15 years' survey of safety and efficacy of Serenoa repens extract in benign prostatic hyperplasia patients with risk of progression.

2018-05-09
Urologia 86(1)
- Andrey Zinovievich Vinarov
- Leonid Grigorievich Spivak
- Darina Vladimirovna Platonova
- Leonid Mikhailovich Rapoport
- Dmitry Olegovich Korolev

PubMed: 29741118
DOI: 10.1177/0391560318772466

Study Design

Type: Observational
Sample size: n = 30
Population: 30 patients at risk for benign prostatic hyperplasia progression
Methods: open non-comparative observational study of the continuous use of S. repens plant extract at a dosage of 320 mg once a day for 15 years
Blinding: Open-label
Duration: 15 years
Funding: Unclear

Aim:

The aim of this study is to investigate the efficacy and safety of long-term therapy with Serenoa repens extract with regard to halting benign prostatic hyperplasia progression.

Material and methods:

An open non-comparative observational study of the continuous use of S. repens plant extract at a dosage of 320 mg once a day for 15 years was performed in 30 patients at risk for benign prostatic hyperplasia progression. Changes in IPSS (International Prostatic Symptoms Scale) and QoL (Quality of life) scores and changes in Qmax, voided volume, residual urine volume, and prostate volume were evaluated during the study.

Results:

The study showed an absence of progression based on both subjective (the sum of scores on the IPSS and QoL scales) and objective (prostate volume, urination rate, residual urine volume) criteria. Furthermore, the patients had no adverse events related to the study drug, including prostate cancer.

Conclusions:

The 15 years' study results suggest that taking S. repens plant extract continuously at a daily dose of 320 mg is an effective and safe way to prevent the progression of benign prostatic hyperplasia.

Research Insights

Saw Palmetto→Improved Maximum Urinary Flow Rate
The study showed an absence of progression based on both subjective (the sum of scores on the IPSS and QoL scales) and objective (prostate volume, urination rate, residual urine volume) criteria.
Effect
Beneficial
Effect size
Small
Dose
320 mg once a day
Saw Palmetto→Improved Quality of Life
The study showed an absence of progression based on both subjective (the sum of scores on the IPSS and QoL scales) and objective (prostate volume, urination rate, residual urine volume) criteria.
Effect
Beneficial
Effect size
Small
Dose
320 mg once a day
Saw Palmetto→Improved Voided Volume
Changes in IPSS (International Prostatic Symptoms Scale) and QoL (Quality of life) scores and changes in Qmax, voided volume, residual urine volume, and prostate volume were evaluated during the study.
Effect
Beneficial
Effect size
Small
Dose
320 mg once a day
Saw Palmetto→Reduced International Prostate Symptom Score
The study showed an absence of progression based on both subjective (the sum of scores on the IPSS and QoL scales) and objective (prostate volume, urination rate, residual urine volume) criteria.
Effect
Beneficial
Effect size
Small
Dose
320 mg once a day
Saw Palmetto→Reduced Prostate Volume
The study showed an absence of progression based on both subjective (the sum of scores on the IPSS and QoL scales) and objective (prostate volume, urination rate, residual urine volume) criteria.
Effect
Beneficial
Effect size
Small
Dose
320 mg once a day
Saw Palmetto→Reduced Residual Urine Volume
The study showed an absence of progression based on both subjective (the sum of scores on the IPSS and QoL scales) and objective (prostate volume, urination rate, residual urine volume) criteria.
Effect
Beneficial
Effect size
Small
Dose
320 mg once a day

Adverse Events Reported

Saw Palmetto→Overall tolerability
the patients had no adverse events related to the study drug, including prostate cancer
Finding
Reported