Adverse effects in homeopathy. A systematic review and meta-analysis of observational studies.

BACKGROUND: Almost all health care interventions have the potential to be associated with risk to patient safety. Different terminologies are used to define treatment induced risk to patient safety and a common definition is the term adverse effect. Beyond the concept of adverse effect and specific to homeopathy is the concept of homeopathic aggravation. Homeopathic aggravation describes a transient worsening of the patients' symptoms, which is not understood as an adverse effect. In order to ensure patient safety within a homeopathic treatment setting, it is important to identify adverse effects, as well as homeopathic aggravations, even though it may be challenging to distinguish between these two concepts. To date there is an obvious lack of systematic information on how adverse effects and homeopathic aggravations are reported in studies. This systematic review and meta-analysis focuses on observational studies, as a substantial amount of the research base for homeopathy are observational. METHOD: Eight electronic databases, central webpages and journals were searched for eligible studies. The searches were limited from the year 1995 to January 2020. The filters used were observational studies, human, English and German language. Adverse effects and homeopathic aggravations were identified and graded according to The Common Terminology Criteria for Adverse Effects (CTCAE). Meta-analysis was performed separately for adverse effects and homeopathic aggravations. RESULTS: A total of 1,169 studies were identified, 41 were included in this review. Eighteen studies were included in a meta-analysis that made an overall comparison between homeopathy and control (conventional medicine and herbs). Eighty-seven percent (n = 35) of the studies reported adverse effects. They were graded as CTCAE 1, 2 or 3 and equally distributed between the intervention and control groups. Homeopathic aggravations were reported in 22,5% (n = 9) of the studies and graded as CTCAE 1 or 2. The frequency of adverse effects for control versus homeopathy was statistically significant (P < 0.0001). Analysis of sub-groups indicated that, compared to homeopathy, the number of adverse effects was significantly higher for conventional medicine (P = 0.0001), as well as other complementary therapies (P = 0.05). CONCLUSION: Adverse effects of homeopathic remedies are consistently reported in observational studies, while homeopathic aggravations are less documented. This meta-analysis revealed that the proportion of patients experiencing adverse effects was significantly higher when receiving conventional medicine and herbs, compared to patients receiving homeopathy. Nonetheless, the development and implementation of a standardized reporting system of adverse effects in homeopathic studies is warranted in order to facilitate future risk assessments.

Selecting Instruments for Measuring the Clinical Learning Environment of Medical Education: A 4-Domain Framework.

Learning environments shape the experiences of learners and practitioners, making them an important component of program evaluation. However, educators find it challenging to decide whether to measure clinical learning environments with existing instruments or to design their own new instrument and, if using an existing instrument, which to choose. To assist educators with these decisions, the authors compared clinical learning environment instruments based on their characteristics, underlying constructs, and degree to which items reflect 4 domains (personal, social, organizational, material) from a recently developed model for conceptualizing learning environments in the health professions. Building on 3 prior literature reviews as well as a literature search, the authors identified 6 clinically oriented learning environment instruments designed for medical education. They collected key information about each instrument (e.g., number of items and subscales, conceptual frameworks, operational definitions of the learning environment) and coded items from each instrument according to the 4 domains. The 6 instruments varied in number of items, underlying constructs, subscales, definitions of clinical learning environment, and domain coverage. Most instruments focused heavily on the organizational and social domains and less on the personal and material domains (half omitted the material domain entirely). The variations in these instruments suggest that educators might consider several guiding questions. How will they define the learning environment and which theoretical lens is most applicable (e.g., personal vitality, sociocultural learning theory)? What aspects or domains of the learning environment do they most wish to capture (e.g., personal support, social interactions, organizational culture, access to resources)? How comprehensive do they want the instrument to be (and correspondingly how much time do they expect people to devote to completing the instrument and how frequently)? Whose perspective do they wish to evaluate (e.g., student, resident, fellow, attending, team, patient)? Each of these considerations is addressed.

Rebound effect of modern drugs: serious adverse event unknown by health professionals.

OBJECTIVE: Supported in the Hippocratic aphorism primum non nocere, the bioethical principle of non-maleficence pray that the medical act cause the least damage or injury to the health of the patient, leaving it to the doctor to assess the risks of a particular therapy through knowledge of possible adverse events of drugs. Among these, the rebound effect represents a common side effect to numerous classes of modern drugs, may cause serious and fatal disorders in patients. This review aims to clarify the health professionals on clinical and epidemiological aspects of rebound phenomenon. METHODS: A qualitative, exploratory and bibliographic review was held in the PubMed database using the keywords 'rebound', 'withdrawal', 'paradoxical', 'acetylsalicylic acid', 'anti-inflammatory', 'bronchodilator', 'antidepressant', 'statin', 'proton pump inhibitor' and 'bisphosphonate'. RESULTS: The rebound effect occurs after discontinuation of numerous classes of drugs that act contrary to the disease disorders, exacerbating them at levels above those prior to treatment. Regardless of the disease, the drug and duration of treatment, the phenomenon manifests itself in a small proportion of susceptible individuals. However, it may cause serious and fatal adverse events should be considered a public health problem in view of the enormous consumption of drugs by population. CONCLUSION: Bringing together a growing and unquestionable body of evidence, the physician needs to have knowledge of the consequences of the rebound effect and how to minimize it, increasing safety in the management of modern drugs. On the other hand, this rebound can be used in a curative way, broadening the spectrum of the modern therapeutics.

Efeito rebote dos fármacos modernos: evento adverso grave desconhecido pelos profissionais da saúde / Rebound effect of modern drugs: Serious adverse event unknown by health professionals

OBJETIVO: Apoiado no aforismo hipocrático primum non nocere, o princípio bioético da não maleficência roga que o ato médico cause o menor dano ou agravo à saúde do paciente, incumbindo ao médico avaliar os riscos de determinada terapêutica por meio do conhecimento dos possíveis eventos adversos das drogas. Dentre esses, o efeito rebote representa um efeito colateral comum a inúmeras classes de fármacos modernos, podendo causar transtornos graves e fatais nos pacientes. Esta revisão tem o objetivo de esclarecer os profissionais da saúde sobre os aspectos clínicos e epidemiológicos do fenômeno rebote. MÉTODOS: Uma revisão qualitativa, exploratória e bibliográfica foi realizada na base de dados PubMed utilizando os unitermos 'rebound', 'withdrawal', 'paradoxical', 'acetylsalicylic acid', 'anti-inflammatory', 'bronchodilator', 'antidepressant', 'statin', 'proton pump inhibitor' and 'bisphosphonate' RESULTADOS: O efeito rebote ocorre após a descontinuação de inúmeras classes de fármacos com ação contrária aos distúrbios da doença, exacerbando-os a níveis superiores aos anteriores do tratamento. Independente da doença,dadrogaedaduração do tratamento, o fenômeno se manifesta numa pequena proporção de indivíduos suscetíveis. No entanto, pode causar eventos adversos graves e fatais, devendo ser considerado um problema de saúde pública em vista do enorme consumo de fármacos pela população CONCLUSÃO: Reunindo um corpo de evidências crescente e inquestionável, o médico precisa ter conhecimento das consequências do efeito rebote e de como minimizá-lo, aumentando a segurança no manejo das drogas modernas. Por outro lado, este efeito rebote pode ser utilizado de forma curativa, ampliando o espectro da terapêutica moderna.

OBJECTIVE: Supported in the Hippocratic aphorism primum non nocere, the bioethical principle of non-maleficence pray that the medical act cause the least damage or injury to the health of the patient, leaving it to the doctor to assess the risks of a particular therapy through knowledge of possible adverse events of drugs. Among these, the rebound effect represents a common side effect to numerous classes of modern drugs, may cause serious and fatal disorders in patients. This review aims to clarify the health professionals on clinical and epidemiological aspects of rebound phenomenon. METHODS: A qualitative, exploratory and bibliographic review was held in the PubMed database using the keywords 'rebound', 'withdrawal', 'paradoxical', 'acetylsalicylic acid', 'anti-inflammatory', 'bronchodilator', 'antidepressant', 'statin', 'proton pump inhibitor' and 'bisphosphonate'. RESULTS: The rebound effect occurs after discontinuation of numerous classes of drugs that act contrary to the disease disorders, exacerbating them at levels above those prior to treatment. Regardless of the disease, the drug and duration of treatment, the phenomenon manifests itself in a small proportion of susceptible individuals. However, it may cause serious and fatal adverse events should be considered a public health problem in view of the enormous consumption of drugs by population. CONCLUSION: Bringing together a growing and unquestionable body of evidence, the physician needs to have knowledge of the consequences of the rebound effect and how to minimize it, increasing safety in the management of modern drugs. On the other hand, this rebound can be used in a curative way, broadening the spectrum of the modern therapeutics.