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United States FDA approved trials Traditional Chinese Herbal Medicine

New York Trail: Sho-saiko-to for patients with chronic hepatitis C who are intolerant to or have contraindication to Interferon-based therapy.

San Diego Trial: Safety and Tolerability of Sho-saiko-to in Patients with Compensated Cirrhosis due to Chronic HCV Infection

 

SST (Sho-Saiko-To), a botanical product based on Kampo herbal medicine has been successfully used by over 1.5 million people in Japan for liver care. Currently, Honso Sho-Saiko-To is in clinical studies at leading US hospitals and universities. In a New York cancer center the herbal preparation is studied for the liver health issue that is referred to as “non-responders” to conventional therapy. Meanwhile, a liver center at a San Diego university hospital is testing the capsule SST for strengthening the liver.

Sho-saiko-to is composed of 7 botanical ingredients including bupleurum root, licorice, ginseng, jujube, pinellia tuber, ginger, and scutellaria root. The standardized full-dosage Sho-saiko-to (H09) has been available in Japan and US only in granule form through licensed practitioners. [Ed Kasper LAc, the Happy Herbalist  www.Happyherbapist.com ]

These 7 herbs comprise the Traditional Chinese Medicine's Herbal Formula Xiao Chai Hu Tang (Minor Bupleurum formula, in English). This formula is probably the most widely prescribed herbal prescription treating a great many western life-style disorders. There are a great many numerous variations to this formula that tailor the prescription uniquely to the individual (which is a hall mark of TCM).

 

Liver function can be compromised by a number of things—virus infections, pollution, pharmaceuticals, pesticides, steroids, poor diet, insufficient rest, stress, obesity, smoking, and illness, to name a few. Since the liver is one of the most important organs when it comes to fighting illness, liver problems can have serious consequences.

SST formula has stayed the same for hundreds of years, because it has repeatedly proven successful for protecting the liver. While the ingredients work synergistically, they are also quite potent individually.

The seven active ingredients and their actions include the following:

 
Bupleurum root: [24.1%] Radix Bupleuri - chai hu - Chinese Thorowax root is bitter and slightly cold. It harmonizes interior and exterior, courses the Liver, vents Pathogenic qi, and raises the yang. It enters the Liver, Pericardium, Gallbladder and Triple Burner meridians. Reduces adhesion of tumor cells, activates natural defenses against tumor cells*

Pinellia tuber: [19.6%]  Rhizoma Pinelliae Ternatae - ban xia - Treated Pinellia rhizome is acrid and warm. It regulates and circulates the qi and disperses Phlegm. It is used whenever Dampness accumulates and causes vomiting, excess sputum, or poor digestion. It enters the Spleen and Stomach meridians. Increases interferon activity*

Scutellaria root: [19.9%] Radix Scutellariae Baicalensis - huang qin - Baikal Skullcap root is cold and bitter, entering the Heart, Lung, and Gallbladder channels. It effectively clears Damp Heat and Fire, resolves phlegm, relaxes the Liver. Scavenges free radicals, relaxes blood vessels, reduces blood pressure, and exhibits antitumor activity*

Licorice: [10.3%] Radix Glycyrrhize Uralensis - gan cao - Licorice root Generates interferon activity, protects the gastric system, is sweet and warm. It supplements qi, strengthens the Heart, Spleen, Stomach while harmonizing the prescription. It enters the Spleen and Lung meridians. chemopreventive, and has antiviral activity*

Ginger:  [6.9%] Rhizoma Zingiberis Officinalis - gan jiang - Dried Ginger rhizome is acrid and warm. It harmonizes and supplements the Middle Burner, and harmonizes the prescription. It enters the Lung, Spleen and Stomach .Inhibits the spread of cancer cells*

Jujube: [8.9%] Frutus Zizyphi Jujubae - hong zao - Red Jujube fruit is sweet, warm and supplements and enters the Spleen and Stomach. It reinforces qi, harmonizes the Constructive qi and Defensive qi, resolves drug toxins and harmonizes the characteristics of harsh herbs. Increases natural killer cell activity and is antiasthmatic*

Ginseng: [10.3%] Radix Ginseng - ren shen - Oriental White Ginseng root is sweet, bitter and warm. It supplements the Ancestral (yuan) qi, strengthens the Spleen/Stomach, helps create new Blood, and quiets the Spirit. It enters the Spleen, Lung and Kidney meridians.
 Inhibits cancer cell growth by suppressing their DNA and increases natural immune factors*

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Currently, SST is under clinical phase II trials at leading US medical institutions in New York and San Diego for patients with disorders of liver function. The New York study has produced very encouraging preliminary results, which were presented at the 1st Annual Society of Integrative Oncology Conference in New York on November 18th, 2004 – proving the positive effect of SST on the liver. No adverse events have been attributed to SST among all participants who enrolled in the trial.

Origin and Development

"Minor Bupleurum Decoction" (xiao chai hu tang) is a famous prescription, first recorded in the classic herbal text "Treatise on Febrile Diseases Caused by Cold" (shang han lun), written by Dr. Zhang Zhong-Jing. With its many applications, it is mentioned over 30 times in "Treatise on Febrile Diseases Caused by Cold" and "Essentials from the Golden Cabinet." In the former, it is stated that in patients with injury from Cold or Wind attack, only one of the symptoms of the Minor Bupleurum (xiao chai hu tang) pattern is needed to confirm the diagnosis. The clinical scope of this formula has been greatly expanded over the centuries to include a wide variety of problems associated with lesser yang (half exterior, half interior) condition, but which have not necessarily progressed through the stages of an externally-contracted disorder. Modern practitioners use this formula in treating a myriad of conditions including childhood diarrhea, habitual constipation, renal colic, acute rheumatic fever and malaria.
 

The hallmark symptom is alternating fever and chills. The prescription was designed originally for conditions like malaria, marked by alternating fever and chills along with periods of latency and activity. This alternation of Heat/Cold complex plus periods of latency and activity is also common with chronic immune disorders, such as chronic fatigue syndrome and other viral conditions for which Minor Bupleurum is extremely useful. It is helpful in cases where the symptoms of a cold or flu may linger for weeks after the initial acute phase of the illness is over. This formula helps the patient resolve the illness more quickly. It is highly effective for the treatment of ear infections, mumps, and tonsillitis in children. In Japan this formula is used as an immuno-stimulant to prevent the common cold.

What are the benefits of SST?
SST has shown in clinical studies to slow down the progression of the liver injury. In New York, a clinical phase II trial using SST to treat hepatitis C patients has shown encouraging benefits. Patients report significant improvement of symptoms including increase in overall energy within the first month of treatment. Blood tests and liver biopsy of these patients showed improvement as well. These findings are similar to the many Japanese research papers that have been already published in the past decades. It is particularly beneficial to all forms of chronic liver damage in helping to prevent further formation of liver fibrosis and scaring.

Is Sho-saiko-to safe?
The Chinese and Japanese people have been safely using the herbal formula for hundreds of years. The only serious adverse effect reported in literature in the past two decades was pneumonitis. The majority of these occurrences were with patients who had complications with an underlying lung disease, were elderly (70-80 years old), continued taking Sho-saiko-to after the onset of pneumonitis, or had severe hypoxemia. The combination therapy of Sho-saiko-to and interferon has also been reported in causing pneumonitis more likely than either alone. When these two therapies are used simultaneously the effects can be harmful to the lung tissue. Sho-saiko-to is not recommended for people who are taking interferon-based therapy or have underlying lung dysfunction*.

How long should I take Sho-saiko-to?
In the on-going clinical trial physicians are giving their patients 7.5g/day of Sho-saiko-to for one year. Most people in Japan take Sho-saiko-to for years. Ask your healthcare practitioner for further information.

How long does a consumer take your product before noticing results?

The results vary by individual. However, there are reports that people feel a significant boost in energy within the first month of usage. In general, Japanese physicians recommend their patients to take SST for 6-12 months. For chronic liver damage, SST can be taken for even a longer period of time.


Does this mean, SST offers a solution for interferon non-responders?
Our clinical trial in New York is to treat the patients who are not responding well to the current conventional therapy. A large percentage of liver disease patients do not respond to conventional treatment due to a specific virus infection (genotype I), some cannot tolerate the side effects of the conventional treatment. SST offers a new hope to these liver disease patients.
 


Sho-saiko-to help to improve liver function?
Sho-saiko-to is the most extensively researched Chinese herbal formula in Japan. It has been reported that over 1.5 million hepatitis patients use the herbal formula. There is a large amount of research showing that Sho-saiko-to improves liver function*. There is evidence that Sho-saiko-to benefits patients by helping to improve their liver function and slow down the progress of liver damage*. In fact the research data for Sho-saiko-to was so strong that doctors at a prestigious New York cancer hospital have decided to study it in a clinical phase II trial under an FDA approved Investigative New Drug (IND). The study is entitled “Sho-saiko-to for Patients with Chronic Hepatitis C Who are Intolerant to or have Contraindications to Interferon-Based Therapy: A Phase II Study”. It is a 52 week trial, where patients receive Sho-saiko-to granules at 7.5g per day. The outcome will be based upon comparisons of liver biopsies before and after the treatment. The initial results have been encouraging and were reported at the 1st International Conference of the Society for Integrative Oncology in November 2004*.

About Honso USA, Inc.

At Honso, we take science and quality as seriously as you do. With 30 years experience in serving the Japanese medical community with premium-quality Kampo products, Honso is making a long-term commitment to complementary and alternative medicine practitioners throughout the world.

About HepCare, Inc.  HepCare, Inc. developed a new application form of SST – the development was conducted together with physicians and patients in mind. The product is now available in veggie capsules – making it easy for people to fit SST into their liver health routine.

Hundreds of research papers have been published, mostly by Japanese scientists. Studies in cell lines, animal models and human clinical trials have all pointed in a positive direction for using SST formula to fight liver dysfunction. For more detailed research information, visit Pubmed.com or Medline.com and search the keyword sho-saiko-to.

published reports on medline

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=search&term=Sho-saiko-to

 available in vegi-capsules, tablets, granules or liquid extract

presented by

www.HappyHerbalist.com

Ed Kasper L.Ac, Acupuncturist & Herbalist

417 Laurent St. Santa Cruz, CA 95060

 

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