Saw Palmetto No Better Than Placebo For Enlarged Prostate

kruz · 24-03-2006, 08:15 PM

First of all a quick hello to everyone as I haven't been around for a while.

Thought this could be of interest to a lot of people due to the fact that Saw Palmetto is usually recomended to all pro-hormone/steriod users. You might be better of saving your money.

Saw Palmetto No Better Than Placebo For Enlarged Prostate
http://www.medicalnewstoday.com/med...p?newsid=37468#
14 Feb 2006

Saw palmetto, an herbal extract commonly taken to improve urinary symptoms in men with enlargement of the prostate gland, is no more effective than a placebo, according to a new study.

The year-long, double-blind study of 225 men was led by Stephen Bent, MD, a staff physician at the San Francisco VA Medical Center, and Andrew Avins, MD, MPH, of the Northern California Kaiser Permanente Division of Research.

The results are published in the February 9, 2006 issue of the New England Journal of Medicine.

In their study, the researchers randomly assigned patients with enlargement of the prostate, also known as or benign prostate hyperplasia or BPH, to take either saw palmetto or a placebo twice a day for one year. Subjects returned at regular intervals to be assessed for symptoms and side effects. Symptoms were assessed according to a standard symptom score for BPH and objective measures of urinary function.

"If you look at the change in symptoms over time between the two groups, it was almost identical," reports Bent, who is also an assistant professor of medicine at the University of California, San Francisco. "There was no statistically significant difference at any time point during the study."

The researchers also looked at subgroups of patients - those with more and less severe symptoms and those with larger and smaller prostates - and found no difference in any of the subgroups between the herbal extract and placebo.

"The results of this study clearly do not support a strong clinical benefit of saw palmetto for BPH," concludes Bent. "However, whether other doses, formulations, or patient populations might respond differently is unknown."

The researchers estimate that saw palmetto is used by over two million men in the United States for treatment of BPH, which is said by the National Institutes of Health to affect more than 50 percent of men over 60 and upwards of 90 percent of men over 70.

Bent acknowledges that the study results are surprising, since many earlier studies concluded that saw palmetto is effective against BPH. However, he points out a number of differences between the current study and earlier research.

"Prior studies were generally small in size and short in duration," he says. "Plus, the vast majority of them did not use the standard symptom score that we used for assessing the severity of BPH," which is now commonly used to judge the efficacy of pharmaceutical drugs for treatment of the condition.

Another potential problem with earlier studies has to do with the nature of saw palmetto itself, according to Bent. "This is a very pungent herb, and it took our research team a long time to create a placebo that convincingly duplicates its strong smell and taste. We suspect that prior trials didn't adequately address that problem." As a result, he says, "it's possible that some of the positive findings in earlier work may be due to the fact that the blinding wasn't adequate." In other words, patients in those studies knew whether they were taking the herb or the placebo, and "someone who's taking something that's smelly and likely to be the plant extract is perhaps more likely to report a benefit than someone who's taking an odorless and tasteless tablet."

At the end of the current study, 40 percent of patients in the saw palmetto group believed they were taking the herbal extract versus 46 percent in the placebo group, demonstrating that the blinding was adequate, says Bent.

Bent notes that his research team took pains to select an herbal product that matched the levels of fatty acids and sterols - commonly believed to be saw palmetto's active ingredients - found in most commonly available commercial preparations of the herb.

Almost all prior studies of saw palmetto used exactly the same dose, says Bent - 160 milligrams twice a day - and the current study used that dose as well. He notes that such consistency of dose is not typical among studies of most other herbal medications.

The current study subjects reported no statistically significant side effects from saw palmetto.

Bent cautions that while the study is strongly indicative, it is not conclusive. "This is a surprising finding that contradicts the weight of prior evidence," he observes. "There is good reason for other researchers to conduct another study to validate these results, taking care that blinding is done carefully once again."

In addition, says Bent, "Some people believe that higher doses may be potentially effective, and that's an area that we did not address."

A major new NIH-funded study of saw palmetto and another commonly-used herbal treatment for BPH is currently in the final planning stages, according to Avins, who is a co-author of the current study. The new study will involve several hundred patients at 11 centers nationwide, and researchers hope it will shed more definitive light on the questions of adequate doses and other potentially useful natural treatments for BPH, says Avins.

Other co-authors of the current study include Christopher Kane, MD, and Katsuto Shinohara, MD, of SFVAMC; John Neuhaus, PhD, and Esther S. Hudes, PhD, MPH, of UCSF; and Harley Goldberg, DO, of UCSF and KPNC.

###

Original Article: http://content.nejm.org/cgi/content/abstract/354/6/557

flug · 24-03-2006, 08:39 PM

Hi kev, (ps you havnt replied to my email),

As far as i know the active ingredient in Saw Palmetto is Beta-Sitosterol but it contains such minute amounts that it has little to no effect.

Some info on Beta Sitosterol :-

What Is Beta-Sitosterol Used for Today?

Some conditions are luckier than others. For some mysterious reason, there seem to be more useful herbal treatments for BPH than almost any other disease. Beta-sitosterol joins saw palmetto, pygeum, nettle, and grass pollen as a moderately well-documented treatment for BPH.

Based on highly preliminary evidence, it has been suggested that sitosterols may also help strengthen the immune system. 2 In particular, one study suggests that beta-sitosterol can help prevent the temporary immune weakness that typically occurs during recovery from endurance exercise, and can lead to a post-race infection. 3

--------------------------------------------------------------------------------

What Is the Scientific Evidence for Beta-Sitosterol?
A review of the literature, published in 1999, found a total of four double-blind placebo-controlled studies on beta-sitosterol for BPH, enrolling a total of 519 men. 4–7 All but one of these studies found significant benefits in both perceived symptoms and objective measurements, such as urine flow rate.

The largest study followed 200 men with BPH for a period of 6 months. 8 After the trial was completed, many of the participants were followed for an additional year, during which the benefits continued. 9 Similar results were seen in a 6-month double-blind trial of 177 individuals. 10

Beta-sitosterol binds to prostate tissue and affects the metabolism of prostaglandins, substances found in the body that affect pain and inflammation. 1 However, it is not clear whether this is the correct explanation for how beta-sitosterol might help in BPH.

--------------------------------------------------------------------------------

Dosage
The daily dosage of beta-sitosterol is 60 to 135 mg. Effects usually take 4 weeks to develop.

--------------------------------------------------------------------------------

Safety Issues
Although detailed safety studies have not been performed, beta-sitosterol is believed to be safe. No significant side effects or drug interactions have been reported. 11

--------------------------------------------------------------------------------

References

1. Schulz V, Hansel R, Tyler VE. Rational Phytotherapy: A Physicians' Guide to Herbal Medicine. 3rd ed. Berlin, Germany: Springer-Verlag; 1998:231.

2. Pegel KH. The importance of sitosterol and sitosterolin in human and animal nutrition. S Afr J Sci. 1997;93:263–268.

3. Bouic PJD, Clark A, Lamprecht J, et al. The effects of B-sitosterol (BSS) and B-sitosterol glucoside (BSSG) mixture on selected immune parameters of marathon runners: inhibition of post marathon immune suppression and inflammation. Int J Sports Med. 1999;20:258–262.

4. Wilt TJ, MacDonald R, Ishani A. Beta-sitosterol for the treatment of benign prostatic hyperplasia: a systematic review. BJU Int. 1999;83:976–983.

5. Klippel KF, Hiltl DM, Schipp B. A multicentric, placebo-controlled, double-blind clinical trial of beta-sitosterol (phytosterol) for the treatment of benign prostatic hyperplasia. German BPH-Phyto Study group. Br J Urol. 1997;80:427–432.

6. Kadow C, Abrams PH. A double-blind trial of the effect of beta-sitosteryl glucoside (WA184) in the treatment of benign prostatic hyperplasia. Eur Urol. 1986;12:187–189.

7. Berges RR, Windeler J, Trampisch HJ, et al. Randomised, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Beta-sitosterol Study Group. Lancet. 1995;345:1529-1532.

8. Berges RR, Windeler J, Trampisch HJ, et al. Randomised, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Beta-sitosterol Study Group. Lancet. 1995;345:1529–1532.

9. Berges RR, Kassen A, Senge T. Treatment of symptomatic benign prostatic hyperplasia with beta-sitosterol: an 18-month follow-up. BJU Int. 2000;85:842–846.

10. Klippel KF, Hiltl DM, Schipp B. A multicentric, placebo-controlled, double-blind clinical trial of beta-sitosterol (phytosterol) for the treatment of benign prostatic hyperplasia. German BPH-Phyto Study group. Br J Urol. 1997;80:427–432.

11. Berges RR, Windeler J, Trampisch HJ, et al. Randomised, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Beta-sitosterol Study Group. Lancet. 1995;345:1529–1532.

razg · 24-03-2006, 09:48 PM

I've read this study before, and it is extremely flawed - there is no positive control, and numerous respectable studies have shown SP to have a beneficial localized effect on the prostate, rather than using 5AR inhibitors which are systematic, and can cause a number of problems.

***Extreme*** · 25-03-2006, 12:08 PM

I agree Razg, if you look hard enough you will find a study to contradict pretty much anything you want.

This is how some of these guys get their 15 minutes of fame, produce a study that flies in the face of convention and you get noticed.

24-03-2006, 08:15 PM	#1 (permalink)
kruz Making Progress Join Date: Dec 2005 Location: honiton, devon Posts: 128 Rep Power:	Saw Palmetto No Better Than Placebo For Enlarged Prostate First of all a quick hello to everyone as I haven't been around for a while. Thought this could be of interest to a lot of people due to the fact that Saw Palmetto is usually recomended to all pro-hormone/steriod users. You might be better of saving your money. Saw Palmetto No Better Than Placebo For Enlarged Prostate http://www.medicalnewstoday.com/med...p?newsid=37468# 14 Feb 2006 Saw palmetto, an herbal extract commonly taken to improve urinary symptoms in men with enlargement of the prostate gland, is no more effective than a placebo, according to a new study. The year-long, double-blind study of 225 men was led by Stephen Bent, MD, a staff physician at the San Francisco VA Medical Center, and Andrew Avins, MD, MPH, of the Northern California Kaiser Permanente Division of Research. The results are published in the February 9, 2006 issue of the New England Journal of Medicine. In their study, the researchers randomly assigned patients with enlargement of the prostate, also known as or benign prostate hyperplasia or BPH, to take either saw palmetto or a placebo twice a day for one year. Subjects returned at regular intervals to be assessed for symptoms and side effects. Symptoms were assessed according to a standard symptom score for BPH and objective measures of urinary function. "If you look at the change in symptoms over time between the two groups, it was almost identical," reports Bent, who is also an assistant professor of medicine at the University of California, San Francisco. "There was no statistically significant difference at any time point during the study." The researchers also looked at subgroups of patients - those with more and less severe symptoms and those with larger and smaller prostates - and found no difference in any of the subgroups between the herbal extract and placebo. "The results of this study clearly do not support a strong clinical benefit of saw palmetto for BPH," concludes Bent. "However, whether other doses, formulations, or patient populations might respond differently is unknown." The researchers estimate that saw palmetto is used by over two million men in the United States for treatment of BPH, which is said by the National Institutes of Health to affect more than 50 percent of men over 60 and upwards of 90 percent of men over 70. Bent acknowledges that the study results are surprising, since many earlier studies concluded that saw palmetto is effective against BPH. However, he points out a number of differences between the current study and earlier research. "Prior studies were generally small in size and short in duration," he says. "Plus, the vast majority of them did not use the standard symptom score that we used for assessing the severity of BPH," which is now commonly used to judge the efficacy of pharmaceutical drugs for treatment of the condition. Another potential problem with earlier studies has to do with the nature of saw palmetto itself, according to Bent. "This is a very pungent herb, and it took our research team a long time to create a placebo that convincingly duplicates its strong smell and taste. We suspect that prior trials didn't adequately address that problem." As a result, he says, "it's possible that some of the positive findings in earlier work may be due to the fact that the blinding wasn't adequate." In other words, patients in those studies knew whether they were taking the herb or the placebo, and "someone who's taking something that's smelly and likely to be the plant extract is perhaps more likely to report a benefit than someone who's taking an odorless and tasteless tablet." At the end of the current study, 40 percent of patients in the saw palmetto group believed they were taking the herbal extract versus 46 percent in the placebo group, demonstrating that the blinding was adequate, says Bent. Bent notes that his research team took pains to select an herbal product that matched the levels of fatty acids and sterols - commonly believed to be saw palmetto's active ingredients - found in most commonly available commercial preparations of the herb. Almost all prior studies of saw palmetto used exactly the same dose, says Bent - 160 milligrams twice a day - and the current study used that dose as well. He notes that such consistency of dose is not typical among studies of most other herbal medications. The current study subjects reported no statistically significant side effects from saw palmetto. Bent cautions that while the study is strongly indicative, it is not conclusive. "This is a surprising finding that contradicts the weight of prior evidence," he observes. "There is good reason for other researchers to conduct another study to validate these results, taking care that blinding is done carefully once again." In addition, says Bent, "Some people believe that higher doses may be potentially effective, and that's an area that we did not address." A major new NIH-funded study of saw palmetto and another commonly-used herbal treatment for BPH is currently in the final planning stages, according to Avins, who is a co-author of the current study. The new study will involve several hundred patients at 11 centers nationwide, and researchers hope it will shed more definitive light on the questions of adequate doses and other potentially useful natural treatments for BPH, says Avins. Other co-authors of the current study include Christopher Kane, MD, and Katsuto Shinohara, MD, of SFVAMC; John Neuhaus, PhD, and Esther S. Hudes, PhD, MPH, of UCSF; and Harley Goldberg, DO, of UCSF and KPNC. ### Original Article: http://content.nejm.org/cgi/content/abstract/354/6/557

25-03-2006, 12:08 PM	#4 (permalink)
*Extreme* Super Moderator Super Moderator Join Date: Oct 2004 Location: UK Posts: 1,321 Rep Power:	I agree Razg, if you look hard enough you will find a study to contradict pretty much anything you want. This is how some of these guys get their 15 minutes of fame, produce a study that flies in the face of convention and you get noticed. ______________________ www.extremenutrition.co.uk - 25% OFF FOR ALL MC MEMBERS, discount code MCD25. www.betterbodies.uk.com Seriously cheap sports nutrition! Dorian Yates Ultimate Protein 908g with free T-shirt NOW ONLY £14.95!

Thread Tools
Show Printable Version Email this Page
Display Modes
Linear Mode Switch to Hybrid Mode Switch to Threaded Mode

24-03-2006, 08:39 PM	#2 (permalink)
flug Making Progress Join Date: Jul 2005 Location: essex Posts: 110 Rep Power:	Hi kev, (ps you havnt replied to my email), As far as i know the active ingredient in Saw Palmetto is Beta-Sitosterol but it contains such minute amounts that it has little to no effect. Some info on Beta Sitosterol :- What Is Beta-Sitosterol Used for Today? Some conditions are luckier than others. For some mysterious reason, there seem to be more useful herbal treatments for BPH than almost any other disease. Beta-sitosterol joins saw palmetto, pygeum, nettle, and grass pollen as a moderately well-documented treatment for BPH. Based on highly preliminary evidence, it has been suggested that sitosterols may also help strengthen the immune system. 2 In particular, one study suggests that beta-sitosterol can help prevent the temporary immune weakness that typically occurs during recovery from endurance exercise, and can lead to a post-race infection. 3 -------------------------------------------------------------------------------- What Is the Scientific Evidence for Beta-Sitosterol? A review of the literature, published in 1999, found a total of four double-blind placebo-controlled studies on beta-sitosterol for BPH, enrolling a total of 519 men. 4–7 All but one of these studies found significant benefits in both perceived symptoms and objective measurements, such as urine flow rate. The largest study followed 200 men with BPH for a period of 6 months. 8 After the trial was completed, many of the participants were followed for an additional year, during which the benefits continued. 9 Similar results were seen in a 6-month double-blind trial of 177 individuals. 10 Beta-sitosterol binds to prostate tissue and affects the metabolism of prostaglandins, substances found in the body that affect pain and inflammation. 1 However, it is not clear whether this is the correct explanation for how beta-sitosterol might help in BPH. -------------------------------------------------------------------------------- Dosage The daily dosage of beta-sitosterol is 60 to 135 mg. Effects usually take 4 weeks to develop. -------------------------------------------------------------------------------- Safety Issues Although detailed safety studies have not been performed, beta-sitosterol is believed to be safe. No significant side effects or drug interactions have been reported. 11 -------------------------------------------------------------------------------- References 1. Schulz V, Hansel R, Tyler VE. Rational Phytotherapy: A Physicians' Guide to Herbal Medicine. 3rd ed. Berlin, Germany: Springer-Verlag; 1998:231. 2. Pegel KH. The importance of sitosterol and sitosterolin in human and animal nutrition. S Afr J Sci. 1997;93:263–268. 3. Bouic PJD, Clark A, Lamprecht J, et al. The effects of B-sitosterol (BSS) and B-sitosterol glucoside (BSSG) mixture on selected immune parameters of marathon runners: inhibition of post marathon immune suppression and inflammation. Int J Sports Med. 1999;20:258–262. 4. Wilt TJ, MacDonald R, Ishani A. Beta-sitosterol for the treatment of benign prostatic hyperplasia: a systematic review. BJU Int. 1999;83:976–983. 5. Klippel KF, Hiltl DM, Schipp B. A multicentric, placebo-controlled, double-blind clinical trial of beta-sitosterol (phytosterol) for the treatment of benign prostatic hyperplasia. German BPH-Phyto Study group. Br J Urol. 1997;80:427–432. 6. Kadow C, Abrams PH. A double-blind trial of the effect of beta-sitosteryl glucoside (WA184) in the treatment of benign prostatic hyperplasia. Eur Urol. 1986;12:187–189. 7. Berges RR, Windeler J, Trampisch HJ, et al. Randomised, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Beta-sitosterol Study Group. Lancet. 1995;345:1529-1532. 8. Berges RR, Windeler J, Trampisch HJ, et al. Randomised, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Beta-sitosterol Study Group. Lancet. 1995;345:1529–1532. 9. Berges RR, Kassen A, Senge T. Treatment of symptomatic benign prostatic hyperplasia with beta-sitosterol: an 18-month follow-up. BJU Int. 2000;85:842–846. 10. Klippel KF, Hiltl DM, Schipp B. A multicentric, placebo-controlled, double-blind clinical trial of beta-sitosterol (phytosterol) for the treatment of benign prostatic hyperplasia. German BPH-Phyto Study group. Br J Urol. 1997;80:427–432. 11. Berges RR, Windeler J, Trampisch HJ, et al. Randomised, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Beta-sitosterol Study Group. Lancet. 1995;345:1529–1532.

24-03-2006, 09:48 PM	#3 (permalink)
razg Legend Join Date: Nov 2004 Location: Birmingham/Bristol Posts: 887 Rep Power:	I've read this study before, and it is extremely flawed - there is no positive control, and numerous respectable studies have shown SP to have a beneficial localized effect on the prostate, rather than using 5AR inhibitors which are systematic, and can cause a number of problems.