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ORIGINAL RESEARCH ARTICLE

Evidence-Based Efficacy of Kampo Formulas in a Model of Non Alcoholic Fatty Liver

Makoto Fujimoto^*,, Koichi Tsuneyama^,, Mosaburo Kainuma, Nobuyasu Sekiya^||, Hirozo Goto^*,, Yasuo Takano, Katsutoshi Terasawa^,¶, Carlo Selmi^#,**, M. Eric Gershwin^# and Yutaka Shimada^*,,1

^* Department of Japanese Oriental Medicine, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan; Department of Diagnostic Pathology, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, Toyama, Japan; 21st Century COE Program, University of Toyama, Toyama, Japan; Department of Environmental Medicine and Infectious Diseases, Kyushu University, Maidashi Higashi-ku, Fukuoka, Japan; ^|| Department of Frontier Japanese Oriental Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan; ^¶ Department of Japanese Oriental Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan; ^# Division of Rheumatology, Allergy and Clinical Immunology, University of California at Davis, Davis, California; and ^** Department of Clinical Sciences ‘Luigi Sacco’, University of Milan, Italy

To whom requests for reprints should be addressed at ¹ Department of Japanese Oriental Medicine, Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama, 2630 Sugitani, Toyama 930-0194, Japan. E-mail: shimada{at}med.u-toyama.ac.jp

Data on the efficacy of herbal compounds are often burdened by the lack of appropriate controls or a limited statistical power. Treatments to prevent the progression of non alcoholic fatty liver disease (NAFLD) to steatohepatitis (NASH) remain unsatisfactory. A total of 56 rabbits were arrayed into 7 groups fed with standard rabbit chow (SRC), SRC with 1% cholesterol, or each of the five experimental treatments (Kampo formulas 1% keishibukuryogan [KBG], 1% orengedokuto [OGT], and 1% shosaikoto [SST]; vitamin E [VE]; or pioglitazone [PG]) in a 1% cholesterol SRC. We analyzed changes after 12 weeks in plasma and liver lipid profiles, glucose metabolism, adipocytokines, oxidative stress, and liver fibrosis. Data demonstrated that all five treatments were associated with significant amelioration of lipid profiles, oxidative stress, and liver fibrosis compared to no supplementation. KBG was superior to VE and PG in the reduction of liver total cholesterol (P < 0.01) and lipid peroxidase levels (P < 0.05), urinary 8-hydroxy-2'-deoxyguanosine (P < 0.05), hepatic -smooth muscle actin positive areas (P < 0.01) and activated stellate cells (P < 0.01). In conclusion, there was a statistically significant benefit of Kampo formulas (KBG in particular) on a dietary model of NAFLD/NASH. Future studies need to be directed at the mechanisms in the treatment of NASH.

Key Words: nonalcoholic steatohepatitis • alternative medicine • hepatic stellate cells • adiponectin