Title: Quality Assessment for Randomized Controlled Trials of TCM Therapy for Non-small Cell Lung Cancer
Abstract:Objective:To assess the quality of the published randomized controlled trials (RCTs) of non-small cell lung cancer (NSCLC) treated with TCM therapy. Methods:Guided by the Cochrane Center guidelines, w...Objective:To assess the quality of the published randomized controlled trials (RCTs) of non-small cell lung cancer (NSCLC) treated with TCM therapy. Methods:Guided by the Cochrane Center guidelines, we searched the literatures in Chinese biomedicine journals from 1997 to 2006 by computer retrieval and manual retrieval. The data were extracted according to the principles of clinical epidemiology and Consolidated Standards of Reporting Trials(CONSORT), and were managed by descriptive analysis and uniformity test. Results:124 RCTs were enrolled. The inclusion and exclusion criterias were reported in 37 trials (29.84%) and 13 trials (10.48%) respectively. The type of TCM syndrome was involved in 37 trials (29.84%).None of the trials mentioned the estimation of sample size. The randomization and allocation concealment was reported in 24 trials (19.35%) and 8 trials (6.45%) respectively. The baseline data were described in 85 trials (68.55%). Blind method was mentioned in 3 trials (2.42%). Statistics method was described in 77 trials (62.10%). Informed consent was acquired in 6 trials (4.84%).Adverse events were described in 88 trails (70.97%). Follow-up visit was mentioned in 38 trials (30.65%). Conclusions:There are deficiencies in these RCTs, and it is necessary to improve the quality of clinical research in TCM. Most of the trials do not describe the randomization method or use it in a wrong way,only a few trials use the allocation concealment and blind method, most of the trials do not report the inclusion and exclusion criterias, has no description of comparability of baseline data, and none estimate the sample size, the clinical research assessment standards and syndrome differentiation are not unification, the analysis of treatment compliance, dropped-out case, follow-up visit are neglected.Read More
Publication Year: 2007
Publication Date: 2007-01-01
Language: en
Type: article
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