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MEDICAL: TREATMENTS:
Saw Palmetto no More Effective than Placebo for Urinary Symptoms
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Date: Tue, 27 Sep 2011 16:07:43 -0400
From: "NIH OLIB (NIH/OD)" <[log in to unmask]>
To: [log in to unmask]
Subject: Saw Palmetto no More Effective than Placebo for Urinary Symptoms
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U.S. Department of Health and Human Services
NATIONAL INSTITUTES OF HEALTH NIH News
National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK)
http://www.niddk.nih.gov/
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Embargoed for Release: Tuesday, September 27, 2011, 4 p.m. EDT
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CONTACT:
Bill Polglase
301-496-3583
e-mail:
[log in to unmask]
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SAW PALMETTO NO MORE EFFECTIVE THAN PLACEBO FOR URINARY SYMPTOMS
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NIH-funded study finds dietary supplement does not alleviate BPH
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Saw palmetto, a widely used herbal dietary supplement, does not reduce
urinary problems associated with prostate enlargement any better than a
placebo, according to research funded by the National Institutes of
Health. The study was published Sept. 28 in the Journal of the American
Medical Association.
Prostate enlargement, also called benign prostatic hyperplasia (BPH), can
cause frequent urination, a weak or intermittent urine stream and an
inability to empty the bladder completely. More than half of men in their
60s, and up to 90 percent in their 70s and 80s, have symptoms of BPH.
The National Institute of Diabetes and Digestive and Kidney Diseases
(NIDDK), the National Center for Complementary and Alternative Medicine
(NCCAM) and the Office of Dietary Supplements (ODS) supported the study.
All are part of the NIH.
According to Robert A. Star, M.D., director of the NIDDK's Division of
Kidney, Urologic and Hematologic Diseases, the current study met an
important need for rigorous evaluation of standard and higher doses of saw
palmetto. The trial also confirmed results of the earlier NIDDK- and
NCCAM-sponsored Saw Palmetto Trial for Enlarged Prostates (STEP), which
found that a standard daily dose of 320 milligrams provided no greater
symptom relief than placebo.
"Investigators designed the current trial to determine whether daily doses
of up to 960 milligrams - three times the standard daily dose -- would
prove better than a placebo at improving lower urinary tract symptoms in
men due to BPH," said Star. "We were disappointed to find that higher
doses of saw palmetto did not improve symptoms more than placebo."
Josephine P. Briggs, M.D., director of NCCAM, added that this study
further illustrates the importance of conducting research on botanical
products that are used extensively by the general public.
"This was a well-designed study that addressed limitations of earlier,
smaller trials - it was a multicenter study with a larger sample size and
tested different doses of a carefully analyzed saw palmetto product,"
Briggs said. "The NIH is committed to bringing rigorous science to the
study of natural products and to building the evidence base that can guide
consumer decisions."
The study was a double-blind randomized placebo-controlled clinical trial
conducted at 11 North American clinical sites from June 2008 to October
2010. A cohort of 369 men aged 45 years or older participated, each with
a peak urine flow rate of at least four milliliters per second at the
beginning of the study -- which is less than normal. Also, all had an
American Urological Association Symptom Index (AUASI) score of between
eight and 24 -- a lower score is better. The AUASI score ranges from zero
to 35. Escalating doses of saw palmetto or placebo were given, starting
at one, then two, and then three pills of 320 milligrams per day, with
dose increases at 24 and 48 weeks.
The study measured the differences between the AUASI score at the start of
the trial and after 72 weeks of treatment. Secondary measures included
improvements in frequency, nocturia (nighttime urination), peak urine
flow, prostate-specific antigen (PSA) level, sexual function, incontinence
and sleep quality.
Between baseline and 72 weeks, mean AUASI scores decreased from 14.4 to
12.2 points with saw palmetto extract and from 14.7 to 11.7 points with
placebo. The group average change in AUASI score from baseline to 72
weeks between the saw palmetto and placebo groups was 0.79 points,
favoring placebo. Saw palmetto was not more effective than placebo in
reducing urinary symptoms for any of the secondary outcomes.
According to Joseph M. Betz, Ph.D., director of the Analytical Methods and
Reference Materials program at ODS and a study co-author, the study used a
very well-characterized saw palmetto product. Through batch testing,
study investigators took extreme care to ensure that the composition of
the supplement was consistent over the whole study.
"Saw palmetto and other herbs are often manufactured in different ways, so
no two brands are likely to have the same composition," Betz said.
Rottapharm/Madaus, Cologne, Germany, donated the saw palmetto extract and
matching placebo used in the study.
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For more information on the trial, search for NCT00603304 at
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http://www.clinicaltrials.gov
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Learn about BPH at
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http://kidney.niddk.nih.gov/kudiseases/pubs/prostateenlargement
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To interview an NIH official or scientist, contact:
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Bill Polglase
NIDDK
301-435-8115
or
301-496-3583
(BPH and urinary symptoms)
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NCCAM Press
NCCAM
301-496-7790
(complementary and alternative medicine)
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Kelli Marciel
ODS
301-496-4819
(dietary supplements)
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The NIDDK, a component of the NIH, conducts and supports research on
diabetes and other endocrine and metabolic diseases; digestive diseases,
nutrition and obesity; and kidney, urologic and hematologic diseases.
Spanning the full spectrum of medicine and afflicting people of all ages
and ethnic groups, these diseases encompass some of the most common,
severe and disabling conditions affecting Americans. For more information
about the NIDDK and its programs, see
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http://www.niddk.nih.gov
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The NCCAM's mission is to define, through rigorous scientific
investigation, the usefulness and safety of complementary and alternative
medicine (CAM) interventions and their roles in improving health and
health care. For additional information, call NCCAM's Clearinghouse toll
free at
1-888-644-6226
or visit the NCCAM Web site at
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http://nccam.nih.gov
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The mission of the NIH ODS is to strengthen knowledge and understanding of
dietary supplements by evaluating scientific information, stimulating and
supporting research, disseminating research results, and educating the
public to foster an enhanced quality of life and health for the U.S.
population. For additional information about ODS, visit
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http://ods.od.nih.gov
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About the National Institutes of Health (NIH): NIH, the nation's medical
research agency, includes 27 Institutes and Centers and is a component of
the U.S. Department of Health and Human Services. NIH is the primary
federal agency conducting and supporting basic, clinical, and
translational medical research, and is investigating the causes,
treatments, and cures for both common and rare diseases. For more
information about NIH and its programs, visit
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http://www.nih.gov
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##
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This NIH News Release is available online at:
http://www.nih.gov/news/health/sep2011/niddk-27.htm
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Sincerely,
David Dillard
Temple University
(215) 204 - 4584
[log in to unmask]
http://daviddillard.businesscard2.com
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