Saw Palmetto Extract in Benign Prostatic Hyperplasia

• ClinicalTrials.gov Identifier: NCT00037154
• Recruitment Status: Completed
• First Posted: May 17, 2002
• Last Update Posted: January 14, 2010
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: National Center for Complementary and Integrative Health (NCCIH)
• Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Benign Prostatic Hyperplasia	Drug: Saw Palmetto	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Saw Palmetto Extract In Benign Prostatic Hyperplasia
• Study Start Date: August 1999
• Study Completion Date: December 2002

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Northern California Kaiser Permanente

Oakland, California, United States, 94611

Veterans Affairs Medical Center

San Francisco, California, United States, 94121

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Andrew Avins, MD, MPH; Northern California Kaiser Permanente; University of California, San Francisco; San Francisco Veterans Affairs Medical Center
• Study Director: Stephen Bent, MD; University of California, San Francisco; San Francisco Veterans Affairs Medical Center

More Information

Publications of Results:

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. doi: 10.1056/NEJMoa053085.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Avins AL, Bent S, Padula A, Staccone S, Badua E, Goldberg H. Initial experience with a group presentation of study results to research participants. Trials. 2008 Mar 21;9:16. doi: 10.1186/1745-6215-9-16.

• ClinicalTrials.gov Identifier: NCT00037154
• Other Study ID Numbers: 5 R01 DK056199 (completed)
• First Posted: May 17, 2002
• Last Update Posted: January 14, 2010
• Last Verified: January 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Benign Prostatic Hyperplasia; Herbal Therapies; Complementary and Alternative Medicine; Men's Health

Additional relevant MeSH terms:

Prostatic Hyperplasia; Hyperplasia; Pathologic Processes; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Saw palmetto extract; Urological Agents