Quality Assessment of the Clinical Studies on Randomized Controlled Trials of Chinese Herb Medicine and Chemotherapy in the Treatment of Hepatocellular Carcinoma

Objective:To investigate the quality of the reports on randomized controlled trials(RCTs)on Chinese herb medicine and chemotherapy for hepatocellular carcinoma and assessed whether it was adequate to provide evidence for clinical practice.Methods:We collected All the published clinical studies on Chinese Herb Medicine and Chemotherapy for Hepatocellular Carcinoma were collected and all the included reports were assessed according to Jadad scale,CONSORT statements and all other self-laying items,The electric searched databases comprised CENTER,Medline,Embase,CBM,CNKI and VIP.Results:The Jadad score of one was 5,one was 3,ten RCTs were 2,seventy-one RCTs were 1 and twenty RCTs were 0.Three RCTs performed allocation concealment.According to CONSORT criteria,Only one(0.97%)described randomization sequence generation,among them one was quasi-randomized,no RCT provided randomization implementation,one(0.97%)carried out placebo control,fifty-four RCTs(52.43%)reported endpoint,two RCTs(1.94%)adopted single blinding,two RCTs(1.94%)adopted double blinding,fourteen RCTs(13.59%)calculated statistic values,fifty-four RCTs(52.43%)reported record of follow-up,seven RCTs(6.80%)reported negative outcome,sixteen RCTs(15.53%)offered adverse events,only one(0.97%)described estimation of sample size,intent-to-treat analysis(ITT),two RCTs reported correlation analysis,one reported muti-center,no RCT completed ethicapprobation and informed consent,and tree RCTs(2.91%)described syndrome type of TCM.Conclusion:Because the majority of RCTs may existed selective and measurement bias in this study,currently the quality of methodology and report of studies on Chinese Herb Medicine and Chemotherapy for Hepatocellular Carcinoma were not good enough to provide reliable evidence for clinical practice.