Less can be better than more

There is a broad agreement that laboratory tests can help to clear important questions about TCM medicinals. But in some way we always have to consider that daily experience in clinical practice is somehow different from lab test results.
In medical literature you can find reports which prove that low levels of some ingredients can be helpfull but high contents can harm (look e.g. on reports about ingredients like vitamines or substances like selene etc.).
Furthermore we have to keep an eye on the quality of clinical trials and other reports like the articles mentioned in your blog. As we know from Western medicine reports even in highly recommended journals we find lots of trials lacking methodologically acceptable quality. Some people say 90% of all published data don't show clear evidence that a supposed result is proven. Look at the discussion with betablockers. After 40 years of using those substances it was finally found that we didn't help people to prevent stroke, heart attack. But for almost half a century it was the gold standard. I don't want to start a discussion whether clinical and scientific trials from China are of better or poorer quality than reports from Western scientist paid by pharmaceutical companies. But one has to look closer and approach should be critical.
One big problem is a very basic one: The identity and quality of TCM herbs is the starting point of all efforts in proving the different aspects of TCM therapy. In the last 10 years we tested in Phytax (www.phytax.ch) about 10'000 batches of extracts (single herbs as well as classic formulas) from Mainland Chinese and Taiwanese companies and furthermore build op a stock of references of a few thousand herbs (herbs conforming the PPRC (Pharmacopoeia of the Peoples Republic of China), conforming the Chinese Materia Medica, conforming Bensky's Materia Medica as well as adulterations, alternate species and local variants)and we are now after 10 years happy to be able to say that we solved almost all the problems of identification. And we found what we expected: there are big differences in the quality of the suppliers. Good suppliers show errors in correct identity of the used starting material in the range of 1-2% whereas some companies show 25% of not acceptable material. Not every case of error is a disaster. Often the used herb is not there is big danger. It might be that the used species is not listed in the PPRC but it is a local variant and well accepted substitute. But some companies seem not to be able to do the correct identification. They just don't care very much. Almost all companies engage pharmacognosist. But they are not botanist which know exactly systematic botany. Only few companies employ real botanists. But untill now we didn't find a company cooperating with botanists which can identify all incoming herb material correctly. Let's take Sang Ji Sheng. It is one of the most tricky herbs to be identified. It took us several years to solve the problem of correct identification and we had to apply several methods like microscopy, TLC, HPLC as well as even more sophisticated methods like molecular tracking, identification of genes etc. Even we can see that often the used stock is a mixture of several botanical species of Sang Ji Sheng. As you know Sang Ji Sheng is growing on several species of shrubs and trees. Some of them are toxic and we even know that Sang Ji Sheng accumulates the toxic substances from its host plant.

The discussion about the preferences of the prescribers using different galenic preparations can only be followed after the correct identification of the starting material. And there is also the starting point to further discussions: Which quality of a certain herb is best? Chinese define Dao Di areas which means that the traditionally known best herbs come from that area. Does it mean that they show a higher content of certain ingredients? Maybe! But it could also mean that it contains a range of ingredients in a well balanced ratio. Look at Cannabis: you can produce Cannabis rich in THC but you will have more psachotic patients whereas traditional Cannabis seems to have a better balanced ingredient profile avoiding such symptoms. Not all TCM herbs can be cultivated and analysing herbs from wild collection and cultivation show differences. If you collect wild herbs you can have several varieties of the same species. Look at apples: there are hundreds or thousands of varieties. Taste and ingredients are in a huge range but still all is apple. So you immediately understand that varieties of a single herb can have many different ratios of ingredients. And this is also changing according to daytime and sesons of harvest, drying, processing etc. Who could say which batch is best? But to start clinical trials you need some comparable parameters.

Even traditionally TCM knows all kind of preparations: Most known is the water extraction by cooking, be it at home with the decoction pot or be it done under pressure.
Extracts are made and the result can be dried extracts, usually done by the help of starch. There again you have some discussions. Concentration ratios are given. But this is just to give the pracitioner an approximate idea. And it is more marketing stuff than scientific. The given numbers are almost very far from being correct. In fact we know from companies which report concentration factors 5:1 to be between 1,5:1 till 17:1. But they wouldn't tell it since it would be too confusing for therapists to consider individual concentration factors in calculating and precribing formulas. And more than that: All companies supplying a wide range of herbs have a rather large number of so called extracts which are in fact no extracts but just grinded raw herbs. You have this for certainly for all minerals but also for most animal herbs and furthermore for quite a big number of herbs like all carbonized herbs, resins, some woods etc. And even worse: A part of the mentioned special cases is even not concentrated but it is diluted! Diluted by starch. Since it would be a sticky powder of grinded raw herbs if not mixed with starch.

If you look at other galenic preparations you can have just grinded raw herbs without any concentration or otherwise processed than capsuled or pressed as tablets. In US there are US suppliers just doing this and they seem to have good results in clinical use. But here again you certainly have a completely different spectrum of ingredients than with several water cooking processes.

Talking about capsules and tablets can also be interesting. Producing tablets means also testing pressure of the tabletting machine because it influences the dissolving and aborption process in the digestive system. Who can tell which way is best and gives the best clinical resuslts.

Then you know that since ancient times Chinese used the method of using alcohol in extracting herbs. There you have a different result: you not only extract unipolar substances but you work bipolar. The ratio between the different ingredient will change a lot by applying this processing method. And it changes again slightly if you add other extraction material like glycerine.

It will probably take a couple of years or even generations to clear some of the problems brought up here. Basic rules must be followed. One of them is correct identification. Next is the setup of a suitable clinical trial by the help of methodologically good trained people like those with an education in evidence based medicine.

Phytax can help solving problems of correct botanical identification and lab analysis on some ingredients as well as testing heavy metals, pesticides, aflatoxines and other contaminants.