Benign prostatic hyperplsia (BPH) is the most common non-malignant neoplasn in the aging male. The number of 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 phytoterapy, to prevent and manage health care needs has Increased dramaticaly in recent years. The use of phytotherapy to relieve lower urinary tract symptoms, particularly BPH, has spurred interest in Serenoa repens (Saw palmetto). The primary objective of the study is to determine if Serenoa repens extract reduces the AUA symptoms score compared to placebo over 72 weeks. The overall goal of this study is to compare the efficacy of a widely available phytotherapy, extract of berries of Serenoa repens, against placebo in terms of impact on lower urinary tract symptoms. The phytotherapy selected for study has demonstrated short-term efficacy at relieving LUTS with minimal side effects in a number of clinical trials. However, a recent NIDDK/NCCAM supported trial of a different preparation of Serenoa repens at the 320 mg daily dose versus placebo did not demonstrate efficacy in terms of symptom reduction over 12 months of follow-up. As a result, this study is being conducted to compare higher-than-standard (double and triple) doses of this agent to determine its short-term effect on lower urinary tract symptoms and other parameters of BPH disease severity, and whether there is sufficient short-term efficacy and tolerability to merit testing for long-term efficacy in a long-term trial focused on the prevention of BPH progression. Because CAMUS will use doses of this agent higher than generally used, participants will be monitored closely for toxicity/tolerability and have their doses slowly increased at 24-week intervals. Yale has consistently demonstrated an outstanding ability to implement this protocol throughout all phases

Public Health Relevance

With a growing interest in the use of complementary and alternative therapies in this country, specifically agents targeting prostate health, the results of this study will provide much needed data on the efficacy, safety and side effects of Serenoa repens

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Research Project--Cooperative Agreements (U01)
Project #
2U01DK063862-08
Application #
7991900
Study Section
Special Emphasis Panel (ZDK1-GRB-R (M2))
Program Officer
Kusek, John W
Project Start
2002-09-30
Project End
2011-06-30
Budget Start
2010-09-20
Budget End
2011-06-30
Support Year
8
Fiscal Year
2010
Total Cost
$101,787
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
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
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; 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