Meta-analysis of the clinical value of Astragalus membranaceus in diabetic nephropathy

doi:10.1016/j.jep.2010.10.012

Journal of Ethnopharmacology

Volume 133, Issue 2, 27 January 2011, Pages 412-419

https://doi.org/10.1016/j.jep.2010.10.012 Get rights and content

Abstract

Aim of study

Nowadays diabetic nephropathy (DN) has become a serious problem. Astragalus membranaceus is a traditional herb used for thousands of years in China and East Asia for kidney disease. In modern medicine, Astragalus shows significant renal protective effect in DN. We aimed to systematically review the randomized and semi-randomized control trials to ascertain its role in the treatment of DN.

Materials and methods

PUBMED, MEDLINE, Chinese journal full-test database (CJFD), Chinese biological and medical database were searched by computer and manual searching. Two assessors independently reviewed each trial. 25 studies comprising 21 RCTs and 4 CCTs were involved including 1804 patients (945 in treatment group and 859 in control group).

Results and conclusions

Astragalus injection had more therapeutic effect in DN patients including renal protective effect (BUN, SCr, CCr and urine protein) and systemic state improvement (serum albumin level) compared with the control group.

Ethnopharmacological relevance

This study investigates the effect of Astragalus in DN patients. It suggests that although of unknown bioactive ingredients and mechanism of renal protection, the role of Astragalus in the treatment of DN can be disclosed and of profound significance.

Graphical abstract

Astragaloside IV (C41H68O14) injection, from Astragalus alexandrinus Boiss, can reduce serum creatinine and urine protein in CKD patients.

Introduction

Nowadays diabetic nephropathy (DN) has been a devastating medical, social, and economic problem. According to a recent survey, DN is the most common cause of end-stage renal disease (ESRD) in the United States and accounts for 35% of patients with ESRD (Bethesda, 1996). In Asia, due to the growing number of patients with diabetic mellitus, DN has become an increasingly serious health problem. In China, about 30% of type 1 and 20% type 2 diabetic patients develop into DN, of which 53% will die of renal failure (Jiao, 2004).

Astragalus membranaceus (Fisch.) Bunge of the family Fabaceae (Fabaceae Astragalus L.), also named as syn, Huang-qi, syn: Milk-Vetch Root or syn: Huang Chi's, is a traditional Chinese medicine from Mongolian milkvetch or Membranaceus milkvetch. For thousands of years, Astragalus has been widely used in East Asia as a kind of medicine for different kinds of diseases. Especially in Traditional Chinese Medicine, which laid a lot of emphasis on Qi (vital energy) and Yin–Yang balance (negative and positive equilibrium), Astragalus is considered as benefiting Qi and helping to pass water. Modern analytic techniques have identified more than 100 compounds contained in Astragalus membranaceus (Wu and Chen, 2004). The major bioactive constituents are GABA, flavonoid, saponin etc.

With a sweet taste and a warm property, Astragalus is frequently used in many symptoms that in modern western medicine may be considered as kidney disease. First recorded in Shen Nong Ben Cao Jing (Shennong's Herbal Classic), a traditional Chinese medical book written in 500 AD. Astragalus has diuretic effect for kidney disease (Li, 2004).

In modern medicine, Astragalus shows significant renal protective effect in diabetic nephropathy (DN). Astragalus and its active extracts have been integrated in clinical management of diabetes mellitus (Huang and Lu, 2003) and early DN with satisfying safety profiles (Liu et al., 2001), partly for its protective effect against oxidative stress as a free radical scavenger (Toda and Shirataki, 1999). Although widely used for thousands of years, our knowledge is still limited about the mechanism of Astragalus in renal diseases especially in diabetic nephropathy. By now many clinical trials have reported the effect of Astragalus in renal protective and adjustment of serum glucose and lipid metabolism in DN. But uncertainties still exist in the efficacy of Astragalus due to the lack of high-quality, large-sample random clinical trials. Thus, we aimed to systematically review the randomized and semi-randomized control trials to ascertain its role in the treatment of DN.

Section snippets

Study design

All the randomized control trials (RCT) and semi-randomized control trials (CCT) searched were involved without limitation of language or publication.

Study object

All the patients studied met the definition of diabetic mellitus (WHO diabetes diagnostic criteria of 1980, 1985 or 1999 or ADA criteria of 1999). Clinic stage III–IV of diabetic nephropathy according to the Mogensen criteria (Mogensen et al., 1983). Patient with chronic diseases (chronic heart disease, chronic liver disease, chronic respiratory

Description of studies

25 studies comprising 21 RCTs and 4 CCTs were found to be eligible. The included studies are summarized in Tables 1 and 2. A total of 1804 patients were enrolled (945 in treatment group and 859 in control group). All these studies were carried out in People's Republic of China and all the patients involved were Chinese.

Blood urea nitrogen (BUN)

Eight clinical trials, all RCT, had evaluated the serum urea nitrogen of Astragalus injection group as compared to control group. There were 284 patients in treatment group and

Discussion and conclusion

DN has replaced primary glomerular diseases as the leading cause of proteinuria in the United States and Europe (Vassalotti et al., 2007). In addition to the high risk of progression to ESRD, DN is associated with a very high risk of cardiovascular morbidity and mortality, which is not abolished by dialysis and renal transplantation (Hisham et al., 1999). How to reduce the urine protein and protect the kidney function is the great challenge for the nephrologists.

Astragalus membranaceus, a

Conflict of interest statement

None declared.

Acknowledgement

We appreciate Dr. Peter Ahrenholz, who rechecked the paper for language.

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Cumulative evidence (Peng et al., 2005; Zhong et al., 2013, 2015) suggests that CKD progression can be mitigated by the multi-targeted effects of several multi-functional Chinese herbal medicines (CHMs), including Astragalus membranaceus (A) (Peng et al., 2005; Zhong et al., 2013, 2015), Angelica sinensis (S) (Peng et al., 2005; Zhong et al., 2013), Rhubarb (R) (Peng et al., 2005; Zhong et al., 2013, 2015), and Danshen (D) (Tong et al., 2010; Hsieh et al., 2017; Huang et al., 2018), which alleviate renal fibrosis by exerting RAAS-independent, anti-inflammatory activity, and suppressing transforming growth factor-β overproduction. However, the level of evidence supporting the potentially renoprotective effect of ASRD is limited to in vitro (Peng et al., 2005; Zhong et al., 2013, 2015), animal (Tong et al., 2010; Peng et al., 2005; Zhong et al., 2013, 2015), and small-scale, short-term clinical studies (Li et al., 2011; Zhong et al., 2013, 2015; Mao et al., 2021; Wu et al., 2021), as well as low-quality meta-analyses (Wang et al., 2012a; Zhang et al., 2019; Zhong et al., 2013, 2015), or review (Stanifer et al., 2017). In Taiwan, CHM services are covered and strictly regulated under the National Health Insurance (NHI) program.
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In addition, another meta-analysis comprising 66 RCTs with in total 4785 DN patients demonstrated that adjunctive use of Astragalus Injection could markedly reduce more albuminuria [SMD (95% CI): −2.05 (−2.49, −1.61)], proteinuria [SMD (95% CI): −1.85 (−2.34, −1.37)], and SCr levels than conventional therapies alone did, while Astragalus Oral Liquid was also observed to decrease more albuminuria [SMD (95% CI): −1.27 (−1.82, −0.73)]24. Adverse effects were not observed/reported by original studies in the above meta-analysis24,25. These results suggested that Radix Astragali may be a good approach to treat DN with satisfying efficacy and safety, no matter used as a dominant therapy or an adjunctive medicine.
Diabetic nephropathy (DN) has been recognized as a severe complication of diabetes mellitus and a dominant pathogeny of end-stage kidney disease, which causes serious health problems and great financial burden to human society worldwide. Conventional strategies, such as renin-angiotensin-aldosterone system blockade, blood glucose level control, and bodyweight reduction, may not achieve satisfactory outcomes in many clinical practices for DN management. Notably, due to the multi-target function, Chinese medicine possesses promising clinical benefits as primary or alternative therapies for DN treatment. Increasing studies have emphasized identifying bioactive compounds and molecular mechanisms of reno-protective effects of Chinese medicines. Signaling pathways involved in glucose/lipid metabolism regulation, antioxidation, anti-inflammation, anti-fibrosis, and podocyte protection have been identified as crucial mechanisms of action. Herein, we summarize the clinical efficacies of Chinese medicines and their bioactive components in treating and managing DN after reviewing the results demonstrated in clinical trials, systematic reviews, and meta-analyses, with a thorough discussion on the relative underlying mechanisms and molecular targets reported in animal and cellular experiments. We aim to provide comprehensive insights into the protective effects of Chinese medicines against DN.

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¹: These authors contributed equally to this work.

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Meta-analysis of the clinical value of Astragalus membranaceus in diabetic nephropathy

Abstract

Aim of study

Materials and methods

Results and conclusions

Ethnopharmacological relevance

Graphical abstract

Introduction

Section snippets

Study design

Study object

Description of studies

Blood urea nitrogen (BUN)

Discussion and conclusion

Conflict of interest statement

Acknowledgement

Biochemical Pharmacology

Journal of Ethnopharmacology

Life Science

Aqueous extract of Astragali Radix induces human natriuresis through enhancement of renal response to atrial natriuretic peptide

Journal of Ethnopharmacology

Screening and management of micro albuminuria in patients with diabetes mellitus: recommendations to the Scientific Advisory Board of the National Kidney Foundation from an ad hoc committee of the Council on Diabetes Mellitus of the National Kidney Foundation

American Journal of Kidney Diseases

The National Institute of Health, National Institute of Diabetes and Digestive and Kidney Diseases. United States Renal Data System. USRDS Annual Data Report

Application of Astragalus injection on 68 patients with diabetic nephropathy

Chinese Journal of Integrative Medicine on Cardio–Cerebro Vascular Disease

The abnormality of arginine presson system in diabetic rats and the treatment effect of Astragalus

Chinese Journal of Nephrology Dialysis & Transplantation

The effect of Astragalus injection on serum cytokine of chronic kidney failure patients

Chinese Journal of Traditional Medical Science and Technology

The effect of Astragalus on human renal interstitial fibroblasts proliferation and TGF-β1 expression

Journal of Zhenzhou University (Medical Science)

Astragalus polysaccharides: an effective treatment for diabetes prevention in NOD mice

Experimental and Clinical Endocrinology & Diabetes

Observation of treatment of early stage of diabetic nephropathy with Astragalus injection

Liaoning Journal of Practical Diabetes

The effect of Astragalus on diabetic nephropathy stage V

Hainan Medicine

The effect of Astragalus on improvement of renal injury in early stage of diabetic nephropathy

Lishizhen Medicine and Materia Medica Research

Observation of the therapeutic effect of Astragalus injection on early stage of diabetic nephropathy

Chinese Journal of Rural Medicine

Diabetic nephropathy

Bailliere's Clinical Endocrinology and Metabolism

Effect of astragalus injection on insulin resistance in auxiliary treating patients with diabetes mellitus type 2

Zhongguo Zhong Xi Yi Jiehe Za Zhi

Efficacy of Astragalus injection for diabetic nephropathy

Practical Journal of Medicine and Pharmacology

Study and improvement in protection mechanism of astragalus on diabetic nephropathy

Jiling TCM

Macrophage activation by polysaccharide isolated from Astragalus membranaceus

International Immunopharmacology

Compendium of Materia Medica

Diabetic nephropathy treating with Astragalus

Chinese Journal of Practice Medicine

The effect of Astragalus on serum TNF of chronic renal failure rats with heavy proteinuria

Liaoning Journal of Chinese Traditional Medicine