[Comparison of a phytotherapeutic agent (Permixon) with an alpha-blocker (Tamsulosin) in the treatment of benign prostatic hyperplasia: a 1-year randomized international study].
OBJECTIVE
While the lipidosterolic extract (LSESr) of Serenoa repens--Permixon--has been shown to have an equivalent efficacy to finasteride in patients with benign prostatic hyperplasia (BPH), to date, there has been no valid comparison of phytotherapy with alpha-blockers. The aim of this study was to assess the equivalent efficacy of Permixon and tamsulosin.


METHODS
Eight hundred and eleven men with symptomatic BPH (international prostdate symptom score, I-PSS > or = 10) were recruited in 11 European countries for a 12-month, double-blind randomized trial. After a 4-week run-in period, 704 patients were randomly assigned to either tamsulosin 0.4 mg per day (N = 354) or Permixon 320 mg per day (N = 350). I-PSS, QoL and maximum urinary flow rate (Qmax) were evaluated at baseline and periodically for 1 year. Prostate volume and serum prostate-specific antigen (PSA) were measured at selection and at endpoint. The endpoint analysis was performed on the per-protocol (PP) population of 542 patients (tamsulosin: N = 273; Permixon: N = 269).


RESULTS
At 12 months, I-PSS decreased by 4.4 in each group and no differences were observed in either irritative or obstructive symptom improvements. The increase in Qmax was similar in both treatment groups (1.8 ml/s Permixon, 1.9 ml/s tamsulosin). PSA remained stable while prostate volume decreased slightly in the Permixon-treated patients. The two compounds were well tolerated, however, ejaculation disorders occurred more frequently in the tamsulosin group.


CONCLUSIONS
This study demonstrated that Permiwon and tamsulosin are equivalent in the medical treatment of lower urinary tract symptoms in men with BPH, during and up to 12 months of therapy.
Academic Hospital Nijmegen, Nijmegen Sint Radboud, Pays-Bas.
Frans
F
Debruyne
Gary
G
Koch
Peter
P
Boyle
Fernando Calais
FC
Da Silva
Jay G
JG
Gillenwater
Freddie C
FC
Hamdy
Paul
P
Perrin
Pierre
P
Teillac
Remigio
R
Vela-Navarrete
Jean-Pierre
JP
Raynaud
D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D017430:Prostate-Specific Antigen / Q000032:analysis; D011470:Prostatic Hyperplasia / Q000175:diagnosis / Q000188:drug therapy*; D012680:Sensitivity and Specificity; D028024:Serenoa; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D000077409:Tamsulosin
D000317:Adrenergic alpha-Antagonists; D000726:Androgen Antagonists; D010936:Plant Extracts; D013449:Sulfonamides; D017430:Prostate-Specific Antigen; D000077409:Tamsulosin; C040972:saw palmetto extract