title: 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.
  
  
  METHODS
  
  
  
  METHODS
  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.
  
  
  METHODS
  Manuscripts that reported RCTs of TCM were included.
  
  
  METHODS
  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.
authors.forename: Jinnong
authors.initials: J
authors.lastname: Li
authors.forename: Zhenhua
authors.initials: Z
authors.lastname: Liu
authors.forename: Ruiqi
authors.initials: R
authors.lastname: Chen
authors.forename: Dan
authors.initials: D
authors.lastname: Hu
authors.forename: Wenjuan
authors.initials: W
authors.lastname: Li
authors.forename: Xiajing
authors.initials: X
authors.lastname: Li
authors.forename: Xuzheng
authors.initials: X
authors.lastname: Chen
authors.forename: Baokang
authors.initials: B
authors.lastname: Huang
authors.affiliation: Department of Oncology, Fujian Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou 350112, PR China. llm@fjtcm.edu.cn.
authors.forename: Lianming
authors.initials: L
authors.lastname: Liao
mesh_terms: D035843:Biomedical Research / Q000592:standards; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D006801:Humans; D008516:Medicine, Chinese Traditional / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*
chemical_list: D004365:Drugs, Chinese Herbal