How It Works
Bottom Line: Because so little research has been performed with sho-saiko-to, it should only be used under the guidance of a doctor. It may have liver-protectant effects. There is no evidence that it can treat or prevent any other type of cancer.
From laboratory and animal studies, sho-saiko-to appears to act in multiple ways to prevent liver injury and enhance immunity. Sho-saiko-to and its isolated chemical components show an ability to reduce or stop the proliferation of liver cancer cell lines in the laboratory, but have little effect on normal human white blood cells (this is an advantage because most chemotherapy drugs kill healthy human blood cells as well as tumor cells). In rats, sho-saiko-to prevents liver injury, promotes liver regeneration, and prevents the development of pre-cancerous growths in the liver. Other cancers have also been shown to be sensitive to sho-saiko-to in laboratory tests. In addition, scientists have shown through laboratory tests that sho-saiko-to may stimulate many aspects of the immune system. It is not known whether these effects occur in the human body, but it has been documented that people who use ginseng, one of the herbs found in sho-saiko-to, have a lower risk of hepatocellular carcinoma (liver cancer).
Purported Uses
To prevent and treat cancer
One clinical trial showed that sho-saiko-to was associated with a decreased risk of developing hepatocellular carcinoma (liver cancer) in patients with cirrhosis of the liver, but there is no other proof from clinical trials that this herbal mixture can prevent or treat cancer. Clinical trials are now being performed to determine whether sho-saiko-to can increase survival in patients with hepatocellular carcinoma.
To reduce fevers
No scientific evidence supports this use.
To treat gastrointestinal disorders
No scientific evidence supports this use.
To treat infections
No scientific evidence supports this use.
To treat liver diseases, such as cirrhosis and hepatitis
Laboratory and animal studies suggest that sho-saiko-to has a protective effect on the liver, but there is no proof from clinical trials that it can treat cirrhosis or hepatitis (although it may prevent cirrhosis from progressing to liver cancer). The effectiveness of sho-saiko-to in treating hepatitis C is currently under study in a clinical trial.
To treat malaria
No scientific evidence supports this use.
Research Evidence
Cirrhosis of the liver:
Patients with cirrhosis of the liver are at a greater risk of developing hepatocellular carcinoma (liver cancer). A clinical trial studied the ability of sho-saiko-to to prevent the development of hepatocellular carcinoma in 260 patients with cirrhosis. Patients were randomly given sho-saiko-to or a placebo pill. After five years of follow-up, fewer patients taking sho-saiko-to had developed hepatocellular carcinoma (23% vs 34% in the placebo group) and fewer had died (24% vs 40% in the placebo group). This suggests that sho-saiko-to may act as a liver-protectant.
Warnings
Sho-saiko-to may cause interstitial pneumonitis, a potentially fatal condition. Use of interferon at the same time may increase this risk.
Because it is not regulated by the FDA, this product may be contaminated with other botanicals and/or the concentration listed on the label may be inaccurate.
Do Not Take If
You are pregnant or nursing
You are currently undergoing interferon treatment (This can increase the risk of interstitial pneumonitis, a potentially fatal condition).
You are taking warfarin or other blood thinners (In theory, sho-saiko-to may increase the risk of bleeding and bruising).
You are taking monoamine oxidase inhibitors (MAOIs) (Some ingredients in sho-saiko-to, such as ginseng and licorice, may have additive effects).
Side Effects
Sho-saiko-to related pneumonitis has been reported in 74 patients (approximately 1 in 20,000).
Common Name
Xiao-chai-hu-tang, minor bupleurum decoction
Clinical Summary
Sho-saiko-to or 'Xiao Chai Hu Tang' is a classic Chinese botanical formulation widely known by its Japanese name. Traditionally, it is used to treat fever, malaria, gastrointestinal disorders and chronic liver diseases. A prescription form has been used extensively in Japan, predominantly for hepatitis (1). Sho-saiko-to and its isolated chemical components demonstrate marked antiproliferative effects on hepatoma lines and ovarian cancer cell lines (15). Morphological analysis of cells grown in the presence of Sho-saiko-to show evidence of apoptosis (6). Sho-saiko-to has been shown to prevent liver injury and promote liver regeneration in animal models (7) and to enhance various aspects of immune function, including effects on killer cells (12), interleukins (9), interferon (10) and macrophages (11) (13). Data also indicate that Sho-saiko-to causes enhancement of granulocyte colony-stimulating factor (14). Although Sho-saiko-to has a good safety profile, its use has been associated with interstitial pneumonitis (3), liver injuries (16) hepatitis (17). It should only be used under the supervision of a qualified practitioner. Clinical studies are currently underway to determine whether Sho-saiko-to can increase survival in patients with liver cancer and to evaluate its therapeutic effect on hepatitis C.
Food Sources
Some of the ingredients, such as jujube, ginger and licorice, are commonly found in Asian recipes.
Purported uses
- Cancer prevention
- Cancer treatment
- Fever
- GI disorders
- Infections
- Liver disease
- Malaria
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
Given the complexity of Sho-saiko-to, it is unlikely that all active components have been identified.
(4)
Mechanism of Action
ginseng
Sho-saiko-to (SST) appears to have a multi-factorial activity, inhibiting proliferation of hepatocellular carcinoma (HCC) cells, preventing liver injury, promoting liver regeneration and enhancing immune function. Human studies show reduced incidence of HCC in users of ginseng, one of the botanicals in this formula (5). SST and its isolated chemical components demonstrate marked antiproliferative effects on hepatoma lines in vitro. Of particular interest is that SST shows only minimal inhibitory effects on normal human peripheral lymphocytes, even at high concentrations. Morphological analysis of cells grown in the presence of SST shows evidence of apoptosis (6). SST prevents liver injury and promotes liver regeneration in animal models: rats treated with SST show less fibrosis as indicated by reduced liver hydroxyproline and a smaller increase in serum hyaluronic acid. Moreover, these rats develop fewer preneoplastic lesions (7). SST has also been shown to prevent development or metastasis of carcinomas other than HCC (8). SST enhances various aspects of immune function including effects on interleukins (9), interferon (10), macrophages (11) (13) and killer cells (12). Data also indicate that SST causes enhancement of granulocyte colony-stimulating factor (14).
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.
(2)
Warnings
Sho-saiko-to may cause interstitial pneumonitis, a potentially fatal condition. Concurrent use of interferon may increase this risk.
(3)
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)
(3).
Liver injuries and hepatitis have been associated with the use of Sho-saiko-to
(16) (17).
Herb-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.
Lab Interactions
May affect AST/ALT
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
- Bensky D, Gamble A. Chinese Herbal Medicine: Materia Medica. Revised Ed. Seattle: Eastland Press; 1993.
- Mizoguchi Y, et al. The effects of sho-saiko-to oninterleukin production by hepatic sinusoidal endothelial cells. J Med Pharm Soc 1989;6:172-6.
- Sato A, at al. Pneumonitis induced by the herbal medicine sho-saiko-to in Japan. Nihon Kyobu Shikkan Gakkai Zasshi 1997;35:391-5.
- Honso Professional Catalog 2002. Honso USA, Inc. Tempe, Arizona.
- Oka H, et al. Prospective study of chemoprevention of hepatocellular carcinoma with Sho-saiko-to (TJ-9). Cancer 1995;76:743-9.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Zhu K, et al. Inhibitory effects of herbal drugs on the growth of human ovarian cancer cell lines through the induction of apoptosis. Gynecol Oncol 2005;97(2):405-9.
- Itoh S, Marutani K, Nishijima T, et al. Liver injuries induced by herbal medicine, syo-saiko-to (xiao-chai-hu-tang). Dig Dis Sci. 1995 Aug;40(8):1845-8.
- Hsu LM, Huang YS, Tsay SH, et al. Acute hepatitis induced by Chinese hepatoprotective herb, xiao-chai-hu-tang. J Chin Med Assoc. 2006 Feb;69(2):86-8.
