Abstract
Traditional Chinese medicine (TCM) prescriptions lack standardization due to the complex composition of the prescribed herbs, the unclear mechanism of the formulas, and a lack of scientific data to support the dose-response relationship. Here, we proposed a new clinical strategy of dosage modification for TCM prescriptions to evaluate the clinical efficacy and guide the clinical medication. This study used two TCM prescriptions for the treatment of newly diagnosed type 2 diabetes mellitus (T2DM) to explore the key indications and the most appropriate critical values of dosage modification by analyzing two randomized controlled trials (RCTs). In this study, the indications refer to a change in the indicators from baseline at a certain time point (week 4, week 8, week 12), which could predict the change in outcome indicators, and the critical values refer to the change ranges closely related to the decrease in HbA1c at week 12. In Study 1, the correlation analysis between the change range of indicators at three time points (weeks 4, 8, and 12) from baseline and the decrease in HbA1c at week 12 from baseline (HbA1c 012) was carried out to screen the related indications. Next, we evaluate the related indications and the respective critical values to determine the key indicators, indications, and the most appropriate critical value. We conducted a correlation between the change range of key indicators (obtained from the result of Study 1) at three time points from baseline and HbA1c 012 to screen the key indications in the drug group, high-dose group, and low-dose group in Study 2. Key indications with critical values were determined to investigate the most appropriate critical value in the three groups separately. In Study 1, the key indicator was FBG, the key indication was FBG 04, and the most appropriate critical value was 0.5 mmol/L. In Study 2, the key indication was FBG 04 and the most appropriate critical value was 0.6 mmol/L in the drug group. In the high-dose group, the key indication was FBG 04, and the most appropriate critical value was 0.3 mmol/L. In the low-dose group, the key indication was FBG08, and the most appropriate critical value was 0.1 mmol/L. In addition, we summarized a verification strategy for dosage modification.
Highlights
Traditional Chinese medicine (TCM), which is characterized by multiple components and targets, has been widely used in clinical practice in China (Xu et al, 2021; Zhao et al, 2021; Zhou et al, 2021)
The related indications of dosage modification were the change range of fasting blood glucose (FBG) 04, the change range in FBG 08, the change range in 2-hour postprandial blood glucose (2hPG) 04, and the change range in weight 08
The critical values of the related indications (FBG 04, FBG 08, 2hPG 04) were set as 0.1 mmol/L, 0.2 mmol/L, 0.3 mmol/L, 0.4 mmol/L, 0.5 mmol/L, 0.6 mmol/L, 0.7 mmol/L, 0.8 mmol/L, 0.9 mmol/L, 1.0 mmol/L, and 1.1 mmol/L, and weight 08 were set as 0.5, 1, 2, 3, and 4 kg to calculate the percentage of efficacy and explore the key indications and the most appropriate critical value of dosage modification
Summary
Traditional Chinese medicine (TCM), which is characterized by multiple components and targets, has been widely used in clinical practice in China (Xu et al, 2021; Zhao et al, 2021; Zhou et al, 2021). Previous studies have shown that TCM can effectively and safely control blood pressure (Wu et al, 2014; Zhang et al, 2019), blood lipids (Zhai et al, 2012; Tong et al, 2018; Shi et al, 2020), and glycosylated hemoglobin (HbA1c) (Lian et al, 2015). To make clinical medication more individualized, we propose a new clinical strategy of dosage modification for TCM prescriptions based on the dose-effect relationship and have focused on the evaluation of clinical efficacy.
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