Evidence map›Paper›PMID 23383975›Full record

Trial reportJournal of alternative and complementary medicine (New York, N.Y.)2014

Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto.

Jeannette Y Lee, Page Moore, John Kusek, Michael Barry, CAMUS Study Group

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of alternative and complementary medicine (New York, N.Y.), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

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

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Jeannette Y Lee1 Department of Biostatistics, University of Arkansas for Medical Sciences , Little Rock, AR.
Page Moore
John Kusek
Michael Barry
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 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

objectivesThis report assesses participant perception of treatment assignment in a randomized, double-blind, placebo-controlled trial of saw palmetto for the treatment of benign prostatic hyperplasia (BCM).

designParticipants randomized to receive saw palmetto were instructed to take one 320 mg gelcap daily for the first 24 weeks, two 320 mg gelcaps daily for the second 24 weeks, and three 320 mg gelcaps daily for the third 24 weeks. Study participants assigned to placebo were instructed to take the same number of matching placebo gelcaps in each time period. At 24, 48, and 72 weeks postrandomization, the American Urological Association Symptom Index (AUA-SI) was administered and participants were asked to guess their treatment assignment. SETTINGS: The study was conducted at 11 clinical centers in North America.

participantsStudy participants were men, 45 years and older, with moderate to low severe BPH symptoms, randomized to saw palmetto (N=151) or placebo (N=155). OUTCOME MEASURES: Treatment arms were compared with respect to the distribution of participant guesses of treatment assignment.

resultsFor participants assigned to saw palmetto, 22.5%, 24.7%, and 29.8% correctly thought they were taking saw palmetto, and 37.3%, 40.0%, and 44.4% incorrectly thought they were on placebo at 24, 48, and 72 weeks, respectively. For placebo participants, 21.8%, 27.4%, and 25.2% incorrectly thought they were on saw palmetto, and 41.6%, 39.9%, and 42.6% correctly thought they were on placebo at 24, 48, and 72 weeks, respectively. The treatment arms did not vary with respect to the distributions of participants who guessed they were on saw palmetto (p=0.823) or placebo (p=0.893). Participants who experienced an improvement in AUA-SI were 2.16 times more likely to think they were on saw palmetto.

conclusionsBlinding of treatment assignment was successful in this study. Improvement in BPH-related symptoms was associated with the perception that participants were taking saw palmetto.

Indexed as

AgedDouble-Blind MethodHumansMaleMiddle AgedPlacebosPlant ExtractsProstatic HyperplasiaRandomized Controlled Trials as TopicResearch SubjectsSerenoaPlacebosPlant Extractssaw palmetto extract

Identifiers

PMID23383975
PMCPMC3904527

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.