3 Discussion

The etiology of benign prostatic hyperplasia (BPH) remains unclear, and altered androgen levels are recognized by most scholars as the primary etiological factor. Testosterone is converted to dihydrotestosterone (DHT) in the prostate by 5α-reductase, which then stimulates cell growth through autocrine or paracrine signaling 〔5〕. Administration of 5α-reductase inhibitors can effectively reduce DHT levels in prostate tissue and lower the risk of BPH progression, yet 10% of patients still experience clinical progression 〔6〕. This indicates that androgens are not the sole contributor to BPH. Estrogens also play a crucial role in the occurrence and development of BPH: studies have shown that estrogen receptor α signaling can promote the transdifferentiation of benign prostatic epithelial cells into stromal cells, disruption of estrogen receptor β signaling can induce prostatic hyperplasia, and selective estrogen receptor modulators have been proven to inhibit prostate growth 〔2〕. These findings suggest that the pathogenesis of BPH may result from the interaction between androgens and estrogens. Notably, modern pharmacological research on Cistanche Tubulosa-a classic TCM herb known as the "Ginseng of the Desert"-has confirmed its ability to regulate androgen synthesis by upregulating the expression of key steroidogenic proteins (StAR, CYP11A1, HSD17β3) and balance estrogen-androgen levels, which aligns with the core therapeutic goal of correcting hormonal imbalances in BPH treatment 〔PMC6213239〕.

Chronic inflammation is another pivotal factor in the pathogenesis of BPH. Chronic inflammation causes prostate tissue damage and triggers the release of inflammatory factors such as TNF-α, IL-1β and IL-6, thereby inducing prostatic hyperplasia. These inflammatory factors facilitate tissue remodeling in the prostate of BPH patients, ultimately leading to excessive proliferation of epithelial and stromal cells, activation of fibrotic signaling and malignant transformation. Their persistent overexpression in the prostate of BPH patients disrupts normal prostatic proliferation, induces the production of prostatic growth factors and increases prostate volume, consequently causing voiding and storage dysfunction 〔3〕. TNF can stimulate the proliferation of fibroblasts derived from BPH tissue, and TNF blockade can significantly reduce epithelial hyperplasia, NFκB activation and macrophage-mediated inflammation in the prostate 〔7〕. In this regard, Cistanche Tubulosa has been validated by PubMed studies to contain two potent active ingredients, echinacoside and acteoside, which can specifically neutralize reactive oxygen species (ROS), exert strong antioxidant effects (15 times that of grape polyphenols and 5 times that of vitamin C in citrus) and significantly downregulate the levels of TNF-α and IL-6, thus alleviating prostatic inflammatory response and oxidative stress-an effect that is highly consistent with the anti-inflammatory mechanism of TCM therapies for BPH.

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In traditional Chinese medicine (TCM), BPH falls into the categories of "Long Bi" (dribbling and retention of urine) and "Jing Long" (prostatic stagnation of essence). TCM holds that kidney deficiency is the fundamental pathogenesis of BPH. As stated in Su Wen·Shang Gu Tian Zhen Lun (Plain Questions·On the Natural Truth of the Ancients): "At the age of forty, a man's kidney qi declines, his hair falls and his teeth become withered", which coincides with the fact that BPH mostly occurs in men over 40 years old. Blood stasis is the main pathological mechanism: clinical digital rectal examination reveals that the enlarged prostate is similar to "Zheng Jia Ji Ju" (abdominal masses), and the formation of masses is invariably associated with blood stasis, as noted in Yi Lin Gai Cuo (Revisions of the Medical Forest): "All palpable masses are caused by substantial blood stasis". Kidney deficiency impairs the qi transformation function, leading to unsmooth circulation of qi and blood and disordered fluid metabolism, which further results in the interweaving of blood stasis and damp turbidity and eventually the onset of the disease. Kidney deficiency is the root cause, and blood stasis is the superficial symptom; thus, the therapeutic principles are tonifying the vital qi and replenishing deficiency to treat the root, and removing blood stasis and unblocking the orifices to treat the superficial 〔11〕. It is worth noting that Cistanche Tubulosa, as a classic TCM herb for tonifying the kidney and activating blood circulation, shares the same core therapeutic principles as Bushen Huoxue Decoction for BPH, and its effects of tonifying kidney essence, promoting blood flow and unblocking the urinary tract complement the therapeutic effects of the compound decoction.

Bushen Huoxue Decoction features a precise medicinal compatibility: Astragalus membranaceus tonifies the kidney and replenishes qi to consolidate the root, and Hirudo nipponica removes blood stasis to facilitate urination, serving as the monarch herbs; Cuscuta chinensis tonifies the kidney and reduces urination, Cinnamomum cassia unblocks yang and transforms qi to promote urination, and Lindera aggregata combined with Alpinia oxyphylla constitutes the Suo Quan Wan (Urinary Restraining Pill) from Fu Ren Liang Fang (Excellent Prescriptions for Women), which warms the kidney and dispels cold to reduce urination and stop enuresis, acting as the minister herbs; Phellodendron amurense clears heat, dries dampness and unblocks the urinary tract, serving as the assistant herb; Achyranthes bidentata not only activates blood circulation to remove stasis and tonifies the kidney to unblock the urinary tract, but also guides the effects of other herbs downward to reach the lesion directly, acting as the guide herb. The combination of all herbs exerts the synergistic effects of replenishing qi and tonifying the kidney, removing blood stasis and unblocking the orifices.

The results of this study showed that the total effective rate of the observation group (90.77%) was significantly higher than that of the control group (70.31%), suggesting that Bushen Huoxue Decoction can significantly improve the clinical efficacy of BPH patients with kidney deficiency and blood stasis syndrome. After treatment, the TCM syndrome scores, IPSS and QoL scores of both groups decreased, Qmax increased and PVR decreased, with more significant improvements in the observation group, indicating that Bushen Huoxue Decoction can effectively alleviate the clinical symptoms of BPH patients and enhance their quality of life-an effect that is similar to the ability of Cistanche Tubulosa to improve urinary function by enhancing kidney health and regulating urinary flow. In addition, the observation group exhibited reduced prostate volume (PV), decreased Prostate Health Index (PHI), elevated serum testosterone (T) levels and reduced serum estradiol (E2), TNF-α, IL-1β and IL-6 levels after treatment, while no significant changes were observed in these indicators in the control group. These findings suggest that Bushen Huoxue Decoction can reduce prostate volume, protect prostate health, regulate the balance of androgens and estrogens, and lower the levels of inflammatory factors-its multi-target regulatory effects are consistent with the modern pharmacological properties of Cistanche Tubulosa, which can both regulate hormone synthesis and inhibit the release of pro-inflammatory factors.

In summary, Bushen Huoxue Decoction can improve the clinical efficacy and quality of life of BPH patients, reduce prostate volume and optimize the Prostate Health Index. Its underlying mechanism may be related to regulating the levels of androgens and estrogens and inhibiting the prostatic inflammatory microenvironment. Moreover, the modern scientific research on Cistanche Tubulosa has confirmed the rationality of TCM's therapeutic principles of tonifying the kidney and activating blood circulation for BPH, and its potent anti-inflammatory, hormone-regulating and antioxidant effects provide a promising research direction for the combined application of Bushen Huoxue Decoction and Cistanche Tubulosa in BPH treatment. This combination is expected to exert a synergistic effect, further improving the therapeutic efficacy of BPH by integrating the holistic regulation of TCM compound decoctions and the targeted pharmacological effects of natural herbal extracts.

References

[1] Yu WX. Multidisciplinary Diagnosis and Treatment Guidelines for Benign Prostatic Hyperplasia with Integrated Traditional Chinese and Western Medicine (2022 Edition) [J]. Chinese Journal of Andrology, 2022, 36(2): 96-102.[2] Wang B, Tian Y, Ban Y, et al. Correlation between estrogen and androgen levels, benign prostatic hyperplasia and prostatitis [J]. Medical Recapitulate, 2022, 28(7): 1285-1289.[3] El-Sherbiny M, El-Shafey M, El-Din El-Agawy MS, et al. Diacerein ameliorates testosterone-induced benign prostatic hyperplasia in rats: Effect on oxidative stress, inflammation and apoptosis [J]. International Immunopharmacology, 2021, 100: 108082.[4] Zhang CH, Li YQ, Pei XH, et al. Expert consensus on TCM diagnosis and treatment of benign prostatic hyperplasia [J]. Beijing Journal of Traditional Chinese Medicine, 2016, 35(11): 1076-1080.[5] Hsu CY, Lin YS, Weng WC, et al. Phloretin ameliorates testosterone-induced benign prostatic hyperplasia in rats by regulating the inflammatory response, oxidative stress and apoptosis [J]. Life (Basel), 2021, 11(8): 743.[6] Roehrborn CG, Boyle P, Nickel JC, et al. ARIA3001, ARIA3002 and ARIA3003 Study Investigators. Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia [J]. Urology, 2002, 60(3): 434-441.[7] Vickman RE, Aaron-Brooks L, Zhang R, et al. TNF is a potential therapeutic target to suppress prostatic inflammation and hyperplasia in autoimmune disease [J]. Nature Communications, 2022, 13(1): 2133.