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Although Chinese herbal medicine may not satisfy the more narrowed conventional western medical definition (i.e. eradication), what it CAN do probably expresses the feelings of most people regarding their experience with pain and suffering. A realistic approach to a poorly functioning liver, in Chinese medicine, would then consist of the restoration of improved liver function, the return to liver wellness, and an expectation of having a more normal "quality of life."
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What is Sho-saiko-to (Liver Kampo), and how does "Nu-Liver compare to it?
Sho-saiko-to (also known as Liver Kampo, TJ9 or HO9) is a Japanese formulation made up of seven Chinese herbs, currently being used in Japan for liver complaints. The word "kampo" (as in Liver Kampo) means 'Han Method', a reference to the Chinese culture of the Han era (206BC-220AD). Kampo is an older tradition preserved in Japan and is based upon classical Chinese Medicine.
The herbal mixture is also known in China as "minor bupleurum formula" (xiao-chai-hu-tang), one of a number of preparations used extensively by the Chinese for poor liver health. Interestingly, by the late 1960's and in large part due to public demand, kampo was integrated into the medical mainstream of Japan. Today, the large majority of physicians in Japan use kampo formulas that are available by prescription in almost all pharmacies.
After sho-saiko-to was approved for coverage by Japan's national health insurance in 1976, usage in Japan skyrocketed, with sales hitting a peak of more than $400 million in 1992. Sho-saiko-to seemed the perfect example of a blissful marriage between traditional medicine and modern health-care techniques.
THEN CAME THE BAD NEWS: In 1990, four patients developed worsening liver problems after being prescribed sho-saiko-to. In 1993, a wave of cases of Interstitial Pneumonia linked to sho-saiko-to use began appearing among liver patients, many of whom were using it simultaneously with other drugs. An investigation in 1996 by Japan's Health Ministry revealed that over the previous two years, 10 people had died while using the herb mixture. Sales of sho-saiko-to have since fallen to an eighth of their 1992 high. The number of victims is now pegged at twenty-six. The following warning and contraindications were mandated by the Japanese Ministry of Health and Welfare and are included in every package insert:
WARNING:
Treatment with this product may cause serious outcomes such as death, unless appropriate measures are taken in the early phase. The patient should be carefully monitored, and if fever, cough, dyspnea, abnormal pulmonary sound (fine crepitation), X-ray abnormalities, etc. are observed, administration of this product should be discontinued immediately.
WHAT WENT SO WRONG IN JAPAN THAT DID NOT OCCUR WITH THE SAME FORMULATION IN CHINA? This is what we believe happened:
In a further attempt to "westernize" its medical care, with regard to their herbal preparations, in the late 1980's and early 1990's the Japanese Ministry of Health and Welfare mandated Japanese manufacturers of traditional herbal medicines to "standardize" their formulas for specific levels of key chemical constituents (ingredients) in order to be approved as "medicines." Rather than modifying formulas as the traditional Chinese have done for centuries, Japanese kampo now uses fixed and precise combinations of herbs in standardized amounts. Manufacturers in Japan now test herbs for at least two key chemical compounds as the quality control markers on every formula they produce. By standardizing their herbal formulas, this is PRECISELY where, we believe, the Japanese erred. Our reasons are based, in major part, on hazards that are associated with using standardized extracts. These hazards are best explained and illustrated by Dr. Michael Tierra's 1999 article written for the periodical, "The Natural Foods Merchandiser". Dr. Tierra is an American born licensed herbalist, an Oriental Medical Doctor (OMD) and acupuncturist. He is also the author of several best selling books on herbal medicine, and the formulator of many of the herbal remedies found in Planetary Formulas, a well-respected herbal company. The full article text may be found at: www.planetherbs.com/articles/standardized%20extracts.htm Because it is a very long article, we have condensed it by including the summary below:
WHY STANDARDIZED HERBAL EXTRACTS?
Michael Tierra L.AC., O.M.D.
Standardized extracts arose out of the need to create a uniform product for clinical trials. Broadly speaking, there are two types: One is based on identifying and quantifying an extract to a characteristic "chemical marker" compound. The second identifies and concentrates one or more as active constituents (ingredients), making it closer to the level of a chemical isolate. This means that other naturally occurring constituents are displaced at the expense of one or a number of compounds. Those who support standardized extracts believe that they represent a trend towards higher technological refinement. They believe that they will provide a more consistent, stronger and more effective product backed by chemical analysis to confirm the presence and ratio quantity of one or a number of characteristic plant constituents. They further assert that this will increase consumer confidence, and that this is ultimately good for greater acceptance of herbs by the medical establishment and the mainstream.
In some aspects, the high degree of concentration is a positive attribute. In other respects, it begs the question of what herbalists are trying to accomplish with complex formulas. The main critical issues to consider when standardizing herbal products include:
1. Standardization based on a high concentration of active constituents and chemical marker compounds displaces other naturally occurring constituents which have been shown, many times, to be even more effective than the originally presumed active compound. By pumping up one ingredient of a product at the expense of its other ingredients, the active constituent may be eventually found not to be primarily responsible for the therapeutic action of the herb (other constituents may be discovered to be more biologically active). For example, in 1996, a German company, Lichter-Pharma, launched a standardized extract of St. John's Wort to target the most common mental illness, depression. Known as 'Jarsin 300' and marketed to doctors, by 1999 the extract, standardized to contain 0.3% hypericin, was outselling its rival Prozac. Now it has been found that the "active constituent" of 0.3% hypericin is inaccurate because hyperforin, another of the 100's of compounds in St. John's Wort, is the real active constituent. Already, German pharmaceutical companies are gearing up to market St. John's Wort standardized to its content of hyperforin.
Chinese herbal medicine, on the other hand, is an empirically based system that has demonstrated efficacy for thousands of years. Herbalists generally maintain that it is the interaction of the myriads of biochemical constituents within an herb that is responsible for its action(s). The public is led to believe that these standardized products are somehow better than nature can make them, and are more desirable than the simple plant remedy. Martha Benedict, a California State clinical herbalist with over 25 years of experience states: "There are too many plant components, interactions and interdependencies for us to be so witless as to think we can CONTROL the outcome of a complex event merely by controlling one or a limited number of components of a plant."
2. Standardization requires that all herbs are manufactured the same; different methods produce significant differences in the finished product of which the consumer is not aware. Furthermore, there is no standard for how standardized extracts are manufactured. This raises the basic question as to what is the best extract. Bob Brucea, co-founder of the American Herb Association believes that the process of bringing an herbal product closer to a total isolate through biochemical constituent extracts typically involves the use of a highly toxic and strong solvent, such as hexane, benzene, methyl-chloride, acetone, etc., all of which have an affinity for the intended constituent. In the end, it is impossible to completely evaporate and eliminate all traces of these solvents so there will usually be a residue in the finished product.
3. Standardization does not guarantee the same effects as more conventional herbal products. Christopher Hobbs, professional member of the American Herbalists Guild which was founded in 1989 in Santa Cruz, California states: "While the scientific work around standardization has certainly given our industry more credibility, especially in the medical field and the mainstream-don't equate standardization with efficacy and potency." The primary reason standardized herbal extracts exist is because they are considered necessary to achieve as much control in double blind studies as is possible. Researchers, however, never intended to establish that standardized extracts were superior to whole herbs or more conventional preparations.
4. The need to extract high isolates of an herb leads to the exclusive use of cultivated herbs over wild harvested ones. Herbalists have always felt that herbs grown in the wild are superior to those under cultivation. By definition, wild herbs cannot be standardized. This is because the wild herb possesses adaptive qualities based on subtle factors of biochemical composition and potency that would be lacking in the cultivated variety. In the process of standardization, it would be preferable to use what herbalists consider inferior herbs that are cultivated rather than superior wild herbs for the manufacture of standardized extracts.
FURTHER CONSIDERATIONS
To manipulate herbs to conform to an artificial process of standardization makes them more like 'phytopharmaceutical' drugs. This, in turn, means that they can only be manufactured into products by well-vested pharmaceutical companies to be distributed and sold in pharmacies under prescription by medical doctors. With profit as the primary motive, there is good reason to distrust pharmaceutical companies, since, with the advent of standardization, there is a pattern established where a company that is able to spend huge amounts of money on research is entitled to develop an exclusive patent for the process of extraction and standardization of an herbal product accompanied with a license to sell them on the international market. Remember, herbs, unlike chemical drugs, themselves, are not patentable. However, a standardized product used for research is patentable. Further, the notion that there are only one or two chemical compounds responsible for an herb's action is similar to saying that there are only one or two compounds that are useful in a specific food. Therefore, extracts based on one or a number of presumed active constituents are highly questionable.
If it becomes necessary to establish the positive identification of a plant, high-pressure liquid chromatography (HPLC) and nuclear magnetic resonance are used. These readings establish a fingerprint of all the chemicals contained in the plant or extract. To establish the identity of a plant, matching biochemical fingerprints are all that is needed. Of course, it is also possible to simply make a stronger herbal concentrate that is not standardized to a marker compound by following good conventional manufacturing practices. However, in doing so, there is also a tendency to having an increased risk for an adverse reaction with stronger preparations, so that the dose would need to be carefully regulated.
With the world clamoring for a magic bullet for a given condition, we at Samglo Enterprises believe that we should be more concerned about selecting the most effective herb or herbal formulas for boosting natural processes within the body that defend and protect the body, and that man should not fool around with nature. We believe that products, like "Nu-Liver", and other Chinese herbal formulas that use whole herbal extracts that have ALL of their constituents (both major and minor) intact, and that have been used for thousands of years by the Chinese are the BEST formulas. These formulas have been modified over the decades and centuries and have been further refined based upon human testing. Having said that, we leave the final decision as to which product you use up to you, the consumer.
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