorders is still yet to come. Over the years, several therapeutic approaches complementary or alternative to traditional pharmacological treatments, including probiotics, prebiotics, synbiotics, fibre and herbal medicinal products, have been investigated for the management of both groups of diseases. However, most available studies are biased by several drawbacks, including small samples and poor methodological quality. Probiotics, in particular Saccharomyces boulardii and Lactobacilli (among which Lactobacillus rhamnosus), synbiotics, psyllium, and some herbal medicinal products, primarily peppermint oil, seem to be effective in ameliorating IBS symptoms. Synbiotics and fibre seem to be beneficial in FC patients. The probiotic combination VSL#3 may be effective in inducing remission in patients with mild‐to‐moderate ulcerative colitis, in whom Escherichia coli Nissle 1917 seems to be as effective as mesalamine in maintaining remission. No definite conclusions can be drawn as to the efficacy of fibre and herbal medicinal products in IBD patients due to the low number of studies and the lack of randomized controlled trials that replicate the results obtained in the individual studies conducted so far. Thus, further, well‐designed studies are needed to address the real role of these therapeutic options in the management of both FBD and IBD. Linked Articles This article is part of a themed section on Principles of Pharmacological Research of Nutraceuticals. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph

Using SSR-HRM to Identify Closely Related Species in Herbal Medicine Products: A Case Study on Licorice.

PubMed

Li, Jingjian; Xiong, Chao; He, Xia; Lu, Zhaocen; Zhang, Xin; Chen, Xiaoyang; Sun, Wei

2018-01-01

Traditional herbal medicines have played important roles in the ways of life of people around the world since ancient times. Despite the advanced medical technology of the modern world, herbal medicines are still used as popular alternatives to synthetic drugs. Due to the increasing demand for herbal medicines, plant species identification has become an important tool to prevent substitution and adulteration. Here we propose a method for biological assessment of the quality of prescribed species in the Chinese Pharmacopoeia by use of high resolution melting (HRM) analysis of microsatellite loci. We tested this method on licorice, a traditional herbal medicine with a long history. Results showed that nine simple sequence repeat (SSR) markers produced distinct melting curve profiles for the five licorice species investigated using HRM analysis. These results were validated by capillary electrophoresis. We applied this protocol to commercially available licorice products, thus enabling the consistent identification of 11 labels with non-declared Glycyrrhiza species. This novel strategy may thus facilitate DNA barcoding as a method of identification of closely related species in herbal medicine products. Based on this study, a brief operating procedure for using the SSR-HRM protocol for herbal authentication is provided.

Using SSR-HRM to Identify Closely Related Species in Herbal Medicine Products: A Case Study on Licorice

PubMed Central

Li, Jingjian; Xiong, Chao; He, Xia; Lu, Zhaocen; Zhang, Xin; Chen, Xiaoyang; Sun, Wei

2018-01-01

Traditional herbal medicines have played important roles in the ways of life of people around the world since ancient times. Despite the advanced medical technology of the modern world, herbal medicines are still used as popular alternatives to synthetic drugs. Due to the increasing demand for herbal medicines, plant species identification has become an important tool to prevent substitution and adulteration. Here we propose a method for biological assessment of the quality of prescribed species in the Chinese Pharmacopoeia by use of high resolution melting (HRM) analysis of microsatellite loci. We tested this method on licorice, a traditional herbal medicine with a long history. Results showed that nine simple sequence repeat (SSR) markers produced distinct melting curve profiles for the five licorice species investigated using HRM analysis. These results were validated by capillary electrophoresis. We applied this protocol to commercially available licorice products, thus enabling the consistent identification of 11 labels with non-declared Glycyrrhiza species. This novel strategy may thus facilitate DNA barcoding as a method of identification of closely related species in herbal medicine products. Based on this study, a brief operating procedure for using the SSR-HRM protocol for herbal authentication is provided. PMID:29740326

Radicalism, Marxism, and medicine.

PubMed

Navarro, V

1983-01-01

This article presents a critique of recent radical interpretations of medicine and provides an alternative explanation of such interpretations. It analyzes 1) the articulation of medical practices, knowledge, and institutions within specific modes of production and social formations; 2) the dual functions of medicine within capitalist relations of production; 3) the reproduction of power within medicine; and 4) the meaning of capitalist, socialist, and communist medicine. The political practice derived from these analyses is also elaborated.

Assessment of faculty productivity in academic departments of medicine in the United States: a national survey.

PubMed

Kairouz, Victor F; Raad, Dany; Fudyma, John; Curtis, Anne B; Schünemann, Holger J; Akl, Elie A

2014-09-26

Faculty productivity is essential for academic medical centers striving to achieve excellence and national recognition. The objective of this study was to evaluate whether and how academic Departments of Medicine in the United States measure faculty productivity for the purpose of salary compensation. We surveyed the Chairs of academic Departments of Medicine in the United States in 2012. We sent a paper-based questionnaire along with a personalized invitation letter by postal mail. For non-responders, we sent reminder letters, then called them and faxed them the questionnaire. The questionnaire included 8 questions with 23 tabulated close-ended items about the types of productivity measured (clinical, research, teaching, administrative) and the measurement strategies used. We conducted descriptive analyses. Chairs of 78 of 152 eligible departments responded to the survey (51% response rate). Overall, 82% of respondents reported measuring at least one type of faculty productivity for the purpose of salary compensation. Amongst those measuring faculty productivity, types measured were: clinical (98%), research (61%), teaching (62%), and administrative (64%). Percentages of respondents who reported the use of standardized measurements units (e.g., Relative Value Units (RVUs)) varied from 17% for administrative productivity to 95% for research productivity. Departments reported a wide variation of what exact activities are measured and how they are monetarily compensated. Most compensation plans take into account academic rank (77%). The majority of compensation plans are in the form of a bonus on top of a fixed salary (66%) and/or an adjustment of salary based on previous period productivity (55%). Our survey suggests that most academic Departments of Medicine in the United States measure faculty productivity and convert it into standardized units for the purpose of salary compensation. The exact activities that are measured and how they are monetarily compensated

[European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development].

PubMed

Zhu, You-Ping

2017-06-01

This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union（EU）, and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients. Special attention is paid to the technical details of three authorized EU herbal medicinal products (Veregen, Sativex and Episalvan) in comparison with Andrographis paniculata extract HMPL-004 that failed the phase Ⅲ clinical trial for ulcerative colitis. The paper further emphasizes the importance of enriching active fractions of herbal extracts and taking regulatory and quality considerations into account in early stage of botanical drug development. Copyright© by the Chinese Pharmaceutical Association.

Good manufacturing practices for medicinal products for human use.

PubMed

Gouveia, Bruno G; Rijo, Patrícia; Gonçalo, Tânia S; Reis, Catarina P

2015-01-01

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability.

Good manufacturing practices for medicinal products for human use

PubMed Central

Gouveia, Bruno G.; Rijo, Patrícia; Gonçalo, Tânia S.; Reis, Catarina P.

2015-01-01

At international and national levels, there are public and private organizations, institutions and regulatory authorities, who work and cooperate between them and with Pharmaceutical Industry, in order to achieve a consensus of the guidelines and laws of the manufacturing of medicinal products for human use. This article includes an explanation of how operate and cooperate these participants, between them and expose the current regulations, following the line of European Community/European Economic Area, referencing, wherever appropriate, the practiced guidelines, outside of regulatory action of space mentioned. In this way, it is intended to achieve quality, security and effectiveness exceptional levels in the manufacturing of health products. Good Manufacturing Practice aim the promotion of the human health and consequently, to the improvement of quality of life. For achieve the proposed objectives, it is necessary to ensure the applicability of the presented concepts and show the benefits arising from this applicability. PMID:25883511

Complementary and alternative medicine for rheumatic diseases: A systematic review of randomized controlled trials.

PubMed

Phang, Jie Kie; Kwan, Yu Heng; Goh, Hendra; Tan, Victoria Ie Ching; Thumboo, Julian; Østbye, Truls; Fong, Warren

2018-04-01

To summarize all good quality randomized controlled trials (RCTs) using complementary and alternative medicine (CAM) interventions in patients with rheumatic diseases. A systematic literature review guided by the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) was performed. We excluded non-English language articles and abstract-only publications. Due to the large number of RCTs identified, we only include "good quality" RCTs with Jadad score of five. We identified 60 good quality RCTs using CAM as intervention for patients with rheumatic diseases: acupuncture (9), Ayurvedic treatment (3), homeopathic treatment (3), electricity (2), natural products (31), megavitamin therapies (8), chiropractic or osteopathic manipulation (3), and energy healing therapy (1). The studies do not seem to suggest a particular type of CAM is effective for all types for rheumatic diseases. However, some CAM interventions appear to be more effective for certain types of rheumatic diseases. Acupuncture appears to be beneficial for osteoarthritis but not rheumatoid arthritis. For the other therapeutic modalities, the evidence base either contains too few trials or contains trials with contradictory findings which preclude any definitive summary. There were only minor adverse reactions observed for CAM interventions presented. We identified 60 good quality RCTs which were heterogenous in terms of interventions, disease, measures used to assess outcomes, and efficacy of CAM interventions. Evidence indicates that some CAM therapies may be useful for rheumatic diseases, such as acupuncture for osteoarthritis. Further research with larger sample size is required for more conclusive evidence regarding efficacy of CAM interventions. Copyright © 2018 Elsevier Ltd. All rights reserved.

Alternative Medicine on the Internet

PubMed Central

Muret, Marc

2000-01-01

the right to be different, show respect and tolerance, act correctly regarding copyright. More good authors should put their articles on the Net to increase the amount of basic data available online (theory, case reports, FAQ etc.). The need to create a specific (virtual) team in order to establish quality criteria, screen, control and grade the online information about alternative medicine seems obvious. This team must include professional experts with specific knowledge and experience. A homeopath should evaluate homeopathy, an acupuncturist should evaluate acupuncture. Serious thought has to be given to creating a central data bank on alternative medicine, to provide quality information to different portals and websites, as well as to patients, doctors, educators and journalists.

[History of "special therapeutic directions": the example of homeopathy].

PubMed

Hopff, W H

1996-04-01

As for generally accepted therapeutic methods, the "special methods" may appear to be effective due to spontaneous recovery provided by nature. A great number of sceptical physicians are aware of this fact. The pharmacologist works continuously to differentiate effects directly caused by medical treatments - mainly drugs - from effects resulting from spontaneous recovery. This is one of the most difficult problems in medical treatment. As a representative example of all "special methods", we concentrate here on the history of homeopathy. As is generally known, there is no conformity in homeopathy, for example monotherapy versus therapy with complex homeopathic products; refusing the simile-rule; treatment with high potencies versus treatment with low potencies; classic versus scholastic homeopathy. The number of homeopathies really equals the number of homeopathic physicians. For this reason, instruction in homeopathy on the academic level is impossible. In addition, we have to forget all natural laws only to prove that "potentiation" may be true. Therapeutic success due purely to chance may be explained rationally and is occasionally seen in all other "special methods". The theories of homeopaths for the action with homeopathic products are neither in accordance with our natural laws nor comply with a rational philosophy.

Clinical evidence for orphan medicinal products-a cause for concern?

PubMed

Picavet, Eline; Cassiman, David; Hollak, Carla E; Maertens, Johan A; Simoens, Steven

2013-10-16

The difficulties associated with organising clinical studies for orphan medicinal products (OMPs) are plentiful. Recent debate on the long-term effectiveness of some OMPs, led us to question whether the initial standards for clinical evidence for OMPs, set by the European Medicines Agency (EMA) at the time of marketing authorization, are too low. Therefore, the aim of this study was to quantitatively evaluate the characteristics and quality of clinical evidence that is presented for OMPs to obtain marketing authorization in Europe, using the new and validated COMPASS tool. We quantitatively assessed the characteristics and quality of clinical evidence of the pivotal studies of 64 OMPs as described in the European Public Assessment Report and/or the Scientific Discussion document prepared by the Committee for Human Medicinal Products of the EMA. The 64 OMPs were altogether authorized for 78 orphan indications, for which 117 studies were identified as 'pivotal' or 'main' studies. In approximately two thirds of the studies, the allocation was randomized (64.8%) and a control arm was used (68.5%). Half of the studies applied some type of blinding. Only a minority (26.9%) of the studies included a Quality-of-Life (QoL) related endpoint, of which a third claim an improvement in QoL. Upon analyzing the quality of reporting, we found that some aspects (i.e. the endpoints, the sampling criteria, and the interventions) are well described, whereas other items (i.e. a description of the patients and of potential biases) are not reported for all studies. In conclusion, the pivotal studies that are the basis for marketing authorization of OMPs are a cause for concern, as they exhibit methodological flaws i.e. the lack of QoL-related endpoints as outcome, lack of blinding in the study design and the use of surrogate endpoints. Additionally, there are shortcomings in the reporting of those studies that complicate the interpretation. A more demanding regulatory process for OMPs is

Condensed tannins in extracts from European medicinal plants and herbal products.

PubMed

Ropiak, Honorata M; Ramsay, Aina; Mueller-Harvey, Irene

2016-03-20

Medicinal plant materials are not usually analysed for condensed tannins (CT). Thirty commercially available European medicinal plants and herbal products were screened for CT and fourteen CT samples were analysed in detail. This is also the first comprehensive CT analysis of pine buds, walnut leaves, heather flowers and great water dock roots. Acetone/water extracts contained between 3.2 and 25.9 g CT/100g of extract, had CT with mean degrees of polymerisation of 2.9 to 13.3, procyanidin/prodelphinidin ratios of 1.6/98.4 to 100/0 and cis/trans flavan-3-ol ratios of 17.7/82.3 to 97.3/2.7. The majority of samples contained procyanidins, four contained A-type linkages (blackthorn flowers, heather flowers, bilberry leaves and cowberry leaves) and one sample also had galloylated procyanidins (great water dock roots). Copyright © 2015 Elsevier B.V. All rights reserved.

[General aspects of homeopathy].

PubMed

Avello L, Marcia; Avendaño O, Cristian; Mennickent C, Sigrid

2009-01-01

Homeopathic medicine is a type of therapy that appeared in Europe at the end of the eighteenth century. At the present time, it is widely accepted in developed countries as a form of alternative medicine. In Chile, health regulation includes homeopathy as pharmaceutical products and homeopathy is also considered a form of complementary medicine, that is well accepted by the public. The scientific rationale of homeopathy is based on an empiric type of thought that goes from the general to the particular. The symptoms that are valued are those that are particular to each sick individual. It uses diluted solutions of plants, minerals, animals and even venoms. There are basically two hypotheses to explain its mechanisms of action: The "immunological memory" and the "memory of water" or the transmission of electromagnetic information of the water. There still is needed to perform new studies to scientifically assess homeopathy and its usefulness, as an accepted alternative therapy.

The use of community herbal monographs to facilitate registrations and authorisations of herbal medicinal products in the European Union 2004-2012.

PubMed

Peschel, Wieland

2014-12-02

The provisions for the simplified registration of traditional herbal medicinal products in the European Union were introduced by Directive 2004/24/EC amending Directive 2001/83/EC (Chapter 2a) in 2004. Since implementation in the European member states until December 2012 a total of 1015 registrations (traditional use) and 514 authorisations (well-established use) have been granted for products containing substances/ preparations from about 200 different herbal drugs. The overall number of received applications with more than one third still under assessment suggests a further increase for the next years. This review summarises the main features of registered and authorised herbal medicinal products in the EU and evaluates available data against provisions of Directive 2004/24/EC and European standards established by the Committee on Herbal Medicinal Products at the European Medicines Agency. The supportive function of Community herbal monographs is described as regards availability and their use in national procedures, which is complemented by an analysis of specific future challenges from experiences made with the implementation of Directive 2004/24/EC so far. Copyright © 2014. Published by Elsevier Ireland Ltd.

Hospital Exemption for Advanced Therapy Medicinal Products: Issue in Application in the European Union Member States.

PubMed

Ivaskiene, Tatjana; Mauricas, Mykolas; Ivaska, Justinas

2017-01-01

Regulation (EC) 1394/2007 of the European Parliament and the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 allowed the use of non - authorized advanced therapy medicinal products under the certain circumstances. This socalled hospital exemption rule needs to be applied in the each Member State of the European Union individually and for this purpose Member States should provide national procedures and control measures. The aim of this article is to clear up the criteria for hospital exemption listed in Regulation (EC) 1394/2007 and to contrast the difference in implementing hospital exemption rule into national legal regimes on examples of the United Kingdom, Lithuania and Poland.

Safe Use of Complementary Health Products and Practices

MedlinePlus

... Mind and Body Practices for Children and Teens Dietary Supplement Safety Information Using Dietary Supplements Wisely Dietary Supplement ... Homeopathic Drugs Dietary Supplements—Adverse Event Reporting ( FDA ) Dietary Supplement Alerts and Advisories Alerts and Advisories Clinical Practice ...

77 FR 52744 - Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-30

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting. The Food and Drug Administration's (FDA) Office of Orphan Products Development...

Is There a Role for Homeopathy in Cancer Care? Questions and Challenges.

PubMed

Frenkel, Moshe

2015-09-01

Patients with cancer commonly use complementary and integrative medicine, including homeopathy. Homeopathy has grown in popularity with the public but is viewed with skepticism by medical academia and is still excluded from conventionally prescribed treatments. In recent years, homeopathy has been used in cancer care in Europe and other countries worldwide. This use raised the question if there is any benefit in utilizing this type of care with cancer patients. The purpose of this manuscript is to explore the evidence related to the benefit of homeopathy in cancer care. Limited research has suggested that homeopathic remedies appear to cause cellular changes in some cancer cells. In animal models, several homeopathic remedies have had an inhibitory effect on certain tumor development. Some clinical studies of homeopathic remedies combined with conventional care have shown that homeopathic remedies improve quality of life, reduce symptom burden, and possibly improve survival in patients with cancer. The findings from several lab and clinical studies suggest that homeopathy might have some beneficial effect in cancer care; however, further large, comprehensive clinical studies are needed to determine these beneficial effects. Although additional studies are needed to confirm these findings, given the low cost, minimal risks, and the potential magnitude of homeopathy's effects, this use might be considered in certain situations as an additional tool to integrate into cancer care.

The production of radionuclides for nuclear medicine from a compact, low-energy accelerator system.

PubMed

Webster, William D; Parks, Geoffrey T; Titov, Dmitry; Beasley, Paul

2014-05-01

The field of nuclear medicine is reliant on radionuclides for medical imaging procedures and radioimmunotherapy (RIT). The recent shut-downs of key radionuclide producers have highlighted the fragility of the current radionuclide supply network, however. To ensure that nuclear medicine can continue to grow, adding new diagnostic and therapy options to healthcare, novel and reliable production methods are required. Siemens are developing a low-energy, high-current - up to 10 MeV and 1 mA respectively - accelerator. The capability of this low-cost, compact system for radionuclide production, for use in nuclear medicine procedures, has been considered. The production of three medically important radionuclides - (89)Zr, (64)Cu, and (103)Pd - has been considered, via the (89)Y(p,n), (64)Ni(p,n) and (103)Rh(p,n) reactions, respectively. Theoretical cross-sections were generated using TALYS and compared to experimental data available from EXFOR. Stopping power values generated by SRIM have been used, with the TALYS-generated excitation functions, to calculate potential yields and isotopic purity in different irradiation regimes. The TALYS excitation functions were found to have a good agreement with the experimental data available from the EXFOR database. It was found that both (89)Zr and (64)Cu could be produced with high isotopic purity (over 99%), with activity yields suitable for medical diagnostics and therapy, at a proton energy of 10MeV. At 10MeV, the irradiation of (103)Rh produced appreciable quantities of (102)Pd, reducing the isotopic purity. A reduction in beam energy to 9.5MeV increased the radioisotopic purity to 99% with only a small reduction in activity yield. This work demonstrates that the low-energy, compact accelerator system under development by Siemens would be capable of providing sufficient quantities of (89)Zr, (64)Cu, and (103)Pd for use in medical diagnostics and therapy. It is suggested that the system could be used to produce many other

Safety concerns of herbal products and traditional Chinese herbal medicines: Dehydropyrrolizidine alkaloids and aristolochic acid

USDA-ARS?s Scientific Manuscript database

In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids ...

Medicinal plants and finished marketed herbal products used in the treatment of malaria in the Ashanti region, Ghana.

PubMed

Komlaga, Gustav; Agyare, Christian; Dickson, Rita Akosua; Mensah, Merlin Lincoln Kwao; Annan, Kofi; Loiseau, Philippe M; Champy, Pierre

2015-08-22

Ethnobotanical survey was performed to document medicinal plants employed in the management of malaria in the Bosomtwe and Sekyere East Districts of the Ashanti Region (Ghana), in comparison with the plant ingredients in herbal antimalarial remedies registered by the Ghana Food and Drug Administration. Two hundred and three (203) herbalists from 33 communities within the two districts were interviewed on medicinal plants they use to manage malaria. A literature search was made to determine already documented plants. In addition, 23 finished marketed herbal products indicated for the management of malaria were identified and their labels examined to find out which of the plants mentioned in our survey were listed as ingredients and whether these products are in anyway regulated. Ninety-eight (98) species of plants were cited for the management of malaria. In comparison with literature citations, 12 (12.2%) species were reported for the management of malaria for the first time and 20 (20.4%) others for the first time in Ghana. Twenty-three (23) finished marketed herbal antimalarial products examined contained aerial or underground parts of 29 of the plants cited in our survey as ingredients. Twenty-two (22) of these products have been registered by the Ghana Food and Drugs Authority, four (4) of which were included in the recommended herbal medicine list for treating malaria in Ghana. This study provides new additions to the inventory of medicinal plants used for the management of malaria and reports the commercial availability and regulation of finished marketed labelled herbal products intended for the treatment of malaria in Ghana. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

[Analysis on influential factors in China's exports of primary and semi-finished products of traditional Chinese medicine to ASEAN].

PubMed

Qian, Yun-Xu; Yang, Yue; Zhao, Wei; Bi, Kai-Shun

2014-04-01

Two regression models, based on panel data over the period of 2000-2011, are built and used to analyze what factors determine China's exports of primary and semi-finished products of traditional Chinese medicine to ASEAN. The results indicate that, China GDP, the ratio of ASEAN to China GDP per capita, average export price, the ratio of state-owned assets to total assets, have a significant positive influence on the export volumes of primary products of Chinese medicine. At the same time, RMB appreciation, the ratio of three kinds of foreign-invested assets to total assets, China-ASEAN Early Harvest Program, ASEAN-China Free Trade Area have a significant negative influence. In respect of the export volumes of semi-finished products of Chinese medicine, the significant influential factors are ASEAN GDP and the ratio of ASEAN to China GDP per capita. The former is positive and the latter is negative. In order to optimize the commodity composition of experts, it is needed to increase export volumes of both primary and semi-finished products of Chinese medicine. According to the analysis above, some proposals are put forward, such as, improving the performance of foreign capital, playing an exemplary and leading role in technological innovation by state-owned enterprises, taking advantage of bargaining power of suppliers, increasing outward foreign direct investment.

Safety concerns of herbal products and traditional Chinese herbal medicines: Dehydopyrrolizidine alkaloids and aristolochic acid

USDA-ARS?s Scientific Manuscript database

In many countries, including the United States, herbal supplements, tisanes and vegetable products including traditional Chinese medicines are largely unregulated and their content is not registered, monitored or verified. Consequently potent plant toxins including dehydopyrrolizidine alkaloids and...

The flow synthesis of heterocycles for natural product and medicinal chemistry applications.

PubMed

Baumann, Marcus; Baxendale, Ian R; Ley, Steven V

2011-08-01

This article represents an overview of recent research from the Innovative Technology Centre in the field of flow chemistry which was presented at the FROST2 meeting in Budapest in October 2009. After a short introduction of this rapidly expanding field, we discuss some of our results with a main focus on the synthesis of heterocyclic compounds which we use in various natural product and medicinal chemistry programmes.

A Supramolecular Approach to Medicinal Chemistry: Medicine Beyond the Molecule

NASA Astrophysics Data System (ADS)

Smith, David K.

2005-03-01

This article focuses on the essential roles played by intermolecular forces in mediating the interactions between chemical molecules and biological systems. Intermolecular forces constitute a key topic in chemistry programs, yet can sometimes seem disconnected from real-life applications. However, by taking a "supramolecular" view of medicinal chemistry and focusing on interactions between molecules, it is possible to come to a deeper understanding of recent developments in medicine. This allows us to gain a real insight into the interface between biology and chemistry—an interdisciplinary area that is crucial for the development of modern medicinal products. This article emphasizes a conceptual view of medicinal chemistry, which has important implications for the future, as the supramolecular approach to medicinal-chemistry products outlined here is rapidly allowing nanotechnology to converge with medicine. In particular, this article discusses recent developments including the rational design of drugs such as Relenza and Tamiflu, the mode of action of vancomycin, and the mechanism by which bacteria develop resistance, drug delivery using cyclodextrins, and the importance of supramolecular chemistry in understanding protein aggregation diseases such as Alzheimer's and Creutzfield Jacob. The article also indicates how taking a supramolecular approach will enable the development of new nanoscale medicines.

Software support in automation of medicinal product evaluations.

PubMed

Juric, Radmila; Shojanoori, Reza; Slevin, Lindi; Williams, Stephen

2005-01-01

Medicinal product evaluation is one of the most important tasks undertaken by government health departments and their regulatory authorities, in every country in the world. The automation and adequate software support are critical tasks that can improve the efficiency and interoperation of regulatory systems across the world. In this paper we propose a software solution that supports the automation of the (i) submission of licensing applications, and (ii) evaluations of submitted licensing applications, according to regulatory authorities' procedures. The novelty of our solution is in allowing licensing applications to be submitted in any country in the world and evaluated according to any evaluation procedure (which can be chosen by either regulatory authorities or pharmaceutical companies). Consequently, submission and evaluation procedures become interoperable and the associated data repositories/databases can be shared between various countries and regulatory authorities.

Medicinal and cosmetics soap production from Jatropha oil.

PubMed

Shahinuzzaman, M; Yaakob, Zahira; Moniruzzaman, M

2016-06-01

Soap is the most useful things which we use our everyday life in various cleansing and cosmetics purposes. Jatropha oil is nonedible oil which has more benefits to soap making. It has also cosmetics and medicinal properties. But the presence of toxic Phorbol esters in Jatropha oil is the main constrains to use it. So it is necessary to search a more suitable method for detoxifying the Jatropha oil before the use as the main ingredient of soap production. This review implies a more suitable method for removing phorbol esters from Jatropha oil. Several parameters such as the % yield of pure Jatropha oil soap, TFM value of soap, total alkali content, free caustic alkalinity content, pH, the antimicrobial activity, and CMC value of general soap should be taken into consideration for soap from detoxified Jatropha oil. © 2016 Wiley Periodicals, Inc.

Integrative Medicine in Preventive Medicine Education

PubMed Central

Jani, Asim A.; Trask, Jennifer; Ali, Ather

2016-01-01

During 2012, the USDHHS’s Health Resources and Services Administration funded 12 accredited preventive medicine residencies to incorporate an evidence-based integrative medicine curriculum into their training programs. It also funded a national coordinating center at the American College of Preventive Medicine, known as the Integrative Medicine in Preventive Medicine Education (IMPriME) Center, to provide technical assistance to the 12 grantees. To help with this task, the IMPriME Center established a multidisciplinary steering committee, versed in integrative medicine, whose primary aim was to develop integrative medicine core competencies for incorporation into preventive medicine graduate medical education training. The competency development process was informed by central integrative medicine definitions and principles, preventive medicine’s dual role in clinical and population-based prevention, and the burgeoning evidence base of integrative medicine. The steering committee considered an interdisciplinary integrative medicine contextual framework guided by several themes related to workforce development and population health. A list of nine competencies, mapped to the six general domains of competence approved by the Accreditation Council of Graduate Medical Education, was operationalized through an iterative exercise with the 12 grantees in a process that included mapping each site’s competency and curriculum products to the core competencies. The competencies, along with central curricular components informed by grantees’ work presented elsewhere in this supplement, are outlined as a roadmap for residency programs aiming to incorporate integrative medicine content into their curricula. This set of competencies adds to the larger efforts of the IMPriME initiative to facilitate and enhance further curriculum development and implementation by not only the current grantees but other stakeholders in graduate medical education around integrative medicine

Hurdles in tissue engineering/regenerative medicine product commercialization: a survey of North American academia and industry.

PubMed

Johnson, Peter C; Bertram, Timothy A; Tawil, Bill; Hellman, Kiki B

2011-01-01

The Tissue Engineering and Regenerative Medicine International Society-North America (TERMIS-NA) Industry Committee was formed in February 2009 to address the common roadblocks (i.e., hurdles) in the commercialization of tissue engineering/regenerative medicine products for its members. A semiquantitative online opinion survey instrument that delineated potentially sensitive hurdles to commercialization in each of the TERMIS constituency groups that generally participate in the stream of technology commercialization (academia, startup companies, development-stage companies, and established companies) was developed. The survey was opened to each of the 863 members of TERMIS-NA for a period of 5 weeks from October to November 2009. By its conclusion, 215 members (25%) had responded. Their proportionate numbers were closely representative of TERMIS-NA constituencies. The resulting data delineate what each group considers to be its most difficult and also its easiest hurdles in taking a technology to full product development. In addition, each group ranked its perception of the difficult and easy hurdles for all other groups, enabling an assessment of the degree of understanding between groups. The data depict not only critical hurdles in the path to commercialization at each stage in product development but also a variable understanding of perceptions of hurdles between groups. This assessment has provided the Industry Committee with activity foci needed to assist individual groups in the technology-commercialization stream. Moreover, the analysis suggests that enhanced communication between groups engaged in commercialization will be critical to the successful development of products in the tissue engineering/regenerative medicine sector.

The European Medicines Agency's approval of new medicines for type 2 diabetes.

PubMed

Blind, Eberhard; Janssen, Heidi; Dunder, Kristina; de Graeff, Pieter A

2018-05-08

Since 2005, more than 40 new medicines for the treatment of type 2 diabetes have been introduced on the market. These consist of 15 new active substances establishing three new classes of non-insulin products, and several new or modified insulin products and combinations. The approval of these products in Europe is regulated via the centralized procedure at the European Medicines Agency. Demonstration of benefit with regard to improved glucose control remains the principal outcome required from confirmatory studies to demonstrate efficacy. For the majority of these new medicines approved since 2005, cardiovascular outcome trials have now been completed, and have invariably supported the cardiovascular safety of these products. In some of these trials additional important benefits have been observed, for instance, a reduction in major adverse cardiovascular events and improvement of renal outcome. The existing regulatory framework and the continuous adaption of regulatory requirements to emerging developments will continue to guide the approval of new products in the future. © 2018 John Wiley & Sons Ltd.

[Academic cell therapy facilities are challenged by European regulation on advanced therapy medicinal products].

PubMed

Chabannon, Christian; Sabatier, Florence; Rial-Sebbag, Emmanuelle; Calmels, Boris; Veran, Julie; Magalon, Guy; Lemarie, Claude; Mahalatchimy, Aurélie

2014-05-01

Regulation (EC) n° 1394/2007 from the European Parliament and the Council describes a new category of health products termed « Advanced Therapy Medicinal Products » (ATMPs). ATMPs derive from cell engineering, tissue engineering or genetic manipulations, and can in some instances be combined with medical devices. ATMPs are distributed and administered to patients, after biotechnology or pharmaceutical companies have obtained a marketing authorization that is granted by the European Commission on the basis of the European Medicines Agency (EMA) assessment. Seven years after the publication of the regulation, few of these therapies have received a marketing authorization, and even fewer have met commercial success, suggesting that a number of medical and economic issues still need to be sorted out in order to achieve sustainability in this field. The coexistence of three sets of rules for three categories of health products that are biologically and medically related - ATMPs, ATMPs produced under the hospital exemption rule, and cell therapy products (CTPs) (a specific legal category in France) that have long been used in hematopoietic cell transplantation - constitutes a complex regulatory framework. This situation raises significant issues for historical as well as emerging operators in this moving field that are discussed thereafter. © 2014 médecine/sciences – Inserm.

[Current cases of falsified medicinal products within the competence of the Federal Institute for Drugs and Medical Devices (BfArM) : Case studies and extent].

PubMed

Wittstock, Marcus; Paeschke, Norbert

2017-11-01

The nature of a falsification of a medicinal product can vary a lot. Therefore the means to detect them and the potential risk to patient safety can also be very different. The whole range of falsification will be described using observed cases from the Federal Institute for Drugs and Medical Devices (BfArM).Based on the relatively low number of detected cases of falsified medicines, the legal supply chain can still be regarded as safe. It has to be assumed that in the illegal supply chain, e. g. illegal internet trade, the majority of the offered medicinal products are not only falsifications due to illegal trade but because they are completely falsified. Therefore there is an especially high risk for the consumer to be harmed by medicinal products that do not fulfil the required specifications.The trend indicates that increased efforts will be necessary to keep the legal supply chain safe and to contain illegal trade with falsifications. The higher federal authorities BfArM, PEI and BVL are involved in this task by coordinating and ensuring the flow of information to the concerned authorities and stakeholders as well as informing the public. Increased efforts are also necessary due to the rising involvement of organised crime in the falsification of medicinal products. A package of measures was enacted with the Falsified Medicines Directive 2011/62/EU to protect the legal supply chain from falsified medicinal products.

Assessment of Likelihood Ratio for Four Contact Dermatitis Symptoms of Vinca Minor.

PubMed

Bagchi, Suman; Nayak, Chaturbhuja; Rutten, Lex; Koley, Munmun; Saha, Subhranil; Roy, Mousumi; Abbas, Sk Jahir; Ghosh, Simantini; Halder, Suman; Wani, Ghulam Nabi; Mir, Anaitulah Ahmad; Bhat, Showket Ahmad

2018-05-21

 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.  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.  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.  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. The Faculty of Homeopathy.

[Closed-loop management model of clinical investigational product for new drug of traditional Chinese medicine].

PubMed

Wu, Ping; Zhang, Jian-Wu

2013-09-01

This paper discussed the management regulations and technical requirements of clinical investigational product for new drug of traditional Chinese medicine, analyzed some common problems on the management of them, and proposed the establishment of closed-loop management model and management requirements in various aspects.

Food effects in paediatric medicines development for products Co-administered with food.

PubMed

Batchelor, Hannah; Kaukonen, Ann Marie; Klein, Sandra; Davit, Barbara; Ju, Rob; Ternik, Robert; Heimbach, Tycho; Lin, Wen; Wang, Jian; Storey, David

2018-02-05

A small amount of food is commonly used to aid administration of medicines to children to improve palatability and/or swallowability. However the impact of this co-administered food on the absorption and subsequent pharmacokinetic profile of the drug is unknown. Existing information on food effects is limited to standard protocols used to evaluate the impact of a high fat meal in an adult population using the adult medication. In the absence of a substantial body of data, there are no specific guidelines available during development of paediatric products relating to low volumes of potentially low calorie food. This paper brings together expertise to consider how the impact of co-administered food can be risk assessed during the development of a paediatric medicine. Two case studies were used to facilitate discussions and seek out commonalities in risk assessing paediatric products; these case studies used model drugs that differed in their solubility, a poorly soluble drug that demonstrated a positive food effect in adults and a highly soluble drug where a negative food effect was observed. For poorly soluble drugs risk assessments are centred upon understanding the impact of food on the in vivo solubility of the drug which requires knowledge of the composition of the food and the volumes present within the paediatric gastrointestinal tract. Further work is required to develop age appropriate in vitro and in silico models that are representative of paediatric populations. For soluble drugs it is more important to understand the mechanisms that may lead to a food effect, this may include interactions with transporters or the impact of the food composition on gastro-intestinal transit or even altered gastric motility. In silico models have the most promise for highly soluble drug products although it is essential that these models reflect the relevant mechanisms involved in potential food effects. The development of appropriate in vitro and in silico tools is

[History of homeopathy in Franconia].

PubMed

Dross, Fritz; Ruisinger, Marion Maria

2007-01-01

The research for this paper was initiated by an Erlangen exhibition project on the history of homeopathy on the occasion of the 250th anniversary of Samuel Hahnemann's birth in 2005. The founder of homeopathic medicine received his doctor of medicine degree at the University of Erlangen in 1779. As Hahnemann spent only four months in Erlangen, homeopathic physicians, patients and apothecaries in the region from Hahnemann's time until today were investigated. The aim was to provide a concise survey of the general problems in the history of homeopathy derived from regional cases which could be illustrated by objects suitable for an exhibition. Thus, the article is not only about the history of homeopathy in Northern Bavaria (Franconia), but also about a shift in the use of media and about doing science the other way round, viz. by starting at the presentation and ending with the sources. The outcome of the project was that most of the crucial topics of the history of homeopathy could be covered on a micro-historic scale: trials, pharmacy, hospital, patients, university, National Socialism.

Plausibility and evidence: the case of homeopathy.

PubMed

Rutten, Lex; Mathie, Robert T; Fisher, Peter; Goossens, Maria; van Wassenhoven, Michel

2013-08-01

Homeopathy is controversial and hotly debated. The conclusions of systematic reviews of randomised controlled trials of homeopathy vary from 'comparable to conventional medicine' to 'no evidence of effects beyond placebo'. It is claimed that homeopathy conflicts with scientific laws and that homoeopaths reject the naturalistic outlook, but no evidence has been cited. We are homeopathic physicians and researchers who do not reject the scientific outlook; we believe that examination of the prior beliefs underlying this enduring stand-off can advance the debate. We show that interpretations of the same set of evidence--for homeopathy and for conventional medicine--can diverge. Prior disbelief in homeopathy is rooted in the perceived implausibility of any conceivable mechanism of action. Using the 'crossword analogy', we demonstrate that plausibility bias impedes assessment of the clinical evidence. Sweeping statements about the scientific impossibility of homeopathy are themselves unscientific: scientific statements must be precise and testable. There is growing evidence that homeopathic preparations can exert biological effects; due consideration of such research would reduce the influence of prior beliefs on the assessment of systematic review evidence.

Essential medicines are more available than other medicines around the globe.

PubMed

Bazargani, Yaser T; Ewen, Margaret; de Boer, Anthonius; Leufkens, Hubert G M; Mantel-Teeuwisse, Aukje K

2014-01-01

The World Health Organization (WHO) promotes the development of national Essential Medicines Lists (EMLs) in order to improve the availability and use of medicines considered essential within health care systems. However, despite over 3 decades of international efforts, studies show an inconsistent pattern in the availability of essential medicines. We evaluated and compared the availability of essential medicines, and medicines not included in national EMLs, at global and regional levels. Medicine availability in the public and private sector were calculated based on data obtained from national and provincial facility-based surveys undertaken in 23 countries using the WHO/HAI methodology. The medicines were grouped according to their inclusion ('essential') or exclusion (termed 'non-essential') in each country's EML current at the time of the survey. Availability was calculated for originator brands, generics and any product type (originator brands or generics) and compared between the two groups. Results were aggregated by WHO regions, World Bank country income groups, a wealth inequality measure, and therapeutic groups. Across all sectors and any product type, the median availability of essential medicines was suboptimal at 61·5% (IQR 20·6%-86·7%) but significantly higher than non-essential medicines at 27·3% (IQR 3·6%-70·0%). The median availability of essential medicines was 40·0% in the public sector and 78·1% in the private sector; compared to 6·6% and 57·1% for non-essential medicines respectively. A reverse trend between national income level categories and the availability of essential medicines was identified in the public sector. EMLs have influenced the provision of medicines and have resulted in higher availability of essential medicines compared to non-essential medicines particularly in the public sector and in low and lower middle income countries. However, the availability of essential medicines, especially in the public sector does not

Medicinal and aromatic crops: Production, Phytochemistry, and Utilization

USDA-ARS?s Scientific Manuscript database

In the later part of the 20th century the United States experienced a remarkable surge in public interest towards medicinal and aromatic crops and this trend continues. This consumer interest helped create a significant demand for plants with culinary and medicinal applications as the public discove...

Conceptions of health, illness and treatment of patients who use homeopathy in Santos, Brazil.

PubMed

Patriani Justo, C M; Dé Andrea Gomes, Mara H

2008-01-01

To investigate the conceptions of health and illness, the reasons for seeking homeopathy and continuing treatment, compliance and the meaning of the relationship between religiosity and health for patients who adhere to homeopathy. A qualitative study of 20 adult patients in Santos (Brazil) treated by homeopaths in the public and private sector for at least 2 years. Semi-structured interviews, organized by predefined thematic categories, the content of the interviews was analyzed. The conceptions of health and illness of the interviewed patients are related to the idea of vital balance/imbalance mediated by body-mind interaction. Dissatisfaction with conventional treatment, family influence and suggestions of others were the reasons for seeking homeopathic treatment. Patients continued homeopathic treatment due to positive therapeutic results, cure without being aggressive to the organism, the holistic integrated approach, the preventive nature of the treatment and low prices of medicine. For these patients, the availability of homeopathy in the public health sector extends the possibility of access. The need for a wider dissemination of homeopathy and the difficulties in following the prescription are the main problems involved in continuing treatment. Faith is an important component. We found a correlation between the conceptions of health and illness and the principles of homeopathy, assimilated through a strong bond between patients and the homeopathic practitioners. To investigate the beliefs, values and meanings that patients attribute to homeopathy helps to understand subjective aspects that may interfere with treatment compliance.

The potential of three different PCR-related approaches for the authentication of mixtures of herbal substances and finished herbal medicinal products.

PubMed

Doganay-Knapp, Kirsten; Orland, Annika; König, Gabriele M; Knöss, Werner

2018-04-01

Herbal substances and preparations thereof play an important role in healthcare systems worldwide. Due to the variety of these products regarding origin, composition and processing procedures, appropriate methodologies for quality assessment need to be considered. A majority of herbal substances is administered as multicomponent mixtures, especially in the field of Traditional Chinese Medicine and ayurvedic medicine, but also in finished medicinal products. Quality assessment of complex mixtures of herbal substances with conventional methods is challenging. Thus, emphasis of the present work was directed on the development of complementary methods to elucidate the composition of mixtures of herbal substances and finished herbal medicinal products. An indispensable prerequisite for the safe and effective use of herbal medicines is the unequivocal authentication of the medicinal plants used therein. In this context, we investigated the potential of three different PCR-related methods in the characterization and authentication of herbal substances. A multiplex PCR assay and a quantitative PCR (qPCR) assay were established to analyze defined mixtures of the herbal substances Quercus cortex, Juglandis folium, Aristolochiae herba, Matricariae flos and Salviae miltiorrhizae radix et rhizoma and a finished herbal medicinal product. Furthermore, a standard cloning approach using universal primers targeting the ITS region was established in order to allow the investigation of herbal mixtures with unknown content. The cloning approach had some limitations regarding the detection/recovery of the components in defined mixtures of herbal substances, but the complementary use of two sets of universal primer pairs increased the detection of components out of the mixture. While the multiplex PCR did not retrace all components in the defined mixtures of herbal substances, the established qPCR resulted in simultaneous and specific detection of the five target sequences in all defined

Rasing the ivory tower: the production of knowledge and distrust of medicine among African Americans

PubMed Central

Wasserman, J; Flannery, M A; Clair, J M

2007-01-01

African American distrust of medicine has consequences for treatment seeking and healthcare behaviour. Much work has been done to examine acute events (eg, Tuskegee Syphilis Study) that have contributed to this phenomenon and a sophisticated bioethics discipline keeps watch on current practices by medicine. But physicians and clinicians are not the only actors in the medical arena, particularly when it comes to health beliefs and distrust of medicine. The purpose of this paper is to call attention not just to ethical shortcomings of the past, but to the structural contexts of those events and the contributions and responsibilities of popular media and academic disciplines in the production of (often mythic) knowledge. We argue that ignoring context and producing inaccurate work has real impacts on health and healthcare, particularly for African Americans, and thus engenders ethical obligations incumbent on disciplines traditionally recognised as purely academic. PMID:17329393

The curious case of charles darwin and homeopathy.

PubMed

Ullman, Dana

2010-03-01

In 1849, Charles Darwin was so ill that he was unable to work one out of every 3 days, and after having various troubling symptoms for 2-12 years, he wrote to a friend that he was 'going the way of all flesh'. He sought treatment from Dr James Manby Gully, a medical doctor who used water cure and homeopathic medicines. Despite being highly skeptical of these treatments, he experienced a dramatic improvement in his health, though some of his digestive and skin symptoms returned various times in his life. He grew to appreciate water cure, but remained skeptical of homeopathy, even though his own experiments on insectivore plants using what can be described as homeopathic doses of ammonia salts surprised and shocked him with their significant biological effect. Darwin even expressed concern that he should publish these results. Two of Darwin's sons were as incredulous as he was, but their observations confirmed the results of his experiments. Darwin was also known to have read a book on evolution written by a homeopathic physician that Darwin described as similar to his own but 'goes much deeper.'

Publication Productivity of Faculty of Medicine, Mansoura University Indexed in PubMed.

PubMed

Helal, Rm; Abou-ElWafa, Hs; El-Gilany, Ah

2014-09-01

Analysis of PubMed publications as an indicator of the research productivity of individual countries, regions, or institutions has recently become a field of interest. The aim was to assess the past trends in PubMed-indexed medical publications from Mansoura Faculty of Medicine and to have an idea about the current situation in medical research. PubMed was searched for publications affiliated to Mansoura from the end of the calendar year 2012 and earlier. Of 2798 papers related to Mansoura, 1756 publications were included in the analysis, and 1042 publications were excluded (false positives). The highest number of publications was in 2011 (10.6%, 187/1756) followed by 2012 (10.2%, 179/1756). There was an increase of the publication rate over 5-years period until it reaches 47.0% (826/1756) during the period from 2008 to 2012. The main high-producing department was Urology and Nephrology, which accounted for 35.9% (631/1756) of the total publications followed by Pediatrics and Parasitology. The median number of authors participated in the researches was four ranging from 1 to 23. Most of the publications were in the form of intervention/clinical trials (38.4%, 662/1756) followed by descriptive/cross-sectional study (38.3%, 659/1756). The median of the impact factor was 1.99 ranging from 0.27 to 53.3. The publication productivity of Mansoura Faculty of Medicine showed fluctuating pattern from the end of the calendar year 2012 and earlier. Future prospects for increasing research productivity should be considered to increase the number and quality of publications and academic staff participating in high-quality international researches.

A critical overview of homeopathy.

PubMed

Jonas, Wayne B; Kaptchuk, Ted J; Linde, Klaus

2003-03-04

Homeopathy is a 200-year-old therapeutic system that uses small doses of various substances to stimulate autoregulatory and self-healing processes. Homeopathy selects substances by matching a patient's symptoms with symptoms produced by these substances in healthy individuals. Medicines are prepared by serial dilution and shaking, which proponents claim imprints information into water. Although many conventional physicians find such notions implausible, homeopathy had a prominent place in 19th-century health care and has recently undergone a worldwide revival. In the United States, patients who seek homeopathic care are more affluent and younger and more often seek treatment for subjective symptoms than those who seek conventional care. Homeopathic remedies were allowed by the 1939 Pure Food and Drug Act and are available over the counter. Some data--both from randomized, controlled trials and laboratory research--show effects from homeopathic remedies that contradict the contemporary rational basis of medicine. Three independent systematic reviews of placebo-controlled trials on homeopathy reported that its effects seem to be more than placebo, and one review found its effects consistent with placebo. There is also evidence from randomized, controlled trials that homeopathy may be effective for the treatment of influenza, allergies, postoperative ileus, and childhood diarrhea. Evidence suggests that homeopathy is ineffective for migraine, delayed-onset muscle soreness, and influenza prevention. There is a lack of conclusive evidence on the effectiveness of homeopathy for most conditions. Homeopathy deserves an open-minded opportunity to demonstrate its value by using evidence-based principles, but it should not be substituted for proven therapies.

Influence of adjunctive classical homeopathy on global health status and subjective wellbeing in cancer patients - A pragmatic randomized controlled trial.

PubMed

Frass, Michael; Friehs, Helmut; Thallinger, Christiane; Sohal, Narinderjit Kaur; Marosi, Christine; Muchitsch, Ilse; Gaertner, Katharina; Gleiss, Andreas; Schuster, Ernst; Oberbaum, Menachem

2015-06-01

The use of complementary and alternative medicine has increased over the past decade. The aim of this study was to evaluate whether homeopathy influenced global health status and subjective wellbeing when used as an adjunct to conventional cancer therapy. In this pragmatic randomized controlled trial, 410 patients, who were treated by standard anti-neoplastic therapy, were randomized to receive or not receive classical homeopathic adjunctive therapy in addition to standard therapy. The study took place at the Medical University Vienna, Department of Medicine I, Clinical Division of Oncology. The main outcome measures were global health status and subjective wellbeing as assessed by the patients. At each of three visits (one baseline, two follow-up visits), patients filled in two different questionnaires. 373 patients yielded at least one of three measurements. The improvement of global health status between visits 1 and 3 was significantly stronger in the homeopathy group by 7.7 (95% CI 2.3-13.0, p=0.005) when compared with the control group. A significant group difference was also observed with respect to subjective wellbeing by 14.7 (95% CI 8.5-21.0, p<0.001) in favor of the homeopathic as compared with the control group. Control patients showed a significant improvement only in subjective wellbeing between their first and third visits. Results suggest that the global health status and subjective wellbeing of cancer patients improve significantly when adjunct classical homeopathic treatment is administered in addition to conventional therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

The early career researcher's toolkit: translating tissue engineering, regenerative medicine and cell therapy products.

PubMed

Rafiq, Qasim A; Ortega, Ilida; Jenkins, Stuart I; Wilson, Samantha L; Patel, Asha K; Barnes, Amanda L; Adams, Christopher F; Delcassian, Derfogail; Smith, David

2015-11-01

Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in tissue engineering and regenerative medicine translation, we discuss common pitfalls associated with translational research, providing practical solutions and important considerations which will aid process and product development. Suggestions range from effective project management, consideration of key manufacturing, clinical and regulatory matters and means of exploiting research for successful commercialization.

Petroleum: a series of 25 cases.

PubMed

Gnaiger-Rathmanner, J; Schneider, A; Loader, B; Böhler, M; Frass, M; Singer, S R; Oberbaum, M

2008-04-01

This study is based on 25 well documented reports of cases which responded well to treatment with Petroleum. Materia medica data were compared with results in contemporary clinical practice. Many patients had characteristic skin problems; children often had recurrent or chronic upper respiratory tract problems. The most prominent mental feature is a quiet, withdrawn or stubborn disposition. The mental symptoms may be difficult to recognise. Detailed documentation in daily practice can be helpful for preserving data of the effect of a medicine; confirmation of statements given in materia medica; improving understanding of homeopathic medicines and differentiating the indications for medicines.

[Working as a clinician-scientist in psychosomatic medicine: status, skills and research productivity].

PubMed

Hartmann, Mechthild; Wild, Beate; Herzog, Wolfgang; Nikendei, Christoph; Zipfel, Stephan; Henningsen, Peter; Löwe, Bernd

2008-06-01

Even though there is a high need of clinical research for the medical and psychotherapeutic practice in Germany, the interest in clinical research seems to be decreasing. The aim of this study was to assess the circumstances under which clinical research in psychosocial medicine is performed and to identify opportunities for improvement. n = 53 residents of the departments for Psychosomatic Medicine of the University Hospitals of Heidelberg and Tübingen and of the Technical University of Munich were asked about their research activities, their subjective research skills, and their productivity in clinical psychosocial research. In addition, objective research knowledge was investigated using a multiple-choice test. Both, subjective research skills and objective research knowledge were relatively low. The percentage of correct answers in the multiple choice test was 33 %. Subjective problems were predominately stated regarding "biostatistics" and "study design". In terms of research productivity, 33 % of residents had published as first authors of an original journal article, and 12 % had submitted a successful grant proposal. Altogether, there is a high need of training in the field of clinical psychosomatic research. We are presenting a training model that is adapted to the conditions of young clinicians and that addresses both general clinical research and specific psychosocial clinical research.

Evaluation of phytochemicals from medicinal plants of Myrtaceae family on virulence factor production by Pseudomonas aeruginosa.

PubMed

Musthafa, Khadar Syed; Sianglum, Wipawadee; Saising, Jongkon; Lethongkam, Sakkarin; Voravuthikunchai, Supayang Piyawan

2017-05-01

Virulence factors regulated by quorum sensing (QS) play a critical role in the pathogenesis of an opportunistic human pathogen, Pseudomonas aeruginosa in causing infections to the host. Hence, in the present work, the anti-virulence potential of the medicinal plant extracts and their derived phytochemicals from Myrtaceae family was evaluated against P. aeruginosa. In the preliminary screening of the tested medicinal plant extracts, Syzygium jambos and Syzygium antisepticum demonstrated a maximum inhibition in QS-dependent violacein pigment production by Chromobacterium violaceum DMST 21761. These extracts demonstrated an inhibitory activity over a virulence factor, pyoverdin, production by P. aeruginosa ATCC 27853. Gas chromatography-mass spectrometric (GC-MS) analysis revealed the presence of 23 and 12 phytochemicals from the extracts of S. jambos and S. antisepticum respectively. Three top-ranking phytochemicals, including phytol, ethyl linoleate and methyl linolenate, selected on the basis of docking score in molecular docking studies lowered virulence factors such as pyoverdin production, protease and haemolytic activities of P. aeruginosa to a significant level. In addition, the phytochemicals reduced rhamnolipid production by the organism. The work demonstrated an importance of plant-derived compounds as anti-virulence drugs to conquer P. aeruginosa virulence towards the host. © 2017 APMIS. Published by John Wiley & Sons Ltd.

Medicinal herbs as a potential strategy to decrease methane production by rumen microbiota: a systematic evaluation with a focus on Perilla frutescens seed extract.

PubMed

Wang, Jiakun; Liu, Mei; Wu, Yuelei; Wang, Liang; Liu, Jianxin; Jiang, Linshu; Yu, Zhongtang

2016-11-01

Mitigation of the methane (CH 4 ) emission from ruminants is needed to decrease the environmental impact of ruminant animal production. Different plant materials and chemicals have been tested, but few are both effective and practical. Medicinal herbs contain biological compounds and antimicrobials that may be effective in lowering the CH 4 production. However, few studies have systematically evaluated medicinal herbs for their effect on CH 4 production or on the rumen microbiota. In this study, extracts from 100 medicinal herbs were assessed for their ability to decrease CH 4 production by rumen microbiota in vitro. The extracts of 12 herbs effectively lowered the CH 4 production, with the extract of Perilla frutescens seeds being the most effective. The major components of P. frutescens seed extract were identified, and the effects of the extract on the fermentation characteristics and populations of rumen methanogens, fungi, protozoa, and select bacteria were also assessed. The decreased CH 4 production induced by the P. frutescens seed extract was accompanied by an increased abundance of Ruminobacter, Selenomonas, Succinivibrio, Shuttleworthis, Pseudobutyrivbrio, Anaerovibrio, and Roseomonas and a decreased abundance of Methanobrevibacter millerae. The abundance of Pedobacter, Anaeroplasma, Paludibacter, Ruminococcus, and unclassified Lachnospiraceae was positively correlated with the CH 4 production, with no effects on volatile fatty acids. This study suggests that medicinal herbs may be used to mitigate the CH 4 emission from ruminants.

Special Section: Complementary and Alternative Medicine (CAM):Quiz on Complementary and Alternative Medicine

MedlinePlus

... Special Section CAM Quiz on Complementary and Alternative Medicine Past Issues / Winter 2009 Table of Contents For ... low back pain. True False Complementary and alternative medicine (CAM) includes: Meditation Chiropractic Use of natural products, ...

Micellar liquid chromatographic determination of arbutin and hydroquinone in medicinal plant extracts and commercial cosmetic products.

PubMed

Thogchai, W; Liawruangrath, B

2013-06-01

A simple micellar liquid chromatographic (MLC) procedure for simultaneous determination of arbutin and hydroquinone in medicinal plant extracts and commercial cosmetic products was proposed. This method was developed and validated. The chromatographic conditions were also optimized. All analyses were performed at room temperature in an isocratic mode, using a mixture of 1% (v/v) acetonitrile and 0.006 mol L⁻¹ Brij 35 (pH 6.0) as a mobile phase. The flow rate was set at 1.0 mL min⁻¹. The analytical column was a 150 × 3.9 mm Nova-Pak C-18 column. The effluent from the analytical column was monitored by UV detection at 280 nm. Under the optimum conditions, arbutin and hydroquinone could be determined within a concentration range of 2-50 μg mL⁻¹ of arbutin, and hydroquinone was obtained with the regression equations; y = 0.045x + 0.042 (r² = 0.9923) and y = 0.091x + 0.050 (r² = 0.9930) respectively. The limits of detection were found to be 0.51 μg mL⁻¹ and 0.37 μg mL⁻¹ for arbutin and hydroquinone respectively. The proposed MLC method was applied for the determination of arbutin and hydroquinone contents in medicinal plant extracts and commercial cosmetic products. This proposed MLC method is thus suitable for routine analysis of arbutin and hydroquinone in the pharmaceutical formulations, cosmetic products and raw medicinal plant extracts. ICS © 2013 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

An Investigation of the Use of Traditional Chinese Medicine and Complementary and Alternative Medicine in Stroke Patients.

PubMed

Yeh, Mei-Ling; Chiu, Wei-Ling; Wang, Yu-Jen; Lo, Chyi

This study aimed to investigate the use of traditional Chinese medicine and complementary and alternative medicine in stroke patients in Taiwan. Chinese herbal medicine, massage, acupuncture, natural products, and exercise were widely used among stroke patients. Integrating safe and effective traditional Chinese medicine and complementary and alternative medicine into conventional therapies is suggested.

Knowledge, Attitude, and Practice Related to Diabetes Mellitus Among Diabetics and Nondiabetics Visiting Homeopathic Hospitals in West Bengal, India.

PubMed

Koley, Munmun; Saha, Subhranil; Arya, Jogendra Singh; Choubey, Gurudev; Ghosh, Shubhamoy; Chattopadhyay, Rajat; Das, Kaushik Deb; Ghosh, Aloke; Hait, Himangsu; Mukherjee, Rajarshi; Banerjee, Tanapa

2016-01-01

High prevalence of undiagnosed cases of diabetes mellitus and poor knowledge, awareness, and practice has increased premature death, costly complications, and financial burden. A cross-sectional survey was conducted in November 2014 on 273 diabetics and 355 nondiabetics in 3 government homeopathic hospitals in West Bengal, India. A self-administered questionnaire assessing knowledge, awareness, and practice related to diabetes was used. A total of 17.5% to 29.3% of the participants were aware of the normal blood sugar level. Lack of insulin, frequent urination, hypertension, and poor wound healing were identified most frequently as the cause, symptom, association, and complications. A total of 35.5% to 46.5% said that diabetes was preventable; 14.1% to 31.9% knew that diabetes was controllable rather than curable. Consumption of planned diet, avoiding sugar, and testing blood sugar were the most frequently identified components of healthy lifestyle, diabetic diet, and diagnostic domain. Diabetics had higher knowledge and awareness than nondiabetics (P < .0001); still the latter need to be made aware and knowledgeable to curtail the ever-increasing burden of diabetes. © The Author(s) 2015.

75 FR 50771 - Draft Revised Guidance for Industry on Residual Solvents in New Veterinary Medicinal Products...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-17

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-1999-D-2955] (formerly Docket No. 1999D-4071) Draft Revised Guidance for Industry on Residual Solvents in New Veterinary...) entitled ``Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients...

Exploring Consumer and Patient Knowledge, Behavior, and Attitude Toward Medicinal and Lifestyle Products Purchased From the Internet: A Web-Based Survey.

PubMed

Assi, Sulaf; Thomas, Jordan; Haffar, Mohamed; Osselton, David

2016-07-18

In recent years, lifestyle products have emerged to help improve people's physical and mental performance. The Internet plays a major role in the spread of these products. However, the literature has reported issues regarding the authenticity of medicines purchased from the Internet and the impact of counterfeit medicines on public health. Little or no data are available on the authenticity of lifestyle products and actual toxicity associated with their use and misuse. Our aim was to investigate consumer and patient attitudes toward the purchase of lifestyle products from the Internet, their knowledge of product authenticity and toxicity, and their experiences with counterfeit lifestyle products. A Web-based study was performed between May 2014 and May 2015. Uniform collection of data was performed through an anonymous online questionnaire. Participants were invited worldwide via email, social media, or personal communication to complete the online questionnaire. A total of 320 participants completed the questionnaire. The results of the questionnaire showed that 208 (65.0%) participants purchased lifestyle products from the Internet mainly due to convenience and reduced cost. More than half (55.6%, 178/320) of participants purchased cosmetic products, whereas only a minority purchased medicinal products. Yet, 62.8% (201/320) of participants were aware of the presence of counterfeit lifestyle products from the Internet, and 11.9% (38/320) experienced counterfeit products. In only 0.9% (3/320) of those cases were counterfeit lifestyle products reported to authorities. Moreover, 7.2% (23/320) of the participants experienced adverse effects due to counterfeit lifestyle products. In summary, patients experienced counterfeit lifestyle products that resulted in adverse effects on their health. Although certain adverse effects were reported in this study, counterfeit products were underreported to authorities. Further public awareness campaigns and patient education are

Exploring Consumer and Patient Knowledge, Behavior, and Attitude Toward Medicinal and Lifestyle Products Purchased From the Internet: A Web-Based Survey

PubMed Central

Thomas, Jordan

2016-01-01

Background In recent years, lifestyle products have emerged to help improve people’s physical and mental performance. The Internet plays a major role in the spread of these products. However, the literature has reported issues regarding the authenticity of medicines purchased from the Internet and the impact of counterfeit medicines on public health. Little or no data are available on the authenticity of lifestyle products and actual toxicity associated with their use and misuse. Objective Our aim was to investigate consumer and patient attitudes toward the purchase of lifestyle products from the Internet, their knowledge of product authenticity and toxicity, and their experiences with counterfeit lifestyle products. Methods A Web-based study was performed between May 2014 and May 2015. Uniform collection of data was performed through an anonymous online questionnaire. Participants were invited worldwide via email, social media, or personal communication to complete the online questionnaire. A total of 320 participants completed the questionnaire. Results The results of the questionnaire showed that 208 (65.0%) participants purchased lifestyle products from the Internet mainly due to convenience and reduced cost. More than half (55.6%, 178/320) of participants purchased cosmetic products, whereas only a minority purchased medicinal products. Yet, 62.8% (201/320) of participants were aware of the presence of counterfeit lifestyle products from the Internet, and 11.9% (38/320) experienced counterfeit products. In only 0.9% (3/320) of those cases were counterfeit lifestyle products reported to authorities. Moreover, 7.2% (23/320) of the participants experienced adverse effects due to counterfeit lifestyle products. Conclusions In summary, patients experienced counterfeit lifestyle products that resulted in adverse effects on their health. Although certain adverse effects were reported in this study, counterfeit products were underreported to authorities. Further

[Vigilance for veterinary medicinal products: Reports of adverse reactions in the year 2015].

PubMed

Müntener, C; Kupper, J; Naegeli, H; Gassner, B

2016-11-01

A total of 292 adverse reactions to veterinary medicinal products were reported during the year 2015. This represents an increase of 9% compared to the previous year (268 reports). Similar to previous years, most of the reactions reported were linked to the use of antiparasitics (55.1%), non-steroidal anti-inflammatory products (8.9%) or antiinfectives (9.3%). The affected animal species were primarily dogs (198 reports) and cats (42 reports), followed by cattle (31 reports) and horses (8 reports). Additional 42 reports were provided within the frame of consultations with Tox Info Suisse in Zürich and involved mainly the excessive intake of flavored tablets. Eight signals were identified from the reports received or the periodic safety update reports. They resulted in revisions of the product information in sections addressing contraindications, adverse reactions or withdrawal times.

Immunology and Homeopathy. 4. Clinical Studies—Part 1

PubMed Central

Bellavite, Paolo; Ortolani, Riccardo; Pontarollo, Francesco; Piasere, Valeria; Benato, Giovanni; Conforti, Anita

2006-01-01

The evidence-based research of the effectiveness of homeopathic medicines in common immunologic disorders is reviewed. In part 1, we introduce methodological issues of clinical research in homeopathy, and criteria utilized to evaluate the literature. Then 24 studies (12 randomized and 12 non-randomized) on common upper respiratory tract infections and otorhinolaryngologic complaints are described. In part 2, the focus will be on allergic diseases and the effectiveness of homeopathy will be globally evaluated and discussed using the criteria of evidence-based medicine. PMID:16951713

Smoking - Medicines to Help You Quit

MedlinePlus

... Consumers Consumer Information by Audience For Women Smoking - Medicines To Help You Quit Share Tweet Linkedin Pin ... name of your product at: Drugs@FDA. Other Medicines to Help You Quit Some prescription medicines have ...

Concise Review: Bone Marrow Mononuclear Cells for the Treatment of Ischemic Syndromes: Medicinal Product or Cell Transplantation?

PubMed Central

Rico, Laura; Herrera, Concha

2012-01-01

In November of 2011, the Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) published two scientific recommendations regarding the classification of autologous bone marrow-derived mononuclear cells (BM-MNCs) and autologous bone marrow-derived CD133+ cells as advanced therapy medicinal products (ATMPs), specifically tissue-engineered products, when intended for regeneration in ischemic heart tissue on the basis that they are not used for the same essential function (hematological restoration) that they fulfill in the donor. In vitro and in vivo evidence demonstrates that bone marrow cells are physiologically involved in adult neovascularization and tissue repair, making their therapeutic use for these purposes a simple exploitation of their own essential functions. Therefore, from a scientific/legal point of view, nonsubstantially manipulated BM-MNCs and CD133+ cells are not an ATMP, because they have a physiological role in the processes of postnatal neovascularization and, when used therapeutically for vascular restoration in ischemic tissues, they are carrying out one of their essential physiological functions (the legal definition recognizes that cells can have several essential functions). The consequences of classifying BM-MNCs and CD133+ cells as medicinal products instead of cellular transplantation, like bone marrow transplantation, in terms of costs and time for these products to be introduced into clinical practice, make this an issue of crucial importance. Therefore, the recommendations of EMA/CAT could be reviewed in collaboration with scientific societies, in light of organizational and economic consequences as well as scientific knowledge recently acquired about the mechanisms of postnatal neovascularization and the function of bone marrow in the regeneration of remote tissues. PMID:23197819

Quality assurance of medicines supplied to low-income and middle-income countries: poor products in shiny boxes?

PubMed Central

Schiavetti, B; Meessen, B; Pouget, C; Caudron, J M; Marchal, B; Massat, P; Thys, S; Ravinetto, R

2017-01-01

Objective In today's context of globalisation of pharmaceutical production and distribution, international and national procurement agencies play a de facto key role in defining the quality of medicines available in sub-Saharan Africa. We evaluated the compliance of a sample of pharmaceutical distributors active in sub-Saharan Africa with the standards of the WHO guideline ‘Model Quality Assurance System (WHO MQAS) for procurement agencies’, and we investigated factors favouring or hindering the adequate implementation of the guideline. Methods We used mixed-methods methodology to analyse quantitative and qualitative data. The quantitative study consisted of a retrospective secondary analysis of data collected by QUAMED (Quality Medicines for all), a partnership that pleads for universal access to quality-assured medicines. The qualitative survey consisted of formal and informal interviews with key informants. We adopted an embedded multiple-case study design. Findings Our analysis suggests that international distributors based in Europe perform, on average, better than sub-Saharan African distributors. However, some weaknesses are ubiquitous and concern critical processes, such as the initial selection of the products and the ongoing reassessment of their quality. This is due to several different factors: weak regulatory oversight, insufficient human/financial resources, weak negotiating power, limited judicial autonomy and/or lack of institutional commitment to quality. Conclusions Our findings suggest that pharmaceutical distributors active in sub-Saharan Africa generally do not apply stringent criteria for selecting products and suppliers. Therefore, product quality is not consistently assured but depends on the requirements of purchasers. While long-term solutions are awaited, the WHO MQAS guideline should be used as an evaluation and training tool to upgrade current standards. PMID:28589013

78 FR 51732 - The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] The Food and Drug Administration/European Medicines Agency Orphan Product Designation and Grant Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug...

UK medicines regulation: responding to current challenges

PubMed Central

Richards, Natalie

2016-01-01

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk‐proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand. PMID:27580254

[Counterfeit medicines: a growing threat].

PubMed

Barbereau, S

2006-12-01

The medical drug market has undergone considerable transformation in recent years. Like other products, medicines have been affected by globalization. Free trade policies have had a number of negative effects including a reduction in quality control not only for some products but also for raw materials and finished products. The global environment has also created conditions conducive to counterfeit medicines. The term counterfeit medicine is defined differently from one country to another in terms of quality, legality and fraudulent intent. This situation prompted the WHO to propose the following definition: "A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging." Weak pharmaceutical regulation often compounded by widespread corruption in developing countries has greatly facilitated the development of this illicit market with harmful and costly effects on public health. Due to the lack of pharmocovigilance accidents involving use of counterfeit drugs go unreported. For this reason it is not possible to measure the economic impact. While counterfeiting has become a major threat in developing countries, it also affects industrialized countries. Fraudulent behavior occurs all over the world.

Value added medicines: what value repurposed medicines might bring to society?

PubMed

Toumi, Mondher; Rémuzat, Cécile

2017-01-01

Background & objectives : Despite the wide interest surrounding drug repurposing, no common terminology has been yet agreed for these products and their full potential value is not always recognised and rewarded, creating a disincentive for further development. The objectives of the present study were to assess from a wide perspective which value drug repurposing might bring to society, but also to identify key obstacles for adoption of these medicines and to discuss policy recommendations. Methods : A preliminary comprehensive search was conducted to assess how the concept of drug repurposing was described in the literature. Following completion of the literature review, a primary research was conducted to get perspective of various stakeholders across EU member states on drug repurposing ( healthcare professionals, regulatory authorities and Health Technology Assessment (HTA) bodies/payers, patients, and representatives of the pharmaceutical industry developing medicines in this field). Ad hoc literature review was performed to illustrate, when appropriate, statements of the various stakeholders. Results : Various nomenclatures have been used to describe the concept of drug repurposing in the literature, with more or less broad definitions either based on outcomes, processes, or being a mix of both. In this context, Medicines for Europe (http://www.medicinesforeurope.com/value-added-medicines/) established one single terminology for these medicines, known as value added medicines, defined as 'medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers'. Stakeholder interviews highlighted three main potential benefits for value added medicines: (1) to address a number of medicine-related healthcare inefficiencies related to irrational use of medicines, non-availability of appropriate treatment options, shortage of mature products, geographical inequity in medicine access

Herbal medicine-related hepatotoxicity

PubMed Central

Stournaras, Evangelos; Tziomalos, Konstantinos

2015-01-01

Herbal medicine products represent a common therapeutic approach in the East and are gaining increasing popularity in Western countries. They are unjustifiably considered to be side-effect free; on the contrary, severe toxicity, including catastrophic hepatic injury has been reported in association with their use. Vigilance is required from both physicians and the general public. Physicians should always suspect herbal medicines when evaluating a patient with unexplained liver injury. Regulation standards for herbal products need to be reconsidered, so that the efficacy and safety of these products have been clearly demonstrated before they enter the markets. PMID:26380043

Regulation of medicinal plants for public health--European community monographs on herbal substances.

PubMed

Knöss, Werner; Chinou, Ioanna

2012-08-01

The European legislation on medicinal products also addresses the medicinal use of products originating from plants. The objective of the legislation is to ensure the future existence of such products and to consider particular characteristics when assessing quality, efficacy, and safety. Two categories are defined: i) herbal medicinal products can be granted a marketing authorisation; and ii) traditional herbal medicinal products can be granted a registration based on their longstanding use if they are complying with a set of provisions ensuring their safe use. The Committee on Herbal Medicinal Products (HMPC) was established at the European Medicines Agency (EMA) to provide monographs and list entries on herbal substances and preparations thereof. Meanwhile, approx. 100 monographs have been published, which define a current scientific and regulatory standard for efficacy and safety of herbal substances and herbal preparations used in medicinal products. This harmonised European standard will facilitate the availability and adequate use of traditional herbal medicinal products and herbal medicinal products within the European Union. Consequent labelling shall also enable patients and health care professionals to differentiate medicinal products from other product categories like cosmetics, food supplements, and medical devices. Georg Thieme Verlag KG Stuttgart · New York.

Natural products in medicine: transformational outcome of synthetic chemistry.

PubMed

Szychowski, Janek; Truchon, Jean-François; Bennani, Youssef L

2014-11-26

This review brings to the forefront key synthetic modifications on natural products (NPs) that have yielded successful drugs. The emphasis is placed on the power of targeted chemical transformations in enhancing the therapeutic value of NPs through optimization of pharmacokinetics, stability, potency, and/or selectivity. Multiple classes of NPs such as macrolides, opioids, steroids, and β-lactams used to treat a variety of conditions such as cancers, infections, inflammation are exemplified. Molecular modeling or X-ray structures of NP/protein complexes supporting the observed boost in therapeutic value of the modified NPs are also discussed. Significant advancement in synthetic chemistry, in structure determination, and in the understanding of factors controlling pharmacokinetics can now better position drug discovery teams to undertake NPs as valuable leads. We hope that the beneficial NPs synthetic modifications outlined here will reignite medicinal chemists' interest in NPs and their derivatives.

Contending medical ideologies and state formation: the nineteenth-century origins of medical pluralism in contemporary Colombia.

PubMed

Sowell, David

2003-01-01

This article addresses the encounter between contending medical ideologies in nineteenth-century Colombia. The first era of medical pluralism, in colonial Latin America, developed from the imposition of Hispanic medicine on existing indigenous medical systems through an imperial structure. This produced a "colonial medical spectrum" incorporating various medical ideologies that came under attack by practitioners of scientific medicine in the 1800s. As scientific physicians gained privileged access to state resources, they undertook partially successful campaigns to deny Hispanic, homeopathic, and other medical systems the right to be practiced. As the state authorized scientific medicine, other practices became "popularized," thereby laying the foundation for the medical pluralism of contemporary Colombia that juxtaposes "academic" and "traditional" medicines.

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation

PubMed Central

Arguello, Blanca; Salgado, Teresa M; Fernandez-Llimos, Fernando

2015-01-01

Aims To assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). Methods SmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing ‘conclusive’ or ‘ambiguous’ information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. Results Of the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. Conclusions Important information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. PMID:25224071

Assessing the information in the Summaries of Product Characteristics for the use of medicines in pregnancy and lactation.

PubMed

Arguello, Blanca; Salgado, Teresa M; Fernandez-Llimos, Fernando

2015-03-01

To assess the completeness and applicability of information for the use of medicines in pregnancy and lactation contained in European Summaries of Product Characteristics (SmPCs). SmPCs available on the EMA website in April 2011 were retrieved, and information on the use of medicines during pregnancy and lactation was analyzed. A form was designed to extract information regarding drug concentrations crossing the placenta, excretion of the drug in milk, the existence of pre-clinical and clinical studies and clinical experience describing the use of the medicine in pregnancy and lactation, medicine effects on human fertility, medicines use in women of child-bearing potential and specific recommendations for use during pregnancy and breastfeeding. SmPCs were classified as containing 'conclusive' or 'ambiguous' information depending on whether (or not) they provided clear instructions regarding medicine use in pregnancy and lactation. Of the 534 SmPCs, 89.3% did not mention whether the drug crossed the placenta, 67.6% indicated that there was no clinical experience during pregnancy and in 61.4% it was unknown whether the medicine was excreted in human milk. Recommendations for medicine use during pregnancy and breastfeeding were ambiguous in 57.0% and 16.5% of the SmPCs, respectively, and medicine use was restricted in over 90% SmPCs for both pregnancy and breastfeeding, despite no information supporting these restrictions being reported. The time elapsed since a SmPCs first approval was not associated with an increase in information quality. Important information deficits on the use of medicines during pregnancy and breastfeeding were found in European SmPCs. © 2014 The British Pharmacological Society.

UK medicines regulation: responding to current challenges.

PubMed

Richards, Natalie; Hudson, Ian

2016-12-01

The medicines regulatory environment is evolving rapidly in response to the changing environment. Advances in science and technology have led to a vast field of increasingly complicated pharmaceutical and medical device products; increasing globalization of the pharmaceutical industry, advances in digital technology and the internet, changing patient populations, and shifts in society also affect the regulatory environment. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood products to protect and improve public health, and supports innovation through scientific research and development. It works closely with other bodies in a single medicines network across Europe and takes forward UK health priorities. This paper discusses the range of initiatives in the UK and across Europe to support innovation in medicines regulation. The MHRA leads a number of initiatives, such as the Innovation Office, which helps innovators to navigate the regulatory processes to progress their products or technologies; and simplification of the Clinical Trials Regulations and the Early Access to Medicines Scheme, to bring innovative medicines to patients faster. The Accelerated Access Review will identify reforms to accelerate access for National Health Service patients to innovative medicines and medical technologies. PRIME and Adaptive Pathways initiatives are joint endeavours within the European regulatory community. The MHRA runs spontaneous reporting schemes and works with INTERPOL to tackle counterfeiting and substandard products sold via the internet. The role of the regulator is changing rapidly, with new risk-proportionate, flexible approaches being introduced. International collaboration is a key element of the work of regulators, and is set to expand. © 2016 The British Pharmacological Society.

Contact dermatitis as an adverse reaction to some topically used European herbal medicinal products - part 2: Echinacea purpurea-Lavandula angustifolia.

PubMed

Gangemi, Sebastiano; Minciullo, Paola L; Miroddi, Marco; Chinou, Ioanna; Calapai, Gioacchino; Schmidt, Richard J

2015-04-01

This review focuses on contact dermatitis as an adverse effect of a selection of topically used herbal medicinal products for which the European Medicines Agency has completed an evaluation up to the end of November 2013 and for which a Community herbal monograph has been produced. Part 2: Echinacea purpurea Moench-Lavandula angustifolia Mill. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Observational study of Arctium lappa in the treatment of acne vulgaris.

PubMed

Miglani, Anjali; Manchanda, Raj K

2014-07-01

Arctium lappa (Lappa) is used in traditional Western and Chinese medicine for acne. It is mentioned in homeopathic literature for acne, but its effect has not previously been evaluated. To determine the effectiveness of homeopathic medicine Lappa in treatment of acne vulgaris. An uncontrolled observational interventional study was conducted on human subjects who fulfilled the inclusion criteria and gave written informed consent. Lappa was prescribed in potencies starting from 6c rising to 1M as required, over a period of 6 months. Objective assessment was change in acne lesion counts supplemented with Global Acne Grading System (GAGS) and subjective assessment by using Acne-Specific Quality of Life questionnaire (Acne-QoL). Out of 34 human subjects, 32 completed the follow-up. Statistical significant results were seen in lesion counts, GAGS and Acne-QoL score (p value <0.001). Lappa has shown positive effects in the treatment of acne especially of inflammatory type. Further controlled, randomized studies with larger sample size are desirable. Trial is registered at ClinicalTrials.gov Identifier: NCT01040390. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

An alternate approach to the production of radioisotopes for nuclear medicine applications

NASA Astrophysics Data System (ADS)

D'Auria, John M.; Keller, Roderich; Ladouceur, Keith; Lapi, Suzanne E.; Ruth, Thomas J.; Schmor, Paul

2013-03-01

There is a growing need for the production of radioisotopes for both diagnostic and therapeutic medical applications. Radioisotopes that are produced using the (n,γ) or (γ,n) reactions, however, typically result in samples with low specific activity (radioactivity/gram) due to the high abundance of target material of the same element. One method to effectively remove the isotopic impurity is electro-magnetic mass separation. An Ion Source Test Facility has been constructed at TRIUMF to develop high-intensity, high-efficiency, reliable ion sources for purification of radioactive isotopes, particularly those used in nuclear medicine. In progress studies are presented.