Adult urologyRole of mepartricin in category III chronic nonbacterial prostatitis/chronic pelvic pain syndrome: a randomized prospective placebo-controlled trial
Section snippets
Material and methods
Between June 2001 and November 2002, 30 patients with CPPS were examined at our outpatient department. All of these patients were eligible for our study and provided written informed consent to the same physician. We did not request institutional review board approval because our study was a spontaneous, and not a financed, trial. We treated 30 patients with CPPS who had already been treated with other drugs with no improvement of their genitourinary symptoms. All the patients agreed to pay the
Results
All 26 patients completed the study. Two patients in group 1 reported episodes of mild epigastralgia associated with nausea. However, it was not severe enough to require the treatment to be discontinued.
Using the scores obtained from the NIH-CPSI questionnaires, we compared the efficacy of mepartricin in group 1 with that of the placebo in group 2. We observed a decrease in the total score from 25.0 to 10.0 in group 1 and from 25.0 to 20.0 in group 2 (Table II). The difference between the two
Comment
The etiology of CPPS is still unknown. Recent reports have excluded bacteria, obligate anaerobes, fungi, Trichomonas, and viruses as pathogenic agents.3, 4 Animal model studies have suggested a genetic predisposition, an increase in estrogen levels, and autoimmune mechanisms.5, 6, 7
The role played by abnormal levels of estrogens and androgens has also been suggested.8 CPPS, in test animals, as well as in humans, might be the result of an increased estrogen/androgen ratio, which in turn leads to
Conclusions
Therapy with mepartricin is well tolerated and provides a significant symptomatic improvement in men with CPPS compared with placebo. Our data showed a statistically significant decrease in estrogen plasmatic levels in the patients treated with mepartricin. Even if we had not measured the estrogen levels in the prostate, we could indirectly suppose a low concentration of them first in the plasmatic fluid and then in the prostate.
The findings of a number of experimental studies seem to confirm
References (19)
- et al.
Does the chronic prostatitis/pelvic pain syndrome differ from nonbacterial prostatitis and prostatodynia?
J Urol
(2000) - et al.
Comparison of expressed prostatic secretions with urine after prostatic massage—a means to diagnose chronic prostatitis/inflammatory chronic pelvic pain syndrome
Urology
(2000) - et al.
Diagnosing and treating chronic prostatitisdo urologists use the four-glass test?
Urology
(2000) - et al.
The chronic prostatitis-chronic pelvic pain syndrome can be characterized by prostatic tissue pressure measurements
J Urol
(2002) - et al.
17 beta estradiol induced prostatitis in the rat is an autoimmune disease
J Urol
(1996) - et al.
Research guidelines for chronic prostatitisconsensus report from the first National Institutes of Health International Prostatitis Collaborative Network
Urology
(1999) - et al.
The National Institutes of Health Chronic Prostatitis Symptom Indexdevelopment and validation of a new outcome measure
J Urol
(1999) - et al.
The role of androgens and estrogens in the pathogenesis of experimental non bacterial prostatitis
J Urol
(1988) National Institutes of Health Summary Statement: Executive Summary
(1995)
Cited by (50)
Effect of mobile phase pH on liquid chromatography retention of mepartricin related compounds and impurities as support to the structural investigation by liquid chromatography–mass spectrometry
2022, Journal of Pharmaceutical and Biomedical AnalysisCitation Excerpt :As all the member of aromatic heptane macrolide family, mepartricin binds to steroids and, thanks to its capabilities to reduce the effects of estrogen on the prostate gland, it is widely used for the treatment of benign prostatic hyperplasia (BPH). Currently, mepartricin is the active principle of Ipertrofan, which is recommended for the treatment of BPH and chronic nonbacterial prostatitis/chronic pelvic pain syndrome [3,4]. Partricin complex consists in two major components with comparable biological activity, named partricins A and B, and differing for the presence of N-methyl substitution on the aromatic amino group in partricin A.
Interventions to chronic prostatitis/Chronic pelvic pain syndrome treatment. Where are we standing and what's next?
2019, European Journal of PharmacologyCitation Excerpt :A research study on 26 CP/CPPS men demonstrated a statistically significant improvement with 40 mg mepartricin, a drug that reduces estrogen levels in the prostate, as compared to placebo in the 60-day treatment plan. The outcomes revealed a decrease in pelvic pain intensity and frequency, improved quality of life and a significant reduction in estrogen plasmatic levels in the patients treated with mepartricin (De Rose et al., 2004a). Fispemifene [Z-2-{2-[4-(4-Chloro-1,2-diphenylbut-1-enyl)-phenoxy] ethoxy-ethanol] is a selective estrogen receptor modulator (SERM) and serves as an anti-inflammatory and antiestrogenic that alleviates the signs of inflamed acini, expression of progesterone receptor (PR) and Fos-related antigen 2 (Fra2) in chronic prostatitis model.
Comprehensive overview of prostatitis
2017, Biomedicine and PharmacotherapyCitation Excerpt :Although, the response rate of patients was twice to 6 months finasteride therapy compared with placebo, but the actual extent of improvement was not statistically significant. From the results of a small, single-center, pilot study of mepartricin, a drug that lowers the levels of prostatic estrogen, it was shown that it might be useful in dealing with CPPS [87], but it is necessary to carry out a larger, well-designed, multicenter trial to confirm this. For the treatment of pain and symptoms associated with CP/CPPS, neuromodulators (pregabalin and gabapentin), anti-anxiolytics, and antidepressants (particularly benzodiazepines) are also used, but no precise and firm evidence is available to allow an evidence-based recommendation to be made [88].
Testosterone and Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Propensity Score-Matched Analysis
2016, Journal of Sexual MedicineCitation Excerpt :A recent study investigated the role of testosterone in CP/CPPS. However, only a small amount of data is available to date.5–9 In addition, the effect of testosterone (T) has not been consistent across studies.
Contemporary Management of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
2016, European UrologyCitation Excerpt :It represents a standard treatment for LUTS in patients with BPH, but finasteride (5 mg 4 times per day) over 6 mo was not able to significantly improve the clinical outcome in this study population. Another clinical trial by De Rose et al investigated the role of mepartricin, a compound known to decrease estrogen levels in the prostate [31]. This small trial reported a significant clinical improvement measured by the NIH-CPSI after a course of 60 d with mepartricin (40 mg 4 times per day) compared with placebo.
Clinical assessment and management of patients with National Institutes of Health categories IIIA and IIIB chronic prostatitis/chronic pelvic pain syndrome
2014, Tzu Chi Medical JournalCitation Excerpt :The NIH Chronic Prostatitis Symptom Index (NIH-CPSI) is an established international standard index for the evaluation of symptoms of prostatitis, but not its diagnosis [2]. The validated NIH-CPSI has been recommended to evaluate the severity of symptoms [3] and to measure the outcome of a variety of therapeutic agents for CP/CPPS [4–13]. As an evaluative tool, the NIH-CPSI provides an insight into the severity of symptoms relevant to chronic prostatitis.