Redesigning a large-scale clinical trial in response to negative external trial results

The CAMUS study of phytotherapy for benign prostatic hyperplasia

Jeannette Lee, Gerald Andriole, Andrew Avins, E. David Crawford, Harris Foster, Steven Kaplan, Karl Kreder, John Kusek, Andrew McCullough, Kevin McVary, Sreeleth Melatha, Michael Naslund, J. Curtis Nickel, Leroy Nyberg, Claus Roehrborn, O. Dale Williams, Michael Barry

Research output: Contribution to journalArticle

18 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)628-636
Number of pages9
JournalClinical Trials
Volume6
Issue number6
DOIs
StatePublished - 2009

Fingerprint

Phytotherapy
Prostatic Hyperplasia
Complementary Therapies
Serenoa
Clinical Trials
Placebos
5-alpha Reductase Inhibitors
Adrenergic alpha-Antagonists
Receptors, Adrenergic, alpha
Lower Urinary Tract Symptoms
Transurethral Resection of Prostate
Adrenergic Agents
Prostate
Fruit
Therapeutics
Hot Temperature
Morbidity

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology

Cite this

Redesigning a large-scale clinical trial in response to negative external trial results : The CAMUS study of phytotherapy for benign prostatic hyperplasia. / Lee, Jeannette; Andriole, Gerald; Avins, Andrew; Crawford, E. David; Foster, Harris; Kaplan, Steven; Kreder, Karl; Kusek, John; McCullough, Andrew; McVary, Kevin; Melatha, Sreeleth; Naslund, Michael; Nickel, J. Curtis; Nyberg, Leroy; Roehrborn, Claus; Williams, O. Dale; Barry, Michael.

In: Clinical Trials, Vol. 6, No. 6, 2009, p. 628-636.

Research output: Contribution to journalArticle

Lee, J, Andriole, G, Avins, A, Crawford, ED, Foster, H, Kaplan, S, Kreder, K, Kusek, J, McCullough, A, McVary, K, Melatha, S, Naslund, M, Nickel, JC, Nyberg, L, Roehrborn, C, Williams, OD & Barry, M 2009, 'Redesigning a large-scale clinical trial in response to negative external trial results: The CAMUS study of phytotherapy for benign prostatic hyperplasia', Clinical Trials, vol. 6, no. 6, pp. 628-636. https://doi.org/10.1177/1740774509352199
Lee, Jeannette ; Andriole, Gerald ; Avins, Andrew ; Crawford, E. David ; Foster, Harris ; Kaplan, Steven ; Kreder, Karl ; Kusek, John ; McCullough, Andrew ; McVary, Kevin ; Melatha, Sreeleth ; Naslund, Michael ; Nickel, J. Curtis ; Nyberg, Leroy ; Roehrborn, Claus ; Williams, O. Dale ; Barry, Michael. / Redesigning a large-scale clinical trial in response to negative external trial results : The CAMUS study of phytotherapy for benign prostatic hyperplasia. In: Clinical Trials. 2009 ; Vol. 6, No. 6. pp. 628-636.
@article{6a39f27748ea44569bdb7871a68b1993,
title = "Redesigning a large-scale clinical trial in response to negative external trial results: The CAMUS study of phytotherapy for benign prostatic hyperplasia",
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.",
author = "Jeannette Lee and Gerald Andriole and Andrew Avins and Crawford, {E. David} and Harris Foster and Steven Kaplan and Karl Kreder and John Kusek and Andrew McCullough and Kevin McVary and Sreeleth Melatha and Michael Naslund and Nickel, {J. Curtis} and Leroy Nyberg and Claus Roehrborn and Williams, {O. Dale} and Michael Barry",
year = "2009",
doi = "10.1177/1740774509352199",
language = "English (US)",
volume = "6",
pages = "628--636",
journal = "Clinical Trials",
issn = "1740-7745",
publisher = "SAGE Publications Ltd",
number = "6",

}

TY - JOUR

T1 - Redesigning a large-scale clinical trial in response to negative external trial results

T2 - The CAMUS study of phytotherapy for benign prostatic hyperplasia

AU - Lee, Jeannette

AU - Andriole, Gerald

AU - Avins, Andrew

AU - Crawford, E. David

AU - Foster, Harris

AU - Kaplan, Steven

AU - Kreder, Karl

AU - Kusek, John

AU - McCullough, Andrew

AU - McVary, Kevin

AU - Melatha, Sreeleth

AU - Naslund, Michael

AU - Nickel, J. Curtis

AU - Nyberg, Leroy

AU - Roehrborn, Claus

AU - Williams, O. Dale

AU - Barry, Michael

PY - 2009

Y1 - 2009

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=77149124569&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=77149124569&partnerID=8YFLogxK

U2 - 10.1177/1740774509352199

DO - 10.1177/1740774509352199

M3 - Article

VL - 6

SP - 628

EP - 636

JO - Clinical Trials

JF - Clinical Trials

SN - 1740-7745

IS - 6

ER -