Literature DB >> 21527335

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.

Gary Deng1, Robert C Kurtz, Andrew Vickers, Nancy Lau, K Simon Yeung, Jinru Shia, Barrie Cassileth.   

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE: Hepatitis C is a major public health problem internationally. Many patients cannot benefit from the current treatment regimen (interferon/ribavirin combinations) due to its side effects or ineffectiveness. Xiao-Chai-Hu-Tang or Sho-sai-ko-to (SST), a compound of seven botanical extracts used for liver diseases traditionally in East Asia, was shown to reduce transaminases and the incidence of hepatocellular carcinoma in hepatitis B patients. We conducted a phase II trial of SST in hepatitis C patients who were not candidates for interferon-based therapy to determine whether this agent is worthy of further study.
MATERIALS AND METHODS: Twenty four chronic hepatitis C patients received SST at 2.5 g per os (p.o.) three times daily (t.i.d.) for 12 months. Liver function, hepatitis C virus (HCV) viral load and liver biopsy histology were assessed before and after the intervention.
RESULTS: Improvement of aspartate aminotransferase (AST) was observed in 16 (67%) of study participants. Improvement of alanine aminotransferase (ALT) was seen in 18 (75%) patients. Viral load response was mixed, with 7 patients showing reductions, 10 increases and 7 indeterminate due to assay limitations. Among the 9 (38%) subjects who showed improvement per Knodell's histology activity index (HAI) scores in paired comparison of pre- and post-treatment liver biopsy (the primary endpoints of the study), 5 (21%) showed an improvement of 2 points or greater, meeting the pre-defined criteria for "response.
CONCLUSIONS: Sho-sai-ko-to (SST or Xiao Chai Hu Tang) may improve liver pathology in selected hepatitis C patients who are not candidates for interferon based treatment. Larger, controlled studies of this botanical formulation may be warranted.
Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

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Year:  2011        PMID: 21527335     DOI: 10.1016/j.jep.2011.04.008

Source DB:  PubMed          Journal:  J Ethnopharmacol        ISSN: 0378-8741            Impact factor:   4.360


  19 in total

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5.  Current understanding on antihepatocarcinoma effects of xiao chai hu tang and its constituents.

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9.  Gadoxetic acid-enhanced MRI and sonoelastography: non-invasive assessments of chemoprevention of liver fibrosis in thioacetamide-induced rats with Sho-Saiko-To.

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Review 10.  Current Status of Herbal Medicines in Chronic Liver Disease Therapy: The Biological Effects, Molecular Targets and Future Prospects.

Authors:  Ming Hong; Sha Li; Hor Yue Tan; Ning Wang; Sai-Wah Tsao; Yibin Feng
Journal:  Int J Mol Sci       Date:  2015-12-02       Impact factor: 5.923

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