RESUMO
The present successor article comprises more than 180 substances representing a continuative compilation of toxicologically evaluated starting materials prompted by the wide use and high number of homeopathic and anthroposophic medicinal products (HMP) on the market together with the broad spectrum of active substances of botanical, mineral, chemical or animal origin contained therein, and by the equally important requirement of applying adequate safety principles as with conventional human medicinal products in line with the European regulatory framework. The February 2019 issue of the Regulatory Toxicology and Pharmacology journal includes the antecedent article bearing the same title and entailing safety evaluations of more than 170 raw materials processed in HMP. This part 2 article highlights scientific evaluation following recognized methods used in toxicology with a view to drug-regulatory authority's assessment principles and practice in the context of HMP, and offers useful systematic, scientifically substantiated and simultaneously pragmatic approaches in differentiated HMP risk assessment. As a unique feature, both articles provide the most extensive publicly available systematic compilation of a considerable number of substances processed in HMP as a transparent resource for applicants, pharmaceutical manufacturers, the scientific community and healthcare authorities to actively support regulatory decision making in practice.
Assuntos
Homeopatia , Animais , Humanos , Medição de Risco/métodosRESUMO
Homeopathy is widely used and broadly accepted by health care professionals and the general public but less in academic circles. To assess possible material health risks of homeopathic medicinal products, it is necessary to identify, select, and synthesize the findings of recent reviews of controlled homeopathic clinical trials. Matching these findings with experimental data from toxicological studies helps to clarify what is known and not known about the material risks of homeopathic medicines. Rules for toxicological risk assessment and management need to be applied independently of individual attitudes towards specific therapeutic options. European regulatory bodies have developed special protocols and decision trees to assure the safety of nonindividualized homeopathic remedies. This narrative review leads to suggestions that could ease and improve toxicological decision making. No homeopathy-specific type or pattern of side effects could be extracted from the meta-analysis data. No differences in the frequency of adverse reactions between homeopathic treatment and placebo treatment could be seen, no matter whether adverse events were reported in a quantitative or a qualitative manner. Some patterns of side effects show that adverse reactions do not necessarily correlate with treatment but with the condition of the patient. Overall, the controlled clinical data available for the material risk assessment of homeopathic remedies support the statement that, if a risk exists, it must be so small that it has not yet been established. To make our risk findings useful for personal decisions regarding homeopathy, we provide a thought experiment based on four different health situations and ask the question: is homeopathy as a monotherapy or as an add-on treatment an option or should it be rejected?
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Homeopatia , Materia Medica , Homeopatia/efeitos adversos , Homeopatia/normas , Humanos , Materia Medica/efeitos adversos , Materia Medica/normasRESUMO
The considerable number of homeopathic medicinal products (HMP) on the German market and the staggering breadth of active substances of various origin along with the specific legal requirements of adequate safety principles posed the need to compile data on toxicologically evaluated raw materials. In line with the European regulatory framework, HMP applications must consider appropriate safety standards in analogy to conventional human medicinal products. This review presents an option for a systematic and scientifically substantiated approach for regulatory use. Furthermore, this paper provides a multitude of data for selected raw materials processed in HMP with up to now rather scarce knowledge and, thus, aims at filling data gaps on acceptable amounts per day (AAD). The inclusion of raw materials into the compilation was determined considering the frequencies of their occurrence in HMP in Germany along with the availability of appropriate safety assessments. This safety evaluation compilation represents a practical, fairly comprehensive and systematic set of more than 170 raw materials. It is designed to both effectively support regulatory decision making and to be recognized and exploited by applicants, stakeholders and the scientific community.
Assuntos
Homeopatia/efeitos adversos , Materia Medica/efeitos adversos , Alemanha , Humanos , Medição de RiscoRESUMO
RESUMEN Durante el climaterio y la menopausia debido a cambios hormonales pueden presentarse en las mujeres síntomas que afectan la calidad de vida y las relaciones interpersonales. La homeopatía puede ser utilizada como terapia alternativa o complementaria en el manejo de sus síntomas proporcionando múltiples beneficios, escasos efectos secundarios, ahorro de recursos y apertura de una nueva línea para investigar. La bibliografía sobre este tema es insuficiente y se encuentra dispersa lo que dificulta la consulta por parte de los profesionales que la necesitan. Se realizó una revisión bibliográfica con el objetivo de identificar y describir los principales medicamentos homeopáticos que pueden ser utilizados para tratar los síntomas durante el climaterio y la menopausia. Los artículos se identificaron básicamente a través de la búsqueda automatizada en las bases de datos Scielo, PubMed y EBSCO, entre los meses de enero de 2017 a mayo de 2018. Se revisaron aquellos libros y artículos que por su trascendencia fueron considerados como referentes en el tema. Se escogieron 26 referencias bibliográficas que se ajustaban a los objetivos de esta investigación. Fueron identificados y descritos 22 medicamentos homeopáticos susceptibles de ser utilizados en el tratamiento de los síntomas de climaterio y menopausia por lo que puede ser una fuente útil de consulta (AU).
ABSTRACT During the climacteric and menopause, due to hormonal changes, women may present symptoms affecting life quality and interpersonal relations. Homeopathy could be used as an alternative or complementary therapy in the management of those symptoms, providing several benefits, scarce secondary effects, saving resources and opening a new research field. There is not enough bibliography on this topic and it is dispersed, making it difficult for the professional to consult it when it is necessary. A bibliographic review was carried out with the objective of identifying and describing the main homeopathic medicinal products that could be used to treat the symptoms during the climacteric and menopause. The articles were identified mainly through an automated search in Scielo, PubMed and EBSCO databases, in the period from January 2017 and May 2018. Those books and articles considered as referents in the topic because of their transcendence were reviewed. 26 bibliographic references were chosen because they complied with the objective of this research. 20 homeopathic medicinal products capable of being used in the treatment of the climacteric and menopause symptoms were identified and described, being therefore a useful consultation source (AU).
Assuntos
Humanos , Feminino , Climatério/efeitos dos fármacos , Menopausa/efeitos dos fármacos , Medicamento Homeopático/efeitos dos fármacos , Qualidade de Vida/psicologia , Mulheres/psicologia , Literatura de Revisão como AssuntoRESUMO
RESUMEN Durante el climaterio y la menopausia debido a cambios hormonales pueden presentarse en las mujeres síntomas que afectan la calidad de vida y las relaciones interpersonales. La homeopatía puede ser utilizada como terapia alternativa o complementaria en el manejo de sus síntomas proporcionando múltiples beneficios, escasos efectos secundarios, ahorro de recursos y apertura de una nueva línea para investigar. La bibliografía sobre este tema es insuficiente y se encuentra dispersa lo que dificulta la consulta por parte de los profesionales que la necesitan. Se realizó una revisión bibliográfica con el objetivo de identificar y describir los principales medicamentos homeopáticos que pueden ser utilizados para tratar los síntomas durante el climaterio y la menopausia. Los artículos se identificaron básicamente a través de la búsqueda automatizada en las bases de datos Scielo, PubMed y EBSCO, entre los meses de enero de 2017 a mayo de 2018. Se revisaron aquellos libros y artículos que por su trascendencia fueron considerados como referentes en el tema. Se escogieron 26 referencias bibliográficas que se ajustaban a los objetivos de esta investigación. Fueron identificados y descritos 22 medicamentos homeopáticos susceptibles de ser utilizados en el tratamiento de los síntomas de climaterio y menopausia por lo que puede ser una fuente útil de consulta (AU).
ABSTRACT During the climacteric and menopause, due to hormonal changes, women may present symptoms affecting life quality and interpersonal relations. Homeopathy could be used as an alternative or complementary therapy in the management of those symptoms, providing several benefits, scarce secondary effects, saving resources and opening a new research field. There is not enough bibliography on this topic and it is dispersed, making it difficult for the professional to consult it when it is necessary. A bibliographic review was carried out with the objective of identifying and describing the main homeopathic medicinal products that could be used to treat the symptoms during the climacteric and menopause. The articles were identified mainly through an automated search in Scielo, PubMed and EBSCO databases, in the period from January 2017 and May 2018. Those books and articles considered as referents in the topic because of their transcendence were reviewed. 26 bibliographic references were chosen because they complied with the objective of this research. 20 homeopathic medicinal products capable of being used in the treatment of the climacteric and menopause symptoms were identified and described, being therefore a useful consultation source (AU).
Assuntos
Humanos , Feminino , Climatério/efeitos dos fármacos , Menopausa/efeitos dos fármacos , Medicamento Homeopático/efeitos dos fármacos , Qualidade de Vida/psicologia , Mulheres/psicologia , Literatura de Revisão como AssuntoRESUMO
For active substances of botanical, mineral or chemical origin processed in homeopathic medicinal products for human use, the adequate safety principles as with other human medicinal products are applied in line with the European regulatory framework. In homeopathy, nonclinical safety assessment is facing a particular challenge because of a multitude and diversity of source materials used and due to rarely available toxicological data. Thus, current concepts applied by the national regulatory authority in Germany (BfArM) on integrative safety assessment of raw materials used in homeopathic medicinal products involve several evaluation approaches like the use of the Lowest Human Recommended Dose (LHRD), toxicological limit values, Threshold of Toxicological Concern (TTC), data from food regulation or the consideration of unavoidable environmental or dietary background exposure. This publication is intended to further develop and clarify the practical use of these assessment routes by exemplary application on selected homeopathic preparations. In conclusion, the different approaches are considered a very useful scientific and simultaneously pragmatic procedure in differentiated risk assessment of homeopathic medicinal products. Overall, this paper aims to increase the visibility of the safety issues in homeopathy and to stimulate scientific discussion of worldwide existing regulatory concepts on homeopathic medicinal products.
