The quality of reports of randomized clinical trials on traditional Chinese medicine treatments: a systematic review of articles indexed in the China National Knowledge Infrastructure database from 2005 to 2012

Abstract

Background: 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.

Data 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.

Results: A 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).

Conclusions: Although 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.

Figure 1

The process of collecting materials.

Figure 2

CONSORT results of title, abstract, background and objectives in each year.

Figure 3

CONSORT results of materials and methods in each year.

Figure 4

CONSORT results of ‘randomization’ in each year.

Figure 5

CONSORT results of ‘results’ in each year.

Figure 6

CONSORT results of ‘discussion’ in each year.

Figure 7

The distribution of the mean scores before and after 2010.

Figure 8

The mean score of publication of each year.

Figure 9

The annual distributions of the CONSORT score of reports.

Figure 10

The Jadad score before and after 2010. The scores of reports are similar for both periods (2005–2009 vs 2011–2012, P = 0.405).

Figure 11

The annual distributions of the Jadad score of reprts. The mean scores are similar from 2005 to 2012 (P =1.000)