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XIAO CHAI HU TANG (MINOR BUPLEURUM DECOCTION)
TRADITIONAL USE, PHARMACOLOGICAL EFFECTS AND CLINICAL RESEARCH

By John Chen, L.Ac., O.M.D., Pharm.D., Ph.D.

The following information on Xiao Chai Hu Tang (Minor Bupleurum Decoction) is from Chinese Herbal Formulas and Applications by Dr. John Chen. The anticipated date of publication for this long awaited text is June 2008. Four out of fifteen pages of this formula are included here for your review.

Dr. Alex Chen will be discussing this formula in combination with other formulas in his seminar Mix and Match 30 Formulas for Clinical Success. Click here to find out more.

*Xiao Chai Hu Tang* (Minor Bupleurum Decoction)
Diagnosis	Signs and Symptoms	Treatment	Herbs
Shaoyang syndrome	Alternating spells of fever and chills: the location of the illness is between the exterior and interior Chest and hypochondriac fullness and discomfort: qi stagnation A bitter taste in the mouth, a dry throat, and irritability: heat in the shaoyang Gallbladder channel Lack of appetite, nausea, and vomiting: Gallbladder heat invading the Stomach Thin, white tongue coating: exterior condition Wiry pulse: qi stagnation	Harmonizes shaoyang syndrome	Chai Hu (Radix Bupleuri) releases the exterior, and Huang Qin (Radix Scutellariae) clears the interior. Together, they harmonize shaoyang disorders. Ban Xia (Rhizoma Pinelliae) harmonizes the Stomach to relieve nausea and vomiting, and disperses stagnation. Sheng Jiang (Rhizoma Zingiberis Recens) harmonizes the middle jiao. Ren Shen (Radix Ginseng), Zhi Gan Cao (Radix Glycyrrhizae Preparata), and Da Zao (Fructus Jujubae) tonify Stomach qi, nourish body fluids, and harmonize the ying (nutritive) and wei (defensive) levels.

CHINESE THERAPEUTIC ACTIONS

Harmonizes shaoyang syndrome.

CLINICAL MANIFESTATIONS

Shaoyang syndrome: alternating spells of fever and chills, chest and hypochondriac fullness and discomfort, irritability, a bitter taste in the mouth, lack of appetite, nausea, vomiting, vertigo, a dry throat, a thin, white tongue coating, and a wiry pulse.

Any of the following diseases that have symptoms of shaoyang syndrome: gynecological disorders with heat in the uterus, Liver, or chong (thoroughfare) channel; malaria; jaundice; or any internal injury characterized by shaoyang syndrome.

CLINICAL APPLICATIONS

Hepatitis, viral hepatitis, chronic hepatitis, hepatic fibrosis and carcinoma, hepatocellular carcinomas, jaundice, cholecystitis, cholelithiasis, pancreatitis, fever, fever in cancer, nephritis, chronic renal insufficiency, acute tonsillitis, infectious parotitis, stomatitis, common cold, influenza, measles, bronchitis, pneumonia, pulmonary tuberculosis, cough, allergic rhinitis, bronchial asthma, reflux esophagitis, antral gastritis, gastritis, gastric pain, gastric prolapse, constipation, Meniere’s syndrome, dizziness, seizures, migraine, angina, depression, chronic fatigue syndrome, morning sickness, postpartum infection, postpartum fever, dysmenorrhea, premenstrual syndrome, and malaria.

PHARMACOLOGICAL EFFECTS

Hepatoprotective: Administration of Xiao Chai Hu Tang was associated with preventive and beneficial effects against various types of drug- or chemical-induced liver damage. In one study, intraperitoneal injection of the formula in rats effectively controlled galactose-induced liver disorder in 65-70% of subjects by lowering the SGOT and SGPT levels. (i) Other studies have indicated that the formula is also effective against liver cirrhosis induced by carbon tetrachloride. (ii) Yet another study reported that Xiao Chai Hu Tang was effective in treating liver inflammation and fibrosis. (iii) One proposed mechanism of this hepatoprotective effect is the augmentation of natural killer (NK) cell activity in the liver. (iv) Another proposed mechanism is a dose-dependent increase in the production of granulocyte colony-stimulating factor (G-CSF) on peripheral blood mononuclear cells. (v)

Cholagogic: Administration of Xiao Chai Hu Tang was associated with a marked effect of increasing the secretion of bile acid from the gallbladder and its excretion into the intestines in animals. (vi)

Immunostimulant: Administration of Xiao Chai Hu Tang has marked effect on the immune system. In one study of mice, 100 mg/kg of the herb was associated with stimulating natural killer (NK) cells activities, while 200 mg/kg was associated with the inhibition of NK cell activities. (vii)

Anti-inflammatory: Intraperitoneal injection of the formula in rats at 200 mg/kg was associated with a marked anti-inflammatory effect for up to 4 hours. (viii) The anti-inflammatory effect was also present in rats whose adrenal glands had been surgically removed. (ix)

CLINICAL STUDIES AND RESEARCH

Cholecystitis and cholelithiasis: One hundred patients with cholecystitis and cholelithiasis were treated with a combination of Xiao Chai Hu Tang and Xiao Cheng Qi Tang (Minor Order the Qi Decoction) with an 85% success rate of passing the stones. (x)

Cholecystitis: One study reported 98.9% effectiveness using Xiao Chai Hu Tang to treat cholecystitis. Of 285 patients (134 male, 151 female, average of 40.1 years of age, 2.7 years average duration of illness), 61 had acute cholecystitis and 224 had chronic cholecystitis. The treatment protocol was to administer the herbs in decoction once daily for 15 days per course of treatment. The study reported complete recovery in 273 cases, improvement in 9 cases, and no effect in 3 cases. (xi)

Pancreatitis: Fifty patients with acute pancreatitis were treated with marked improvement using acupuncture, modified Xiao Chai Hu Tang, and atropine. The average duration of treatment was 6.8 days, with most patients showing improvement after about 3 days. (xii)

Chronic hepatitis: In a double-blind multicenter clinical study involving 222 patients with chronic active hepatitis, use of Xiao Chai Hu Tang was associated with a decrease of HBeAg and an increase of anti-HBe antibodies. No remarkable side effects were noticed. (xiii) In another study, two groups of patients with chronic hepatitis were treated with modified Xiao Chai Hu Tang with good results. In one group of 41 patients with chronic infectious hepatitis, 26 cases had significant improvement and 13 cases had moderate improvement. In another group of 21 patients with chronic active hepatitis, 10 cases had significant improvement and 8 cases had moderate improvement. The formula used contained Chai Hu (Radix Bupleuri) 12g, Huang Qin (Radix Scutellariae) 12g, Tai Zi Shen (Radix Pseudostellariae) 15g, Ban Xia (Rhizoma Pinelliae) 10g, Gan Cao (Radix Glycyrrhizae) 6g, and dry-fried Zhi Zi (Fructus Gardeniae) 10g. (xiv) In another study, administration of Xiao Chai Hu Tang for 2-3 months was associated with marked symptomatic relief and improvement of liver function among 45 chronic hepatitis patients who did not respond to prednisone. (xv)

HERB-DRUG INTERACTION

Interferon: Increased risk of acute pneumonitis may be associated with the use of interferon, Xiao Chai Hu Tang, or both in combination. Among patients with chronic hepatitis or liver cirrhosis, the frequency of drug-induced pneumonitis was 0.5% in those given only interferon-alpha, 0.7% in those given only Xiao Chai Hu Tang, and 4.0% in those given both interferon-alpha and Xiao Chai Hu Tang. (xvi) Many theories have been proposed on the mechanism of this interaction. One theory stated that the herbs have not been shown to injure the lung tissues, but may over stimulate the neutrophils to release granulocytes, elastase and oxygen radicals, which subsequently damage lung tissue. The fibroblasts that repair the damaged tissue may increase the risk of pulmonary fibrosis. (xvii) Another theory stated that acute pneumonitis associated with concurrent use of interferon and Xiao Chai Hu Tang may be due to allergic-immunological mechanisms. (xviii)

Interleukin 2: Concurrent use of Xiao Chai Hu Tang and interleukin 2 showed a synergistic antitumor effect against murine renal cell carcinoma cell line in mice. The treatment protocol was to administer Xiao Chai Hu Tang at 2.5 g/kg daily over 30 days, and interleukin 2 at 10(4) U/subject by subcutaneous injection every other day for a total of 8 doses. The combination of these two substances inhibited growth of the tumor and prolonged survival significantly as compared with the untreated mice. (xix)

Lamivudine (Epivir; 3TC): One study reported synergistic antiviral effect when Xiao Chai Hu Tang is combined with antiviral drugs such as zidovudine (AZT), lamivudine (3TC) or AZT plus 3TC. Used alone, Xiao Chai Hu Tang moderately inhibited HIV-1 replication at a concentration of 25 mcg/ml. Used together, Xiao Chai Hu Tang enhanced the anti-HIV-1 activity of 3TC. The researchers suggested that the combination of Xiao Chai Hu Tang and 3TC has potential as a chemotherapeutic modality for HIV-1 infection. (xx)

5-fluorouracil (5-FU): The combination of 5-FU and Xiao Chai Hu Tang had a synergistic effect for treatment of cancer in mice by increasing the life span by 56% and alleviating side effects of 5-FU. (xxi)

Liver enzyme inhibition: The effect of Xiao Chai Hu Tang on cytochrome P450 enzymes was evaluated in vivo in 26 healthy subjects. Use of this herbal formula (2.5g twice daily for 5 days) was associated with a decreased mean activity of CYP1A2 by 16% on both day 1 and day 5 compared with the baseline (P=0.001). (xxii) In another study on the metabolic activity of different cytochrome P450 (CYP) isoforms, Xiao Chai Hu Tang was reported to be a competitive inhibitor of CYP2C9, but not CYP2D6. The study concluded that because of this inhibitory effect on liver metabolism, care should be taken with concurrent use of Xiao Chai Hu Tang and drugs. (xxiii)

OTHER USES

Xiao Chai Hu Tang is traditionally used to treat alternating chills and fever, but can also be used for patients with temperature differences in the body, such as cold limbs but warm body, or warm limbs and cold body. Another condition that can also be treated with this formula is drastic temperature differences on the dorsal and palmar aspects of the hands, with the palmar aspect being cold and the dorsal aspect being warm.

Xiao Chai Hu Tang can be used for unremitting fever in children approximately one week after contracting an exterior condition. These patients exhibit fever that is not alleviated with antipyretic or antibiotic drugs. Though these drugs work well to temporarily bring down body temperature, the fever tends to return as soon as the therapeutic effect is over.

REFERENCES
(i) Yao Xue Za Zhi (Journal of Medicinals), 1984, 104(7):798
(ii) Guo Wai Yi Xue (Foreign Medicine), 1984, (5)279
(iii) Kusunose M, Qiu B, Cui T, Hamada A, Yoshioka S, Ono M, Miyamura M, Kyotani S, Nishioka Y.Effect of Sho-saiko-to extract on hepatic inflammation and fibrosis in dimethylnitrosamine induced liver injury rats. Biol Pharm Bull. 2002 Nov;25(11):1417-21.
(iv) Kaneko M, Kawakita T, Tauchi Y, Saito Y, Suzuki A, Nomoto K. Augmentation of NK activity after oral administration of a traditional Chinese medicine, xiao-chai-hu-tang (shosaiko-to). Immunopharmacol Immunotoxicol. 1994 Feb;16(1):41-53.
(v) Yamashiki M, Asakawa M, Kayaba Y, Kosaka Y, Nishimura A.Herbal medicine "sho-saiko-to" induces in vitro granulocyte colony-stimulating factor production on peripheral blood mononuclear cells. J Clin Lab Immunol. 1992;37(2):83-90.
(vi) Guo Wai Yi Xue (Foreign Medicine), 1991, 13(4):46
(vii) Guo Wai Yi Xue (Foreign Medicine), 1991, 13(4):43
(viii) Yao Xue Za Zhi (Journal of Medicinals), 1984, 104(5):509
(ix) Zhong Yi Fang Ji Xian Dai Yan Jiu (Modern Study of Medical Formulae in Traditional Chinese Medicine), 1997, (1):184
(x) Fu Jian Zhong Yi Yao (Fujian Chinese Medicine and Herbology), 1986, 17(3):48
(xi) Shi Yong Zhong Xi Yi Jie He Za Zhi (Practical Journal Integrated Chinese and Western Medicines), 1993, 4:218
(xii) Zhong Yi Za Zhi (Journal of Chinese Medicine), 1982, 9:40
(xiii) Hirayama C, Okumura M, Tanikawa K, Yano M, Mizuta M, Ogawa N.A multicenter randomized controlled clinical trial of Shosaiko-to in chronic active hepatitis. Gastroenterol Jpn. 1989 Dec;24(6):715-9.
(xiv) Hu Nan Zhong Yi Za Zhi (Hunan Journal of Chinese Medicine), 1989, 5(3):5
(xv) Xin Yao Yu Lin Chuang (New Medicine and the Clinical Application), 1982, 4:651
(xvi) Nakagawa A et al. Five cases of drug-induced pneumonitis due to Sho-saiko-to or interferon-alpha or both. Nihon Kyobu Shikkan Gakkai Zasshi. 1995 Dec;33(12):1361-1366
(xvii) Murakami K et al. A possible mechanism of interstitial pneumonia during interferon therapy with sho-saiko-to. Nihon Kyobu Shikkan Gakkai Zasshi. 1995 Apr;33(4):389-94
(xviii) Ishizaki T. Sasaki F. Ameshima S. Shiozaki K. Takahashi H. Abe Y. Ito S. Kuriyama M. Nakai T. Kitagawa M. Pneumonitis during interferon and/or herbal drug therapy in patients with chronic active hepatitis. European Respiratory Journal. 9(12):2691-6, 1996 Dec.
(xix) Huang Y, Marumo K, Murai M.Antitumor effects and pharmacological interaction of xiao-chai-hu-tang (sho-saiko-to) and interleukin 2 in murine renal cell carcinoma. Keio J Med. 1997 Sep;46(3):132-7.
(xx) Piras G. Makino M. Baba M. Sho-saiko-to, a traditional Kampo medicine, enhances the anti-HIV-1 activity of lamivudine (3TC) in vitro. Microbiology & Immunology. 41(10):835-9, 1997.
(xxi) Ohta T, Tawara M, Tatsuka M, Abe H, Odashima S. An approach to prolongation of survival rate in tumor bearing mice using 5-fluorouracil in combination with various kinds of herb medicine. Gan To Kagaku Ryoho. 1983 Aug;10(8):1858-65.
(xxii) Saruwatari J. Nakagawa K. Shindo J. Nachi S. Echizen H. Ishizaki T. The in-vivo effects of sho-saiko-to, a traditional Chinese herbal medicine, on two cytochrome P450 enzymes (1A2 and 3A) and xanthine oxidase in man. Journal of Pharmacy & Pharmacology. 55(11):1553-9, 2003 Nov.
(xxiii) Takahashi K. Uejima E. Morisaki T. Takahashi K. Kurokawa N. Azuma J. In vitro inhibitory effects of Kampo medicines on metabolic reactions catalyzed by human liver microsomes. Journal of Clinical Pharmacy & Therapeutics. 28(4):319-27, 2003 Aug.

ABOUT THE AUTHOR

John K. Chen, L.Ac., Pharm.D., O.M.D., Ph.D.

Dr. John Chen is a recognized authority in both western pharmacology and Chinese Herbal Medicine. He teaches at the USC School of Pharmacy, Emperor’s College, Yo San University of TCM, OCOM, Five Branches, AOMA and ACTCM. Dr. Chen’s most recent published work is Chinese Medical Herbology and Pharmacology (2003, AOM Press) and Chinese Herbal Formulas and Applications (2008, AOM Press) for which he was lead author.

This article was taken out of Dr. Chen’s book Chinese Herbal Formulas and Applications.
To order a copy, click here.

To learn more about this formula and the combination of this formula with others to yield maximum clinical effect, Dr. Alex Chen is speaking on the following topics for Lotus Institute. All classes are approved for 8 CEUs/PDAs by the California Acupuncture Board and NCCAOM.

CLASSES BY DR. ALEX CHEN

Mix & Match 30 Formulas for Clinical Success

8/17/08 Fullerton, CA

Practical Qi Gong for Optimal Health

5/4/08 Washington DC
11/16/08 Chicago, IL
12/7/08 Los Angeles, CA