Serenoa repens (saw palmetto) and Pygeum africanum appear to have modest benefit on the pathophysiology of established benign prostatic hyperplasia (BPH) but even more importantly these agents may affect the pathogenesis of the progressive disease process. Almost every individual study, systematic review and meta-analysis report analyzing the effect of these phytotherapeutic agents on BPH have come to the same conclusion: further research is needed to determine the long term safety and effectiveness and ability to prevent complications associated with progressive BPH. The primary objective of this study is to determine if serenoa repens or pygeum africanum delays or prevents clinical progression of benign prostatic hyperplasia compared to placebo treatment. Secondary objectives will compare relative efficacy of these two treatments and also determine whether either of these agents ameliorate symptoms of BPH, improve BPH specific quality of life, improve maximum flow rate and reduce residual urine in men with BPH. Men with mild to moderate symptoms of BPH who do not desire or require immediate medical or surgical treatment will be randomized to placebo, serenoa repens or pygeum africanum after placebo run in and will be followed for disease progression for a minimum of four years. Progression will be defined as an increase in AUA symptom score of 4 or more points from baseline, or occurrence of any of the following complications of BPH; acute urinary retention, incontinence, obstructive uropathy (measured as increased creatinine) or BPH related urinary tract infection. The Canadian BPH Research Group (Canadian CETC) have demonstrated experience and expertise in designing and implementing multi-center clinical trials in BPH and are the most successful research group in Canada in recruiting patients to multi-center BPH trials. The principal investigator has been a successful and effective collaborator in studies funded by NIH-NIDDK. The members of this group have demonstrated their willingness and ability to work in an effective and congenial manner in collaborative international multi-center studies including NIH sponsored collaborative groups. The Canadian BPH study group would be a valuable partner in the proposed NIH phytotherapeutic BPH prevention trial.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01DK063797-01
Application #
6586962
Study Section
Special Emphasis Panel (ZDK1-GRB-3 (O2))
Program Officer
Kusek, John W
Project Start
2003-09-30
Project End
2009-03-31
Budget Start
2003-09-30
Budget End
2004-03-31
Support Year
1
Fiscal Year
2003
Total Cost
$276,990
Indirect Cost
Name
Queen's University at Kingston
Department
Type
DUNS #
207884032
City
Kingston
State
ON
Country
Canada
Zip Code
K7 3-N6
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Barry, Michael J; Cantor, Alan; Roehrborn, Claus G et al. (2013) Relationships among participant international prostate symptom score, benign prostatic hyperplasia impact index changes and global ratings of change in a trial of phytotherapy in men with lower urinary tract symptoms. J Urol 189:987-92
Andriole, Gerald L; McCullum-Hill, Christie; Sandhu, Gurdarshan S et al. (2013) The effect of increasing doses of saw palmetto fruit extract on serum prostate specific antigen: analysis of the CAMUS randomized trial. J Urol 189:486-92
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Barry, Michael J; Avins, Andrew L; Meleth, Sreelatha et al. (2011) Performance of the American Urological Association Symptom Index with and without an additional urge incontinence item. Urology 78:550-4
Barry, Michael J; Meleth, Sreelatha; Lee, Jeannette Y et al. (2011) Effect of increasing doses of saw palmetto extract on lower urinary tract symptoms: a randomized trial. JAMA 306:1344-51
Helfand, Brian T; McVary, Kevin T; Meleth, Sreelatha et al. (2011) The relationship between lower urinary tract symptom severity and sleep disturbance in the CAMUS trial. J Urol 185:2223-8
Lee, Jeannette Y; Foster Jr, Harris E; McVary, Kevin T et al. (2011) Recruitment of participants to a clinical trial of botanical therapy for benign prostatic hyperplasia. J Altern Complement Med 17:469-72
Lee, Jeannette; Andriole, Gerald; Avins, Andrew et al. (2009) Redesigning a large-scale clinical trial in response to negative external trial results: the CAMUS study of phytotherapy for benign prostatic hyperplasia. Clin Trials 6:628-36
Nickel, J Curtis; Roehrborn, Claus G; O'Leary, Michael P et al. (2008) The relationship between prostate inflammation and lower urinary tract symptoms: examination of baseline data from the REDUCE trial. Eur Urol 54:1379-84

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