Effects of Shenkang Decoction on Creatinine and Blood Urea Nitrogen in Chronic Renal Failure Hemodialysis Patients: A Randomized Controlled Trial

Abstract

Objective:

To explore the clinical effect of Shenkang Decoction in chronic renal failure (CRF) patients with hemodialysis (HD).

Methods:

From November 2020 to December 2021, a total of 160 patients with CRF, who received HD, were included as the research objects, and they were divided into a reference group and a treatment group by random number table method (80 cases in each group). The former group was given basic drug treatment, and the latter group was given Shenkang decoction treatment at the same time as basic drug treatment. The renal function indexes, Traditional Chinese Medicine (TCM) syndrome scores, nutritional status, dialysis adequacy, treatment efficiency, and adverse reactions, were compared between the two groups.

Results:

After treatment, the patients in the treatment group had lower levels of creatinine and blood urea nitrogen, lower TCM syndrome scores, and higher levels of various nutritional status indicators than the reference group (p < 0.05). After treatment, the effective rate of the treatment group was higher compared with the reference group (p < 0.05). There was no significant difference between the two groups of dialysis adequacy index (p > 0.05). No adverse reaction was found in the two groups of patients in routine urine, blood, stool, liver, and kidney function tests, and electrocardiogram monitoring.

Conclusions:

Shenkang decoction applied to CRF and HD patients can significantly improve clinical symptoms and renal function, maintain a good nutritional status and little impact on dialysis adequacy, and improve life quality with significant curative effect, high safety, and little adverse reactions.

Introduction

Chronic renal failure (CRF) is a common and serious kidney disease. The prevalence of this disease in Chinese adults is about 10%, and is increasing year by year. CRF is mainly substantial renal lesions caused by diabetic nephropathy, primary glomerular disease and other diseases leading to renal dysfunction. The clinical symptoms are mainly environmental imbalance in the body, metabolite retention, and renal function decline, accompanied by anemia and renal malnutrition. With the progress of the disease, it can develop into proteinuria and uremia with serious condition, difficulty for treatment, and high mortality,^1,2 posing great threat to people's lives.^3,4 Therefore, early treatment is necessary. The focus is to intervene in the course of the disease, improve the kidney lesions and adjust the body function, and improve the quality of life of patients.

Hemodialysis (HD) is a common method for the treatment of CRF. It can complete the exchange of substances in the blood through diffusion, ultrafiltration, adsorption, and other processes, and discharge the metabolic waste and excessive water from the body, maintaining the acid-base and electrolyte balance, prolonging the lives of patients with chronic kidney failure, and improving the life quality,⁵ effectively saving the lives of patients with end-stage kidney disease. With the increasing prevalence, the number of HD patients is also increasing.⁶ However, HD treatment is difficult to complete the complex endocrine function and metabolic function of the kidney, and can also cause some new iatrogenic pathological changes, so a single HD is difficult to meet the treatment needs of CRF.⁷ To further improve the patient's condition, drug treatment can be combined, mainly to control blood pressure and diuresis, and correct acid-base and electrolyte balance.

With the improvement of Traditional Chinese Medicine (TCM) treatment level, some progress has been made in the treatment of kidney disease. The TCM compound Shuxuetong could reduce the quantitative urine protein and blood lipid level in patients with renal fibrosis, improve blood hypercoagulability, protect renal function, exert antirenal fibrosis, and delay the decline of renal function.⁸ Bushen Huoxue Paidu recipe could significantly reduce serum laminin, fibronectin, type III procollagen, and type IV collagen in patients with CRF; Bushen Huoxue Paidu recipe also improves CRF.⁹ When conducting HD treatment for such patients, nitrogen metabolic waste can be effectively removed, with psoriasis as the main contradiction. At this time, we should follow the idea of strengthening the body and eliminating evils.^10,11

Shenkang decoction is a self-prepared Chinese medicine compound for the treatment of end-stage renal diseases.¹² It can promote blood circulation and remove blood stasis, Yiqi Wenyang, invigorating spleen and tonifying kidney, improve kidney function, and reduce creatinine (Cre) and urea nitrogen (blood urea nitrogen [BUN]).¹³ Cre and BUN are protein metabolites, which can be excreted through the kidney.¹⁴ Increased Cre level suggests the renal detoxification function is affected. Higher BUN content indicates abnormal glomerular filtration function. These two indicators are common biochemical indicators to evaluate renal function.^15,16

At present, there are few studies on the Shenkang decoction in the treatment of CRF, and its action mechanism and specific effects are still in the research stage. To highlight the effect of the Shenkang decoction in HD patients with CRF, the following studies are carried out.

Data and Methods

Clinical data

This was a randomized clinical trial. One hundred sixty patients hospitalized at the Chinese Medicine and Nephrology between November 2020 and December 2021 were included in this study. Random sequence was generated using Excel and the patients were subsequently grouped according to the following steps: study subjects who met the inclusion criteria were numbered from 1 to 160. Then, 160 random numbers were selected in the same direction starting from any number in the random number table and matched to the study subjects individually.

Random numbers were divided by 2 to obtain the residuals, with those rounded off being the control group and those not rounded off being the treatment group, adjusted until there were 80 patients in each group. The study was approved by the Ethics Committee of the First People's Hospital of Zunyi City and raw data were submitted for review under trial registration number NCT05631782. All patient data are fully recorded. The patient and their family were informed of the study and signed the informed consent. The CONSORT Flow Diagram is shown in Figure 1. This study strictly follows the CONSORT (Consolidated Standards of Reporting Trials) standard.¹⁷

FIG. 1.

The CONSORT flow diagram.

Inclusion criteria

The diagnosis of western medicine meets the diagnostic criteria of chronic kidney failure in Internal Medicine,¹⁸ and the diagnosis of TCM meets the diagnostic criteria of disease in the Guiding Principles for Clinical Research of New Chinese Medicine.¹⁹ The patient should be older than 18 years, able to think independently and have civil conduct, strictly follow the doctor's advice, maintain stable condition, and regular HD treatment.

Exclusion criteria

Patients with HD time of no more than 3 months, severe uncontrolled infection, other malignant diseases, heart, liver, brain, and digestive system dysfunction, mental diseases such as dementia or depression, contraindications to HD or contraindications to the study (shock or systolic blood pressure below 80 mmHg, severe bleeding or a tendency to bleed, serious infection such as sepsis, or a blood-borne infection, advanced tumor, extremely debilitating, or not cooperating with doctor), drug allergy, and chronic use of glucocorticoids and immunosuppressants, and women during pregnancy or lactation were excluded from the study.

Methods

Patients in both groups were treated with HD. The instrument is a Nipro dialyzer produced by Nipro Pharmaceutical Packaging Container Co., Ltd. (Shanghai, China), and the model is FB-U. Before the treatment, the relevant knowledge of HD treatment was introduced to the patients in detail, including the treatment principle, operation content, treatment time, and matters needing attention, to remind the patients to actively cooperate with the treatment. The HD membrane was a polysulfone membrane with an effective area of 1.6 m². The dialysate was a bicarbonate dialysate with a urea transport coefficient of 180 mL/min and an ultrafiltration coefficient of 14 mL/(h·mmHg). Blood flow was controlled at 180–250 mL/min and the dialysate flow was 500 mL/min for 4 h three times a week for a treatment cycle of 16 weeks.

Patients in the control group were given conventional drug treatment. Losartan tablets were taken orally (specification 50 mg, J20180054; Hangzhou Merck Pharmaceutical Co., Ltd.) at a dose of 50 mg/day. Furosemide was injected intravenously (specification 20 mg:2 mL; TCM approved by H41021056; Suicheng Pharmaceutical Co., Ltd.) at a dose of 100 mg/day. Uremic clearance granule was mixed with water and taken (specification 5 g, Z20073256; Kangchen Pharmaceutical Co., Ltd., Khorgos, China) at a dose of 5 g at 6:00 and 12:00 hours and 10 g at 22:00 hours every day. Treatment lasted for 10–14 days.

Patients in the treatment group were given Shenkang decoction on the basis of the above treatment. Shenkang decoction prescription: 15 g of semen cuscutae, herba Epimedii, and Arecae pericarpium. Twenty grams of Eucommia ulmoides Oliv., Radix Astragali, Codonopsis pilosula, Salvia miltiorrhiza, tuckahoe, Atractylodes macrocephala, Chinese yam, honeysuckle, Polyporus umbellatus, and dandelion. Fifteen grams of safflower. Twelve grams of processed Fuzi. Ten grams of Radix phytolacca and sage. Golden cherry son 20 g and puzzle kernel 15 g were added to patients with frequent proteinuria and nocturia. Yellow cypress 15 g was added to patients with damp-heat in lower-Jiao.

The decoction pieces were purchased from the Traditional Chinese Medicine and Pharmacy Department of the First People's Hospital of Zunyi City. They were decocted by computer automatic decocting machine (model) and divided into 150 mL per bag, taken orally, once in the morning, noon, and evening, three times per day, one bag per time, one pair a day. Treatment lasted for 10–14 days.

Observation indicators

Renal function index. The AU5800 fully automatic biochemical analyzer produced by Beckman Coulter Co., Ltd. was selected for renal function index determination. Peripheral venous blood (3–5 mL) was extracted before and after treatment, and Cre and urea nitrogen were measured after centrifugation (centrifugation speed 3000 rpm for 8 min, radius 8 mm).

TCM syndrome points

According to the relevant contents of the Clinical Guiding Principles of New Chinese Medicine,¹³ clinical symptoms of shortness of breath, fatigue, anorexia, chills, abdominal fullness and distension, unsolid stool, and weak waist were evaluated. According to the severity of the symptoms, 0 (asymptomatic), 2 (mild), 4 (moderate), and 6 (severe) were given. The higher the score, the more severe the symptoms. The evaluation was performed before treatment and on the day of end of treatment.

Nutritional status index²⁰

In patients, 3 mL of fasting venous blood was collected and given anticoagulant treatment. The total serum protein, serum albumin, hemoglobin, and total red blood cells were measured by Mindray automatic biochemical analyzer (model BS-280; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.). The evaluation was performed before treatment and on the day of end of treatment.

Dialysis adequacy judgment index^21,22

The urea dynamic model was used to evaluate the overall urea clearance judgment of a single dialysis effect, and Kt/V was calculated according to the Daugirdas formula: Kt/V = −ln (BUN before dialysis/BUN after dialysis −0.008 t) + (4 − 3.5 BUN before dialysis/BUN after dialysis) ultrafiltration volume/dialysis body weight. Long-term dialysis components are protein catabolism rate (calculated by Gotch formula) and time-average urea concentration (calculated by Lowrie formula). Protein catabolism rate = 9.35G × 0.29Vt.

Treatment efficiency²³

The efficacy of the two groups was compared with the TCM syndrome points and the biochemical examination indexes. The evaluation criteria included obvious effective: the clinical symptom points are reduced by at least 70% compared with before treatment and biochemical indicators such as Cre and urea nitrogen returned to the normal range or improved by more than 30%; effective: the clinical symptom score is reduced by more than 30% than before treatment, but not by 70%, the improvement of biochemical indicators is more than 15%, but not by 30%; invalid: the symptoms are not improved or even aggravated, and the biochemical indicators do not change significantly. Total efficiency = apparent efficiency + active efficiency.

After the treatment, the patient underwent a general physical examination, including heart rate, blood pressure, breathing, pulse, and urine volume. Urine routine, blood routine, stool routine, liver and kidney function testing, and electrocardiogram monitoring were conducted before and during treatment. We observed whether the patients had symptoms of palpitation and chest tightness after taking drugs, took a timely detailed examination and expert consultation measures for the abnormal conditions, and recorded the adverse reactions.

Statistics

The sample size of this study was calculated. The information of 160 patients and various indicators were entered into the SPSS 20.0 statistical software. Repeated observations were analyzed by repeated-measures ANOVA (Mauchly's test of sphericity, using & correction coefficient Huynh-Feldt [HF] correct degree of freedom [F]), least-significant difference (LSD)-t-test between pairwise groups (statistics LSD-t), and pair-wise time difference t-test (statistics t). The value is 0.05 as a standard test. Count data are described in examples and rates. Comparisons between the two groups were either chi-square test or corrected chi-square test (statistic is χ²). Comparison between multiple groups was the whole and split chi-square test (statistic 2). The value is 0.05 as the cutoff value, below which it is statistically significant.

We used the PASS 15 Software (NCSS, LLC., Kaysville, UT) for sample size calculation. The power for the primary endpoint treatment efficiency was calculated based on the chi-square test. Group sample sizes of 29 in control group and 29 in treatment group achieved 90.328% power to detect a difference between the group proportions. According to a previous study,²⁴ the treatment efficiency in treatment group and control group was assumed to be 93.3% and 60.0%, respectively. The significance level of the test (alpha value) is 0.05.

Results

General information

According to pre-experimental calculations, the sample size on the subject met the criteria for the number of cases in the field study. As shown in Table 1, the basic data parameters such as age, gender, and disease duration of the 2 groups (80 patients in each group) remained homogeneous (p > 0.05).

Table 1.

Comparison of General Information Between the Two Groups

Group	Sex, M/F	Age, years	BMI, kg/m²	Course of disease	Disease types
Group	Sex, M/F	Age, years	BMI, kg/m²	Course of disease	Chronic glomerulonephritis, n	Diabetic nephritis, n	Hypertensive nephropathy, n	Compensated renal insufficiency, n	Chronic pyelonephritis, n
The control group (n = 80)	44/36	58.87 ± 6.32	25.12 ± 2.16	2.76 ± 1.04	24	20	18	12	6
The treatment group (n = 80)	42/38	58.43 ± 6.20	25.32 ± 2.08	2.50 ± 1.07	26	23	17	10	4

BMI, body mass index.

Comparison of renal function indicators between the two groups

After treatment, the Cre levels and BUN levels in the treatment group were lower than those in the control group, and the difference was significant (p < 0.05). Table 2.

Table 2.

Comparison of Renal Function Indexes Between the Two Groups ( $\bar{x}$ ± s)

Group	Creatinine, mol/L		Blood urea nitrogen, nmol/L
Group	Before treatment	After treatment	Before treatment	After treatment
The control group (n = 80)	643.23 ± 43.09	388.54 ± 39.65	22.42 ± 5.45	18.32 ± 3.11
The treatment group (n = 80)	639.50 ± 47.22	350.22 ± 41.32	22.87 ± 4.87	14.76 ± 2.07
t	—	5.985	—	8.523
p	—	0.000	—	0.000

Comparison of TCM syndrome points between the two groups

After treatment, compared with the control group, the treatment group had lower TCM syndrome points such as shortness of breath, fatigue, anorexia, chills, abdominal fullness and distension, unsolid stool, and weak waist, and the difference was statistically significant (p < 0.05; Table 3).

Table 3.

Comparison of Traditional Chinese Medicine Syndrome Scores Between the Two Groups ([ $\bar{x}$ ± s], Score)

Group	Shortness of breath		Fatigue		Anorexia		Chills		Abdominal fullness and distension		Unsolid stool		Weak waist
Group	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment
The control group (n = 80)	4.07 ± 1.02	3.23 ± 0.65	4.65 ± 1.21	3.44 ± 0.50	4.06 ± 1.02	3.21 ± 0.76	4.44 ± 0.57	3.30 ± 0.55	4.04 ± 0.88	3.49 ± 0.76	4.11 ± 0.76	3.33 ± 0.68	4.00 ± 0.40	3.38 ± 0.54
The treatment group (n = 80)	4.11 ± 1.00	2.76 ± 0.50	4.49 ± 1.18	2.60 ± 0.49	4.03 ± 0.96	2.65 ± 0.45	4.38 ± 0.69	3.03 ± 0.42	4.01 ± 0.78	3.02 ± 0.69	4.06 ± 0.73	2.90 ± 0.59	3.92 ± 0.45	2.88 ± 0.66
t	—	5.126	—	10.732	—	5.671	—	3.490	—	4.095	—	4.272	—	5.244
p	—	0.000	—	0.000	—	0.000	—	0.001	—	0.000	—	0.000	—	0.000

Comparison of the nutritional status between the two groups

After treatment, the levels of serum albumin, total serum protein, total red blood cells, and hemoglobin of nutritional status index were higher in the treatment group than in the reference group (p < 0.05), with significant differences (Table 4).

Table 4.

Comparison of the Nutritional Status of the Two Groups ( $\bar{x}$ ± s)

Group	Serum albumin, g/L		Total serum protein, g/L		Total number of red blood cells, × 10¹²/L		Hemoglobin, g/L
Group	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment	Before treatment	After treatment
The control group (n = 80)	31.21 ± 4.90	35.23 ± 3.89	60.78 ± 5.89	63.65 ± 3.90	2.77 ± 0.70	3.01 ± 0.44	87.59 ± 11.43	92.45 ± 8.98
The treatment group (n = 80)	31.77 ± 4.53	37.55 ± 3.11	60.20 ± 4.88	66.03 ± 3.33	2.81 ± 0.68	3.29 ± 0.38	89.03 ± 10.88	98.54 ± 7.90
t	—	4.166	—	4.151	—	4.308	—	4.554
p	—	0.000	—	0.000	—	0.000	—	0.000

Comparison of dialysis adequacy judgment indicators between the two groups

After treatment, there was no significant difference between the two groups of dialysis adequacy index (protein catabolism rate, overall urea clearance, and time mean urea concentration) (p > 0.05; Table 5).

Table 5.

Comparison of Dialysis Adequacy Indicators in Two Groups ( $\bar{x}$ ± s)

Group	Protein catabolic rate, g/·(kg·d)	Overall urea clearance rate	Time-average urea concentration, mmol/L
The control group (n = 80)	1.10 ± 0.13	1.16 ± 0.29	13.87 ± 2.00
The treatment group (n = 80)	1.08 ± 0.10	1.20 ± 0.26	13.51 ± 2.03
t	1.091	0.919	1.130
p	0.277	0.360	0.260

Comparison of treatment efficiency between the two groups

The total treatment efficiency of the treatment group was 94.87%, higher than 74.36% of the control group, which was statistically significant (p < 0.05; Table 6).

Table 6.

Comparison of Treatment Efficiency Between the Two Groups (n, %)

Group	Obvious effective	Effective	Invalid	Total efficiency
The control group (n = 80)	15 (38.46)	13 (33.33)	10 (25.64)	29 (74.36)
The treatment group (n = 80)	18 (46.15)	19 (48.72)	2 (5.13)	37 (94.87)
χ²				6.303
p				0.012

Comparison of the adverse reactions between the two groups

In the two groups, no abnormal manifestation in urine routine, blood routine, stool routine, liver and kidney function, and electrocardiogram monitoring was observed, and no adverse drug reaction was found during, before, and after drug period.

Discussion

To further explore the efficacy of Shenkang decoction in the treatment of CRF, this study detected a series of indicators that could reflect renal function and nutritional status and evaluated the efficacy of Shenkang decoction according to the TCM clinical symptom scoring standard. The results showed that after treatment, there was significant difference in the related indicators of renal function and nutritional status, as well as the scores of various TCM clinical symptoms between the two groups. The scores were decreased (p < 0.05), and the treatment group was lower than the control group, and the nutritional status indicators and the effective rate in the treatment group were higher than those in the control group (p < 0.05). No adverse reaction was found in the two groups, indicating that Shenkang decoction has significant curative effect and certain safety.

In the Shenkang decoction, Radix Astragali, Chinese yam, tuckahoe, S. miltiorrhiza, safflower, A. macrocephala, P. umbellatus, processed Fuzi, semen cuscutae, herba Epimedii, E. ulmoides Oliv., R. phytolacca, Arecae pericarpium, dandelion, honeysuckle, and sage can achieve the effect of promoting blood circulation and removing blood stasis, diuretic and removing dampness, and tonifying kidney and benefiting essence.²⁵

Radix Astragali could effectively increase plasma protein level, promote water and sodium excretion, reduce the patient's kidney damage, and play a protective role in the patients. S. miltiorrhiza effectively inhibits the fibrous proliferation of the kidney and promotes its apoptosis, thereby promoting metabolism and improving the renal microcirculation of patients.²⁶ Safflower has the effect of promoting blood circulation and removing blood stasis, and can effectively control the formation of blood clots²⁷ P. umbellatus, E. ulmoides, and Atractylodes can be diuretic and enhance immunity.^28,29 The mechanism of TCM compound delaying the progression of CRF is mainly the effect of TCM on improving glomerular sclerosis and renal interstitial fibrosis, reducing podocyte injury by affecting glomerular hemodynamics, inhibiting transforming growth factor-β expression, adjusting lipid metabolic disorders to improve glomerular sclerosis, improving renal interstitial fibrosis by reducing macrophage infiltration, inhibiting renal tubular epithelial cell transdifferentiation, and reducing urinary protein toxicity.³⁰

According to the action mechanism of the above prescription, the drugs that promote blood circulation and remove blood stasis can promote the improvement of kidney microcirculation, and promote the discharge of toxic metabolic waste and oxygen-free radicals. Diuresis clearing damp drugs can discharge all kinds of metabolic waste in the kidney, and reduce the burden of residual nephrons. Drugs to clear heat and detoxification can enhance immunity and play anti-inflammatory effect, relieve inflammatory damage, and protect residual kidneys. Drugs to tonify the kidney and invigorate the spleen can enhance immunity and promote the self-repair of kidney tissues, thus improving clinical symptoms.^31,32

Patients with chronic kidney failure have poor physical quality, poor tolerance to disease injury and drug stimulation, and a high case fatality rate. Therefore, in the actual clinical treatment, if we choose drug treatment, rapid and safe remission of disease is the most ideal treatment effect. Under the idea of integrated traditional Chinese and western medicine, TCM treatment should not only play a therapeutic effect but also play an auxiliary treatment effect, so as to achieve the best ideal effect of treating.³³

Limitations of this study

First, this study only compared the efficacy of Shenkang decoction and conventional drugs and second, there are few studies on HD patients with chronic kidney failure treated with Shenkang decoction at home and abroad. The theoretical mechanisms involved in this study need to be further investigated.

Conclusions

Shenkang decoction applied to HD patients with CRF can effectively improve the kidney function, maintain good nutritional state, have little impact on dialysis adequacy, and improve life quality with significant curative effect, high safety, and little adverse reactions. And there are few studies on HD patients with chronic kidney failure treated with Shenkang decoction at home and abroad. The theoretical mechanisms involved in this study need to be further investigated.

Footnotes

Author Disclosure Statement

No competing financial interests exist.

Funding Information

Effect of Shenkang Decoction on creatinine and urea nitrogen in hemodialysis patients with chronic renal failure. Project number: QZYY-2020-093.

Supplementary Material

CONSORT 2010 Checklist

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Supplementary Material

Please find the following supplemental material available below.

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