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. CONCLUSION: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.

journal_name

BMC Surg

journal_title

BMC surgery

authors

Iacono F,Prezioso D,Illiano E,Ruffo A,Romeo G,Amato B

doi

10.1186/1471-2482-12-S1-S22

subject

Has Abstract

pub_date

2012-01-01 00:00:00

pages

S22

issn

1471-2482

pii

1471-2482-12-S1-S22

journal_volume

12 Suppl 1

pub_type

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