Characteristics and quality of randomized controlled trials in the treatment of hepatocellular carcinoma.

Although many randomized controlled trials (RCTs) have been performed to date in the field of the treatment for hepatocellular carcinoma (HCC), there has not been any detailed analysis or evaluation of the quality of these RCTs. This study analyzed the characteristics and quality of RCTs investigating the treatment of HCC. A MEDLINE search was performed to identify prospective RCTs investigating HCC treatment published between 1991 and 2005. Eligible RCTs were analyzed by using several items, such as publication year, geographic area, and study theme. Moreover, all RCTs were evaluated by grading five items, including sample size, calculation of sample size, intention-to-treat analysis, mean observational period, loss to follow-up rate, and summing of each point. Seventy-five articles were eligible for review. Geographically, more than half of RCTs (46 RCTs) were performed in Asia, 25 RCTs in Europe, and 3 RCTs in North America. RCTs concerning transarterial chemoembolization were most frequently performed, and RCTs on hormonal therapy, ablation therapy, and chemotherapy follow thereafter in numerical order. The mean total scores were not high, although scores have recently increased. The six high-grade RCTs were all published in the recent 5 years. Many RCTs on the treatment of HCC have been performed all over the world, especially in Asia and Europe. The quality of these RCTs is, however, unsatisfactory and most of the RCTs are still inadequately performed. High-quality RCTs are needed to establish common therapeutic guidelines.