Health Care Professional Information
Common Name
Xiao-chai-hu-tang, minor bupleurum decoction
Clinical Summary
Sho-saiko-to or “Xiao Chai Hu Tang” is a Chinese botanical formulation widely known by its Japanese name. It contains seven herbs and has been 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) (18) and macrophages (11) (13). Data also indicate that Sho-saiko-to causes enhancement of granulocyte colony-stimulating factor (14).
A clinical study shows Sho-saiko-to may improve liver pathology in hepatitis C patients who do not respond to interferon based treatment (22).
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.
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
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
Interferon: Concurrent use may increase the risk of interstitial pneumonitis (3).
Cytochrome P450 enzymes:
Sho-saiko-to upregulated expression of CYP2B, CYP3A1 and CYP4A1 and can alter the plasma concentration of drugs that are metabolized by these enzymes (19).
Sho-saiko-to interacts with drugs metabolized by CYP3A4, CYP2C9 and CYP1A2 enzymes (20).
Tolbutamide: Sho-saiko-to reduces the bioavailability following concurrent oral administration (21).
Literature Summary and Critique
Dosage (Inside MSKCC Only)
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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.
- Kang H, Choi TW, Ahn KS, et al. Upregulation of interferon-gamma and interleukin-4, Th cell-derived cytokines by So-Shi-Ho-Tang (Sho-Saiko-To) occurs at the level of antigen presenting cells, but not CD4 T cells. J Ethnopharmacol. 2009 May 4;123(1):6-14.
- Nose M, Tamura M, Ryu N, Mizukami H, Ogihara Y. Sho-saiko-to and Saiko-keisi-to, the traditional Chinese and Japanese herbal medicines, altered hepatic drug-metabolizing enzymes in mice and rats when administered orally for a long time. J Pharm Pharmacol. 2003 Oct;55(10):1419-26.
- Takahashi K, Uejima E, Morisaki T, et al. In vitro inhibitory effects of Kampo medicines on metabolic reactions catalyzed by human liver microsomes. J Clin Pharm Ther. 2003 Aug;28(4):319-27.
- Nishimura N, Naora K, Hirano H, Iwamoto K. A Chinese traditional medicine, sho-saiko-to (xiao-chaihu-tang), reduces the bioavailability of tolbutamide after oral administration in rats. Am J Chin Med. 1999;27(3-4):355-63.
- Deng G, Kurtz RC, Vickers A, et al. A single arm phase II study of a Far-Eastern traditional herbal formulation (sho-sai-ko-to or xiao-chai-hu-tang) in chronic hepatitis C patients. J Ethnopharmacol. 2011 Apr 17. [Epub ahead of print]
Consumer Information
How It Works
Bottom Line: Because limited research has been performed on sho-saiko-to, it should be used only under the supervision of a doctor. It may have liver-protective 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. 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
There are no data to back this claim.
- 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. A clinical study showed that it may improve liver pathology in hepatitis C patients.
- To treat malaria
This use is not backed by research.
Patient Warnings
- Sho-saiko-to may cause interstitial pneumonitis, a potentially fatal condition. Use of interferon at the same time may increase this risk.
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 medications that are metabolized by Cytochrome P450 enzymes (Sho-saiko-to upregulated expression of CYP2B, CYP3A1 and CYP4A1 and can alter the plasma concentration of drugs that are metabolized by these enzymes. Sho-saiko-to also interacts with drugs metabolized by CYP3A4, CYP2C9 and CYP1A2 enzymes).
- You are taking Tolbutamide (Sho-saiko-to reduces the bioavailability following concurrent oral administration.)
Side Effects
- Sho-saiko-to related pneumonitis has been reported in 74 patients (approximately 1 in 20,000).
- Liver injuries and hepatitis have been associated with the use of Sho-saiko-to.
Last updated: September 30, 2012
acid (A-sid)
A chemical that gives off hydrogen ions in water and forms salts by combining with certain metals. Acids have a sour taste and turn certain dyes red. Some acids made by the body, such as gastric acid, can help organs work the way they should. An example of an acid is hydrochloric acid. Acidity is measured on a scale called the pH scale. On this scale, a value of 7 is neutral, and a pH value of less than 7 to 0 shows increasing acidity.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)administration (ad-MIH-nih-STRAY-shun)
In medicine, the act of giving a treatment, such as a drug, to a patient. It can also refer to the way it is given, the dose, or how often it is given.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)analysis (uh-NA-lih-sis)
A process in which anything complex is separated into simple or less complex parts.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)apoptosis (A-pop-TOH-sis)
A type of cell death in which a series of molecular steps in a cell leads to its death. This is the body’s normal way of getting rid of unneeded or abnormal cells. The process of apoptosis may be blocked in cancer cells. Also called programmed cell death.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)blood (blud)
A tissue with red blood cells, white blood cells, platelets, and other substances suspended in fluid called plasma. Blood takes oxygen and nutrients to the tissues, and carries away wastes.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)cancer (KAN-ser)
A term for diseases in which abnormal cells divide without control and can invade nearby tissues. Cancer cells can also spread to other parts of the body through the blood and lymph systems. There are several main types of cancer. Carcinoma is a cancer that begins in the skin or in tissues that line or cover internal organs. Sarcoma is a cancer that begins in bone, cartilage, fat, muscle, blood vessels, or other connective or supportive tissue. Leukemia is a cancer that starts in blood-forming tissue such as the bone marrow, and causes large numbers of abnormal blood cells to be produced and enter the blood. Lymphoma and multiple myeloma are cancers that begin in the cells of the immune system. Central nervous system cancers are cancers that begin in the tissues of the brain and spinal cord. Also called malignancy.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)carcinoma (KAR-sih-NOH-muh)
Cancer that begins in the skin or in tissues that line or cover internal organs.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)cell (sel)
The individual unit that makes up the tissues of the body. All living things are made up of one or more cells.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)chemical (KEH-mih-kul)
A substance made up of elements, such as hydrogen or sodium.
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(http://www.cancer.gov/dictionary)chemotherapy (KEE-moh-THAYR-uh-pee)
Treatment with drugs that kill cancer cells.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)cirrhosis (seh-ROH-sis)
A type of chronic, progressive liver disease in which liver cells are replaced by scar tissue.
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(http://www.cancer.gov/dictionary)clinical (KLIH-nih-kul)
Having to do with the examination and treatment of patients.
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(http://www.cancer.gov/dictionary)clinical study (KLIH-nih-kul STUH-dee)
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical trial.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)clinical trial (KLIH-nih-kul TRY-ul)
A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Also called clinical study.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)colony-stimulating factor (KAH-luh-nee-STIM-yoo-LAY-ting FAK-ter)
A substance that stimulates the production of blood cells. Colony-stimulating factors include granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and promegapoietin.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)concentration (KON-sen-TRAY-shun)
In science, the amount of a substance, such as a salt, that is in a certain amount of tissue or liquid, such as blood. A substance becomes more concentrated when less water is present. For example, the salt in urine may become more concentrated when a person doesn’t drink enough water.
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(http://www.cancer.gov/dictionary)condition (kun-DIH-shun)
In medicine, a health problem with certain characteristics or symptoms.
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(http://www.cancer.gov/dictionary)fibrosis (fy-BROH-sis)
The growth of fibrous tissue.
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(http://www.cancer.gov/dictionary)GI
Refers to the stomach and intestines. Also called gastrointestinal.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)ginseng (JIN-seng)
An herb with a root that has been used in some cultures to treat certain medical problems. It may have anticancer effects.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)granulocyte (GRAN-yoo-loh-SITE)
A type of immune cell that has granules (small particles) with enzymes that are released during infections, allergic reactions, and asthma. Neutrophils, eosinophils, and basophils are granulocytes. A granulocyte is a type of white blood cell. Also called granular leukocyte, PMN, and polymorphonuclear leukocyte.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)granulocyte colony-stimulating factor (GRAN-yoo-loh-SITE KAH-luh-nee-STIM-yoo-LAY-ting FAK-ter)
A colony-stimulating factor that stimulates the production of neutrophils (a type of white blood cell). It is a cytokine that is a type of hematopoietic (blood-forming) agent. Also called filgrastim and G-CSF.
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(http://www.cancer.gov/dictionary)hepatitis (HEH-puh-TY-tis)
Disease of the liver causing inflammation. Symptoms include an enlarged liver, fever, nausea, vomiting, abdominal pain, and dark urine.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)hepatocellular carcinoma (heh-PA-toh-SEL-yoo-ler KAR-sih-NOH-muh)
A type of adenocarcinoma and the most common type of liver tumor.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)hepatoma (HEH-puh-TOH-muh)
A liver tumor.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)herbal (ER-bul)
Having to do with plants.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)herbal medicine (ER-bul MEH-dih-sin)
A type of medicine that uses roots, stems, leaves, flowers, or seeds of plants to improve health, prevent disease, and treat illness.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)immune function (ih-MYOON FUNK-shun)
Production and action of cells that fight disease or infection.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)immune system (ih-MYOON SIS-tem)
The complex group of organs and cells that defends the body against infections and other diseases.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)immunity (ih-MYOO-nih-tee)
The condition of being protected against an infectious disease. Immunity can be caused by a vaccine, previous infection with the same agent, or by transfer of immune substances from another person or animal.
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(http://www.cancer.gov/dictionary)in vitro (in VEE-troh)
In the laboratory (outside the body). The opposite of in vivo (in the body).
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(http://www.cancer.gov/dictionary)interferon (in-ter-FEER-on)
A biological response modifier (a substance that can improve the body's natural response to infections and other diseases). Interferons interfere with the division of cancer cells and can slow tumor growth. There are several types of interferons, including interferon-alpha, -beta, and -gamma. The body normally produces these substances. They are also made in the laboratory to treat cancer and other diseases.
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(http://www.cancer.gov/dictionary)liver (LIH-ver)
A large organ located in the upper abdomen. The liver cleanses the blood and aids in digestion by secreting bile.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)liver cancer (LIH-ver KAN-ser)
Primary liver cancer is cancer that forms in the tissues of the liver. Secondary liver cancer is cancer that spreads to the liver from another part of the body.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)metastasis (meh-TAS-tuh-sis)
The spread of cancer from one part of the body to another. A tumor formed by cells that have spread is called a “metastatic tumor” or a “metastasis.” The metastatic tumor contains cells that are like those in the original (primary) tumor. The plural form of metastasis is metastases (meh-TAS-tuh-SEEZ).
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)oral (OR-ul)
By or having to do with the mouth.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)ovarian (oh-VAYR-ee-un)
Having to do with the ovaries, the female reproductive glands in which the ova (eggs) are formed. The ovaries are located in the pelvis, one on each side of the uterus.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)plasma (PLAZ-muh)
The clear, yellowish, fluid part of the blood that carries the blood cells. The proteins that form blood clots are in plasma.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)pneumonitis (NOO-moh-NY-tis)
Inflammation of the lungs. This may be caused by disease, infection, radiation therapy, allergy, or irritation of lung tissue by inhaled substances.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)practitioner (prak-TIH-shuh-ner)
A person who works in a specific profession. For example, a doctor or nurse is a healthcare practitioner.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)regeneration (ree-JEH-neh-RAY-shun)
In biology, regrowth of damaged or destroyed tissue or body part.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)serum (SEER-um)
The clear liquid part of the blood that remains after blood cells and clotting proteins have been removed.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)Sho-saiko-to (shoh-sah-ee-koh-toh)
A Japanese formulation of seven Chinese herbs that is being studied as a treatment for cancer.
Source: The National Cancer Institute's Dictionary of Cancer Terms
(http://www.cancer.gov/dictionary)tumor (TOO-mer)
An abnormal mass of tissue that results when cells divide more than they should or do not die when they should. Tumors may be benign (not cancer), or malignant (cancer). Also called neoplasm.
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(http://www.cancer.gov/dictionary)
