Phase IV trial evaluates safety and efficacy of Serenoa repens extract to treat chronic prostatitis/chronic pelvic pain syndrome

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Created On: 25/03/2021

Phase IV trial evaluates safety and efficacy of Serenoa repens extract to treat chronic prostatitis/chronic pelvic pain syndrome

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.

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Key take away

Serenoa repens extract is effective and safe for treating chronic pelvic pain syndrome/chronic prostatitis. It improves pain, quality of life, and urinary symptoms.

Background

Method

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.

Result

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.

Conclusion

Compared to placebo, the Serenoa repens extract was effective, safe, and clinically superior to manage patients suffering from chronic pelvic pain syndrome/chronic prostatitis.

Source:

World Journal of Urology

Link:

https://link.springer.com/article/10.1007%2Fs00345-020-03577-2

Article:

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