Debate on Ayush protocols for Covid-19

Recently, the Indian Ministry of Health released Ayush protocols (Ayush an acronym for Ayurveda, Yoga and naturopathy, Unani, Siddha and Homeopathy) for prophylaxis and support in treating Covid-19 patients. The protocols involved recommendations of yoga, certain Ayush herbs and the use of products to support and prevent viral infections, in addition to other measures. The Ministry did not say the protocols were geared towards treating severe Covid-19 cases. 

Almost immediately, the Indian Medical Association, a body of medical practitioners shot off a letter questioning the release of these protocols. The medical body demanded whether these protocols have gone through Randomized Controlled Double-Blind clinical trials (RCDB). Such trials are generally accepted as gold standards for the generation of evidence for drugs. However, such clinical trials are debated and in some scientific circles. Controlled clinical trials are one part that is discussed. All aspects of subjects or patients, the conduct of the studies and sometimes the drug is not fully controllable.

The mental status of the subjects, stress and stress tolerance levels, potential mood disturbances are not controllable amongst the enrolled subjects. In case of studies involving adult subjects of both sexes, the monthly cycles of female participants and the impact of hormonal changes also may not be controlled. In studies that involve the administration of the drug for longer periods, fatigue is known to set in, affecting the compliance to diet restrictions, exercise, consumption of medicines at right time in the right way and consumption of undeclared other products (viz. Fruit juices, herbal juices, vitamin and other supplements) also affect the controls. These factors would affect the outcomes. 

It is known that the outcomes measured even in RCDB trials vary drastically. Declaration of the effectiveness of a drug in such studies is not always looking at ”all patients to show positive outcome”. In the 90’s when Taxol injection was approved to treat breast and ovarian cancer only 6% of patients showed complete recovery and about 26% of cancer patients showed 50% reduction in tumour size with Taxol treatment.

There is debate on the trials being conducted for vaccines to protect from Covid-19. It was stated to be effective, the vaccine should show a response in 50% of people who took the vaccine. Some scientists demanded this number should be 70% and not 50%. This would mean a cleared vaccine may not protect all those who take the vaccine. Efficacy measures vary from medicine to medicine and seldom is a 100% seen in controlled studies. A number of confounding factors impact even controlled studies. Scientists are still working to understand why drugs don’t work in all 100% of patients? Some patients may get cured while others show only partial response. 

Applying an RCDB trial design to holistic treatment and protocols of Ayush is a challenge, and the medical body should recognize this. Unlike drugs which work on a single receptor, cell or an organ, the Ayush protocol consists of multiple components, multiple targets/organs and is holistic in nature. Scientists studying Ayush treatments or products often struggle to decide what is to be tested. Should the product only be tested in an RCDB trial or the complete protocol involving yoga, diet controls, product be tested? Systems biology approach is evolving in such situations. 

The role of neuroendocrine functions is important in controlled trials which should be recognized as being almost absent in what the medical body questioned for Ayush protocols. The tone and tenor of IMA’s letter are not what is expected from such a professional body. A body consisting of professional medical physicians should have offered to be part of observing such protocol being administered and come out with the findings. 

(The writer is a scientist involved in drug development and research on Ayush)