MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Ayurvedic medicine

Ayush-64 is an Ayurvedic formulation, developed by the Central Council for Research in Ayurvedic Sciences (CCRAS), the apex body for research in Ayurveda under the Ministry of Ayush. Originally developed in 1980 for the management of Malaria, this drug has now been repurposed for COVID-19 as its ingredients showed notable antiviral, immune-modulator, and antipyretic properties. Its ingredients are:

Alstonia scholaris R. Br. Aqueous extract of (Saptaparna) Bark-1 part
Picrorhiza Kurroa Royle Aqueous extract of (Kutki) Rhizome-1 part
Swertia chirata Buch-Ham. Aqueous extract of (Chirata) Whole plant-1 part
Caesalphinia crista, Linn. Fine powder of seed (Kuberaksha) Pulp-2 parts

The crucial question, of course, is does AYUSH-64 work?

An open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India with 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone.

The outcome measures were:

  • the proportion of participants who attained clinical recovery on days 7, 15, 23, and 30,
  • the proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point,
  • change in pro-inflammatory markers,
  • metabolic functions,
  • HRCT chest (CO-RADS category),
  • the incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE).

Out of 80 participants, 74 (37 in each group) contributed to the final analysis. A significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. The mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG.

The authors concluded that AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.

I do object to these conclusions for several reasons:

  1. The study cannot possibly determine the safety of AYUSH-64.
  2. Even for assessing its efficacy, it was too small.
  3. The trial design followed the often-discussed A+B vs B concept and is thus prone to generate false-positive results.

I believe that it is highly irresponsible, during a medical crisis like ours, to conduct studies that can only produce unreliable findings. If there is a real possibility that a therapy might work, we do need to test it, but we should take great care that the test is rigorous enough to generate reliable results. This, I think, is all the more true, if – like in the present case – the study was done with governmental support.

A press release informs us that the World Health Organization (WHO) and the Government of India recently signed an agreement to establish the ‘WHO Global Centre for Traditional Medicine’. This global knowledge centre for traditional medicine, supported by an investment of USD 250 million from the Government of India, aims to harness the potential of traditional medicine from across the world through modern science and technology to improve the health of people and the planet.

“For many millions of people around the world, traditional medicine is the first port of call to treat many diseases,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General. “Ensuring all people have access to safe and effective treatment is an essential part of WHO’s mission, and this new center will help to harness the power of science to strengthen the evidence base for traditional medicine. I’m grateful to the Government of India for its support, and we look forward to making it a success.”

The term traditional medicine describes the total sum of the knowledge, skills and practices indigenous and different cultures have used over time to maintain health and prevent, diagnose and treat physical and mental illness. Its reach encompasses ancient practices such as acupuncture, ayurvedic medicine and herbal mixtures as well as modern medicines.

“It is heartening to learn about the signing of the Host Country Agreement for the establishment of Global Centre for Traditional Medicine (GCTM). The agreement between Ministry of Ayush and World Health Organization (WHO) to establish the WHO-GCTM at Jamnagar, Gujarat, is a commendable initiative,” said Narendra Modi, Prime Minister of India. “Through various initiatives, our government has been tireless in its endeavour to make preventive and curative healthcare, affordable and accessible to all. May the global centre at Jamnagar help in providing the best healthcare solutions to the world.”

The new WHO centre will concentrate on building a solid evidence base for policies and standards on traditional medicine practices and products and help countries integrate it as appropriate into their health systems and regulate its quality and safety for optimal and sustainable impact.

The new centre focuses on four main strategic areas: evidence and learning; data and analytics; sustainability and equity; and innovation and technology to optimize the contribution of traditional medicine to global health and sustainable development.

The onsite launch of the new WHO global centre for traditional medicine in Jamnagar, Gujarat, India will take place on April 21, 2022.

__________________________

Of course, one must wait and see who will direct the unit and what work the new centre produces. But I cannot help feeling a little anxious. The press release is full of hot air and platitudes and the track record of the Indian Ministry of Ayush is quite frankly abominable. Here are a few of my previous posts that, I think, justify this statement:

 

WATCH THIS SPACE!

People often say WHAT’S THE HARM?

Why not let Prince Charles promote any nonsense he likes?

Let him be!

He means well!

He is not harming anyone!

I think this attitude is not correct. Charles’s advocacy of quackery is by no means harmless. This is one of the points I have been trying to make repeatedly, most recently in my biography of Charles.

And there are plenty of examples for this; just think of the Gerson therapy (a whole chapter in the said book). Another, less obvious example is homeopathy. Charles has promoted homeopathy during all his adult life. When he fell ill with COVID in the early phase of the pandemic, the realm of homeopathy predictably decided that he recovered so well because he homeopathic treatment. A report dated 7 April 2020, for example, is quite clear about it:

British Crown Prince Charles has been “101 per cent” cured of COVID-19 using Ayurveda and Homeopathy treatment, Union Minister of State for AYUSH Shripad Naik … “I am proud that the Ministry which I head, managed to cure such a great man, there is no greater credit than this. He may have some problem (admitting to it) because the system in his country does not give recognition to Ayurveda. He may have felt he would violate rules, that is why his refusal to admit is obvious,” Naik told a local cable news channel in an interview late on Monday. “I believe 101 per cent, that he has been cured (using Ayurveda and Homeopathy),” Naik also said.

On April 2, Naik had told a press conference in Goa, that Prince Charles had been cured of COVID-19 after seeking treatment from a Bengaluru-based alternative treatment resort, SOUKYA International Holistic Health Centre’ run by a doctor Isaac Mathai. A day after his statement, Clarence House, the official residence of Prince Charles had said that the claim was incorrect and that the royal “followed the medical advice of the National Health Service in the UK and nothing more”. The royal had been diagnosed COVID-19 positive last month.

Naik in the cable TV interview on Monday continued to insist that Ayurveda and Homeopathy had indeed cured the Prince and that it was a “victory” for Indian traditional medicine systems. Naik also said that there was no need to disbelieve the doctor Isaac Mathai, who cured Prince Charles. “The man (Dr. Mathai) himself is saying this. He is a doctor, an owner of a resort, he is trustworthy, when he says this, it is a victory of our Indian system,” Naik said.

The royal denial had little effect; Indian officials had persuaded themselves and key decision-makers that Charles’s case was proof for homeopathy’s effectiveness against COVID. Consequently, homeopathy was widely used for that purpose. As a result, millions of Indians deemed themselves sufficiently protected (possibly not taking other measures seriously). And the rest is history: in the summer of 2020, about 1000 Indians per day were reported to have died of COVID (the number of unreported deaths was estimated to be even higher).

The point I am trying to make is this: the promotion of quackery by a ‘VIP’ can have dramatic unforeseen consequences, even if (like in Charles’s case) a direct cause-effect relationship is impossible to prove.

 

We all need cheering up a bit, I’m sure.

Luckily, I found just the thing.

The New York Post reported that a former Versace model, Tom Casey, is crediting his youthful looks to drinking his own urine, and to perineum sunning (exposing your butt hole to sunshine). “I drink my own urine every morning — I call it hair of the dog!” Casey proclaimed, “the feeling is electric.” The ex-model also flushes his urine into his rectum and applies it to his skin as a moisturizer. 

“It wasn’t as bad as the mental barrier in my own mind,” the ex-catwalk star reminisced. “I felt a cool buzz. Intuitively, it just felt good. I drank my urine on and off for a while from there.”

Casey began drinking his own urine on a daily basis back in 2008 and hasn’t looked back. He has even completed a “seven-day urine fast,” drinking nothing but his own urine for an entire week. He also bottles his pee, lets it “ferment” and uses it in an enema. “I would cultivate my own urine and ferment it in a sealed Mason jar for two weeks before transferring it into my rectum,” he explained. “Aged urine enemas are so powerful for your health and I got my six-pack abs after doing them. It flushed out my gut and that’s when I got really ripped.”

Casey uses his urine also as a moisturizer, which he believes helps maintain his appearance. “What it did for my mood and muscle building was amazing. I put it on my skin, especially when I’m on the beach, and it’s so electrifying and strengthening,” he cooed. “It’s a big psychological leap for people to use their own urine as a moisturizer but it’s so euphoric and anti-aging. Uric acid is used in high-end skin care products.”

“I’m 55 years old and most people don’t look and feel like I do at my age. No one can deny that I’m ripped, and that’s down to the fact that I love being extremely healthy and practicing natural healing methods.”

Casey claims Big Pharma is terrified of people learning that the secret to their health lies within themselves.

“What so many pharmaceutical companies don’t want to tell you is that we as humans are the secret to health. That’s what I try to teach people in everything I do,” he stated.

“People should be scared if they’re eating s–tty food and doing pharmaceutical drugs. Why should they be scared to try their own urine?”

____________________________

Personally, I feel that Casey believes the sun might be shining out of his arse. In any case, it is hard to deny that the former Versace model is suffering from proctophasia and/or is taking the piss.

Boris Johnson has recently bent over backward in order to please the Indian PM, Narendra Mondi. Some even say that a trade agreement between the two countries was achieved at the cost of letting the Delta variant into the UK. Now it seems that political considerations are at the heart of the decision to lend official support to Indian traditional medicine in the UK. The ‘2030 Roadmap for India-UK future relations‘ is a policy document of the UK government. In it, we find that the UK government intends to:

  • Explore cooperation on research into Ayurveda and promote yoga in the UK.
  • Increase opportunities for generic medicine supply from India to the UK by seeking access for Indian pharma products to the NHS and recognition of Indian generic and Ayurvedic medicines that meet UK regulatory standards.

This clearly begs the question, are these plans good or bad for UK public health?

Ayurveda is a system of healthcare developed in India around the mid-first millennium BCE. Ayurvedic medicine involves a range of techniques, including meditation, physical exercises, nutrition, relaxation, massage, and medication. Ayurvedic medicine thrives for balance and claims that the suppression of natural urges leads to illness. Emphasis is placed on moderation. Ayurvedic medicines are extremely varied. They usually are mixtures of multiple ingredients and can consist of plants, animal products, and minerals. They often also contain toxic substances, such as heavy metals which are deliberately added in the ancient belief that they can have positive health effects. The truth, however, is that they can cause serious adverse effects.

Relatively few studies of Ayurvedic remedies exist and most are methodologically weak. A Cochrane review, for instance, concluded that” although there were significant glucose-lowering effects with the use of some herbal mixtures, due to methodological deficiencies and small sample sizes we are unable to draw any definite conclusions regarding their efficacy. Though no significant adverse events were reported, there is insufficient evidence at present to recommend the use of these interventions in routine clinical practice and further studies are needed.”

The efficacy of Ayurvedic remedies obviously depends on the exact nature of the ingredients. Generalizations are therefore problematic. Promising findings exist for a relatively small number of ingredients, including Boswellia, Frankincense, Andrographis paniculata.

Yoga has been defined in several different ways in the various Indian philosophical and religious traditions. From the perspective of alternative medicine, it is a practice of gentle stretching exercises, breathing control, meditation, and lifestyles. The aim is to strengthen prana, the vital force as understood in traditional Indian medicine. Thus, it is claimed to be helpful for most conditions affecting mankind. Most people who practice yoga in the West practise ‘Hatha yoga’, which includes postural exercises (asanas), breath control (pranayama), and meditation (dhyana). It is claimed that these techniques bring an individual to a state of perfect health, stillness, and heightened awareness. Other alleged benefits of regular yoga practice include suppleness, muscular strength, feelings of well-being, reduction of sympathetic drive, pain control, and longevity. Yogic breathing exercises are said to reduce muscular spasms, expand available lung capacity and thus alleviate the symptoms of asthma and other respiratory conditions.

There have been numerous clinical trials of various yoga techniques. They tend to suffer from poor study design and incomplete reporting. Their results are therefore not always reliable. Several systematic reviews have summarised the findings of these studies. An overview included 21 systematic reviews relating to a wide range of conditions. Nine systematic reviews arrived at positive conclusions, but many were associated with a high risk of bias. Unanimously positive evidence emerged only for depression and cardiovascular risk reduction (Ernst E, Lee MS: Focus on Alternative and Complementary Therapies Volume 15(4) December 2010 274–27).

Yoga is generally considered to be safe. However, the only large-scale survey specifically addressing the question of adverse effects found that approximately 30% of yoga class attendees had experienced some type of adverse event. Although the majority had mild symptoms, the survey results indicated that attendees with chronic diseases were more likely to experience adverse events associated with their disease. Therefore, special attention is necessary when yoga is introduced to patients with stress-related, chronic diseases. 

So, should we be pleased about the UK government’s plan to promote Ayurveda and yoga? In view of the mixed and inconclusive evidence, I feel that a cautious approach would be wise. Research into these subjects could be a good idea, particularly if it were aimed at finding out what the exact risks are. Whole-sale integration does, however, not seem prudent at this stage. In other words, let’s find out what generates more good than harm for which conditions and subsequently consider adopting those elements that fulfill this vital criterium.

This systematic review and meta-analyses explored the strength of evidence on efficacy and safety of Ayurvedic herbs for hypercholesterolemia. Methods: Literature searches were conducted and all randomized controlled trials on individuals with hypercholesterolemia using Ayurvedic herbs (alone or in combination) with an exposure period of ≥ 3 weeks were included. The primary outcomes were total cholesterol levels, adverse events, and other cardiovascular events.

A total of 32 studies with 1386 participants were found. They tested three Ayurvedic herbs:

  • Allium sativum (garlic),
  • Commiphora mukul (Guggulu),
  • Nigella sativa (black cumin).

The average duration of intervention was 12 weeks. The meta-analysis of the trials showed that

  • Guggulu reduced total cholesterol and low-density lipoprotein levels by 16.78 mg/dL (95% C.I. 13.96 to 2.61; p-value = 0.02) and 18.78 mg/dL (95% C.I. 34.07 to 3.48; p = 0.02), respectively.
  • Garlic reduced LDL-C by 10.37 mg/dL (95% C.I. -17.58 to -3.16; p-value = 0.005).
  • Black cumin lowered total cholesterol by 9.28 mg/dL (95% C.I. -17.36, to -1.19, p-value = 0.02).

Reported adverse side effects were minimal.

The authors concluded that there is moderate to high level of evidence from randomized controlled trials that the Ayurvedic herbs guggulu, garlic, and black cumin are moderately effective for reducing hypercholesterolemia. In addition, minimal evidence was found for any side effects associated with these herbs, positioning them as safe adjuvants to conventional treatments.

For the following reasons, I fail to see how these conclusions can be justified:

  • Too many of the included studies are of poor quality.
  • Only for garlic are there a sufficient number of trials for attempting to reach a generalizable conclusion.
  • Giving garlic to patients with hypercholesterolemia is hardy Ayurvedic medicine.
  • Even the effect of the best-tested herbal remedy, garlic, is not as large as the effects of conventional lipid-lowering drugs.
  • Conclusions about the safety of medicines purely on the basis of RCTs are unreliable.
  • The affiliations of the authors include the College of Integrative Medicine, Maharishi International University, Fairfield, USA, the School of Science of Consciousness, Maharishi University of Information Technology, Noida, India, and the Maharishi International University, Fairfield.

The Indian AYUSH ministry has a track record of doing irresponsible stuff. Now they have published guidelines for treating Mucormycosis (black fungus) with homeopathy. Allow me to show you the crucial passages of their announcement:

… With the increasing cases of special variety of fungal infection, Mucormycosis (black fungus) the present information have been prepared with experience of senior clinicians in treating specific fungal infections and researchers of the system, for efficient treatment of suspected and diagnosed cases of Mucormycosis with Homoeopathy. This condition requires hospital based treatment under supervision and Homoeopathic medicines can be prescribed in an integrated manner. Since mostly immune compromised patients get this infection, strict monitoring of blood sugar and other vitals is required…

As a system with holistic approach, homoeopathy medicines may be selected based on the presenting signs and symptoms of each patient(4). Fungal infections are amenable to homoeopathic treatment. Various research studies undertaken on various fungi in-vitro model showed that homoeopathy medicine could prevent the growth of the fungus(5-8). Clinical studies have shown encouraging results on fungal infections (9-10). The medicines given here are suggestive based on their clinical use.

Symptomatic Homoeopathy management of Suspected and Diagnosed cases of Mucormycosis-

 

 

 

Note: -Apart from these lists of medicines any other medicine and any other potency may be
prescribed based on the symptom similarity in each case.

__________________________

END OF QUOTE

Mucormycosis (black fungus) is a disease of immunocompromised patients. Five types can be differentiated:

  1. rhinocerebral (most common),
  2. pulmonary,
  3. cutaneous,
  4. disseminated,
  5. gastrointestinal (rare).

Rhinocerebral mucormycosis commonly causes headaches, visual changes, sinusitis, and proptosis. Pulmonary mucormycosis commonly presents as a cough. Late diagnosis may result in dissemination, leading to high mortality. Treatment consists of amphotericin B, surgery, and immune restoration.

It is believed that the current surge of mucormycosis in India has an overall mortality rate of 50% and is triggered by the use of steroids which are often life-saving for critically ill Covid-19 patients. It almost goes without saying that homeopathy has not been shown to be effective against this (or any other) condition. As to the AYUSH ministry, the less they interfere with public health in India, the better for the survival of patients, I fear.

This amazing announcement reached me via Twitter. It seems that the people in the AYUSH ministry are highly delusional. According to Wikipedia, the Ministry of AyurvedaYogaNaturopathyUnaniSiddha, Sowa-Rigpa and Homoeopathy (abbreviated as AYUSH) is purposed with developing education, research and propagation of indigenous alternative medicine systems in India. As per a recent notification published in the Gazette of India on 13 April 2021, the  Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy), will now be known as the Ministry of Ayush.

India is suffering from a very severe health crisis, and the ministry should stop its propaganda for useless solutions.

  • Ayurveda,
  • Homeopathy (considered to be indigenous in India),
  • Yoga,
  • Naturopathy,
  • Unani,
  • Sidda,
  • Sowa-Rigpa (the traditional medicine of Tibet)

have in common that they can offer very little help to patients infected by COVID-19. In view of this fact, the announcement is ununderstandable and irresponsible, in my view.

On 20 February 2021, I published on my blog a comment on a new study of an Ayurvedic remedy for COVID-19. The study was in my view suspect, and I expressed this as follows:

I have the following concerns or questions about this trial:

  • Why do the authors call it a pilot study? A pilot study is merely for testing the feasibility of a trial design and is not meant to yield definitive efficacy results.
  • The authors state that the patients were asymptomatic yet in the discussion they claim they were asymptomatic or mildly symptomatic.
  • Some of the effect sizes reported here are extraordinary and seem almost too good to be true.
  • The claim of no adverse effect is implausible; even placebos would cause perceived adverse effects in a percentage of patients.
  • If the study is solid and withstands the scrutiny of the raw data, it is of huge relevance for public health. So, why did the authors publish it in PHYTOMEDICINE, a relatively minor and little-known journal?

An article in The Economic Times’ reported this:

Patanjali Ayurved released what it called the first “evidence-based” medicine for Covid-19 on Friday. It claimed it has been “recognised by the WHO (World Health Organization) as an ayurvedic medicine for corona”. Patanjali promoter, yoga guru Baba Ramdev, released a scientific research paper in this regard at the launch, presided over by Union health minister Harsh Vardhan and transport minister Nitin Gadkari. The Ayurveda products maker said it has received a certification from the Ayush ministry. “Coronil has received the Certificate of Pharmaceutical Product (CoPP) from the Ayush section of Central Drugs Standard Control Organisation (CDSCO) as per the WHO certification scheme,” it said in a statement. Under the CoPP, Coronil can be exported to 158 countries, the company said, adding that based on the presented data, the ministry has recognised Coronil as medicine for “supporting measure in Covid-19”.

Am I the only one who fears that something is not entirely kosher about the study? (This is an honest question, and I would be pleased to receive answers from my readers)

What happened next is most puzzling. After putting it on Facebook several times, I got banned for 72 hours from posting this article or anything else on Facebook. When this period had elapsed, I put the article in question again on Facebook. Subsequently, I was banned again but this time for 7 days. Facebook gave the following explanation:

You can’t post or comment for 7 days

This is because your previous posts didn’t follow our Community Standards.

No one else can see these posts.

1 Mar

Your post goes against our Community Standards on misinformation that could cause physical harm

We usually offer the chance to request a review, and follow up if we’ve gotten decisions wrong.

We have fewer reviewers available at the moment because of the coronavirus (COVID-19) outbreak. We’re trying hard to prioritise reviewing content with the most potential for harm.

This means that we may not be able to follow up with you, though your feedback helps us do better in the future.

Thank you for understanding.

On Twitter, the hype had begun even before its text was available. Priti Gandhi, for instance, tweeted:

Yet another feather in India’s cap!! 1st evidence-based, CoPP-WHO GMP certified medicine for Covid-19 released today. Congratulations to @yogrishiramdev ji, @Ach_Balkrishna ji & the team of scie…

EDZARDERNST.COM An RCT on the efficacy of ayurvedic treatment on asymptomatic COVID-19 patients

________________________________

As I did not feel I had broken any rules, I protested against the bans each time. When the 2nd ban was over, I posted my article yet again and, sure enough, yesterday I got banned again, this time for 30 days. Here is how they let me know:

You can’t post or comment for 30 days

This is because you previously posted something that didn’t follow our Community Standards.

This post goes against our standards on misinformation that could cause physical harm, so only you can see it.

Learn more about updates to our standards. On Twitter, the hype had begun even before its text was available. Priti Gandhi, for instance, tweeted: Yet another feather in India’s cap!! 1st evidence-based, CoPP-WHO GMP certified medicine for Covid-19 released today. Congratulations to @yogrishiramdev ji, @Ach_Balkrishna ji & the team of scie…

EDZARDERNST.COM An RCT on the efficacy of ayurvedic treatment on asymptomatic COVID-19 patients

____________________________

As the reason for the ban always seems to be the Ayurvedic study, I suspect that some party interested in the product is behind the complaints that lead to the bans. I find it extraordinary that I can be banned repeatedly without having done anything wrong and without my objections ever being considered.

Has anyone else experienced similar things?
Can anyone shed more light on this mysterious story?
Is there anything I can do, except for objecting, which I have now done thrice?

On Twitter, the hype had begun even before its text was available. Priti Gandhi, for instance, tweeted:

Yet another feather in India’s cap!! 1st evidence-based, CoPP-WHO GMP certified medicine for Covid-19 released today. Congratulations to @yogrishiramdev ji, @Ach_Balkrishna ji & the team of scientists at Patanjali Research Institute. Your efforts have been successful!! #Ayurveda

So, what is it all about? This study included 100 patients and was designed to evaluate the impact of traditional Indian Ayurvedic treatment on asymptomatic patients with COVID-19 infection. It is a placebo-controlled randomized double-blind pilot clinical trial that was conducted at the Department of Medicine in the National Institute of Medical Sciences and Research, Jaipur, India.

The verum treatment consisted of:
  • 1 g of Giloy Ghanvati (Tinospora cordifolia)
  • 2 g of Swasari Ras (traditional herbo-mineral formulation)
  • 0.5 g of Ashwagandha (Withania somnifera)
  • 0.5 g of Tulsi Ghanvati (Ocimum sanctum)

The treatment was given orally to the patients in the treatment group twice per day for 7 days. Medicines were given in the form of tablets and each tablet weighed 500 mg. While Swasari Ras was administered in powdered form, 30 min before breakfasts and dinners, rest were scheduled for 30 min post-meals. Patients in the treatment group also received 4 drops of Anu taila (traditional nasal drop) in each nostril every day 1 h before breakfast. Patients in the placebo group received identical-looking tablets and drops, post-randomization, and double-blinded assortments. The RT-qPCR test was used for the detection of viral load in the nasopharyngeal and oropharyngeal swab samples of study participants during the study. Chemiluminescent immunometric assay was used to quantify serum levels of interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α), and high sensitivity C-reactive protein (hs-CRP) on day 1 and day 7 of the study. Patient testing negative for SARS-CoV-2 in the RT-PCR analysis was the primary outcome of this study.

By day three, 71.1 % and 50.0 % of patients recovered in the treatment and placebo groups, respectively. The treatment group witnessed 100 % recovery by day 7, while it was 60.0 % in the placebo group. Average fold changes in serum levels of hs-CRP, IL-6, and TNF-α in the treatment group were respectively, 12.4, 2.5 and 20 times lesser than those in the placebo group at day 7. There was a 40 % absolute reduction in the risk of delayed recovery from infection in the treatment group.

The authors concluded that Ayurvedic treatment can expedite virological clearance, help in faster recovery and concomitantly reduce the risk of viral dissemination. Reduced inflammation markers suggested less severity of SARS-CoV-2 infection in the treatment group. Moreover, there was no adverse effect observed to be associated with this treatment.

I have the following concerns or questions about this trial:

  • Why do the authors call it a pilot study? A pilot study is merely for testing the feasibility of a trial design and is not meant to yield definitive efficacy results.
  • The authors state that the patients were asymptomatic yet in the discussion they claim they were asymptomatic or mildly symptomatic.
  • Some of the effect sizes reported here are extraordinary and seem almost too good to be true.
  • The claim of no adverse effect is implausible; even placebos would cause perceived adverse effects in a percentage of patients.
  • If the study is solid and withstands the scrutiny of the raw data, it is of huge relevance for public health. So, why did the authors publish it in PHYTOMEDICINE, a relatively minor and little-known journal?

An article in The Economic Times’ reported this:

Patanjali Ayurved released what it called the first “evidence-based” medicine for Covid-19 on Friday. It claimed it has been “recognised by the WHO (World Health Organization) as an ayurvedic medicine for corona”.

Patanjali promoter, yoga guru Baba Ramdev, released a scientific research paper in this regard at the launch, presided over by Union health minister Harsh Vardhan and transport minister Nitin Gadkari.

The Ayurveda products maker said it has received a certification from the Ayush ministry. “Coronil has received the Certificate of Pharmaceutical Product (CoPP) from the Ayush section of Central Drugs Standard Control Organisation (CDSCO) as per the WHO certification scheme,” it said in a statement.

Under the CoPP, Coronil can be exported to 158 countries, the company said, adding that based on the presented data, the ministry has recognised Coronil as medicine for “supporting measure in Covid-19”.

Am I the only one who fears that something is not entirely kosher about the study? (This is an honest question, and I would be pleased to receive answers from my readers)

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