A supplement called Profluss triggered molecular pathways that lead to cell death and improved prostate symptom scores in a clinical trial of patients with enlarged prostate.
The findings suggest that the molecular players could be targeted to develop better treatments for benign prostatic hyperplasia (BPH).
The study, “Survivin and NAIP in Human Benign Prostatic Hyperplasia: Protective Role of the Association of Serenoa repens, Lycopene and Selenium from the Randomized Clinical Study,” was published in the International Journal of Molecular Sciences.
Profluss is a combination of two herbal extracts — Serenoa repens, or saw palmetto, and the carotenoid Lycopene — plus the trace element selenium. It is used for prostate problems.
Researchers at the University of Catania and the University of Messina — both in Italy — had already shown that the supplement triggered prostate cell death in rats by reducing factors called survivin and NAIP (neuronal apoptosis inhibitory protein). These molecules, which act to prevent cell death, are found in higher levels in animal models of BPH.
To see if their findings could be translated to humans, the team designed a clinical trial that included 90 patients with lower urinary tract symptoms caused by BPH.
The patients were randomized to receive Profluss or a placebo for three months. Both study staff and patients were unaware of which treatment each patient was assigned to.
After three months, the International Prostatic Symptoms Score (IPSS) of those who received Profluss had dropped significantly, while there was no change in the placebo group. Prostate-specific antigen levels and urinary flow were unaffected by the treatment.
Comparing tissue samples from before and after the treatment, researchers noted that Profluss significantly lowered abnormally high levels of survivin and NAIP in the prostate. Patients who received a placebo continued to have high levels of the molecules after three months of treatment.
The treatment boosted a factor known as Caspase-3, a known driver of apoptosis, or programmed cell death. This cell death pathway is a way for the body to get rid of unwanted cells in a controlled fashion. In BPH, as in prostate cancer, programmed cell death is inhibited.
Analysis also showed that, although blood levels of PSA did not decrease, fewer prostate cells were producing the protein.
“Our results add to a growing body of literature indicating a beneficial effect of the association Ser-Se-Ly [Profluss] for managing BPH. We propose that this association induces a positive modulation of the apoptosis pathways, which, in combination with other mechanisms, produces a decrease in the cellular proliferation; thus slowing down the progression of BPH,” the researchers concluded.