title: Prospective study of chemoprevention of hepatocellular carcinoma with Sho-saiko-to (TJ-9).
abstract: BACKGROUND
  Most hepatocellular carcinomas (HCC) arise in patients with cirrhosis, in whom its incidence is high. The prevention of HCC in patients with cirrhosis is important.
  
  
  METHODS
  A prospective, randomized, nonblind controlled study was performed to evaluate the preventive effect of Sho-saiko-to (TJ-9) on HCC development. TJ-9 is a Chinese herbal medicine that contains crude extracts of seven herbs; it has antitumor effects in experimental animals. Two hundred sixty patients with cirrhosis were randomly assigned to two groups, matched for age, sex, presence of hepatitis B surface antigen, and the severity of liver damage. The patients in the trial group were given TJ-9 at a daily oral dose of 7.5 g in addition to the conventional drugs given to the control patients. The patients were prospectively monitored for 60 months and the cumulative incidence of HCC and the survival rate in the two groups were calculated.
  
  
  RESULTS
  The cumulative incidence curve for 5 years of the trial group was lower than that of the control group (P = 0.071). For the patients without HBs antigen, the difference was significant (P = 0.024). The survival curve for 5 years of the trial group was higher than that of the control group (P = 0.053). For the patients without HBs antigen, the difference was significant (P = 0.043).
  
  
  CONCLUSIONS
  TJ-9 helped to prevent the development of HCC in patients with cirrhosis, particularly in patients without HBs antigen.
authors.affiliation: Third Department of Internal Medicine, Osaka City University Medical School, Japan.
authors.forename: H
authors.initials: H
authors.lastname: Oka
authors.forename: S
authors.initials: S
authors.lastname: Yamamoto
authors.forename: T
authors.initials: T
authors.lastname: Kuroki
authors.forename: S
authors.initials: S
authors.lastname: Harihara
authors.forename: T
authors.initials: T
authors.lastname: Marumo
authors.forename: S R
authors.initials: SR
authors.lastname: Kim
authors.forename: T
authors.initials: T
authors.lastname: Monna
authors.forename: K
authors.initials: K
authors.lastname: Kobayashi
authors.forename: T
authors.initials: T
authors.lastname: Tango
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000209:etiology / Q000517:prevention & control*; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications / Q000401:mortality; D008113:Liver Neoplasms / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D000970:Antineoplastic Agents; D004365:Drugs, Chinese Herbal; C018142:saiko-keishi-to