Early urodynamic effects of the lipido-sterolic extract of Serenoa repens (Permixon®) in patients with lower urinary tract symptoms due to benign prostatic hyperplasia

Abstract

This prospective, controlled study was undertaken to evaluate the early urodynamic and symptomatic impact of the lipido-sterolic extract of Serenoa repens (Permixon 1 1 ) in the treatment of patients with benign prostatic hyperplasia (BPH).A total of 75 patients, aged 52 ± 78 y with lower urinary tract symptoms due to mild/moderate BPH (mean International Prostate Symptom Score (I-PSS) 8.2) were included in the study, of which 57 received Permixon 1 1 160 mg twice daily for 9 weeks. Urodynamic evaluation, including maximum urinary¯ow rate (Q max ) and detrusor pressure (DP), was performed at baseline and endpoint. Prostate volume and post-void residual urine volume were assessed by transrectal and transabdominal ultrasound respectively. In addition, the I-PSS and its associated quality of life (QoL) score were determined and adverse events were recorded.Baseline parameters were comparable between the active treatment and control groups. After 9 weeks of Permixon 1 1 treatment Q max increased (6.0%, P`0.001), and there were reductions in DP at maximum¯ow (12.8%, P`0.001), opening DP (12.6%, P`0.001), and residual urine volume (12.6%, P`0.05). In addition, the I-PSS and QoL score both decreased signi®cantly from baseline in the active treatment group (26.8% and 18.2% respectively, P`0.001). None of these parameters improved signi®cantly in control patients. There were also improvements in prostate volume (2.7%) and maximum DP (5.2%) in the Permixon 1 1 group which did not reach signi®cance. Three patients receiving Permixon 1 1 experienced gastrointestinal disturbances but these did not lead to withdrawal or require additional therapy.In patients with mild/moderate BPH, Permixon 1 1 treatment reduced infravesical obstruction and produced a rapid improvement in urodynamic parameters and symptoms. The drug was well tolerated. These data support the use of Permixon 1 1 as ®rst-line therapy in patients with uncomplicated symptomatic BPH. Prostate Cancer and Prostatic Diseases (2000) 3, 195±199.

Efficacy and safety of a hexanic extract of Serenoa repens (Permixon®) for the treatment of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH): systematic review and meta‐analysis of randomised controlled trials and observational studies

“…Data for meta‐analysis were extracted from a total of 27 studies, of which 15 were RCTs and 12 were observational studies. The selected studies included 5 800 patients corresponding to: Permixon ( n = 3 926); α‐blockers ( n = 775; tamsulosin [ n = 377], unspecified [ n = 398]); 5ARIs ( n = 578; finasteride [ n = 484], unspecified [ n = 94]); placebo ( n = 301); control group ( n = 190); and gestonorone caproate ( n = 30).…”

Extracts from Pygeum africanum and Other Ethnobotanical Species with Antiandrogenic Activity

“…There are numerous clinical studies performed with S. repens. Al-Shukri et al [12] described an improvement in IPSS, QoL and urinary flow rate. A six-month study illustrated that S. repens extracts led to a statistically significant improvement in urinary symptoms in men with lower urinary tract problems compared with placebo, however with no measurable effect on the urinary flow rates or sexual life as compared with placebo [13].…”

Phytotherapeutical Alternatives for the Treatment of Benign Prostatic Hyperplasia in Obesity

“…For example, an open-label study performed on 50 patients treated with Serenoa repens for 6 months, showed an improvement of symptoms but found no significant effect in other parameters such as flow rate and bladder pressure [39] showing a significant placebo-effect in symptom perception. In contrast, another study of 75 patients treated with Permixon ® (lipidosterolic Serenoa repens extract) found a significant improvement in urodynamic parameters in comparison to placebo [40].…”