Efectos de las diluciones homeopáticas altas sobre los modelos in vitro: revisión de la literatura / Effects of high homeopathic dilutions on in vitro models: a review of the literature

Los efectos de las diluciones homeopáticas altas (HD, por sus siglas en inglés) son controvertidos debido a que superan el número de Avogadro. Objetivo: Realizar una revisión de la literatura sobre los efectos de las HD sobre los modelos in vitro. Métodos: Se realizó una búsqueda sistemática en la base de datos PubMed de estudios que evaluaran las HD simples sobre modelos in vitro, publicados de 2007 en adelante. Resultados: 28 publicaciones cumplieron con los criterios de inclusión/exclusión. 26 estudios mostraron efectos evidentes de las HD simples sobre modelos in vitro. La mayor parte de tales estudios fueron realizados en países en donde la homeopatía ha alcanzado un alto nivel de institucionalización. Conclusiones: Los modelos in vitro evidencian de forma clara la actividad biológica de las HD superiores al número de Avogadro y dan cuenta de los efectos encontrados en la práctica clínica. La mayor parte de los estudios fueron realizados en países en donde la homeopatía es reconocida oficialmente, lo cual facilita el acceso a recursos para el desarrollo de la investigación.

the effects of homeopathic high dilutions (HDs) are controversial because they exceed Avogadro's number. Aim: to perform a literature review on the effects of HDs on in vitro models. Methods: a systematic search was performed in database PubMed for studies assessing simple HDs on in vitro models published from 2007 onward. Results: 28 publications met the inclusion/exclusion criteria; 26 studies demonstrated patent effects of simple HDs on in vitro models; most such studies were conducted in countries where homeopathy attained a high level of institutionalization. Conclusions: in vitro models patently evidence biological activity of HDs above Avogadro's number and account for effects found in clinical practice. Most studies were conducted in countries where homeopathy is officially recognized, which facilitates access to resources for the development of research.

Investigación clínica en homeopatía: revisiones sistemáticas y estudios clínicos aleatorizados / Clinical research in homeopathy: systematic reviews and randomized clinical trials

Se considera que las revisiones sistemáticas y estudios clínicos aleatorizados (RCT) presentan el nivel de evidencia más alto. Objetivo: Realizar una revisión descriptiva de las revisiones sistemáticas y estudios clínicos controlados aleatorizados (RCT, por sus siglas en inglés) sobre la efectividad y eficacia de la homeopatía. Métodos: Los datos del reporte publicado por la Liga Medicorum Homeopathica Internationalis (LMHI) en 2014 fueron actualizados mediante una búsqueda en la base de datos PubMed. Resultados: Se localizaron 7 revisiones sistemáticas con meta-análisis, 6 de las cuales concluyeron que los efectos de la homeopatía no son compatibles con el efecto placebo; sólo una revisión sistemática llegó a la conclusión opuesta, aunque fue severamente criticado debido a sus errores metodológicos. Un total de 19 RCT fueron publicados a lo largo del periodo analizado. El 84.2% tuvo por lo menos un resultado positivo. Conclusiones: Con base en las evidencias disponibles del más alto nivel, no es posible afirmar que los efectos de la homeopatía son exclusivamente un efecto placebo. Por el contrario, se han detectado efectos específicos en varios estudios.

Systematic reviews and randomized clinical trials (RCT) are considered to have the highest level of evidence. Aim: To perform a descriptive review of systematic reviews and RCT on the effectiveness and efficacy of homeopathy. Methods: Data from the report published by Liga Medicorum Homeopathica Internationalis (LMHI) in 2014 were updated by means on a search conducted in database PubMed. Results: 7 systematic reviews with meta-analysis were located, 6 of them concluded that the effects of homeopathy are not compatible with placebo effect; only 1 systematic review arrived to the opposite conclusion, but was severely criticized due to methodological flaws. A total of 19 RCT were published along the analyzed period; 84.2% had at least one positive outcome. Conclusions: Based on the available evidences of the highest level it is not possible to assert that the effects of homeopathic are exclusively placebo effect. On the opposite, specific effects were detected in several studies.

Carcinosinumproduces phenotypic changes of 4T1 tumor cells in vitro

Considering that there are few published studies that specifically address the exclusive use of Carcinosinumin different potencies and, most of them focused on genotypic and clinical effects, the present study was proposed to identify possible phenotypic changes, including viability, expression of HER-2 and metastatic abilities, using 4T1 cells in vitroas a model. Carcinosinum was tested in different homeopathic potencies (12cH; 30cH; 200cH) mechanically prepared using sterile pure water. The time space between preparing the potencies and using them was 24 hours.The final dilutions were inserted into the culture medium in a volume equal to 10%, at the time of cell seeding. The same succussed vehicle used to prepare the drugs (70% ethanol) diluted 1:100 in sterile pure water was used as control. All treated cells were cultured in 25 mL flasks, with cell density of 5 x 105cells/mL. After 24 hours of treatment, cells were analyzed for apoptosis index using Annexin V kit and the Countess® system. The morphology of 4T1 cells was monitored by staining cell smears with hematoxylin-eosin and Giemsa methods. HER-2 expression was assessed by immunocytochemistry and metalloproteinase activity was assessed by zymography. The determination of the cytokine profile was performed using Cytometric Bead Array (CBA). The samples were evaluated in quadruplicate and the data were analyzed by one-way ANOVA. Carcinosinum30cH presented the highest apoptotic index and reduction of MMP-9-Pro expression; Carcinosinum200cH produced the highest positivity for HER-2 and no specific effect was seen after the treatment with Carcinosinum12cH. No change in cytokine expression was seen among treatments. We conclude that Carcinosinum30cH and 200cH can change phenotypic features important totumor development in vitro. The clinical meaning of these data deserves further investigation.

Formation of Self-organized Structures in Drying Droplets: a Promising Analytical Tool for Homeopathy Basic Research

The droplet evaporation method (DEM) is based on the evaporation-induced pattern formation in droplets and is applied mainly for medical diagnosis[1].Here, we present aseries of experiments performed by our team showing DEMs potential also forhomeopathy basic research, in particular, for the investigation of(i) low potencies, (ii) low potency complexes (physical model), and (iii) the action of high potencies (plant-based model).Methods:(i) DEM differentiated significantly between Luffa, Baptisia, Echinacea, and Spongiauntil 4x[2]. Furthermore, the patterns varied in function of the numberof succussion strokes (0, 10, or 100) applied during potentization[3]. The performance of chaotic succussions vs. laminar flow vs. slight mixing during the potentization of Viscum album quercus3x influenced the DEM patterns; the chaotic succussions reduced, whereas laminar flow enhanced the patterns complexity vs. the unsuccussed control.(ii) The addition of Mercurius bijodatus9x to Luffa4x changed significantly the DEM patterns, even if the material quantity present in the 9x potency lied far beyond that of ultrapure water.(iii) Leakages obtained by placing healthy or arsenic-damaged wheat-seeds into Arsenicum album45x orheat-damaged intoZincum metallicum30c vs. water created significantly different DEM structures [4, 5]. Results:The damaged seeds put into the potency created structures characterized by a higher complexity than those obtained from damaged seeds put into control water. Furthermore, the potency action seemed to increase with rising numbers ofsuccussion strokes applied during potentization,ascould be shown by means of DEM patterns and germination rate using the same wheat-seed model[6].In all our studies, the pattern evaluation was computerized (texture and fractal analysis performed by means of ImageJ) or based on deep-learning algorithms and the robustness of the experimental system was checked by means of systematic control experiments.Conclusion:DEM together with other similarmethods has also been reviewed by our team for what concerns theapplication in homeopathy basic research[7].

Bioactive compounds in aqueous extracts of lemon balm (Melissa officinalis) cultivated in Mexico

Lemon balm (Melissa officinalis) is a plant in the family of Lamiaceae. In Mexican traditional medicine it is used to alleviate gastrointestinal and hepatic problems. Studies carried out mainly in ethanolic and methanolic extracts, have revealed the presence of diverse compounds to which those medicinal properties are attributed. The objective of this research work was to extract in aqueous solution the antioxidants present in lemon balm and identify them through HPLC-MS. A Box-Behnken design was applied to determine the physical conditions of antioxidant extraction, where the analyzed variables were time, temperature and sample quantity. The antioxidant activity was determined through methodologies of DPPH*, FRAP and total phenolics. The aqueous solution with the highest antioxidant activity was analyzed through HPLC-MS. The results showed that the interaction temperature-time has a positive influence on the liberation of antioxidants. The best condition for a conventional extraction of antioxidants was 90°C, 15 min and 2 g of sample. Higher correlations were observed at r2>0.6 between determined antioxidant activity by DPPH* (or FRAP) vs Total phenolics; this would indicate that such activity could be attributed to phenolic compounds whose presence was confirmed through an analysis by HPLC-MS(AU)

El toronjil (Melissa officinalis) es una planta de la familia Lamiaceae. En la medicina tradicional mexicana es utilizado para aliviar problemas gastrointestinales y hepáticos. Algunos estudios realizados con extractos etanólicos y metanólicos de dicha planta, han revelado la presencia de diversos compuestos a los que se les atribuye sus propiedades medicinales. El objetivo de esta investigación fue extraer en solución acuosa los antioxidantes presentes en el toronjil e identificarlos a través de HPLC-MS. Para ello, se aplicó un diseño de experimentos Box-Behnken a fin de determinar las condiciones físicas de extracción de antioxidantes; las variables analizadas fueron tiempo, temperatura y cantidad de muestra. La actividad antioxidante fue determinada a través de las metodologías de DPPH*, FRAP y fenoles totales. El extracto acuoso con la mayor actividad antioxidante fue analizado mediante HPLCMS. Los resultados mostraron que la interacción tiempotemperatura tuvo una influencia positiva en la liberación de antioxidantes. La mejor condición para la extracción de antioxidantes presentes en el toronjil fue 90°C, 15 min y 2 g de muestra. Correlaciones superiores a r2>0.6 fueron determinadas entre la actividad antioxidante medida por DPPH* (o FRAP) vs Fenoles totales; esto podría indicar que la actividad antioxidante encontrada podría atribuirse a compuestos de tipo fenólico cuya presencia fue confirmada por el análisis en HPLC-MS(AU)

As evidências a favor da homeopatia e as ciências básicas / Evidence for the homeopathic principles in the basic sciences

Como toda área da medicina, a homeopatia é tanto arte quanto ciência. Enquanto a pesquisa clínica visa responder "se" e "quando" os medicamentos homeopáticos são capazes de restabelecer a saúde, as ciências básicas ­ biologia, imunologia, patologia, química, física e farmacologia ­ geram diversas hipóteses plausíveis para dar conta do "como" agem os medicamentos diluídos e dinamizados (MDD) em modelos experimentais rigorosos. A ação farmacodinâmica dos MDD depende do fornecimento de pequenas quantidades de informação a alvos orgânicos específicos, de maneira a restabelecer um comportamento mais próximo do estado ótimo de saúde. Alguns mecanismos de ação dos MDD podem ser identificados em estudos de laboratório. O princípio de semelhança terapêutica pode ser observado em modelos horméticos, de acordo com a lei de Arndt-Schutz, nos quais a inversão de efeitos é obtida modificando a dose. Igualmente, em modelos de tipo Wilder, são comparados organismos estressados e normais. No entanto, a hormese utiliza medicamentos em pequenas doses, enquanto na homeopatia são utilizados medicamentos em diluições além da faixa material, que além disso precisam ser agitados. O presente artigo dedica atenção especial ao modelo de degranulação dos basófilos, que em 2018 completa 30 anos de desenvolvimento. Igualmente são abordados os trabalhos do nosso grupo, na Universidade de Verona, Itália. (AU)

As any other medical field, homeopathy is both art and science. Clinical research seeks to answer the questions on "whether" and "when" homeopathic medicines are able to restore health. In turn, the fundamental sciences­biology, immunology, pathology, chemistry, physics and pharmacology­generate plausible hypothesis to explain "how" serially diluted and agitated medicines (SDAM) act in rigorous experimental models. The pharmacodynamic action of SDAM depends on the supply of subtle information input to specific body targets in order to restore a pattern of behavior closer to optimal health. Some mechanisms of action of SDAM might be identified in laboratory studies. The therapeutic similarity principle might be observed in hormesis models, according to Arndt-Schutz's law, in which effect inversion is obtain through changes of dose. Wilder-like models compared stressed and healthy subjects. However, hormesis uses drugs in small doses, while homeopathy uses medicines diluted beyond the scope of matter, which in addition must be agitated. In the present article I paid special attention to the basophil degranulation, as in 2018 it completes its 30th anniversary. I also summarized the results of our work at University of Verona, Italy. (AU)

Importancia de crear una cultura bioética en las investigaciones de la terapéutica homeopática / Importance of creating a culture Bioethics in research homeopathic therapeutics

Indiscutiblemente, la divulgación de un conocimiento fundamentado en investigaciones científicas de calidad, valor ético y con gran sentido humanístico y respetoa los derechos de quienes participan en un estudio –humanos o animales– en elárea de la salud, proporcionan un sistema de referencia actualizado en su campode estudio de valor inigualable. El trabajo que se presenta pretende retomar los aspectos bioéticos cardinales de una investigación científica con el objetivo de que guíen los pasos de quienes se inicien es este campo y, en consecuencia, se pueda generar una cultura bioética en el quehacer científico de quienes participen en una investigación. Por tanto, el trabajo está dirigido a los estudiantes de medicina y las personas que pretendan incursionar en la investigación científica, principalmente a quienes deseen realizar investigación homeopática, teniendo presente el principio fundamental de que “el bienestar del individuo debe prevalecer sobre los interesesde la ciencia y de la sociedad”.

Unquestionably, the dissemination of knowledge based on researchquality scientific, ethical value and great humanistic sense and respect the rights of those participating in a study-humans or animals-in the area of ​​health, provide a reference current in your field of study unbeatable value. The work presented aims to retake the cardinal bioethical aspects of scientific research with the aim of guiding the steps of those who start is this field and therefore can generate a bioethics culture in the scientific work of those involved in a research. Therefore, the work is aimed at medical students and people seeking to break into the scientific research, primarily those wishing to make homeopathic research, bearing in mind the fundamental principle that "the welfare of the individual should take precedence over the interests of the science and society.

Homeopatia: uma realidade evidente / Homeopathy: a patent reality

A homeopatia é uma descoberta nas ciências naturais com muitas facetas. Começou como um ramo das ciências da saúde, uma terapêutica utilizada nas grandes epidemias europeias, iniciadas no século XVII e que perduraram até o XIX. Com o tempo, outras disciplinas, como a física, a biologia, a físico-química, a eletrônica e a agronomia, passaram a se interessar na homeopatia. No presente artigo, são revisadas as etapas históricas do desenvolvimento das bases científicas da homeopatia, desde sua formulação na virada do século XVIII, assim como discutidas as perspectivas presentes e futuras.

Homeopathy is a multi-faceted discovery within the realm of natural science. It began as a branch of the health sciences, a therapeutic approach widely used in the major epidemic outbreaks that devastated Europe starting in the 17th century and persisting until the 1800s. Also other fields of knowledge, like physics, biology, physical chemistry, electronics and agronomy, began to take an interest in homeopathy over time. In the present study, the historical stages in the development of the scientific basis of homeopathy are reviewed, and its present and future perspectives are discussed.

Physical chemistry evaluation of stability, spreadability, in vitro antioxidant, and photo-protective capacities of topical formulations containing Calendula officinalis L. leaf extract

Calendula is used widely in cosmetic formulations that present phenolic compounds in their chemical constitution. The objective of our research was to develop and evaluate the stability of topical formulations containing 5% hydro-ethanolic extract of calendula leaves, including spreadability, and in vitro photo-protective, and antioxidant capacity. To evaluate the stability, we used organoleptic characteristics, pH, and viscosity parameters. Antioxidant capacity was measured by the DPPH (2,2-diphenyl-1-picrylhydrazyl) method, and the photo-protective capacity by SPF spectrophotometric measure. All formulations were stable. The calendula extract formulations in gel and cream showed no significant variations in pH, and the cream formulations presented lower viscosity variations than gel formulations. The spreadability of the gel formulations was superior to those in cream. The formulations also presented good antioxidant capacities and an FPS of around 1.75. In accordance with the results, the formulations can be used as antioxidants, but considering the low SPF obtained, calendula cannot be considered as a stand-alone sunscreen, yet may well be tested in future studies towards verifying enhancement of synthetic sunscreens.

A calêndula é amplamente utilizada em formulações cosméticas, apresentando compostos fenólicos em sua constituição química. Desta forma, o objetivo desta pesquisa foi desenvolver e avaliar a estabilidade de formulações tópicas contendo 5% de extrato hidroetanólico das folhas de calêndula, bem como a espalhabilidade, capacidade antioxidante e fotoprotetora in vitro nas mesmas. Para a avaliação da estabilidade, foram usados parâmetros como a verificação das características organolépticas, pH e viscosidade. A capacidade antioxidante foi verificada pelo método do DPPH (2,2-difenil,1- picril-hidrazila) e a capacidade fotoprotetora pela medida espectrofotométrica do FPS. Para as formulações testadas, observou-se que apresentaram uma boa estabilidade. As formulações de creme e gel com extrato de calêndula não apresentaram variações significativas nos valores de pH e o creme apresentou as menores variações de viscosidade em relação ao gel. A espalhabilidade das formulações de gel foi superior à do creme. As formulações também apresentaram uma boa capacidade antioxidante e um FPS em torno de 1.75. De acordo com os resultados, a formulação pode ser utilizada com ação antioxidante, porém com o FPS obtido, a calêndula não pode ser considerada um filtro solar isolado, mas poderá ser testada em estudos futuros para verificar a potencialização de filtros solares sintéticos.

Las bases científicas de la homeopatía / The scientific basis of homeopathy

A través de un recorrido por los principios de la Homeopatía y la evolución de sus ideas es posible delimitar las líneas de investigación que podrían desarrollarse para responder las dudas e interrogantes que surgen de la aplicación de esta disciplina,situada entre las ciencias médicas, humanas, biológicas y físicas.A continuación se presenta el resumen de diversas investigaciones que han comprobado, por ejemplo, que los medicamentos homeopáticos sí actúan en células, modelos animales y seres humanos, aunque no se ha logrado explicarcómo; además, se pone de manifiesto que los criterios para evaluar no pueden ser idénticos a los que se emplean en la farmacología clásica, si bien existe cierta similitud.Se concluye que a pesar de que hay demasiados aspectos de la Homeopatía que siguen sin tener una explicación coherente en términos científicos clásicos, no deben rechazarse sin miramientos, sino estudiarse.

Through a tour of the principles of homeopathy and the evolution of his ideas is possible to delineate the lines of research that could be developed to answer the doubts and questions that arise from the application of this discipline, between the medical and social sciences, biological and physical.The summary of several studies that have found, for example is presented, that homeopathic medicines do act on cells, animal models and humans, but has not been able to explainhow; moreover, shows that the criteria for evaluating may not be identical to those used in classical pharmacology, while there is some similarity.We conclude that although there are too many aspects of homeopathy that still lack a coherent explanation in classical scientific terms, should not be rejected without consideration, but studied.

En busca de la explicación de la homeopatía / In search of an explanation of homeopathy

En años recientes ha existido una demanda cada vez mayor de evidencia científica acerca de la Homeopatía. Varias hipótesis se han propuesto para explicarla en términos físicos y químicos. Publicaciones científicas recientes sugieren algunos posibles caminos para validar la realidad de toda una nueva clase de fenómenos fisicoquímicos relacionados con el agua. Este artículo intenta introducir algunas ideas para explicar este tema.

In recent years there has been an increasing demand for scientific evidenceabout homeopathy. Various hypotheses have been put forward to explain it in terms of conventional physics and chemistry. Recent scientific publications suggest some possible ways to validate the reality of a whole new class of physicochemical new phenomena concerning water. This paper makes an attempt to introduce some explanatory ideas about this item.

Cationic topical formulations tested in high dilutions offers protective effects in fibroblast cells culture

Topical administration is a simple and comfortable form of cutaneous administration of drugs. However, in this route of administration the drug needs to overcome the barrier posed by the skin to reach an effective concentration. For this reason, many topical formulations are developed with a cationic component. The promotion of absorption occurs due to the disruption of the stratum corneum. But this cationic component has also high irritating potential to the skin. The biotherapics are medicines prepared from a toxic product or etiologic agent, following the homeopathic pharmacopoeia technique, and they are used mainly in cases of hipersensitization. In this experiment, high dilutions (HD) obtained from a cationic formulation were prepared and evaluated considering cell viability in “in vitro” mouse fibroblast (L929) culture cells model by a colorimetric MTT assay. No signs of toxicity were observed, which demonstrates the safety of these HD preparations to the healthy cells. The effectiveness of these HD was also investigated in cells damaged by cationic formulations. The results demonstrated that the HD 30c was the most effective preparation in preventing the cell damage caused by the tested irritating product, increasing cell viability from 56.6% (damaged cells) to 100% (similar to negative control group, p>0.05). These results provide evidence of the positive action of high dilutions against the exposure to a cytotoxic agent.

Estudos homeopáticos: coletânea de artigos publicados na Revista de Homeopatia da APH e na Revista de Homeopatia da AMHB / Homeopathic studies: collection of articles published in the Journal of Homeopathy of APH and in the Journal of Homeopathy of AMHB

Coletânea de artigos publicados na Revista de Homeopatia da APH e na Revista de Homeopatia da AMHB pelo autor Marcus Zulian Teixeira entre os anos 1995 a 2007.

Efecto in vitro de la Matricaria recutita L. sobre la respuesta de linfocitos y neutrófilos / In vitro effect of Matricaria recutita L. on Lymphocytes and Neutrophils response

La manzanilla de Castilla, dulce o cimarrona (Matricaria recutita o Matricaria chamomilla), es una planta herbácea anual de la familia de las asteráceas, nativa de Europa y de regiones templadas de Asia, que se ha naturalizado en algunas regiones de América, África y Australia. Ha sido utilizada por el hombre desde hace miles de años con diferentes fines medicinales. Se estudió el efecto in vitro de un extracto fluido de esta planta sobre los linfocitos de 20 donantes voluntarios de sangre y de 20 enfermos con diagnóstico de inmunodeficiencia celular, mediante la cuantificación de los linfocitos T por las técnicas de formación de roseta espontánea y activa y el ultramicrométodo inmunocitoquímico (UMICIQ), así como la función fagocítica (índice opsonofagocítico) de los neutrófilos. No se hallaron diferencias estadísticamente significativas en los parámetros estudiados entre las condiciones experimentales con Matricaria y sin esta

Castilla Chamomile, sweet, or maroon (Matricaria recutita or Matricaria chamomilla) is an annual herbaceous plant of the Asteraceae family, native to Europe and temperate zones of Asia, which has become naturalized in parts of America, Africa, and Australia. It has been used by man for thousands of years with different medicinal purposes. We studied the in vitro effect of an extract fluid of this plant on lymphocytes from 20 blood donors and 20 patients with a diagnosis of cellular immunodeficiency. We quantified T lymphocytes by the techniques of spontaneous and active rosette formation, and the immunocytochemical ultramicromethod (UMICIQ) as well as the phagocytic function (opsonophagocytic index) of neutrophils. There were no statistically significant differences in the studied parameters between experimental conditions with Matricaria and without it

La calidad en el diseño del ensayo clínico en la Medicina Tradicional Natural / Quality in the design of the clinical trial in Natural and Traditional Medicine

La Medicina Tradicional Natural ha entrado en una nueva etapa de desarrollo con el impresionante incremento de la demanda de alternativas terapéuticas. Una de sus limitaciones es la carencia de suficientes investigaciones, constituidas a partir de la aplicación de un método científico para la adquisición y la evaluación de los resultados obtenidos o el incorrecto diseño de estudio, sobre todo, en los que involucran la evaluación de agentes o procedimientos terapéuticos o diagnósticos, de medicina tradicional y natural, a través de ensayos clínicos. Con el objetivo de valorar la calidad del diseño metodológico de los ensayos clínicos en la medicina tradicional y natural, se realizó un estudio transversal de tipo descriptivo mediante el cual se valoraron los protocolos de ensayos clínicos de maestrantes y residentes de esta especialidad, de julio a noviembre de 2011. En total se analizaron 36 protocolos de ensayos clínicos. Los principales problemas detectados fueron: el 41,7 por ciento por considerarse que el ensayo clínico no aportaría información relevante, el 80,5 por ciento por aspectos del diseño, el 22,2 por ciento por no existir una información clínica adecuada previa al inicio del ensayo que lo justifique, y el 16,7 por ciento por no cumplir con los aspectos éticos inherentes a un ensayo clínico.

The Natural and Traditional Medicine has entered a new stage of development with the striking increase of the therapeutic alternatives demand. One of its limitations is the scarcity of researches, done applying the scientific method to acquire and evaluate the obtained results or the incorrect design of the research, mainly in those including the evaluation of agents, therapeutic procedures or diagnosis of Natural and Traditional Medicine, through clinical trials. With the objective of assessing the quality of the methodological design of the clinical trials of Natural and Traditional Medicine we carried out a cross-sectional, descriptive research to evaluate the clinical trials protocols of the Master´s defenders and residents of this specialty, from July to November 2011. We analyzed in total 36 protocols of clinical trials. The main problems detected were: 41,7 per cent of the trials did not add relevant information; 80,5 per cent had problems in the design; in 22,2 per cent of them there was a lack of previous clinical information justifying the beginning of the trial, and 16, 7 per cent did not fulfilled the ethical aspects of a clinical trial.

Pesquisa médica em seres humanos, não maleficência e autoexperimentação homeopática / Medical research in humans, non-maleficence and homeopathic self-experimentation

Este artigo, de natureza conceitual, objetiva estabelecer conexão entre a pesquisa médica em seres humanos, a não maleficência e a autoexperimentação homeopática. A pesquisa médica em seres humanos, geralmente realizada no outro, tem sido permeada de expressivos abusos em relação aos sujeitos participantes. É neste contexto que emerge a não maleficência, princípio ético básico limitante destas violaçães. A não maleficência é o pressuposto que deve nortear as decisães no campo da pesquisa médica, representando sua inocuidade ou moderação. No que tange ao sujeito que experimenta, a investigação no ser humano pode ser conduzida, também, como autoexperimentação, ou seja, como experimentação realizada em si mesmo. A autoexperimentação, de grande valor em diferentes áreas da medicina, é denominada, na homeopatia, de autoexperimentação homeopática. A autoexperimentação homeopática é dotada de importantes características não maleficentes, o que a torna prática ética segura, viável, reproduzível e consistente da pesquisa médica terapêutica em seres humanos.

Sintomas patogenéticos de serotonina: relato de um grupo de auto-experimentadores / Proving symptoms of serotonin: report of a group of self-experimenters

O valor da auto-experimentação realizada pelo homeopata é inestimável, segundo Hahnemann, seja para o auto-conhecimento, para seu o aprendizado como observador e, principalmente, para a vivência dos princípios homeopáticos. Assim, formou-se, em 2005, em Londrina um grupo de auto-experimentação, composto por vários profissionais homeopatas. Vinte auto-experimentadores (12 no primeiro grupo, em 2005, e 8 no segundo grupo, em 2008) provaram sulfato de serotonina na preparação homeopática 30cH e, posteriormente, os sintomas observados pelos dois grupos foram comparados com aqueles descritos na literatura para a síndrome serotoninérgica (SS). O medicamento Serotonina 30cH despertou 370 sintomas, expressos pelos 20 auto-experimentadores, sendo que os sintomas foram reunidos em 47 grupos. Desses sintomas, muitos apareceram nos dois grupos, compostos por experimentadores diferentes, em momentos diversos. O resultado da comparação entre os sintomas da SS e aqueles surgidos nas auto-experimentações mostrou que dos 32 sintomas da SS relatados pela literatura consultada, 17 deles ocorreram nas auto-experimentações. A auto-experimentação foi uma oportunidade ímpar para a vivência dos princípios homeopáticos e um excelente exercício de auto-observação. A riqueza dos sintomas experimentados aliada à reprodução dos mesmos na segunda experimentação e à coincidência com vários sintomas da SS tornam a serotonina agitada e diluída um medicamento homeopático para ser utilizado na clínica.

The value of the self-experimentation the homeopathic physician carries out on him/herself is priceless, according to Hahnemann, be it to acquire self-knowledge, to learn how to observe or chiefly, to experience the homeopathic principles. Consequently, it was formed in 2005 in Londrina a group of self-experimentation, composed by several homeopathic professionals. Twenty self-experimenters (12 in the first group, in 2005, and 8 in the second group, in 2008) tested serotonin sulfate in homeopathic high dilution 30cH; later on, the symptoms observed by both groups were compared with the ones described in the literature in serotonin syndrome (SS). Homeopathic medicine Serotonin 30cH awakened 370 symptoms among 20 experimenters, which were grouped in 47 classes. From these symptoms, many appeared in volunteers from both groups, which were composed by different volunteers in differen moments. The result of the comparison between the symptoms of SS and the ones reported in the self-experimentations showed that, from de 32 symptoms of SS reported by the literature, 17 also happened in our study. This self-experimentation was an unique opportunity to experience the homeopathic principles...