Abstract
BackgroundThe Consolidated Standards for Reporting Trials (CONSORT) are aimed to standardize clinical trial reporting. Our objective is to compare the quality of randomized clinical trials (RCTs) of traditional Chinese medicine (TCM) published in 2005–2009 and 2011–2012 according to the current CONSORT statements and Jadad scale.MethodsData Sources: Reports on RCTs of TCM in the China National Knowledge Infrastructure database (CNKI database) for manuscripts published from 2005 to 2009 and 2011–2012. Search terms included TCM and clinical trial. Study Selection: Manuscripts that reported RCTs of TCM were included. Data Extraction: Independent extraction of articles was done by 3 authors. Disagreement was discussed until agreement was reached. According to the CONSORT checklist, an item was scored as 1 when the item was described in the paper. Otherwise the item was scored as 0.ResultsA total of 4133 trials in 2005–2009 and 2861 trials in 2011–2012 were identified respectively. There was a significant increase in proportion of reports that included details of background (24.71% vs 35.20%, P < 0.001), participants (49.79% vs 65.26%, P < 0.001), the methods of random sequence generation (13.77% vs 19.85%, P < 0.001), statistical methods (63.00% vs 72.77%, P < 0.001) and recruitment date (70.14% vs 80.36%, P < 0.001) in 2011–2012 compared to 2005–2009. However, the percentage of reports with trial design decreased from 4.45% to 3.25% (P = 0.011). Few reports described the blinding methods, and there was a decreasing tendency (4.77% vs 2.48%, P < 0.001). There was a similar decreasing tendency on the reporting of funding (6.53% vs 5.00%, P = 0.007). There were no significant differences in the other CONSORT items. In terms of Jadad Score, the proportion of reports with a score of 2 was markedly increased (15.15% vs 19.71%, P < 0.001).ConclusionsAlthough the quality of reporting RCTs of TCM was improved in 2011–2012 compared to 2005–2009, the percentages of high-quality reports are both very low in terms of Jadad score. There is a need for improving standards for reporting RCTs in China.
Highlights
The Consolidated Standards for Reporting Trials (CONSORT) are aimed to standardize clinical trial reporting
Search strategy The China National Knowledge Infrastructure (CNKI) database is the most comprehensive full-text database of journals published in China and was used in the present study [30]
Characteristics of selected randomized clinical trials (RCTs) After screening the titles, abstracts and texts, we identified a total of 4133 reports in 2005–2009 and 2861 in 2011– 2012 in the CNKI database that met the inclusion and exclusion criteria and were included in this analysis
Summary
The Consolidated Standards for Reporting Trials (CONSORT) are aimed to standardize clinical trial reporting. Our objective is to compare the quality of randomized clinical trials (RCTs) of traditional Chinese medicine (TCM) published in 2005–2009 and 2011–2012 according to the current CONSORT statements and Jadad scale. The CONSORT (consolidated standards of reporting trials) statement was first published in 1996, revised in 2001 and updated in 2010 by the CONSORT Group. They provide authors and editors with a checklist for a minimum set of recommendations for reporting the trial design, analysis and results [6,7,8]. The Jadad score is considered a valid and reliable tool to assess the methodological quality of a clinical trial, and has been applied throughout the medical literature [13,14]
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