Homeopathic remedies are highly diluted formulations without proven clinical benefits, traditionally believed not to cause adverse events. Nonetheless, published literature reveals severe local and non-liver-related systemic side effects. This paper presents the first series on homeopathy-related severe drug-induced liver injury (DILI) from a single center.
A retrospective review of records from January 2019 to February 2022 identified 9 patients with liver injury attributed to homeopathic formulations. Competing causes were comprehensively excluded. Chemical analysis was performed on retrieved formulations using triple quadrupole gas chromatography-mass spectrometry and inductively coupled plasma atomic emission spectroscopy.
Males predominated with a median age of 54 years. The most typical clinical presentation was acute hepatitis, followed by acute on chronic liver failure. All patients developed jaundice, and ascites were notable in one-third of the patients. Five patients had underlying chronic liver disease. COVID-19 prevention was the most common indication for homeopathic use. Probable DILI was seen in 77.8%, and hepatocellular injury predominated (66.7%). Four (44.4%) patients died (3 with chronic liver disease) at a median follow-up of 194 days. Liver histopathology showed necrosis, portal and lobular neutrophilic inflammation, and eosinophilic infiltration with cholestasis. A total of 29 remedies were consumed between 9 patients, and 15 formulations were analyzed. Toxicology revealed industrial solvents, corticosteroids, antibiotics, sedatives, synthetic opioids, heavy metals, and toxic phyto-compounds, even in ‘supposed’ ultra-dilute formulations.
The authors concluded that homeopathic remedies potentially result in severe liver injury, leading to death in those with underlying liver disease. The use of mother tinctures, insufficient dilution, poor manufacturing practices, adulteration and contamination, and the presence of direct hepatotoxic herbals were the reasons for toxicity. Physicians, the public, and patients must realize that Homeopathic drugs are not ‘gentle placebos.’
Over a decade ago, we published a systematic review entitled “Adverse effects of homeopathy: a systematic review of published case reports and case series”:
Aim: The aim of this systematic review was to critically evaluate the evidence regarding the adverse effects (AEs) of homeopathy.
Method: Five electronic databases were searched to identify all relevant case reports and case series.
Results: In total, 38 primary reports met our inclusion criteria. Of those, 30 pertained to direct AEs of homeopathic remedies; and eight were related to AEs caused by the substitution of conventional medicine with homeopathy. The total number of patients who experienced AEs of homeopathy amounted to 1159. Overall, AEs ranged from mild-to-severe and included four fatalities. The most common AEs were allergic reactions and intoxications. Rhus toxidendron was the most frequently implicated homeopathic remedy.
Conclusion: Homeopathy has the potential to harm patients and consumers in both direct and indirect ways. Clinicians should be aware of its risks and advise their patients accordingly.
It caused an outcry from fans of homeopathy who claimed that one cannot insist that homeopathic remedies are ineffective because they contain no active ingredient, while also arguing that they cause severe adverse effects. In a way, they were correct: homeopathic remedies are useless even at causing adverse effects. But this applies only to remedies that are manufactured correctly and that are highly dilute. The trouble is that quality control in homeopathy often seems to be less than adequate. And this is how adverse effects can happen!
The new article from India is an important addition to the literature providing more valuable information about the risks of homeopathy. Its authors were able to do chemical analyses of some of the remedies and could thus show what the reasons for the liver injuries were. The article provides an essential caution for those who delude themselves by assuming that homeopathy is harmless. In fact, the remedies can cause severe problems. But, as we have discussed regularly on this blog, the far greater risk in homeopathy is not the remedy but the homeopath and his/her all too often incompetent advice to patients.