[Evaluation of the clinical benefit of Permixon and tamsulosin in severe BPH patients--PERMAL study subset analysis].
OBJECTIVE
To compare the efficacy of the lipido-sterolic extract of Serenoa repens, Permixon, to that of the a-blocker, tamsulosin, in the treatment of severe low urinary tract symptoms (LUTS) of benign prostatic hyperplasia (BPH).


METHODS
In a 12-month, double-blind, randomized study that showed equivalent efficacy of Permixon 320 mg/day and tamsulosin 0.4 mg/day ("PERMAL study"), 685 BPH patients with IPSS > 10 had been analyzed for efficacy. Of these, the 124 patients with severe LUTS (IPSS > 19) at randomization were retained for this subset analysis. After a 4-week run-in period, 59 and 65 patients had been randomized to tamsulosin and Permixon groups, respectively. Both treatment groups were compared regarding the evolution from baseline of total IPSS and its irritative and obstructive subscores. LUTS-related QpL, prostate volume, Qmax and MSF-4 (sexual activity questionnaire) at different time points over 1 year An analysis of variance of changes from baseline to end point was performed for all the parameters. The over-time evolutions of total, irritative and obstructive IPSS were further compared using a variance analysis for repeated measurements.


RESULTS
At 12 months, total IPSS decreased by 7.8 with Permixon and 5.8 with tamsulosin (p = 0.051); the irritative symptoms improved significantly more (p = 0.049) with Permixon (- 2.9 versus - 1.9 with tamsulosin). The superiority of Permixon in reducing irritative symptoms appeared as soon as month 3 and was maintained up to month 12 (p = 0.03).


CONCLUSIONS
Permixon 320 mg/day was shown to be slightly superior to tamsulosin 0.4 mg/day in reducing LUTS in severe BPH patients after 3 months and up to 12 months of treatment.
Debruyne
Frans
F
Hôpital Universitaire Saint Radboud, Nijmegen, Pays-Bas. f.debruyne@uro.ucm.nl
Boyle
Peter
P
Calais da Silva
Fernando
F
Gillenwater
Jay G
JG
Hamdy
Freddie C
FC
Perrin
Paul
P
Teillac
Pierre
P
Vela-Navarrete
Remigio
R
Raynaud
Jean-Pierre
JP
Schulman
Claude
C
D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D028024:Serenoa; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin
D000317:Adrenergic alpha-Antagonists; D000726:Androgen Antagonists; D010936:Plant Extracts; D013449:Sulfonamides; D000077409:Tamsulosin; C040972:saw palmetto extract
Evaluation du bénéfice clinique de Permixon et de la tamsulosine dans le traitement de l'hypertrophie bénigne de la prostate (HBP) sévère: analyse d'un sous-groupe de l'étude PERMAL.