OBJECTIVE: To assess the efficacy and safety of a treatment regimen based on rectal administration of Boswellia resin extract and propolis derived polyphenols in patients with type IIIa and type IIIb chronic prostatitis and chronic pelvic pain syndrome (CP/CPPS).

METHODS: Patients with type IIIa and type IIIb CP/CPPS received one rectal suppository a day for 15 days per month for 3 consecutive months. Participants were evaluated with National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI), the International Prostate Symptom Scores (IPSS), International Index of Erectile Function (IIEF), four-glass test, uroflowmetry, and prostate-specific antigen assessments at baseline and at Week 4, and Week 12. Primary endpoints were improvement in pain domain of NIH-CPSI and improvement of NIH-CPSI total score. Secondary outcomes included improvement of micturition and quality of life (QoL) domains of NIH-CPSI questionnaire.

RESULTS: A total of 61 males were enrolled. No adverse events were reported. Significant improvements from baseline to Day 30 were reported for NIH-CPSI total score (mean difference: -9.2; <0.01), NIH-CPSI pain domain (mean difference: -5.5; <0.01), NIH-CPSI micturition domain, NIH-CPSI QoL domain, and IPSS total score (mean difference: -5.6; <0.01). No significant changes from baseline in terms of IIEF score or maximum flow rate were observed. At final follow-up (Day 90), further significant improvements in terms of NIH-CPSI total score (mean difference: -12.2; <0.01), NIH-CPSI pain domain (mean difference: -6.6; <0.01), NIH-CPSI micturition domain, NIH-CPSI QoL domain, and IPSS total score were reported.

CONCLUSION: Rectal administration of Boswellia resin extract and propolis derived polyphenols is well tolerated and delivers a significant symptomatic improvement in most patients with type IIIa and type IIIb CP/CPPS.

BACKGROUND: Urinary tract infections (UTIs) are among the most common bacterial infection diagnosed in women. The standard therapy is represented by short course of anti-microbial treatment to eradicate causative pathogens. However, due to antibiotic treatment, normal microbiota of the gastrointestinal tract is at risk of depletion and prolonged use of antibiotics can lead to the development of resistant strains. The aim of this pilot study was to assess the efficacy of Acidif plus®, a novel preparation containing L-Methionine, Boswellia serrata and Hibiscus sabdariffa, in the treatment of UTIs in women, in comparison with standard antibiotic treatment with fosfomycin.

METHODS: We performed a pilot clinical study with 88 patients with uncomplicated UTIs treated in ambulatory care clinics. The subjects recruited in the study were divided into two groups: the treatment group included 57 patients with both symptomatic and asymptomatic uncomplicated, bacteriuria-positive UTIs, who were treated by oral administration of Acidif plus® two tablets per day (1 tablet in the morning and 1 tablet in the evening) for 7 days. The control group included 31 patients with both symptomatic and asymptomatic bacteriuria-positive uncomplicated UTIs, treated with fosfomycin for two consecutive days. Clinical improvement of symptoms and urine bacteriuria were evaluated as treatment outcomes.

RESULTS: More than 50% of Acidif plus® treated patients were free of symptoms of UTIs at the end of the treatment regime. In addition, Acidif plus® treatment was effective in eliminating the bacterial infection in the post-treatment urine cultures in more than 85% of the patients.

CONCLUSIONS: In this study Acidif plus® treatment in patients with uncomplicated UTIs was found to be non-inferior to the standard antibiotic therapy. In acute setting, Acidif plus® was shown to be even more effective in alleviating the symptoms than fosfomycin and in eliminating bacteria in urine cultures. It is therefore possible to propose Acidif plus® as a potential alternative option to reduce the problem of multi-drug resistance in urinary infections.

OBJECTIVES: Chronic prostatitis syndrome is a bothering and poorly understood condition. Many patients report genitourinary pain and Lower Urinary Tract Symptoms as a main complaint. Many different pharmacological or behavioural therapies are prescribed in daily clinical practice, but efficacy data are still lacking. The aim of our study was to test the efficacy and safety of a transrectal delivered association of Boswellia resin extract and propolis derived polyphenols for the relief of prostatitis - like symptoms.

MATERIALS AND METHODS: Patients affected by chronic/recurrent prostatitis - like symptoms were prospectively enrolled in our study from December, 2016 to December, 2018. Patients were screened at baseline through clinical examination and validated questionnaires administration: Chronic Prostatitis Symptom Index (CPSI), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF). Inclusion criteria were: age ≥ 18; prostatitis symptoms persisting for at least 3 of the last 6 months; CPSI pain domain score ≥ 5; previous negative Meares-Stamey test. Treatment consisted on the administration of 1 suppository containing Boswellia resin extract and propolis derived polyphenols, once a day for 20 days. The primary endpoint of the study was the improvement of quality of life after treatment, defined by a reduction of ≥ 2 points, or ≥ 25%, of mean CPSI pain domain score, compared to baseline. Secondary endpoints were the improvement of post-treatment CPSI total score and the analysis of treatment - related adverse events. All patients were re-evaluated 1 month after treatment.

RESULTS: 40 patients were enrolled in our study. Median age (Inter - Quartile Range IQR) was 51.5 (41.5-63.2) years. Mean baseline CPSI scores were: 22.15 (total score), 9.67 (pain domain), 5.15 (micturition domain) and 7.35 (quality of life domain), respectively. No significant adverse events were reported. At 1 month follow-up, CPSI scores appeared modified as follows: 16.40 (total score, p = 0.001); 6.92 (pain domain; p = 0.001; 4.02 (micturition domain, p = 0.09); 5.45 (quality of life domain, p = 0.002). Mean CPSI pain domain score reduction was -2.75 points (-28.5%). Mean CPSI total score reduction was -5.75 points (-26%).

CONCLUSIONS: The association of Boswellia resin extract and propolis derived polyphenols can reduce genitourinary pain and then improve quality of life of men affected by bothersome prostatitis - like symptoms.

BACKGROUND: Proxelan® and antibiotics combined therapy was successfully previously used in the treatment of symptoms of patients with chronic prostatitis. Aim of the present study was to investigate the effects of Proxelan® monotherapy on pain symptoms of patients with chronic prostatitis (CP) or chronic pelvic pain syndrome (CPPS) in a prospective pilot study.

METHODS: Thirty consecutive patients with CP/CPPS symptoms younger than 50, without urinary obstruction, total prostate-specific antigen (PSA) <4 ng/mL, negative microbiology testing on prostate fluid and urethral swab, naïve from other treatments during the previous three months were enrolled in a pilot study. IPSS and NIH-CPSI questionnaires were administered to all the patients. Patients could choose to be investigated regarding semen quality and IL6/IL8 seminal markers for inflammatory disease prior and after the therapy course. Proxelan® suppositories were prescribed for each patient for a month with a daily dosage of 1 suppository at bed-time. The primary endpoint of the study included at least a 30% reduction of pain symptoms because similar results can be obtained in each previously investigated placebo group. Effects on semen parameters such as leukocytospermia, spermatozoa concentration and motility, cytokine levels were considered as secondary endpoints.

RESULTS: Subjective pain relief was obtained in all the patients with significant decrease of NIH-CPSI pain items (P=0.04). Urinary symptoms, investigated by IPSS questionnaire, decreased significantly (P=0.04) as well as quality of life items (P=0.04). Leukocytospermia was found in 5/15 patients available for further investigations. IL6 decreased by 11.55% one month after the treatment while sperm motility resulted increased by 17.3%.

CONCLUSIONS: Proxelan® monotherapy may represents a promising valid alternative to combined treatment with antibiotics in patients with CP/CPPS symptoms although the results obtained should be investigated in randomized controlled trials.

BACKGROUND: Prostatitis is a recurrent urinary infection in males and is often difficult to cure. The aim of the study was to examine whether anti-inflammatory effects of enhanced drainage of prostatic secretions, obtained through two months treatment with a proteolytic enzyme mucoactive (PEM) compound (Serrazyme and other constituents), influenced qualitative or quantitative expressions of bacterial growth in seminal cultures.

METHOD: 450 patients with prostatitis syndromes were randomized either to PEM therapy (intervention group) or to no treatment group. All patients were followed at the end of a 2-month PEM continuous treatment period (T2) and further two months after withdrawal (T4).

RESULTS: After treatment, 15 out of 107 (14.1%) patients with Chronic Bacterial Prostatitis (CBP) showed negative seminal cultures, while in patients with cat NIH-IIIA prostatitis seminal cultures became positive in 33.3% cases with low bacteriospermia. After two months from withdrawal, although among CBP patients the total number of isolates and colony forming units (CFU) counts showed not significant changes compared to matched-values observed at T2, microbial parameters varied significantly among inflammatory prostatitis patients.

CONCLUSION: The results of the present study showed that 2 months of treatment with PEM, decreasing bacterial adherence and inflammatory prostatitis, reveals a subgroup of apparent inflammation associated with infection that microbial biofilms likely mask in inflammatory prostatitis patients.

OBJECTIVE: To evaluate the efficacy of a phytotherapic combination of L-Methionine associated with Hibiscus sabdariffa and Boswellia serrata for treatment of acute episodes of uncomplicated urinary tract infections (UTI) in women affected by recurrent UTIs.

MATERIALS AND METHODS: In this randomized phase III clinical trial, adult females with uncomplicated UTI were enrolled into one of the following treatment groups: Group A: phytotherapic combination 1 tablet in the morning and 1 tablet in the evening for 7 days; Group B: Short term antibiotic treatment according to international guidelines recommendations. At baseline, all patients were evaluated by a urologist and quality of life (QoL) questionnaires and mid-stream urine culture. Same clinical and laboratory investigations were repeated at each follow-up visit.

RESULTS: Forty-six patients were enrolled in Group A and 47 in Group B. At the first follow-up (30 days), both groups showed a statistically significant improvement in quality of life scores as compared with baseline assessment [Group A: (QoL 94.3 VS 98.5 p < 0.001); Group B: (QoL 94.5 VS 98.7 p < 0.001)]. An improvement from baseline was also seen at the second followup evaluation after 3 months [Group A: (QoL 94.3 VS 99.1 p < 0.001); Group B: (QoL 94.5 VS 98.1 p < 0.001)]. At the second follow-up visit, a statistically significant difference in QoL was reported between the two groups (99.1 VS 98.1; p < 0.003) and a transition from UTI to asymptomatic bacteriuria (ABU) was observed 12 of 46 (26%) patients in Group A, while no patients in Group B demonstrated ABU (p = 0.007).

CONCLUSIONS: Here, we demonstrated that this phytotherapic combination is able, in comparison to antibiotic treatment, to improve patients quality of life, reducing symptoms in acute setting and preventing the recurrences. Interestingly, a significantly higher proportion of patients in the phytotherapy group had ABU after three months. Our findings are of great interest in an antibiotic stewardship perspective.

OBJECTIVE: Adjuvants or alternatives to antibiotics in urinary tract infections (UTIs) during pregnancy seem advisable because of possible fetal stress. The present study assessed the effectiveness of a food supplement containing L-methionine and Hibiscus sabdariffa L. and Boswellia serrata Roxb. extracts as a treatment for symptomatic UTIs in pregnancy.

DESIGN: Pregnant patients with symptomatic cystitis were screened for UTIs in three different clinical centers. Those unwilling to take antibiotics were offered two alternative treatments: (A) a 1-week treatment with the food supplement or (B) a week in which they were advised to increase their fluid consumption to more than 1.5 L daily. After 1 week, group B patients who still had positive urine cultures (UCs) or had no UC performed took the food supplement for an additional week. UCs were performed on all patients at the first visit (w0) and on most of them at 7 days (w1). Patients who were still positive at w1 or had no UC performed at w1 had UC performed 14 days (w2) thereafter.

RESULTS: Of 264 pregnant women enrolled, 216 joined group A, while 48 joined group B. At w1, 70.0% of group A patients and 43.2% of those in group B had negative UCs (p = 0.003). The reduction of bacterial load was 42.2% ± 8.0% and 4.5% ± 9.2%, respectively (p < 0.0001). At w1, symptoms disappeared in 135 patients (62.5%) in group A and 22 patients (45.8%) in group B (p = 0.03). At w2, 30 of 32 group B patients who switched to taking the supplement for the second week had negative UCs, including 20 who had been positive at w1. At w2, all group A patients had negative UCs. No side effects were reported.

CONCLUSIONS: The food supplement provided effective treatment and might be an adjuvant or alternative to antibiotic therapy of symptomatic UTI in pregnancy.

AIM: Inflammatory diseases of the prostate are one of the most difficult problems to manage in the fertile male aged between 20 and 50. Antibiotics are the gold standard for the treatment of both bacterial (category II-NIH) and non bacterial prostatitis (category III-NIH). However, antibiotics need to be associated with other therapies focused on reducing symptoms and providing a better quality of life. In the present study we sought to test the effectiveness of antibiotics and the medical device Proxelan suppositories taken together.

METHODS: Starting in January 2011, we conducted a randomized controlled trial involving 60 subjects with bacterial and non bacterial chronic prostatitis, who were divided into two groups. Subjects allocated in group A received only antibiotics for 28 days; subjects in group B received antibiotics + Proxelan, for 28 days as well. Before randomization all subjects underwent Meares-Stamey test, IPSS and NIH-CPSI questionnairs. All of those were repeated 60 and 120 days after randomization. Microbiological and clinical efficacy were compared using specific statistical analyses.

RESULTS: Data were obtained from 29 subjects allocated in group A and 31 in group B. Minor side effects were observed which did not cause study interruption in any case. Of the total population, 68,3% resulted positive to the Meares-Stamey test at study start. Proxelan was not better than antibiotics alone under a microbiological point of view (OR)=0.9; (IR) 0.3-2.8; P=0.46. According to the answers provided at the NIH-CPSI questionnaire, subjects in the group B obtained a better score compared to group A, either after 2 months (OR:2.8; 95%IC 1.2-4.1; P=0.017) and after 4 months (OR:1.67; 95%IC 0.9-2.9; P=0.04). With regards to the IPSS questionnaire, 2 months after treatment start, subjects in the group A had a probability of having urinary symptoms 2 times higher compared to subjects in group B (OR:1.9; 95%IC 1.0-3.5; P=0.028). Although Proxelan seems to improve IPSS also after 4 months, the difference does not reach the level of statistical significance.

CONCLUSION: Compared to antibiotics alone, the combination of antibiotics and Proxelan improve both symptoms associated to chronic prostatitis and urinary symptoms, however microbiological results are not different. Future studies may be required to confirm our results and to explain the mechanism of action of Proxelan.