This study evaluated the quality of randomized controlled trials (RCTs) involving the treatment of hepatocellular carcinoma (HCC). A MEDLINE search was performed to identify prospective RCTs investigating HCC treatment published between 1991 and 2005. Eligible RCTs were evaluated by grading 5 items including sample size, calculation of sample size, intention to treat analysis, mean observational period, and loss to follow-up rate.
Seventy-five papers were eligible for analysis. Geographically, more than half of these RCTs were performed in Asia and the most papers were published by Japan. However, the quality of RCTs from Japan was the lowest in the top five countries. Improvement of internal validity with adequate study design is important to obtain reliable evidence.