Do homeopathic medicines cause drug-dependent adverse effects or aggravations?

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 system 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.

O medicamento homeopático provoca efeitos adversos ou agravações medicamentos-dependentes? / Does the homeopathic medicine cause adverse effects or drug-dependent aggravations?

A apreciação crítica sobre a segurança do medicamento homeopático tem sido desenvolvida recentemente, sendo muito importante para a tomada de decisões por parte de médicos, pacientes e agências reguladoras de medicamentos. Apesar da aparente implausibilidade arguida sobre a possibilidade dos medicamentos homeopáticos serem ativos, em função dos procedimentos farmacotécnicos de diluição e agitação a que são submetidos, observa-se na literatura médica relatos de casos atribuindo efeitos tóxicos aos mesmos, até com sérios riscos à vida. Revisões sistemáticas sobre os efeitos adversos de medicamentos homeopáticos indicam que os medicamentos homeopáticos produzem mais efeitos adversos do que o placebo em estudos randomizados controlados, embora os mesmos sejam leves e transitórios. A implantação de um sistema eficiente online de monitoramento de efeitos adversos dos medicamentos – homeopáticos, convencionais ou fitoterápicos – pode ser de grande importância, facilitando a coleta de dados e a avaliação imparcial das informações geradas por consumidores ou profissionais da saúde. (AU)

Critical appraisal of the safety of homeopathic medicines developed recently. This is an important matter for decision making by doctors, patients and medicines regulatory authorities. Despite the apparent implausibility of the action of homeopathic medicines due to the pharmacotechnical processes of dilution and agitation involved in their preparation, there are reports in the conventional medical literature on the toxicity of homeopathic medicines, including apparently life-threatening events. Systematic reviews on adverse effects of homeopathy show that homeopathic medicines provoke more adverse effects than placebo in randomized controlled trials, albeit mild and transient. It would be very important to establish an online monitoring system for collection of data on the adverse effects of homeopathic, herbal or conventional medicines to attain an impartial evaluation of the information gathered from consumers or health professionals. (AU)

Do homeopathic medicines cause drug-dependent adverse effects oraggravations?

Critical appraisal of the safety of homeopathic medicines developed recently. Thismatter is relevant for decision making by doctors, patients and drug regulatoryagencies. Despite the apparent implausibility of the action of homeopathic medicinesdue to the pharmacotechnical processes of dilution and agitation used for theirpreparation, there are reports in the conventional medical literature on the toxicity ofhomeopathic medicines, including apparently life-threatening events. Systematicreviews of randomized controlled trials show that homeopathic medicines cause moreadverse effects than placebo, albeit mild and transient. Establishing an onlinemonitoring system for collection of data on the adverse effects of homeopathic, herbalor conventional medicines is relevant for non-biased assessment of the informationgathered from consumers and health care providers. (AU)

O medicamento homeopático provoca efeitos adversos ou agravações medicamentos-dependentes? / Do homeopathic medicines cause drug-dependent adverse effects or aggravations?

A apreciação crítica sobre a segurança do medicamento homeopático tem sido desenvolvida recentemente, sendo muito importante para a tomada de decisões por parte de médicos, pacientes e agências reguladoras de medicamentos. Apesar da aparente implausibilidade arguida sobre a possibilidade dos medicamentos homeopáticos serem ativos, em função dos procedimentos farmacotécnicos de diluição e agitação a que são submetidos, observa-se na literatura médica relatos de casos atribuindo efeitos tóxicos aos mesmos, até com sérios riscos à vida. Revisões sistemáticas sobre os efeitos adversos de medicamentos homeopáticos indicam que os medicamentos homeopáticos produzem mais efeitos adversos do que o placebo em estudos randomizados controlados, embora os mesmos sejam leves e transitórios. A implantação de um sistema eficiente online de monitoramento de efeitos adversos dos medicamentos – homeopáticos, convencionais ou fitoterápicos – pode ser de grande importância, facilitando a coleta de dados e a avaliação imparcial das informações geradas por consumidores ou profissionais da saúde. (AU)

Adverse effects of homeopathy, what do we know? A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: Homeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients' symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed. DESIGN AND SETTING: Sixteen electronic databases were searched for Randomized Controlled Trials (RCTs). The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055 participants were included. A subtotal of 39 studies was included in the additional meta-analysis. RESULTS: A total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86-1.14, I(2)=54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade 2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high. CONCLUSION: Adverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine.

Risk in homeopathy: Classification of adverse events and homeopathic aggravations--A cross sectional study among Norwegian homeopath patients.

UNLABELLED: The registration of adverse events is important to identify treatment that might impose risk to patients. Homeopathic aggravation, a concept unique for homeopathy may impose a particular risk, as it is tolerant towards a worsening of the patients' symptoms. The aim of this study was to explore the classification of patient reported reactions as homeopathic aggravations or adverse drug reactions. DESIGN AND SETTING: In a cross sectional survey, patients were asked to register any reactions they had experienced 14 days after taking homeopathic remedies. Worsening of symptoms was classified as homeopathic aggravation if it was (i) an increase of the patients' existing symptoms (ii) and/or a feeling of well-being that emerged 1-3 days after taking the remedy (iii) and/or headache and/or fatigue accompanying these symptoms. RESULTS: A total of 26% of the participants reported worsening of symptoms. One third was classified as adverse events. Half of these were graded as minor and the other half as moderate according to the Common Terminology Criteria for Adverse Events. Two thirds were classified as homeopathic aggravations. Of these, 73% were classified as minor and 27% as moderate, giving a tendency towards milder severity for those classified as homeopathic aggravations (p=0.065). CONCLUSION: Patients reported a substantial part of the short-term reactions after taking homeopathic remedy as a worsening of symptoms. These reactions were classified as mild and moderate. Hence, the risk connected to homeopathic treatment is minor. More studies are needed to confirm the existence of homeopathic aggravation and how to classify the concept in a clinically meaningful way.