Outcome measures in clinical trials of traditional Chinese medicine for stable angina pectoris

Abstract

Objective: This work aimed to present a descriptive analysis of the outcome measures used in clinical trials of traditional Chinese medicine (TCM) for patients with stable angina pectoris, and to provide baseline data for the development of core outcome sets (COSs) for relevant clinical trials. Methods: Medical databases were searched to identify randomized trials of the effects of TCM for the treatment of stable angina pectoris. Outcome measures of each trial were extracted. Descriptive statistics were used to analyze the baseline characteristics of outcomes in clinical trials of TCM. Results: 94 randomized trials (with 9,111 participants) involving 79 different outcomes were identified. The mean number of outcomes was 5 (1-21 per trial). The 5 most commonly reported outcomes were efficacy rate of electrocardiogram, efficacy rate of angina pectoris, efficacy rate of TCM syndrome, fasting lipid indices, and withdrawal rate of nitroglycerin. Several challenges were identified: (1) significant heterogeneity of outcomes and differences in the technique and timing of the measurement of the same outcome; (2) transformation of continuous data into categorical data and presented as such in >90% of trials; (3) few trials on the outcomes associated with the advantages and characteristics of TCM; and (4) selective reporting of outcomes. Conclusions: The outcomes used are excessively heterogenous, and the choice of some outcomes (timing and techniques) for measurement is confusing or inappropriate. Hence, developing and implementing a COS is necessary for greater consistency.

Keywords

Core outcome set / Outcome measures / Randomized trial / Traditional Chinese medicine

Funding

This work was supported by the National Natural Science Foundation Project of China (81473544), Ministry of Education Program for Innovative Research Team (IRT1276), National key research and development projects of modernization of traditional Chinese medicine (2019YFC1710000,2019YFC1710003), Henan Youth Talent Promotion Project (2020HYTP060) and the National Basic Research Program of China (2015CB554401).

Author contributions

Dongmei Xing performed the literature search and data analysis, and worked on the manuscript. Mingjun Zhu designed the study and prepared the first version of this manuscript. Dongmei Xing and Chunxiang Liu screened literature for inclusion and abstracted data. Hui Wang contributed to the data analysis.

Ethical approval of studies and informed consent

Not applicable.

Acknowledgements

All authors thank Mike Clarke for his excellent work in language revision.

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Acupuncture and Herbal Medicine