Efficacy and safety of Qianlieshutong Capsules in the treatment for Type III prostatitis: A post-marketing, multicenter, randomized, double-blind, single-dummy, active-controlled, parallel-group clinical trial.

BACKGROUND

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS, NIH category III) remains a challenging condition with no universally accepted treatment. Although alpha-blockers and antibiotics are commonly used, their efficacy is inconsistent.

PURPOSE: In this study, we aimed to evaluate the efficacy and safety of Qianlieshutong Capsules (QLSTCs, a standardized traditional Chinese medicine) combined with tamsulosin versus tamsulosin alone in patients with CP/CPPS.

METHODS

In this post-marketing, multicenter, randomized, double-blind, single-dummy clinical trial, 240 male patients aged 18-50 years diagnosed with CP/CPPS were randomly assigned (1:1) to receive either QLSTCs (0.4 g/capsule, 3 capsules, three times daily) plus tamsulosin (0.2 mg nightly) or a matching placebo plus tamsulosin for 8 weeks. The primary endpoint was the change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline to week 8. Secondary outcomes included changes in the NIH-CPSI score at week 4, domain-specific scores (pain, urinary symptoms, quality of life), and treatment response rates. Safety was assessed through adverse events (AEs), laboratory tests, vital signs, and ECG.

RESULTS

Of the 240 randomized patients, baseline characteristics were comparable. At week 8, the combination group showed a significantly greater reduction in the total NIH-CPSI score than the control group (14.30 ± 0.53 vs. 10.60 ± 0.54; mean difference = 3.70, 95% CI: 2.36-5.04; P < 0.0001). The effective response rate and marked improvement rate were significantly higher in the combination group. Improvements were also significant in all NIH-CPSI domains at week 8. AE incidences were low and comparable between groups (10.00% vs. 9.24%), with no serious AEs reported.

CONCLUSION

The combination of QLSTCs and tamsulosin is a safe and more effective treatment than tamsulosin alone for CP/CPPS, offering superior symptom relief, particularly in pain, urinary symptoms, and quality of life. This approach may serve as a promising multimodal therapeutic option in clinical practice.