Trine Stub1, Agnete E Kristoffersen2, Terje Alræk2, Frauke Musial2, Aslak Steinsbekk3. 1. The National Research Center in Complementary and Alternative Medicine (NAFKAM) Department of Community Medicine, Faculty of Health Science, UiT The Arctic University of Norway, 9037 Tromsø, Norway. Electronic address: trine.stub@uit.no. 2. The National Research Center in Complementary and Alternative Medicine (NAFKAM) Department of Community Medicine, Faculty of Health Science, UiT The Arctic University of Norway, 9037 Tromsø, Norway. 3. Norwegian University of Science and Technology, Department of Public Health and General Practice, Trondheim, Norway.
Abstract
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.
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.
Authors: Agnete Egilsdatter Kristoffersen; Miek C Jong; Johanna Hök Nordberg; Esther T van der Werf; Trine Stub Journal: BMC Complement Med Ther Date: 2022-09-03
Authors: Heidemarie Haller; Felix J Saha; Barbara Ebner; Anna Kowoll; Dennis Anheyer; Gustav Dobos; Bettina Berger; Kyung-Eun Choi Journal: BMC Complement Altern Med Date: 2018-11-27 Impact factor: 3.659