title: Observational study: daily treatment with a new compound "Tradamixina" plus serenoa repens for two months improved the lower urinary tract symptoms.
abstract: BACKGROUND
  Lower urinary tract symptoms (LUTS) are associated with great emotional costs to individuals and substantial economic costs to society. This study seeks to evaluate the effect of a new natural compound "Tradamixina plus Serenoa Repens" in order to improve lower urinary tract symptoms.
  
  
  METHODS
  100 patients (≥ 45 years) who had had LUTS/BPH for >6 mo at screening and with IPSS -The international Prostate symptom scores- ≥ 13 and maximum urinary flow rate (Qmax) ≥ 4 to ≤ 15 ml/s. were recruited. The compound "Tradamixina plus Serenoa Repens" (80 mg of Alga Ecklonia Bicyclis, 100 mg of Tribulus Terrestris and 100 mg of D-Glucosamine and N-Acetyl-D-Glucosamine plus 320 mg of Serenoa Repens) was administered daily for 2 months. At visit and after 60 days of treatment patients were evaluated by means of detailed medical urological history, clinical examination, laboratory investigations (total PSA), and instrumental examination like urolfowmetry. Efficacy measures included IPSS-International Prostate Sympto, BPH Impact Index (BII), Quality-of-Life (QoL) Index. Measures were assessed at baseline and end point (12 wk or end of therapy) and also at screening, 1 and 4 wk for IPSS, and 4 wk for BII. Statistical significance was interpreted only if the results of the preceding analysis were significant at the 0.05 level.
  
  
  RESULTS
  After 2 months of treatment the change from baseline to week 12 relative to "Tradamixina plus Seronea Repens" in total IPSS and Qol was statistically significant. Differences from baseline in BII were statistically significant for "Tradamixina plus Seronea Repens" above all differences in BII were also significant at 4 wk (LSmean ± SE: -0.8 ± 0.2). In the distribution of subjects over the PGI-I and CGI-I response categories were significant for"Tradamixina plus Seronea Repens" (PGI-I: p = 0.001; CGI-I). We also observed a decrease of total PSA.
  
  
  CONCLUSIONS
  The daily treatment with a new compound "Tradamixina plus Serenoa Repens" for 2 months improved the male sexual function , it improved the bother symptoms which affect the patient's quality of life , improved uroflowmetric parameters, and we also observed a decrease of serum PSA level.
authors.affiliation: Department of Urology, University Federico II of Naples, Via S, Pansini 5, 80131 Naples, Italy. ester.illiano@inwind.it
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Iacono
authors.forename: Domenico
authors.initials: D
authors.lastname: Prezioso
authors.forename: Ester
authors.initials: E
authors.lastname: Illiano
authors.forename: Antonio
authors.initials: A
authors.lastname: Ruffo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Romeo
authors.forename: Bruno
authors.initials: B
authors.lastname: Amato
mesh_terms: D000117:Acetylglucosamine / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D000975:Antioxidants / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005944:Glucosamine / Q000627:therapeutic use*; D006305:Health Status Indicators; D006801:Humans; D007610:Kallikreins / Q000097:blood; D008297:Male; D008875:Middle Aged; D000459:Phaeophyceae; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D028321:Plant Preparations / Q000627:therapeutic use*; D017430:Prostate-Specific Antigen / Q000097:blood; D028024:Serenoa; D016896:Treatment Outcome; D032444:Tribulus; D014555:Urination Disorders / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*
chemical_list: D000893:Anti-Inflammatory Agents; D000975:Antioxidants; D015415:Biomarkers; D004338:Drug Combinations; D010936:Plant Extracts; D028321:Plant Preparations; C581150:tradamixina plus Serenoa Repens; C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen; D005944:Glucosamine; D000117:Acetylglucosamine