Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Saw palmetto no more effective than placebo for urinary symptoms

28.09.2011
NIH-funded study finds dietary supplement does not alleviate BPH

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.

For more information on the trial, search for NCT00603304 at www.clinicaltrials.gov. Learn about BPH at http://kidney.niddk.nih.gov/kudiseases/pubs/prostateenlargement.

To interview an NIH official or scientist, contact:

Bill Polglase, NIDDK, 301-435-8115 or 301-496-3583(BPH and urinary symptoms)

NCCAM Press, NCCAM, 301-496-7790 (complementary and alternative medicine)

Kelli Marciel, ODS, 301-496-4819 (dietary supplements)

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 www.niddk.nih.gov.

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 nccam.nih.gov.

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 ods.od.nih.gov.

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 www.nih.gov.

Bill Polglase | EurekAlert!
Further information:
http://www.nih.gov

Further reports about: BPH NCCAM NIH dietary supplement health services kidney disease medical research

More articles from Health and Medicine:

nachricht Team discovers how bacteria exploit a chink in the body's armor
20.01.2017 | University of Illinois at Urbana-Champaign

nachricht Rabies viruses reveal wiring in transparent brains
19.01.2017 | Rheinische Friedrich-Wilhelms-Universität Bonn

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Traffic jam in empty space

New success for Konstanz physicists in studying the quantum vacuum

An important step towards a completely new experimental access to quantum physics has been made at University of Konstanz. The team of scientists headed by...

Im Focus: How gut bacteria can make us ill

HZI researchers decipher infection mechanisms of Yersinia and immune responses of the host

Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...

Im Focus: Interfacial Superconductivity: Magnetic and superconducting order revealed simultaneously

Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.

While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...

Im Focus: Studying fundamental particles in materials

Laser-driving of semimetals allows creating novel quasiparticle states within condensed matter systems and switching between different states on ultrafast time scales

Studying properties of fundamental particles in condensed matter systems is a promising approach to quantum field theory. Quasiparticles offer the opportunity...

Im Focus: Designing Architecture with Solar Building Envelopes

Among the general public, solar thermal energy is currently associated with dark blue, rectangular collectors on building roofs. Technologies are needed for aesthetically high quality architecture which offer the architect more room for manoeuvre when it comes to low- and plus-energy buildings. With the “ArKol” project, researchers at Fraunhofer ISE together with partners are currently developing two façade collectors for solar thermal energy generation, which permit a high degree of design flexibility: a strip collector for opaque façade sections and a solar thermal blind for transparent sections. The current state of the two developments will be presented at the BAU 2017 trade fair.

As part of the “ArKol – development of architecturally highly integrated façade collectors with heat pipes” project, Fraunhofer ISE together with its partners...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Sustainable Water use in Agriculture in Eastern Europe and Central Asia

19.01.2017 | Event News

12V, 48V, high-voltage – trends in E/E automotive architecture

10.01.2017 | Event News

2nd Conference on Non-Textual Information on 10 and 11 May 2017 in Hannover

09.01.2017 | Event News

 
Latest News

Helmholtz International Fellow Award for Sarah Amalia Teichmann

20.01.2017 | Awards Funding

An innovative high-performance material: biofibers made from green lacewing silk

20.01.2017 | Materials Sciences

Ion treatments for cardiac arrhythmia — Non-invasive alternative to catheter-based surgery

20.01.2017 | Life Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>