Long-Term Efficacy of <i>Serenoa repens</i> Treatment in Patients with Mild and Moderate Symptomatic Benign Prostatic Hyperplasia

Abstract

Introduction: The study aimed to evaluate the long-term efficacy of treatment with extract of Serenoa repens (Prostamol Uno) in patients with lower urinary tract symptoms (LUTS) induced by benign prostatic hyperplasia (BPH). Patients and Methods: We studied 120 patients with mild or moderate LUTS induced by BPH, maximal urinary flow (Q_max) <15 ml with a voided volume ≧150 ml, prostate-specific antigen <4 ng/ml, and residual urinary volume <150 ml, treated daily for 24 months with one capsule of 320 mg ethanolic extract of Serenoa repens. Results: Statistically significant improvements in the International Prostate Symptom Score (5.5 points), quality of life (QoL; 1.8 points), Q_max (5.6 ml/s), International Index of Erectile Function (IIEF; 6.4 points) and reduction in residual urinary volume were observed during the study period. The mean prostate volume at 24 months was 36 ml, compared to 39.8 ml at baseline. Conclusions: Long-term treatment with 320 mg ethanolic extract of Serenoa repens proved to be efficient in reducing urinary obstruction, improving symptomatology and QoL of BPH patients. It also had a positive effect on sexual function, demonstrated by the statistically significant increase in the IIEF.

Serenoa repens extract in the treatment of benign prostatic hyperplasia

“…When the irritative and obstructive IPSS subscores were separately evaluated, a decrease in both was seen [Sinescu et al 2011;Debruyne et al 2004a]. This combined action of Serenoa repens extract may offer at least a theoretical advantage over a-blocking therapy.…”

“…More recently, a few studies included a longterm follow up [Pytel et al 2002]. One of them is FLUX, an observational, multicentre clinical trial that aimed to determine the effect of the daily intake of 320 mg Serenoa repens extract (Prostamol Uno) over a 24-month period [Sinescu et al 2011].…”

“…Regarding the quality-of-life score, although some studies reported only a limited improvement at 6 months [Gerber et al 2001], others described a significant decrease between 9 and 24 months [Sinescu et al 2011]. It is not completely clear whether the study period is the only parameter explaining this difference, or there are some other issues involved.…”

Comparative Effects of Roystonea Regia (D-004) and Saw Palmetto Lipid Extracts On Blood Oxidative Variables in Men with Benign Prostate Hyperplasia (BPH)

“…SP capsules: caprylic 1.5%, capric 2.5%, lauric 29.9%, myristic 10.8%, palmitic 8.2%, palmitoleic 0.2%, stearic 1.9%, oleic + linoleic + linolenic 33.3%, with a purity of 88.4% The daily dosage (320 mg/day) was selected taken into account that D-004 (320 mg/day) administered for short-term reduced plasma MDA, TOH, SHG and increased TAS in healthy males [27,28], and the most common dose of SP used in different clinical studies [9][10][11][12]. D-004 and SP capsules, identical on appearance and packaged in identical codified containers, were given to the subjects according to their serial progressive inclusion.…”

“…Cumulative ROS effect may contribute to lipids, proteins, and DNA damage. Prostate gland is prone to OS probably due to inflammation and hormonal deregulation processes and epigenetic modifications, frequently occurring in such target, which may contribute to develop benign prostate hyperplasia (BPH) and associated lower urinary tract symptoms (LUTS) [3,4].The link between increased OS and BPH is underlined by the efficacy of antioxidant phytotherapy agents in experimentally-induced prostate hyperplasia and in BPH, as well [5,6].Despite some recent negative results [7,8], other studies and views support the use of the lipid extracts of saw palmetto (SP) (Serenoa repens) fruits, widely used for decades, as the main phytotherapeutic agent to treat BPH [9][10][11][12]. SP extracts contain a mixture of fatty acids, mainly oleic, lauric and myristic acids [13].…”