Saw Palmetto Extract in Benign Prostatic Hyperplasia
Saw Palmetto Extract in Benign Prostatic Hyperplasia
The purpose of this study is to test whether an extract of the saw palmetto plant is
 effective for relieving symptoms of Benign Prostatic Hyperplasia (BPH).
This proposal describes a double-blind, placebo-controlled randomized clinical trial of the
 effect of saw palmetto extract on symptoms, objective parameters of disease severity, and
 quality of life in men with moderate-to-severe benign prostatic hyperplasia. BPH, one of the
 most common morbid medical conditions in middle-aged and elderly men, is generally treated
 with alpha-adrenergic blocking agents, finasteride, surgical interventions, or no specific
 therapy ("watchful waiting"). In the past several years, however, many patients have begun to
 self-medicate with an extract of the saw palmetto plant (Serenoa repens), a medicinal herb
 grown in the southeastern United States. Saw palmetto has become the fifth leading medicinal
 herb consumed in the U.S. and is considered first-line therapy for BPH in several Western
 European countries. Several small studies suggest that saw palmetto may have clinical
 benefit, but the methodologic quality of most prior studies has been poor. Very few side
 effects of the herb have been observed, but few studies have been conducted for more than
 three months. We propose to conduct a high-quality clinical trial of saw palmetto, with
 careful attention to the methodologic deficiencies of prior studies. After a single-blind
 placebo run-in period, 224 patients with mode moderate-to-severe BPH (American Urological
 Association Symptom Index score greater than or equal to 8) and objective measurement of
 urinary obstruction, will be randomized to receive either 160mg BID of the herbal extract or
 an identical placebo. Patients will discontinue any other medical therapy for BPH prior to
 enrollment and all participants will undergo a trans-rectal ultrasound examination at
 baseline and closeout. Participants in the trial will be seen at 3-month intervals for a
 total one-year follow-up. Outcome measurements include changes in the AUASI score (the
 primary outcome measurement), the peak urinary flow rate, the post-void residual urine
 volume, the BPH Impact Index, the Olmstead County Study Questionnaire of BPH-specific
 symptoms and quality of life, and the Short-Form 36 (a generic health status instrument).
 Numerous laboratory parameters will measured at intervals throughout the trial and
 symptomatic side effects will be assessed.
Eligibility Criteria:

 -  Participants must be men, aged 50 years or older with moderate-to-severe BPH.

 -  Participants must not have a history of prostate cancer, prior surgery on the
 prostate, kidney failure, or taking furosemide (Lasix), warfarin (Coumadin), or
 hormone medications. Individuals taking medicine for their BPH must stop them for one
 month (prazosin, terazosin (Hytrin), doxazosin (Cardura), tamsulosin (Flomax)) or six
 months (saw palmetto, finasteride (Proscar or Rogaine)) prior to entering the study.