HONSO is a respected Japanese evidence based oriental medicine company who produces Traditional Chinese Herbal Medicine (Kampo). Kampo has been an intergal part of Japanese health care for over 900 years. In Japan only licensed medical doctors may prescribe Kampo herbs. Additionally Japanese insurance companies cover the cost of these herbal prescriptions. There is emerging scientific evidence that Sho-saiko-to may benefit patients with hepatitis (a western defined disorder) say researchers at Memorial Sloan-Kettering Cancer Center. Phase II studies include;

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.

LITERATURE SUMMARY AND CRITIQUE

Oka H, et al. Prospective study of chemoprevention of hepatocellular carcinoma with Sho-saiko-to (TJ-9). Cancer 1995;76:743-9.
Two hundred and sixty patients with cirrhosis were randomized using age, sex, heptitis B antigen status and liver function strata to treatment with Sho-saiko-to or control. Patients were followed for 5 years with bimonthly alpha-fetopretein measurement and quarterly ultrasonography. Hepatocellular carcinoma diagnoses were confirmed by angiography, computed tomography and, where indicated, biopsy. Sho-saiko-to led to a one-third reduction in the incidence of hepatocellular carcinoma (23% vs 34%) and a 40% reduction in death (24% vs 40%). Analysis of this data suggests that Sho-saiko-to has multifactorial action, both reducing the incidence of hepatocellular carcinoma and acting as a hepatoprotective agent.

In Traditional Chinese Herbal Medicine (my area of expertise) Sho-saiko-to (Xiao ChaiHu Tang in Chinese, and Minor Bupleurum Decoction in English) is one of the most popular perscribed herbal formulas. It treats a wide-range of disorders mainly used to harmonize the body in what is termed Shao Yang Disorders.

Most Shao yang disorders when treated properply resolve quickly, usually within one month. In the clinical trials stated above long term use of the herbs were presecribed and monitored. Traditinally overuse of this formula may injure the Qi and cause headache, dizziness and bleeding of the gums. In the studed quoted above Women who are nursing or pregnant and patients currently undergoing interferon treatment should not take Sho-saiko-to. Sho-saiko-to related pneumonitis (which may be fatal) has been reported in 74 patients (approximately 1 in 20,000).

Anticoagulants / Antiplatelets: Theoretically, SST may cause additive effects when administered concurrently. Interferon: Concurrent use may increase the risk of interstitial pneumonitis.
Monoamine oxidase inhibitors (MAOIs): Some ingredients, such as ginseng and licorice, may potentiate activity of MAOIs.

Cautions and Contraindications

Existing Lung Impairment:

One key concern is a report of lung difficulties among some users. Out of the 1.5 million prescriptions written in Japan, it was found that 1 in 20,000 had contracted pneumonitis, or interstitial pneumonia, serious conditions of the lung that results in inflamed airways. So, just to be safe, patients with underlying lung issues are recommended to avoid this remedy.

Pneumonitis was most often found in elderly, frail or infirm patients. People who already had an underlying lung disease, or who continued taking the product after breathing difficulties began, experienced a poorer outcome with this condition.

This is the Japanese government's actual recommended monitoring for physicians: exclude patients with lung disease, cigarette smokers and asthmatics. Screen for abnormal lung function at baseline and one month on treatment, and screen patients during treatment for signs or symptoms of pneumonitis.

Patients need to monitor lung function closely. Any shortness of breath, persistent cough or congestion should be cause for concern and would necessitate the immediate cessation of Sho-saiko-to or SST.

Concurrent Interferon Usage:

Interferon, itself, can cause pneumonitis. For this reason persons taking Interferon should not take Sho-saiko-to or SST concurrently, as it may compound their risk of contracting pneumonitis.

Additional Glycyrrhizin Intake:

Anyone with hypertension (high blood pressure) should be advised to avoid products with licorice extract that contains very high levels of glycyrrhizin.

Glycyrrhizin has been shown to significantly up-regulate blood pressure.

Both Sho-saiko-to and SST contain glycyrrhizin but not enough to cause concern on its own.

Studies show the potential side effect of hypertension by glycyrrhizin happens only when the daily dosage of it is over 100 mg. When taken as directed, the amount of glycyrrhizin in Sho-saiko-to and SST is between 24.7 to 46.0 mg per day, which is well below the caution level.

When taking Sho-saiko-to or SST, patients should avoid other licorice-containing products that might increase the dosage of glycyrrhizin into the caution range.

Serious Pre-existing Liver Damage Caution:

Sho-saiko-to and SST are not recommended for patients who are both diagnosed with cirrhosis and have a platelet count below 100,000. In these cases, careful consideration by, and close supervision of, a physician to proceed with Sho-saiko-to or SST is strongly advised.

Pregnancy and Lactation:

Sho-saiko-to and SST are contraindicated for women who are pregnant or nursing.
Additional Cautions:
 
A small percentage of individuals are sensitive to Bupleurum, the primary herb in this formula. If the following conditions worsen while taking Sho-saiko-to or SST, discontinue its use:

Migraine
Very high blood pressure (systolic over 180 mmHg)
Epistaxis (nose bleeds)
Please use the form below to indicate that you have read and understood the information presented.

Patient Verification:

-I have read and understand the cautions and contraindications above.

-I do not have underlying lung concerns. I am not asthmatic. I am not a cigarette smoker.

-I will discuss any concerns or questions with my primary care provider.

-I will not take Sho-saiko-to or SST concurrently with Interferon therapy.

-I do not have both cirrhosis and a platelet count under 100,000*

-I will not ingest other forms of licorice extract or any product with additional glcyrrhizin while using Sho-saiko-to or SST.

-I am not pregnant or nursing.

 *If you are diagnosed with cirrhosis, you agree and understand that you must consult with your health care provider to  determine your platelet count prior to taking sho-saiko-to or SST.

I have read and understand the cautions and contraindications for Sho-saiko-to and SST and will inform my primary care provider that I am taking this product. I also accept responsibility for informing my primary care provider of Sho-saiko-to's or SST's cautions and contraindications, and in requesting my progress and overall state of health be monitored.

Cautions and Contraindications

Existing Lung Impairment:

One key concern is a report of lung difficulties among some users. Out of the 1.5 million prescriptions written in Japan, it was found that 1 in 20,000 had contracted pneumonitis, or interstitial pneumonia, serious conditions of the lung that results in inflamed airways. So, just to be safe, patients with underlying lung issues are recommended to avoid this remedy.

Pneumonitis was most often found in elderly, frail or infirm patients. People who already had an underlying lung disease, or who continued taking the product after breathing difficulties began, experienced a poorer outcome with this condition.

This is the Japanese government's actual recommended monitoring for physicians: exclude patients with lung disease, cigarette smokers and asthmatics. Screen for abnormal lung function at baseline and one month on treatment, and screen patients during treatment for signs or symptoms of pneumonitis.

Patients need to monitor lung function closely. Any shortness of breath, persistent cough or congestion should be cause for concern and would necessitate the immediate cessation of Sho-saiko-to or SST.

Concurrent Interferon Usage:

Interferon, itself, can cause pneumonitis. For this reason persons taking Interferon should not take Sho-saiko-to or SST concurrently, as it may compound their risk of contracting pneumonitis.

Additional Glycyrrhizin Intake:

Anyone with hypertension (high blood pressure) should be advised to avoid products with licorice extract that contains very high levels of glycyrrhizin.

Glycyrrhizin has been shown to significantly up-regulate blood pressure.

Both Sho-saiko-to and SST contain glycyrrhizin but not enough to cause concern on its own.

Studies show the potential side effect of hypertension by glycyrrhizin happens only when the daily dosage of it is over 100 mg. When taken as directed, the amount of glycyrrhizin in Sho-saiko-to and SST is between 24.7 to 46.0 mg per day, which is well below the caution level.

When taking Sho-saiko-to or SST, patients should avoid other licorice-containing products that might increase the dosage of glycyrrhizin into the caution range.

Serious Pre-existing Liver Damage Caution:

Sho-saiko-to and SST are not recommended for patients who are both diagnosed with cirrhosis and have a platelet count below 100,000. In these cases, careful consideration by, and close supervision of, a physician to proceed with Sho-saiko-to or SST is strongly advised.

Pregnancy and Lactation:

Sho-saiko-to and SST are contraindicated for women who are pregnant or nursing.
Additional Cautions:
 
A small percentage of individuals are sensitive to Bupleurum, the primary herb in this formula. If the following conditions worsen while taking Sho-saiko-to or SST, discontinue its use:

Migraine
Very high blood pressure (systolic over 180 mmHg)
Epistaxis (nose bleeds)
Please use the form below to indicate that you have read and understood the information presented.

Patient Verification:

-I have read and understand the cautions and contraindications above.

-I do not have underlying lung concerns. I am not asthmatic. I am not a cigarette smoker.

-I will discuss any concerns or questions with my primary care provider.

-I will not take Sho-saiko-to or SST concurrently with Interferon therapy.

-I do not have both cirrhosis and a platelet count under 100,000*

-I will not ingest other forms of licorice extract or any product with additional glcyrrhizin while using Sho-saiko-to or SST.

-I am not pregnant or nursing.

 *If you are diagnosed with cirrhosis, you agree and understand that you must consult with your health care provider to  determine your platelet count prior to taking sho-saiko-to or SST.

I have read and understand the cautions and contraindications for Sho-saiko-to and SST and will inform my primary care provider that I am taking this product. I also accept responsibility for informing my primary care provider of Sho-saiko-to's or SST's cautions and contraindications, and in requesting my progress and overall state of health be monitored.

I have completed the Free Online TCM Diagnosis form diagnosis.htm and have corresponded with Ed Kasper LAc.

Additional Information