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The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial.

ABSTRACT: 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.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.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.Saw palmetto extract does not affect serum prostate specific antigen more than placebo, even at relatively high doses.

SUBMITTER: Andriole GL

PROVIDER: S-EPMC3979451 | biostudies-other | 2013 Feb

REPOSITORIES: biostudies-other

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The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial.

Andriole Gerald L GL McCullum-Hill Christie C Sandhu Gurdarshan S GS Crawford E David ED Barry Michael J MJ Cantor Alan A

The Journal of urology 20121214 2

<h4>Purpose</h4>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.<h4>Materials and methods</h4>The CAMUS trial was a randomized, placebo controlled, double-blind, multicenter, N ...[more]

PMID: 23253958

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Project description:ContextSaw palmetto fruit extracts are widely used for treating lower urinary tract symptoms attributed to benign prostatic hyperplasia (BPH); however, recent clinical trials have questioned their efficacy, at least at standard doses (320 mg/d).ObjectiveTo determine the effect of saw palmetto extract (Serenoa repens, from saw palmetto berries) at up to 3 times the standard dose on lower urinary tract symptoms attributed to BPH.Design, setting, and participantsA double-blind, multicenter, placebo-controlled randomized trial at 11 North American clinical sites conducted between June 5, 2008, and October 10, 2010, of 369 men aged 45 years or older, with a peak urinary flow rate of at least 4 mL/s, an American Urological Association Symptom Index (AUASI) score of between 8 and 24 at 2 screening visits, and no exclusions.InterventionsOne, 2, and then 3 doses (320 mg/d) of saw palmetto extract or placebo, with dose increases at 24 and 48 weeks.Main outcome measuresDifference in AUASI score 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.ResultsBetween baseline and 72 weeks, mean AUASI scores decreased from 14.42 to 12.22 points (-2.20 points; 95% CI, -3.04 to -1.36) [corrected]with saw palmetto extract and from 14.69 to 11.70 points (-2.99 points; 95% CI, -3.81 to -2.17) with placebo. The group mean difference in AUASI score change from baseline to 72 weeks between the saw palmetto extract and placebo groups was 0.79 points favoring placebo (upper bound of the 1-sided 95% CI most favorable to saw palmetto extract was 1.77 points, 1-sided P = .91). Saw palmetto extract was no more effective than placebo for any secondary outcome. No clearly attributable adverse effects were identified.ConclusionIncreasing doses of a saw palmetto fruit extract did not reduce lower urinary tract symptoms more than placebo.Trial registrationclinicaltrials.gov Identifier: NCT00603304.

Project description:The enhancement of plant tolerance toward abiotic stresses is increasingly being supported by the application of biostimulants. Salinity represents a serious problem in the Mediterranean region. To verify the effects deriving from the application of biostimulants, trials on Romaine lettuce plants under salt exposure were performed, in greenhouse. Plants were subjected to three NaCl solutions with 0.8, 1.3, and 1.8 dS/m of electrical conductivity. The volume of the solution was 200 mL/plant and delivered every 3 days. Biostimulant treatments started after crop establishment and were: control (water) and two doses (0.1 or 0.2 mL/plant) of the commercial biostimulant Retrosal® (Valagro S.p.A), containing calcium, zinc, and specific active ingredients. Four Retrosal® treatments were applied, every 7 days, directly to the substrate. Non-destructive analyses were conducted to assess the effects on leaf photosynthetic efficiency. At harvest, plants fresh weight (FW) and dry weight were determined, as well as the concentration of chlorophylls, carotenoids, total sugars, nitrate, proline, and abscisic acid (ABA). The biostimulant tested increased significantly the FW of lettuce (+65% in the highest dose) compared to controls. Results indicate that treatments positively affected the chlorophyll content measured in vivo (+45% in the highest dose) and that a general positive effect was observable on net photosynthesis rate. Retrosal® seems to improve the gas exchanges under our experimental conditions. The total sugars levels were not affected by treatments. Biostimulant allowed maintaining nitrate concentration similar to the untreated and unstressed controls. The increasing levels of water salinity caused a raise in proline concentration in control plants (+85%); biostimulant treatments at 0.2 mL/plant dose kept lower the proline levels. All plants treated with the biostimulant showed lower value of ABA (-34%) compared to controls. Results revealed that Retrosal® is able to stimulate plant growth independently from the salinity exposure. However, treated plants reached faster the commercial maturity stage. The fresh biomass of control at the end of experiment, after 30 days, ranged from 15 to 42 g/head, while in biostimulant treated plants ranged from 45 to 94 g/head. The product applied at maximum dose seems to be the most effective in our experimental conditions.

Project description:Cistus ladanifer (rockrose) is a perennial shrub quite abundant in the Mediterranean region, and it is a rich source in secondary compounds such as condensed tannins (CTs). Condensed tannins from C. ladanifer were able to change the ruminal biohydrogenation (BH), increasing the t11-18:1 and c9,t11-18:2 production. However, the adequate conditions of the C. ladanifer CTs used to optimize the production of t11-18:1 and c9,t11-18:2 is not yet known. Thus, we tested the effect of increasing the doses of C. ladanifer CT extract (0, 25, 50, 75 and 100 g/kg dry matter (DM)) on in vitro rumen BH. Five in vitro batch incubations replicates were conducted using an oil supplemented high-concentrate substrate, incubated for 24 h with 6 mL of buffered ruminal fluid. Volatile fatty acids (VFAs) and long chain fatty acids (FA) were analyzed at 0 h and 24 h, and BH of c9-18:1, c9, c12-18:2 and c9, c12, c15-18:3, and BH products yield were computed. Increasing doses of C. ladanifer CTs led to a moderate linear decrease (p < 0.001) of the VFA production (a reduction of 27% with the highest dose compared to control). The disappearance of c9-18:1 and c9,c12-18:2 as well as the production of t11-18:1 and c9, t11:18:2 was not affected by increasing doses of C. ladanifer CTs, and only the disappearance of c9, c12, c15-18:3 suffered a mild linear decrease (a reduction of 24% with the highest dose compared to control). Nevertheless, increasing the C. ladanifer CT dose led to a strong depression of microbial odd and branched fatty acids and of dimethyl acetals production (less than 65% with the highest dose compared to control), which indicates that microbial growth was more inhibited than fermentative and biohydrogenation activities, in a possible adaptative response of microbial population to stress induced to CTs and polyunsaturated fatty acids. The ability of C. ladanifer to modulate the ruminal BH was not verified in the current in vitro experimental conditions, emphasizing the inconsistent BH response to CTs and highlighting the need to continue seeking the optimal conditions for using CTs to improve the fatty acid profile of ruminant fat.

Dataset Information

The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial.

Publications

The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial.

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