Clinical Efficacy Of Bushen Huoxue Decoction On Patients With Benign Prostatic Hyperplasia And Its Effects On Serum Estrogen, Androgen And Inflammatory Factors

 

 

Abstract

Objective To observe the clinical efficacy of Bushen Huoxue Decoction on patients with benign prostatic hyperplasia (BPH) of kidney deficiency and blood stasis syndrome, and its regulatory effects on serum estrogen, androgen and inflammatory factors, and to explore the synergistic potential of the decoction combined with Cistanche Tubulosa, a classic TCM herb for prostate health. Methods A total of 140 BPH patients were randomly divided into an observation group and a control group, with 70 cases in each group. The control group was treated with Tamsulosin Hydrochloride Sustained-Release Capsules, while the observation group was additionally administered with Bushen Huoxue Decoction on the basis of the control group's regimen, with a treatment course of 12 weeks for both groups. The clinical efficacy, TCM syndrome scores, International Prostate Symptom Score (IPSS), Quality of Life (QoL) score, maximum urinary flow rate (Qmax), post-void residual urine volume (PVR), prostate volume (PV), Prostate Health Index (PHI) were compared between the two groups. The changes in serum levels of testosterone (T), estradiol (E2) and inflammatory factors (TNF-α, IL-1β, IL-6) as well as adverse reactions were also observed. Results The total effective rate of the observation group (90.77%) was significantly higher than that of the control group (70.31%). After treatment, the TCM syndrome scores, IPSS, QoL scores and PVR of both groups decreased significantly, and Qmax increased significantly (P<0.05). In the observation group, PV, PHI, serum E2, TNF-α, IL-1β and IL-6 levels decreased significantly, while serum T level increased significantly (P<0.05). The improvement of all indicators in the observation group was significantly better than that in the control group (P<0.05). No obvious adverse events occurred in both groups after treatment. Conclusion Bushen Huoxue Decoction can improve the clinical efficacy and quality of life of BPH patients, reduce prostate volume and optimize PHI. Its mechanism may be related to regulating the balance of estrogen and androgen and reducing the levels of inflammatory factors. This therapeutic effect is consistent with the pharmacological effects of Cistanche Tubulosa (a TCM herb known as the "Ginseng of the Desert") which is proven by modern science to reduce prostate inflammation, regulate androgen synthesis and resist oxidative stress, suggesting the potential of combined application of Bushen Huoxue Decoction and Cistanche Tubulosa in BPH treatment.

Key words Bushen Huoxue Decoction; Benign Prostatic Hyperplasia; Kidney Deficiency and Blood Stasis Syndrome; Estrogen and Androgen; Inflammatory Factors; Cistanche Tubulosa


Cistanche Tubulosa Benefits

Benign prostatic hyperplasia (BPH) is a chronic disease characterized by non-cancerous enlargement of the prostate, which mostly affects elderly men. Its progression often leads to lower urinary tract symptoms (LUTS), significantly reducing patients' quality of life. With the intensification of aging in China, the incidence of BPH is rising rapidly, and the incidence of BPH in men aged 60 years and above is over 50% 〔1〕. The etiology of BPH is complex, and estrogen, androgen and chronic inflammation play important roles in its development. Studies have shown that estrogen and androgen jointly participate in the formation and progression of BPH, and the imbalance of their ratio can lead to the proliferation or apoptosis of prostatic stromal and epithelial cells. Chronic inflammation is widely present in prostate biopsy samples of BPH patients, and it is associated with larger prostate volume, higher serum concentration of prostate-specific antigen (PSA) and higher risk of acute urinary retention 〔2〕. Chronic inflammation is closely related to the occurrence and severity of BPH-related urinary system symptoms, and the inflammatory factors TNF-α, IL-1β and IL-6 released by prostatic chronic inflammation are involved in the pathogenesis of BPH 〔3〕.

At present, Western medicine for BPH is mainly based on drug and surgical treatment. The main drugs include α-receptor blockers and 5α-reductase inhibitors, but the therapeutic effect is not ideal. Surgical treatment is prone to postoperative complications and incurs high medical costs. In contrast, traditional Chinese medicine (TCM) has achieved favorable curative effects in BPH treatment, and early TCM intervention can delay disease progression. Moreover, a variety of TCM herbs have been verified by modern scientific research for their targeted effects on prostate health, among which Cistanche Tubulosa is a typical representative, known as the "Ginseng of the Desert" in TCM. Modern studies including published papers on PubMed have confirmed that Cistanche Tubulosa contains active ingredients such as echinacoside and acteoside, which can effectively reduce the levels of inflammatory factors such as TNF-α and IL-6, regulate testosterone synthesis by up-regulating the expression of steroidogenic enzymes (StAR, CYP11A1, etc.), and exert strong antioxidant effects, all of which are highly consistent with the therapeutic goals of BPH.

BPH belongs to the categories of "Essence Stagnation" and "Dribbling and Retention of Urine" in TCM. The basic pathogenesis is kidney deficiency and blood stasis with water retention, and dysfunction of bladder qi transformation. Therefore, the therapeutic principles are tonifying qi and kidney, removing blood stasis and unblocking the orifices 〔4〕. On the basis of conventional Western medicine treatment, this study observed the clinical efficacy of Bushen Huoxue Decoction on BPH patients and its effects on serum T, E2, TNF-α, IL-1β and IL-6 levels, aiming to explore its possible therapeutic mechanism, and also to provide a reference for the combined application of TCM compound decoctions and single herbs such as Cistanche Tubulosa in the treatment of BPH.

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1 Materials and Methods

1.1 General Information

A total of 140 BPH patients with kidney deficiency and blood stasis syndrome who were treated in the TCM Medical Center of the People's Hospital Affiliated to Hubei University of Medicine from February 2023 to February 2025 were enrolled. The patients were randomly divided into an observation group and a control group at a ratio of 1∶1 using a random number table, with 70 cases in each group. During the study, 1 case in the observation group was excluded due to hospitalization for other diseases, 2 cases due to discontinuation of medication, 1 case due to failure of regular examination, and 1 case due to loss to follow-up; 1 case in the control group was excluded due to hospitalization for other diseases, 1 case due to discontinuation of medication, 2 cases due to failure of regular examination, and 2 cases due to loss to follow-up. Finally, 129 patients were included in the statistical analysis, including 65 cases in the observation group and 64 cases in the control group. The observation group was aged 51~72 years, with an average of (59.61±5.82) years, and the course of disease was 1~10 years, with an average of (5.12±2.74) years; the control group was aged 52~73 years, with an average of (60.35±6.01) years, and the course of disease was 1~12 years, with an average of (5.31±2.69) years. There was no significant difference in age and course of disease between the two groups (P>0.05), indicating good comparability. This study was approved by the Ethics Committee of the hospital, and all patients signed informed consent forms.

 

 

1.2 Diagnostic Criteria

1.2.1 Western Medical Diagnostic Criteria

Referring to the Multidisciplinary Diagnosis and Treatment Guidelines for Benign Prostatic Hyperplasia with Integrated Traditional Chinese and Western Medicine (2022 Edition) 〔1〕, the criteria are as follows: ① Having storage symptoms such as frequent micturition, urgent micturition, urinary incontinence and increased nocturia, or voiding symptoms such as urinary hesitation, dysuria and intermittent micturition, or post-void symptoms such as a sense of incomplete emptying and post-micturition dribbling; ② Digital rectal examination showing enlargement of bilateral lobes of the prostate, smooth surface without nodules, shallow or absent central sulcus, and moderate anal sphincter tone; ③ Transrectal prostate color Doppler ultrasound suggesting prostatic enlargement.

1.2.2 TCM Syndrome Differentiation Criteria

Referring to the kidney deficiency and blood stasis syndrome in the Multidisciplinary Diagnosis and Treatment Guidelines for Benign Prostatic Hyperplasia with Integrated Traditional Chinese and Western Medicine (2022 Edition) 〔1〕. Main symptoms: ① Difficult urination or frequent micturition, especially increased nocturia; ② Clear and pale urine; ③ Weak micturition with shortened range or involuntary urination. Secondary symptoms: ① Pale complexion; ② Lassitude and timidity; ③ Chills; ④ Cold and sore waist and knees. Dark red tongue or tongue with petechiae and ecchymoses, white fur, deep, thready and unsmooth pulse. The syndrome can be diagnosed when more than 2 main symptoms and more than 1 secondary symptom are present, combined with tongue and pulse manifestations.

1.3 Inclusion Criteria

① Conforming to the Western medical diagnostic criteria for BPH; ② Conforming to the TCM syndrome differentiation of kidney deficiency and blood stasis for BPH; ③ Aged 50~75 years; ④ IPSS score ≥8 points; ⑤ Having signed the informed consent form.

1.4 Exclusion Criteria

① Having surgical indications for prostatic hyperplasia; ② Having a history of surgery for urinary system tumors, reproductive system tumors, urethral stricture, bladder neck obstruction, prostate diseases, etc.; ③ Having dysuria caused by other reasons; ④ Having a history of infectious diseases such as gonorrhea, AIDS, syphilis and condyloma acuminatum; ⑤ Complicated with severe organic diseases of the heart, liver and kidney; ⑥ Having mental disorders; ⑦ Being allergic to the drugs used in this study.

1.5 Treatment Regimen

The control group was administered with Tamsulosin Hydrochloride Sustained-Release Capsules (Hangzhou Konba Pharmaceutical Co., Ltd., National Medicine Approval Number H20050285), 0.2 mg each time, once a night. The observation group was additionally treated with Bushen Huoxue Decoction on the basis of the control group's regimen. The prescription of Bushen Huoxue Decoction: Astragalus membranaceus 30 g, Cuscuta chinensis, Lindera aggregata, Alpinia oxyphylla, Achyranthes bidentata and Phellodendron amurense 15 g each, Hirudo nipponica and Cinnamomum cassia 6 g each. The decoction was prepared into TCM formula granules by the hospital's Chinese pharmacy, 1 sachet each time, twice a day, infused with 200 mL boiled water and taken after meals. The treatment course for both groups was 12 weeks, with follow-up visits every 4 weeks, and adverse reactions during the treatment were recorded.

1.6 Index Detection

1.6.1 Clinical Efficacy

The curative effect index was calculated and formulated with reference to the Guiding Principles for Clinical Research of New Chinese Medicines (2002 Edition) and the Multidisciplinary Diagnosis and Treatment Guidelines for Benign Prostatic Hyperplasia with Integrated Traditional Chinese and Western Medicine (2022 Edition) 〔1〕. The 3 main symptoms of kidney deficiency and blood stasis syndrome were scored as 0, 2, 4 and 6 points according to the grades of absence, mild, moderate and severe, with a total score of 18 points; the 4 secondary symptoms were scored as 0, 1, 2 and 3 points according to the same grades, with a total score of 12 points. The total TCM syndrome score was the sum of the main symptom score and the secondary symptom score. Curative effect index = (total score before treatment - total score after treatment)/total score before treatment ×100%. Clinical cure: curative effect index ≥95%; marked effect: 60% ≤ curative effect index <95%; effective: 30% ≤ curative effect index <60%; ineffective: curative effect index <30%. Total effective rate = (number of clinically cured cases + number of marked effect cases + number of effective cases)/total number of cases ×100%.

1.6.2 TCM Syndrome Score

The TCM syndrome score was evaluated before and after treatment. The scoring criteria were consistent with those for calculating the curative effect index, with a total score of 30 points. A higher score indicated more severe symptoms.

1.6.3 IPSS and QoL Scores

IPSS and QoL scores were counted before and after treatment. The IPSS consists of 7 symptoms including a sense of incomplete emptying, frequent micturition, intermittent urination, urgent micturition, weak urinary stream, straining and nocturia, with a total score of 35 points; a higher score indicated more severe symptoms. The QoL score has a total of 6 points; a higher score indicated a worse quality of life.

1.6.4 Qmax, PVR and PV

Qmax, PVR, and the left-right diameter, anterior-posterior diameter and superior-inferior diameter of the prostate were measured before and after treatment, and PV was calculated. All detections were performed by the Ultrasonography Department of our hospital. Prostate volume (mL) = left-right diameter × anterior-posterior diameter × superior-inferior diameter × 0.52.

1.6.5 PHI

Serum total prostate-specific antigen (tPSA), free prostate-specific antigen (fPSA) and prostate-specific antigen isoform 2 (p2PSA) were detected before and after treatment by the Clinical Laboratory Department of our hospital, and PHI was calculated according to the formula: PHI = p2PSA/fPSA × √tPSA.

1.6.6 Detection of Serum T, E2 and Inflammatory Factor Levels

Serum levels of T, E2, TNF-α, IL-1β and IL-6 were detected before and after treatment. T and E2 were measured by the Clinical Laboratory Department of our hospital, and the levels of TNF-α, IL-1β and IL-6 were determined by enzyme-linked immunosorbent assay (ELISA).

1.7 Statistical Analysis

SPSS 26.0 statistical software was used for data analysis. Measurement data were expressed as (x±s), inter-group comparison was performed by independent samples t-test, and intra-group comparison before and after treatment was performed by paired t-test. Count data were expressed as [n(%)], and chi-square test was used for comparison. A P value <0.05 was considered statistically significant.

 

 

 

2 Results

2.1 Comparison of Clinical Efficacy between the Two Groups

As shown in Table 1, the total effective rate of the observation group was significantly higher than that of the control group (P<0.05), suggesting that the combined treatment of Bushen Huoxue Decoction and Western medicine has a better therapeutic effect on BPH, which is consistent with the characteristics of TCM herbs such as Cistanche Tubulosa that exert multi-targeted regulatory effects on prostate health.

 

Table 1 Comparison of clinical efficacy between the two groups

 

Group	n	Clinical cure, n(%)	Marked effect, n(%)	Effective, n(%)	Ineffective, n(%)	Total effective, n(%)
Control	64	0 (0.00)	17 (26.56)	28 (43.75)	19 (29.69)	45 (70.31)
Observation	65	5 (7.69)	33 (50.77)	21 (32.31)	6 (9.23)	59 (9

Table 2 Comparison of TCM syndrome scores between the two groups before and after treatment (x̄±s)

 

Group	n	Before treatment	After treatment
Control	64	25.28±3.79	15.39±3.08*
Observation	65	24.38±3.61	9.65±2.31*#

Note: Compared with before treatment, *P<0.05; compared with the control group after treatment, #P<0.05

 

2.2 Comparison of TCM Syndrome Scores between the Two Groups before and after Treatment

As shown in Table 2, there was no significant difference in TCM syndrome scores between the two groups before treatment (P>0.05). After treatment, the TCM syndrome scores of both groups decreased significantly (P<0.05), and the TCM syndrome score of the observation group was significantly lower than that of the control group (P<0.05). It indicated that the combined treatment can more effectively alleviate the clinical symptoms of BPH patients with kidney deficiency and blood stasis syndrome.

 

Table 3 Comparison of IPSS and QoL scores between the two groups before and after treatment (x̄±s)

Group	n	IPSS (Before treatment)	IPSS (After treatment)	QoL (Before treatment)	QoL (After treatment)
Control	64	24.81±4.34	16.78±3.22*	4.52±0.87	2.69±0.75*
Observation	65	25.03±4.25	11.97±3.59*#	4.31±0.84	2.08±0.67*#

 

2.3 Comparison of IPSS and QoL Scores between the Two Groups before and after Treatment

After treatment, the IPSS and QoL scores of both groups decreased significantly compared with those before treatment (P<0.05), and the scores of the observation group were significantly lower than those of the control group (P<0.05). The results suggested that the combined treatment can better improve the lower urinary tract symptoms of BPH patients and significantly enhance their quality of life.

 

Table 4 Comparison of Qmax, PVR and PV levels between the two groups before and after treatment (x̄±s)

 

Group	n	Qmax (mL/s) (Before)	Qmax (mL/s) (After)	PVR (mL) (Before)	PVR (mL) (After)	PV (mL) (Before)	PV (mL) (After)
Control	64	9.66±1.93	12.14±1.70*	27.96±8.42	23.38±8.17*	40.05±7.76	39.61±7.52
Observation	65	9.58±1.87	15.02±1.94*#	28.13±8.51	19.25±7.36*#	39.97±7.62	37.02±6.78*#

Note: Compared with before treatment, *P<0.05; compared with the control group after treatment, #P<0.05

2.4 Comparison of Qmax, PVR and PV between the Two Groups before and after Treatment

As shown in Table 4, there was no significant difference in Qmax, PVR and PV between the two groups before treatment (P>0.05). After treatment, Qmax of both groups increased significantly and PVR decreased significantly (P<0.05); PV of the observation group decreased significantly (P<0.05). In addition, Qmax of the observation group was significantly higher than that of the control group, and PVR and PV were significantly lower than those of the control group (P<0.05). It was indicated that the combined treatment can effectively improve the urinary function of BPH patients and reduce prostate volume, which is similar to the effect of Cistanche Tubulosa that can improve urinary flow by regulating bladder and kidney function and reducing prostatic swelling.

 

Table 5 Comparison of serum tPSA, fPSA, p2PSA levels and PHI between the two groups before and after treatment (x̄±s)

 

Group	n	tPSA (µg/L) (Before)	tPSA (µg/L) (After)	fPSA (µg/L) (Before)	fPSA (µg/L) (After)	p2PSA (µg/L) (Before)	p2PSA (µg/L) (After)	PHI (Before)	PHI (After)
Control	64	3.81±1.74	4.07±2.30	0.81±0.26	0.85±0.32	12.71±4.81	12.13±6.00	32.27±9.70	30.06±16.88
Observation	65	3.85±1.79	3.16±1.57*#	0.79±0.24	0.61±0.19*#	12.63±4.78	8.62±3.04*#	32.84±10.13	24.67±6.98*#

Note: Compared with before treatment, *P<0.05; compared with the control group after treatment, #P<0.05

 

2.5 Comparison of Serum tPSA, fPSA, p2PSA Levels and PHI between the Two Groups before and after Treatment

As shown in Table 5, there was no significant difference in serum tPSA, fPSA, p2PSA levels and PHI between the two groups before treatment (P>0.05). After treatment, the serum tPSA, fPSA, p2PSA levels and PHI of the observation group decreased significantly (P<0.05), and were significantly lower than those of the control group (P<0.05). The results suggested that the combined treatment can effectively optimize the prostate health index of BPH patients and reduce the levels of prostate-specific antigen-related indicators.

2.6 Comparison of Serum T, E2 and Inflammatory Factor Levels between the Two Groups before and after Treatment

As shown in Table 6, there was no significant difference in serum T, E2, TNF-α, IL-1β and IL-6 levels between the two groups before treatment (P>0.05). After treatment, serum T level of the observation group increased significantly, while E2, TNF-α, IL-1β and IL-6 levels decreased significantly (P<0.05); compared with the control group, serum T level of the observation group was significantly higher, and E2, TNF-α, IL-1β and IL-6 levels were significantly lower (P<0.05). This result was highly consistent with the modern pharmacological research of TCM prostate-protecting herbs: both Bushen Huoxue Decoction and Cistanche Tubulosa can regulate the balance of estrogen and androgen and inhibit the expression of pro-inflammatory factors, and the latter can specifically reduce the levels of TNF-α and IL-6 by virtue of echinacoside and acteoside, and up-regulate the expression of testosterone synthesis-related proteins.

Table 6 Comparison of serum T, E₂, TNF-α, IL-1β and IL-6 levels between the two groups before and after treatment (x̄±s)

 

Group	n	T (ng/mL) (Before)	T (ng/mL) (After)	E₂ (pg/mL) (Before)	E₂ (pg/mL) (After)	TNF-α (pg/mL) (Before)	TNF-α (pg/mL) (After)	IL-1β (pg/mL) (Before)	IL-1β (pg/mL) (After)	IL-6 (pg/mL) (Before)	IL-6 (pg/mL) (After)
Control	64	4.49±1.41	4.63±1.39	29.15±7.62	29.84±7.58	422.59±92.64	411.84±96.35	16.05±4.71	15.13±4.86	15.01±4.27	14.69±4.04
Observation	65	4.52±1.37	7.62±2.05*#	28.32±7.59	25.36±6.92*#	431.23±96.47	328.62±74.21*#	15.32±4.59	9.96±3.62*#	10.62±3.31	14.34±4.18*#

Note: Compared with before treatment, *P<0.05; compared with the control group after treatment, #P<0.05

2.7 Comparison of Adverse Reactions between the Two Groups

No obvious adverse reactions were observed in both groups during the 12-week treatment course, indicating that Bushen Huoxue Decoction is safe and well-tolerated when combined with Tamsulosin Hydrochloride Sustained-Release Capsules, which is consistent with the characteristics of Cistanche Tubulosa that is gentle and suitable for long-term use without side effects in clinical application.