J Urol. 2004 Jan;171(1):284-288.


A Prospective, 1-Year Trial Using Saw Palmetto Versus Finasteride in
the Treatment of Category III Prostatitis/Chronic Pelvic Pain
Syndrome.

Kaplan SA, Volpe MA, Te AE.

SUMMARY: PURPOSE This study was designed to assess the safety and
efficacy of saw palmetto or finasteride in men with category III
prostatitis/chronic pelvic pain syndrome (CP/CPPS).MATERIALS AND
METHODS A prospective, randomized, open label, 1-year study was
designed to assess the safety and efficacy of saw palmetto and
finasteride in the treatment of men diagnosed with CP/CPPS. Patients
were randomized to finasteride (5 mg once daily) or saw palmetto (325
mg daily) for 1 year. Patients were evaluated using the National
Institutes of Health Chronic Prostatitis Symptom Index, individual
domains (pain, urinary symptoms, quality of life and mean pain score)
and the American Urological Association Symptom Score at baseline, 3,
6 and 12 months.RESULTS A total of 64 consecutive men 24 to 58 years
old (mean age 43.2) with a diagnosis of CP/CPPS were equally
randomized to the 2 treatment arms. All 64 men had previously received
antibiotics (duration of 3 to 93 weeks), 52 (82%) had been on
alpha-blockade. There were 61, 57 and 56 patients evaluable at 3, 6
and 12 months, respectively. At 1 year mean total National Institutes
of Health Chronic Prostatitis Symptom Index score decreased from 23.9
to 18.1 in the finasteride group (p <0.003), and from 24.7 to 24.6 in
the saw palmetto arm (p = 0.41). In the finasteride arm the quality of
life and pain domains were significantly improved at 1 year; however,
urination was not. Adverse events included headache (3 cases) in the
saw palmetto group and decreased libido (2 cases) in the finasteride
group. At the end of the trial 13 of 32 (41%) and 21 of 32 (66%) opted
to continue saw palmetto and finasteride, respectively.CONCLUSIONS
CP/CPPS treated with saw palmetto had no appreciable long-term
improvement. In contrast, patients treated with finasteride had
significant and durable improvement in all various parameters except
voiding. Further studies are warranted to ascertain the mechanism and
reproducibility of these effects in a placebo controlled trial.