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Clinical Trial
. 2002 Jun;12(3):395-403; discussion 404.

[Tamsulosin with or without Serenoa repens in benign prostatic hyperplasia: the OCOS trial]

[Article in French]
Pascal Glemain  1 , Christian Coulange, Thierry Billebaud, Bernard Gattegno, Raphaël Muszynski, Gérard Loeb; Groupe de l'essai OCOS
Affiliations
  • PMID: 12189745
Clinical Trial

[Tamsulosin with or without Serenoa repens in benign prostatic hyperplasia: the OCOS trial]

[Article in French]
Pascal Glemain et al. Prog Urol. 2002 Jun.

Abstract

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.

Material and 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].

Conclusion: 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.

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