Long-term clinical and biologic effects of the lipidosterolic extract ofSerenoa repens in patients with symptomatic benign prostatic hyperplasia

Abstract

Permixon, the lipidosterolic extract of Serenoa repens, is widely used for the treatment of symptoms associated with benign prostatic hyperplasia (BPH). This open study assessed the efficacy and tolerability of Permixon 160 mg twice daily administered for 2 years. One hundred fifty-five men with clinically diagnosed BPH and complaints of prostatic symptoms were enrolled in the study. At 6, 12, 18, and 24 months, the International Prostate Symptom Score (I-PSS), quality of life, and sexual function score were recorded, and urodynamics and biologic values were measured. Adverse events were recorded every 3 months. I-PSS and quality of life improved significantly from baseline at each evaluation time point. At the end of the study and at each evaluation, maximum urinary flow also improved significantly. Prostate size decreased. Sexual function remained stable during the first year of treatment and significantly improved (P = .001) during the second year. Prostate-specific antigen was not affected, and no changes in plasma hormone levels were observed. Nine patients reported 10 adverse events, none related to treatment. Improvements in efficacy parameters began at 6 months and were maintained up to 24 months. These data demonstrate the long-term efficacy and tolerability of Permixon and support its use as a first-line medical therapy for uncomplicated symptomatic BPH.

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

“…The effects measured after 6 and 12 months were comparable to those reported by other authors for the same periods of treatment [2,4]. Similarly, the extent of overall improvement was comparable to that shown by Pytel et al [12] in another 2-year study. BPH usually combines obstructive and irritative symptoms.…”

Efficacy and safety of a combination of Sabal and Urtica extract in lower urinary tract symptoms—long-term follow-up of a placebo-controlled, double-blind, multicenter trial

“…The 53% decrease in the I-PSS total score (reflecting the patients' subjective perceptions of LUTS), accompanied by an equally pronounced improvement in quality of life, clearly represents a clinically relevant advantage maintained after almost 2 years of treatment; it is slightly larger than the 41% observed by Pytel and colleagues after 2 years of treatment with 2 · 160 mg/day of a saw palmetto mono-preparation [27]. It is also important to note that, in a disease that is known to progress when not adequately treated, only ten out of a total of 209 patients with valid data (4.8%) showed a considerable deterioration of LUTS (represented by a change to a more unfavorable class of I-PSS severity).…”

Comparison of Tamsulosin Plus Serenoa Repens with Tamsulosin in the Treatment of Benign Prostatic Hyperplasia in Korean Men: 1-Year Randomized Open Label Study

“…This agent is derived from the berries of the dwarf palm trees, and has not been associated with any significant toxicity. In a variety of European clinical trials, the use of Serenoa repens in men with LUTS has led to significant subjective and objective improvements [1,2,3]. In contrast, the unfavorable results on the efficacy of Serenoa repens compared to placebo have been reported recently [4,5].…”