Context Previous findings indicate that vitamin K2 (menaquinone)
may play a role in controlling cell growth.
Objective To determine whether vitamin K2has preventive effects on
the development of hepatocellular carcinoma in women with viral cirrhosis
of the liver.
Design, Setting, and Participants Forty women diagnosed as having viral liver cirrhosis were admitted
to a university hospital between 1996 and 1998 and were randomly assigned
to the treatment or control group. The original goal of the trial was to assess
the long-term effects of vitamin K2 on bone loss in women with
viral liver cirrhosis. However, study participants also satisfied criteria
required for examination of the effects of such treatment on the development
of hepatocellular carcinoma.
Interventions The treatment group received 45 mg/d of vitamin K2 (n = 21).
Participants in the treatment and control groups received symptomatic therapy
to treat ascites, if necessary, and dietary advice.
Main Outcome Measure Cumulative proportion of patients with hepatocellular carcinoma.
Results Hepatocellular carcinoma was detected in 2 of the 21 women given vitamin
K2 and 9 of the 19 women in the control group. The cumulative proportion
of patients with hepatocellular carcinoma was smaller in the treatment group
(log-rank test, P = .02). On univariate analysis,
the risk ratio for the development of hepatocellular carcinoma in the treatment
group compared with the control group was 0.20 (95% confidence interval [CI],
0.04-0.91; P = .04). On multivariate analysis with
adjustment for age, alanine aminotransferase activity, serum albumin, total
bilirubin, platelet count, α-fetoprotein, and history of treatment with
interferon alfa, the risk ratio for the development of hepatocellular carcinoma
in patients given vitamin K2 was 0.13 (95% CI, 0.02-0.99; P = .05).
Conclusion There is a possible role for vitamin K2 in the prevention
of hepatocellular carcinoma in women with viral cirrhosis.