Saw Palmetto Extract in Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Saw Palmetto Extract In Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00037154
• Other study ID #: 5 R01 DK056199 (completed)
• Status: Completed
• Phase: Phase 3
• First received: May 16, 2002
• Last updated: January 12, 2010
• Start date: August 1999
• Est. completion date: December 2002

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• Saw Palmetto

Locations

Country	Name	City	State
United States	Northern California Kaiser Permanente	Oakland	California
United States	Veterans Affairs Medical Center	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bent S, Kane C, Shinohara K, Neuhaus J, Hudes ES, Goldberg H, Avins AL. Saw palmetto for benign prostatic hyperplasia. N Engl J Med. 2006 Feb 9;354(6):557-66. — View Citation