Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial

Jin, De; Huang, Wenjing; Meng, Xiang; Yang, Fan; Bao, Qi; Zhang, Meizhen; Yang, Yaran; Ni, Qing; Lian, Fengmei; Tong, Xiaolin

doi:10.1186/s13063-019-3821-6

Cited by 10 publications

(9 citation statements)

References 44 publications

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“…The harm caused by diabetes concerns not only the elevation of sugar levels in the bloodstream but also the complications that arise as a result. Diabetic kidney disease (DKD) is one of the most common complications of diabetes ( 2 , 3 ), which, in turn, is the main cause of chronic kidney disease (CKD) and can eventually lead to end-stage renal disease and death. According to statistics ( 4 ), 25%–40% of patients with type 2 diabetes (T2D) will eventually develop diabetic nephropathy.…”

Section: Introductionmentioning

confidence: 99%

The Association Between the Decline of eGFR and a Reduction of Hemoglobin A1c in Type 2 Diabetic Patients

An¹,

Chen³

et al. 2022

Front. Endocrinol.

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ObjectiveThis study aimed to explore the relationship between short-term (≤12 months) changes in the estimated glomerular filtration rate (eGFR) and hemoglobin A1c (HbA1c) in patients with type 2 diabetes (T2D).MethodA total of 2,599 patients with T2D were enrolled if they were registered in the Diabetes Sharecare Information System, were aged 18–75 years, and had 2–3 HbA1c and eGFR measurements within the preceding 12 months. The studied patients were categorized into five groups based on eGFR, i.e., the relatively stable (RS), fast decline (FD), modest decline (MD), modest increase (MI), and fast increase (FI) groups.ResultsThe median eGFR changes from baseline were −22.14, −6.44, 0.00, 6.32, and 20.00 ml/min per 1.73 m2 for patients in the FD, MD, RS, MI, and FI groups, respectively. Up to 1,153 (44.4%) subjects experienced an eGFR decline of ≥3.5 ml/min per 1.73 m2, including 821 (31.6%) FD subjects and 332 (12.8%) MD subjects. A decreased trend was found between the eGFR change and HbA1c decrease category, even after multivariable adjustment. In general, an eGFR FD was frequently found in patients who had an HbA1c reduction of ≥3.00% and a baseline HbA1c ≥8.0%; alternatively, such a result was also observed for a urinary albumin-to-creatinine ratio (UACR) of 30.0–300.0 mg/g, regardless of a diabetes duration of <10.0 or ≥10.0 years, or in patients who had an HbA1c reduction of ≥1.00% accompanied by hyperfiltration.ConclusionsSome patients with T2D experienced an eGFR FD or MD during the ≤12-month follow-up period. A significant downward trend in eGFR change was demonstrated alongside an HbA1c reduction, independent of UACR stage, diabetes duration, and hyperfiltration. Sustained monitoring and cautious interpretation of the HbA1c and eGFR changes will be needed in clinical practice.

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Section: Introductionmentioning

confidence: 99%

The Association Between the Decline of eGFR and a Reduction of Hemoglobin A1c in Type 2 Diabetic Patients

An¹,

Chen³

et al. 2022

Front. Endocrinol.

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“…81 of the Ministry of health of China). 34 Incidence of AEs (except for myelosuppression and anemia), percentage of patient dropouts due to serious AEs as determined in accordance with the CTCAE v4.03, and risk of the promotion of tumor progression caused by the FFEJS formulation will be analyzed between the 2 groups. 35 Cost-effectiveness evaluation.…”

Section: Assessment Of Qol Will Be Measured With Edmonton Symptom Ass...mentioning

confidence: 99%

Exploring the Safety, Effectiveness, and Cost-Effectiveness of a Chinese Patent Medicine (Fufang E’jiao Syrup) for Alleviating Cancer-Related Fatigue: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial

Song

Sun

et al. 2021

Integr Cancer Ther

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Objective: To provide higher level evidence on the benefits of a Chinese patent medicine (CPM) (Fufang E’jiao Syrup, FFEJS) for alleviating cancer-related fatigue (CRF), this article describes a protocol for a randomized controlled trial. Methods/design: We designed a double-blind, placebo-controlled stratified permuted block randomization clinical trial on CRF among 3 types of cancer in China. Participants will be equally allocated to FFEJS group or placebo group according to the randomization sequence and the hospitals they were enrolled at. Each patient will receive 20 ml of either the study formula FFEJS or a placebo formula, 3 times a day for 6 weeks. The follow-up period will be another 4 weeks for safety evaluation. The primary outcome is the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV). Secondary outcomes include change in fatigue (measured by routine blood panel and hormones in peripheral blood) and QoL (measured by Edmonton symptom assessment scale and Functional Assessment of Cancer Therapy). Patient safety will be measured by liver, renal or cardiac damage, and the risk of FFEJS having a tumor promotion and progression effect will be monitored throughout this study. Cost-effectiveness will also be evaluated mainly by incremental cost per each quality-adjusted life year gained. Discussion: This article describes the study design of a CPM for CRF in patients with advanced cancer through exploring the effectiveness, safety, and cost-effectiveness of FFEJS. Trial registration: ClinicalTrials.gov, NCT04147312. Registered on 1 Sep 2019.

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“…2,3,5,4-TDG is also closely related to HIF-1 and a related study ( Yang and Liu, 2016 ) has found that it can significantly reduce the production of HIF-1, thus delaying the progression of the disease. Morroniside also has been reported to be useful in protecting the kidney ( Liu et al, 2018 ; Jin et al, 2019 ). Moreover, disorder of glucose metabolism is still a difficult problem in medical field.…”

Section: Disscussionmentioning

confidence: 99%

Qian Yang Yu Yin Granule Improves Renal Injury of Hypertension by Regulating Metabolic Reprogramming Mediated by HIF-1α/PKM2 Positive Feedback Loop

Qian

Ren

et al. 2021

Front. Pharmacol.

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Protection against hypoxia injury is an important therapeutic strategy for treating hypertensive nephropathy. In this study, the effects of Qian Yang Yu Yin granule (QYYY) on spontaneously hypertensive rats fed with high salt diet and HEK293T cells exposed to hypoxia were investigated. After eight weeks’ treatment of QYYY, blood pressure, serum creatinine, serum cystatin C, blood urea nitrogen, urinary β2-microglobulin, urinary N-acetyl-β-glucosaminidase, and urinary microalbumin were assessed. The changes of hypoxia-inducible factor-1α (HIF-1α), pyruvate kinase M2 (PKM2), glucose transport 1 (GLUT1), lactate dehydrogenase A (LDH-A), connective tissue growth factor (CTGF), transforming growth factor-β1 (TGF-β1), ATP, lactate, pyruvate, and pathology were also assessed in vivo. HEK293T cells pre-treated with QYYY and/or HIF-1α over expressing cells were cultured in a three gas hypoxic incubator chamber (5% CO2, 1% O2, 94% N2) for 12 h and then the expressions of HIF-1α, PKM2, GLUT1, LDH-A, CTGF, TGF-β1, ATP, lactate, and pyruvate were detected. Our results showed that QYYY promoted the indicators of renal inflammation and fibrosis mediated by HIF-1α/PKM2 positive feedback loop in vivo and vitro. Our findings indicated that QYYY treated hypertensive nephropathy by regulating metabolic reprogramming mediated by HIF-1α/PKM2 positive feedback loop.

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Chinese herbal medicine Tangshen Formula treatment for type 2 diabetic kidney disease in the early stage: study protocol for a randomized controlled trial

Cited by 10 publications

References 44 publications

The Association Between the Decline of eGFR and a Reduction of Hemoglobin A1c in Type 2 Diabetic Patients

The Association Between the Decline of eGFR and a Reduction of Hemoglobin A1c in Type 2 Diabetic Patients

Exploring the Safety, Effectiveness, and Cost-Effectiveness of a Chinese Patent Medicine (Fufang E’jiao Syrup) for Alleviating Cancer-Related Fatigue: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial

Qian Yang Yu Yin Granule Improves Renal Injury of Hypertension by Regulating Metabolic Reprogramming Mediated by HIF-1α/PKM2 Positive Feedback Loop

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