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

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Research Project--Cooperative Agreements (U01)
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Special Emphasis Panel (ZDK1-GRB-R (M2))
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Kusek, John W
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Yale University
Schools of Medicine
New Haven
United States
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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
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