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Patanjali Ayurvedas claimed cure for COVID-19 has been criticised for making unsubstantiated claims of efficacy. However, can ayurveda, or alternative medicine in general, be evaluated in the same way as modern medicine? Jacob Koshy discusses the question with Dr. S.P. Kalantri and Dr. Bhavana Prasher. Edited excerpts:

Dr. Prasher, could you begin by explaining what really is the process of testing a new investigational drug in ayurveda? Does it follow the phased system of clinical trials as in modern medicine?

Bhavana Prasher: There are two aspects to the use of ayurvedic drugs for clinical use. Some are those described in classical text and listed in the Drugs and Cosmetics Act of India. These have formulations that prescribe use in certain [conditions]. These are classical medicines that have been used for several hundreds of years in our country as well as in many parts of the world. If these drugs are to be used for a new condition, as we are seeing in the case of COVID-19, and there is some textual evidence to suggest that they could be useful, then they can straight away progress to human trials. We dont need studies on toxicity or pre-clinical aspects as these are already well-understood. However, if the drug is an entirely new formula, for a new set of conditions, then it has to follow the same path of toxicity, pre-clinical efficacy and subsequent clinical trials.

In a typical drug trial, an investigational drug is tested on various groups. Theres phase one, phase two... all the way up to multicentre phase three, etc. Then, it is medical statistics that decides whether the drug is actually safe and measurably improves outcomes. You also have to separate out the placebo effect. Do those same standards also apply to ayurveda?

Bhavana Prasher: For evaluating safety and efficacy, there is no difference in testing standards. But when it comes to trial design, what is an effective placebo for COVID-19? Right now, I dont think theres any medicine, or standard of care, that we can reliably compare a new drug with. However, as far as the trial design is concerned, what is more important is the outcome measures that you decide. In the context of disease management, it is not the case that one drug would work for the entire population and a single one would be useful for that patients lifetime. Drugs are evaluated based on what specific endpoint is expected. There is a very clear-cut flowchart or diagram given by the CCRS (Central Council for Research in Ayurvedic Sciences) guidelines. They say that the drug must not ignore the parameters on which it is judged by modern medicine.

Dr. Kalantri, In the case of COVID-19, several drugs are being re-purposed by pharmaceutical companies. Many times, drugs are hyped as potential antivirals, and they edge through the appraisal process by the expected outcomes being changed. We saw that in the case of remdesivir. So, dont you think that in some sense, you know, the pharmaceutical drugs, have it slightly easier, and a higher burden of proof is applied on alternative medicine?

S.P. Kalantri: Well, a science is a science is a science. I have great respect for ayurveda and its basic philosophy gels well with the Eastern approach of health and disease, in sharp contrast to the Western approach. But my point is that any drug or any intervention must figure out if the drug is safe and effective. For that, you need to follow certain rules. By merely drawing from experience in the past, quoting literature for which the drug might have worked in the past, does it mean that this drug will be as simple, as effective for a new disease? Ebola would be a great example. We thought that certain drugs worked well in Ebola and then we tried to extrapolate the results of those drugs to COVID-19, but they did not work. So often, what works in petri dishes might not work so far as actually human beings are concerned. My point is that no matter what branch you are practising, whether it is modern medicine or alternative medicine, comprising unani, siddha or homeopathy, there are certain scientific principles that absolutely must be followed. These scientific principles are basically aimed at making sure that you are minimising the bias as much as you can.

In the pharmaceutical world, normally what happens is, results of a trial are peer-reviewed and published in a journal. Independent experts can then evaluate the drugs benefits or non-efficacy. How often does that happen in alternative medicine? Are negative results reported?

Bhavana Prasher: There is a problem in that ayurvedic research publications dont appear as frequently in high-impact journals. However, I think that in general there is a paucity of negative outcomes being published and is not really a problem of ayurveda alone. Ayurvedic knowledge does not just come from experience but also relies on extensive documentation.

There are several universities and research counsellors who keep doing clinical trials that appear in ayurveda journals and thesis reports of research students. There is definitely the case that this reporting needs to be upgraded and the quality of journals improved.

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It is now well-understood that when disease reaches a certain level, you need technological interventions like, in the case of COVID-19, ventilators and pulse oximeters. However, ayurveda and other branches of alternative medicine mostly rely on natural concoctions. So, how do you integrate devices that are known to be life-saving into an ayurvedic framework?

Bhavana Prasher: They are absolutely integrated into the ayurvedic framework. I would recommend you to visit any of the modern ayurvedic institutes where the examination of the patient with respect to all these objective methods is very much adopted. There is no allergy to modern technological devices being integrated in the clinical protocols of ayurveda. Nevertheless, ayurveda also retains the methodology of assessment of disease in ayurvedic style, which is not only about focusing on the virus, but also looks at the baseline health parameters like diet and sleep. These are the immediate indicators of whether treatment is working.

Also read | Patanjali to sell Coronil as 'immunity booster,' not 'cure for COVID-19'

Dr. Kalantri, is there a way in which these two systems of medicines can be integrated? Or are they two different schools that cannot really exist under one roof but can only run parallel paths?

S.P. Kalantri: I guess an integrated approach would be a win-win situation for both disciplines because modern medicine approaches treatment from a left-brain perspective it is more rational, more analytic, more structured. Ayurveda has a holistic, more intuitive approach. It takes into consideration the person as a whole. So, while modern medicine is obsessed with a cell, or an organ, or a disease, which is a part of a body, ayurveda considers the person as a whole and believes that the whole is more important than some of the parts that it is composed of. I completely agree with this. But when we are integrating them, we should not forget the principles of science and ethics.

The way the Patanjali trial was publicised, the results were shared with the media without getting published. The most meaningful outcome we are looking at from a drug is that it should be able to save lives. A strength of modern medicine is that it looks very strongly at these endpoints (saving lives and recovery). We need to look at the large trials conducted in the last two months, the solidarity trial and the recovery trial. Both not only produced some positive results, but [the researchers] also had the humility and transparency to say that hydroxychloroquine does not work, remdesivir does not reduce mortality, the dual combination of antiviral drugs does not work.

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Dr. Prasher, would you agree that the benefits of Patanjalis drug were hyped? And didnt it do more harm to ayurveda in the process?

Bhavana Prasher: In the case of this particular trial, I would agree that their claims were disproportionate to what was clinically proved. However, I would disagree with Dr. Kalantri in that if we are indeed looking purely at how many lives are saved, I do not know if, anywhere, ayurvedic medicine has even had a chance of [being tested] in ICUs. So, the Patanjali trial was only restricted to mild and moderate cases; all asymptomatic cases were only mildly positive, so as an endpoint, they could only test viral clearance.

There arent tests allowed anywhere where ayurveda can be tested in severe or critically ill situations which could improve outcomes. A confidence has to be built in the modern medical world as well as in society that these things can be tested in those conditions as well.

Also read | FIR against Baba Ramdev, others on COVID-19 cure claim

Ayurveda is said to be a highly personalised system of medicine. So, by definition, can treatments so customised to an individual be sold to a general population? Modern medicine, on the other hand, recommends a drug for anyone who presents a certain set of conditions.

Bhavana Prasher: Personalisation refers to the disease type or the stage of severity. If, for a given presentation, a certain drug has been useful and tested, then it can be given to others. But the clinical indication has to be very clear. However the one-drug-fits-all notion in modern medicine is itself getting challenged everyday.

Both ayurveda and modern medicine are systems of medicine. However, their products are frequently in the hands of commercial pharmaceutical companies, who deploy similar means to sell more and extol benefits over harm. So, does that undermine medicine in both systems?

S.P. Kalantri: I completely agree. In the case of a drug called Favipiravir, that has now been approved, the company charges 13,000 for a 14-day therapy for a drug that only addresses fever and cough. Most people in our country can never afford such a drug. We must, at this time, de-link this nexus between pharmaceutical companies and medicine.

Bhavana Prasher: In the desperation for a panacea, drugs that are given over the counter compromise with the principles of treatment in Ayurveda too. This does create a lot of problems and sometimes can bring more harm than benefit.

Dr. Bhavana Prasher is an ayurveda doctor and senior scientist at the CSIR-Institute of Genomics and Integrative Biology; Dr. S.P. Kalantri is a Professor at Mahatma Gandhi Institute of Medical Sciences, Wardha

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Can alternative medicine be subject to modern rigour? - The Hindu

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