title: Effects of hexanic extract of Serenoa repens (Permixon® 160 mg) on inflammation biomarkers in the treatment of lower urinary tract symptoms related to benign prostatic hyperplasia.
abstract: BACKGROUND
  Chronic prostatic inflammation (CPI) could be a cause of symptomatic or complicated benign prostatic hyperplasia (BPH). In previous in vitro and in vivo studies, Hexanic Extract of Serenoa repens (HESr) namely Permixon(®) has demonstrated potent anti-inflammatory properties. With the aim to provide new insight onto HESr anti-inflammatory properties in human we explore its effect on CPI biomarkers in men with lower urinary tract symptoms (LUTS) related to BPH using a non-invasive method and investigate links between biomarkers and clinical symptoms.
  
  
  METHODS
  An international, randomized, double-blind, parallel-group, tamsulosin-controlled study was carried out in 206 men with BPH-related LUTS. Patients received oral daily HESr 320mg or tamsulosin 0.4 mg during 3 months. The first urine stream after digital rectal examination (DRE) was collected at Day 1 and Day 90 and mRNA was extracted from prostatic epithelial cells desquaming in the lumen of the glands and seminal plasma fluid after DRE. mRNA quantification of the 29 most significant published inflammation markers in BPH and protein detection in urine was performed.
  
  
  RESULTS
  At D90, a decrease in mean gene expression was observed for 65.4% of the markers detected in the HESr group versus 46.2% in the tamsulosin group. In the 15 most frequently expressed genes, this difference was higher (80% vs. 33% respectively). Three proteins (MCP-1/CCL2, IP-10/CXCL10, and MIF) were detected. At D90, a decrease in the number of patients who expressed MCP-1/CCL2 and IP-10/CXCL10 was observed only in the HESr group. Moreover, MIF expression was significantly reduced by HESr compared with tamsulosin (P = 0.007). Finally, in contrast to tamsulosin, the subgroup of patients treated by HESr and who over expressed MIF at baseline, had a higher response to the International Prostate Symptom Score (I-PSS) than those who did not over express this protein (mean I-PSS change: -6.4 vs. -4.5 respectively). As the study is exploratory, results should be confirmed in a powered clinical study.
  
  
  CONCLUSIONS
  These results showed for the first time at clinical level the anti-inflammatory properties of HESr, already indicated in BPH-related LUTS. Thus, HESr could be of interest to prevent unfavourable evolution in patients with CPI.
authors: Institut de Recherche Pierre Fabre, Toulouse, France.
authors: Alain
authors: A
authors: Latil
authors: Institut de Recherche Pierre Fabre, Toulouse, France.
authors: Marie-Thérèse
authors: MT
authors: Pétrissans
authors: Institut de Recherche Pierre Fabre, Toulouse, France.
authors: Jérôme
authors: J
authors: Rouquet
authors: Department of Urology, Bordeaux Pellegrin University Hospital, Bordeaux, France.
authors: Grégoire
authors: G
authors: Robert
authors: Department of Urology and INSERM U955 Eq07, CHU Henri-Mondor, Créteil, France.
authors: Alexandre
authors: A
authors: de la Taille
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use; D015415:Biomarkers / Q000652:urine; D004311:Double-Blind Method; D006801:Humans; D007249:Inflammation / Q000188:drug therapy / Q000209:etiology / Q000652:urine; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology / Q000652:urine; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications* / Q000652:urine; D028024:Serenoa; D013449:Sulfonamides / Q000627:therapeutic use; D000077409:Tamsulosin; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D015415:Biomarkers; D010936:Plant Extracts; D013449:Sulfonamides; D000077409:Tamsulosin; C040972:saw palmetto extract
keywords: benign prostatic hyperplasia; chronic prostatic inflammation; hexanic extract of serenoa repens; lower urinary tract symptoms; permixon®