Journal article
Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of Phytotherapy for Benign Prostatic Hyperplasia
Clinical trials (London, England), Vol.6(6), pp.628-636
12/01/2009
DOI: 10.1177/1740774509352199
PMCID: PMC3082919
PMID: 20007408
Abstract
Background Benign prostatic hyperplasia (BPH), a common condition among older men, confers its morbidity through potentially bothersome lower urinary tract symptoms. Treatments for BPH include drugs such as alpha-adrenergic receptor blockers and 5-alpha reductase inhibitors, minimally invasive therapies that use heat to damage or destroy prostate tissue, and surgery including transurethral resection of the prostate. Complementary and alternative medicines are gaining popularity in the US. Two phytotherapies commonly used for BPH are extracts of the fruit of Serenoa repens, the Saw palmetto dwarf palm that grows in the Southeastern US, and extracts of the bark of Pygeum africanum, the African plum tree.
Purpose The objective of the Complementary and Alternative Medicines for Urological Symptoms (CAMUS) clinical trial is to determine if phytotherapy is superior to placebo in the treatment of BPH.
Methods CAMUS was originally designed as a 3300-participant, four-arm trial of S. repens, P. africanum, an alpha-adrenergic blocking drug, and placebo with time to clinical progression of BPH, a measure of long-term efficacy, as the primary endpoint. Before enrollment started, a randomized, double-blind, placebo-controlled, single institution clinical trial showed that S. repens at the usual dose did not demonstrate any benefit over placebo with respect to symptom relief at 1 year. Consequently, the focus of CAMUS shifted from evaluating long-term efficacy to determining if any short-term (6-18 months) symptom relief could be achieved with increasing doses of S. repens, the phytotherapy most commonly used in the US for BPH.
Results Results are anticipated in 2011.
Conclusions Trial design occurs in an environment of continually evolving information. In this case, emerging results from another trial suggested that a study of long-term efficacy was premature, and that an effective dose and preparation of S. repens had to be established before proceeding to a long-term clinical trial. Clinical Trials 2009; 6: 628-636. http://ctj.sagepub.com.
Details
- Title: Subtitle
- Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of Phytotherapy for Benign Prostatic Hyperplasia
- Creators
- Jeannette Lee - University of Arkansas for Medical SciencesGerald Andriole - Washington University in St. LouisAndrew Avins - Kaiser PermanenteE. David Crawford - University of Colorado DenverHarris Foster - Yale UniversitySteven Kaplan - Cornell UniversityKarl Kreder - University of IowaJohn Kusek - National Institute of Diabetes and Digestive and Kidney DiseasesAndrew McCullough - New York UniversityKevin McVary - Northwestern UniversitySreelatha Meleth - University of Alabama at BirminghamMichael Naslund - University of Maryland, BaltimoreJ. Curtis Nickel - Queen's UniversityLeroy Nyberg - National Institute of Diabetes and Digestive and Kidney DiseasesClaus Roehrborn - The University of Texas Southwestern Medical CenterO. Dale Williams - University of AlabamaMichael Barry - Harvard University
- Resource Type
- Journal article
- Publication Details
- Clinical trials (London, England), Vol.6(6), pp.628-636
- Publisher
- Sage
- DOI
- 10.1177/1740774509352199
- PMID
- 20007408
- PMCID
- PMC3082919
- ISSN
- 1740-7745
- eISSN
- 1740-7753
- Number of pages
- 9
- Grant note
- U01DK063795 / NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK) U01 DK063862; U01DK063840; U01 DK063788; U01 DK063795; U01 DK063831-08; U01DK063797; U01 DK063833-07; U01 DK063825-07; U01 DK063866-07; U01 DK063862-07; U01 DK063788-05; U01DK063883; U01DK063833; U01 DK063866; U01DK063825; U01DK063862; U01 DK063835; U01DK063788; U01DK063778; U01 DK063778; U01 DK063797-05; U01DK063866; U01 DK063883; U01 DK063883-07; U01 DK063778-07; U01 DK063825; U01 DK063797; U01 DK063788-07; U01 DK063833; U01 DK063835-07; U01 DK063795-07; U01 DK063840; U01DK063795; U01 DK063840-07; U01 DK063831; U01DK063835; U01DK063831 / NIDDK NIH HHS; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Institute of Diabetes & Digestive & Kidney Diseases (NIDDK)
- Language
- English
- Date published
- 12/01/2009
- Academic Unit
- Obstetrics and Gynecology; Urology
- Record Identifier
- 9984383302702771
Metrics
13 Record Views