Effects of Tangshen Formula on urinary and plasma liver-type fatty acid binding protein levels in patients with type 2 diabetic kidney disease: post-hoc findings from a multi-center, randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of Tangshen Formula in patients with type 2 diabetic kidney disease

Abstract

BackgroundTangshen Formula (TSF) is a traditional Chinese medicine for the treatment of diabetic kidney disease (DKD). Liver-type fatty acid binding protein (L-FABP) is expressed in various tissues, including the kidney, where it is known as urinary L-FABP. Other studies demonstrated that urinary L-FABP may be a useful biomarker for monitoring DKD. This post-hoc analysis and cross-sectional study evaluated the changes in urinary L-FABP in DKD patients treated with TSF and conventional medicine.MethodsPost-hoc analysis was conducted on a multicenter, randomized, double-blind, placebo-controlled trial. A total of 180 participants with DKD including 98 with microalbuminuria and 82 with macroalbuminuria were enrolled in the original study. In addition to conventional treatment, 122 participants were randomly assigned to receive TSF and 58 to receive placebo. After 24-weeks of treatment, the intention-to-treat population in microalbuminuria stage was 56 in the TSF group and 25 in the placebo group, and in the macroalbuminuria stage 42 and 19, respectively. The primary outcome in the original trial was urinary protein level. In the current study, urinary and plasma L-FABP levels were measured in 30 microalbuminuria patients (15 in the TSF group and 15 in the placebo group) and 30 macroalbuminuria patients (15 in the TSF group and 15 in the placebo group). In addition, another 30 patients with normoalbuminuria (urinary albumin excretion rate (UAER) < 20 μg/min) were recruited for the cross-sectional study.Results(1) In microalbuminuria patients, UAER in the TSF group displayed a significant decrease after 24 weeks of treatment (P = 0.045). Levels of urinary L-FABP in the TSF group were markedly lower than in the placebo group after 12 and 24 weeks (P = 0.004 and P = 0.047, respectively). (2) In macroalbuminuria patients, 24-h urinary protein levels decreased significantly compared with baseline in the TSF group at week 12 (P = 0.042) and week 24 (P = 0.041). The TSF group showed a significant decrease in urinary L-FABP after 12 and 24 weeks (P = 0.036 and P = 0.046, respectively). (3) Levels of urinary L-FABP increased markedly, correlating with severity of DKD. L-FABP in patients with normoalbuminuria, microalbuminuria, and macroalbuminuria were 5.9 (5.2, 7.8) μg/ml, 11.4 (6.8, 13.4) μg/ml and 18.5 (10.9, 23.4) μg/ml, respectively (P = 0.000).ConclusionsTSF combined with conventional therapy appeared to be effective in reducing urinary protein and urinary L-FABP. Urinary L-FABP levels appear to be associated with the severity of DKD.Trial registrationChinese Clinical Trial Registry ChiCTR-TRC-10000843. Registered 15 April 2010.

Comparative Efficacy and Safety of Antihypertensive Agents for Adult Diabetic Patients with Microalbuminuric Kidney Disease: A Network Meta-Analysis

“…Multiple clinical studies by Ping Li’s research group have demonstrated the efficacy of the Tangshen formula in attenuating diabetic kidney disease in rodent models and human patients [25]. Notably, a 2015 multicenter RCT in type 2 diabetic patients with diabetic kidney disease has also revealed that the Tangshen formula produces a significant decrease in 24-hour urinary protein as well as significant improvements in the estimated glomerular filtration rate (eGFR) relative to placebo [26].…”

Tangshen formula improves inflammation in renal tissue of diabetic nephropathy through SIRT1/NF-κB pathway

“…According to the traditional Chinese medicine theory of Professor Kefu Chai, it is believed that the basic pathogenesis of early-and medium-stage DN is the deficiency of both Qi and Yin, which results in blood stasis (15). Previous results have indicated that a Chinese herbal compound prescription, Tangshen (TS) formula, has demonstrated good clinical efficacy in managing early-stage DN, as it is believed in traditional Chinese medicine that it supplements Qi, nourishes Yin, improves blood flow and removes obstructions in the blood vessels (16). In the present study, the molecular mechanisms of TS formula in a DN rat model were analyzed, providing a deeper insight into the effects of TS formula in the treatment of DN.…”

Traditional Chinese Medicine Could Play an Important Role in Integrative Palliative Care in China

“…[2][3][4][5][6][7][8][9][10][11] Qigong can also improve cognitive function in the early stages of dementia, 12 whereas TCM decoctions can be used as adjuvant treatment for patients with stroke and chronic obstructive pulmonary disease, chronic liver disease, chronic heart failure, and chronic or type 2 diabetic kidney disease. [13][14][15][16][17][18][19][20][21][22][23][24][25][26] Second, TCM can improve symptoms. For example, acupuncture and Chinese herbal medicines are recommended for cancer pain and serve to reduce opioid abuse.…”