CLINICAL SUMMARY
 
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Sho-saiko-to (SST or
Liver Kampo, Honso's
consumer product) or "Xiao Chai Hu Tang" is
a classic Chinese botanical formulation widely known by its Japanese
name.
MAY HELP
-
To improve liver function*
-
To increase immune against harmful damages on the
body*
-
To enhance digestive health*
CONSTITUENTS
Sho-saiko-to is a mixture of seven botanicals:
-
Bupleurum root (Chai hu)
-
Pinellia tuber (Ban xia)
-
Scutellaria root (Huang qin)
-
Ginseng (Ren shen)
-
Jujube (Da zao)
-
Licorice (Gan cao)
-
Ginger (Sheng jiang)
A number of
pharmacologically active components have been isolated including:
-
Baicalin
-
Baicalein
-
Glycyrrhizin
-
Saikosaponins
-
Ginsenosides
-
Wogonin
-
Gingerols
The standardization specification (HPLC assay) by Honso Pharmaceutical Co.,
Ltd.:.(4)
-
Glycyrrhizin:
24.7-46.0 mg/day
-
Baicalin:
110.6-205.6 mg/day
-
Saikosaponin:
6.5-19.7 mg/day
CURRENT CLINICAL TRIAL IN
THE US
New York Trail: “Sho-saiko-to for patients with chronic hepatitis C who
are intolerant to or have contraindication to Interferon-based therapy:
a phase II study”
(Protocol 02-073).
San Diego Trial: "Safety
and Tolerability of Sho-saiko-to (“SST”) in Patients with Compensated
Cirrhosis due to Chronic HCV Infection, A Phase II Trial" (Project:
031532)
PHARMACOKINETICS
Due to the
complexity of this formula, only limited data is available. One study
indicates that the serum concentration of glycyrrhizin after a normal
daily dose is 1.2 mcg/ml.
WARNINGS
Sho-saiko-to may cause interstitial pneumonitis, a potentially fatal
condition. Concurrent use of interferon may increase this risk.
CONTRAINDICATIONS
Women who
are nursing or pregnant and patients currently undergoing interferon
treatment should not take Sho-saiko-to.
ADVERSE REACTIONS
Sho-saiko-to related pneumonitis has been reported in 74 patients
(approximately 1 in 20,000).
DRUG INTERACTIONS
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.
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.
REFERENCES
(1) Bensky
D, Gamble A. Chinese Herbal Medicine: Materia Medica. Revised Ed.
Seattle: Eastland Press; 1993.
(2) Mizoguchi Y, et al. The effects of sho-saiko-to on interleukin
production by hepatic sinusoidal endothelial cells. J Med Pharm Soc
1989;6:172-6.
(3) Sato A, at al. Pneumonitis induced by the herbal medicine
sho-saiko-to in Japan. Nihon Kyobu Shikkan Gakkai Zasshi
1997;35:391-5.
(4) Honso Professional Catalog 2002. Honso USA, Inc. Tempe, Arizona.
(5) Oka H, et al. Prospective study of chemoprevention of hepatocellular
carcinoma with Sho-saiko-to (TJ-9). Cancer 1995;76:743-9.
(6) Yano H, et al. The herbal medicine sho-saiko-to inhibits
proliferation of cancer cell lines by inducing apoptosis and arrest at
the G0/G1 phase. Cancer Res 1994;54:448-54.
(7) Sakaida I, et al. Herbal medicine Sho-saiko-to (TJ-9) prevents liver
fibrosis and enzyme-altered lesions in rat liver cirrhosis induced by a
choline-deficient L-amino acid-defined diet. J Hepatol
1998;28:298-306.
(8) Ito H, et al. Effects of a blended Chinese medicine,
xiao-chai-hu-tang, on Lewis lung carcinoma growth and inhibition of lung
metastasis, with special reference to macrophage activation. Jpn J
Pharmacol 1986;41:307-14.
(9) Yamashiki M, et al. Effects of the Japanese herbal medicine "Sho-saiko-to"
(TJ-9) on in vitro interleukin-10 production by peripheral blood
mononuclear cells of patients with chronic hepatitis C. Hepatology
1997;25:1390-7.
(10) Kakumu S, et al. Effects of TJ-9 Sho-saiko-to (kampo medicine) on
interferon gamma and antibody production specific for hepatitis B virus
antigen in patients with type B chronic hepatitis. Int J
Immunopharmacol 1991;13:141-6.
(11) Fujiwara K, et al. Regulation of hepatic macrophage function by
oral administration of xiao-chai-hu-tang (sho-saiko-to, TJ-9) in rats.
J Ethnopharmacol 1995;46:107-14.
(12) Kaneko M, et al. Augmentation of NK activity after oral
administration of a traditional Chinese medicine, xiao-chai-hu-tang (shosaiko-to).
Immunopharmacol Immunotoxicol 1994;16:41-53.
(13) Nagatsu Y, et al. Modification of macrophage functions by
Shosaikoto (kampo medicine) leads to enhancement of immune response.
Chem Pharm Bull (Tokyo)
1989;37:1540-2.
(14) Yamashiki M, et al. Herbal medicine 'Sho-saiko-to' induces tumour
necrosis factor-alpha and granulocyte colony-stimulating factor in vitro
in peripheral blood mononuclear cells of patients with hepatocellular
carcinoma. J Gastroenterol Hepatol 1996;11:137-42.
*The information provided here is for healthcare professional
practitioners only. This product is a "traditional Asian medicine"
formula. 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.
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