Key Takeaways & Executive Findings
- •• • Combination therapy (TCM + tamsulosin) achieved a significantly greater IPSS reduction (mean change -8.2 vs -5.4, p<0.01) compared to tamsulosin monotherapy, indicating enhanced symptom relief in BPH patients. • • Peak urinary flow rate (Qmax) improved by +4.5 mL/s in the combination group versus +2.8 mL/s in the control group (p<0.05), demonstrating objective improvement in urinary obstruction. • • Post-void residual volume (PVR) decreased by 32 mL in the combination group versus 18 mL in the control group (p<0.05), suggesting better bladder emptying and reduced risk of urinary retention. • • The combination regimen showed a favorable safety profile with no significant increase in adverse events, supporting its clinical applicability for long-term BPH management.
Abstract
Benign prostatic hyperplasia (BPH) is a common urological condition in aging men, often managed with combination therapy. This randomized controlled trial evaluated the efficacy and safety of a combined traditional Chinese medicine (TCM) and Western medicine regimen versus Western medicine alone in patients with moderate-to-severe BPH. A total of 120 patients were randomized to receive either combination therapy (TCM formula plus tamsulosin) or tamsulosin monotherapy for 12 weeks. The primary outcome was the change in International Prostate Symptom Score (IPSS). Secondary outcomes included peak urinary flow rate (Qmax), post-void residual volume (PVR), and prostate volume. Results showed that the combination group had a significantly greater reduction in IPSS (mean change -8.2 vs -5.4, p<0.01) and improvement in Qmax (+4.5 mL/s vs +2.8 mL/s, p<0.05) compared to the control group. PVR decreased by 32 mL in the combination group versus 18 mL in the control group (p<0.05). Prostate volume reduction was modest but not statistically significant. Adverse events were mild and comparable between groups. The combination of TCM and tamsulosin demonstrated superior symptomatic relief and urinary flow improvement without additional safety concerns, suggesting a beneficial role for integrative therapy in BPH management.
1. Introduction
Benign prostatic hyperplasia (BPH) remains a leading cause of lower urinary tract symptoms (LUTS) in aging men, affecting over 50% of men aged 60 and above. Conventional pharmacotherapy with alpha-blockers such as tamsulosin provides rapid symptomatic relief but often yields suboptimal long-term outcomes, with up to 30% of patients experiencing inadequate response or bothersome side effects. Surgical interventions, while effective, carry risks of bleeding, infection, and sexual dysfunction, underscoring the need for more efficacious and safer medical alternatives.
Traditional Chinese medicine (TCM) has long been used to manage urinary disorders, with formulations designed to tonify kidney qi, activate blood circulation, and resolve dampness. However, rigorous clinical evidence supporting its integration with Western pharmacotherapy is limited. This randomized controlled trial addresses this gap by evaluating a standardized TCM formula combined with tamsulosin against tamsulosin monotherapy, measuring both subjective symptom scores and objective urodynamic parameters. The findings provide quantitative evidence that integrative therapy can significantly enhance symptom relief and urinary flow, offering a promising strategy to improve patient outcomes in BPH management.
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ZHANG Wei, LI Ming, WANG Fang, et al. (2025). Efficacy of Combined Traditional Chinese Medicine and Western Medicine in Treating Benign Prostatic Hyperplasia: A Randomized Controlled Trial. Chinese Journal of New Drugs. https://doi.org/pub_80__articleID_249
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Frequently Asked Questions
What is the clinical significance of the observed IPSS reduction in the combination group compared to tamsulosin monotherapy?
The combination group achieved a mean IPSS reduction of 8.2 points, which is 2.8 points greater than the control group (p<0.01). This exceeds the minimal clinically important difference (MCID) of 3 points for IPSS, indicating a meaningful improvement in patient-reported symptoms. Such a difference can translate to better quality of life and reduced need for additional interventions.
How does the improvement in Qmax in the combination group compare to established thresholds for treatment success?
The combination group showed a mean increase in Qmax of 4.5 mL/s, compared to 2.8 mL/s in the control group (p<0.05). An increase of ≥3 mL/s is generally considered a clinically significant improvement in urinary flow. The additional 1.7 mL/s gain suggests that the TCM components may enhance relaxation of prostatic smooth muscle or reduce prostatic inflammation, leading to better uroflowmetry outcomes.
What are the potential mechanisms by which the TCM formula enhances the efficacy of tamsulosin?
While the exact mechanisms are not fully elucidated, TCM ingredients such as Astragalus membranaceus and Poria cocos may exert anti-inflammatory and immunomodulatory effects, reducing prostatic inflammation that contributes to BPH progression. Additionally, some herbs may improve blood circulation and reduce oxidative stress, potentially sensitizing the prostate to alpha-blockade. Further pharmacokinetic and pharmacodynamic studies are warranted to confirm these interactions.
Were there any differences in adverse events between the combination and monotherapy groups that could affect clinical decision-making?
Adverse events were mild and comparable between groups, with no significant differences in incidence rates. The most common side effects were dizziness and headache, consistent with tamsulosin use. The lack of additional toxicity supports the safety of combining TCM with tamsulosin, making it a viable option for patients who require enhanced symptom control without compromising tolerability.
How does the combination therapy impact post-void residual volume (PVR), and what are the implications for long-term outcomes?
The combination group experienced a mean PVR reduction of 32 mL, compared to 18 mL in the control group (p<0.05). Lower PVR is associated with reduced risk of urinary tract infections, bladder stones, and renal impairment. This improvement suggests that combination therapy may help preserve bladder function and delay disease progression, potentially reducing the need for surgical intervention in the long term.
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