title: Serenoa repens associated with selenium and lycopene extract and bromelain and methylsulfonylmethane extract are able to improve the efficacy of levofloxacin in chronic bacterial prostatitis patients.
abstract: OBJECTIVE
  To date, the management of patients with chronic bacterial prostatitis (CBP) is not satisfactory, especially in terms of symptoms relief. Here, we evaluated the efficacy and the safety of a combination of serenoa repens, selenium and lycopene extract + bromelain and methylsulfonylmethane extract associated with levofloxacin in patients with CBP.
  
  
  METHODS
  All patients with clinical and instrumental diagnosis of CBP, admitted to a single Urological Institution from March to June 2015 were enrolled in this phase III study. All enrolled patients were randomized into two groups: Group A received levofloxacin 500 mg o.d. for 14 days associated with lycopene and methylsulfonylmethane; Group B received levofloxacin (500 mg o.d. for 14 days) only. Clinical and microbiological analyses were carried out at the time of admission (T0) and during the followups at 1 month (T1) and 6 months (T2) from the end of the treatment. NIH Chronic Prostatitis Symptom Index (CPSI), International Prostatic Symptom Score (IPSS) and Quality of Well-Being (QoL) questionnaires were used. The main outcome measures were the rate of microbiological cure and the improvement in questionnaire results from baseline at the end of the follow-ups period.
  
  
  RESULTS
  Forty patients were enrolled in Group A and 39 in Group B. During the follow-up (T1), we recorded a significant changes in terms of NIH-CPSI and IPSS in Group A (mean difference: 17.6 ± 2.65; 12.2 ± 2.33; p &lt; 0.01; p &lt; 0.05, respectively) and versus Group B at the intergroup analysis (mean difference: -9 ± 1.82; -8.33 ± 1.71; p &lt; 0.05; p &lt; 0.05, respectively). No differences were reported in terms of microbiological findings between the two groups. At the second follow-up visit (T2), questionnaire results demonstrated statistically significant differences between groups (p &lt; 0.001). One patient in Group A (2.5%) and 7 patients (17.9%) in Group B showed a symptomatic and microbiological recurrence (p = 0.02).
  
  
  CONCLUSIONS
  The combination of serenoa repens, selenium, lycopene + bromelain and methylsulfonylmethane extracts improved the clinical efficacy of levofloxacin in patients affected by CBP without the development of side effects.
authors.affiliation: Department of Urology, Santa Chiara Regional Hospital, Trento. ktommy@libero.it.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Cai
authors.forename: Daniele
authors.initials: D
authors.lastname: Tiscione
authors.forename: Luca
authors.initials: L
authors.lastname: Gallelli
authors.forename: Paolo
authors.initials: P
authors.lastname: Verze
authors.forename: Alessandro
authors.initials: A
authors.lastname: Palmieri
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Mirone
authors.forename: Riccardo
authors.initials: R
authors.lastname: Bartoletti
authors.forename: Gianni
authors.initials: G
authors.lastname: Malossini
mesh_terms: D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001963:Bromelains / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002338:Carotenoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002908:Chronic Disease; D004121:Dimethyl Sulfoxide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077276:Lycopene; D008297:Male; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011472:Prostatitis / Q000188:drug therapy* / Q000382:microbiology; D012643:Selenium / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D028024:Serenoa / Q000737:chemistry; D013450:Sulfones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D010936:Plant Extracts; D013450:Sulfones; D002338:Carotenoids; D064704:Levofloxacin; D001963:Bromelains; C025910:dimethyl sulfone; D012643:Selenium; D000077276:Lycopene; D004121:Dimethyl Sulfoxide