Evidence map›Paper›PMID 23253958›Full record

Trial reportThe Journal of urology2013

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

Gerald L Andriole, Christie McCullum-Hill, Gurdarshan S Sandhu, E David Crawford, Michael J Barry, Alan Cantor, CAMUS Study Group

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of urology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Gerald L AndrioleDivision of Urologic Surgery, Washington University School of Medicine, St. Louis, Missouri 63110, USA. andrioleg@wustl.edu
Christie McCullum-Hill
Gurdarshan S Sandhu
E David Crawford
Michael J Barry
Alan Cantor
CAMUS Study Group

Funding

Data Coordinating Center for Benign Prostate SymptomsU01DK063788 · NIDDK · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI CANTOR, ALAN B. · 2002 to 2011
$5.4M
Phytotherapy for Benign Prostatic HyperplasiaU01DK063795 · NIDDK · KAISER FOUNDATION RESEARCH INSTITUTE · PI AVINS, ANDREW L · 2002 to 2010
$1.6M
Phythotherapy for the Treatment of BPH SymptomsU01DK063862 · NIDDK · YALE UNIVERSITY · PI FOSTER, HARRIS E · 2002 to 2010
$1.6M
Alternative Therapies for Benign Prostate SymptomsU01DK063840 · NIDDK · UNIVERSITY OF IOWA · PI KREDER, KARL J · 2002 to 2011
$1.5M
Alternative Therapies for BPH, Multiethnic VariablilityU01DK063831 · NIDDK · WEILL MEDICAL COLL OF CORNELL UNIV · PI KAPLAN, STEVEN A · 2002 to 2010
$1.4M
ALTERNATIVE THERAPIES FOR BENIGN PROSTATIC SYMPTOMSU01DK063778 · NIDDK · UNIVERSITY OF MARYLAND BALTIMORE · PI NASLUND, MICHAEL J · 2002 to 2010
$1.4M
Saw palmetto and Pygeum africanum on BPH ProgressionU01DK063866 · NIDDK · NORTHWESTERN UNIVERSITY AT CHICAGO · PI MCVARY, KEVIN T. · 2002 to 2010
$1.3M
Alternate Therapies for Benign Prostate SymptomsU01DK063835 · NIDDK · UT SOUTHWESTERN MEDICAL CENTER · PI ROEHRBORN, CLAUS G · 2002 to 2010
$1.3M
Alternative Therapies for Benign Prostate SymptomsU01DK063883 · NIDDK · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI MCCULLOUGH, ANDREW R · 2002 to 2010
$1.2M
Phytotherapy of Prostateic Symptoms (POPW)U01DK063833 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI CRAWFORD, E DAVID · 2002 to 2010
$1.1M
Clinical Evaluation &Treatment Center for BPHU01DK063825 · NIDDK · WASHINGTON UNIVERSITY · PI ANDRIOLE, GERALD LOUIS · 2002 to 2011
$1.1M
Alternative Therapies for Benign Prostatic Hyperplasia (CAMUS)U01DK063797 · NIDDK · QUEEN'S UNIVERSITY AT KINGSTON · PI NICKEL, JOHN CURTIS · 2003 to 2010
$841k
NIDDK NIH HHS U01 DK063778NIDDK NIH HHS U01 DK063788NIDDK NIH HHS U01 DK063795NIDDK NIH HHS U01 DK063797NIDDK NIH HHS U01 DK063825NIDDK NIH HHS U01 DK063831NIDDK NIH HHS U01 DK063833NIDDK NIH HHS U01 DK063835NIDDK NIH HHS U01 DK063840NIDDK NIH HHS U01 DK063862NIDDK NIH HHS U01 DK063866NIDDK NIH HHS U01 DK063883NIDDK NIH HHS U01 DK63778NIDDK NIH HHS U01 DK63788NIDDK NIH HHS U01 DK63795NIDDK NIH HHS U01 DK63797NIDDK NIH HHS U01 DK63825NIDDK NIH HHS U01 DK63831NIDDK NIH HHS U01 DK63833NIDDK NIH HHS U01 DK63835NIDDK NIH HHS U01 DK63840NIDDK NIH HHS U01 DK63862NIDDK NIH HHS U01 DK63866NIDDK NIH HHS U01 DK63883
6 · The paper itself

Abstract

purposeSaw 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

methodsThe 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.

resultsSerum 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.

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

Indexed as

Androgen AntagonistsDose-Response Relationship, DrugDouble-Blind MethodHumansMaleMiddle AgedPlant ExtractsProstate-Specific AntigenProstatic HyperplasiaSerenoaAndrogen AntagonistsPlant ExtractsProstate-Specific Antigensaw palmetto extract

Identifiers

PMID23253958
PMCPMC3979451

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.