Combined therapy with Serenoa Repens plus Pinus Massoniana Bark Extract (PMBE) plus Crocus Sativus extract (IDIProst Gold®) in patients with LUTS and ED

Maurizio Carrino1, Luigi Pucci1, Maurizio Fedelini1, Clemenete Meccariello1, Andrea Oliva1, Fausto Monaco1, Marco Capece1, Paolo Fedelini1
  • 1 AORN A. Cardarelli - U.O.S. Andrologia Chirurgica (Napoli)

Objective

Lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) are highly prevalent, frequently co-associated, and significantly contribute to the quality of life. They may share a common pathophysiology. Approximately 70% of men with LUTS/BPH have co-existing ED. Recent treatment guidelines for LUTS/BPH include the use of several regulatory-approved pharmacologic classes including the phosphodiesterase type 5 inhibitor (PDE5i) tadalafil. The ability to treat both BPH and ED with one medication is noteworthy. The aim of the present study was to evaluate the efficacy of a combined therapy with serenoa repens plus pinus massoniana plus crocus sativus extract (IDIProst Gold®) in patients with LUTS and ED.

Methods and results

We performed a randomized, placebo controlled trial. A total of 54 men complaining of both mild ED (International Index of Erectile Function – 5 (IIEF-5) score 17-21) and mild LUTS/BPH (International Prostatic Symptom Score (IPSS) 0-7) were included in the study. Concomitant therapies for ED and/or LUTS/BPH, hypogonadism, diabetes mellitus, antihypertensive therapy, previous pelvic surgery or radiotherapy, and severe cardiovascular diseases were exclusion criteria. Patients were assessed at baseline and were randomized (1:1) to either IDIProst Gold® (active treatment) once a day or placebo once a day for 6 months. All participants completed the IIEF-5 and the IPSS questionnaire at the end of the study.
Mean patients’ age was 60 years (range 45-70). At baseline evaluation, mean IIEF-5 score were 19.07 (range: 17-21) and 19 (range: 17-21) in the active treatment and placebo groups, respectively (p: not significant). Mean IPSS scores were 4.37 (range 1-7) and 4.04 (range 1-7) in the active treatment and placebo groups, respectively (p: not significant). All patients completed the study protocol, tolerated the treatments well, and were available for follow-up assessments. At the end of the treatment mean IIEF-5 score improved in the active treatment group and also in the placebo group (20.8 vs 19.7 respectively), even though there has been shown a statistically significant difference between the groups (p<0.05) in favour of Idiprost Gold group. Similarly, mean IPSS score improved in both groups ( 2.78 vs 3.41 respectively) but the difference between the two arms was statistically significant (p< 0.05), always in favour of Idiprost Gold group.

Discussion

There is a revival of interest in phytotherapeutic agents, especially as a consequence of patients’ dissatisfaction with the adverse effects of medical alternatives. Serenoa Repens is efficacious in patients with LUTS/BPH. Pre-clinical evidences have demonstrated that pinus massoniana extract is efficacious to protect against oxidative damage and that crocus sativus has aphrodisiac effects in animal and humans. We evaluated, for the first time, the efficacy of the association of these three compound in patients with mild ED and mild LUTS/BPH.
The association of serenoa repens plus pinus massoniana plus crocus sativus extracts is better than placebo in improving IIEF-5 and IPSS scores in patients complaining of both ED and LUTS/BPH.

Argomenti: