« Clinical Trials

It's better than "hearsay based herbal medicine". It can be very valuable - nature has done most of the living systems work already.

The differencs are less in clinical pharmacology and more in the drug drug interactions (plants contain many active compounds)_ and in dose / batch consistency.

So once you've sorted them out "herbal" and "synthetic" have very few differences.

Think Taxol.

The body of evidence supporting the use of alternative/herbal remedies is not very deep.  Health care payors have typically refused to cover any non-legend (non-prescription) therapies based mainly on the lack of clinical literature/evidence to support their use. 

Most herbal remedies are not evidence based, and the clinical literature supporting their safety and efficacy is very limited.  FDA is forbidden by law from vetting their usefulness, which allows the herbal and nutraceutical industry to make outrageous, and often false, claims, such as the ads with Smiling Bob and his "male enhancement."  There are, of course, some herbal products that have demonstrated clinical usefulness such as glucosamine and chondroitin for arthritis, and saw palmetto for benign prostatic hypertrophy, but for the vast majority of herbal products it is the wild west at Madison Avenue, where any claim can be made, regardless of the lack of clinical evidence.  Most herbal products are not dangerous (there are exceptions, such as ephedra), but neither do they have sufficiently powered double blind studies to show efficacy, and they are often simply a waste of patients' money.  It is a very sad state of affairs, and taints the entire herbal industry.  Until herbal products are required to be subjected to the same rigorous standards that ethical pharmaceuticals are, including large double blind placebo controlled studies, one should be very skeptical about herbal product claims.

Germany has done the most advanced regulatory and clinical coverage of herbal based medicines.  Commission E has built the largest clinical database of herbal clinical studies, properly defined the essential bioactive ingredient(s) and set standards for minimum efficacious levels.

As many other countries have cultures of indigenous herbal medicines (Ayervedic, TCM likely the largest), the work has been left to local practitioners without evidence based medicine (thus the slaughter of rhinos for their tusks, deer genetalia, etc. as medicines).  In advanced countries, these traditional herbal medicines do not provide the intellectual property protection that would justify investing in rigorous clinical trials for approval.   Therefore it has been left to the few groups such as Commission E and industry associations to compile clincial data however poor the quality. 

The U.S. market has been a major set back for the practice of rigorous herbal medicine due to shame products, false and misleading claims, etc.   Although many medicines have been derived from natural sources (Aspirin from White Willow Bark, Taxol, etc.)  the R&D was focused on converting to a "test tube" source to gain patentability and predictable source of supply. 

With uncertain consistency in products, inconsistent regulatory monitoring, less rigorous or poorly designed clinical studies, the future of herbal medicines in standard medical practice faces real challenges.  The economic return potential for anyone achieving effective clinical outcomes is the biggest deterent.   

Dear Vishwanath,

Till today India is not developed its impact especially in  Ayurveda as a Indian System of Medicine which can give  full fledge option for modern medicine.It is called as a Evidence based medicine. Being as a Ayurveda Doctor as well as a Researcher I can say first of all u have to use Ayurvedic Medicine for ailments that  ur suffering .

Nowadays Ayurveda is taking a boom in India as well as Abroad. Firstly u have to use the medicine, then automatically u will say results to other.Till  today I have 80% success rate as a Physician within short tenure (only 1.5 yrs) by using ayurvedic medicines only for various disorders .

Same thing I can say about  Homeopathy/ Yoga/ Naturopathy.

Regards,

Dr Prashant Bhokardankar  MD(Ayurveda)

Dear Vishwanatha,

The questions are too generalised.  What is one's take on traditional medicine ?.  It depends.  Some people are for it and some people are totally against it.

Evidence based, yes, but must be in terms of modern science.  That means, clinical documentation based on modern science.

Dr. Majeed

Thank you all...

However, I guess I need to clarify my question further...

My primary interest is to get the opinion from people who've got experience with both clinical trials of Herbal Products as well as regular drug products..

Dr. Majeed, thank you for the response. I was targeting to get your response too when I posted this new topic... I am assuming your organization surely conducted/ sponsored studies that compared the clinical pharmacologies, outcomes of certain Herbal's vis-a-vis' synthetic drug products..... you could share any one such experience wherein the therapeutic performance of herbal/in herbal extract was very comparable to that of the reference (synthetic) drug Product

I beleive both the regulatory agencies across the world as well as researchers related to herbal medicine are evolving and we can hopefully see many "useful" products being approved and used.Recent approval of a green tea extract by FDA is a significant event.

Although uniqueness associated with each herbal product makes it difficult for regulatory agencies to address key issues and approve, few approvals in this feild accelerate the learning and the process. I understand that many herbal products are in the process of getting themselves registered with FDA.

THere is no doubt that herbal medicines in some disease areas and at different stages of the disease are useful than synthetic alternatives, key is in addressing issues like consistency in properties of API, Raw material, Understanding right profile of the product and then conduct trails towards the selected therapeutic area.

I am very positive about the future of herbal based medicines.

Raj

Excuse my bluntness, but this message is typical of the nonsense that the herbal industry disseminates.  The FDA does NOT approve herbal products, as the prior message states.  The "Dietary Supplement Health And Education Act of 1994" (Public Law 103-417) included herbal products in its definition of "dietary supplements" and eliminated FDA's oversight for these products' effectiveness.  This bill was spearheaded by the herbal industry in order to weaken FDA oversight of its products, because the herbal industry did not want to be required to show proof for claims of effectiveness.  This is the major reason why there are so few evidence-based herbal product claims.

Dear Marc,

I am referring to this product, not the DSHEA.

http://www.veregenrx.com/

Raj

Dear Rajasekhar,

Thank you for the clarification that you are referring to a New Drug Application approval for a prescription drug, and are not writing about an herbal product's DSHEA 'approval' (which is not possible).  We are in complete agreement that Veregen is an excellent example of employing traditional pharmacognosy and randomized, double blind clinical studies to demonstrate evidence based medical proof of a natural-origin product's effectiveness.  It is my sincere hope that we see many more such efforts.

Marc