Abstract
Objective
To observe the effect of Danzhi Jiangtang capsule (DJC) on the clinical indexes and vascular endothelial function indexes in patients with impaired glucose tolerance (IGT).
Methods
A total of 106 patients were enrolled and randomly assigned to the treatment group and control group following a four-week washout period. The patients in the control group received a general lifestyle intervention, while those in the treatment group received DJC (2.0 g 3× a day) in conjunction with the intervention given to the control group patients. The physiological and biochemical levels, vascular endothelial function indices, and traditional Chinese medicine (TCM) syndrome ratings of the patients in the two groups were compared after 12 weeks of therapy.
Results
In the control group, the diastolic blood pressure (DBP) was significantly improved compared with those before treatment (83.31 ± 6.47 vs. 79.21 ± 6.17, p < .01) (CI: 1.45, 6.73; Cohen’s d: 10.51), as was the case with the nitric oxide (NO) levels and TCM syndrome points (35.71 ± 4.58 vs. 43.96 ± 5.17, 9.57 ± 2.63 vs. 5.38 ± 1.79, p < .001) (CI: –10.28, –6.24; 3.12, 5.18; Cohen’s d: 0.90). In the treatment group, the levels of fasting blood glucose, endothelin and vascular endothelial growth factor were significantly improved compared with control group (4.92 ± 0.21 vs. 5.59 ± 0.31, 59.37 ± 13.25 vs. 72.13 ± 12.37, 19.25 ± 2.80 vs. 26.76 ± 1.88, p < .001) (CI: 0.55, 0.78; 7.40, 18.13; 6.52, 8.50; Cohen’s d: 4.94, 0.41, 1.32), as was the case with 2-h post-load plasma glucose and total cholesterol (TC) (8.33 ± 0.62 vs. 8.89 ± 1.55, 4.61 ± 1.05 vs. 5.22 ± 1.12, p < .05) (CI: 0.07, 1.07; 0.15, 1.06; Cohen’s d: 0.40, 0.51).
Conclusions
Treatment with DJC could significantly improve the physiological and biochemical indicators, vascular endothelial function, and TCM syndrome points of IGT patients, indicating that DJC could be a potential drug to treat patients with IGT of Qi–Yin deficiency type.
Acknowledgements
The registration number: ChiCTR2100049613.
Author contributions
Conception and design of the research: Zhaohui Fang, Jindong Zhao and Ruimin Lu. Acquisition of data: Zheng Bi, Di Wu and Yixuan Lin. Analysis and interpretation of the data: Jindong Zhao, Yixuan Lin, and Sihai Wang. Statistical analysis: Sihai Wang, Ruimin Lu, and Zheng Bi. Obtaining financing: Zhaohui Fang. Writing of the manuscript: Zhaohui Fang and Zheng Bi. Critical revision of the manuscript for intellectual content: Zheng Bi and Jindong Zhao. All authors read and approved the final draft.
Ethical approval
This study was conducted with approval from the Ethics Committee of The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine (2015AH-32(Z)). This study was conducted in accordance with the Declaration of Helsinki.
Consent form
Written informed consent was obtained from all participants.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Data availability statement
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.