Objective: To investigate the published randomized controlled trials (RCTs) concerning the treatment of liver carcinoma with TCM, and to assess their methodologic quality and quality of report.
Methods: Related RCT reports published from Jan. 2004 to June 2006 were retrieved by computerized and manual search, and the criteria of CONSORT statement (revised edition) were applied to assess the articles searched.
Results: Forty-six articles up to the RCTs inclusion standard were searched, among them, the method for randomized distribution sequence producing was described in 9 articles (19.57%), none mentioned randomization concealment and the estimation of the sample size. The blinded method was adopted in 3 articles (6.52%), the inclusion and exclusion criteria were reported in 18 (39.13%) and 1 (2.17%), respectively. Participant flow was reported in 3 (6.52%), but flow chart was not described in any article. Patients' compliance was reported in 5 (10.87%), and the concrete P value was reported in 6 (13.04%), but with no report involving the confidence interval. Adverse events were described in 15 (32.61%). Only 5 articles (10.87%) discussed the limitations of the present study in their section of discussion.
Conclusion: The quality of RCTs reports on treatment of liver carcinoma with TCM are still in low quality, not meeting the CONSORT statement.