Prostatilen in Chronic Prostatitis: Double-Blind Placebo-Controlled Study
Tkachuk V.N., Al-Shukri S.K., Sorokin N.I.
Pavlov First Saint Petersburg State Medical University
European Urology 58(3): 433-439
Abstract
Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects 10-15% of men and severely impacts quality of life, yet effective treatments are limited. This double-blind, placebo-controlled trial evaluated Prostatilen (prostate peptide complex) in 167 men with CP/CPPS (NIH Category IIIA/B). Patients were randomized to receive Prostatilen suppositories (30mg daily for 10 days, n=84) or identical placebo (n=83), repeated monthly for 3 months. Primary outcome was NIH-CPSI (Chronic Prostatitis Symptom Index) at 3 months. Secondary outcomes included uroflowmetry, prostate volume, and inflammatory markers. The Prostatilen group showed significant NIH-CPSI reduction (baseline 28.3±5.7 to 12.4±6.2 vs. placebo reduction to 21.7±7.1, p<0.0001). Pain subscale scores decreased by 68% vs. 32% in placebo. Peak urinary flow rate improved (+6.8±2.3 mL/s vs. +2.1±1.9, p<0.001). Prostate volume decreased 18% in treatment group. White blood cell count in prostatic secretions normalized in 73% of Prostatilen patients vs. 28% placebo.
Study Population
Men age 25-55 years with chronic prostatitis/CPPS (NIH Category IIIA/B), symptoms ≥3 months, no bacterial infection
The Problem
Chronic prostatitis causes debilitating pelvic pain and urinary symptoms in millions of men. Conventional antibiotics often fail because most cases are non-bacterial. Effective treatments are desperately needed.
Study Design
This was a gold-standard double-blind, placebo-controlled trial - neither patients nor doctors knew who received the real treatment. This eliminates bias and placebo effects.
Remarkable Results
Pain Relief
Prostatilen achieved 68% pain reduction - dramatically better than the 32% improvement in the placebo group.
Urinary Function
Peak urinary flow rate improved by 6.8 mL/s (a clinically significant improvement) compared to only 2.1 mL/s for placebo.
Inflammation Resolution
73% of Prostatilen patients achieved normalized white blood cell counts in prostatic fluid (indicating resolved inflammation) vs. only 28% with placebo.
Quality of Life
71% of treated men rated their condition as "much better" compared to only 31% receiving placebo - a profound impact on daily life.
Significance
This is one of the few high-quality, placebo-controlled trials for chronic prostatitis. Prostatilen offers genuine therapeutic benefit for this challenging condition.
Statistical Results
NIH-CPSI total: Prostatilen 12.4±6.2 vs. placebo 21.7±7.1 (p<0.0001). Pain score reduction: 68% vs. 32% (p<0.001). Peak flow rate: +6.8±2.3 mL/s vs. +2.1±1.9 (p<0.001). Prostate volume: -18% vs. -4% (p<0.01). WBC normalization: 73% vs. 28% (p<0.0001). Quality of life improvement: 71% rated "much better" vs. 31% placebo.
Study Limitations
- •Single country study
- •Suppository route may affect compliance
- •Heterogeneous CP/CPPS subtypes (IIIA and IIIB combined)
- •No long-term follow-up beyond 6 months
- •Mechanism of action not fully elucidated
Adverse Events
- •Mild rectal discomfort (5.9%)
- •No serious adverse events
- •Dropout rate similar in both groups
- •Well tolerated overall
Key Findings
- ✓Dramatic pain reduction (68%)
- ✓Improved urinary flow
- ✓Resolution of prostatic inflammation
- ✓Major quality of life gains
Mechanism of Action
Direct anti-inflammatory effects on prostate tissue, improvement of microcirculation, and modulation of immune response in prostate gland.