Alternative Therapies for BPH, Multiethnic Variablility

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DESCRIPTION (provided by applicant): Benign prostatic hyperplasia (BPH) is the most common affliction of men over the age of 50. There has been a rapid increase in the use of alternative therapies and specifically, phytotherapuetic agents, to treat BPH. Published studies have focused on the relative efficacy, i.e. symptoms, urinary flow rate and nocturia and side effect profile of these therapies. To date, there have been no studies which have described the natural history of BPH progression in those who are treated with phytotherapeutic agents such as Serenoa repens (Saw palmetto berry) or Pygeurn africanum (African plum tree). Moreover, the natural history of BPH in various age and ethnic groups have been poorly characterized. The Prostate Canter and the The Center for Holistic Urology at The New York Presbyterian Hospital evaluates and treats an ethnically diverse group of more than 3,200 men per year with lower urinary tract symptoms secondary to BPH. It is well positioned to meet the recruitment and patient retention goals as a CETC in this important multi - center, 7 year trial. This trial will provide enormous insight into the progression of BPH and related symptoms in both an untreated population, i.e. placebo versus one treated with phytotherapeutic agents. This is of particular importance because efficacy can be truly determined only with an understanding of the untreated natural history of BPH. Our primary objective is to ascertain if Serenoa repens or Pygeum africanum delays or prevents the clinical progression of BPH. Patients will be classified as 1) Progression of disease as defined by one of the following: rise in baseline AUA Symptom Score of 4 points; urinary retention; incontinence; or recurrent urinary tract infections; 2) Crossover to known therapy, i.e. medical or invasive prior to clinical progression; 3) non - compliance with the coded medication treatment regimen including patients who elect watchful waiting or open - label phytotherapy. Secondary outcomes include comparative efficacy between Serenoa repens and Pygeum africanum as defined by symptoms and urodynamic measurements. Through this full scale BPH trial, we hope to ascertain: A) the effects, if any, of phytotherapeutic agents on the clinical progression of BPH, B) the optimal temporal intervention in the treatment of BPH, C) whether specific ethnic groups manifest various forms of BPH resulting in different rates of progression and differential response to therapy? and, D) whether concomitant prostate conditions such as prostatitis are effected by phytotherapeutic intervention for BPH?