[Tamsulosin with or without Serenoa repens in benign prostatic hyperplasia: the OCOS trial].
OBJECTIVE
In the treatment of the symptoms of benign prostatic hyperplasia (BPH), a French guideline opposes the use of drugs in conjunction, in the absence of proven utility. The OCOS trial therefore compared one of the possible drug combinations (tamsulosin and Serenoa repens) with tamsulosin alone, to see if there was any difference in effectiveness and to evaluate the clinical tolerance of each in patients with symptoms of BPH.


METHODS
In this double-blind, randomised trial, patients had to have an IPSS (International Prostate Symptom Score) > or = 13 and a Qmax between 7 and 15 mL/s. Tamsulosin (0.4 mg) was to be administered once a day for 52 weeks, with, twice daily, a placebo (TAM) or Serenoa repens 160 mg (TAM + SR).


RESULTS
352 patients were recruited by 47 centres; 329 (average age 65) were randomised: 161 into the TAM group and 168 into the TAM + SR group. No statistically significant difference was found between the two groups, neither for the major end-point [change in total IPSS between the baseline value and the final evaluation (TAM: -5.2; TAM + SR: -6.0; p = 0.286)], nor for the secondary end-points [changes in the voiding scores (p = 0.239) and in filling scores (p = 0.475) of the IPSS, Qmax (p = 0.564), percentage of respondents according to the IPSS (p = 0.361), improvement in quality of life (IPSS-QoL: p = 0.091; UROLIFE BPH QoL: p = 0.442), safety].


CONCLUSIONS
The addition of Serenoa repens to tamsulosin did not provide any significant benefit to the patients: the OCOS trial does not cast doubt on the guideline applicable to the treatment of BPH.
Glemain
Pascal
P
Centre Hospitalo-Universitaire, Hôtel-Dieu, Clinique Urologique, Place Alexis Ricordeau, BP 1005, 44093 Nantes. pglemain@chu-nantes.fr
Coulange
Christian
C
Billebaud
Thierry
T
Gattegno
Bernard
B
Muszynski
Raphaël
R
Loeb
Gérard
G
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; D015990:Placebo Effect; D010936:Plant Extracts / Q000627:therapeutic use; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D011788:Quality of Life; 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