RESUMEN
La valoración crítica de la seguridad de los medicamentos homeopáticos se ha desarrollado recientemente. Esta cuestión es relevante para la toma de decisiones de los médicos, pacientes y dependencias regulatorias de fármacos. A pesar de la aparente inverosimilitud de la acción de los medicamentos homeopáticos debido a los procesos farmacotécnicos de la dilución y agitación empleados para su preparación, existen reportes en la literatura médica convencional sobre la toxicidad de los medicamentos homeopáticos, incluyendo eventos que aparentemente ponen en riesgo la vida. Las revisiones sistemáticas de estudios clínicos controlados aleatorizados muestran que los medicamentos homeopáticos provocan más efectos adversos que el placebo, aunque leves y transitorios. El establecimiento de un sistema de monitoreo en línea para la recolección de datos sobre los efectos adversos de los medicamentos homeopáticos, herbolarios o convencionales, es relevante para una evaluación no sesgada de la información reunida a partir de los consumidores y proveedores de atención médica.
Critical appraisal of the safety of homeopathic medicines developed recently. This matter is relevant for decision making by doctors, patients and drug regulatory agencies. Despite the apparent implausibility of the action of homeopathic medicines due to the pharmacotechnical processes of dilution and agitation used for their preparation, there are reports in the conventional medical literature on the toxicity of homeopathic medicines, including apparently life-threatening events. Systematic reviews of randomized controlled trials show that homeopathic medicines cause more adverse effects than placebo, albeit mild and transient. Establishing an online monitoring terapéusystem for collection of data on the adverse effects of homeopathic, herbal or conventional medicines is relevant for non-biased assessment of the information gathered from consumers and health care providers.
Asunto(s)
/efectos de los fármacos , Medicamento Homeopático , Seguridad del PacienteRESUMEN
La valoración crítica de la seguridad de los medicamentos homeopáticos se ha desarrollado recientemente. Esta cuestión es relevante para la toma de decisiones de los médicos, pacientes y dependencias regulatorias de fármacos. A pesar de la aparente inverosimilitud de la acción de los medicamentos homeopáticos debido a los procesos farmacotécnicos de la dilución y agitación empleados para su preparación, existen reportes en la literatura médica convencional sobre la toxicidad de los medicamentos homeopáticos, incluyendo eventos que aparentemente ponen en riesgo la vida. Las revisiones sistemáticas de estudios clínicos controlados aleatorizados muestran que los medicamentos homeopáticos provocan más efectos adversos que el placebo, aunque leves y transitorios. El establecimiento de un sistema de monitoreo en línea para la recolección de datos sobre los efectos adversos de los medicamentos homeopáticos, herbolarios o convencionales, es relevante para una evaluación no sesgada de la información reunida a partir de los consumidores y proveedores de atención médica.
Critical appraisal of the safety of homeopathic medicines developed recently. This matter is relevant for decision making by doctors, patients and drug regulatory agencies. Despite the apparent implausibility of the action of homeopathic medicines due to the pharmacotechnical processes of dilution and agitation used for their preparation, there are reports in the conventional medical literature on the toxicity of homeopathic medicines, including apparently life-threatening events. Systematic reviews of randomized controlled trials show that homeopathic medicines cause more adverse effects than placebo, albeit mild and transient. Establishing an online monitoring terapéusystem for collection of data on the adverse effects of homeopathic, herbal or conventional medicines is relevant for non-biased assessment of the information gathered from consumers and health care providers.
Asunto(s)
Medicamento Homeopático , Síntomas en Homeopatía , Terapéutica Homeopática , BrasilRESUMEN
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.
Asunto(s)
Homeopatía , Empleos en Salud , Homeopatía/efectos adversos , Humanos , Estudios Observacionales como Asunto , Medición de RiesgoRESUMEN
BACKGROUND: This non-interventional study was performed to generate data on safety and treatment effects of a complex homeopathic drug (Contramutan N Saft). PATIENTS AND METHODS: 1050 outpatients suffering from common cold were treated with the medication for 8days. The study was conducted in 64 outpatient practices of medical doctors trained in CAM. Tolerability, compliance and the treatment effects were assessed by the physicians and by patient diaries. Adverse events were collected and assessed with specific attention to homeopathic aggravation and proving symptoms. Each adverse effect was additionally evaluated by an advisory board of experts. RESULTS: The physicians detected 60 adverse events from 46 patients (4.4%). Adverse drug reactions occurred in 14 patients (1.3%). Six patients showed proving symptoms (0.57%) and only one homeopathic aggravation (0.1%) appeared. The rate of compliance was 84% in average for all groups and the global assessment of the treatment effects attributed to "good" and "very good" in 84.9% of all patients. CONCLUSIONS: The homeopathic complex drug was shown to be safe and effective for children and adults likewise. Adverse reactions specifically related to homeopathic principles are very rare. All observed events recovered quickly and were of mild to moderate intensity.
