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Randomized Controlled Trial Clinical Trial
Role of mepartricin in category III chronic nonbacterial prostatitis/chronic pelvic pain syndrome: a randomized prospective placebo-controlled trial.
- Aldo Franco De Rose, Fabrizio Gallo, Matteo Giglio, and Giorgio Carmignani.
- Luciano Giuliani Urology Department, University of Genoa, Genoa, Italy.
- Urology. 2004 Jan 1; 63 (1): 13-6.
ObjectivesTo verify the efficacy of mepartricin versus placebo with regard to symptom improvement in patients with chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CPPS) and to verify a relation between hormonal levels and clinical improvement in these patients.MethodsTwenty-six patients with CPPS were included in our study and randomized into two groups of 13 subjects each. Group 1 patients were treated with mepartricin (40 mg daily) and group 2 patients with placebo. All patients underwent treatment for 60 days. At the beginning and end of therapy, all patients underwent evaluation, including a standardized history, physical examination, luteinizing hormone, follicle-stimulating hormone, testosterone, and beta-estradiol measurements, and a National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) questionnaire.ResultsWe observed a decrease in the total NIH-CPSI score from 25.0 to 10.0 in group 1 and from 25.0 to 20.0 in group 2, revealing a 60% and 20% improvement in groups 1 and 2, respectively. A statistically significant decrease was observed with regard to pain (from 11.0 to 4.0 and from 10.0 to 8.0, respectively) and quality of life (from 10.0 to 5.0 and 10.0 to 9.0, respectively). No statistically significant difference was observed in urinary dysfunctions. The luteinizing hormone, follicle-stimulating hormone, and testosterone values were similar in both groups before and after treatment; the 17-beta-estradiol levels were significantly lower in group 1 compared with group 2 at the end of the study.ConclusionsMepartricin provides significant symptomatic improvement in men with CPPS compared with placebo. The role of mepartricin in decreasing estrogen plasmatic levels and their concentration in the prostate may account for this clinical improvement.
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