TY - JOUR
T1 - The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen
T2 - Analysis of the CAMUS randomized trial
AU - Andriole, Gerald L.
AU - McCullum-Hill, Christie
AU - Sandhu, Gurdarshan S.
AU - Crawford, E. David
AU - Barry, Michael J.
AU - Cantor, Alan
N1 - Funding Information:
Supported by cooperative agreements from the National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases U01 DK63795, U01 DK63797, U01 DK63825, U01 DK63835, U01 DK63866, U01 DK63833, U01 DK63862, U01 DK63840, U01 DK63883, U01 DK63831, U01 DK63778 and U01 DK63788. Also supported by the National Center for Complementary and Alternative Medicine, and the Office of Dietary Supplements, NIH.
PY - 2013/2
Y1 - 2013/2
N2 - Purpose: Saw palmetto extracts are used to treat lower urinary tract symptoms in men despite level I evidence that saw palmetto is ineffective in reducing these lower urinary tract symptoms. We determined whether higher doses of saw palmetto as studied in the CAMUS (Complementary and Alternative Medicine for Urologic Symptoms) trial affect serum prostate specific antigen levels. Materials and Methods: The CAMUS trial was a randomized, placebo controlled, double-blind, multicenter, North American trial conducted between June 5, 2008 and October 10, 2012, in which 369 men older than 45 years with an AUA symptom score of 8 to 24 were randomly assigned to placebo or dose escalation of saw palmetto, which consisted of 320 mg for the first 24 weeks, 640 mg for the next 24 weeks and 960 mg for the last 24 weeks of this 72-week trial. Serum prostate specific antigen levels were obtained at baseline and at weeks 24, 48 and 72, and were compared between treatment groups using the pooled t test and Fisher's exact test. Results: Serum prostate specific antigen was similar at baseline for the placebo (mean ± SD 1.93 ± 1.59 ng/ml) and saw palmetto groups (2.20 ± 1.95, p = 0.16). Changes in prostate specific antigen during the study were similar, with a mean change in the placebo group of 0.16 ± 1.08 ng/ml and 0.23 ± 0.83 ng/ml in the saw palmetto group (p = 0.50). In addition, no differential effect on serum prostate specific antigen was observed between treatment arms when the groups were stratified by baseline prostate specific antigen. Conclusions: Saw palmetto extract does not affect serum prostate specific antigen more than placebo, even at relatively high doses.
AB - Purpose: Saw palmetto extracts are used to treat lower urinary tract symptoms in men despite level I evidence that saw palmetto is ineffective in reducing these lower urinary tract symptoms. We determined whether higher doses of saw palmetto as studied in the CAMUS (Complementary and Alternative Medicine for Urologic Symptoms) trial affect serum prostate specific antigen levels. Materials and Methods: The CAMUS trial was a randomized, placebo controlled, double-blind, multicenter, North American trial conducted between June 5, 2008 and October 10, 2012, in which 369 men older than 45 years with an AUA symptom score of 8 to 24 were randomly assigned to placebo or dose escalation of saw palmetto, which consisted of 320 mg for the first 24 weeks, 640 mg for the next 24 weeks and 960 mg for the last 24 weeks of this 72-week trial. Serum prostate specific antigen levels were obtained at baseline and at weeks 24, 48 and 72, and were compared between treatment groups using the pooled t test and Fisher's exact test. Results: Serum prostate specific antigen was similar at baseline for the placebo (mean ± SD 1.93 ± 1.59 ng/ml) and saw palmetto groups (2.20 ± 1.95, p = 0.16). Changes in prostate specific antigen during the study were similar, with a mean change in the placebo group of 0.16 ± 1.08 ng/ml and 0.23 ± 0.83 ng/ml in the saw palmetto group (p = 0.50). In addition, no differential effect on serum prostate specific antigen was observed between treatment arms when the groups were stratified by baseline prostate specific antigen. Conclusions: Saw palmetto extract does not affect serum prostate specific antigen more than placebo, even at relatively high doses.
KW - Serenoa
KW - permixon
KW - prostate-specific antigen
KW - prostatic hyperplasia
UR - http://www.scopus.com/inward/record.url?scp=84872145291&partnerID=8YFLogxK
U2 - 10.1016/j.juro.2012.09.037
DO - 10.1016/j.juro.2012.09.037
M3 - Article
C2 - 23253958
AN - SCOPUS:84872145291
SN - 0022-5347
VL - 189
SP - 486
EP - 492
JO - Journal of Urology
JF - Journal of Urology
IS - 2
ER -