Quality Assessment on Randomized Controlled Trials of Chinese Reports in Treating Gastric Cancer in TCM Therapy

Objective:To assess the quality of the published Chinese articles of randomized controlled trials(RCTs) about gastric cancer by using T C M therapy.Methods:Guided by the Cochrane Center guidelines,we searched the literatures in biomedicine journals and conferences by using computed retrieval and manual retrieval from 2002 to 2006.The data were extracted according to the principles of clinical epidemiology and consolidated standards of reporting trials(CONSORT).The data were managed by descriptive analysis and uniformity test.Results:There were 79 RCTs.The inclusion and exclusion criteria were reported in 7 trials(8.86%) and 3 trials(3.79%)respectively.17 trials(21.52%)used the types of TCM syndromes.59 trials(74.68%) mentioned criteria of curative effect evaluation.None estimation of sample size was mentioned.The randomization and allocation concealment were reported in 5 trials(6.33%)and 2 trials(2.53%) respectively.The baseline data were described in 42 trials(53.16%).Blinding was mentioned in 2 trials(2.57%).Statistics method were described in 45 trials(56.96%).Adverse drug reactions were mentioned in 46 trails(58.23%).Follow-up visit were mentioned in 4 trials(5.06%).Conclusion:There are deficiencies in these RCTs,it is necessary to improve the quality of clinical research in TCM.Most of the trials did not describe the randomization or used it in a wrong way,only a few trials used the allocation concealment and blinded method,most of the trials did not report the inclusion and exclusion criteria.Other problems include the unification of clinical research assessment standards and types of TCM syndromes,incomplete description of comparability of baseline data and no estimation of the sample size,neglect of the analysis of treatment compliance,withdrawal and follow-up visit.