Evidence map›Paper›PMID 23063633›Full record

Trial reportThe Journal of urology2013

Safety and toxicity of saw palmetto in the CAMUS trial.

Andrew L Avins, Jeannette Y Lee, Catherine M Meyers, Michael J Barry, CAMUS Study Group

Open access · greenAbstract readRandomized 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 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 17% of its field
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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

  1. Investigative and clinical urology · 2021
    Pooled it
  2. Efficacy and Safety ofNutrients · 2026
    Trial
  3. Trial
  4. Review
  5. Article
  6. Article
  7. Article
  8. BPH in 2012: novel agents in treatment of BPH.Nature reviews. Urology · 2013
    Review
  9. IsAmerican journal of men's health
    Article
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

5 authors at 4 institutions in 1 country.

Andrew L AvinsNorthern California Kaiser-Permanente Division of Research, Oakland and Departments of Medicine and Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, California 94612, USA. andrew.avins@ucsf.edu
Jeannette Y Lee
Catherine M Meyers
Michael J Barry
CAMUS Study Group
Kaiser Permanente · USMassachusetts General Hospital · USNational Center for Complementary and Integrative Health · USUniversity of Arkansas for Medical Sciences · US

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 DK063883
6 · The paper itself

Abstract

purposeExtracts of the saw palmetto berry are used by many men in the United States as self-treatment for lower urinary tract symptoms due to benign prostatic hyperplasia. While the most recent data from double-blind clinical trials do not support efficacy superior to that of placebo, there are sparse data on saw palmetto toxicity. MATERIALS AND

methodsA total of 369 patients were randomized in the CAMUS (Complementary and Alternative Medicine for Urological Symptoms) trial, of whom 357 were included in this modified intent to treat analysis. Participants were randomized to 320, 640 and 960 mg daily of an ethanolic saw palmetto extract or to an identical-appearing placebo in an escalating manner at 6-month intervals for a total of 18 months of followup. Adverse event assessments, vital signs, and blood and urine laboratory tests were obtained at regular intervals.

resultsThere were no statistically significant differences between the groups in the rates of serious or nonserious adverse events, changes in vital signs, digital prostate examination findings or study withdrawal rates. Overall, there were no significant intergroup differences in laboratory test abnormalities, while differences in individual laboratory tests were rare and small in magnitude. No evidence of significant dose-response phenomena was identified.

conclusionsThe saw palmetto extract used in the CAMUS trial showed no evidence of toxicity at doses up to 3 times the usual clinical dose during an 18-month period.

Indexed as

PhytotherapyAgedHumansLower Urinary Tract SymptomsMiddle AgedPlant ExtractsSerenoaPlant Extractssaw palmetto extract

Identifiers

PMID23063633
PMCPMC3716255
OpenAlexW2032953608

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.