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Table of Contents
REVIEW ARTICLE
Year : 2019  |  Volume : 5  |  Issue : 4  |  Page : 193-201

Meta-analysis of niaoduqing granules combined with raas system blocker in the treatment of diabetic nephropathy


Department of Nephroendocrine, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China

Date of Submission03-May-2019
Date of Decision03-Jul-2019
Date of Acceptance08-Jul-2019
Date of Web Publication03-Dec-2019

Correspondence Address:
Dr. Jing Li
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/wjtcm.wjtcm_26_19

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  Abstract 


To systematically evaluate the efficacy of urinary granules combined with RAAS system blockers in the treatment of diabetic nephropathy (DN). A meta-analysis of the data required in the literature in accordance with this study was performed using RevMan 5.3 software. Fifteen randomized controlled trials were analyzed in the present study to evaluate the clinical effect of Niaoduqing-angiotensin converting enzyme inhibitors/angiotensin receptor blocker (ACEI/ARB) in DN patients. A total of 1063 patients were involved, including 538 patients receiving the combination treatment and 525 patients in the control group. The results showed that the clinical efficacy of Niaoduqing granule combined with ACEI/ARB was significantly better than of the control group (odds ratio = 2.92, 95% confidence interval [CI] 1.76–4.86). The treatment combined with Niaoduqing granule decreased the 24-h urinary protein quantitation (mean difference [MD] 0.71, 95% CI 0.28–1.14) and urine albumin excretion rate (UAER) (MD 41.13, 95% CI 26.66–55.59) levels. However, the combination group had no treatment advantage on reducing serumurea nitrogen (MD 0.86, 95% CI 0.05–1.68, P = 0.02) and fasting blood glucose (MD −0.03, 95% CI −0.15–0.09, P = 0.61). And there was no significance in adverse events between two groups (risk ratio = 2.34, 95% CI 0.69–7.95, P = 0.17). Niaoduqing granule-ACEI/ARB combination group maybe as safe as ACEI/ARB alone, and the combination played an advantage in improvement in total effective rate, reduction of 24-h urinary protein quantitation and UAER.

Keywords: Diabetic nephropathy, meta-analysis, niaoduqing granules, RAAS system blocker


How to cite this article:
Zhang J, Li J, Zhang HL, Qu HS, Zhang XZ, Cheng YQ, Zhang ZM, Huang JQ. Meta-analysis of niaoduqing granules combined with raas system blocker in the treatment of diabetic nephropathy. World J Tradit Chin Med 2019;5:193-201

How to cite this URL:
Zhang J, Li J, Zhang HL, Qu HS, Zhang XZ, Cheng YQ, Zhang ZM, Huang JQ. Meta-analysis of niaoduqing granules combined with raas system blocker in the treatment of diabetic nephropathy. World J Tradit Chin Med [serial online] 2019 [cited 2019 Dec 13];5:193-201. Available from: http://www.wjtcm.net/text.asp?2019/5/4/193/271966




  Introduction Top


Diabetic nephropathy (DN) is one of the most common and serious chronic complications of diabetes mellitus (DM). Current therapeutic strategies for DN are based on lifestyle and diet habits changing, blood glucose and blood pressure control, and dyslipidemia correction.[1] Through the study, it is found that the application of angiotensin converting enzyme inhibitors (ACEI) and angiotensin receptor blocker (ARB) can reduce the creatinine and albuminuria, and delay the progress of DN.[2] However, the use of ACEI/ARBs has limitations. RENAAL and PRIME research shows that although RAAS system blockers has made remarkable achievements, but also can reduce risk of developing end-stage renal disease <30% of the patients with DN and delay the progress of DN patients to not more than 10%, the proportion of the clinical DN but also high potassium, transient kidney function not entire side effects and expensive costs, and other problems.[3]

Traditional Chinese medicine (TCM) demonstrates definite clinical efficacy in the treatment of DN. As a typical compound preparation of TCM, Niaoduqing granule has attracted the attention of researchers. Niaoduqing granule is composed of 16 TCMs, such as Huangqi, Baizhu, Fuling, Zhiheshouwu, Danshen, Juhua, Jiangbanxia, Gancao. Contain a variety of effective biological active ingredients, such as isoflavone, emodin, astragaloside iv, paeoniflorin, salvianolic acid A. The synergistic effect of these components can improve renal function with multiple targets and multiple ways, and effectively delay the progress of DN.[4] Niaoduqing granule has been more than 20 years of clinical application, and by 2010, Niaoduqing granule has 23 provinces and cities nationwide, Hong Kong, Macao and Taiwan regions, Indonesia, Malaysia, Singapore, Thailand, the United States, Japan and other countries and regions more than 50,000 patients in the application, that can effectively improve symptoms, stable renal function, reduce serum creatinine (Scr) and serum urea nitrogen, etc., the total effective rate reached 69%.[5] Several clinical studies have also reported that Niaoduqing granule has improved renal function, anti-glomerulosclerosis and renal interstitial fibrosis, and has a protective effect on endothelial function in patients with DN.[6] Moreover, It is sugar-free and can be used safely in patients with DN. Proteinuria is an important factor in the acceleration of glomerulosclerosis and deterioration of renal function. Both basic and clinical studies have confirmed that Niaoduqing granule can reduce urinary albumin and total urinary protein in DN rats and DN patients.[7] Niaoduqing granule can also significantly reduce blood lipid, reduce cardiovascular complications, correct calcium and phosphorus metabolism disorders, improve renal anemia,[8],[9],[10] also can reduce blood sugar, regulate glucose metabolism, reduce the amount of insulin in DN patients, significantly improve the insulin sensitivity index in DN patients.[11]

The Niaoduqing granules-ACEI/ARB combination therapy is commonly used in clinical. However, due to the limitation of research quality, it is difficult to provide reliable scientific guidance for clinical practice. Therefore, this study is based on evidence-based medicine and follows the scientific evidence research method, aiming to systematically evaluate the efficacy and safety of Niaoduqing granule combined with RAAS system blocker in DN, so as to provide reliable evidence for clinical application.


  Materials and Methods Top


Search strategy

This systematic review was conducted according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA): The PRISMA Statement.

In this study, the following databases were searched: CNKI (http://www.cnki.net/), Wanfang (http://www.wanfangdata.com.cn/index.html), VIP (http://www.cqvip.com/), PubMed, Embase, and the Cochrane Library. The time frame was from the inception of the individual database to February 2019. We also hand-searched the reference lists of all full text papers for additional relevant reports. The search terms used included (“diabetic nephropathy” OR “diabetic renal disease” OR “diabetic proteinuria”) AND (“Niaoduqing granules” OR “Niaoduqing KELI”OR “niaoduqing-keli”) AND (̶ACEI/ARB”) AND“randomized control.”

Inclusion and exclusion criteria

Types of studies

Randomized controlled trials (RCTs) or quasi-RCTs were included, regardless of whether the blind method and assignment are hidden or not. No language restrictions, population characteristics and publication types were imposed.

Types of participants

Patients with DN diagnostic standards were eligible to be included, and patients were classified according to the Mogensen DN staging system.[12]

Exclusion criteria

(1) An excessive number of variables were evaluated. (2) Animals experiments or cell experiments. (3) Theoretical articles and literature reviews. (4) Interventions included other Chinese traditional patent medicine. (5) Data were not available for analysis or the article was identified as a repetitive publication.

Types of interventions

The study compared Niaoduqing gradules-ACEI/ARB combination with ACEI/ARB, regardless of dosage, type, duration of treatment. The basic therapies in the Niaoduqing gradules-ACEI/ARB combination and ACEI/ARB group were similar.

Types of outcomes

The primary outcomes were 24-h urinary protein excretion, urine albumin excretion rate (UAER), adverse reaction (AR), serumurea nitrogen (BUN), Scr and total effective rate.

Secondary outcomes were fasting plasma glucose, serum total cholesterol and serum cholesterol (TG).

Effective criteria

Remarkable effect: Based on Scr decreased by 15%–30% or more; or Ccr increased by 15% or more and there was an obvious improvement in the clinical symptom. Effect: Scr decreased by 5%–15%; or Ccr increased by 5%–15%, and the clinical symptom improved partly. Noneffect: It didn't reach the standard of efficiency, and even exacerbation. The total effect = remarkable effect + effect.

Data extraction

Two investigators (Zhang J, Zhang HL) independently extracted information from the selected publications. The extracted contents included author (year), sample size, disease stage, patient age, interventions, comparators, treatment period, outcome measures and main results. When the two investigators had different opinions on a certain publication, the corresponding author (Li J) made an independent assessment and provided the final judgment.

Risk of bias assessment

Two investigators (Zhang J and Huang JQ) independently evaluated the quality of the selected publications using the Cochrane Collaboration's risk of bias tool. Assessments included random sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other possible biases. Using relevant criteria listed in The Cochrane Handbook for Systematic Reviews of Interventions, the publications were categorized as “low risk of bias,” “high risk of bias,” and “unclear risk of bias.”

Statistical analysis

Statistical analyses were performed in RevMan 5.3 software (Cochrane Central Executive Team, St Albans House, 57-59 Haymarket, London). Risk ratio (RR) or odds ratio (OR) and a 95% confidence interval (CI) were used for dichotomous variables. Continuous data were presented as mean difference (MD) with 95% CI. The difference was considered statistically significant if P < 0.05. Heterogeneity was assessed using the I-squared (I2) statistic. If P ≥ 0.1, the difference was considered not statistically significant. When P < 0.1, if I2 > 50%, a random effect model was applied; for any other conditions, a fixed effect model was used.


  Results Top


Studies identified

There were 305 articles, 15 RCTs[13],[14],[15],[16],[17],[18],[19],[20],[21],[22],[23],[24],[25],[26],[27],[28] were finally included in the meta-analysis. All the RCTs were conducted in China and published in Chinese. [Figure 1] showed the search process and study selection.
Figure 1: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram

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Study characteristics

All 15 studies were published between 2009 and 2018. There were 1063 participants included (538 in the Niaoduqing granules-ACEI/ARB combination group and 525 in the ACEI/ARB group). Sample sizes of the included studies ranged from 42 to 74. All 15 studies included the corresponding basic treatments in the treatment strategy. The duration of combination ranged from 4 to 24 weeks. The dosage of Niaoduqing granules was 5–10 g three or four times a day. The characteristics of included trials were listed in [Table 1].
Table 1: Characteristics of included studies

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Quality of the included studies

Randomized was mentioned in all 14 studies. However, only 4 trials (Wang FX, 2009; Wang YX, 2013; Wei XF, 2018; Zhang XX, 2016)[15],[],[17],[19] claimed that they had used the random number table. In addition, all the trials did not mention allocation concealment, blinding of participants, personnel and outcome assessment. Therefore, the risk of bias of included studies was high. More details of the trials were presented in [Figure 2] and [Figure 3].
Figure 2: Risk of bias assessment for each included study

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Figure 3: Risk of bias graph

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Outcome measures

Total effective rate

Six studies contributed to this analysis and involved an overall sample of 529 patients (267 in the combination group and 262 in the ACEI/ARB group) (Fan, 2013; Hao, 2015; Li Y, 2017; Wang YX, 2013; Wei, 2018; Zhang XX, 2016). The data were analyzed with a fixed-effects model according to the test of heterogeneity (P = 0.19; I2 = 32%). Over the treatment period, the total effective rate in the Niaoduqing granuels-ACEI/ARB combination group was higher than that in ACEI/ARB group (OR = 2.92, 95% CI 1.76–4.86) [Figure 4].
Figure 4: Meta-analysis of the total effective rate

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Twenty-four-hour urine protein quantitation

Twenty-four-hour urinary protein quantification was reported in 8 studies. A total of 529 patients were included, 269 in the combination group and 260 in the ACEI/ARB group. Due to a substantial heterogeneity among the studies (P < 0.00001, I2 = 99.3%), a random effects model was used. The results showed that the efficacy of the Niaoduqing granule was significantly better than that of the comparators (MD 0.71, 95% CI 0.28–1.14).

In order to analyze the source of heterogeneity, subgroup analysis was carried out. The 8 studies were divided into 2 subgroups based on the Mogensen DN staging system, including the Stage IV–V DN group (5 studies) and the unclear Stage group (3 studies). High heterogeneity (P < 0.0001, I2 = 90%) was found in the unclear stage group, while the stage IV–V DN group was not heterogeneous (P = 0.98, I2 = 0%). The above results show that the difference in DN stage is an important reason for the heterogeneity [Figure 5].{Figure 5}

Urine albumin excretion rate

Five studies reported UAER, a total of 297 patients were included, 149 in the treatment group and 148 in the comparator group. A random effects model was used as there was substantial heterogeneity among the studies (P = 0.08, I2 = 52%). Compared with the comparators, the efficacy of the Niaoduqing granule was significantly better (MD 41.13, 95% CI 26.66–55.59, P < 0.00001) [Figure 6].
Figure 6: Meta-analysis of urine albumin excretion rate

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In order to analyze the source of heterogeneity, sensitivity analysis was carried out. One of the 5 studies was excluded from the analysis each time, and the results showed that the heterogeneity reduced (P = 0.23, I2 = 30%) after the removal of the study by Liu XQ. Therefore, the study by Liu XQ was identified as the source of heterogeneity of this outcome measure (maybe because of her study during 24 weeks, patient compliance cannot be guaranteed).

Serum creatinine

Scr was reported in 13 studies. A total of 840 patients were included, 425 in the combination group and 415 in the ACEI/ARB group. Due to a substantial heterogeneity among the studies (P < 0.00001, I2 = 85%), a random effects model was used. The results showed that the efficacy of the Niaoduqing granule group was significantly better than that of the ACEI/ARB group.

In order to analyze the source of heterogeneity, subgroup analysis was carried out. The 13 studies were divided into 3 subgroups based on the Mogensen DN staging system, including the Stage IV–V DN group (7 studies), the Stage III DN group (5 studies) and the unclear stage group (1 studies). High heterogeneity (P < 0.00001, I2 = 87%) was found in the Stage IV–V DN Stage group, while the Stage III DN group was not heterogeneous (P = 0.71, I2 = 0%). The above results show that the IV–V DN Stage group results were the main source of heterogeneity [Figure 7].
Figure 7: Meta-analysis of serum creatinine

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Serumurea nitrogen (BUN)

There were 12 studies that included BUN in the results. A total of 829 patients were included, 417 in the treatment group and 412 in the comparator group. Because of the substantial heterogeneity among the studies (P < 0.00001, I2 = 86%), a random effects model was used. The results showed that the efficacy of Niaoduqing granules group was not significantly different from that of the comparators (MD 0.86, 95% CI 0.05–1.68, P = 0.02) [Figure 8].
Figure 8: Meta-analysis of BUN

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A subgroup analysis was performed subsequently. The 12 studies were divided into 2 subgroups based on the DN stage, including the DN stage III group (6 studies) and the DN Stage IV–V group (6 studies). High heterogeneity (P < 0.00001, I2 = 85%) was found in the DN Stage III group, and he DN Stage IV–V group also has high heterogeneity (P < 0.00001, I2 = 83%). No significant source of heterogeneity was found. The subgroup results showed that the efficacy of the DN Stage III group (MD 0.11, 95% CI − 0.7–0.91, P = 0.8) was not significantly different when compared with the comparator group. The efficacy of the DN Stage IV–V group was significantly better than that of the comparator group (MD 2.45, 95% CI 0.63–4.26, P = 0.04).

Fasting blood glucose (FPG)

Five studies reported fasting blood glucose in the results. A total of 406 patients were included, 205 in the treatment group and 201 in the control group. Since no heterogeneity was detected (P = 0.98, I2 = 0%), a fixed effect model was used for the analysis. The results showed that there was no significance between the treatment group and the control group (MD − 0.03, 95% CI − 0.15–0.09, P = 0.61) [Figure 9].
Figure 9: Meta-analysis of fasting plasma glucose

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Adverse events

Six studies mentioned adverse events (AEs) and provided an overall sample of 649 patients (328 in the combination group and 321 in the ACEI/ARB group). Only two study reported no AEs in both groups. All studies showed no patients suffering from mortality and disability. AEs in the combination group mainly included diarrhea (51.06%), allergy (14.89%), nausea (17.02%), hyperkalemia (6.38%), dry cough (4.26%), elevated Scr (4.26%).

Meta-analysis of the random effects model indicated that there was no significant difference in AEs between combination group and ACEI/ARB group (RR = 2.34, 95% CI 0.69–7.95, P = 0.17, I2 = 49%). Details were described in [Figure 10].
Figure 10: Meta-analysis of adverse events

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Publication bias of effective rate

We used a funnel plot to show the publication bias of effective rate. The effect value is the abscissa, the sample size is the ordinate, and the scatter plot is made. If there is no publication bias, the inverted funnel plot is basically symmetrical; if there is publication bias, the inverted funnel plot is not completely symmetrical or incomplete. It showed that the funnel plot was not completely symmetrical, which suggested the possibility of publication bias [Figure 11].
Figure 11: Funnel plot of total effect rate

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  Discussion Top


The significance of this meta-analysis

DN is an illusion of elimination of thirst disease, an illusion of destruction of the kidney. The location of the disease is centered on the kidney, often involving the liver, spleen and other organs. Later will also affect the heart and lung, resulting in five viscera disease. The disease is more mixed with false and real. In the early stage, qi and yin were dominant, and in the late stage, both qi blood yin and yang were deficient, and turbidity toxin was retained internally. Ancient physicians treated from kidney deficiency, although modern physicians have different understanding, but all of them follow the basic principles of syndrome differentiation of TCM. Professor Lv Renhe, based on his long experience in clinical practice, proposed the theory of “tiny syndrome,”[28] guaranteeing the diagnosis of DN. In his opinion, DN is caused by the aging of DM, the deficiency of solid kidney, improper diet and emotional disorder, etc., internal heat damages yin and consumes qi, later, the damage of qi and yin, cause the deficiency of yin and yang, the chronic disease enters the collateral, qi deficiency and blood stasis, and phlegm-heat stagnation. It forms a tiny syndrome in the kidney's complex, causing damage to the kidney body and loss of function. So in the treatment attaches importance to the treatment of blood circulation and blood stasis. In Niaoduqing granules, raw Dahuang relieving turbidity, promoting blood circulation and removing stasis, purging intestines and purging bowels, and removing dampness and turbidity. It can promote the excretion of metabolites, improve the nitrogenemia, inhibit the production of oxygen free radicals and molecular toxins, correct the abnormal metabolism of lipid and calcium and phosphorus; Huangqi can not only strengthen the spleen and qi, but also inducing diuresis to alleviate edema. It can alleviate proteinuria, improve lipid and sugar metabolism, reduce platelet aggregation, prevent oxygen free radicals, and prevent renal interstitial fibrosis; Chuanxiong tastes spicy, warming blood vessels, can not only promote blood circulation and remove stasis, but also promote qi circulation and stagnation, it is the qi-activating drug of blood-activating drugs. Danshen promoting blood circulation and removing stasis is relatively gentle, removing stasis but not hurting the body, promoting blood circulation, reaching the viscera and removing stasis. They can inhibit platelet aggregation, activate fibrinolytic system, reduce the degree of renal fibrosis, and delay the progression of glomerulosclerosis; therefore, meta-analysis of Niaoduqing granules combined with RAAS system blockers is very necessary.

Summaries of results

Fifteen RCTs were analyzed in the present study to evaluate the clinical effect of Niaoduqing-ACEI/ARB in DKD patients. A total of 1063 patients were involved, including 538 patients receiving the combination treatment and 525 patients in the control group. The results showed that the clinical efficacy of Niaoduqing granule combined with ACEI/ARB was significantly better than of the control group (OR = 2.92, 95% CI 1.76–4.86). The treatment combined with Niaoduqing granule decreased the 24-h urinary protein quantitation (MD 0.71, 95% CI 0.28–1.14) and UAER (MD 41.13, 95% CI 26.66–55.59) levels. However, the combination group had no treatment advantage on reducing serumurea nitrogen (MD 0.86, 95% CI 0.05–1.68, P = 0.02) and fasting blood glucose (MD − 0.03, 95% CI − 0.15–0.09, P = 0.61). And there was no significance in AEs between two groups (RR = 2.34, 95% CI 0.69–7.95, P = 0.17). From the results of the analysis can be seen, except for the effective rate and UAER, all other indicators have significant heterogeneity, which may have resulted from different clinical baseline characteristics and intervention protocols among the included studies. Through GRADE evaluation of evidence quality, it was found that the included literatures were moderate.

Limitations

  1. The quality of the literature included in this study is not high. All the 15 literatures included in this study described the use of random grouping. None of the 15 included literatures described the random hiding method and blind method, which may have measurement bias, and also did not mention the withdrawal, which may have an impact on the overall quality of the meta-analysis. And none of the trials had mentioned the follow-up results. Moreover, the current search strategy is too simple, maybe it's difficult to find all target literature
  2. The risk of bias of included studies was high that it may affect the strength of the results. Most of the trials are small sample studies with positive findings. All included trials were published in Chinese
  3. The included literatures in this study had a large follow-up period (4 weeks to 24 weeks), part of which was short, small sample size, lack of multi-center collaboration, and differences in clinical efficacy judgment, all of which affected the reliability of the results of this study. In terms of ARs, fewer cases and studies were included, resulting in low intensity of research evidence.



  Conclusion Top


In conclusion, the results in this study suggested that Niaoduqing granule-ACEI/ARB combination group maybe as safe as ACEI/ARB alone. The combination played an advantage in improvement in total effective rate, reduction of 24-h urinary protein quantitation and UAER. It is more necessary to design a more rigorous randomized double-blind trial with multiple centers and large samples in the future to further verify the efficacy of Niaoduqing granules combined with RAAS system blocker in the treatment of DN, maybe Niaoduqing granule-RAAS system blocker can become a complementary therapy for DN treatment.

Financial support and sponsorship

This study was supported by the National Natural Science Foundation Project of China (youth science fund project. 81603570).

Conflicts of interest

There are no conflicts of interest.



 
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