#LongThread
1.
"Why creating credible evidence supporting the use of Ayurveda in clinical scenario is extremely difficult?" - is going to be today's thread.
1.
"Why creating credible evidence supporting the use of Ayurveda in clinical scenario is extremely difficult?" - is going to be today's thread.
2.
The best quality clinical evidence is meta-analysis and systematic review. But the individual clinical trials in Ayurveda employ diverse parameters and use diverse interventions making such efforts difficult. Improving the quality of individual clinical trials is crucial.
The best quality clinical evidence is meta-analysis and systematic review. But the individual clinical trials in Ayurveda employ diverse parameters and use diverse interventions making such efforts difficult. Improving the quality of individual clinical trials is crucial.
3.
"Blinding" an essential component of good clinical trials, is impossible while employing complex interventions such as Panchakarma.
"Blinding" an essential component of good clinical trials, is impossible while employing complex interventions such as Panchakarma.
4.
Accommodating "individualisation" of interventions is another challenge, even if Panchakarma is excluded.
Preparing placebos for complex formulations such as Asava / Kashaya is another challenge.
Accommodating "individualisation" of interventions is another challenge, even if Panchakarma is excluded.
Preparing placebos for complex formulations such as Asava / Kashaya is another challenge.
5.
So far there has been only published clinical trial where they have employed placebos. However the trial is not reproducible because individualisation is not based on any predictable algorithm.
So far there has been only published clinical trial where they have employed placebos. However the trial is not reproducible because individualisation is not based on any predictable algorithm.
6.
A workable solution is to not incorporate Panchakarma and to frame a predictable algorithm for employing individualisation.
Instead of placebo, a control group with standard of care can be employed.
A workable solution is to not incorporate Panchakarma and to frame a predictable algorithm for employing individualisation.
Instead of placebo, a control group with standard of care can be employed.
7.
However, that isn't how Ayurveda is practised in real-world. Physicians employ various complex interventions such as Panchakarma. Hence even if a trial incorporating "black box design" allowing for individualisation is planned, it does not represent real-world scenario.
However, that isn't how Ayurveda is practised in real-world. Physicians employ various complex interventions such as Panchakarma. Hence even if a trial incorporating "black box design" allowing for individualisation is planned, it does not represent real-world scenario.
8.
Hence, long term well-planned observational studies are the next best available designs. If a large sample size is included, they can give valuable insights.
For instance, the link between smoking and lung cancer was established through an observational study.
Hence, long term well-planned observational studies are the next best available designs. If a large sample size is included, they can give valuable insights.
For instance, the link between smoking and lung cancer was established through an observational study.
9.
A good online patient-data documentation system can be designed and a few identified centres can be asked to enter the data on a daily basis for certain specific conditions. This can establish the usefulness of or failure of these interventions in a real world scenario.
A good online patient-data documentation system can be designed and a few identified centres can be asked to enter the data on a daily basis for certain specific conditions. This can establish the usefulness of or failure of these interventions in a real world scenario.
10.
N-of-1 trial is another possible option. They allow for individualisation of therapies.
But again, incorporating Panchakarma is not possible in this sequencial format (A-B-A-B etc).
Synthesizing such trials when there is too much of heterogeneity too is difficult.
N-of-1 trial is another possible option. They allow for individualisation of therapies.
But again, incorporating Panchakarma is not possible in this sequencial format (A-B-A-B etc).
Synthesizing such trials when there is too much of heterogeneity too is difficult.
11.
Hence, arguably, long-term observational studies are best suited for Ayurveda. The physicians are free to prescribe all the interventions they believe are useful. They can combine Panchakarma too. They need not bother about blinding or placebos.
Hence, arguably, long-term observational studies are best suited for Ayurveda. The physicians are free to prescribe all the interventions they believe are useful. They can combine Panchakarma too. They need not bother about blinding or placebos.
12.
Now the "actual challenge" part:
There are hundreds of pharmacies that market thousands of their own patent and proprietary formulations, the quality of which is not uniform.
Physicians prescribe locally available, commercially viable formulations to their patients.
Now the "actual challenge" part:
There are hundreds of pharmacies that market thousands of their own patent and proprietary formulations, the quality of which is not uniform.
Physicians prescribe locally available, commercially viable formulations to their patients.
13.
The quality of the classical formulations too differs hugely from one pharmacy to another.
Same product is available at different MRPs depending on the pharmacy.
There is no guarantee that all ingredients mentioned are actually found in the products.
The quality of the classical formulations too differs hugely from one pharmacy to another.
Same product is available at different MRPs depending on the pharmacy.
There is no guarantee that all ingredients mentioned are actually found in the products.
14.
There is no routinely available method to confirm the quality and authenticity of all the ingredients in these formulations.
There is no routinely available method to confirm the quality and authenticity of all the ingredients in these formulations.
15.
Many physicians co-prescribe western medicine "off the record". Such co- prescriptions can go undetected in such studies.
Many physicians co-prescribe western medicine "off the record". Such co- prescriptions can go undetected in such studies.
16.
Many patients do not reveal what other medicines they are already on. E.g., medicines such as antibiotics, NSAIDs etc.
Capturing such practices in a study are challenging.
Many patients do not reveal what other medicines they are already on. E.g., medicines such as antibiotics, NSAIDs etc.
Capturing such practices in a study are challenging.
17.
Many poor quality formulations available in the market have been reported to be containing antibiotics, NSAIDs, bronchodilators, steroids etc.
Subjecting each of the formulations for such chemical analysis is practically impossible.
Many poor quality formulations available in the market have been reported to be containing antibiotics, NSAIDs, bronchodilators, steroids etc.
Subjecting each of the formulations for such chemical analysis is practically impossible.
18.
Any study if at all can be planned, that takes into account all these aspects, can only give credible evidence to support the clinical utility of Ayurveda.
We need to come up with some such studies as early as possible.
Any study if at all can be planned, that takes into account all these aspects, can only give credible evidence to support the clinical utility of Ayurveda.
We need to come up with some such studies as early as possible.
19.
Small, isolated clinical trials with "one drug-one disease" approach are going to be of no use.
Large studies that examine real world scenario are required.
Ensuring that all co-prescriptions are recorded and confirming uniform quality of formulations is crucial.
Small, isolated clinical trials with "one drug-one disease" approach are going to be of no use.
Large studies that examine real world scenario are required.
Ensuring that all co-prescriptions are recorded and confirming uniform quality of formulations is crucial.
20.
End of thread.
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