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 lipido-sterolic extract of Serenoa repens (LSESr)-Permixon((R))-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 (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 0.4mg/day (N=354) or Permixon 320mg/day (N=350). I-PSS, QoL and Q(max) 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 population of 542 patients (tamsulosin: N=273; Permixon: N=269).


RESULTS
At 12 months, I-PSS decreased by 4.4in each group and no differences were observed in either irritative or obstructive symptom improvements. The increase in Q(max) was similar in both treatment groups (1.8ml/s Permixon, 1.9ml/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 demonstrates that Permixon 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.
Debruyne
Frans
F
Academic Hospital Nijmegen Sint Radboud, Nijmegen, The Netherlands.
Koch
Gary
G
Boyle
Peter
P
Da Silva
Fernando Calais
FC
Gillenwater
Jay G
JG
Hamdy
Freddie C
FC
Perrin
Paul
P
Teillac
Pierre
P
Vela-Navarrete
Remigio
R
Raynaud
Jean-Pierre
JP
D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D017430:Prostate-Specific Antigen / Q000097:blood / Q000187:drug effects; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000473:pathology; D028024:Serenoa; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D000077409:Tamsulosin; D016896:Treatment Outcome; D014563:Urodynamics / Q000187:drug effects
D000317:Adrenergic alpha-Antagonists; D000726:Androgen Antagonists; D010936:Plant Extracts; D013449:Sulfonamides; D017430:Prostate-Specific Antigen; D000077409:Tamsulosin; C040972:saw palmetto extract