Rationale and design of the Helping Ease Renal failure with Bupi Yishen compared with the Angiotensin II Antagonist Losartan (HERBAAL) trial: a randomized controlled trial in non-diabetes stage 4 chronic kidney disease

Mao, Wei; Zhang, Lei; Zou, Chuan; Li, Chuang; Wu, Yifan; Su, Guobin; Guo, Xinfeng; Wu, Yuchi; Lu, Fuhua; Lin, Qian; Wang, Lixin; Bao, Kun; Xu, Peng; Zhao, Daixin; Yu, Peng; Liang, Hui; Lu, Zhaoyu; Gao, Yanxiang; Jie, Xina; La, Zhang; Wen, Zehuai; Liu, Xusheng

doi:10.1186/s12906-015-0830-1

Cited by 8 publications

(8 citation statements)

References 29 publications

(23 reference statements)

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“…These suggest that ARB can prevent the severe periodontitis frequently seen in Marfan syndrome. Combination with Chinese medicine and angiotensin-converting enzyme inhibitors (ACEI) or ARB showed kidney protection effect [143,144] and tannic acid inhibited AT1 gene expression and cellular response [145]. However, previous studies have not yet investigated whether traditional medicines and dietary polyphenols inhibit the periodontitis through blocking the AT1.…”

Section: Dental Application Of Angiotensin II Receptor Blocker Formentioning

confidence: 99%

Recent Progress of Basic Studies of Natural Products and Their Dental Application

et al. 2018

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The present article reviews the research progress of three major polyphenols (tannins, flavonoids and lignin carbohydrate complexes), chromone (backbone structure of flavonoids) and herbal extracts. Chemical modified chromone derivatives showed highly specific toxicity against human oral squamous cell carcinoma cell lines, with much lower toxicity against human oral keratinocytes, as compared with various anticancer drugs. QSAR analysis suggests the possible correlation between their tumor-specificity and three-dimensional molecular shape. Condensed tannins in the tea extracts inactivated the glucosyltransferase enzymes, involved in the biofilm formation. Lignin-carbohydrate complexes (prepared by alkaline extraction and acid-precipitation) and crude alkaline extract of the leaves of Sasa species (SE, available as an over-the-counter drug) showed much higher anti-HIV activity, than tannins, flavonoids and Japanese traditional medicine (Kampo). Long-term treatment with SE and several Kampo medicines showed an anti-inflammatory and anti-oxidant effects in small size of clinical trials. Although the anti-periodontitis activity of synthetic angiotensin II blockers has been suggested in many papers, natural angiotensin II blockers has not yet been tested for their possible anti-periodontitis activity. There should be still many unknown substances that are useful for treating the oral diseases in the natural kingdom.

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Section: Dental Application Of Angiotensin II Receptor Blocker Formentioning

confidence: 99%

Recent Progress of Basic Studies of Natural Products and Their Dental Application

et al. 2018

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“…BYF is prepared from the extract mixture of nine herbs, namely Astragali Radix, Codonopsis Radix, Atractylodis Macrocephalae Rhizoma, Poria, Dioscoreae Rhizoma, Polygoni Multiflori Radix Praeparata, Cuscutae Semen, Coicis Semen, and Salviae Miltiorrhizae Radix Rhizoma (Liu et al, 2012 ). The clinical application of BYF is treating and delaying the progression of chronic kidney disease, including postponing chronic renal failure symptoms, defering early and mid-renal dysfunction, delaying entering the dialysis time, and protection of residual renal function (Mao et al, 2015 ). Modern pharmacological studies revealed that the decoction could effectively delay glomerular filtration rate (GFR) of patients on the fourth stage of chronic kidney disease.…”

Section: Introductionmentioning

confidence: 99%

Chemical Analysis and Multi-Component Determination in Chinese Medicine Preparation Bupi Yishen Formula Using Ultra-High Performance Liquid Chromatography With Linear Ion Trap-Orbitrap Mass Spectrometry and Triple-Quadrupole Tandem Mass Spectrometry

Zhang

Wang

et al. 2018

Front. Pharmacol.

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Bupi Yishen Formula (BYF), a Chinese medicine preparation, has been clinically applied for the recovery of chronic kidney disease and for delaying its progress. Nevertheless, the chemical components in BYF have yet to be fully clarified. Ultra-high performance liquid chromatography with linear ion trap-Orbitrap mass spectrometry (UHPLC-LTQ-Orbitrap-MSn) and triple-quadrupole tandem mass spectrometry (UHPLC-TQ-MS/MS) methods were developed for qualitative chemical profiling and multi-components quantitative analysis in BYF. The chromatographic separation was performed on a Phenomenex Kinetex C18 column (2.1 × 100 mm i.d., 1.7 μm) using gradient elution of water (A) and acetonitrile (B) both containing 0.1% formic acid. Eighty-six compounds, including flavones, saponins, phenolic acids, and other compounds were authenticated or temporarily deduced according to their retention behaviors, mass mensuration, and characteristic fragment ions with those elucidated reference substances or literatures. Among the herbal medicinal materials of the formula, Astragali Radix, Codonopsis Radix, Salviae Miltiorrhizae Radix Rhizoma, and Polygoni Multiflori Radix Praeparata contributed to the bulk of the dissolved metabolites of the formula extraction. In addition, seven analytes were simultaneously determined by UHPLC-TQ-MS/MS, which was validated and has managed to determine major components in BYF. The study indicated that the established qualitative and quantitative methods would be potent and dependable analytical tools for characterizing multi-constituent in complex prescriptions decoction and provided a basis for the evaluation of bioactive components in BYF.

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“…Detailed inclusion and exclusion criteria for this trial are described in the protocol ( Mao et al, 2015 ). We included eligible non-diabetic adult patients (18–80 years) diagnosed with CKD4 ( Hou et al, 2007 ) for at least 3 months, with well-controlled blood pressure (<140/90 mmHg) and the Chinese Medicine syndrome of Spleen and Kidney Qi deficiency.…”

Section: Methodsmentioning

confidence: 99%

“…After enrollment and prior to randomization, the participants who were taking ACEi and/or ARB before enrollment were administered alternative antihypertensive agents during a 3 week run-in period according to the protocol ( Mao et al, 2015 ). In the BYF group, the participants were instructed to dissolve 15 g of BYF granules ( Supplementary Tables S2,S3 ) in 150 ml of boiled water and to take this solution orally thrice daily, and losartan matched placebo tablet once daily for 48 weeks.…”

Section: Methodsmentioning

confidence: 99%

Bupi Yishen Formula Versus Losartan for Non-Diabetic Stage 4 Chronic Kidney Disease: A Randomized Controlled Trial

et al. 2021

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Chinese herbal medicine (CHM) might have benefits in patients with non-diabetic chronic kidney disease (CKD), but there is a lack of high-quality evidence, especially in CKD4. This study aimed to assess the efficacy and safety of Bupi Yishen Formula (BYF) vs. losartan in patients with non-diabetic CKD4. This trial was a multicenter, double-blind, double-dummy, randomized controlled trial that was carried out from 11-08-2011 to 07-20-2015. Patients were assigned (1:1) to receive either BYF or losartan for 48 weeks. The primary outcome was the change in the slope of the estimated glomerular filtration rate (eGFR) over 48 weeks. The secondary outcomes were the composite of end-stage kidney disease, death, doubling of serum creatinine, stroke, and cardiovascular events. A total of 567 patients were randomized to BYF (n = 283) or losartan (n = 284); of these, 549 (97%) patients were included in the final analysis. The BYF group had a slower renal function decline particularly prior to 12 weeks over the 48-week duration (between-group mean difference of eGFR slopes: −2.25 ml/min/1.73 m2/year, 95% confidence interval [CI]: −4.03,−0.47), and a lower risk of composite outcome of death from any cause, doubling of serum creatinine level, end-stage kidney disease (ESKD), stroke, or cardiovascular events (adjusted hazard ratio = 0.61, 95%CI: 0.44,0.85). No significant between-group differences were observed in the incidence of adverse events. We conclude that BYF might have renoprotective effects among non-diabetic patients with CKD4 in the first 12 weeks and over 48 weeks, but longer follow-up is required to evaluate the long-term effects.Clinical Trial Registration:http://www.chictr.org.cn, identifier ChiCTR-TRC-10001518.

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Rationale and design of the Helping Ease Renal failure with Bupi Yishen compared with the Angiotensin II Antagonist Losartan (HERBAAL) trial: a randomized controlled trial in non-diabetes stage 4 chronic kidney disease

Cited by 8 publications

References 29 publications

Recent Progress of Basic Studies of Natural Products and Their Dental Application

Recent Progress of Basic Studies of Natural Products and Their Dental Application

Chemical Analysis and Multi-Component Determination in Chinese Medicine Preparation Bupi Yishen Formula Using Ultra-High Performance Liquid Chromatography With Linear Ion Trap-Orbitrap Mass Spectrometry and Triple-Quadrupole Tandem Mass Spectrometry

Bupi Yishen Formula Versus Losartan for Non-Diabetic Stage 4 Chronic Kidney Disease: A Randomized Controlled Trial

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