The Ministry of Health has taken a decisive step in the debate on homeopathy by endorsing, through the Spanish Agency for Medicines and Health Products (AEMPS)A technical document states unequivocally that these preparations have not demonstrated therapeutic efficacy. The analysis maintains that the effects attributed to homeopathy do not surpass those observed with a placebo in any of the ailments studied.
This position is supported by a broad review of the available evidence and by assessments carried out by public bodies in various countries. According to the report, There is no published scientific evidence to support the notion that homeopathy is a valid therapeutic option.and its use can pose a risk when it leads to delaying or abandoning treatments that have proven their usefulness.
A comprehensive report that debunks the supposed effectiveness
The document, titled "Homeopathy and homeopathic products: Evaluation of the evidence regarding their efficacy and safety"It compiles and analyzes 64 systematic reviews published since 2009. These reviews were selected after screening biomedical databases such as Medline and EMBASE, as well as from reports by state and international agencies.
The overall conclusion is clear: The effectiveness of homeopathic products does not surpass that of a placebo in any of the pathologies studied.This includes rheumatic, dermatological, psychiatric, and other common conditions for which these remedies are often promoted. When rigorously compared to conventional treatments or inert substances, the differences disappear.
The report insists that much of the research suggesting potential benefits of homeopathy is flawed. serious methodological limitationsAmong the most frequent problems are very small sample sizes, excessively short follow-up periods, errors in patient randomization, lack of adequate blinding, or biases that are difficult to rule out.
In fact, the AEMPS highlights a pattern repeated in the literature: As the quality and rigor of clinical trials increases, the supposed effect of homeopathy diminishes until it disappears.In other words, the more demanding the study design, the fewer differences are observed compared to the placebo, which for the agency prevents these products from having a place in evidence-based medicine.
Clash with physics, pharmacology, and the concept of dose
Beyond the clinical results, the text devotes a significant portion to questioning the theoretical foundations of homeopathyRemember that this approach, formulated at the end of the 18th century by Samuel Hahnemann, is based on principles such as "like cures like" and on the use of extremely high dilutions of active substances, usually combined with a process called "dynamization".
From the perspective of current pharmacology, the AEMPS emphasizes that the Homeopathic principles of high dilutions do not fit with physical laws or with knowledge about how drugs actIn common dilutions such as 12 CH—which involves mixing one part of the original substance with one hundred parts of solvent and repeating the process twelve times—it is mathematically impossible for a single molecule of the initial substance to remain in the final preparation.
According to the report, this situation breaks any cause-and-effect relationship between the administered product and a hypothetical therapeutic effectIf no material trace of the starting substance remains, there is no plausible mechanism to explain how a direct pharmacological action could be exerted on the organism.
To make the degree of dilution understandable, the AEMPS uses a very graphic analogy: A 6 CH dilution, which is less extreme than the 12 CH dilution and common in homeopathic products, would be equivalent to dissolving a packet of sugar in the entire Mediterranean Sea.On this basis, theories such as the so-called "memory of water"—the idea that the liquid would retain properties of a substance even though there are no longer any molecules present—are described in the document as postulates without empirical support that contradict both scientific knowledge and simple logical reasoning.
Health risks: more from what is not done than from what is taken
One of the ideas that most worries the Ministry of Health is the widespread perception that these products are completely harmless because they are considered “natural” or “soft”The report qualifies this belief and points out that absolute safety cannot be guaranteed. It cites, for example, poisonings associated with dosage errors and cases of severe reactions in infants linked to homeopathic teething preparations in other countries.
The review summarizes a compilation of 38 publications with incidents related to homeopathy that affected more than a thousand patients, with allergic reactions, poisonings and several deaths documented. Among them are hospital admissions in Israel due to a product for infant colic and data from the US FDA on formulations for infant teething with concentrations of belladonna higher than those declared on the label.
However, the AEMPS insists that the main problem lies not so much in the contents of the bottles as in the decisions they may induce. The key risk is the abandonment or delay of medical treatments whose effectiveness is solidly demonstratedWhen a patient with a chronic or serious illness substitutes evidence-based therapy for a remedy without scientific basis, their prognosis can worsen significantly.
Professionals from different specialties share this concern. Primary care pediatricians emphasize that There is no published evidence to support the effectiveness of homeopathic preparations.While there is abundant data on conventional treatments for the same pathologies, hospital pharmacy professionals emphasize that pharmaceutical practice must be based on demonstrable and reproducible clinical trials.
Furthermore, some experts add that the introduction of homeopathic products into complex regimens may complicate medication regimensThis can lead to administration errors or interfere with adherence to truly necessary treatments. They also warn of potential problems arising from undeclared excipients or ingredients in unregistered products.
Regulatory status: no authorized indications in Spain
The report takes the opportunity to review the regulatory evolution of homeopathy in SpainFor years, these products were marketed under transitional provisions, without having completed the same processes required of conventional medicines. In compliance with European and national legislation, the Spanish Agency for Medicines and Health Products (AEMPS) has carried out a regularization process that has resulted in the withdrawal of numerous preparations from the market.
Today, There are no homeopathic products in Spain with an authorized therapeutic indication.The 976 products that remain registered are so through a simplified procedure designed for formulations so diluted that they are considered harmless. Precisely for this reason, the legislation does not require them to demonstrate therapeutic efficacy, but in return expressly prohibits them from including therapeutic indications on their labels or in their authorized advertising.
This regulatory framework means that, although some of these preparations will still be available in pharmacies, They cannot legally be presented as treatments for specific diseases nor can clinical benefits be claimed.The AEMPS emphasizes that authorization in this framework does not in any case imply a scientific endorsement of its usefulness, but only a control over its composition and a minimum guarantee of safety.
Experts who have closely followed this process believe that the agency's current positioning represents a a turning point in how institutions address pseudotherapiesUntil now, they point out, much of the debate had taken place in professional and academic circles, while the public pronouncements of health authorities were more limited.
Those critical of these practices appreciate that the administration has moved from an ambiguous stance to a clear message: Homeopathy has not been proven effective and should not replace evidence-based treatments.However, it is recognized that the legal status of the sale of these products in pharmacies also depends on the community framework and could require changes at the European level if further progress is desired.
A growing international consensus
The Spanish position is not an isolated exception, but rather is part of a international trend of critical review The report from the Spanish Agency for Medicines and Health Products (AEMPS) details the decisions of several agencies and committees in other countries that have reached very similar conclusions regarding the lack of efficacy and associated potential risks.
In the United Kingdom, the House of Commons Science and Technology Committee recommended withdraw public funding for homeopathy and require that the labeling warn of the lack of reliable evidence regarding their effectiveness. This approach has led the British National Health Service to progressively reduce the use of these products in clinical practice.
Australia, through the National Health and Medical Research Council, concluded that There is no clinical condition for which there is robust evidence that homeopathy worksand advises against their use for treating chronic or serious illnesses. France, for its part, eliminated public reimbursement for these remedies in 2021 following an evaluation by its health authority.
In Germany, the following is expected: definitive elimination of homeopathy coverage by legal medical insuranceThis will mean their removal from the list of covered benefits. And in the United States, the FDA considers these preparations to be "new unapproved drugs," prioritizing the monitoring of those that may pose a greater risk, while the Federal Trade Commission requires clear labeling when there is no scientific evidence to support advertising claims.
Given this scenario, Spain aligns itself with the countries that have opted for align its health policy with the scientific consensuslimiting the space of homeopathy in clinical practice and reinforcing the role of evidence-based medicine as the axis of decision-making.
The position of the Ministry of Health and the message to the public
The presentation of the report by the Ministry of Health has served to highlight the practical implications of these conclusions. The Minister and other officials from the department have emphasized that, beyond the theoretical discussion, what is at stake is the protection of public health and quality of care that patients receive.
In this context, the message they convey is clear: Homeopathy has not been shown to work better than a placebo.The real problem arises when its use means abandoning interventions that have proven beneficial. Messages like "it's not what you take, but what you stop taking" aim to summarize this idea in language understandable to the general public.
The health authorities argue that citizens have the right to have access to transparent, clear and data-driven information about the different treatment options. The goal is for anyone to be able to evaluate the alternatives critically, without confusing marketing authorization with a guarantee of effectiveness, and without being swayed solely by marketing campaigns or the false sense of security that these products sometimes offer.
At the same time, the Ministry places this report within a broader strategy to combat so-called pseudotherapies and practices without scientific backing, such as naturopathy, with resources that explain What does it mean to be a naturopath?In recent years, technical analyses of various interventions of dubious effectiveness have been published in order to provide clear references to both professionals and patients and to avoid fraud or unfounded expectations.
The AEMPS emphasizes that modern medicine must be based on well-designed, reproducible, and independently evaluated studiesThe lack of consistent results in the case of homeopathy, coupled with the lack of a mechanism of action compatible with current knowledge, leads to a verdict consistent with that reached by other international agencies.
Thus, the message coming from health authorities can be summarized simply: homeopathy, as it is used today, It cannot be considered an effective or safe therapeutic alternative from the point of view of scientific evidence.and its use should not justify delaying or abandoning medical treatments that have been shown to improve people's health and quality of life.