2006•Zhongguo xunzheng yixue zazhiRequires access
Quality Assessment of the Reporting of Randomized Controlled Trials Published in the Chinese Journal of Integrated Traditional and Western Medicine with the Revised CONSORT Statement
Ting-qian Li
Open publisher page 6 citations
Abstract
Objective To explore the quality of the reporting of randomized controlled trials (RCTs) published in the Chinese Journal of Integrated Traditional and Western Medicine from 1999 to 2004. Methods A manual search was performed and the 22 checklists of CONSORT statement and other self-established criteria were applied.Results Six volumes and 72 issues were checked. There were 1 874 clinical trials of which 1288 (68.73%) RCTs were identified in 2 765 articles. Randomization methods were described in 630 (48.92%) RCTs which showed there was more significant difference than the RCTs published in 1998 (P0.001).In the 1288 RCTs, placebo control was reported only in 21 trials (1.63%) and endpoint measurements were reported in 114 trials (8.85%). Seven trials (0.55%) mentioned the estimation of sample size. None mentioned randomization concealment. Blinding was reported in 54 trials (4.2%) and P value was reported in 9 trials (0.70%).Flow chart was not mentioned in any trials. Compliance was reported in 2 trials (0.16%), and only one trial (0.08%) reported negative results. Ancillary analysis was used in 33 trials (2.57%). 10 trials are multi-centre RCTs. None of the trials reported the approval of ethics committee. Informed consent was reported in 3 trials (0.24%). Acknowledgements were mentioned in 3 trials (0.24%). Syndrome types defined by traditional Chinese medicine (TCM) were reported in 163 trials (12.66%). The criteria of intervention quality control was mentioned in 2 trials (0.15%). Double dummy was used in 8 trials (0.63%) and outcome measurement of TCM was reported in 258 trials (20.04%). All Items reported in RCTs were of low quality. Conclusions The quality of reporting of RCTs published in the Chinese Journal of Integrated Traditional and Western Medicine from 1999 to 2004 has been improved, but it does not meet the CONSORT statement.