The efficacy and safety of duloxetine in a multidrug regimen for chronic prostatitis/chronic pelvic pain syndrome.
OBJECTIVE
To evaluate the efficacy and safety of duloxetine hydrochloride in the treatment of patients affected by chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).


METHODS
Thirty-eight CP/CPPS patients completed the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) and International Index of Erectile Function-Erectile Function-5 (IIEF-5) questionnaires, uroflowmetry, and evaluation of psychologic status using Hamilton Anxiety Scale (HAM-A) and Hamilton Depression Scale (HAM-D). Patients were randomly assigned to 2 treatments groups. Treatment in group 1 consisted of a simultaneous oral administration of tamsulosin (0.4 mg/d, 60 mg/d), saw palmetto (320 mg/d), and duloxetine (60 mg/d). Treatment in group 2 consisted of tamsulosin (0.4 mg/d) and saw palmetto (320 mg/d). NIH-CPSI and IIEF-5 questionnaires, uroflowmetry, and evaluation of the psychological status were repeated at 16 weeks of follow-up.


RESULTS
At 16 weeks, a significant improvement in NIH-CPSI pain subscore, NIH-CPSI quality of life subscore, and NIH-CPSI total score were observed in group 1 patients compared with those in group 2 (P <.01, respectively), together with a significant improvement in HAM-A and HAM-D scores (P <.01, respectively). Patients in group 2 showed a significant improvement in NIH-CPSI total score, in the urinary symptoms subscore, and in the HAM-A total score. No significant differences were observed in IIEF-5 scores in the 2 groups. Maximum flow rate significantly increased in both groups. In group 1, 20% of patients stopped the study due to adverse effects.


CONCLUSIONS
The use of duloxetine in a multimodal treatment with an α-blocker medication and a saw palmetto extract allowed better results in controlling clinical symptoms, psychologic status and quality of life patients affected by CP/CPPS.
Department of Urology and Andrology, University of Perugia, Ospedale Santa Maria della Misericordia, Perugia, Italy. Electronic address: agianton@libero.it.
Antonella
A
Giannantoni
Department of Urology and Andrology, University of Perugia, Ospedale Santa Maria della Misericordia, Perugia, Italy.
Massimo
M
Porena
Department of Urology and Andrology, University of Perugia, Ospedale Santa Maria della Misericordia, Perugia, Italy.
Marilena
M
Gubbiotti
Department of Urology and Andrology, University of Perugia, Ospedale Santa Maria della Misericordia, Perugia, Italy.
Stefania
S
Maddonni
Department of Urology, Tor Vergata University, Rome, Italy.
Savino M
SM
Di Stasi
D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D000068736:Duloxetine Hydrochloride; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011472:Prostatitis / Q000188:drug therapy* / Q000628:therapy; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*
D000700:Analgesics; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride