NEVILLEWOOD, Pa., July 12 /PRNewswire/ -- A new study, published in the July issue of Advances in Therapy, revealed that a novel saw palmetto extract (SPE), SPET-085, is as effective as finasteride, the standard prescription drug therapy, in blocking the critical enzyme that leads to benign prostatic hyperplasia (BPH).
BPH, also known as an enlarged prostate, is the most common benign proliferative disorder in men, affecting more than 50 percent of men over the age of 70. Symptoms include urinary hesitancy, weak urine stream, nocturia, incontinence, and recurrent urinary tract infections.
The study, sponsored by Euromed, makers of SPET-085, evaluated the in-vitro potency of SPET-085, an inhibitor of the 5alpha-reductase isoenzyme type II, in a cell-free test system. It revealed that SPET-085 can effectively inhibit the enzyme linked to BPH, at a lower dose as compared to hexane extracts of saw palmetto, currently regarded as the most clinically effective saw palmetto, but unavailable in the United States. Importantly, the study revealed that SPET-085 has bioactivity similar to finasteride, the most commonly prescribed prescription medicine for the treatment of BPH. Common finasteride side effects may include decreased sex drive, impotence, or decreased ejaculate amount.
"I look forward to seeing if these interesting results in the laboratory translate into better patient outcomes in the National Institutes of Health-funded CAMUS study, an ongoing 18 month clinical trial comparing this saw palmetto supplement against a placebo for urinary symptoms attributed to benign prostatic enlargement," said Michael J. Barry, M.D., Professor of Medicine, Harvard Medical School.
While finasteride is currently the most common treatment for BPH, SPEs provide a more natural phytotherapeutic alternative to manage symptoms of the condition. There are many types of SPEs available today, based on a variety of extraction processes. This study demonstrates that the approach to extraction may impact levels of BPH-related bioactivity among the various extracts of saw palmetto.
"The results of this study verify the high activity of our novel saw palmetto extract, SPET-085, to help maintain healthy prostate function," said Joe Veilleux, General Manager, Euromed USA. "Euromed is committed to ongoing clinical research to provide scientific evidence which will differentiate SPET-085 from other saw palmetto extracts."
About the Study
The nicotinamide adenine dinculeotide phosphate (NADPH)-dependent membrane protein 5alpha-reductase irreversibly catalyses the conversion of testosterone to the most potent androgen, 5alpha-dihydrotestosterone (DHT). In humans, two 5alpha-reductase isoenzymes are expressed: type I and type II. Type II is found primarily in prostate tissue. Saw palmetto extract (SPE) has been widely used for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH). The mechanisms of the pharmacological effects of SPE include the inhibition 5alpha-reductase, among other actions. Clinical studies of SPE have been equivocal, with some showing significant results and others not. These inconsistent results may be due, in part, to varying bioactivities of the SPE used in the studies.
The aim of the present study was to determine the in vitro potency of a novel saw palmetto ethanol extract (SPET-085) an inhibitor of the 5alpha-reductase isoenzyme type II, in a cell-free test system. On the basis of the enzymatic conversion of the substrate androstenedione to the 5alpha-reductase product 5alpha- androstenedione, an inhibitory potency was measured and compared to those of finasteride, an approved 5alpha-reductase inhibitor.
SPET-085 concentration-dependently inhibited 5alpha-reductase type II in vitro. The approved 5alpha-reductase inhibitor, finasteride, tested as positive control, led to 61% inhibition of 5alpha-reductase type II.
Euromed saw palmetto extract, known as SPET-085, is a standardized herbal extract of Sabal serrulata Roem et Schult fruits, a small species of palms native to the USA. Saw palmetto extract is commonly used to help maintain prostate health and address symptoms associated with BPH – often referred to as enlarged prostate. Symptoms of BPH include: urinary hesitancy, weak urine stream, nocturia, incontinence, and recurrent urinary tract infections. The saw palmetto extract from Euromed gives most patients some relief of symptoms within the first 30 days of use.
Euromed is one of the world's most well-known and well-respected manufacturers of standardized botanical (herbal) extracts. Euromed extracts have been utilized in numerous human clinical studies including those evaluating saw palmetto, milk thistle, St. John's Wort and others. Euromed extracts are used for supplement, pharmaceutical, nutraceutical, and cosmetic purposes. Euromed was founded in 1971 as a part of the multi-national phytopharmaceutical company MADAUS (Cologne, Germany) and since 2007 part of the Rottapharm/Madaus Group headquartered in Monza Italy. For more information about Euromed, please call toll free 877-696-3960 or visit http://www.euromedusa.com.