JMIR Publications

ABSTRACT

Background:

Diabetes and pre-diabetes are diagnosed differentially by Western and Chinese Medicine. While Western medicine uses Fasting Plasma Glucose and hemoglobin A1C tests to define the severity of diabetes and prediabetes, TCM uses a unique diagnostic system to determine the underlying causes of the symptoms and devise individualised treatment plans to restore balance and promote health.

Objective:

Our study aims to identify the gap in conventional diagnoses for syndrome differentiation analysis. We devised a protocol for a non-randomized, exploratory, observational case-control study with equal allocations in five arms to investigate the syndrome differentiation of diabetes and pre-diabetes. We hypothesize that the local TCM syndrome differentiation of diabetes and prediabetes in the tropical climate may differ from that defined based on the Chinese demographic. We also speculate that the high-frequency spectral energy may reflect a difference in pulse wave intensity and density between the healthy and diabetic groups.

Methods:

250 eligible participants will be equally assigned to one of five arms (healthy or sub-healthy, prediabetes, diabetes, prediabetes with hypertension and dyslipidaemia, and diabetes with hypertension and dyslipidaemia). Participants aged 2175, of any gender or race, and have been diagnosed with diabetes (FPG7 mmol/L, or 2hPG11.1 mmol/L) or prediabetes (IFG of FPG 6.16.9 mmol/L, and/or IGT with 2hPG of 7.811 mmol/L) will be included. The Health Evaluation Questionnaire, Physical Activity Questionnaire and Sugar Intake, Constitution in Chinese Medicine Questionnaire, radial pulse diagnosis, and tongue diagnosis will be performed in a single visit. An unpaired t-test with a significance level of p<0.05 will analyse the assessments.

Results:

We designed this protocol with the exploratory goal to examine objectively the syndrome differentiation of diabetic and prediabetic patients utilizing TCM diagnostic technologies. Thus, our findings may potentially increase the accuracy of identification, diagnosis, treatment and prevention of diabetes and prediabetes through a system of targeted treatment.

Conclusions:

To the best of our knowledge, this is the first study to use contemporary TCM diagnostic instruments to map expert and empirical knowledge of TCM to its scientific equivalents for the purpose of evaluating the syndrome differentiation of diabetes. Traditional methods of syndrome differentiation determination, such as pulse diagnosis and tongue diagnosis, are highly subjective and skill-dependent; as a result, the observations lack clinical significance. Objective assessment using contemporary tools will eliminate subjectivity. Clinical Trial: ClinicalTrials.gov (NCT05563090)