Safety of Treatment Provided by Homeopaths Homeopathic Aggravations, Adverse Effects and Risk Assessment

Abstract

Introduction Homeopathic treatment has a long tradition. Because of its widespread use as alternative therapy in Norway and Europe, but also in nations such as India, investigation into patient safety related to homeopathic treatment is important. Risk in homeopathy can be divided into direct and indirect risk. Direct risk is directly linked to the intervention itself while indirect risk is related to the setting effects, such as e.g. the practitioner, rather than to the homeopathic remedy. Homeopathic aggravation, a concept specific for homeopathy, may impose a particular risk as it allows the health status of the patient to deteriorate before there is an improvement. In homeopathic theory, such a temporary deterioration is seen as being a part of the healing process. Aims In this research plan, adverse effect was understood as all diseases or unwanted and/or harmful reactions appearing during a study period, regardless of their relation to the actual treatment. The term encompasses all unwanted effects, without making assumptions about their mechanisms. It thus avoids ambiguity and the risk of misclassification. The aim was to explore and provide more knowledge about patient safety in homeopathy. With regard to safety, particular emphasis was placed on the concept of homeopathic aggravation. Materials and Methods A mixed method approach combining qualitative and quantitative methods was used, including four focus group interviews, a cross-sectional survey, a systematic review, and a meta-analysis. Results Initial steps were taken towards development of guidelines for the assessment of risk in homeopathy. The results suggest that both lay as well as medical homeopaths assessed the patient risk precisely according to the guidelines developed in this research project. Adverse effects as well as homeopathic aggravations were reported by patients after homeopathic treatment. According to the CTCAE criteria, these events were mild to moderate and transient. According to the systematic review and meta-analysis included in this research plan, direct risk related to the homeopathic remedy was found to be minor and moderate, apart from five cases of homeopathic aggravations that were graded as serious. The meta-analysis suggested that adverse effects were reported to a similar degree in the homeopathy compared to the placebo groups. Conclusion According to the systematic review and cross-sectional study included in this research plan, homeopathic treatment is generally associated with low to moderate direct risk related to the remedy. Indirect risk, however, is associated with homeopathic practice where the concept of homeopathic aggravations imposes a particular risk. To control for indirect risk and improve patient safety, it is important to distinguish between homeopathic aggravations and adverse effects within homeopathic theory. Criteria to distinguish these two concepts must, however, be acceptable to homeopaths and applicable in everyday practice. Furthermore, it allows comparison of safety data across studies on homeopathy. A reporting system for adverse effects in homeopathy should include criteria to distinguish these two concepts, among others, which enables homeopaths to apply this reporting system. Moreover, severity and duration of both homeopathic aggravations and adverse effects need to be classified within the same grading system. The criteria developed in the research plan presented here were tested and found relevant for safety purposes. In addition, it turned out that high medical and homeopathic skills are required to assess patient risk accordingly, which is heavily dependent on homeopathic training and education. Consequently, there is considerable potential for risk related to homeopathic practice due to the current, legal regulation of the profession.