A Qualitative Investigation of Provers' Experiences of Participation in Homeopathic Pathogenetic Trials.

BACKGROUND: Information on homeopathic medicines is derived from "provings" or homeopathic pathogenetic trials (HPTs), in which people (often homeopaths and homeopathy students) are invited to take an unnamed and often untested highly diluted and serially succussed substance, and record in detail their experiences and perceived effects. HPTs are assumed to have an "excellent safety record", but there has been no academic research to date into provers' experiences of participating in an HPT. AIMS: This qualitative study aimed to explore the lived experience of participation in an HPT. It is hoped that the results from this study will inform the future conduct of HPTs. METHODS: Semi-structured interviews were conducted in person, by phone or via Skype, according to the interviewees' preferences. Thematic analysis was used for the generation of themes. RESULTS: Eight former provers were interviewed from across the European Union (EU) and Australia. Of these, seven were practicing homeopaths and one was not a practitioner. Overarching themes were identified as: (1) the ethical conduct of HPTs, and (2) the impact of participation in HPTs. CONCLUSION: Former provers who participated in this study reported enthusiasm for, and trust in, the proving process. However, some also reported adverse events, which varied in intensity and duration. The process of gaining fully informed consent for participation in an HPT is complex and there were examples of both failure and inadequacy in terms of informed consent and support mechanisms. RECOMMENDATIONS: The researchers recommend that HPTs are subject to ethical approval processes and that consent is fully informed and ongoing. It is also recommended that appropriate and robust support mechanisms be developed.

Model validity of randomised placebo-controlled trials of non-individualised homeopathic treatment.

BACKGROUND: The comprehensive systematic review of randomised placebo-controlled trials (RCTs) in homeopathy requires examination of a study's model validity of homeopathic treatment (MVHT) as well as its risk of bias (extent of reliable evidence). OBJECTIVE: To appraise MVHT in those RCTs of non-individualised homeopathy that an associated investigation had judged as 'not at high risk of bias'. DESIGN: Systematic review. METHODS: An assessment of MVHT was ascribed to each of 26 eligible RCTs. Another 49 RCTs were ineligible due to their high risk of bias. MAIN OUTCOME MEASURES: MVHT and the prior risk of bias rating per trial were merged to obtain a single overall quality designation ('high', 'moderate', 'low'), based on the GRADE principle of downgrading. RESULTS: The trials were rated as 'acceptable MVHT' (N = 9), 'uncertain MVHT' (N = 10) and 'inadequate MVHT' (N = 7); and, previously, as 'reliable evidence' (N = 3) and 'non-reliable evidence' (N = 23). The 26 trials were designated overall as: 'high quality' (N = 1); 'moderate quality' (N = 18); 'low quality' (N = 7). CONCLUSION: Of the 26 RCTs of non-individualised homeopathy that were judged 'not at high risk of bias', nine have been rated 'acceptable MVHT'. One of those nine studies was designated 'high quality' overall ('acceptable MVHT' and 'reliable evidence'), and is thus currently the only reported RCT that represents best therapeutic practice as well as unbiased evidence in non-individualised homeopathy. As well as minimising risk of bias, new RCTs in this area must aim to maximise MVHT and clarity of reporting.

Personal knowledge and study participation.

Scientists in earlier times considered personal research participation an essential component of their work.Exposing themselves to untested interventions was seen as the most ethical way to gauge the human response to those interventions. The practice was also educational, for it generated useful information that helped researchers plan subsequent human studies.Self-experimentation was eventually replaced by more comprehensive ethical codes governing human research.But it is time to bring back the practice of self-experimentation, albeit in modified form. Through serving as a study subject, investigators and other research professionals can obtain valuable information about their work.

Recommended standards for conducting and reporting ethnopharmacological field studies.

ETHNOPHARMACOLOGICAL RELEVANCE: What are the minimum methodological and conceptual requirements for an ethnopharmacological field study? How can the results of ethnopharmacological field studies be reported so that researchers with different backgrounds can draw on the results and develop new research questions and projects? And how should these field data be presented to get accepted in a scientific journal such as the Journal of Ethnopharmacology? The objective of this commentary is to create a reference that covers the basic standards necessary during planning, conducting and reporting of field research. MATERIALS AND METHODS: We focus on conducting and reporting ethnopharmacological field studies on medicinal plants or materia medica and associated knowledge of a specific people or region. The article highlights the most frequent problems and pitfalls, and draws on published literature, fieldwork experience, and extensive insights from peer-review of field studies. RESULTS: Research needs to be ethical and legal, and follow local and national regulations. Primary ethnopharmacological field data need to be collected and presented in a transparent and comprehensible way. In short this includes: 1) Relevant and concise research questions, 2) Thorough literature study encompassing all available information on the study site from different disciplines, 3) Appropriate methods to answer the research questions, 4) Proper plant use documentation, unambiguously linked to voucher specimens, and 5) Qualitative and quantitative analyses of the collected data, the latter relying on use-reports as basic units. CONCLUSION: Although not exhaustive, we provide an overview of the necessary main issues to consider for field research and data reporting including a list of minimal standards and recommendations for best practices. For methodological details and how to correctly apply specific methods, we refer to further reading of suggested textbooks and methods manuals.

Tratamento homeopático e prevenção da Covid-19: protocolo de pesquisa clínica para avaliar a eficácia e a segurança do medicamento do gênio epidêmico / Homeopathic treatment and prevention of Covid-19: clinical research protocol to evaluate the effectiveness and safety of the epidemic genius medicine

Além da reconhecida aplicação nas doenças crônicas, a homeopatia individualizada também pode atuar de forma resolutiva ou complementar nos casos agudos, incluindo as doenças epidêmicas. No entanto, para atingir esse intento, apresenta uma metodologia semiológica e terapêutica específica que deve ser seguida e respeitada, com o risco de não apresentar a eficácia e a segurança desejada. No caso das doenças epidêmicas, que pela virulência dos seus agentes provoca um quadro sintomatológico comum na maioria dos indivíduos suscetíveis, o medicamento homeopático individualizado (medicamento homeopático do gênio epidêmico) deve apresentar semelhança com o conjunto de sinais e sintomas característicos dos pacientes acometidos nos diferentes estágios de cada surto epidêmico. Estudos evidenciam a eficácia e a segurança desta prática terapêutica e/ou profilática em diversas epidemias do passado. Assim sendo, após o levantamento dos possíveis medicamentos homeopáticos individualizados do gênio epidêmico de cada epidemia, sua aplicação terapêutica e/ou profilática em larga escala deve ser sustentada por ensaios clínicos prévios que demonstrem sua eficácia e segurança, em consonância com os aspectos éticos e bioéticos da pesquisa envolvendo seres humanos. Cumprindo essas premissas da boa prática clínica, elaboramos, em março de 2020, esse protocolo de pesquisa para investigar, em ensaio clínico randomizado, duplo-cego e placebo-controlado, a eficácia e a segurança de possíveis medicamentos homeopáticos individualizados do gênio epidêmico da COVID-19. Caso a eficácia e a segurança se confirmem, e tão somente nessa condição, o medicamento poderá ser utilizado de forma generalizada e coletiva no tratamento e na prevenção da atual epidemia. Com esse intuito, encaminhamos este projeto a médicos, pesquisadores e gestores de diversos hospitais públicos e privados, solicitando uma oportunidade para aplicar essa proposta em pacientes internados em enfermarias e/ou centros de terapia intensiva destinadas ao tratamento da COVID-19.

In addition to the recognized application in chronic diseases, individualized homeopathy can also act in a resolutive or complementary way in acute cases, including epidemic diseases. However, to achieve this intent, it presents a specific semiologic and therapeutic methodology that must be followed and respected, with the risk of not presenting the desired efficacy and safety. In the case of epidemic diseases, which due to the virulence of their agents causes a common symptomatological picture in most susceptible individuals, the individualized homeopathic medicine (homeopathic medicine of the epidemic genius) should present similarity with the set of characteristic symptoms and signs of the patients affected in the different stages of each epidemic outbreak. Studies show the efficacy and safety of this therapeutic and/or prophylactic practice in several epidemics of the past. Therefore, after the survey of possible individualized homeopathic medicine from the epidemic genius of each epidemic, its therapeutic and/or large-scale prophylactic application should be supported by previous clinical trials that demonstrate its effectiveness and safety, in line with the ethical and bioethical aspects of research involving human beings. Fulfilling these premises of good clinical practice, we developed, in March 2020, this research protocol to investigate, in a randomized, double-blind and placebo-controlled clinical trial, the effectiveness and safety of possible individualized homeopathic medicines of epidemic genius of COVID-19. If effectiveness and safety are confirmed, and only in this condition, the medicine may be used in a generalized and collective manner in the treatment and prevention of the current epidemic. To this end, we refer this project to physicians, researchers and managers of several public and private hospitals, requesting an opportunity to apply this proposal to patients hospitalized in wards and/or intensive care units for the treatment of COVID-19.

Clinical research protocol to evaluate the effectiveness and safety of individualized homeopathic medicine in the treatment and prevention of the COVID-19 epidemic

In addition to the recognized application in chronic diseases, individualized homeopathy can also act in a resolutive or complementary way in acute cases, including epidemic diseases. However, to achieve this intent, it presents a specific semiologic and therapeutic methodology that must be followed and respected, with the risk of not presenting the desired efficacy and safety. In the case of epidemic diseases, which due to the virulence of their agents causes a common symptomatological picture in most susceptible individuals, the individualized homeopathic medicine (homeopathic medicine of the epidemic genius) should present similarity with the set of characteristic symptoms and signs of the patients affected in the different stages of each epidemic outbreak. Studies show the efficacy and safety of this prophylactic and/or therapeutic practice in several epidemics of the past. Therefore, after the survey of possible homeopathic drugs individualized from the epidemic genius of each epidemic, its prophylactic and/or large-scale therapeutic application should be supported by previous clinical trials that demonstrate its efficacy and safety, in line with the ethical and bioethical aspects of research involving human beings. Fulfilling these premises of good clinical practice, we developed the current protocol with the objective of investigating, in a randomized, double-blind and placebo-controlled clinical trial, the effectiveness and safety of possible individualized homeopathic drugs of epidemic genius of COVID-19, in adjuvant and complementary treatment of patients affected by the disease. If effectiveness and safety are confirmed, and only in this condition, the medicine may be used in a generalized and collective manner in the treatment and prevention of the current epidemic. (AU)

Protocolo de pesquisa clínica para avaliar a eficácia e a segurança de medicamento homeopático individualizado no tratamento e na prevenção da epidemia de COVID-19 / Clinical research protocol to evaluate the efficacy and safety of individualized homeopathic medicine in the treatment and prevention of the COVID-19 epidemic

Além da reconhecida aplicação nas doenças crônicas, a homeopatia individualizada também pode atuar de forma resolutiva ou complementar nos casos agudos, incluindo as doenças epidêmicas. No entanto, para atingir esse intento, apresenta uma metodologia semiológica e terapêutica específica que deve ser seguida e respeitada, com o risco de não apresentar a eficácia e a segurança desejada. No caso das doenças epidêmicas, que pela virulência dos seus agentes provoca um quadro sintomatológico comum na maioria dos indivíduos suscetíveis, o medicamento homeopático individualizado (medicamento homeopático do gênio epidêmico) deve apresentar semelhança com o conjunto de sinais e sintomas característicos dos pacientes acometidos nos diferentes estágios de cada surto epidêmico. Estudos evidenciam a eficácia e a segurança desta prática profilática e/ou terapêutica em diversas epidemias do passado. Assim sendo, após o levantamento dos possíveis medicamentos homeopáticos individualizados do gênio epidêmico de cada epidemia, sua aplicação profilática e/ou terapêutica em larga escala deve ser sustentada por ensaios clínicos prévios que demonstrem sua eficácia e segurança, em consonância com os aspectos éticos e bioéticos da pesquisa envolvendo seres humanos. Cumprindo essas premissas da boa prática clínica, elaboramos o atual protocolo com o objetivo de investigar, em ensaio clínico randomizado, duplo-cego e placebo-controlado, a eficácia e a segurança de possíveis medicamentos homeopáticos individualizados do gênio epidêmico da COVID-19, em tratamento adjuvante e complementar de pacientes acometidos pela doença. Caso a a eficácia e a segurança se confirme, e tão somente, o(s) medicamento(s) poderão ser utilizado de forma generalizada e coletiva no tratamento e na prevenção da atual epidemia. (AU)

In addition to the recognized application in chronic diseases, individualized homeopathy can also act in a resolutive or complementary way in acute cases, including epidemic diseases. However, to achieve this intent, it presents a specific semiological and therapeutic methodology that must be followed and respected, with the risk of not presenting the desired efficacy and safety. In the case of epidemic diseases, which due to the virulence of their agents causes a common symptomatological picture in most susceptible individuals, the individualized homeopathic medicine (homeopathic medicine of the epidemic genius) should present similarity with the set of characteristic symptoms and signs of the patients affected in the different stages of each epidemic outbreak. Studies show the efficacy and safety of this prophylactic and/or therapeutic practice in several epidemics of the past. Therefore, after the survey of possible homeopathic drugs individualized from the epidemic genius of each epidemic, its prophylactic and/or large-scale therapeutic application should be supported by previous clinical trials that demonstrate its efficacy and safety, in line with the ethical and bioethical aspects of research involving human beings. Fulfilling these premises of good clinical practice, we developed the current protocol with the objective of investigating, in a randomized, double-blind and placebo-controlled clinical trial, the efficacy and safety of possible individualized homeopathic drugs of epidemic genius of COVID-19, in adjuvant and complementary treatment of patients affected by the disease. If efficacy and safety are confirmed, and only in this condition, the medicine may be used in a generalized and collective manner in the treatment and prevention of the current epidemic. (AU)

The Nuremberg Code: its history and implications.

The Nuremberg Code is a foundational document in the ethics of medical research and human experimentation; the principle its authors espoused in 1946 have provided the framework for modern codes that address the same issues, and have received little challenge and only slight modification in decades since. By analyzing the Code's tragic genesis and its normative implications, it is possible to understand some of the essence of modern experimental ethics, as well as certain outstanding controversies that still plague medical science.

The pitfalls of clinical case research: lessons from the Delphi Project

Delphi is a project to make high-quality cases treated with homeopathy available for study. The project encountered a number of major difficulties including small numbers... (AU)