Evidence map›Paper›PMID 21554128›Full record

Trial reportJournal of alternative and complementary medicine (New York, N.Y.)2011

Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia.

Jeannette Y Lee, Harris E Foster, Kevin T McVary, Sreelatha Meleth, Karen Stavris, Joe Downey, John W Kusek

Registry-linked trialOpen access · greenAbstract readComparative 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.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00603304 (Complementary and Alternative Medicine for Urological Symptoms), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
0.6field-weighted citation impact, top 30% 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.

NCT00603304 phase3completednot on this map

Complementary and Alternative Medicine for Urological Symptoms (CAMUS)

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2008 to 2010Enrolled369ConditionsUrologicalArmsSaw Palmetto - first 24 weeks, Placebo - first 24 weeks, Saw Palmetto - weeks 24 - 48, Placebo - weeks 24 - 48, Saw Palmetto - weeks 48 - 72
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Strategies to improve recruitment to randomised trials.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Trial
  4. Review
  5. Observational
  6. 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

7 authors at 6 institutions in 2 countries.

Jeannette Y LeeDepartment of Biostatistics, University of Arkansas for Medical Sciences, 4301 West Markham, Little Rock, AR 72205, USA. jylee@uams.edu
Harris E Foster
Kevin T McVary
Sreelatha Meleth
Karen Stavris
Joe Downey
John W Kusek
Yale University · USNational Institute of Diabetes and Digestive and Kidney Diseases · USNorthwestern Medicine · USQueens University · BDUniversity of Alabama at Birmingham · 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 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 DK 63883
6 · The paper itself

Abstract

objectivesThe timely recruitment of study participants is a critical component of successful trials. Benign prostatic hyperplasia (BPH), a common nonmalignant urologic condition among older men, is characterized by lower urinary tract symptoms (LUTS). Successful recruitment methods for a trial of medical therapy for BPH, Medical Therapy of Prostate Symptoms (MTOPS), were mass mailing and advertising. The Complementary and Alternative Medicines Trial for Urological Symptoms (CAMUS) was designed to evaluate a botanical therapy, saw palmetto, for the treatment of BPH. The objective of this study was to evaluate recruitment strategies for CAMUS and to contrast the baseline characteristics of CAMUS participants with those recruited to a similar trial using conventional medical therapy.

designCAMUS is a randomized, double-blind, placebo-controlled trial designed to evaluate the effects of saw palmetto given at escalating doses over an 18-month period on relief from LUTS. SUBJECTS: The target enrollment goal was 350 men with LUTS from 11 clinical centers over a 12-month period. The recruitment techniques used and participants contacted, screened, and randomized through each technique were obtained from the clinical centers. Baseline characteristics of the CAMUS participants were compared with participants in the MTOPS trial who met the CAMUS eligibility criteria for LUTS.

resultsThe target enrollment goal was achieved in 11 months. The overall monthly recruitment rate per site was 3.7 and ranged from 2.4 to 8.0. The most successful recruitment methods were mass mailing and advertising, which accounted for 39% and 35% of the study participants, respectively. In comparison to MTOPS participants, CAMUS participants were younger, more highly educated, more diverse, and had less severe urinary symptoms.

conclusionsSuccessful recruitment methods for CAMUS were similar to those in MTOPS. The use of botanical therapy attracted a less symptomatic and more educated study population.

Indexed as

Patient SelectionPhytotherapySerenoaAdvertisingAgedHumansMaleMiddle AgedPlant ExtractsProstatic HyperplasiaResearch DesignSocial ClassUrologic DiseasesPlant Extracts

Identifiers

PMID21554128
PMCPMC3155098
OpenAlexW2094348400

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.