Market Updates

Consensus Statement: Saw Palmetto Extract Reduces Prostate Inflammation

The statement, published by a panel of urologists, points to a mechanism of action which may have an effect on lower urinary tract symptoms.

A panel of urologists recently published a consensus statement in the journal Uro which concluded that saw palmetto extract may have benefits to benign prostatic hyperplasia (BPH) and male lower urinary tract symptoms (LUTS), pending further studies. About half of men between the ages of 50 and 60, and 90% of men over the age of 80 are effected by an enlarged prostate, and many of these men will experience lower urinary tract symptoms, such as increased urination, sudden urgency, and more.
 
Saw palmetto extract which is standardized to contain lipidosterolic extract (LSESr) reduces prostate inflammation by inhibiting a pathway known as 5-AR, they concluded, however, the evidence that this specific mechanism of action, or any other mechanisms of action, effect BPH and LUTS symptoms in men is inconclusive, they write.
 
However, the panel determined that, “based on the reviewed evidence, LSESr should be considered as a treatment option for men with mild-to-moderate BPH/LUTS as an alternative to watchful waiting.”
 
 The consensus statement, made up altogether of seven individual statements, comes from a meeting of an international panel of urologists which were discussing the potential role of saw palmetto extract in the management of LUTS in men in North America. Each statement was unanimously supported after discussion over the months following the meeting.
 
The main challenge to reaching a consensus statement on saw palmetto is the variable quality of products on the market – this is the reason for a discrepancy between recommendations made by the European Association of Urology (EAU) and the American Urological Association (AUA) on saw palmetto use. “Across the globe, there has been a lack of consensus with regards to the effectiveness of saw palmetto extract resulting in differing recommendations for the use of saw palmetto extract by health organizations around the world,” said co-author Dr. Jamin Brahmbhatt. “The goal of this expert panel was to contribute to our collective understanding of the science and generate discussion about the role a high-quality saw palmetto extract can play in men’s health.”
 
EAU provides much different guidance, as a saw palmetto extract known as Permixon was classified as a prescription drug for the treatment of mild-to-moderate LUTS in Europe, allowing for greater regulation regarding the quality and dosage of it across the EU. However, Permixon and all other saw palmetto extracts in the U.S. are considered dietary supplements, and subject to less strict scrutiny.
 
“Despite its usage in Europe, a disagreement between guidance provided by AUA and EAU exists for the use of LSESr. Currently, AUA guidelines state, ‘many supplements and nutraceuticals containing ingredients such as saw palmetto […] are popular and have been marketed and studied. Overall, these results have been variable, as have study methods and quality, thus positive recommendations regarding their use are not warranted.’”
 
Therefore, the combined seven consensus statements take into account scientific evidence on the proposed mechanism of action, a required quality profile, and the results from clinical trials examining efficacy and safety.
 
“Our panel recognized that the literature on the benefit of saw palmetto extract for LUTS was specific to a high-quality extract used at 320 mg daily,” said Dr. J. Curtis Nickel, lead author of the panel. Notably, the panel highlighted that the current evidence suggests that high-quality extracts with a profile defined by the United States Pharmacopoeia (USP) monograph are important for achieving clinical efficacy.

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