Objective To evaluate the quality of randomized controlled trials（RCTs） of traditional Chinese medicine（TCM） published in 2018 on T1 level journals of TCM

and to provide references for future improvement of quality of RCTs. Methods CNKI was searched for TCM RCTs published from January to December

2018 on T1 level journals of TCM

including Journal of Traditional Chinese Medicine

China Journal of Traditional Chinese Medicine and Pharmacy

Chinese Archives of Traditional Chinese Medicine

Journal of Beijing University of Traditional Chinese Medicine

China Journal of Chinese Materia Medica

Chinese Traditional and Herbal Drugs

Chinese Journal of Experimental Traditional Medicine Formalae

Chinese Journal of Integrated Traditional and Western Medicine

and Chinese Acupuncture and Moxibustion. CONSORT 2010 statement

Cochrane risk bias scale and additional indicators were used to evaluate the quality of the included RCTs. Results From January to December

2018

there were 669 RCTs published on T1 level journals of TCM. Cochrane risk of bias assessment showed that 76.1%（509） of the included RCTs were at low risk of bias for random sequence generation; 92.7%（620） of the RCTs were assessed at unclear risk for allocation concealment; high risk of bias was found in 93.6%（626） of the included RCTs in terms of blinding of participants and personnel

and in 82.1%（549） of the included RCTs regarding the blinding of outcome assessors; all the RCTs were assessed at low risk of bias for incomplete outcome data

and at unclear risk of bias for selective reporting. According to the CONSORT 2010 statement

all RCTs reported the statistical methods; 90%（600） of the RCTs reported the methods of random sequence generation; 49.5%（331） of the RCTs reported the adverse events; 6.4%（43） and 7.5%（50） of the RCTs reported allocation concealment and blinding items. Additional assessments indicated that the percentage of the included RCTs having reported informed consent

syndrome differentiation

ethical approvement

TCM effectiveness evaluation standard

and a multi-center trial design was 84.3%（564）

61.6%（412）

53.1%（355）

34.5%（231） and 7.2%（48）

respectively. Conclusion The overall quality of the RCTs published on the T1 level journals of TCM in 2018 is relatively high

but there is still much for improvement on the methodological and TCM-specific items.