Kerala

Study finds homoeopathy causes severe liver injury, doctors condemn public funding

The study, based on a retrospective review of the records of 456 patients, found nine patients to have liver injury attributed solely to homoeopathic formulations.

Written by : Azeefa Fathima
Edited by : Maria Teresa Raju

Homoeopathic remedies, commonly considered an “ineffective placebo” by the scientific medicine community, are not without harm, a recent study has found. The study stated that homoeopathic remedies could promote severe liver injury. Titled “A series of homoeopathic remedies-related severe drug-induced liver injury from South India,” the research was was published in the peer-reviewed journal Hepatology Communications. It was undertaken by a team of doctors and researchers from Rajagiri Hospital in Aluva, Kerala. The research was based on a retrospective review of records of 456 patients, who were under treatment for liver-related ailments between January 2019 and February 2022. Nine patients were identified with liver injury attributed solely to homoeopathic formulations, while 447 patients were excluded from the study as they had liver diseases due to other causes. TNM spoke to experts on the methodology and outcomes of the research, and the dangers of consuming homoeopathic remedies.

Dr Libin Abraham, an immunologist who works in Canada, said, “Homoeopathy is pseudoscience, its fundamental principles are flawed. It has been removed from public health insurance in Germany (the birthplace of homoeopathy), Australia, Canada, and many other countries, as it is a waste of taxpayers’ money.” He explained to TNM the principles based on which homoeopathy is practised.

How is homoeopathy practised?

“In homoeopathy, a concentrated extract of a substance, called mother tincture, is serially diluted by mixing it in a solution of water and alcohol. Homoeopaths call the process potentization— as they vigorously shake the mixture in between each dilution step. Most homoeopathic preparations are ultra-diluted below Avogadro’s limit.  Avogadro’s limit refers to the concentration below which a solution becomes so dilute it is unlikely that any of the original molecules in the mother tincture are present. Even aphorism 11 in the Organon of Medicine says that no corporal atoms of substance are present. So how does something work without even an atom?” Dr Libin said. Organon of Medicine is the book that contains the principles of homoeopathy, written by the father of homoeopathy, Samuel Hahnemann. “Hahnemann believed that diseases were caused by de-arrangement of a ‘vital force’ in the body. There was no concept of virus or bacteria back then, and disease symptoms meant that the vital force in the body is somehow de-arranged. Hahneman thought that the medicines have a ‘medicinal energy’ within them that will interact with and put the vital force back in order, thus curing the patient. Today we know about the root cause of many diseases, at a molecular level, while homoeopaths are still stuck with flawed concepts and practise,” Dr Libin explained.
 
Dr Libin further elaborated that since homoeopathic preparations are so diluted, most people have a wrong notion that it is truly harmless and has no side effects. “But there is a catch,” Dr Libin clarifies, “Many homoeopaths give mother tinctures and improperly diluted remedies, instead of ultra-diluted preparations. Some use a cocktail of extracts that contain numerous agents in high concentrations. All these can potentially cause organ damage and harm, especially when there are poor manufacturing practices and when mother tinctures are inherently toxic in nature”. This might seem like unproblematic placebo, as many doctors call it. But the study conducted by the team at Rajagiri has debunked the myth that homoeopathy is a ‘gentle placebo’, and found that it causes severe health issues, including liver injury.

Key research findings

> All patients in the study developed jaundice.

> COVID-19 prevention was the most common reason for homoeopathic use in the patients studied.

> Probable Drug Induced Liver Injury (DILI) was seen in 77.8% of the patients studied. 

> Liver histopathology of six patients (study of cells through biopsy) showed liver necrosis (death of tissues).

> Homoeopathic remedies potentially result in severe liver injury, leading to death in those with underlying liver disease.

> Homoeopathic remedies can potentially cause acute hepatitis and acute chronic liver failure. 

> The toxicity in homoeopathic remedies are caused by a combination of factors, including mother tinctures, insufficient dilution, poor manufacturing practices, adulteration, contamination, and the presence of direct hepatotoxic herbals and alcohol.

> In the 15 homoeopathic remedies that were analysed, 156 unique compounds were identified. This includes heavy metals, industrial solvents, alcohols (including ethanol and traces of methanol), steroids, sedatives, and antibiotics.


Research Team (Special Arrangement)

Other studies on adverse side effects of homoeopathy

Hepatologist Dr Abby Philips, who was part of the research, said, “This is the first study to describe homoeopathic formulations-induced liver injury in a cohort of patients with and without underlying liver disease, and analyse chemical and toxicological properties of homoeopathic remedies retrieved from affected patients.” Dr Abby is known for his research related to alternative medicines and his efforts debunking claims made in the field.

Read: Doctor flags popular herb for causing liver injury, gets notice from Kerala AYUSH council

However, this is not the first study to find that homoeopathic remedies cause adverse side effects. Health bodies like the World Health Organisation (WHO), National Health and Medical Research Council (NHMRC) of Australia, and the National Health Service (NHS) of England have flagged potential health and safety concerns in the manufacturing of homoeopathic remedies.

NHMRC, Australia’s apex body supporting health and medical research, said in 2015, “There are no health conditions for which there is reliable evidence that homoeopathy is effective. Homoeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. People who choose homoeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.” NHS England, recommended in 2017 that homoeopathic remedies not be widely provided and the public funding for the same be stopped as "no clear or robust evidence to support the use of homoeopathy on the NHS" was found. A study done in the United Kingdom by Posadzski, Alotaibi, and Ernst showed severe homoeopathy-related side effects, some leading to fatality. It also listed adverse events such as acute pancreatitis, severe allergic reactions, neurocognitive disorders, sudden cardiac arrest and coma, kidney injury, and thallium poisoning.

Dr Abby said that while adverse events have been reported from homoeopathy medicines previously, their study is the first one where liver-related adverse events have been reported in a series of patients. “We conducted liver biopsies on patients who consented, and described what homoeopathy-related liver injury would look like under the microscope. However, we can only say ‘probable or possible’ homoeopathy-related liver injury and not definite homoeopathy-related liver injury. This is because the latter requires us to follow a separate process that is not ethical as we will have to put healthy persons through the process and see if their liver gets injured,” he said.

“We found patients who have never had alcohol present with alcoholic liver injury. This injury was caused by the alcohol from homoeopathic medicines. Some of the liver biopsies showed various types of liver injuries, like alcohol liver injury, features of allergic reaction in the liver,  features of immune-mediated liver injury, and a mix of other things. This is because multiple homoeopathic products with multiple ingredients were given to these patients,” Dr Abby explained.

'Homoeopathy not a remedy, but poison'

It was a confluence of factors that caused the multiple injuries reported in the patients studied, Dr Libin said. “The vehicle that carries homoeopathic medicines is 90% alcohol. Consuming such a high concentration of alcohol everyday is nothing but micro-dosing of alcohol. While alcohol is one major issue here, the improper manufacturing and adulteration add layers of complications,” he added. Dr Abby agreed with this, adding that patients consume homoeopathic preparations diluted in pure alcohol in large quantities. “They consume five or six bottles of mother tinctures a month. In persons with underlying cirrhosis or fatty liver or liver disease, this causes further damage to the liver. They have the highest risk of dying. We keep saying that homoeopathy is a general placebo, but it is actually reckless fraud,” he said, stressing that not only is homoeopathy not a remedy, but it is poison.

Dr Libin also explained that another issue in homoeopathy is the mixing of multiple remedies together. “Hannheman had said that multiple remedies should not be mixed. However, what is consumed now is a mixture of multiple remedies. In addition to high levels of alcohol, we have a mix of mother tinctures, antibiotics, and steroids. It just adds layers of complications that can cause injury to the organs. It is like being fired at with a machine gun,” he explained. Homoeopathy is bogus either way, he added. “The classical homoeopathic remedy is just sugar pills without a molecule of the original substance. Now, we are cheated with adulteration, and injured on top of being cheated,” he adds.

Dr Arif Hussain Theruvath, an ex-homoeopath who was part of the research, stated, “We would be against homoeopathy even if it was only about creating a placebo effect. But our findings show it is much more dangerous. Poor manufacturing standards, no real medicine, and adulterations pose multiple threats. It is not a gentle, but a dangerous placebo, and we are concerned that it is public-funded in India.”

'Pandemic an eye-opener'

It was during the first wave of the COVID-19 pandemic that the name of a particular homoeopathic remedy became popular—Arsenicum Album 30C. There was mass distribution of Arsenic Album 30 after it was touted as a prophylactic medicine against possible COVID-19 infection by the Ministry of Ayush. This is no different from cigarette smoke, which is injurious to health, according to Dr Libin.

“Arsenicum Album 30C is ultra-diluted arsenic trioxide, which is an extremely toxic poison that was once used to kill rats. If properly prepared, not a single atom of arsenic will exist. But if the dilutions are improper and manufacturing practices are bad, then we have a huge health risk and even death.  But the problem with arsenic is that it has idiosyncratic toxicity,” Dr Libin elaborated. “Idiosyncratic toxicity refers to toxicity at any dose or frequency and hence a safe recommended dose cannot be determined for a large population. For example, one can’t say that it’s safe to have two cigarettes per day but the third one can become injurious. Likewise, there is no safe limit for arsenic due to its idiosyncratic toxicity. It is important to note that cigarettes also contain arsenic,” he added.
 
Dr Libin explained that Arsenicum Album was chosen as the prophylactic for Covid-19 based on the symptoms in those affected by the virus, with no data from clinical trials, and by the principle of Genus Epidemicus. The latter is a term used in homoeopathic remedies to refer to the most effective remedy in a particular epidemic. “The logic is that patients exhibit symptoms because their vital force is de-arranged. Administering this to everybody in an epidemic, ensures that the vital force is held in position for everyone, hence preventing the disease,” he said, adding that after the WHO declared that there was no medicine or prophylaxis for SARS-Cov-2, it was rebranded as an ‘immunity booster’, a concept which research has called fundamentally incorrect.

'No regulation'

Dr Arif pointed to the lack of checks on homoeopathy practise in India by explaining the usual procedure through which a system of medicine is accredited. “The primary point is the effectiveness. It is checked in stages, the first being testimonials of those who have been cured by consuming a remedy. However, we don’t call it a medicine just based on testimonials. We follow it up with retrospective study, based on previous records, and then prospective study, which includes randomised control trials. Then comes meta analysis—analysing other researches. After such extensive and laborious testing, a product is accredited as medicine and clinical guidelines are framed. That is how it becomes an evidence-based medicine,” Dr Arif said. He added that a product that goes through these stages is a ‘medicine’ and not an ‘alternative medicine’.

The problem lies in the fact that homoeopathy doesn't have to go through the rigorous trials that allopathy goes through in India, Dr Libin stated. Echoing the same, Dr Abby said that the government is actively promoting homoeopathy, even though it is not an evidence-based medicine and has been defunded in many other countries. “It is just a whole lot of money wasted to just make placebos and alcohol,” he said.

'What the government and patients must do'

“While an individual has the choice to determine what treatment to take, it should be an informed decision. There should be awareness and people should be educated about the medical system,” Dr Abby said. He stressed that there should be proper regulation on and research into the system. “The government should ensure that products that reach consumers are actually safe. If they have any adverse events associated with them, which have been documented and published, the government should notify and caution the public. Also, the government should monitor if good manufacturing practice (GMP) is followed by the manufacturing units,” he said.

“If a person is detected with homoeopathy-related injuries, the first thing to do is to stop consuming the product, stop insulting the liver further, and give the liver a chance to recover. The liver is an organ that has excellent regenerative properties. Humans can live with just 1/6th of the liver functioning. So, allow the liver to detoxify and regenerate. It also depends upon the health of a person, so consult a proper medical doctor,” said Dr Libin.

Homoeopath reacts

Reacting to the study, Dr Mansoor Ali KR, professor at the Government Homoeopathy Medical College in Thiruvananthapuram, said that the title of the study was highly misleading. “If we read the study, we can see that homoeopathy has caused the least side-effects. Only nine patients, which constitutes 2%, out of the total 456 patients, presented with homoeopathy-related liver injuries. The remaining 98% were associated with other causes,” he pointed out. He said that of the 243 DILI cases reported in the study, 129 (54%) were due to traditional and herbal drugs, 53 (22%) due to allopathic drugs, and only nine (4%) due to homoeopathic remedies. He cited the numbers to say that the title was misleading as a large number of cases reported liver injuries due to other medicines. He also added that the manufacturers should follow the rules and regulations, as well as good manufacturing practices.

When asked about the micro-dosing of alcohol in homoeopathy, he said that the alcohol used in the remedies are not regular alcohol, but extra neutral alcohol used for medicinal preparation that will not cause side effects.

“This is a flawed understanding of the study. We are very clear and truthful to the conclusions. We do not deny it, and it is a proven fact that modern medicines cause liver injuries. It is one of the commonest causes, and it is disclosed. Before prescribing modern medicines, we know their benefits which far outweigh the risks. For example, anti-tuberculosis drugs can cause liver injury commonly but have saved millions of lives worldwide. On the other hand, homeopathy has no benefits, is never recommended as therapy by any clinical societies for any disease in humans, and causes side effects, an avoidable health and financial burden. Even the 2% mentioned by him is a huge number given that homoeopathy is an ineffective and erroneously considered to be a safe option,” Dr. Abby responds and adds that the study was done focusing on nine patients with homoeopathy-related liver injuries, from which conclusions were derived.

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