title: 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.
abstract: BACKGROUND
  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.
  
  
  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.
authors.affiliation: Integrative Medicine Service, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, United States. dengg@mskcc.org
authors.forename: Gary
authors.initials: G
authors.lastname: Deng
authors.forename: Robert C
authors.initials: RC
authors.lastname: Kurtz
authors.forename: Andrew
authors.initials: A
authors.lastname: Vickers
authors.forename: Nancy
authors.initials: N
authors.lastname: Lau
authors.forename: K Simon
authors.initials: KS
authors.lastname: Yeung
authors.forename: Jinru
authors.initials: J
authors.lastname: Shia
authors.forename: Barrie
authors.initials: B
authors.lastname: Cassileth
mesh_terms: D000410:Alanine Transaminase / Q000097:blood*; D001219:Aspartate Aminotransferases / Q000097:blood*; D004365:Drugs, Chinese Herbal / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008099:Liver / Q000187:drug effects* / Q000201:enzymology / Q000473:pathology; D019684:Magnoliopsida; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010946:Plants, Medicinal; D019562:Viral Load / Q000187:drug effects*
chemical_list: D004365:Drugs, Chinese Herbal; C461320:shosaiko-to; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase