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Background: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has been treated with several different interventions with limited success. This meta-analysis aims to review all trials reporting on therapeutic intervention for CP/CPPS using the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI)., Methods: We searched Medline, PubMed, the Cochrane Pain, Palliative & Supportive Care Trials, the Cochrane Register of Controlled Trials, CINAHL, ClinicalTrials.gov, and the NIDDK website between 1947 and December 31, 2011 without language or study type restrictions. All RCTs for CP/CPPS lasting at least 6 weeks, with a minimum of 10 participants per arm, and using the NIH-CPSI score, the criterion standard for CP/CPPS, as an outcome measure were included. Data was extracted from each study by two independent reviewers. Gillbraith and I-squared plots were used for heterogeneity testing and Eggers and Peters methods for publication bias. Quality was assessed using a component approach and meta-regression was used to analyze sources of heterogeneity., Results: Mepartricin, percutaneous tibial nerve stimulation (PTNS), and triple therapy comprised of doxazosin + ibuprofen + thiocolchicoside (DIT) resulted in clinically and statistically significant reduction in NIH-CPSI total score. The same agents and aerobic exercise resulted in clinically and statistically significant NIH-CPSI pain domain score reduction. Acupuncture, DIT, and PTNS were found to produce statistically and clinically significant reductions in the NIH-CPSI voiding domain. A statistically significant placebo effect was found for all outcomes and time analysis showed that efficacy of all treatments increased over time. Alpha-blockers, antibiotics, and combinations of the two failed to show statistically or clinically significant NIH-CPSI reductions., Conclusion: Results from this meta-analysis reflect our current inability to effectively manage CP/CPPS. Clinicians and researchers must consider placebo effect and treatment efficacy over time and design studies creatively so we can more fully elucidate the etiology and role of therapeutic intervention in CP/CPPS.

Introduction: Chronic prostatitis can cause pain and urinary symptoms, and usually occurs without positive bacterial cultures from prostatic secretions (known as chronic abacterial prostatitis or chronic pelvic pain syndrome [CP/CPPS]). Bacterial infection can result from urinary tract instrumentation, but the cause and natural history of CP/CPPS are unknown., Methods and Outcomes: We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatments for chronic bacterial prostatitis? What are the effects of treatments for chronic abacterial prostatitis/chronic pelvic pain syndrome? We searched: Medline, Embase, The Cochrane Library, and other important databases up to August 2010 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA)., Results: We found 33 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions., Conclusions: In this systematic review, we present information relating to the effectiveness and safety of the following interventions: 5 alpha-reductase inhibitors, allopurinol, alpha-blockers, biofeedback, local injections of antimicrobial drugs, mepartricin, non-steroidal anti-inflammatory drugs (NSAIDs), oral antimicrobial drugs, pentosan polysulfate, prostatic massage, quercetin, radical prostatectomy, sitz baths, transurethral microwave thermotherapy, and transurethral resection.

Objectives: To 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., Methods: Twenty-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., Results: We 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., Conclusions: Mepartricin 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.

Background: The purpose of this study was to report our experience on the use of Mepartricine in the treatment of chronic and sub-acute prostatitis and to analyse, on the basis of the literature, the role of estrogens, the target of Mepartricine in the development and maintenance of prostatic inflammatory reactions., Methods: In a retrospective study the data of 110 patients who presented with lower urinary tract symptoms suggestive of prostatitis, from January 1994 to February 1999 have been evaluated: 65 of this patients had an abacterial prostatitis, and 45 a bacterial prostatitis. The Mearers-Stamey test was used to localize inflammation and pathogens to prostate. The clinical symptoms presented were essentially pelvic and perineal pain and irritative and obstructive voiding symptoms. The treatment was based on antibiotic therapy indicated by the sensitivity to antibiotic assay. In abacterial prostatitis, in cases of Chlamidia, Mycoplasma and Ureaplasma positivity, the treatment was based on macrolides and tetracycline use. All the patients received Mepartricine by oral supply, 1 daily tablet (40 mg) for 60 days., Results: After two months of treatment remarkable improvements in symptoms were obtained despite the persistent bacteriological positivity in the prostatic secretion in 68% of cases. Therefore antinflammatory antiedemic and decongestant effects of Mepartricine on prostatic inflammation, are observed., Conclusions: The data of the literature show data estrogens modulate inflammatory reactions: it is possible that their decrease can produce, at prostatic level, antinflammatory effects improving urethro-prostatic bladder functions. Personal experience seems to confirm this supposition and so we think that Mepartri-cine can be considered and excellent coadjuvant in the treatment of prostate inflammation, independent of etiology.

Background: The aim of this paper is to compare the activity of mepartricin vs placebo in male pain pelvic syndrome secondary to chronic nonbacterial prostatitis/prostatodynia., Methods: Forty-two patients have been tested (mean age: 35 years; range 29-44), these proved affected by male pain pelvic syndrome secondary to chronic nonbacterial prostatitis/prostatodynia, and were randomized into 2 groups: the 1st treated with mepartricin 40 mg/die for 60 days, the 2nd with placebo (C vitamin 500 mg/die) for 60 days. The following patterns were examined: spontaneous and rectal examination pain, diurnal and nocturnal urinary frequency and prostatic volume. Side effects in course of therapy were examined as well., Results: Mepartricin proved significantly more active than placebo in reducing spontaneous pain, rectal examination pain, diurnal urinary frequency, nicturia and prostatic volume. No significant difference proved to emerge between placebo and mepartricin in terms of side effects., Conclusions: These data allow us to substain that mepartricin may be a useful and safe drug for the therapy of male pain pelvic syndrome secondary to chronic nonbacterial prostatitis/prostatodynia.

Background: In order to evaluate the benefit of long-term medical treatment (4 years) in benign prostatic hyperplasia in June 1992 we prospectively started a not randomized study in selected benign prostatic hyperplasia patients for whom surgery was not indicated because of high surgical or post-surgical risk, or when they refused the intervention., Methods: We included in the study 239 outpatients; 118 of them were affected by concomitant cardiovascular illness, 37 by neurologic diseases, 29 by neoplastic diseases and 55 refused surgery for the possible general or specific complications like retrograde ejaculation. All subjects have been checked every six months by transabdominal ultrasonography of the urinary tract, evaluation of the prostate volume and percent of post-micturitional residue, associated with uroflussometry. The patients have been divided into three groups and treated by finasteride, mepartricin, alfuzosin, doxazosin. The enlistment concluded in December 1995 and the follow-up extended up to December 1999., Results: Our data clinically and statistically allow to confirm the validity of drug therapy for benign prostatic hyperplasia, not only in selected patients with high surgical risk, but also in subjects without a significant morbidity., Conclusions: In these patients, drug therapy may resolve the pathology, or allow the use of minimally invasive surgery (i.e. lasertherapy, transuretheral incision, etc.).

Androgens and estrogens, mainly testosterone (TES) and dihydrotestosterone (DHT) and 17 beta-estradiol (EST), are widely recognized to regulate the prostate growth and their imbalance with aging, leading to reduction of androgens and relative increase of estrogens, may be responsible for the development of benign prostatic hyperplasia (BPH). Mepartricin (CAS 11121-32-7), a polyene drug for medical treatment of BPH, was assayed in vitro for its ability to bind with 14C-labelled sex hormones, by incubation in buffered saline, serum and bile, followed by centrifugation and dosing of the radioactivity in the supernatant. It proved effective in complexing up to 90% of TES and DHT in buffered saline and up to 80% of EST in bile. Due to minimal absorption of oral mepartricin and to much higher enterohepatic circulation for estrogens than for androgens, the binding effect of mepartricin on EST in the gut should be of particular pharmacological relevance to explain its mechanism of action on BPH.

Estrogen suppression has been introduced as a pharmacotherapeutic strategy in the medical treatment of benign prostatic hyperplasia. Recent negative results obtained in placebo-controlled trials with the aromatase inhibitor atamestane raised doubts about the efficacy of estrogen reduction. However, inhibition of aromatase not only reduces estrogens but also increases androgens which promote prostatic growth. In order to reevaluate the therapeutic efficacy of estrogen suppression, we summarize clinical trials investigating the therapeutic effects of mepartricin in the treatment of uncomplicated benign prostatic hyperplasia. Mepartricin has been reported to lower the levels of circulating estrogens without causing changes in other hormones such as androgens. By applying stringent inclusion criteria, 23 studies (including 7 placebo-controlled trials, 3 post-marketing surveillance studies, and 13 open trials) published between 1982 and 1996 were selected to be included in this report. In 79.9% of 4635 patients treated with mepartricin, its therapeutic effect was rated "good" or "excellent". In 6 out of 7 placebo-controlled trials, the therapeutic efficacy of mepartricin was significantly superior to that of placebo. Comparison of these data with results obtained with alpha 1-adrenoceptor antagonists or with the 5 alpha-reductase inhibitor finasteride indicates that mepartricin is as efficient as these widely accepted medical treatments for benign prostatic hyperplasia. Since mepartricin acts selectively upon estrogens, the present results show that estrogen suppression may be considered an efficient pharmacotherapeutic strategy in the medical treatment of uncomplicated benign prostatic hyperplasia.

Background: Mepartricin, a semisynthetic polyene derivative with a favorable effect on urethro-prostatic function, was clinically evaluated, adopting the diagnostic and research criteria recommended by the First International Consultation on BPH., Methods: A multicenter, randomized, double-blind, parallel-group study compared mepartricin 40 mg/daily to placebo in the treatment of 196 patients with newly diagnosed BPH and mild-to-moderate symptomatology. International Prostate Symptom Score (I-PSS), quality of life (QoL) index and maximum urinary flow-rate (Qmax) were determined every 4 weeks for 6 months; postvoiding volume, prostate volume, and prostate-specific antigen (PSA) were assessed after 3 and 6 months of therapy., Results: Mepartricin was shown to determine a statistically significant improvement over placebo in I-PSS and QoL index from month 2 onwards, and a significant linear increase in Qmax over the study period. At month 6, the improvement in the mepartricin and placebo groups in I-PSS, QoL index, and Qmax was 6.3 (standard error (SE) 0.51) and 4.2 (SE 0.60) points (P = 0.003), 0.99 (SE 0.14) and 0.62 (SE 0.12) points (P = 0.036), and 2.7 (SE 0.46) and 1.2 (SE 0.46) ml/sec (P = 0.051), respectively. No significant differences were noted in postvoiding residual volume, prostate volume, or PSA. Mepartricin tolerability was good, showing no adverse events on sexual function., Conclusions: Mepartricin proved to be an effective treatment of benign prostatic hyperplasia, determining an improvement in symptoms, quality of life, and peak urinary flow.

Background: In order to assess the efficacy of phytotherapeutic agents for the treatment of benign prostatic hyperplasia (BPH), a review of recently published double-blind placebo-controlled trials was undertaken., Methods: Only those studies reviewed by the Other Medical Therapies Committee of the Fourth International Consultation on BPH were included., Results: These studies suggest a possible benefit for the use of phytotherapeutic preparations in the treatment of BPH., Conclusions: These studies need to be confirmed in larger long-term placebo-controlled studies in order to ascertain the true efficacy of these agents.

The therapeutic efficacy and tolerance of a new 150,000 U (40 mg) formulation of mepartricin (to be administered once-a-day in the evening) were evaluated during a double-blind study against placebo in 2 groups of uncomplicated BPH patients treated for 60 days. The data obtained disclosed a positive pharmaco-therapeutic effect of this new formulation coupled with excellent local and systemic tolerance. At the end of trial the various objective and subjective parameters considered showed marked improvement in the group treated with mepartricin, with statistically significant differences from the placebo-treated group. The treatment efficacy was judged positive in 74-78% of cases by patients and physicians in the mepartricin group and in 36.4% of cases in the placebo group.

With the purpose of investigating the relationship between prostatico-vesical inflammation and sexual disturbances, two groups of 15 patients with uncomplicated BPH were treated with mepartricin 150,000 U/die for 60 days. The two groups differed from each other for the presence of sexual disturbances only present in group A. The relationship between BPH and sexual picture was studied on the grounds of both the symptomatic and instrumental variables habitually adopted in the presence of the pathology in question and of a specific method for the quantitative evaluation of dynamic erection. The examination of the results obtained confirmed BPH clinical implications on sexuality as well as mepartricin excellent manageability, confirmed by the fact that never were sexual disturbances brought about by the drug. On the other hand the erectile activity index measured in the two groups, underwent a qualitative improvement even in the absence of changes in the quantitative datum.

The authors assessed the validity of a treatment with mepartricin in BPH at the dose of 150,000 U in a once-a-day evening administration for 6 months. The results from the controlled study were compared with those obtained in a homogeneous group of patients treated with placebo. The analysis of the data obtained would suggest a preferential opinion in favour of the group treated with mepartricin which was effective in improving the symptomatology. Some hypothesis are put forward to interpret the results.

The urethral syndrome is very frequent in women but the etiology is unknown. In all 77 patients suffering from the syndrome, endoscopy revealed characteristic lesions in the trigonal area. As unidentified bacteria may be responsible, a microbiological investigation was carried out. Wide-spectrum or specific antibiotic therapy was prescribed as required. All patients were also randomized to 2 groups to assess the efficacy of local estrogen therapy. The authors concluded that wide-spectrum antibiotic therapy with macrolide and mepartricin should be the first choice of treatment and that local administration of estrogen does not significantly enhance the benefits achieved through antibiotic therapy. A detailed microbiological investigation is necessary when symptoms persist. Overall a positive result was obtained in 75.32% of the cases (58 patients). The presence of Streptococci negatively influenced the results of specific antibiotic therapy.

The Authors propose a medical treatment for Benign Prostatic Hyperplasia (BPH) using mepartricina-simvastatina, two drugs with a hypocholesterolemizing action. We have treated fifty patients with BPH (twelve with permanent catheters) obtaining a complete clinical results in 40% of the total and a partial clinical result in 38%. This therapy, in association with a correct diet and adequate physical activity, significantly improved not only the cervicurethral obstruction but also general hematochemical and, above all, lipidemic parameters.

Seventy one patients were treated with mepartricin or placebo in three urological centres for a mean duration of 102 days (extremes: 60 and 142 days). An analysis of the results was carried out for 34 patients in the placebo group and 36 patients in the mepartricin group. The results indicate a significant improvement in both the placebo group and the mepartricin group. The irritative and obstructive symptoms are improved in the active treatment group with a response rate of the order of 70%, compared to approx. 45% in the placebo group. An improvement of the values on the flow meter, though not statistically significant, is observed following treatment with mepartricin, compared to the placebo group. There were no significant differences in the evolution of the prostate gland volume, determined by ultrasound in the placebo group and the active treatment group. Side-effects were minor and only one patient reported epigastric pain.

Mepartricin, a new semisynthetic heptene, was given for systemic Candida infections to 11 immunocompromised patients. All patients were undergoing bone marrow transplantation or treatment with antilymphocytic globulin: 6 had acute leukemia, 4 aplastic anemia and 1 had Wiskott-Aldrich syndrome. In all patients systemic Candida infection was diagnosed on the basis of fungemia or positive cultures from at least three different sites, two of which were outside the gut. Mepartricin was given intravenously as a slow drip, at the dose of 100-700 U/kg/day for a total of 198 patient-days (range 9-36, mean +/- SD 18 +/- 8). Patients had to be premedicated with steroids and antihistamines to avoid reactions such as chills and fever. The treatment was well tolerated in all patients, and renal function tests were unchanged during therapy. There was a complete resolution of the fungal infection in 10 of the 11 patients.

Mepartricin was given to cirrhotic patients in order to evaluate its effect on the imbalance of sex steroids which is typical of this disorder. Patients were divided into two group: one group received placebo (n = 19) and the other received 150,000 IU/day mepartricin for 30 days (n = 19). The patients were evaluated by separate medical staff who were unaware of the treatment. Mepartricin significantly decreased the plasma concentration of testosterone, oestradiol and prolactin as compared with the values at the start of the trial, while no significant changes were seen in the occurrence of gynaecomastia. No relevant changes were seen in patients receiving the control, except for a slight increase in the peripheral concentration of androstenedione, aldosterone and follicle stimulating hormone.

Acute toxicity and absorption data of a soluble complex of mepartricin with sodium laurylsulphate (SPA-S-222) active against C. albicans and T. vaginalis are reported. The results demonstrate an improved bioavailability with respect to the insoluble substance. Preliminary clinical trials proved the good tolerance of the substance and its effectiveness in oral treatment of vaginal trichomoniasis.

44 patients with candidal vaginitis participated in a trial using a new formulation of a mepartricin-sodium lauryl sulfate complex for local administration (dosage schedule: one 25,000-unit vaginal tablet (SPA-S-222) daily for 6 days). Microbiological examination revealed an 88.6% cure rate (samples tested negative) at the end of treatment and a 90.9% cure rate 30 days after cessation of treatment. In addition, the clinical symptoms observed at the beginning of treatment disappeared rapidly and the patients showed great clinical improvement under the present therapy. Both local and systemic tolerance of the preparation used were excellent.

Mepartricin (SPA-S-160 enteric-coated tablets) fat-lowering effect was evaluated in 20 patients with lipids disorders of various type. The cross-over trial was carried out with clofibrate as reference drug. Posology consisted, in both treatments, of 3 tablets/die. All subjects received each drug for a 30-day period, with a drug-free interval of 30 days. The results proved positive for both drugs but mepartricin showed a better therapeutical index. Local and systemic tolerance was good for both drugs even though the transaminases values were found to be sensibly higher after the therapeutic cycle with clofibrate.

The efficacy and the tolerance of a polyene macrolide, mepartricin (SPA-S-160), able to interfere with intestinal absorption of cholesterol, were evaluated on 50 patients with primary hyperlipemia. Administration of 3 tablets/die for 30 days caused a significant decrease (P less than 0.01) in the lipid values, which, further controlled 30 days following treatment, proved to have remained lower than those observed at the beginning of the study.

Mepartricin (SPA-S-160) fat-lowering effect was evaluated in several groups of rats, normal or with experimental hyperlipidemia. The substance had a normalizing action on the lipid levels, and in particular on the cholesterol component. These findings, compared to those obtained in preliminary clinical studies, confirm a mechanism of action, common to some other polyenes, selecting as molecular target the interaction with the cholesterol component.

Fifteen patients in various stages of benign hypertrophy of the prostate were treated with mepartricin (SPA-S-160). Three tablets a day were given for a standard period of 60 days. The pharmacological effect of the drug was assessed both by traditional techniques and modern instrumental examinations like transrectal echography and urodynamic analysis. All 15 patients were studied on the basis of a protocol that incorporated standard diagnostic surveys before the start of treatment, numerous tests after 30 days and at the end of treatment. The overall clinical result was more than satisfactory especially in terms of the reduction in the frequency of daily and nightly urination. The echographic and urodynamic results were less spectacular. The drug was extremely well tolerated.

The in vitro antimycoplasmal activity of mepartricin was evaluated on several mycoplasma strains. The results demonstrate that this polyene antibiotic possesses a high efficacy against these microorganisms.