Benign prostatic hyperplasia (BPH) is the most common non-malignant neoplasm in the aging male. The number of men with lower urinary tract symptoms secondary to BPH, is expected to increase substantially as the population ages. Interest in using complementary and alternative medicines, such as phytotherapy, to prevent and manage health care needs has increased dramatically in recent years. The use of phytotherapy to relieve lower urinary tract symptoms, particularly BPH, has spurred interest in Serenoa repens (Saw palmetto) and Pygeum africanum. Both phytotherapeutic agents are used extensively in this country to relieve symptoms of BPH, but little is known about their mechanism of action, efficacy, safety, or the side effects. Although a number of randomized placebo-controlled trials have been published, all suffer from a variety of shortcomings. A long-term randomized placebo-controlled trial is needed to determine if Serenoa repens or Pygeum africanum prevents clinical progression of BPH. Secondary objectives should include a direct comparison of the two phytotherapeutic agents in their ability to improve the symptoms of BPH, the relationship between prostate size and clinical progression of BPH or regression of symptoms, and the ability of objective diagnostic studies to determine which patients are optimal candidates for phytotherapy. The primary goal of this application is to emphasize the ability of Yale University School of Medicine and Yale New Haven Hospital to successfully implement this protocol so that quality data is obtained to achieve the goals of a final protocol yet to be determined. The advantages of this site include: 1) investigators with recent experience in successfully implementing similar including National Institutes of Health (NIH)-sponsored] protocols;2) an institution with the necessary infrastructure and experience in participating in large multi-center protocols;3) the presence of the university in an ethnically and socioeconomically diverse community;and 4) peripheral sites in minority communities, that can facilitate inclusion of the historically underserved. The above characteristics and strategies make the Yale University School of Medicine and the Yale-New Haven Hospital an outstanding candidate for a Clinical Center.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01DK063862-07
Application #
7614441
Study Section
Special Emphasis Panel (ZDK1-GRB-3 (O2))
Program Officer
Kusek, John W
Project Start
2002-09-30
Project End
2010-09-19
Budget Start
2009-04-01
Budget End
2010-09-19
Support Year
7
Fiscal Year
2009
Total Cost
$307,457
Indirect Cost
Name
Yale University
Department
Surgery
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Lee, Jeannette Y; Moore, Page; Kusek, John et al. (2014) Treatment assignment guesses by study participants in a double-blind dose escalation clinical trial of saw palmetto. J Altern Complement Med 20:48-52
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
Helfand, Brian T; Lee, Jeanette Y; Sharp, Victoria et al. (2012) Associations between improvements in lower urinary tract symptoms and sleep disturbance over time in the CAMUS trial. J Urol 188:2288-93
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