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STANDARDIZED HERBAL EXTRACTS: AN HERBALIST'S PERSPECTIVE
BY
Dr. Michael Tierra, L.Ac., O.M.D., Founding Member of the American Herbalists Guild
The advent of herbal products in the form of standardized extracts was initiated in 1992 as a result of a European Guaranteed Potency law. Since that time, proponents have heralded standardized herbal extracts as a major historical advance, allowing both consumers and medical doctors to use herbal products with greater confidence and more consistent results. What most don’t realize, however, is that the majority of these advocates consist of:
1. academics and medical doctors who often have little personal or clinical experience with herbs,
2. researchers whose work is funded by drug companies that manufacture the standardized extracts used in their clinical trials, and
3. naturopathic physicians who have financial ties with the companies that produce these products.
One group noticeably lacking from the chorus of standardized extract enthusiasts is professional clinical herbalists who rely on herbs as their primary healing modality. While not categorically condemning standardized extracts, clinical herbalists agree that just because an herb is biochemically standardized, it is not automatically more potent or efficacious than a non-standardized extract.
Standardized Herbal Extracts – What Are They?
Standardized herbal extracts are of two main types: An active constituent extract where there is a known and accepted active biochemical principle, and a marker extract where the active biochemical principle is not known and a characteristic compound is used as a "marker," which signifies the presence of the other biochemical compounds that give the herb its therapeutic properties.
In an active constituent extract, the known biochemical compound is isolated from the herb and concentrated to an amount not naturally found in the plant. Think of caffeine from coffee or morphine from the opium poppy. This type of extract tends to be more drug-like, potentially having undesirable side effects not normally present in the herb or its non-standardized extract.
From the herbalist’s perspective, this type of extract, while stronger in intended action is more of an herbal drug or "phytopharmaceutical" as it is called in Europe. As such, when the isolate is manipulated at the expense of the whole herb’s constituents, one may lose other properties contained within the herb, as well as buffering compounds that may lessen adverse reactions.
Examples of herbs where the known active principle is treated as an isolate include:
gingko (24% flavoglycosides), milk thistle (80% silymarin), grape seed (95% polyphenols), turmeric (95% curcumin), saw palmetto (90% free fatty acids), green tea (60% catechins), cascara sagrada (20-30% anthraquinones), bilberry (25% anthocyanosides), pygeum (12% phytosterols) and kava (30-40% kavalactones).
In a marker extract, no single active constituent is known, so the entire extract is treated as active and all plant constituents are present. With this type of extract, the caffeine in the above example would not be used as the marker compound because it is not unique enough to any one plant. When the ginsenosides of ginseng, for example, are standardized from 5 to 15 percent, all other properties of the herb are present in a marker extract. In the case of ginseng, however, the herb’s strength depends greatly on its age and growing conditions. So the mere presence of a fixed percentage of ginsenosides does not guarantee the tonic properties of a well-aged root. In fact, since ginsenosides are also found in the cheaper leaves, some standardized ginseng extracts are made only with ginseng leaf rather than the root.
Examples of herbs where the active principle is either not known or not treated as an isolate include:
artichoke (2-5% cynarin), chamomile (1.2% apigenin/0.5% essential oil), devil’s claw (5% harpogosides), echinacea (4% echinacosides), ephedra (6-8% ephedrine/pseudoephedrine), feverfew (2.6% parthenolides), ginseng (5-15% ginsenosides), goldenseal (5% hydrastine), horsechestnut (20% aescin), uva ursi (20% arbutin), gotu kola (10% asiaticosides), green tea (20-50% polyphenols), licorice (12% glycyrrhizin), St. John’s wort (0.3-0.5% hypericin), schisandra (2.6-4% schisandrins), valerian (0.8-1% valerenic acid) and willow (8% salicin).
While these represent the most widely used categories, science continues to develop further methods. One created by PharmaPrint Inc. is able to identify and standardize several active constituents. Their process represents the cutting edge of standardization, but with a cost of more than $500,000 per herb is only feasible for the most vested of pharmaceutical companies. They ultimately plan to make pharmaceutical-grade herbal products for the use of medical doctors and pharmacists.
Science versus Tradition
Traditional clinical herbalists use herbs not so much to treat named diseases, but to implement a shift in underlying physiological processes so the body can heal itself. The body’s complex processes can be affected by herbs, drugs, foods, emotional experiences and therapeutic exercises. This alone delineates a fundamental difference between wholistic herbal medicine and the phytotherapeutic or symptomatic drug-like approach of phytotherapy. While neither is fully exclusive of the other, the difference is in the intention of the final therapeutic goal.
Does this mean that one shouldn’t try an herb such as St. John’s wort for mild depression? Certainly not, but herbal medicine’s strength is its capacity to effectively treat based on the individual needs of each patient. The phytotherapist, on the other hand, uses herbs to treat specific named diseases. For this purpose, standardized extracts based on identified chemical constituents are appropriate. However, the fact that standardized garlic is sold for reducing cholesterol and hawthorn for reducing hypertension does not make them the best herbs in all cases. If you are not using the right herb for an individual’s condition and constitution, it makes no difference whether it is a high-priced standardized extract of guaranteed potency or a more traditional preparation of the same herb.
Industry "Standards"
There is no universally accepted "standard" for the manufacture of standardized herbal extracts. Companies’ manufacturing methods may vary so widely their finished products hardly resemble each other. Extracts may not be consistently standardized to one marker. For instance, nettle root is standardized by one company to 5% amino acids, by another to 8% sterols, and yet a third to 35ppm (parts per million) scopoline. Echinacea can be standardized to three different constituents: echinocosides, polysaccharides or polybutylides. And what is considered an active compound for any given herb may change in time, such as the hyperforin of St. John’s wort recently understood to be more active than its previous marker, hypericin.
As with decaffeinated coffee, the manufacture of high isolate standardized extracts may also involve highly toxic solvents such as hexane, benzene, methyl chloride or acetone. Besides leaving minute residue in the finished product, these solvents have hazardous effects on the environment.
Finally, on average, the comparison for the cost of standardized extracts over their non-chemically standardized counterpart is more than double that of the standardized version of the same herb.
Pharmaceutical Takeover of the Herbal and Vitamin Industry
With the development of standardized extracts, pharmaceutical companies are able to obtain exclusive international patents on isolated herbal constituents, as well as on the process of manufacturing them. Standardization may not mean better herbal medicine, but it does mean higher costs and more profits to pharmaceutical companies who can afford research that will guarantee them exclusive rights to these extracts.
This issue of error and deception has been reported down through the ages. According to veteran herbalist James Duke, herbal extracts have been "spiked" to deceptively indicate the presence of a specific marker with little or none of the herb’s associated constituents. In other words, except for the marker compound, there may be a completely different herb or no herb at all present. Therefore, while standardized extracts may offer a degree of assurance that the product is what it claims to be, it is still possible to be deceived.
Science does not exist in a vacuum, as medical and herbal research is dependent upon funding from business and industry. As long as science is influenced by the bottom line, truth will be threatened. The danger for herbs is that the public will be misled to accept primarily scientifically manufactured products that will eventually be superseded by "more effective chemical drugs."
So the questions remain: Is the exclusive sale of herbs in the form of standardized extracts a Trojan horse, bringing increased adverse reactions, increased governmental regulation and intervention, and ultimately the availability of only a few herbs deemed financially expedient to standardize by multinational pharmaceutical companies?
Consumer Acceptance
One thing that all sides agree on is that labeling an herb as a standardized extract is good for business. With a projected 4 1/2 billion dollar sales of herbal products for 1999, standardized extracts are increasingly playing a significant role in the popular acceptance of herbs. Yet, does this really promote herbalism?
As one herbalist-manufacturer glibly commented: "One way I can tell how powerful St. John’s wort is for depression is how good it instantly makes me feel when I look at my sales figures." Today, St. John’s wort standardized to 0.3% hypericin easily outsells its pharmaceutical rival, Prozac, and its derivatives. While it is certainly preferable to substitute the herb for the pharmaceutical, only using St. John’s wort may not fully address the patient’s issues and fails to reflect the high standards of clinical herbal medicine.
There are literally thousands of medicinal herbs growing worldwide – most of them are not, and may never be, standardized. In the North Hawaii Community Hospital on the big island of Hawaii, the focus is on integrating alternative and complementary medicine with conventional medicine. A considerable number of their patrons are of native Hawaiian heritage. Unfortunately, the hospital can’t endorse the use of their time-honored native herbs because, aside from being a long way from standardization, there is no accepted research on them.
Researchers and academics claim scientific separation from industry when it comes to the marketing and sales of the final herbal product. However, a deluge of articles and books currently recommend that consumers purchase only standardized herbs. Any publicized research attesting to the efficacy of an herb is, with few exceptions in the West, fully supported and paid for by vested manufacturers who are increasingly pharmaceutical companies. It is even possible in today’s world to hire a scientist, as if soliciting paid favors from the local brothel, to prove a case for anything from algae to oregano.
From a herbalist’s perspective, the empirical traditions of East and West based on "what works" are of the few sources for impersonal evaluation of an herb’s uses. Herbal products made based on these observations have proven their therapeutic effects for thousands of years without the need for biochemical standardization. Because certain standardized extracts, such as milk thistle extract with 80% silymarin, have been proven through funded research to be effective against liver poisons and toxins, this does not mean that the whole non-standardized herb may not have equally beneficial properties. In fact, there are traditional uses for milk thistle seeds, such as for enlarged spleen, menstrual irregularities and varicose veins, for which the standardized extract is not as suitable.
At this developmental stage of standardization, herbalists agree that most standardized extracts have significant shortcomings and should not be exclusively relied upon for all herbal needs.
Alternatives to Standardized Extracts
One effective alternative to standardization is called "fingerprinting." This involves a chromatographic analysis of an herb for all of its constituents, not just one. This colored graph of valleys and peaks ensures that the intended herb is present in an extract, thus identifying bogus products.
Companies should also hire qualified herbalists to supervise the timing and harvest of herbs, such as fully ripened saw palmetto berries for extracts used in research. If following GMP standards, as many outstanding herb companies do, why would an extract made from a large sampling of the finest quality herb be unsuitable for double blind clinical trials and research?
As herbal medicine extends further into the mainstream, science and industry must not forget that there is an as yet unrecognized profession of highly qualified and experienced clinical herbalists. The American Herbalists Guild (435-722-8452), founded in 1989, represents the emerging herbalist profession.
As science becomes more involved with herbal medicine, which is much needed in one sense, those who are attempting to integrate traditional medicines with holistic medical facilities, such as the native Hawaiians, must not be disempowered. Herbal medicine has always been a medicine by and for the people. Along with the discussions of biochemistry, standardized extracts, phytopharmaceuticals, and the inevitable involvement of pharmaceutical companies, those dedicated to the use of medicinal herbs must not forget their "roots" – an earth-centered awareness that affirms our interdependence with all life, and our relationship with the plant kingdom.
Michael Tierra, is regarded as one of the world's foremost exponent on herbal medicine. He is a Founding Member of the American Herbalists Guild, California state licensed acupuncturist, herbalist, with an Oriental Medical Doctor (OMD) degree. Author of several books including the best selling Way of Herbs, The Way of Chinese Herbs, The Natural Remedy Bible (all published by Pocket Books and Planetary Herbology and Chinese Traditional Herbal Medicine (published by Lotus Press) and the East West Herbal Correspondence Course. He has an extensive website with articles, books, forums and chat room at www.planetherbs.com. .
BY
Dr. Michael Tierra, L.Ac., O.M.D., Founding Member of the American Herbalists Guild
The advent of herbal products in the form of standardized extracts was initiated in 1992 as a result of a European Guaranteed Potency law. Since that time, proponents have heralded standardized herbal extracts as a major historical advance, allowing both consumers and medical doctors to use herbal products with greater confidence and more consistent results. What most don’t realize, however, is that the majority of these advocates consist of:
1. academics and medical doctors who often have little personal or clinical experience with herbs,
2. researchers whose work is funded by drug companies that manufacture the standardized extracts used in their clinical trials, and
3. naturopathic physicians who have financial ties with the companies that produce these products.
One group noticeably lacking from the chorus of standardized extract enthusiasts is professional clinical herbalists who rely on herbs as their primary healing modality. While not categorically condemning standardized extracts, clinical herbalists agree that just because an herb is biochemically standardized, it is not automatically more potent or efficacious than a non-standardized extract.
Standardized Herbal Extracts – What Are They?
Standardized herbal extracts are of two main types: An active constituent extract where there is a known and accepted active biochemical principle, and a marker extract where the active biochemical principle is not known and a characteristic compound is used as a "marker," which signifies the presence of the other biochemical compounds that give the herb its therapeutic properties.
In an active constituent extract, the known biochemical compound is isolated from the herb and concentrated to an amount not naturally found in the plant. Think of caffeine from coffee or morphine from the opium poppy. This type of extract tends to be more drug-like, potentially having undesirable side effects not normally present in the herb or its non-standardized extract.
From the herbalist’s perspective, this type of extract, while stronger in intended action is more of an herbal drug or "phytopharmaceutical" as it is called in Europe. As such, when the isolate is manipulated at the expense of the whole herb’s constituents, one may lose other properties contained within the herb, as well as buffering compounds that may lessen adverse reactions.
Examples of herbs where the known active principle is treated as an isolate include:
gingko (24% flavoglycosides), milk thistle (80% silymarin), grape seed (95% polyphenols), turmeric (95% curcumin), saw palmetto (90% free fatty acids), green tea (60% catechins), cascara sagrada (20-30% anthraquinones), bilberry (25% anthocyanosides), pygeum (12% phytosterols) and kava (30-40% kavalactones).
In a marker extract, no single active constituent is known, so the entire extract is treated as active and all plant constituents are present. With this type of extract, the caffeine in the above example would not be used as the marker compound because it is not unique enough to any one plant. When the ginsenosides of ginseng, for example, are standardized from 5 to 15 percent, all other properties of the herb are present in a marker extract. In the case of ginseng, however, the herb’s strength depends greatly on its age and growing conditions. So the mere presence of a fixed percentage of ginsenosides does not guarantee the tonic properties of a well-aged root. In fact, since ginsenosides are also found in the cheaper leaves, some standardized ginseng extracts are made only with ginseng leaf rather than the root.
Examples of herbs where the active principle is either not known or not treated as an isolate include:
artichoke (2-5% cynarin), chamomile (1.2% apigenin/0.5% essential oil), devil’s claw (5% harpogosides), echinacea (4% echinacosides), ephedra (6-8% ephedrine/pseudoephedrine), feverfew (2.6% parthenolides), ginseng (5-15% ginsenosides), goldenseal (5% hydrastine), horsechestnut (20% aescin), uva ursi (20% arbutin), gotu kola (10% asiaticosides), green tea (20-50% polyphenols), licorice (12% glycyrrhizin), St. John’s wort (0.3-0.5% hypericin), schisandra (2.6-4% schisandrins), valerian (0.8-1% valerenic acid) and willow (8% salicin).
While these represent the most widely used categories, science continues to develop further methods. One created by PharmaPrint Inc. is able to identify and standardize several active constituents. Their process represents the cutting edge of standardization, but with a cost of more than $500,000 per herb is only feasible for the most vested of pharmaceutical companies. They ultimately plan to make pharmaceutical-grade herbal products for the use of medical doctors and pharmacists.
Science versus Tradition
Traditional clinical herbalists use herbs not so much to treat named diseases, but to implement a shift in underlying physiological processes so the body can heal itself. The body’s complex processes can be affected by herbs, drugs, foods, emotional experiences and therapeutic exercises. This alone delineates a fundamental difference between wholistic herbal medicine and the phytotherapeutic or symptomatic drug-like approach of phytotherapy. While neither is fully exclusive of the other, the difference is in the intention of the final therapeutic goal.
Does this mean that one shouldn’t try an herb such as St. John’s wort for mild depression? Certainly not, but herbal medicine’s strength is its capacity to effectively treat based on the individual needs of each patient. The phytotherapist, on the other hand, uses herbs to treat specific named diseases. For this purpose, standardized extracts based on identified chemical constituents are appropriate. However, the fact that standardized garlic is sold for reducing cholesterol and hawthorn for reducing hypertension does not make them the best herbs in all cases. If you are not using the right herb for an individual’s condition and constitution, it makes no difference whether it is a high-priced standardized extract of guaranteed potency or a more traditional preparation of the same herb.
Industry "Standards"
There is no universally accepted "standard" for the manufacture of standardized herbal extracts. Companies’ manufacturing methods may vary so widely their finished products hardly resemble each other. Extracts may not be consistently standardized to one marker. For instance, nettle root is standardized by one company to 5% amino acids, by another to 8% sterols, and yet a third to 35ppm (parts per million) scopoline. Echinacea can be standardized to three different constituents: echinocosides, polysaccharides or polybutylides. And what is considered an active compound for any given herb may change in time, such as the hyperforin of St. John’s wort recently understood to be more active than its previous marker, hypericin.
As with decaffeinated coffee, the manufacture of high isolate standardized extracts may also involve highly toxic solvents such as hexane, benzene, methyl chloride or acetone. Besides leaving minute residue in the finished product, these solvents have hazardous effects on the environment.
Finally, on average, the comparison for the cost of standardized extracts over their non-chemically standardized counterpart is more than double that of the standardized version of the same herb.
Pharmaceutical Takeover of the Herbal and Vitamin Industry
With the development of standardized extracts, pharmaceutical companies are able to obtain exclusive international patents on isolated herbal constituents, as well as on the process of manufacturing them. Standardization may not mean better herbal medicine, but it does mean higher costs and more profits to pharmaceutical companies who can afford research that will guarantee them exclusive rights to these extracts.
This issue of error and deception has been reported down through the ages. According to veteran herbalist James Duke, herbal extracts have been "spiked" to deceptively indicate the presence of a specific marker with little or none of the herb’s associated constituents. In other words, except for the marker compound, there may be a completely different herb or no herb at all present. Therefore, while standardized extracts may offer a degree of assurance that the product is what it claims to be, it is still possible to be deceived.
Science does not exist in a vacuum, as medical and herbal research is dependent upon funding from business and industry. As long as science is influenced by the bottom line, truth will be threatened. The danger for herbs is that the public will be misled to accept primarily scientifically manufactured products that will eventually be superseded by "more effective chemical drugs."
So the questions remain: Is the exclusive sale of herbs in the form of standardized extracts a Trojan horse, bringing increased adverse reactions, increased governmental regulation and intervention, and ultimately the availability of only a few herbs deemed financially expedient to standardize by multinational pharmaceutical companies?
Consumer Acceptance
One thing that all sides agree on is that labeling an herb as a standardized extract is good for business. With a projected 4 1/2 billion dollar sales of herbal products for 1999, standardized extracts are increasingly playing a significant role in the popular acceptance of herbs. Yet, does this really promote herbalism?
As one herbalist-manufacturer glibly commented: "One way I can tell how powerful St. John’s wort is for depression is how good it instantly makes me feel when I look at my sales figures." Today, St. John’s wort standardized to 0.3% hypericin easily outsells its pharmaceutical rival, Prozac, and its derivatives. While it is certainly preferable to substitute the herb for the pharmaceutical, only using St. John’s wort may not fully address the patient’s issues and fails to reflect the high standards of clinical herbal medicine.
There are literally thousands of medicinal herbs growing worldwide – most of them are not, and may never be, standardized. In the North Hawaii Community Hospital on the big island of Hawaii, the focus is on integrating alternative and complementary medicine with conventional medicine. A considerable number of their patrons are of native Hawaiian heritage. Unfortunately, the hospital can’t endorse the use of their time-honored native herbs because, aside from being a long way from standardization, there is no accepted research on them.
Researchers and academics claim scientific separation from industry when it comes to the marketing and sales of the final herbal product. However, a deluge of articles and books currently recommend that consumers purchase only standardized herbs. Any publicized research attesting to the efficacy of an herb is, with few exceptions in the West, fully supported and paid for by vested manufacturers who are increasingly pharmaceutical companies. It is even possible in today’s world to hire a scientist, as if soliciting paid favors from the local brothel, to prove a case for anything from algae to oregano.
From a herbalist’s perspective, the empirical traditions of East and West based on "what works" are of the few sources for impersonal evaluation of an herb’s uses. Herbal products made based on these observations have proven their therapeutic effects for thousands of years without the need for biochemical standardization. Because certain standardized extracts, such as milk thistle extract with 80% silymarin, have been proven through funded research to be effective against liver poisons and toxins, this does not mean that the whole non-standardized herb may not have equally beneficial properties. In fact, there are traditional uses for milk thistle seeds, such as for enlarged spleen, menstrual irregularities and varicose veins, for which the standardized extract is not as suitable.
At this developmental stage of standardization, herbalists agree that most standardized extracts have significant shortcomings and should not be exclusively relied upon for all herbal needs.
Alternatives to Standardized Extracts
One effective alternative to standardization is called "fingerprinting." This involves a chromatographic analysis of an herb for all of its constituents, not just one. This colored graph of valleys and peaks ensures that the intended herb is present in an extract, thus identifying bogus products.
Companies should also hire qualified herbalists to supervise the timing and harvest of herbs, such as fully ripened saw palmetto berries for extracts used in research. If following GMP standards, as many outstanding herb companies do, why would an extract made from a large sampling of the finest quality herb be unsuitable for double blind clinical trials and research?
As herbal medicine extends further into the mainstream, science and industry must not forget that there is an as yet unrecognized profession of highly qualified and experienced clinical herbalists. The American Herbalists Guild (435-722-8452), founded in 1989, represents the emerging herbalist profession.
As science becomes more involved with herbal medicine, which is much needed in one sense, those who are attempting to integrate traditional medicines with holistic medical facilities, such as the native Hawaiians, must not be disempowered. Herbal medicine has always been a medicine by and for the people. Along with the discussions of biochemistry, standardized extracts, phytopharmaceuticals, and the inevitable involvement of pharmaceutical companies, those dedicated to the use of medicinal herbs must not forget their "roots" – an earth-centered awareness that affirms our interdependence with all life, and our relationship with the plant kingdom.
Michael Tierra, is regarded as one of the world's foremost exponent on herbal medicine. He is a Founding Member of the American Herbalists Guild, California state licensed acupuncturist, herbalist, with an Oriental Medical Doctor (OMD) degree. Author of several books including the best selling Way of Herbs, The Way of Chinese Herbs, The Natural Remedy Bible (all published by Pocket Books and Planetary Herbology and Chinese Traditional Herbal Medicine (published by Lotus Press) and the East West Herbal Correspondence Course. He has an extensive website with articles, books, forums and chat room at www.planetherbs.com. .
