Saw palmetto fruit extract, an over-the-counter herb that has been used to treat lower urinary tract symptoms attributed to benign prostatic hyperplasia, proved no more effective than placebo in a study.
Researchers gave increasing doses of Serenoa repens, which comes from saw palmetto berries, to 369 men aged 45 years or older. Dosing of 320 mg was increased from once to twice to three times a day, with dose increases at 24 weeks and 48 weeks.
American Urological Association Symptom Index scores were measured between baseline and 72 weeks. Secondary outcomes included measures of urinary bother, nocturia, peak uroflow, postvoid residual volume, prostate-specific antigen level, participants’ global assessments, and indices of sexual function, continence, sleep quality and prostatitis symptoms.
Increasing saw palmetto doses did not reduce lower urinary tract symptoms more than placebo, the study authors said. There was also no effect on the secondary outcomes.
“We studied only one extract and because the potential active ingredients and mechanisms are unknown, our findings may not be generalizable,” they said. “Nevertheless, a recent series of negative trials using different saw palmetto extract preparations makes it increasingly unlikely a dose of some preparation will be identified that is better than placebo.”
Disclosures: Barry reported serving on the board of and receiving salary support as president of the not-for-profit (501c) Foundation for Informed Medical Decision Making, which develops content for patient education programs. The foundation has an arrangement with a for-profit company, Health Dialog, to coproduce and market these programs to health care organizations. Lee reported that funds were paid to her institution for consultancy to Merck. Nickel reported receiving consultation funds from GlaxoSmithKline, Pfizer, Watson, Astellas, Ferring, Taris, Triton, Farr Labs, Trillium, Cernelle, and Johnson & Johnson; having provided expert testimony for GlaxoSmithKline; and having received payment for development of educational presentations from the Canadian Urological Association. Crawford reported receiving payment for lectures from Ferring Pharmaceuticals and GlaxoSmithKline. Andriole reported receiving consultation funds from Amgen, Bayer, Caris, France Foundation, GenProbe, GlaxoSmithKline, Steba Biotech, Ortho-Clinical Diagnostics, and Ferring Pharmaceuticals; having received royalties from Up to Date; receiving payment for development of educational presentations from Amgen; having stock and/or stock options in Envisioneering Medical, Viking Medical, Augmenix, and Cambridge Endo; and receiving travel, accommodations, and meeting expenses from Amgen, Augmenix, Bayer, Cambridge Endo, Caris, France Foundation, GenProbe, Myriad Genetics, Steba Biotech, and Ortho Clinical Diagnostics. Naslund reported receiving payment for lectures from GlaxoSmithKline and sanofi-aventis, as well as payment for development of educational presentations for France Foundation. McVary reported receiving consultancy funds from Lilly/ICOS, Allergan, National Institute of Diabetes and Digestive and Kidney Diseases, Watson Pharm, and Neotract, as well as payment for lectures from GlaxoSmithKline.