How effective is AYUSH 64?
The government (specifically, the AYUSH ministry) has decided that it will begin distribution of a poly-herbal (mix of many herbs) mix called AYUSH 64 to Covid-19 patients with mild or moderate symptoms and those who are recovering at home. (news report) The government believes that this mix is useful against mild and moderate Covid-19(press release).
However, this claim seems to be absurd, and we are not the only ones saying this. (opinion) AYUSH 64 shows no evidence of working to alleviate the symptoms of Covid-19. But before the explanation on the lack of evidence, a little digression into the history of AYUSH 64… This poly-herbal drug was developed and tested as a cure for malaria. After repeated testing, AYUSH 64 did not show any signs of alleviating the symptoms of malaria. After being a dud in malarial cure, the decision-makers in the AYUSH ministry decided to repurpose AYUSH 64 as a potential cure for Covid-19.
Under normal circumstances, when a drug is to be approved for use for humans, it must undergo a series of tests. The drug must be shown to be effective against the pathogen (disease causing agent – virus, bacteria, worm, etc.) in laboratory conditions. If this is seen, then the drug is tested on laboratory animals (guinea pigs, rats, mice, etc.). In this test there are two major things that scientists look for:
How safe is the drug? - In other words, will taking the drug have any unwanted or unforeseen effects on the individual?
How effective is the drug? - Does the drug work? And how well does it work? Does it reduce the symptoms of the disease?
Generally, when such studies are done, the animals are divided into 2 groups – the control group and the treatment group. The treatment group receives the drug that is being tested. The control group is identical to the treatment group in every way, except that this group does not get the drug. The rationale behind this is that if the scientists see any difference between the control and treatment groups, it must be because of the drug because everything else was identical for both the groups.
Once scientists do a study, they write up the results in the form of a scientific paper, and this is then sent to the rest of the scientific community to be reviewed. Two to three scientists who are experts in the field review the paper. This review process checks the appropriateness of the method of the experiment, checks the data from the experiment, and ensures that the data supports the conclusion that the scientists are making.
Once it is established that the drug is not harmful and is effective in animals, the drugs are tested on humans. This process is the same as the methods used for animals. Have two groups, give the drug to one group, check if the drug is safe and effective, write a paper about your findings, and let the other scientists review it.
I was not able to find results for any such tests done for the effectiveness of AYUSH 64 drug in alleviating the symptoms of Covid-19 on laboratory animals. However, there are a few studies which have tested the effect of this drug on humans. There are only a handful of studies that I could find – and most of them have iffy methods or are making conclusions that may not be supported by data.
The first study (Study 1) was about how AYUSH 64 worked for a group of patients being treated for Covid-19. The patients were getting the regular treatment which has been approved by various agencies. Along with the treatment, these patients also received AYUSH 64. The scientists tested various parameters at different points of time during the infection. They checked Covid-19 symptoms like headache, cough, sore throat, etc. to see how quickly the symptoms vanish.
If you recall, to know the effect of a drug, we need a control group and a treatment group. But there was no control group in this study. So, it is impossible to say whether AYUSH 64 worked or did the rest of the treatment work? The only thing we could say from this study is that AYUSH 64 is not adversely harmful to a patient of Covid-19.
Apart from this study, there are two other studies which have not been reviewed by other scientists (Study 2 and Study 3). It has been shared before the peer review process is over. This is understandable in an emergency. But we need to be more careful of the results from these studies.
Both these studies had a treatment and control group. The treatment group was given AYUSH 64 in addition to the regular treatment. The control group was given the regular treatment only. Both these studies checked a long list of parameters on how long the symptoms of Covid-19 persist and how long it takes from the virus to completely leave the body. Apart from these, they measured various blood parameters to check how quickly infection and inflammation reduced for each group.
In both studies all parameters physical symptoms (cough, fever, etc.) and other blood parameters were indistinguishable between the control and the treatment groups. This essentially means that AYUSH 64 made no difference that the scientists could find in helping with Covid-19 symptoms. Some results that we see in one study is not seen in the other study. For example, inflammation parameters reduced in one study (Study 2), but not the other (Study 3). Other parameters were all within the normal range in both the studies. In fact, this paper (Study 3) writes this in its conclusion – “The AYUSH 64 appears to be safe but no difference in clinical improvement was observed between AYUSH 64 add-on treatment (treatment group) and standalone standard care (control group) in early stage COVID 19 patients.”
Given the flimsy evidence, or more accurately, complete lack of evidence that AYUSH 64 works, we suggest that people exercise extreme caution and avoid using AYUSH 64 as far as possible.
If there are questions, please feel free to write them in the comments.
This blog was an exercise in using the scientific temper to important current events. I highly encourage you to go ahead and do the same for other events.
In the meantime, is there something about the Covid-19 pandemic that is puzzling you? Or do you feel that you need to make sense of all that is happening? Feel free to write to us and tell us what you would like to read about. You can write in the comments section or email us at email@example.com