“This study not only confirms the rampant variability of saw palmetto products but also highlights the need for physicians and industry to verify the quality of the supplements they’re recommending to patients and consumers to ensure the best results possible,” said Dr. Bilal Chughtai, associate professor of urology at Weill Cornell Medicine and lead author on the study.
The study was funded by Eustis, FL-based Valensa International, which markets its USPlus lipidosterolic saw palmetto extract for prostate and hair health.
Concentrated extract for prostate health
Saw palmetto is a wildcrafted plant native to the southeastern United States in remote areas along the Georgia and Florida coastlines. Increased demand for the plant’s berries has led to blending and dilution with less expensive plant oils like coconut, canola, olive and sunflower or use of unripe berries without the clinical benefits. This proliferation of adulterated saw palmetto prompted the American Botanical Council’s Botanical Adulterants Prevention Program (BAPP) to publish a laboratory guidance document in 2019.
“Only concentrated extract of mature saw palmetto berries has been found to inhibit the biological process by which testosterone gets converted to DHT, which leads to benign prostate enlargement,” explained Dr. Chughtai.
Benign prostatic hyperplasia (a.k.a. prostate enlargement) affects about 50% of men between the ages of 51 and 60 and up to 90% of men over the age of 80. As the prostate enlarges, the gland presses against and pinches the urethra. The thickening of the bladder wall and narrowing of the urethra then causes symptoms like more frequent urination, sudden urgency, weak stream and disrupted sleep.
The blinded study, performed at Eurofins Food Chemistry Testing in Madison, WI, evaluated 28 saw palmetto berry powders, powdered extracts, berry blends, lipid extracts and multi-active products purchased from major online retailers and retail outlets. Total fatty acid content and individual fatty acid profile of each product were determined and compared with the US Pharmacopeia monograph standards for lipidosterolic extracts of Serenoa repens (commonly known as saw palmetto).
“There is substantial heterogeneity in fatty acid content and profile in saw palmetto supplements,” the study authors concluded. “Lipidosterolic extracts of saw palmetto berries standardized to ≥80% fatty acids are most likely to meet established criteria for quality and identity.”
Total fatty acid content ranged from 0.796% for a berry powder product to 89.923% for a lipid extract product. None of the berry powders or powdered extracts met the criteria, and only six of the lipid extracts and one multi-active product were found to have the clinically proven 320 mg extract dose and minimum 80% fatty acids to address inflammation and improve symptoms.
Lab tests further confirmed that Valensa’s USPlus extract was the only product that met the criteria established in the US Pharmacopeia monograph for standardized saw palmetto extracts, the lipid profile for an authentic product, and the 320 mg dose.
“Without studies like this to bring quality issues to light, it’s very difficult for consumers to know if they’re taking a supplement full of ‘sawdust’ that doesn’t do anything or a quality saw palmetto product that promotes your prostate health,” said Stephen Hill, vice president of quality and regulatory at Valensa International.
Valensa attributes the potency of its product to rigorous quality-control for mature saw palmetto and its proprietary ultra-high pressure C02 extraction process.
Saw palmetto verification
In September 2022, Professor Emeritus of Urology at Queen’s University in Kingston, Ontario Dr. Curtis Nickel took a motorcycle trip through Valensa’s saw palmetto supply chain, making stops along the way to see how the berries are harvested, cleaned and dried before the extraction and quality control process.
“What we really need is for ethical saw palmetto companies to come forward with documentation of their supply chain,” he told NutraIngredients-USA. “They should be able to substantiate the supply chain from berry picking to drying and finally to their extraction process and then subject their product for independent verification to confirm that it has the fatty acids and the fatty acid fingerprint required.”
Commenting on the recent study, he said that it was regrettable that so few saw palmetto preparations met all the criteria that he would expect to see as a physician but believes that there are other extracts on the market up to USP standard that have yet to submit their products for verification.
“The inconsistency in product standards is the number one reason physicians are reluctant to recommend saw palmetto products for their patients,” he added.
Source: JU Open Plus
“Variability of Commercial Saw Palmetto–Based Supplements for the Management of Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms”
Authors: Bilal Chugtai et al.