Material Risks of Homeopathic Medicinal Products: Regulatory Frameworks, Results of Preclinical Toxicology, and Clinical Meta-Analyses and Their Implications

Abstract

Homeopathy is widely used and broadly accepted by health care professionals and the general public but less in academic circles. To assess possible material health risks of homeopathic medicinal products, it is necessary to identify, select, and synthesize the findings of recent reviews of controlled homeopathic clinical trials. Matching these findings with experimental data from toxicological studies helps to clarify what is known and not known about the material risks of homeopathic medicines. Rules for toxicological risk assessment and management need to be applied independently of individual attitudes towards specific therapeutic options. European regulatory bodies have developed special protocols and decision trees to assure the safety of nonindividualized homeopathic remedies. This narrative review leads to suggestions that could ease and improve toxicological decision making. No homeopathy-specific type or pattern of side effects could be extracted from the meta-analysis data. No differences in the frequency of adverse reactions between homeopathic treatment and placebo treatment could be seen, no matter whether adverse events were reported in a quantitative or a qualitative manner. Some patterns of side effects show that adverse reactions do not necessarily correlate with treatment but with the condition of the patient. Overall, the controlled clinical data available for the material risk assessment of homeopathic remedies support the statement that, if a risk exists, it must be so small that it has not yet been established. To make our risk findings useful for personal decisions regarding homeopathy, we provide a thought experiment based on four different health situations and ask the question: is homeopathy as a monotherapy or as an add-on treatment an option or should it be rejected?

Acute and Sub-acute Oral Toxicity Assessment of Ferrum phosphoricum in Rats

“…However, due to their increased use and high demand, homeopathic medicines have been the subject of some public and government concerns regarding their safety. 3 4 5 6 Furthermore, it has been found that homeopathic medicines are commonly prescribed without scientific evidence or knowledge of any toxicological effects they might possess. Despite the fact that homeopathic medicines are often used at extremely high dilutions, further research into their toxicity is currently required.…”

Pharmacological investigation on acute and sub-acute studies of Arsenicum album in Experimental Rats

“…mostly of developing countries relies on nonconventional medicine in their primary health care. With the growing market demand and the worldwide increase in the use of Homoeopathic medicines, health authorities -and consumers -are quite concerned with their safety (Briggs et al, 2003;Organization, 2009;Singh et al, 2014;Habs et al, 2021). Homeopathic medicines are typically administered are at high ultra dilution, are often thought to present no major safety concerns.…”

Rebuttal to: A series of homeopathic remedies-related severe DILI from South India

“…3 A recent meta-analysis found no differences in the frequency of adverse reactions between homeopathic and placebo treatments. 4 Even NHS, a source quoted by the authors in the paper, reports Homeopathy to be safe. 5 As such, in the nine cases of drug-induced hepatotoxicity, it needs to be identified if: The drugs were indeed homeopathic drugs.…”