Wild Rose College and Wholistic Clinic

(06/30/1999), Canada - Standardization Falls Short of its Mark;
But it might be pointing in a viable direction.

Is Standardization just another marketing tool? We see many standardized products coming on the market. Is this good or not? There is no easy answer for this. Well over 50% of the information on this subject is biased by marketing issues related to financial gain, and contains little scientific or, more importantly, clinical evidence. My view is somewhere in the middle of the road as I feel there are both positives and negatives involved.

One of the major reasons for standardization is the hope of creating a better product. Does it always do this? Not really. Sometimes it creates a better quality, sometimes not. One of the biggest problems is that there are no standards on which to base standardization. Critics of the herbal industry often have stated that until a practitioner can get good reliable, repeatable results in a scientific manner, the herbal industry will never gain the respect of main stream medicine. Standardization is an attempt to answer these critics, but I feel it falls quite a bit short of its mark. Is there a better way? I think so, but let`s first look at the issues and their evolution.

Herbalists in North America and around the world have always had standards to maintain. These standards, for centuries, have reflected the tools available at the time. They included the season in which the herb is picked, the ripeness, the taste, smell and appearance. This was further supplemented with drying, storage, processing of the botanical matter before it was given to the patient. We still find these standards in place in the production of a fine wine or a Cuban cigar. Quality is demanded, and thus produced, by the connoisseur. Do we want any less for our herbal medicines?

Quality of the original botanical material is the most important factor. We don`t want to lose that by moving our attention toward a chemical standard. Machine harvesting of 1,000 acre fields of St. John`s wort will not get the same quality of leaf to flower bud ratio as hand picked herbs. The flowers mature at different rates. On my farm, we harvest St. John`s wort 6 - 8 times throughout the season to assure the quality. To say a product is standardized to 0.3 % hypericin content is a joke. We are lead to believe this makes it better. It was proven in 1996, long before the latest sales trend, that hypericin is not the active ingredient. However this is not to say that some standards are not useful. Let`s say you get up in the morning after a very little sleep. You go to the coffee pot to get some wake-up juice and find it is decaffeinated. All of a sudden one of the active ingredients is important to you.

One of the biggest questions is - What active ingredient do we standardize to? I have been interested in the biochemistry of plants for several years. Heck, I wrote a series of three textbooks on the subject. It holds great fascination to me. But it is not the whole issue. We really don`t know all of the active ingredients of many botanicals. As an example, the ‘active ingredient` of Valerian has changed five times in the last ten years. There are hundreds of thousands of different chemicals in each cell of a plant. To say we know the entire interaction is absurd and is, at the least, arrogant of us to presume this knowledge. Maybe the great architect in the sky has the answer to this question, but I can say this herbalist doesn`t.

It is really interesting to understand how a spark plug fires the engine of a car and it is easy to say it is an active ingredient of a car, but to standardize a car purchase to a spark plug would be pretty absurd. When I buy a car I want to know it has spark plugs, but I also am looking for a few other things such as an engine, tires, a steering wheel and maybe even a rear view mirror. Perhaps when looking at a herb, we should take into consideration a larger array of the active and marker chemicals. This is a concept called finger-printing or SpectrAll, to connote a large array of important chemicals. Instead of looking at hypericin content in St. John`s wort, let`s include pseudohypericin, hyperiforin, biapigenin, quercitin and quercitrin in the spectrum of important ingredients. This is basically the difference between a standardized product and a guaranteed potency product. This can give us a better look at how the environment treated the plant instead of just looking at one single standard.

In an attempt to explain this to my students, I came up with the following stories. As one of my clinics has been in Vancouver where I had members of the X-File staff as patients, the analogy comes out of the X-Files, so please bear with me. Let`s say we are in a board room with closed doors. We are talking about extraterrestrial life and an alien beams into the middle of the room. He looks around and tries to figure out what these human beings are? What is their active ingredient? One of the people gets up, runs to the door, turns the door handle, and disappears from the room. The alien says, ``Eureka! The active ingredient of a human is the hand.``

Well, he goes up to the closest person, cuts off a hand, goes to the door and tries to open it. It doesn`t work. Then he realizes the hand has to be connected to the whole person. This gets the alien studying hands more closely and he realizes over the next few months that some hands are good at painting, others are good at pitching balls and still others are good at playing the piano. It is the personality of the whole person that shows how the hand works. Similarly, it is not a single ingredient that make a herb work - it is a group of factors. The true active ingredient of St. John`s wort is - - - St. John`s wort!

While standardization has problems, it does have benefits. To say it is just a marketing ploy of the pharmaceutical industry`s desire to take over the herbal market is like throwing the baby out with the bath water. As a herbal clinician, I want a certain quality of botanical to use, may it be high quality tincture, standardized extract or herbs picked by the farmer down the road. It is understood that given chemicals can help produce a certain level of activity with patients. It is not the only factor at work though. There might be other active ingredients and most likely a synergistic action of several factors. The true test is how the herb reacts in my patient. Let`s be perfectly blunt, if the pharmaceutical industry thought the single standardized ‘active ingredient` was the reason for the whole medicinal action, they would isolate it, patent it, synthesize it and sell it to us as a single, high cost drug. They can`t because there is much more to the picture and they know it.

Some feel that standardization is more along the lines of finger-printing a plant. Standardization to a single data point such as hypericin is not finger-printing. We need to look at a much larger spectrum of the constituents. Just as concerned parents might keep records of their children`s finger-prints to help find them if they got lost or kidnaped, we might want to finger-print a botanical to make sure we get the right medicinal plant. By looking at a larger spectrum of important constituents of a plant we can create a finger-print. This usually demands five or more active or marker constituents.

As children grow we find that they have certain talents, we might want to assist them in these areas by sending them to special classes to help improve their dance, violin or their football. Similarly if we want a specific ‘talent` of the botanical increased, we may want to concentrate it. This shouldn`t be at the expense of all other important constituents though. The proof of the medicinal substance is how it works on our patients on a regular basis. It is important to note that even though we know the chemistry of a plant, it doesn`t mean it has to be concentrated. Black Cohosh, St John`s wort or Vitex are rarely concentrated when sold as a standardized extract. Understanding a botanical`s chemistry doesn`t mean we are getting further away from nature or losing our ‘roots,` of losing touch with the earth-centeredness of traditional medicine. This is like saying I`m losing touch with my children because I drive them to violin lessons or football practice.

All grape wines are standardized to the same basic alcohol content, using a single plant species, but there are several other factors influencing the quality of the wine. Certainly the ‘year` is a big factor. A bright sun when the buds were full, high humidity, moderate cloud cover during ripening - all of these affect the final quality of wine. The way the grapes were picked and processed have a factor in the color, bouquet, and taste of the wine. These same factors affect the quality of our herbal medicines.

Let`s take a closer look, with a few examples, of what I mean by this SpectrAll idea. Garlic is both a food and a medicine. It has been used throughout history. We can certainly get therapeutic effects from eating raw garlic, but many do not like the social aspect of its odor. By understanding the chemistry of its activity we can get the activity of the garlic without the odor. Many manufacturers talk about the ‘Allicin` content. It is much more meaningful to talk about the Allicin yield in the body. Allicin is produced by both Alliin and Alliinase. Other potent factors in garlic are the thiosulfinates, gamma-glutamylcysteines, and sulfur content. By knowing the levels of all of these ingredients I can be much more specific what dosage to use and the results I will get with my patients and help avoid the odor issue.

Another example would be Kava Kava. Certainly we are looking at the kavalactone content. However there are several different kavalactones and a sweeping statement indicating the highest level of kavalactones is not what I`m interested in. No, I don`t think that 70% kavalactones is better than 30% kavalactones. The kind of results produced by Kava is related to the ratio of at least six of these kavalactones. Each herb has its own rules for the specific action or array of actions desired.

It is very important to realize just because we understand the chemical content of a plant and its relationship to an activity doesn`t mean it works better. It doesn`t mean that because a product label tells you information about its chemical content it will work better than one that does not have this information. Sometimes by knowing the spectrum of chemicals we can aid in concentrating it. We often concentrate the herb for convenience of consumption. Most people prefer to take two or three capsules instead of 20. Let`s not forget these herbs are vegetable matter just like carrots. If I want the therapeutic effect of 10 - 20 carrots, I will make carrot juice. If I were going after the antioxidant effect, it would help to know the mixed carotinoid content of the glass of carrot juice. The knowledge of the carotinoid content does not make it work better, but it helps me decide how many glasses I should drink and assures me I will get the desired action. Of course, sometimes it is nice to sit back and enjoy some carrot juice just because I like it.