Beta-sitosterol is in your diet in common foods we eat every day but only in small amounts. It is considered safe and without serious side effects.

Beta-sitosterol is a plant sterol. The most common source of beta-sitosterol is the soybean due to the fact that it is rich in beta-sitosterol.

Nutritionists recognize two classes of phytosterols: (1) sterols, which have a double bond in the sterol ring; and (2) stanols, which lack a double bond in the sterol ring .

A mixed Phytosterol complex contains the following distinct plant sterols:

1) Beta-sitosterol
2) Campesterol
3) Stigmasterol

There are distinct structural differences between the above three plant sterols.
In the case of prostate health, it is beta-sitosterol that has been studied and reported to provide relief with respect to the symptoms associated with an enlarged prostate.

It should be noted that the FDA allows manufacturers to claim that foods containing plant sterol esters such as beta-sitosterol are for reducing the risk of coronary heart disease (CHD). This rule is based on the FDA's conclusion that plant sterol esters may reduce the risk of CHD by lowering blood cholesterol levels. The FDA has requirements for a minimum daily dose is at least 1.3 grams (1200 mg) of beta-sitosterol daily. In addition the beta-sitosterol should be taken .5 to 1 hours before the meal in divided dosages.

******Best Prostate ® does not meet this requirement due to daily dose of 620 mg in 2 capsules.

Known side effects for Beta-sitosterol have been reported in a small group of individuals that are hypersensitive to the ingredient Beta-sitosterol.  The side effect reported is generally a rash with itching.  If these side effects are experienced one should discontinue the product. Individuals who take 3000 to 4000 mg per day have reported nausea, indigestion, gas, diarrhea or constipation.

Prostate enlargement is becoming increasingly common as men are living longer lives. About 30 million men suffer from benign prostatic hypertrophy (BPH). BPH is the most common disorder of the prostate1 and it is the most common diagnosis by urologists for male patients age 45-74.2 There is a 50 percent chance that you will have prostate problems or symptoms by the time you are 60.3 Each year more than 500,000 men in North America have prostate surgery; and more than a billion dollars a year is spent on the treatment of prostate problems. Prostate surgery often results in both incontinence and impotence and can result in men living a life without sexual intercourse. Unfortunately studies have confirmed that saw palmetto is not an effective remedy for enlarged prostate based upon information published by: Bent S, Kane C, et al. "Saw palmetto for benign prostatic hyperplasia." New England Journal of Medicine, 2006; 354:557-66. The green buttons to the left provide additional information with respect to beta-sitosterol, the prostate gland, saw palmetto, and a comparison of prostate supplements.

Beta-Sitosterol has been recommended by physicians in Europe for over 20 years as a natural supplement to promote prostate health.

Information about Beta-sitosterol:

Helps to reduce waking at night due to constant urge to urinate*4
Helps to Increase Urinary Flow and Promotes Healthy Urinary Function*5,6
Promotes a Healthy Prostate*4,5,6
Beta-sitosterol has shown benefit in relieving the symptoms of an Enlarged Prostate* 7
Many prostate supplements contain saw palmetto, Pygeum africanum, pumpkin seed oil, stinging nettles, and other plant compounds. The fact is that these ingredients have one thing in common and that is beta-sitosterol. 
Saw Palmetto itself contains a small amount of beta-sitosterol in comparison to the amount of beta-sitiosterol that is made available by manufacturers of beta-sitosterol. It is said that the amount of saw palmetto required to achieve 300 mg of Beta-sitosterol would be in the hundreds of capsules.

1 Issa M, Marshall F. Contemporary Diagnosis and Management of Diseases of the Prostate. 3rd ed. Newtown, Pa:Handbooks in Healthcare Co; 2005.
2 Contemporary Urology/Urology Times 2005 Fact Book. Prepared by Advanstar Medical Economics Healthcare Communications Secondary Research Services.
3 American Urological Association Education and Research, Inc. Guideline on the Management of Benign Prostatic Hyperplasia (BPH). 2003.
4 (Bach D., Ebeling L. Long-term drug treatment of benign prostatic hyperplasia - results of a prospective 3-year multicultural study using Sabal extract IDS 89. Phytomedicine, 3:105-11, 1996)
5 (Berges R.R., Windeler J., Trampisch H.J., et al. Randomised, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Lancet; 345:1529–32, 1995)
6 (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. Br J Urol 1997;80:427-32.)
7 (Wilt T, Ishani A, MacDonald R, Stark G, Mulrow C, Lau J. Beta-sitosterols for benign prostatic hyperplasia. Cochrane Database Syst Rev . 2000:CD001043.)

 

Beta-sitosterol is the miraculous common denominator in saw palmetto, Pygeum africanum, pumpkinseed oil, stinging nettles, and other natural prostate remedies.



Numerous international scientific journals have published scientific studies that prove that beta-sitosterol is the most effective remedy known for prostate problems. Journals like the International Journal of Immunopharmacol, 1996; The Lancet, 1995; European Journal of Drug Metab., 1997; Anticancer Research, 1996; European Patent EP 287,000, Minerva Urologia, 1985; British Journal of Clinical Pharmacology, 1984; Medizinische Klinik, 1982; European Urology, 1992 and 1994, and Fortsher. Med., 1980

The following from excerpt was published by:
LE Magazine Special Edition, Winter 2005/2006
Beta-Sitosterol and the Aging Prostate Gland
by Stephen B. Strum, MD, FACP, and William Faloon

“Remarkable Effects of Beta-Sitosterol"
In a randomized, double-blind, placebo-controlled, multicenter study of 200 men with benign prostate enlargement, half the group received 180 mg of Beta-Sitosterol daily, while the other half received placebo.

After six months, the Beta-Sitosterol group saw improvement in the International Prostate Symptom Score, the measurement of urine flow (Qmax), and the amount of residual urine remaining in the bladder (PVR).1

The Beta-Sitosterol group showed a 7.4-point decrease in the International Prostate Symptom Score, compared to a decrease of only 2.1 points in the placebo group. This was a significant 3.5-fold improvement in the men taking Beta-Sitosterol (Figure 1).1

Figure 1. International Prostate Symptom Scores (IPSS): Beta-Sitosterol vs. Placebo. Data comparing men treated with Beta-Sitosterol to those receiving placebo indicate a significant decrease in symptom scores in the Beta-Sitosterol group after three and six months of treatment.3 In a follow-up study, these improvements were maintained for an additional 18 months of observation.4

The measurement of urinary flow increased to an average of 15.2 milliliters (ml) per second from 9.9 ml/second in the men receiving beta- sitosterol. The placebo group only increased to 11.4 ml/second from 10.2 ml/second at baseline. Urinary flow thus improved almost 35% in the group taking Beta-Sitosterol, compared to only 11% in the placebo group.1

Most remarkably, residual urine in the bladder decreased to 30.4 ml from 65.8 ml in the men using Beta-Sitosterol ... a reduction of almost 54%! In the placebo group, residual bladder urine declined from 64.8 ml to 54.3 ml ... a reduction of only around 16%.1

In a follow-up study that evaluated durability of response to Beta-Sitosterol, the beneficial effects for Beta-Sitosterol were found to be maintained during an additional 18 months of observation.2

Figure 1 shows the significant difference in the International Prostate Symptom Score in men receiving Beta-Sitosterol compared to placebo.

Benefits of Beta-Sitosterol Confirmed

To confirm these remarkable effects of Beta-Sitosterol, another study was performed and the results were published in the British Journal of Urology. The study involved 177 patients with benign prostate enlargement. Patients received 130 mg of Beta-Sitosterol each day and were monitored for more than six months. Measurements of the International Prostate Symptom Score, urinary flow, and residual urine in the bladder after voiding were recorded.3

On average, urinary flow values increased by 4.5 ml/second while residual urine volumes decreased by a substantial 33.5 ml. The International Prostate Symptom Scores showed a statistically significant improvement. These results with Beta-Sitosterol are comparable to those seen with the commonly prescribed drug Proscar®, used to treat benign prostate enlargement.3

Table 1. Summary of Key Randomized Studies of Beta-Sitosterol in BPH Patients. Effects of Beta-Sitosterol on the International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax), and post-void residual volume (PVR) are remarkably consistent. The study by Wilt and colleagues7 examined four different randomized studies.

Two years later, a review of all existing studies of Beta-Sitosterol in the treatment of benign prostate enlargement was conducted. The researchers identified randomized, placebo-controlled, double-blind trials involving a total of 519 men. In three of the trials, Beta-Sitosterol was used, and in one trial, a glucoside of Beta-Sitosterol was used. In these studies, Beta-Sitosterol improved urinary symptom scores and urinary flow rates, and significantly reduced the volume of residual urine in the bladder.4,5 Table 1 summarizes some of the randomized studies of Beta-Sitosterol in the treatment of BPH.

The magnitude of reduction in prostate symptoms and improvement in urinary flow rates is a strong incentive for the use of Beta-Sitosterol, either alone or in combination with standard pharmacologic interventions such as alpha-adrenergic blockers (Cardura®, Hytrin®, Uroxatral®, Flomax®) or 5-alpha reductase inhibitors (Proscar®, Avodart®).

Figure 3. Increasing Prevalence of Lower Urinary Tract Symptoms (LUTS) with Advancing Age. As men age, the prevalence of LUTS increases as a reflection of prostate enlargement.2

Conclusion
As men grow older, cells in their prostate glands often overgrow, causing a swelling that obstructs the bladder opening, resulting in slowness in urination and bladder emptying. This non-malignant enlargement of the prostate gland causes pressure on the urethra, acting like a clamp. The result is a weak urinary stream, hesitancy, and other uncomfortable urinary symptoms such as increased nighttime frequency and urgency. See Figure 3.

While a man aged 31 to 40 has only an 8% chance of having benign prostate enlargement, the risk increases to 40-50% in men aged 51 to 60 and to over 80% in men older than 80.14

For millions of men in America, benign prostate enlargement will severely downgrade their quality of life. Yet across the ocean are drugs that have been shown in carefully controlled studies to alleviate much of the discomfort associated with prostate gland overgrowth.

Europeans use Beta-Sitosterol by itself or in combination with saw palmetto to alleviateurinary symptoms of benign prostate enlargement.

As the word gets out about the documented benefits of Beta-Sitosterol, American consumers can expect to see more prostate support products that contain this low-cost plant sterol.

References
1. Berges RR, Kassen A, Senge T. Treatment of symptomatic benign prostatic hyperplasia with Beta-Sitosterol: an 18-month follow-up. BJU Int. 2000 May;85(7):842-6.

2. Berges RR, Windeler J, Trampisch HJ, Senge T. Randomised, placebo-controlled, double-blind clinical trial of Beta-Sitosterol in patients with benign prostatic hyperplasia. Beta-Sitosterol Study Group. Lancet. 1995 Jun 17;345(8964):1529-32.

3. 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 Sep;80(3):427-32.

4. Wilt TJ, MacDonald R, Ishani A. Beta-Sitosterol for the treatment of benign prostatic hyperplasia: a systematic review. BJU Int. 1999 Jun;83(9):976-83.

5. Wilt T, Ishani A, MacDonald R, Stark G, Mulrow C, Lau J. Beta-Sitosterols for benign prostatic hyperplasia. Cochrane Database Syst Rev. 2000;(2):CD001043.

6. von Holtz RL, Fink CS, Awad AB. Beta-Sitosterol activates the sphingomyelin cycle and induces apoptosis in LNCaP human prostate cancer cells. Nutr Cancer. 1998;32(1):8-12.

7. Duan RD. Anticancer compounds and sphingolipid metabolism in the colon. In Vivo. 2005 Jan-Feb;19(1):293-300.

8. Awad AB, Fink CS, Williams H, Kim U. In vitro and in vivo (SCID mice) effects of phytosterols on the growth and dissemination of human prostate cancer PC-3 cells. Eur J Cancer Prev. 2001 Dec;10(6):507-13.

9. Awad AB, Gan Y, Fink CS. Effect of Beta-Sitosterol, a plant sterol, on growth, protein phosphatase 2A, and phospholipase D in LNCaP cells. Nutr Cancer. 2000;36(1):74-8.

10. Awad AB, Downie A, Fink CS, Kim U. Dietary phytosterol inhibits the growth and metastasis of MDA-MB-231 human breast cancer cells grown in SCID mice. Anticancer Res. 2000 Mar;20(2A):821-4.

11. Awad AB, Downie AC, Fink CS. Inhibition of growth and stimulation of apoptosis by Beta-Sitosterol treatment of MDA-MB-231 human breast cancer cells in culture. Int J Mol Med. 2000 May;5(5):541-5.

12. Awad AB, Williams H, Fink CS. Phytosterols reduce in vitro metastatic ability of MDA-MB-231 human breast cancer cells. Nutr Cancer. 2001;40(2):157-64.

13. Awad AB, Burr AT, Fink CS. Effect of resveratrol and Beta-Sitosterol in combination on reactive oxygen species and prostaglandin release by PC-3 cells. Prostaglandins Leukot Essent Fatty Acids. 2005 Mar;72(3):219-26.

14. Glynn RJ, Campion EW, Bouchard GR, Silbert JE. The development of benign prostatic hyperplasia among volunteers in the Normative Aging Study. Am J Epidemiol. 1985 Jan;121(1):78-90. “