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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.

Mao W, Zhang L, Zou C, Li C, Wu Y, Su G, Guo X, Wu Y, Lu F, Lin Q, Wang L, Bao K, Xu P, Zhao D, Peng Y, Liang H, Lu Z, Gao Y, Jie X, Zhang L, Wen Z, Liu X - BMC Complement Altern Med (2015)

Bottom Line: Secondary outcomes include the incidence of endpoint events, liver and kidney function, urinary protein creatinine ratio, cardiovascular function and quality of life.This study will be the first multi-center, double blind RCT to assess whether BYF, compared with losartan, will have beneficial effects on eGFR for non-diabetes stage 4 CKD patients.The results will help to provide evidence-based recommendations for clinicians.

View Article: PubMed Central - PubMed

Affiliation: Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. maowei1274@126.com.

ABSTRACT

Background: Chronic kidney disease (CKD) is a global public health problem. Currently, as for advanced CKD populations, medication options limited in angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB), which were partially effective. A Chinese herbal compound, Bupi Yishen formula, has showed renal protective potential in experiments and retrospective studies. This study will evaluate the efficacy and safety of Bupi Yishen formula (BYF) in patients with CKD stage 4.

Design: In this double blind, double dummy, randomized controlled trial (RCT), there will be 554 non-diabetes stage 4 CKD patients from 16 hospitals included and randomized into two groups: Chinese medicine (CM) group or losartan group. All patients will receive basic conventional therapy. Patients in CM group will be treated with BYF daily while patients in control group will receive losartan 100 mg daily for one year. The primary outcome is the change in estimated glomerular filtration rate (eGFR) over 12 months. Secondary outcomes include the incidence of endpoint events, liver and kidney function, urinary protein creatinine ratio, cardiovascular function and quality of life.

Discussion: This study will be the first multi-center, double blind RCT to assess whether BYF, compared with losartan, will have beneficial effects on eGFR for non-diabetes stage 4 CKD patients. The results will help to provide evidence-based recommendations for clinicians.

Trial registration: Chinese Clinical Trial Registry Number: ChiCTR-TRC-10001518 .

No MeSH data available.


Related in: MedlinePlus

Underlying Multi-compound, multi-target, multi-pathway network of Bupi Yishen formula in retarding progression of chronic kidney disease
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Fig4: Underlying Multi-compound, multi-target, multi-pathway network of Bupi Yishen formula in retarding progression of chronic kidney disease

Mentions: In China, herbal formulas processed by water boiling, called decoctions, have been used clinically for thousands of years. These formulas usually consist of several different herbs formulated based on CM theory. Chinese herbal medicine has also been applied specifically to CKD patients for years. The BYF originated from one of the most famous Chinese prescriptions Sijunzi decoction, and was modified by senior CM practitioners according to the results of data mining 10,000 CKD stage 4 patients’ medical records. This formula, consisting of nine herbs, has been reported to exert a protective effect in CKD. In this formula, Astragalus mongholicus (Huangqi), Codonopsis pilosula (Dangshen), Macrocephalae (Baizhu), Poria cocos (Fuling), Rhizoma dioscoreae (Shanyao) may regulate immune functions, improve nutrient status and reduce the incidence of infection [27–31]. Astragalus mongholicus (Huangqi), Salvia miltiorrhiza (Danshen) and Semen coici (Yiyiren) may exert a anti-fibrotic effect [32–34] while Codonopsis pilosula (Dangshen), Semen cuscutae (Tusizi), Radix polygoni multiflori (Heshouwu), Salvia miltiorrhiza (Danshen) may reduce oxidative stress [35–38]. The underling mechanism and ratio of each component of Bupi Yishen Formula are shown in Chart 1 and Table 2.Chart 1


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 W, Zhang L, Zou C, Li C, Wu Y, Su G, Guo X, Wu Y, Lu F, Lin Q, Wang L, Bao K, Xu P, Zhao D, Peng Y, Liang H, Lu Z, Gao Y, Jie X, Zhang L, Wen Z, Liu X - BMC Complement Altern Med (2015)

Underlying Multi-compound, multi-target, multi-pathway network of Bupi Yishen formula in retarding progression of chronic kidney disease
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4562196&req=5

Fig4: Underlying Multi-compound, multi-target, multi-pathway network of Bupi Yishen formula in retarding progression of chronic kidney disease
Mentions: In China, herbal formulas processed by water boiling, called decoctions, have been used clinically for thousands of years. These formulas usually consist of several different herbs formulated based on CM theory. Chinese herbal medicine has also been applied specifically to CKD patients for years. The BYF originated from one of the most famous Chinese prescriptions Sijunzi decoction, and was modified by senior CM practitioners according to the results of data mining 10,000 CKD stage 4 patients’ medical records. This formula, consisting of nine herbs, has been reported to exert a protective effect in CKD. In this formula, Astragalus mongholicus (Huangqi), Codonopsis pilosula (Dangshen), Macrocephalae (Baizhu), Poria cocos (Fuling), Rhizoma dioscoreae (Shanyao) may regulate immune functions, improve nutrient status and reduce the incidence of infection [27–31]. Astragalus mongholicus (Huangqi), Salvia miltiorrhiza (Danshen) and Semen coici (Yiyiren) may exert a anti-fibrotic effect [32–34] while Codonopsis pilosula (Dangshen), Semen cuscutae (Tusizi), Radix polygoni multiflori (Heshouwu), Salvia miltiorrhiza (Danshen) may reduce oxidative stress [35–38]. The underling mechanism and ratio of each component of Bupi Yishen Formula are shown in Chart 1 and Table 2.Chart 1

Bottom Line: Secondary outcomes include the incidence of endpoint events, liver and kidney function, urinary protein creatinine ratio, cardiovascular function and quality of life.This study will be the first multi-center, double blind RCT to assess whether BYF, compared with losartan, will have beneficial effects on eGFR for non-diabetes stage 4 CKD patients.The results will help to provide evidence-based recommendations for clinicians.

View Article: PubMed Central - PubMed

Affiliation: Nephrology Center, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China. maowei1274@126.com.

ABSTRACT

Background: Chronic kidney disease (CKD) is a global public health problem. Currently, as for advanced CKD populations, medication options limited in angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB), which were partially effective. A Chinese herbal compound, Bupi Yishen formula, has showed renal protective potential in experiments and retrospective studies. This study will evaluate the efficacy and safety of Bupi Yishen formula (BYF) in patients with CKD stage 4.

Design: In this double blind, double dummy, randomized controlled trial (RCT), there will be 554 non-diabetes stage 4 CKD patients from 16 hospitals included and randomized into two groups: Chinese medicine (CM) group or losartan group. All patients will receive basic conventional therapy. Patients in CM group will be treated with BYF daily while patients in control group will receive losartan 100 mg daily for one year. The primary outcome is the change in estimated glomerular filtration rate (eGFR) over 12 months. Secondary outcomes include the incidence of endpoint events, liver and kidney function, urinary protein creatinine ratio, cardiovascular function and quality of life.

Discussion: This study will be the first multi-center, double blind RCT to assess whether BYF, compared with losartan, will have beneficial effects on eGFR for non-diabetes stage 4 CKD patients. The results will help to provide evidence-based recommendations for clinicians.

Trial registration: Chinese Clinical Trial Registry Number: ChiCTR-TRC-10001518 .

No MeSH data available.


Related in: MedlinePlus