Evaluating the therapeutic effects of NiaoDuQing particles on chronic kidney disease based on real world study

Abstract

BACKGROUND:

NiaoDuQing Particle is the first Chinese herbal medicine approved by the China Food and Drug Administration for the treatment of chronic kidney disease. It has been used in clinical practice in China for over twenty years. However, there is limited literature reporting on the long-term therapeutic effects of NiaoDuQing Particles on chronic kidney disease patients.

OBJECTIVE:

This research aimed to comprehensively assess the therapeutic effect of NiaoDuQing Particles (NDQP) on chronic kidney disease patients based on clinical data analysis.

METHODS:

This study was carried out on a total of 148 participants diagnosed with different types of chronic kidney disease. Demographics information, chronic kidney disease classification and chronic kidney disease diganostic indicators were collected and analyzed before and after NiaoDuQing Particles treatment for 3, 6, 9, 12 and 18 months respectively.

RESULTS:

In all 148 patients, mean eGFR value was increased after NiaoDuQing Particles treatment for up to 18 months, and was statistically significant at month 3, 6, 9, 12 and 18 ( $P<$ 0.05). Mean uric acid value was decreased after NiaoDuQing Particles treatment for up to 18 months, and was statistically significant at month 3, 6, 9, 12 and 18 ( $P<$ 0.05). Mean urea nitrogen value was decreased after NiaoDuQing Particles treatment for up to 18 months and was statistically significant at month 3, 6, 9, 12 and 18 ( $P<$ 0.05). While mean creatinine value was decreased after NiaoDuQing Particles treatment for up to 18 months and was statistically significant at month 6 ( $P<$ 0.05).

CONCLUSIONS:

NiaoDuQing Particles could maintain the stable state of chronic kidney disease patients for up to 18 months especially in improving diagnostic indicators like eGFR, uric acid and urea nitrogen.

Keywords

Chronic kidney disease NiaoDuQing particles eGFR uric acid urea nitrogen

1. Introduction

The kidney is an indispensable organ with various functions that play vital roles in maintaining body health and homeostasis. These functions focus on body fluid filtration and excretion to maintain internal balance, blood volume control to keep blood pressure, erythropoietin secretion to stimulate blood cell production, as well as involved in the conversion of inactive vitamin D into active form [1, 2, 3]. Therefore, an impaired or dysfunctional kidney can lead to an accumulation of waste or even toxins in the body as well as imbalance between fluid and electrolyte level, thus leading to medical conditions like urinary protein, hypertension, heart failure, anemia and other severe complications [4, 5].

Chronic Kidney Disease (CKD) is a progressive and irreversible condition that affects millions of people worldwide [6]. It can be caused by various conditions like diabetes, hypertension, nephritis and kidney stones. And risk factors like family history, age, obesity and smoking can also contribute to CKD development [7]. CKD is typically categorized into five stages based on estimated glomerular filtration rate(eGFR) [8]. In early stage, symptoms are absent or not very obvious including common signs like fatigue, frequent urination and swelling [6]. In advanced stage, as the kidney further deteriorates, individuals can experience loss of appetite, nausea, vomiting, and mental dysfunctions like concentration difficulty and hypomnesia [9]. In final stage, as the kidney loses most of the normal structures and functions, previous symptoms become more serious along with other symptoms like weight loss, itching, skin irritation and coma. Moreover, multiple complications of organs and systems caused by CKD will further worsen patient condition [10, 11, 12].

The aims of CKD treatment should focus on slowing down disease progression, managing complications, and improving overall kidney health [13]. And the choice of treatment method is derived from a comprehensive consideration based on CKD stage, individual’s medical history, and specific health needs [14]. Medications are commonly prescribed to manage CKD and its related complications. Commonly prescribed medications aim to (1) control blood pressure like angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs) [13]; (2) remove excess fluid from the body like diuretics [15]; (3) reduce absorption and prevent bone and mineral disorders like phosphate binders [16]; (4) stimulate red blood cell production like erythropoiesis-stimulating agents; and (5) lower cholesterol levels and reduce the risk of cardiovascular complications like statins [17].

Except for western medicines mentioned above, Chinese Traditional Medicine (CTM) has also been used for centuries in various medical conditions including CKD [18]. The components of Chinese herbs are complex and believed to have various therapeutic effects on kidneys, such as promoting blood circulation, reducing inflammation, and protecting kidney function [19, 20]. NiaoDuQing Particles, also known as Uremic Clearance Granules, is the first CTM approved by the China Food and Drug Administration to treat CKD and has been clinically used in China for over twenty years [21]. This compound medicine consists of nine herbs with a total of 182 active components, including Bai Shao, Bai Shu, Che Qian Cao, Da Huang, Dan Shen, Fu Ling, Huang Qi, Ku Shen and Sang Bai Ye [22].

Currently, few papers reported long-term therapeutic effects of NDQP on CKD patients in clinical practice. Although some studies have shown that the use of NDQP in combination with blood purification therapy can significantly improve indicators such as blood viscosity, plasma viscosity, hematocrit, erythrocyte electrophoresis, and erythrocyte sedimentation rate in patients with chronic renal failure (CRF) [23], and have also demonstrated good efficacy in the treatment of early diabetic nephropathy [24], these studies did not directly involve the long-term therapeutic effects of NDQP in CKD patients. Therefore in this study, we collected data from clinical individuals to observe whether NDQP had a long-term therapeutic effect on CKD patients after treatment for up to 18 months based on the changes of diagnostic indicator level. And this study aimed to potentially offer a novel therapeutic option in managing CKD patients.

2. Methods

2.1 Study protocol

2.1.1 Study design and ethical approval

This clinical research was carried out in The First Affiliated Hospital of Anhui University of Science and Technology (The First People’s Hospital of Huainan) from October 2020 to September 2023. In accordance with the tenets of the Declaration of Helsinki. Ethical approval was achieved from the Institutional Review Board of The First Affiliated Hospital of Anhui University of Science and Technology (The First People’s Hospital of Huainan). A total of 148 patients diagnosed with CKD were enrolled in this study, and they should provide written informed consent before participating.

2.1.2 Medication administration and study endpoints

After admission to hospital, all the 148 patients received treatment for other unrelated diseases until those diseases wouldn’t affect the results of this study. Then patients were prescribed to NDQP (Consun Pharmaceutical (Inner Mongolia) Co. Ltd., 5 g/packet, Approval No. 20073256) according to instructions: The recommended usage and dosage are to be dissolved in warm water and taken orally. Take one packet at 6 am, 12 pm, and 6 pm, and two packets at 10 pm daily. Dosage adjustments may be made according to medical advice, but the maximum daily dose should not exceed 8 packets, with no more than an 8-hour interval between two doses.

Efficacy evaluations included changes from baseline in the value of CKD diagnostic indicators of eGFR, creatinine, uric acid, urea nitrogen, as well as the change of CKD stage at month 3, 6, 9, 12 and 18 after NDQP treatment.

2.1.3 Inclusion and exclusion criteria

Inclusion criteria:

Diagnosis: Patients diagnosed with Chronic Kidney Disease (CKD), as confirmed by medical records.

Age: Adults aged 18 years and older.

Consent: Patients who provided written informed consent to participate in the study.

CKD Stages: Patients classified in CKD stages 3, 4, or 5 (nondialysis).

Baseline Measurements: Availability of baseline measurements for eGFR, creatinine, uric acid, and urea nitrogen.

Exclusion criteria:

Other Severe Diseases: Patients with severe comorbid conditions that could interfere with the study outcomes, such as advanced heart failure, severe liver disease, or active malignancies.

Recent Treatment: Patients who have received other treatments for CKD within the last 3 months that could potentially influence the study results.

Non-compliance: Patients who are unable or unwilling to comply with the study protocol, including medication administration and follow-up visits.

Pregnancy or Lactation: Female patients who are pregnant or breastfeeding.

Allergies: Patients with known allergies or hypersensitivity to NDQP or any of its components.

Participation in Other Studies: Patients currently enrolled in other clinical trials that could affect the outcomes of this study.

2.2 Statistical analysis

All statistical analyses were performed by using the Statistical Package for Social Sciences (SPSS) software version 26 (IBM Corporation, Armonk, NY, USA). Data were presented as mean $\pm$ standard deviation (SD) for continuous variables and frequencies (percentages) for categorical variables. The Student’s t test or Wilcoxon rank sum test was used for continuous data. The Chi-square test or Fisher exact test was used to compare categorical variables. A two-tailed $p$ -value of less than 0.05 was considered statistically significant.

Table 1
Demographic and baseline clinical information

Variables	$N=$ 148
Age (years)	65.1 $\pm$ 11.5(24–93)
Gender
Male	82(55.4%)
Female	66(44.6%)
CKD classification
IgA nephropathy	2(1.4%)
Hypertensive nephropathy	10(6.8%)
Diabetic nephropathy	25(16.9%)
Nephrotic syndrome	7(4.7%)
Chronic renal failure	60(40.5%)
Others	44(29.7%)
Diagnostic indicators
eGFR (ml/min/1.73m²)	26.5 $\pm$ 10.9(2.4–44.7)
Creatinine (umol/L)	250.5 $\pm$ 176.2(112.0–1429.0)
Uric acid (umol/L)	426.5 $\pm$ 124.6(85.0–798.0)
Urea nitrogen (mmol/L)	8.6 $\pm$ 4.9(2.1–30.1)
CKD stage
1	0(0.0%)
2	0(0.0%)
3	61(41.2%)
4	60(40.5%)
5 (nondialysis)	27(18.2%)
NiaoDuQingParticles dose (package)
Average during 18 months	5
Month 3	5
Month 6	5
Month 9	5
Month 12	5
Month 18	5

3. Results

3.1 Baseline characteristics

The demographic characteristics of all the participants were shown in Table 1. A total of 148 individuals (82 males, 55% and 66 females, 45%), with mean age with mean age 65.1 $\pm$ 11.5 years (ranging from 24 to 93) were enrolled in this study. In terms of CKD classification, patient distribution included 2(1.4%) IgA nephropathy, 10(6.8%) hypertensive nephropathy, 25(16.9%) diabetic nephropathy, 7(4.7%) nephrotic syndrome, 60(40.5%) chronic renal failure (CRF) and 44(29.7%) other unknown types. In the level of CKD diagnostic indicators before NDQP treatment, mean eGFR was 26.5 $\pm$ 10.9 ml/min/1.73m² (ranging from 2.4 to 44.7), mean creatinine was 250.5 $\pm$ 176.2 umol/L (ranging from 112 to 1429), mean uric acid was 426.5 $\pm$ 124.6 umol/L(ranging from 85 to 798 ), mean urea nitrogen was 8.6 $\pm$ 4.9 mmol/L(ranging from 2.1 to 30.1 ) treatment. And in CKD stage before treatment, there were 61(41.2%) patients at stage 3, 60(40.5%) patients at stage 4 and 27(18.2%) patients at stage 5 (nondialysis).

Table 2
Analysis of eGFR value

eGFR (ml/min/1.73m²)
Baseline	Month 3	Month 6	Month 9	Month 12	Month 18
26.5 $\pm$ 10.9 (2.4–44.7)	28.7 $\pm$ 13.0 (2.4–74.4)	29.5 $\pm$ 13.9 (2.5–78.1)	29.4 $\pm$ 14.4 (2.6–77.0)	28.7 $\pm$ 14.5 (2.8–82.2)	28.7 $\pm$ 14.9 (2.6–83.7)
Change from baseline	$+$ 2.15	$+$ 2.99	$+$ 2.86	$+$ 2.25	$+$ 2.19
$p$ value	0.00	0.00	0.00	0.00	0.01

3.2 Efficacy analysis

Table 2 demonstrated that eGFR value were 28.7 $\pm$ 13.0, 29.5 $\pm$ 13.9, 29.4 $\pm$ 14.4, 28.7 $\pm$ 14.5, and 28.7 $\pm$ 14.9 after treatment for 3, 6, 9, 12, and 18 months respectively. Compared with baseline, mean eGFR value was increased after NDQP treatment for up to 18 months. And $t$ -test analysis showed that the improvement in eGFR value was statistically significant at month 3, 6, 9, 12 and 18 ( $p<$ 0.05).

Table 3
Analysis of creatinine value

Creatinine (umol/L)
Baseline	Month 3	Month 6	Month 9	Month 12	Month 18
250.5 $\pm$ 176.2 (112.0–1429.0)	233.9 $\pm$ 150.9 (93.0–1447.5)	230.2 $\pm$ 147.6 (85.6–1376.3)	237.6 $\pm$ 163.2 (70.9–1365.3)	241.2 $\pm$ 154.2 (80.0–1266.9)	244.6 $\pm$ 161.0 (85.0–1352.8)
Change from baseline	$-$ 16.63	$-$ 20.32	$-$ 12.89	$-$ 9.29	$-$ 5.95
$p$ value	0.07	0.04	0.23	0.37	0.60

Table 3 demonstrated that creatinine value were 233.9 $\pm$ 150.9, 230.2 $\pm$ 147.6, 237.6 $\pm$ 163.2, 241.2 $\pm$ 154.2, and 244.6 $\pm$ 161.0 after treatment for 3, 6, 9, 12, and 18 months respectively. Compared with baseline, mean creatinine value was decreased after NDQP treatment for up to 18 months. And T-test analysis showed that the decrease in creatinine value was statistically significant at month 6 ( $p<$ 0.05).

Table 4

Analysis of uric acid value

Uric acid (umol/L)
Baseline	Month 3	Month 6	Month 9	Month 12	Month 18
426.5 $\pm$ 124.6 (85.0–798.0)	405.6 $\pm$ 115.6 (135.0–714.0)	406.6 $\pm$ 108.7 (130.2–715.0)	405.2 $\pm$ 114.9 (147.0–794.9)	407.3 $\pm$ 112.0 (139.0–760.0)	393.0 $\pm$ 103.6 (163.0–694.0)
Change from baseline	$-$ 20.89	$-$ 19.92	$-$ 21.30	$-$ 19.23	$-$ 33.52
$p$ value	0.04	0.04	0.03	0.04	0.00

Table 4 demonstrated that uric acid value were 405.6 $\pm$ 115.6, 406.6 $\pm$ 108.7, 405.2 $\pm$ 114.9, 407.3 $\pm$ 112.0, and 393.0 $\pm$ 103.6 after treatment for 3, 6, 9, 12, and 18 months respectively. Compared with baseline, mean uric acid value was decreased after NDQP treatment for up to 18 months. And T-test analysis showed that the decrease in uric acid value was statistically significant at month 3, 6, 9, 12 and 18 ( $p<$ 0.05).

Table 5

Analysis of urea nitrogen value

Urea nitrogen (mmol/L)
Baseline	Month 3	Month 6	Month 9	Month 12	Month 18
8.6 $\pm$ 4.9 (2.1–30.1)	7.8 $\pm$ 4.2 (2.4–27.1)	7.4 $\pm$ 3.9 (2.1–24.0)	7.7 $\pm$ 4.8 (2.3–28.2)	7.8 $\pm$ 4.6 (2.1–27.1)	7.5 $\pm$ 4.3 (2.1–23.1)
Change from baseline	$-$ 0.71	$-$ 1.13	$-$ 0.81	$-$ 0.78	$-$ 1.08
$p$ value	0.03	0.00	0.02	0.03	0.00

Table 5 demonstrated that urea nitrogen value were 7.8 $\pm$ 4.2, 7.4 $\pm$ 3.9, 7.7 $\pm$ 4.8, 7.8 $\pm$ 4.6, and 7.5 $\pm$ 4.3 after treatment for 3, 6, 9, 12, and 18 months respectively. Compared with baseline, mean urea nitrogen value was decreased after NDQP treatment for up to 18 months. And T-test analysis showed that the decrease in urea nitrogen value was statistically significant at month 3, 6, 9, 12 and 18 ( $p<$ 0.05).

Table 6

Analysis of CKD stage

Outcome	Month 3	Month 6	Month 9	Month 12	Month 18
Improvement	20(13.5%)	28(18.9%)	20(13.5%)	28(18.9%)	26(17.6%)
Stabilization	120(81.1%)	106(71.6%)	114(77.0%)	101(68.2%)	102(68.9%)
Deterioration	8(5.4%)	14(9.5%)	14(9.5%)	19(12.8%)	20(13.5%)

Table 6 demonstrated that after treatment for 3 months, the outcome of CKD stage included 20 (13.5%) improvement, 120 (81.1%) stabilization and 8 (5.4%) deterioration. At month 6, the outcome of CKD stage included 28(18.9%) improvement, 106 (71.6%) stabilization and 14 (9.5%) deterioration. At month 9, the outcome of CKD stage included 20 (13.5%) improvement, 114 (77.0%) stabilization and 14 (9.5%) deterioration. At month 12, the outcome of CKD stage included 28 (18.9%) improvement, 101 (68.2%) stabilization and 19 (12.8%) deterioration. At month 18, the outcome of CKD stage included 26 (17.6%) improvement, 102 (68.9%) stabilization and 20 (13.5%) deterioration.

4. Discussion

Our study was conducted to detect the therapeutic effects of NDQP on CKD by assessing changes in various diagnostic indicators before and after treatment. We enrolled a diverse cohort of 148 participants, each diagnosed with different types of CKD. This inclusivity ensured that the findings can be generalized to a broader CKD patient population. The demographics of the cohort, including age and gender distribution, were well-documented, ensuring that the results can be interpreted within the context of the patient profiles.

The diagnostic indicators chosen for analysis reflected key aspects of CKD progression. Estimated Glomerular Filtration Rate (eGFR), creatinine, uric acid, and urea nitrogen are established markers for assessing kidney function. The study demonstrated that NDQP treatment led to a statistically significant decrease in mean creatinine value after 6 months, suggesting potential improvements in kidney function. A particularly promising finding is that after 3, 6, 9, 12, and 18 months of NDQG treatment, the mean eGFR values continues to increase, while the mean uric acid and urea nitrogen values continue to decrease. These changes, with statistical significance observed at multiple time points, underscores NDQP’s potential to improves kidney filtration capacity, alleviate waste accumulation and aid in fluid balance regulation within the body. Such results were consistent with the anti-inflammatory and nephroprotective properties of NDQP, suggesting that it could mitigate the inflammatory processes contributing to CKD progression.

The CKD stage evaluation further elucidated NDQP’s impact. The distribution of patients across different CKD stages pre- and post-treatment demonstrated NDQP’s potential to stabilize disease progression. Notably, at month 18, the outcome of CKD stage included 86.5% improvement and stabilization, indicating that NDQP can delay the progression of CKD.

Our research focused on real world study analysis, while most previous papers of NDQP focused on the involved mechanisms. Xu Wang et al. found that the candidate targets of NDQP were mostly related to TGF- $\beta$ , p38MAPK, and erythropoietin receptor signaling pathways, which were known to contribute to renal fibrosis or renal anemia [25]. A retrospective study conducted by Chaoquan Song et al. indicated that NDQP was more effective than traditional therapy alone in CKD treatment, which could improve kidney function, regulate the level of glucose, lipid and inflammatory factors with no obvious side effects [26]. Xuhong Miao et al. [27] found in CRF rat model that kidney functions recovered after treatment with NDQP and TGF- $\beta$ 1 promoter transcription and translation maybe involved in the process in molecular level. Moreover, Zhaoyu Lu et al. demonstrated that NDQP could be a promising agent for treating tubulointerstitial fibrosis by maintaining E-cadherin expression and suppressing vimentin and $\alpha$ -SMA expression in rat kidney tissues [28]. Yanru Huang et al. [29] also found similar mechanisms that NDQP exerted its therapeutic effects through promoting the degradation of extracellular matrix and regulate TGF- $\beta$ 1/Smad pathway to prevent CRF progression.

However, it’s important to acknowledge certain limitations of the study. The absence of a control group raises questions about the causality of the observed effects. External factors, including lifestyle changes or other medications, could potentially contribute to the reported outcomes. The study was relatively small, and the participants were all from China. It is possible that the results of the study may not be generalizable to other populations. Additionally, the study was not blinded, which means that the participants and researchers knew which group they were in. This could have biased the results of the study. To establish NDQP’s efficacy, future studies could incorporate control groups and long-term follow-ups to comprehensively assess its impact on CKD progression.

In a conclusion, our research offered a comprehensive assessment of NDQP’s potential in CKD treatment. The study’s findings provided compelling evidence that NDQP may effectively stabilize CKD progression over a 18-month period, primarily by improving key diagnostic indicators such as eGFR, uric acid, and urea nitrogen. The study may bridge the gap between traditional Chinese medicine and modern CKD management, paving the way for further investigations into NDQP’s mechanisms of action and long-term effects.

5. Conclusion

NDQP is a safe and effective treatment for CKD. NDQP was able to improve kidney function, reduce levels of waste products in the blood, and slow the progression of CKD. These findings are consistent with previous studies on NDQP in the treatment of CKD. Further studies are needed to confirm the findings of this study and to determine the optimal dosage and duration of treatment with NDQP.

Funding

This work was supported by the 2021 Huainan City Science and Technology Bureau guiding project (No. 3549) ‘Correlation analysis between depression state and protein energy consumption in peritoneal dialysis patients’.

Ethical approval

This study was conducted in accordance with the tenets of the Declaration of Helsinki. Approval was obtained from the Institutional Review Board of The First Affiliated Hospital of Anhui University of Science and Technology (The First People’s Hospital of Huainan).

Author contributions

RS, JH and LY designed the study and performed the experiments, QL and WX collected the data, XH, ZC and ZL analyzed the data, RS, JH and LY prepared the manuscript. All authors read and approved the final manuscript.

Footnotes

Conflict of interest

None of the authors has a financial or proprietary interest in any material or method mentioned.

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Evaluating the therapeutic effects of NiaoDuQing particles on chronic kidney disease based on real world study

Abstract

BACKGROUND:

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSIONS:

Keywords

1. Introduction

2. Methods

2.1 Study protocol

2.1.1 Study design and ethical approval

2.1.2 Medication administration and study endpoints

2.1.3 Inclusion and exclusion criteria

2.2 Statistical analysis

Table 1 Demographic and baseline clinical information

3.1 Baseline characteristics

Table 2 Analysis of eGFR value

Table 3 Analysis of creatinine value

5. Conclusion

Funding

Ethical approval

Author contributions

Footnotes

Conflict of interest

References

Table 1
Demographic and baseline clinical information

Table 2
Analysis of eGFR value

Table 3
Analysis of creatinine value