Objective

To evaluate the outcomes used in randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in the treatment of stable angina pectoris

and to provide a basis for the study of the core outcome set of TCM in the treatment of stable angina pectoris.

Methods

We searched RCTs of TCM in the treatment of stable angina pectoris in the databases of PubMed

EMbase

The Cochrane Library

CBM

CNKI

WanFang Data and VIP from January 2016 to August 2019. Two reviewers independently screened all the records

extracted the data and evaluated the risk of bias for the included trials. A qualitative analysis was conducted to describe the outcomes of the included studies.

Results

6349 papers were searched and screened. 24 papers (3 English papers) were included in the final analysis. Outcomes used in these 24 studies were mainly divided into six categories

namely clinical efficacy of angina pectoris

electrocardiogram (ECG)

Quality of life (QoL) scale

blood biochemistry panel

safety profiles (including adverse reactions and adverse events)

and other parameters. Blood biochemical parameters topped the list

followed by angina pectoris. 14 of the 24 studies used TCM syndrome scores as an indicator of outcome.

Conclusion

There are existing problems in the outcomes used in RCTs of TCM treatment of stable angina pectoris. We should establish core outcome set for TCM studies on the basis of combining the international standardized core outcome set with the characteristics and laws of diagnosis and treatment of traditional Chinese medicine.