Comparison of phytotherapy (Permixon) with finasteride in the treatment of benign prostate hyperplasia: a randomized international study of 1,098 patients.
BACKGROUND
Controversy regarding the relative efficacy of treatments for the relief of the symptoms of benign prostatic hyperplasia (BPH).


METHODS
This was a 6-month double-blind randomized equivalence study that compared the effects of a plant extract (320 mg Permixon) with those of a 5 alpha-reductase inhibitor (5 mg finasteride) in 1,098 men with moderate BPH using the International Prostate Symptom Score (IPSS) as the primary end-point.


RESULTS
Both Permixon and finasteride decreased the IPSS (-37% and -39%, respectively), improved quality of life (by 38 and 41%), and increased peak urinary flow rate (+25% and +30%, P = 0.035), with no statistical difference in the percent of responders with a 3 ml/sec improvement. Finasteride markedly decreased prostate volume (-18%) and serum PSA levels (-41%); Permixon improved symptoms with little effect on volume (-6%) and no change in PSA levels. Permixon fared better than finasteride in a sexual function questionnaire and gave rise to less complaints of decreased libido and impotence.


CONCLUSIONS
Both treatments relieve the symptoms of BPH in about two-thirds of patients but, unlike finasteride, Permixon has little effect on so-called androgen-dependent parameters. This suggests that other pathways might also be involved in the symptomatology of BPH.
Carraro
J C
JC
Pierre Fabre Médicament, La Chartreuse, Castres, France.
Raynaud
J P
JP
Koch
G
G
Chisholm
G D
GD
Di Silverio
F
F
Teillac
P
P
Da Silva
F C
FC
Cauquil
J
J
Chopin
D K
DK
Hamdy
F C
FC
Hanus
M
M
Hauri
D
D
Kalinteris
A
A
Marencak
J
J
Perier
A
A
Perrin
P
P
D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D042944:Cholestenone 5 alpha-Reductase; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D018120:Finasteride / Q000627:therapeutic use; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D010088:Oxidoreductases / Q000037:antagonists & inhibitors; D008517:Phytotherapy; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011467:Prostate / Q000187:drug effects / Q000473:pathology; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D028024:Serenoa; D012725:Sexual Behavior / Q000187:drug effects; D016896:Treatment Outcome
D000726:Androgen Antagonists; D004791:Enzyme Inhibitors; D010936:Plant Extracts; D018120:Finasteride; D010088:Oxidoreductases; D042944:Cholestenone 5 alpha-Reductase; C040972:saw palmetto extract