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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Sho Saiko To and Dai Saiko To

Last Update: January 5, 2014.



Sho-saiko-to is an herbal mixture used in Kampo medicine in Japan to treat liver disease and known elsewhere in different formulations as Dai-saiko-to and Xiao Chai Hu Tang, and also spelled as Syo-saiko-to. Both Sho-saiko-to and Dai-saiko-to have been implicated in rare instances of clinically apparent acute liver injury.


Sho-saiko-to is the Japanese name for a widely used mixture of at least 7 herbs that are used together in Kampo medicine to treat patients with liver disease, being purported to decrease the progression of hepatic fibrosis and lessen the likelihood of hepatocellular carcinoma. Sho-saiko-to is widely used in Japan to treat patients with chronic hepatitis. Other names for this mixture include TJ-9 and, in China, Dai-saiko-to and Xiao Chai Hu Tang. These products may have somewhat different combinations of herbs. Typically, they contain Bupleurium root, Pinelliae tuber, Scutellaria root, ginseng root, ginger rhizome, glycyrrhiza root and jujube fruit. Sho-saiko-to has been shown to have antioxidant and cytoprotective properties in vitro and to protect against experimental hepatic injury in several animal models. The components responsible for the hepatoprotective activity of Sho-saiko-to are thought to be saponins (saikosaponin A, B, C and D) and the antioxidants, baicalin and baicalein, which resemble silybinin chemically and appear to have similar properties in vitro and in vivo. The clinical efficacy of Sho-saiko-to in humans has not been well demonstrated, resting largely upon small studies with uncertain clinical endpoints. Sho-saiko-to is usually described as having no significant side effects.


Several case reports have suggested that Sho-saiko-to and Dai-saiko-to are capable of causing rare instances of clinically apparent acute liver injury. The time to onset of liver injury ranged from 3 to 8 weeks and the pattern of serum enzyme elevations was usually hepatocellular. The onset was marked by nausea, abdominal discomfort and fatigue, followed shortly by jaundice. The injury resolved rapidly on stopping the herbal (within 4 to 8 weeks). Most instances of acute liver injury attributed to Sho-saiko-to have occurred in patients with chronic liver disease, most frequently chronic hepatitis C. However, the appearance of jaundice with sudden rise in serum aminotransferase levels is distinctly unusual during the course of chronic hepatitis C and the description of several instances of recurrence on reexposure makes the reports convincing.

Mechanism of Injury

The mechanism of hepatotoxicity of Sho-saiko-to is unknown and, because it is an herbal mixture, the specific ingredient responsible for injury is unclear. Among the constituents, perhaps Scutellaria (skullcap) is the most likely hepatotoxic fraction. The possibility always exists that the rare instances of acute liver injury due to this Sho-saiko-to were due to contamination or misidentification of the herbal.

Outcome and Management

Hepatotoxicity attributed to Sho-saiko-to is usually mild to moderate in severity and rapidly reversible with stopping the medication. No case of acute liver failure, chronic hepatitis or vanishing bile duct syndrome due to Sho-saiko-to or similar herbal mixtures have been published. Recurrence upon reexposure is frequent and should be avoided.

Drug Class: Herbal and Dietary Supplements, Chinese and Other Asian Herbal Medicines



Sho-Saiko-To – Generic


Herbal and Dietary Supplements


Sho-Saiko-To, Dai-Saiko-To63364-01-2Herbal mixtureNot applicable


References updated: 05 January 2014

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  • In, PDR for Herbal Medicines. 4th ed. Montvale, New Jersey: Thomson Healthcare Inc. 2007.
    (Compilation of short monographs on herbal medications and dietary supplements, including sections on ma huang, but not specifically on Sho-saiko-to).
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    (4 cases, 42-58 year old women, taking Sho-saiko-to for 3-7 weeks, developed liver test elevations, 2 with jaundice, 2 with recurrence on restarting [peak ALT 135 to 1335 U/L], with resolution within 2 to 3 months upon stopping).
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    (55 year old woman with chronic hepatitis developed jaundice one month after starting Dai-saiko-to [bilirubin 11.2 mg/dL, ALT 390 U/L, ANA 1:2560], responding rapidly to prednisone therapy).
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    (65 year old man developed dyspnea and interstitial pneumonitis with abnormal liver tests 4 weeks after starting Dai-saiko-to for autoimmune dermatitis, stopping at 6 weeks [bilirubin 1.2 mg/dL, ALT 675 U/L, Alk P 1070 U/L], resolving within a month of stopping).
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  • García-Cortés M, Borraz Y, Lucena MI, Peláez G, Salmerón J, Diago M, Martínez-Sierra MC, et al. Liver injury induced by “natural remedies”: an analysis of cases submitted to the Spanish Liver Toxicity Registry. Rev Esp Enferm Dig 2008; 100: 688-95. [PubMed: 19159172]
    (Among 521 cases of drug induced liver injury submitted to Spanish registry, 13 [2%] were due to herbals, including Camellia sinensis [green tea], Cassia angustifolia [senna], kava, valerian, Rhamnus purshianus [cascara], fitosoja [soy plant], biosoja [soy extract], Aesculus hippocatanum [horse chestnut], chitosan [deacetylated chitin], and Couterea latifloral [Copalchi]).
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    (Among 300 cases of drug induced liver disease in the US collected between 2004 and 2008, 9% of cases were attributed to herbal medications and dietary supplements [HDS] but none specifically to Sho-saiko-to).
  • Navarro VJ. Herbal and dietary supplement hepatotoxicity. Semin Liver Dis 2009; 29: 373-82. [PubMed: 19826971]
    (Overview of the regulatory environment, clinical patterns, and future directions in research with HDS including traditional Chinese herbal medicines and Sho-saiko-to).
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    (Among 1198 patients with acute liver failure enrolled in a US prospective study between 1998 and 2007, 133 [11%] were attributed to drug induced liver injury of which 12 [9%] were due to herbals, but none were attributed specificially to Sho-saiko-to).
  • Lee JK, Kim JH, Shin HK. Therapeutic effects of the oriental herbal medicine Sho-saiko-to on liver cirrhosis and carcinoma. Hepatol Res 2011; 41: 825-37. [PubMed: 21682829]
    (Review of the efficacy and safety of Sho-saiko-to as therapy of liver disease, mentions side effects of interstitial pneumonitis and 3 case reports of hepatic injury).
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  • Deng G, Kurtz RC, Vickers A, Lau N, Yeung KS, Shia J, Cassileth B. 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; 136: 83-7. [PubMed: 21527335]
    (Among 42 patients with chronic hepatitis C who were treated with Sho-saiko-to [2.5 g three times daily] for 12 months, ALT levels decreased in 67% and increased in 29%, while liver histology did not change overall; side effects were not mentioned).
  • Teschke R, Wolff A, Frenzel C, Schulze J, Eickhoff A. Herbal hepatotoxicity: a tabular compilation of reported cases. Liver Int 2012; 32: 1543-56. [PubMed: 22928722]
    (A systematic compilation of all publications on the hepatotoxicity of specific herbals identified 185 publications on 60 different herbs, including 2 reports of Xiao Chai Hu Tang: [Itoh 1995] and Hsu [2005]).


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