Developing a core outcome set of Traditional Chinese Medicine on coronary heart disease complicated with diabetes mellitus

Diabetes mellitus is a major risk factor for coronary atherosclerosis, coronary heart disease and diabetes mellitus have high incidence rate and mortality rate, which pose a continuous challenge to the health of modern society. There is a close relationship between coronary heart disease and diabetes mellitus. The risk of coronary heart disease in diabetics is 2-4 times higher than that in non diabetic patients. The course of treatment is longer and there are more adverse reactions. The use of traditional Chinese medicine in the treatment of coronary heart disease complicated with diabetes can not only effectively avoid the disadvantages of traditional drug treatment, but also achieve the goal of treating both symptoms and root causes, so as to comprehensively improve the prognosis and quality of life. TCM related clinical trials have been on the rise annually. However, the heterogeneity of these trial results pose as an obstacle for synthesizing clinical results in meta-analyses, thus reducing the value of clinical trials. There is also a risk of bias for selective reporting in clinical trials. Therefore, it is necessary and urgent to establish a core outcome set (COS) on TCM for coronary heart disease and diabetes mellitus.

Contributors

Principal investigator:
Ming Ren, Baokang Hospital Affiliated to Tianjin University of traditional Chinese Medicine, Tianjin, China
Junhua Zhang, Mingyan Zhang, Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China

Other contributors: Huiyi Zhao, Xiangyu Zhang, Tianjin University of Traditional Chinese Medicine, Tianjin, China

Further Study Information

Current Stage: Ongoing
Date: December 2020 - June 2022
Funding source(s): National key research and development project (2018YFC1707403)


Health Area

Disease Category: Heart & circulation

Disease Name: Coronary heart disease (CHD), Diabetes mellitus

Target Population

Age Range: 0 - 100

Sex: Either

Nature of Intervention: Complementary and alternative medicine (CAM) therapy, Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)

Study Type

- COS for practice

Method(s)

- Consensus conference
- Delphi process
- Interview
- Systematic review

(1) Systematic literature review
(2) Qualitative semi-structured interview
(3) Two rounds Delphi Survey
(4) Consensus conference

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