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A phase IV, randomized, placebo-controlled, double-blind, multicenter study was performed to determine Serenoa repens extract safety and efficacy to treat chronic pelvic pain syndrome/chronic prostatitis.
Serenoa
repens extract is effective and safe for treating chronic pelvic pain
syndrome/chronic prostatitis. It improves pain, quality of life, and urinary
symptoms.
A
phase IV, randomized, placebo-controlled, double-blind, multicenter study was
performed to determine Serenoa repens extract safety and efficacy to treat
chronic pelvic pain syndrome/chronic prostatitis.
The
study cohort included 221 subjects having chronic pelvic pain syndrome/chronic
prostatitis. Participants were randomly allocated (2:1 ratio) to receive either
Serenoa repens extract (n=148) or placebo (n=73) for about 12 weeks. The major
outcome was the alteration in total score on the National Institutes of
Health-Chronic Prostatitis Symptom Index (NIH-CPSI). The secondary outcome
incorporated improvements within each domain of NIH-CPSI, International Index
of Erectile Function 5 items (IIEF-5), and the clinical response rates.
Substantial improvements were witnessed in NIH-CPSI total score and sub-scores in the Serenoa repens extract-treated subjects in comparison with placebo recipients. Remarkable improvements in NIH-CPSI scores were established after two weeks from the initial dose and sustained to the end of the therapy.
Additionally, a considerably
elevated rate of patients attained a clinical response in the Serenoa repens
extract cohort in comparison with the placebo cohort (73.0% vs 32.9%). Across
the entire study population, only minor side effects were witnessed.
Compared to placebo, the Serenoa
repens extract was effective, safe, and clinically superior to manage patients
suffering from chronic pelvic pain syndrome/chronic prostatitis.
World Journal of Urology
The efficacy and safety of Serenoa repens extract for the treatment of patients with chronic prostatitis/chronic pelvic pain syndrome: a multicenter, randomized, double-blind, placebo-controlled trial
Kai Zhang et al.
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