ZHANG Tong, HE Wenting, SUN Yingying, et al. Evaluation and Thinking on Quality of the Report of Randomize-Controlled Trials of Traditional Chinese Medicine for Colorectal Cancer[J]. Journal of Traditional Chinese Medicine2019, 60(22): 1924-1928.
ZHANG Tong, HE Wenting, SUN Yingying, et al. Evaluation and Thinking on Quality of the Report of Randomize-Controlled Trials of Traditional Chinese Medicine for Colorectal Cancer[J]. Journal of Traditional Chinese Medicine2019, 60(22): 1924-1928.DOI: 10.13288/j.11-2166/r.2019.22.009.
Objective To evaluate the quality of the papers on the randomized controlled trial(RCT) of colorectal cancer treated by traditional Chinese medicine(TCM)
and to discuss the existing problems. Methods The RCT literature on colorectal cancer treated by TCM in Chinese National Knowledge Infrastructure(CNKI) from January 1
1996 to August 31
2018 were searched by two researchers. The CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials(referred to as Statement) was used to evaluate the quality of each item one by one
giving a "yes"or "no"judgment. The papers published from January 1
1996 to December31
2012
and from January 1
2013 to August 31
2018 were compared. Results Compared with the period from January 1
1996 to December 31
2012
the quality of RCT papers on TCM treatment of colorectal cancer published from January 1
2013 to August 31
2018 was significantly improved in the 8 items of scientific background(2 a)
objective(2 b)
eligibility criteria(4 a)
site(4 b)
outcomes results/effect estimates and accuracy(17 a)
dichotomous outcomes relative and absolute effect values(17 b)
promotion(21)
funding(25) in the Statement(P < 0. 05); there was no statistical significance from item 7 a to 11 b involved sample size estimation
randomized
blinding
division of labor and other RCT core methodological entries(P > 0. 05). Conclusion After the publication of the Statement
the reporting quality of the RCT papers has improved
but the reporting quality of the core methodological items is still not high
which may be related to the low awareness of the Statement by the researcher
and may also be that the blinding and random hiding cannot be implemented due to great difficulty in preparing decoction placebo. It is recommended to change the dosage form and other methods to improve the problem
and recommend to refer to the Statement for reporting.