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.

چکیده اصلی

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.

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