Overview:
Despite the order from the Ministry of AYUSH to prevent the public advertisement of AYUSH-related claims for COVID-19, many Indian states, particularly larger cities such as Pune, Vadodara, Mumbai have been found distributing homeopathy drugs such as Arsenicum album 30 by both public and private means. The distribution of Arsenicum Album 30 was done according to the previous AYUSH guidelines on COVID-19. In addition, state authorities in Kerala, Andhra Pradesh, Rajasthan, and even Mumbai BMC has suggested the use of homeopathy prophylactically to increase immunity.
Further, due to the lack of effective treatment and the growing number of COVID positive cases even during the lockdown period, Prime Minister Modi had emphasised to follow the AYUSH guidelines with homeopathy and Ayurveda for protection against COVID-19. These AYUSH guidelines released in January 2020 can be found on the PIB website (link to the release here). After facing criticism in India and internationally, the ministry of AYUSH released Annexure I & Annexure II, that quoted an Italian research review (Bellavite et al. 2015) to stand behind the statements made earlier and to give proof of a mechanistic understanding of Arsenicum Album 30 in ‘boosting immunity’ against COVID-19.
As a result, many now believe that homeopathic pills called Arsenicum album 30 increase the body’s natural defence mechanism. Since none of the homeopathic drugs has been scientifically demonstrated to produce proven action on cells and its receptors, the Central Council of Homeopathy (CCRH) uses “a wide-range mechanism of action review article” (Bellavite et al. 2015) to prove that the homeopathy drugs indeed work in the claimed manner. This paper regularly quoted by CCRH claims to ‘review’ the hypotheses about homeopathic drug action at the cellular and molecular levels.
We sci-checked this review paper’s relevant arguments about the drug Arsenicum album 30 that claims its ‘mechanism of action’.
Claim:
Homoeopathy drugs protect from the coronavirus by increasing the body’s innate immunity.
Verdict:
False
Fact-check:
Our body’s immune system is of two types:
1. Inherent or innate immunity
This is our body’s own natural response to an external pathogen invasion. It is the kind of immunity which we are born with and does not deteriorate unless our body is subjected to immune altering drugs, diseases or process, a few examples of these could be – an HIV infection, a corticosteroid drug administration for immunosuppression or chronic insomnia.
2. Adaptive immunity
This is the immunity that can be altered using natural or artificial factors. It could be acquired in a child through the mother during pregnancy, or via a later infection such as chickenpox; or, it could be through artificial means such as vaccination, and in some cases, antibody transfer from an immune positive individual to a non-infected person.
How does homeopathy claim to interact with the immunity using Arsenicum album 30?
Homeopathy has allegedly considered a method to activate or ‘boost’ the inherent or innate immunity of the person by consuming Arsenicum album 30 pills, which may incur the strength to our bodies to fight against external pathogens such as the coronavirus.
These claims of homeopathy treatment were made on the basis of studies conducted in the human population that claimed to show a change in the expression of proteins such as inflammatory mediators and cytokines. The proteins are released in the body, and largely measured in the blood. The quantity of these proteins in the blood shows the extent of an existing infection or inflammation. Their release also shows a functional immune system and a reduced release during an active infection could show some immune-suppression because of disease or external drugs.
The research quoted by CCRH on Arsenicum album 30
Below, we will review all the studies quoted in Bellavite et al. 2015 that suggest that Arsenicum album 30 helps to ‘boost’ our immune system by causing a change in the release of immune-proteins.
1. Claim of the Arsenicum album 30 as a protective compound for cellular damage against arsenic and UV induced toxicity via controlling genetic modulation.
Studies De et al. 2012, Das et al. 2012 & Das et al. 2011 were referenced to suggest that Arsenicum album 30 may reduce the toxicity of Arsenite in two bacterias E. coli and S. Cerevisae. Since these three referenced research studies were conducted on bacteria, and not conducted in infected humans or even in lab animals, they cannot be used as a proof of mechanism of action.
Further, a study (Marotti et al. 2014) conducted in wheat seedlings was used as proof of protection against genetic modulation by using Arsenicum. Firstly, they extracted RNA and conducted gene expression analysis from seeds of wheat. Gene expression is a method by which the information in the genes is used to instruct protein manufacturing in the body. Despite the results in this study, it cannot be applied to animal cells, or even live animals and humans. Secondly, a change in expression of the gene, i.e. the change in instructions for protein design, does not determine protective or toxic effects of a compound. Genes can be expressed in both scenarios, i.e. for the manufacturing proteins causing detriment, or, manufacturing proteins for the benefit of a living system.
Thus, the research does not have sufficient data to prove that Arsenicum album 30 can modulate genetic expression to provide protection from cellular damage.
2. Claim of change in expression of specific immune-related proteins in such a way that “important genes (turn) on or off, initiating a cascade of gene actions to correct the gene expression that has gone wrong and produced the disorder or disease”- Bellavite et al. 2015
This claim means that, allegedly, a homeopathy drug will change the expression of immunity-related genes in our DNA, i.e. change the information that codes the protein design. It is claimed that the change due to the drug will be in such a way that the new protein manufactured (linked to immunity) will eventually ‘correct’ the initial gene expression. This initial gene expression, which will be corrected by this protein, is also allegedly the process which has caused the disease.
This means that all diseases are caused by their corresponding gene expression and its protein manufacturing, and all cures can be initiated by changing the expression of immunity-related genes. This is a highly canonical argument as many diseases or disorders are unrelated to the genetic factors – environmental and other pathophysiologies play a huge role in treating diseases. This is the most widely quoted and accepted claim of homeopathy.
Also, the discovery of homeopathy by Hanemann was in 1796 and did not come out in print until 1807. However, the first experiment in inheritable units, now we call them genes, was not conducted by Gregor Mendel until 1857-1864, nearly 50 years after the discovery of homeopathy. The founder of homeopathy had died in 1843. So, the mechanism with which homeopathy works in the above research paper does not match on a timeline. Perhaps, Hanemann did not understand the modern mechanisms proposed for homeopathy, which have not been proven till date by homeopaths.
The paper elaborated that (Bellavite et al. 2015), “Mother tinctures and highly diluted drugs were tested in human tumour cell lines or cells challenged with carcinogens; they affected the modulation of the expression of specific mRNA markers (NF-κB, Akt, p53, Bax, Blc-2, caspase 3, Cyt-c) and increased tumour cell death (Sunila et al. 2009, Hofbauer et al. 2010, Sikdar et al. 2014 & Mukherjee et al. 2013).”
Protein markers such as NF-κB can be important in the regulation of innate or the body’s own immunity. However, referenced studies quoted to make such claims do not reflect the strength required to assert such a claim since the studies are not specific to Arsenicum album 30, and most of them in fact do not even refer to the said drug. For example, Sunila et al. 2009 does not have any mention of Arsenicum album 30 and the research was conducted in cultivated cell lines in the lab. Hofbauer et al. 2010 also did not mention arsenicum, while the effect was studied in bacteria.
Further, the research in Sikdar et al. 2014 was conducted in cell lines as well as laboratory rats with lung cancer models, but did not mention homeopathic formulations or Arsenicum or infectious diseases. Finally, the study Mukherjee et al. 2013 mentions the use of another homeopathic drug called ‘Thuja’ in cancer cell lines acquired from the lungs of mice, while no mention of Arsenicum occurs.
Thus, one of the most cited papers in homeopathy, specifically by the CCRH to prove that there is a mechanism of action with Arsenicum drugs, even though the testing hasn’t been conducted in COVID-19 patients, has no mention of Arsenicum album 30 in any of the quoted studies and have not been conducted in humans or in lab animals with infectious diseases.
3. Claim of highly toxic substances used in low doses as therapeutic formulations in homeopathy
In the final claim, studies Betti et al. 1997, Bode & Dong 2002 & Khuda-Bukhsh et al. 2011, were referenced in the article (Bellavite et al. 2015). Amongst the three referenced studies, Bode & Dong 2002 discussed undiluted arsenic which can either cause cancer as well as be therapeutic in cancer, the study Betti et al. 1997 was again a study of toxicity in wheat seedlings. And the final study Khuda-Bukhsh et al. 2011, was the only one conducted in humans, but it was to determine the impact of Arsenicum album 30 on arsenic toxicity.
Thus, no study in the review paper given in the ‘Annexure’ by AYUSH proves that low doses of arsenic or any other drug can be therapeutic. Further, it is evident from years of pharmacological research that the right amount of dose is imperative for the drug to have an effect.
Conclusion:
None of the studies mentioned in the Bellavite et al. 2015 review article proves that Arsenicum album 30 will boost immunity in humans or in animals to protect against infectious diseases. In fact, the claims of cell protection, genetic modulation or the high potency of low doses, has not been conducted systematically in any infectious disease models. Thus, homeopathy as an immune booster against COVID-19 remains heavily marketed and the most dangerous pseudoscience that the AYUSH ministry has produced during this pandemic.
Our previous sci-check at Alt News Science reviewing and questioning the scientific literature on the mechanisms of homeopathy drugs can be found on this link. Further, we have also found that the claimed Arsenicum album 30 has never been tested in human infections in clinical trials (link here) to yield the results that the CCRH claims.
The CCRH scientific advisory board had also confirmed that the medicine advised for recent coronavirus crisis (Arsenicum album 30) had been advised previously for the prevention of Influenza-like Illness (Mathie et al. 2009, Chakraborty et al. 2013, Varanasi, Gupta, et al. 2019). Thus, the drug has neither been specifically developed for the current or previous coronavirus epidemics nor has been tested systematically for efficacy against any coronavirus infections.
Besides the government and media’s dispersal of unchecked science on homeopathy, corporators have been buying the drug at a mass scale to protect themselves, their families and their communities to form ‘herd immunity’ via the administration of Arsenicum album 30. A corporate giant Rajiv Bajaj, Bajaj Auto suggested that Homeopathy and herd immunity, not lockdown, are the best strategy to fight the coronavirus pandemic.
Although it may be possible to increase immunity via lifestyle changes, vitamin D, sleeping efficiently, etc. so far, no drugs have shown the evidence to ‘boost the immunity’ to protect against the COVID-19 pandemic. The most reliable method to protect against the infection is suggested hygiene, physical distancing from humans and fomites as well as using protective gear when required.
Consumption of such untested drugs on such a large scale gives false protection and increases the spread of coronavirus, especially when the country has not been able to control the spread despite the enforcement of physical distancing.
References:
- Mathie, R. T., Baitson, E. S., Frye, J., Nayak, C., Manchanda, R. K., & Fisher, P. (2013). Homeopathic treatment of patients with influenza-like illness during the 2009 A/H1N1 influenza pandemic in India. Homeopathy, 102(03), 187-192.
- Chakraborty, P. S., Lamba, C. D., Nayak, D., John, M. D., Sarkar, D. B., Poddar, A., … & Prusty, A. K. (2013). Effect of individualized homoeopathic treatment in influenza like illness: A multicenter, single blind, randomized, placebo controlled study.
- Varanasi, R., Gupta, J., Raju, K., Prasad, R. V., Sadanandan, G., Arya, J. S., … & Pramanik, A. (2019). Management of early years of simple and mucopurulent chronic bronchitis with pre-defined Homoeopathic medicines–a Prospective Observational Study with 2-Years Follow-Up. International Journal of High Dilution Research-ISSN 1982-6206, 18(3-4), 47-62.
- Bellavite, P., Signorini, A., Marzotto, M., Moratti, E., Bonafini, C., & Olioso, D. (2015). Cell sensitivity, non-linearity and inverse effects. Homeopathy, 104(02), 139-160.
- De A., Das D., Dutta S., Chakraborty D., Boujedaini N., Khuda-Bukhsh A.R. Potentiated homeopathic drug Arsenicum Album 30C inhibits intracellular reactive oxygen species generation and up-regulates expression of arsenic resistance gene in arsenite-exposed bacteria Escherichia coli . Zhong Xi Yi Jie He Xue Bao 2012; 10: 210-227.
- Das S., Saha S.K., De A., Das D., Khuda-Bukhsh A.R. Potential of the homeopathic remedy, Arnica Montana 30C, to reduce DNA damage in Escherichia coli exposed to ultraviolet irradiation through up-regulation of nucleotide excision repair genes. Zhong Xi Yi Jie He Xue Bao 2012; 10: 337-346.
- Das D., De A., Dutta S., Biswas R., Boujedaini N., Khuda-Bukhsh A.R. Potentized homeopathic drug Arsenicum Album 30C positively modulates protein biomarkers and gene expressions in Saccharomyces cerevisae exposed to arsenate. Zhong Xi Yi Jie He Xue Bao 2011; 9: 752-760.
- Marotti I., Betti L., Bregola V., Bosi S., Trebbi G., Borghini G. et al. Transcriptome profiling of wheat seedling following treatment with ultrahigh diluted arsenic trioxide. Evid Based Complement Altern Med 2014; 2014: 851263.
- Betti L., Brizzi M., Nani D., Peruzzi M. Effect of high dilutions of Arsenicum album on wheat seedlings from seed poisoned with the same substance. Br Hom J 1997; 86: 86-89.
- Khuda-Bukhsh A.R., Banerjee A., Biswas S.J., Karmakar S.R., Banerjee P., Pathak S. et al. An initial report on the efficacy of a millesimal potency Arsenicum Album LM 0/3 in ameliorating arsenic toxicity in humans living in a high-risk arsenic village. Zhong Xi Yi Jie He Xue Bao 2011; 9: 596-604.
- Bode A.M., Dong Z. The paradox of arsenic: molecular mechanisms of cell transformation and chemotherapeutic effects. Crit Rev Oncol Hematol 2002; 42: 5-24.
- Sunila E.S., Kuttan R., Preethi K.C., Kuttan G. Dynamized preparations in cell culture. Evid Based Complement Altern Med 2009; 6: 257-263.
- Hofbauer R., Pasching E., Moser D., Frass M. Heparin-binding epidermal growth factor expression in KATO-III cells after Helicobacter pylori stimulation under the influence of strychnos Nux vomica and Calendula officinalis . Homeopathy 2010; 99: 177-182.
- Sikdar S., Mukherjee A., Ghosh S., Khuda-Bukhsh A.R. Condurango glycoside-rich components stimulate DNA damage-induced cell cycle arrest and ROS-mediated caspase-3 dependent apoptosis through inhibition of cell-proliferation in lung cancer, in vitro and in vivo. Environ Toxicol Pharmacol 2014; 37: 300-314.
- Mukherjee A., Boujedaini N., Khuda-Bukhsh A.R. Homeopathic Thuja 30C ameliorates benzo(a)pyrene-induced DNA damage, stress and viability of perfused lung cells of mice in vitro. J Integr Med 2013; 11: 397-404.
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