Pilot clinical trial of the use of alpha-tocopherol for the prevention of hepatocellular carcinoma in patients with liver cirrhosis.
Patients with chronic hepatitis C virus (HCV) infection often develop liver cirrhosis and hepatocellular carcinoma (HCC). The purpose of this study was to test the chemopreventive effect of alpha-tocopherol on hepatocarcinogenesis in patients with liver cirrhosis and a history of HCV infection. Eighty-three patients with liver cirrhosis and with positive history of HCV infection were divided at random into two groups. Forty-four patients were treated with alpha-tocopherol (Vit E group) while the other 39 were followed as controls. The clinical background (gender, age, and laboratory data) was similar in the two groups. Serum levels of alpha-tocopherol, albumin, alanine aminotransferase (ALT), and total cholesterol and platelet count were measured serially over a period of five years. The mean serum concentration of alpha-tocopherol was low in both groups at entry and was significantly higher in the Vit E group than in the control group one month after treatment. Platelet count, serum albumin, ALT, and total cholesterol were not different between the two groups during the five-year period. Cumulative tumor-free survival and cumulative survival rate tended to be higher in the Vit E group than in controls, albeit statistically insignificant. The serum level of alpha-tocopherol was low in patients with liver cirrhosis and positive for HCV. Although the administration of alpha-tocopherol normalized the level one month later, it could neither improve liver function, suppress hepatocarcinogenesis, nor improve cumulative survival. Patients treated with alpha-tocopherol tended to live longer without development of HCC but the difference was not statistically significant.
Takagi
Hitoshi
H
First Department of Internal Medicine, Gunma University Faculty of Medicine, 3-39-15, Showa Machi Maebashi, 371-8511, Japan. htakagi@med.gunma-u.ac.jp
Kakizaki
Satoru
S
Sohara
Naondo
N
Sato
Ken
K
Tsukioka
Gengo
G
Tago
Youko
Y
Konaka
Kazuko
K
Kabeya
Kenshi
K
Kaneko
Mieko
M
Takayama
Hisashi
H
Hashimoto
Yoshiaki
Y
Yamada
Toshihiko
T
Takahashi
Hitomi
H
Shimojo
Hiroshi
H
Nagamine
Takeaki
T
Mori
Masatomo
M
D000410:Alanine Transaminase / Q000097:blood; D000975:Antioxidants / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D002784:Cholesterol / Q000097:blood; D005260:Female; D019698:Hepatitis C, Chronic / Q000097:blood / Q000150:complications*; D006801:Humans; D008103:Liver Cirrhosis / Q000097:blood / Q000150:complications* / Q000821:virology; D008113:Liver Neoplasms / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010976:Platelet Count; D012709:Serum Albumin / Q000032:analysis; D015996:Survival Rate; D000509:alpha-Fetoproteins / Q000032:analysis; D024502:alpha-Tocopherol / Q000097:blood / Q000627:therapeutic use*
D000975:Antioxidants; D012709:Serum Albumin; D000509:alpha-Fetoproteins; D002784:Cholesterol; D000410:Alanine Transaminase; D024502:alpha-Tocopherol