The Ministry of Health has published, through the Spanish Agency of Medicines and Medical Devices (AEMPS), a technical report which has concluded “categorically” that there is no scientific evidence to support the efficacy of homeopathy in any pathology, since that of these products does not exceed that of placebo in any of the diseases analyzed.
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Specifically, the document Homeopathy and homeopathic products: Evaluation of the evidence regarding their efficacy and safety includes the examination of 64 compilations of scientific literature published since 2009.
Effects comparable to placebo
Following a systematic review of scientific literature and evaluations by international state bodies, the report indicates that the observed effects are comparable to placebo.
The Aemps report, which analyzed 64 systematic reviews published since 2009, highlights that most studies suggesting benefits of homeopathy showed low methodological quality, as they are often invalidated by small samples, short follow-up periods, or randomization biases.
Furthermore, the study clarifies, “as the quality and rigor of clinical trials increase, the supposed effect of homeopathy diminishes until it disappears. From a scientific point of view, the principles of homeopathy clash with the laws of current physics and pharmacology.”
In fact, the report states that in common dilutions such as 12 CH, which is when one part of the original substance is mixed with one hundred parts of solvent twelve consecutive times, “it is mathematically impossible for a single molecule of the original ingredient to remain in the preparation, which breaks any cause-and-effect relationship between the product and the therapeutic effect.”
Therapeutic indication
In compliance with European and national regulations, Aemps completed a regularization process that resulted in numerous products being withdrawn from the market. As of the publication date of this report, there is no homeopathic product with an authorized therapeutic indication in Spain.
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The 976 that remain registered did so through a simplified procedure which, being based on extreme dilutions that guarantee the harmlessness of the preparation, does not require proof of therapeutic effect and prohibits them by law from including any therapeutic indication on their labeling.
Regarding other countries, in the United Kingdom, the Science and Technology Committee recommended stopping public funding and warning on labeling about the lack of efficacy; and in Australia, the National Health and Medical Research Council concluded that homeopathy should not be used to treat chronic or serious diseases.
In France, the Haute Autorité de Santé eliminated public reimbursement for these products in 2021 due to lack of demonstrated efficacy; in Germany, the definitive suppression of homeopathy coverage by statutory health insurance is expected to be approved in 2026; and in the United States, the Food and Drug Administration (FDA) considers these products as “new unapproved drugs” and the Federal Trade Commission requires a warning that there is no scientific evidence of their effectiveness.
Serious adverse reactions
Likewise, Aemps warned that, although there is a popular belief that these preparations are harmless because they are “natural,” serious adverse reactions have been reported, including intoxications due to incorrect dosage and cases of infant deaths linked to teething products in other countries.
Similarly, Aemps warned that the main associated risk is the abandonment or delay of medical treatments with demonstrated efficacy. “Citizens who opt for homeopathy to treat serious or chronic ailments can endanger their health by replacing evidence-based therapies with products that lack it,” Aemps stated.
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