Prostate Supplements Review (Saw Palmetto and
Beta-Sitosterol)
Find the Best Prostate
Supplement for Symptoms of BPH. See Which Prostate Supplement Passed or Failed
CL's Tests of Quality.
Medically reviewed and
edited by Tod Cooperman, M.D.
Last Updated: 11/09/2021 | Initially Posted:
02/23/2021Latest Update: Saw Palmetto Concern
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Table of Contents
Summary
·
Which supplements are used to treat symptoms of an enlarged
prostate? Two popular supplements for treating the urinary symptoms of
benign prostate hyperplasia (BPH) are saw palmetto berry extract and
beta-sitosterol. Beta-sitosterol is a plant sterol (or phytosterol) found in
very small amounts in saw palmetto and more commonly obtained from other plant
sources (see What It Is).
·
What are the health benefits of saw palmetto and what is the
right dose? Well-controlled clinical trials report little to no
benefit with saw palmetto in reducing symptoms of BPH, such a urinary
frequency. (see Saw Palmetto -- What It Does). A typical dose
is 320 mg per day of extract standardized to 85% to 95% fatty acids (see Saw Palmetto -- What to Consider When Buying).
·
What are the health benefits of beta-sitosterol and what is the
right dose? Beta-sitosterol has been found in most, but not all
studies, to significantly improve perceived symptoms of BPH and urine rate flow
(see Beta-Sitosterol — What It Does). Doses used in
clinical studies range from 30 mg to 91 mg daily. At a much higher dosage,
beta-sitosterol can also lower cholesterol levels. (See Beta-Sitosterol — What to Consider When Buying)
·
What did CL's tests of prostate supplements find? ConsumerLab.com's
tests identified a number of saw palmetto and beta-sitosterol supplements that
contained the generally recommended amounts of these ingredients. However, CL
discovered that one saw palmetto supplement had none of the key expected marker
compound for saw palmetto (see What CL Found).
·
Which prostate supplements are the best? Among all of the prostate
supplements approved for their quality in this Review, ConsumerLab
chose a Top Pick for
providing a proper dose of beta-sitosterol for treating symptoms of BPH at a
reasonable price.
·
How safe are prostate supplements made with saw palmetto and/or
beta-sitosterol? Saw palmetto and beta-sitosterol are generally well
tolerated, although some individuals experience nausea or other
gastrointestinal symptoms. Be sure to check with a healthcare professional for
a proper diagnosis before using, since symptoms of enlarged prostate may signal
more serious conditions, such as prostate cancer, that require prompt medical
treatment (see Concerns and Cautions).
What It Is:
Saw Palmetto
Saw palmetto (Serenoa repens) is a type
of palm tree, also known as the dwarf palm, which mainly grows in the United
States. Its primary medicinal value lies in the oily compounds found in its
berries. Most dietary supplements are composed of an extract from the berries
or a berry powder.
Among the main constituents of saw palmetto berry extract are fatty acids and
sterols. The sterols (which include beta-sitosterol) are also present in other
herbs (such as pygeum bark, stinging nettle root, and
pumpkin seed extract) that are used in treating symptoms of prostate
enlargement. Depending on the form of saw palmetto used, e.g., extract or whole
dried berry, certain percentages of its weight should be expected (or
"standardized") to specific fatty acids and specific sterols. These
amounts are based on the composition of saw palmetto products that were shown
to work in some clinical trials. (See How Products Were Evaluated for the
expected amounts of fatty acids and sterols and see ConsumerTips™ for
more information on dosing and usage).
Beta-sitosterol
Beta-sitosterol is a type of phytosterol
(plant-derived cholesterol-like compounds). Sources of beta-sitosterol include
rice bran, wheat germ, corn oils, soybeans, avocados, pecans, and peanuts as
well as saw palmetto, pumpkin seed, pygeum bark, and
stinging nettle root. Extracts of African wild potato (also known as South African
star grass) have been used to produce some clinically studied products
consisting of a mixture of phytosterols in which beta-sitosterol is the main
component.
What It Does:
Saw Palmetto:
Men with enlarged prostates (medically known as benign prostatic
hyperplasia, or BPH) often experience difficulty with urinary
flow, increased frequency and urgency of urination, and a fullness of the
bladder after urination. Saw palmetto is believed to inhibit the actions of
testosterone on the prostate that cause prostate enlargement and interference
with urinary flow. It shrinks the inner epithelium of the prostate, but not the
prostate's overall size. It has been believed that saw palmetto dietary
supplements provide mild to moderate improvement in symptoms of prostate
enlargement. However, the evidence of saw palmetto's benefit is conflicting and
a number of studies have failed to show any benefit over placebo.
A large and well-designed study in the U.S. and Canada
published in 2011 showed no greater improvement with saw palmetto extract than
placebo (Barry, JAMA 2011). As an
extra measure, that study used the standard dose of saw palmetto (320 mg per
day of extract standardized to 85% to 95% fatty acids) as well as twice and
three times the dose, each for 24 weeks. None showed a significant benefit. A
large study published in 2006 also did not show a benefit with a different saw
palmetto extract in men with moderate to severe symptoms.
However, a later study among 296 men in China with mild to
moderate BPH and lower urinary tract symptoms (LUTS) found that 160 mg of saw
palmetto extract taken twice daily (a total daily dose of 320 mg -- percentage
of fatty acids not given) for 5 ½ months modestly improved urinary flow and
decreased overall scores of self-reported symptoms compared to placebo (- 4.39
vs. - 1.62 using the International Prostate Symptom Score (I-PSS) which ranges
from 0 - 35). Nevertheless, supplementation did not decrease urinary frequency,
prostate volume, or prostate-specific antigen (PSA) levels compared to placebo.
None of the men took medications to treat BPH (5-alpha-reductase inhibitors or
alpha-adrenergic blockers) during the study. Two participants who took saw palmetto
experienced mild stomach discomfort and poor appetite (Ye, Urology 2019). Other, more limited
studies, have also shown benefit in men with mild symptoms.
Prescription alpha-blockers, meanwhile, may be more effective than saw
palmetto, and there is mixed evidence as to whether adding saw palmetto to
treatment with alpha-blocker medications is helpful. For example, adding saw
palmetto extract (320 mg daily of a liposterolic
extract) to treatment with the alpha-blocker silodosin (Rapaflo)
(8 mg daily), resulted in greater improvement in symptoms, with no increase in
adverse effects, than with silodosin alone in a study in Italy lasting
approximately 14 months. Young patients with severe symptoms appeared to
benefit most (Boeri, Sci Reports 2018).
In contrast, a study in Turkey using tamsulosin (Flomax) (0.4 mg daily) found
no additional benefit from adding saw palmetto extract (320 mg daily) (Hizli, Int Urol Nephrol 2007).
A trial of saw palmetto (160 mg daily) for 5 weeks prior to transurethral
prostatectomy (TURP) failed to decrease the density of prostatic tissue or
lower the risk of bleeding during the procedure (Tuncel, Scan J Urol Nephrol
2009).
A preliminary study suggested that a saw palmetto extract with
added beta-sitosterol (200 mg of saw palmetto standardized to 85% to 95% fatty
acids and 50 mg of beta-sitosterol, given twice daily) may be effective
against androgenic alopecia (male-pattern baldness). Over the
course of the study, which averaged 4.6 months, improvement was seen in 6 of 10
men receiving the supplement, while only 1 of 9 men who received placebo
experienced improvement (Prager, J Alt Comp Med 2002).
However, the results were not considered to be statistically significant due to
the small size of the study. The researchers noted that larger-scale studies
would be designed, but none have been published to date. In a 2-year study of
healthy men ages 20 to 40 with mild to moderate androgenic alopecia, 38% of
those who took saw palmetto extract (320 mg daily -- percentage of fatty acids
not provided) had an increase in hair growth, compared to 68% of those who took
finasteride (1 mg daily) (Rossi, Int J Immunopathol
Pharmacol 2012). However, the study did
not compare these treatments to placebo. Interestingly, saw palmetto extract
appeared to increase hair growth only on the balding area on the top of the
head (vertex), while finasteride increased hair growth on the top of the head
and the front hairline.
Although not supported by clinical evidence, saw palmetto has also been used to
treat bladder inflammation (cystitis), chronic bronchitis, laryngitis, and
asthma-associated nasal inflammation, among other conditions.
Beta-sitosterol:
Most studies of beta-sitosterol, although not all, have found significant
improvement in perceived symptoms of BPH and in urine flow
rate. In addition, benefits seem to persist for months after treatment
according to a follow up study that looked at men one year after treatment (Berges, Br J Urol 2000).
Like the BPH drug finasteride (Proscar), beta-sitosterol may inhibit
5-alpha-reductase activity in the prostate. (See ConsumerTips™ for more information on
dosing and usage of beta-sitosterol). Doses used in clinical studies range from
30 mg to 91 mg daily.
At a much higher dosage (about 800 mg daily), beta-sitosterol can also lower
total cholesterol and LDL cholesterol levels when these supplements
are consumed with meals (see ConsumerLab.com's Review of Cholesterol Lowering Supplements).
In this case, beta-sitosterol works in the gut, where it reduces cholesterol
absorption.
Preliminary evidence suggests that beta-sitosterol may also help strengthen
immunity (and prevent the temporary immune weakness after exercise).
Quality Concerns and
Tests Performed:
Like
other supplements, neither the FDA nor any other federal or state agency
routinely tests the quality of saw palmetto or beta-sitosterol in the
marketplace. Previous tests by ConsumerLab.com have found some products to
contain less saw palmetto than promised or to recommend a dose below that which
has been shown to work in clinical studies. As part of its mission to
independently evaluate health, wellness and nutrition products, ConsumerLab.com
purchased dietary supplements sold in the U.S containing saw palmetto and/or
beta-sitosterol and tested them to determine whether they possessed the amounts
of the key plant compounds suggested by their labels. Products containing whole
herb (as opposed to extract only) or 250 mg of minerals per serving were also
tested for potential contamination with lead, cadmium and arsenic. Tablets and
caplets were also tested for their ability to properly break apart
(disintegrate). See How Products Were Evaluated for more
information.
What CL Found:
Saw Palmetto
Among the supplements evaluated in this Review that claimed to provide saw
palmetto (with or without beta-sitosterol), all but one provided expected
amounts of fatty acids.
The one product that did not deliver on fatty acids was Nature's
Answer Saw Palmetto Extract, which, despite promising 200 mg of berry
extract in a 2 ml serving (56 drops), contained no detectable fatty acids
(i.e., less than 0.18 mg — the limit of detection). Therefore, it is listed as
"Not Approved" in our Results table.
As shown the graph below, the other saw palmetto-containing supplements
provided 140.8 mg to 1,545 mg of fatty acids per serving (although some
included additional ingredients, such as pumpkin seed oil, which contributed to
these fatty acids).
Teraputics ProstatePro contained
the least amount of fatty acids (only 140.8 mg per 2 capsule daily serving) as
it promised a dose of just 200 mg of extract standardized to only 45% fatty
acids, which is far less extract (and a lower fatty acid concentration) than
has been used clinically. Teraputics ProstatePro did, however, provide a clinically
significant amount of beta-sitosterol (162 mg).
The other Approved saw palmetto-containing supplements promised 320 mg daily of
saw palmetto berry extract standardized to 85% fatty acids (which should
provide at least 272 mg of fatty acids per day), which is what has been used
clinically. Each provided this amount of fatty acids
or more in a daily suggested serving.
The cost to obtain 272 mg of fatty acids (the minimum expected dose, as
explained above) ranged from just 5 cents to 86 cents among products that were
Approved. The cost to get this from Nature's Answer would
exceed $1,200 due to its lack of fatty acids.
Beta-sitosterol
All of the beta-sitosterol-containing supplements (including three that
included saw palmetto) passed testing and provided amounts of beta-sitosterol
at or above what has been shown to work clinically (30 to 91 mg daily), as
shown in the graph above. (See What to Consider When Buying for more
about dosage).
Interestingly, all of these products except for Pure Encapsulations provided
much greater amounts of beta-sitosterol (162 to 852 mg daily) than normally
used for BPH. Although this increases the chance of these products causing side
effects, it also means that, if taken with meals, they may have some
cholesterol-lowering effect (typical dosage for this effect is about 400 mg of
beta-sitosterol taken before or during a meal -- see the Review of Cholesterol-Lowerers for
more details.)
As shown below, the cost to obtain a 60 mg dose of beta-sitosterol ranged from
just 5 cents to 23 cents.
Top Pick:
Although
several saw palmetto supplements passed our tests, clinical evidence suggests
that products containing beta-sitosterol are more likely to be effective. The
only product that provided a dose of beta-sitosterol in-line with what has
worked clinically is Pure Encapsulations Beta-sitosterol,
our Top Pick among prostate supplements. It provides 60
mg of beta-sitosterol per capsule for 18 cents, which is a little more
expensive than average for beta-sitosterol. Its label suggests taking one
capsule one to two times daily, although once daily may be sufficient to treat
symptoms of BPH. The label suggests that it be taken with food.
Products containing beta-sitosterol and saw palmetto, and/or
other ingredients, tend to be more expensive and these combinations have
typically not been clinically evaluated. If you are compelled to try one,
consider Life Extension Ultra Prostate Formula (79 cents per
day for 2 softgels) providing 180 mg of
beta-sitosterol plus 320 mg of saw palmetto extract (85% fatty acids) and
significant amount of other botanical ingredients, such as pygeum
and nettle, which may, potentially, provide some benefit. Unlike many of the
other multi-ingredient prostate supplements reviewed, Life Extension does
not include selenium, which may be preferable, as selenium has not been shown
to be beneficial unless one is deficient in selenium (which is uncommon in the
U.S.) — otherwise it may actually carry a downside (see What to Consider When Buying for more
about selenium and other ingredients in prostate formulas.)
As previously noted, the evidence for saw palmetto itself is not compelling.
However, the product that provided the correct dose of saw palmetto extract
with no other ingredients, passed all of our tests, and was least expensive
was Rexall Saw Palmetto (17 cents per daily serving of 2 softgels).
Test Results by Product:
Listed
below are test results for 11 supplements with saw palmetto and/or
beta-sitosterol. Products are shown alphabetically within the category of
ingredient for which they were tested. ConsumerLab.com selected eight products.
Three other products (each indicated with a CL flask) were tested at the
request of their manufacturers/distributors through ConsumerLab.com's
voluntary Quality Certification Program and are
included for having passed testing.
Also shown are the claimed amount and form of the tested ingredient(s) and
serving sizes recommended on labels. Products listed as "Approved"
met their label claims and ConsumerLab.com's quality
criteria (see How Products Were Evaluated). Price
comparisons are shown in the fourth column. Other notable ingredients and
special designations are shown in the second to last column, while the full
list of ingredients is in the last column.
Results of
ConsumerLab.com Testing of Saw Palmetto And
Beta-Sitosterol/Phytosterol Supplements
(Click arrows or swipe left or right to see all columns)
Product Name
(Suggested Serving on Label)
Claimed and Found Amounts of Saw Palmetto and/or
Sterolsⓘ
Heavy Metalsⓘ
Suggested Serving
Pill Sizeⓘ
Cost for Suggested Serving
Price
Notable Features
Full List of Ingredients Per Serving
Saw Palmetto Supplements:
NOT APPROVED
Nature's Answer Saw Palmetto Extract
Mfd. by Nature's Answer®
56 drops [2 ml]
200 mg saw palmetto berry extract
Fatty acids: <0.18 mg
Beta-sitosterol: 0.15 mg
Heavy Metals: NA
Take 1-2 ml (28-56 drops) three (3) times a day in a small amount of water.
Liquid from glass bottle
$0.85/56 drops
$12.74/1 fl oz [30 ml] bottle (approx. 15 servings)
Made from 1,200 mg saw palmetto berries per
serving
Kosher. Gluten Free. Alcohol-Free. Non GMO Project
Verified seal.
56 drops
Saw Palmetto (Serenoa repens) Berry
Extract 200 mg.
Other Ingredients: Vegetable Glycerin, Purified Water.
APPROVED
Mfd. by Puritan's Pride, Inc.
1 softgel
136 mg to 152 mg saw palmetto berry extract (85% fatty acids and sterols)
Found:
Fatty acids: 237 mg
Beta-sitosterol: 0.44 mg
Fatty acids + total phytosterols: 237.6 mg ✔ⓘ
Heavy Metals: NA
For adult men, take 1 softgel twice daily, preferably
with meals.
Medium/large softgel
$0.12/softgel
$45.98/6 bottles of 60 softgels (360 softgels total)
No Artificial Color, Flavor or Sweetener, No
Preservatives, No Sugar, No Starch, No Milk, No Lactose, No Soy, No Gluten, No
Wheat, No Yeast, No Fish, Sodium Free.
1 softgel
Saw Palmetto Extract (Serenoa repens)
(berry) (Standardized to contain 85-95% fatty acids and sterols, 136-152 mg)
160 mg.
Other Ingredients: Gelatin, Pure Olive Oil, Vegetable Glycerin.
APPROVED
Real Health® Prostate™ Complete
Dist. by PharmaCare
US, Inc.
1 softgel
320 mg saw palmetto berry extract (85% fatty acids)
Found:
Fatty acids: 404 mg ✔ⓘ
Beta-sitosterol: 1.6 mg
Heavy Metals: NA
Take 1 softgel daily, or as directed by your
healthcare professional.
Large softgel
$0.46/softgel
$13.92/30 softgels
1 softgel
Zinc 20 mg, selenium 30 mcg, lycopene 6.5 mg, standardized turmeric extract 53
mg, resveratrol 8 mg, pomegranate extract 25 mg.
This formulation is free from added yeast, more...
1 softgel
Zinc (as sulfate monohydrate) 20 mg, Selenium (as selenomethionine)
30 mcg, Standardized Saw Palmetto Extract (Serenoa
repens) (Berry) (standardized to 85% fatty acids) 320 mg, Lycopene 6.5 mg,
Standardized Turmeric Extract, more...
APPROVED
Best Option
for Saw Palmetto
Dist. by Dolgencorp, LLC
2 softgels
272 mg to 304 mg saw palmetto berry extract (85-95% fatty acids and sterols)
Found:
Fatty acids: 468 mg
Beta-sitosterol: 0.86 mg
Fatty acids + total phytosterols: 469.2 mg ✔ⓘ
Heavy Metals: NA
For adult men, take two (2) softgels daily,
preferably with a meal.
Medium/large softgel
$0.17/2 softgels
$5.00/60 softgels
No Gluten, No Yeast, No Wheat, No Milk or Milk
Derivatives, No Lactose, No Sugar, No Preservatives, No Soy, No Artificial
Color, No Artificial Flavor, No Sodium.
2 softgels
Saw Palmetto Extract (Serenoa repens)
(berry) (Standardized to contain 85-95% fatty acids and biologically active
sterols, 272-304 mg) 320 mg.
Other Ingredients: Gelatin, Pure Olive Oil, Glycerin.
APPROVED
Trunature® [Costco] Prostate Plus
Health Complex
1 softgel
320 mg saw palmetto berry extract
Found:
Fatty acids: 605 mg ✔ⓘ
Beta-sitosterol: 1.4 mg
Formula includes 320 mg of pumpkin seed oil and sunflower oil
which increase fatty acid levels.
Heavy Metals: ⓘ
Adults - One softgel daily with food as a dietary
supplement.
Large softgel
$0.12/softgel
$29.99/250 softgels
1 softgel
Zinc 15 mg, selenium 55 mcg, Cran-Max® cranberry
concentrate 50 mg, pumpkin seed oil 320 mg, lycopene 300 mcg
No Artificial Dyes Or Flavors. No Gluten. No
Lactose.
1 softgel
Calories 10, Total Fat 0.5 g, Zinc 15 mg, Selenium 55 mcg, Saw Palmetto (Serenoa repens) (berry) Extract [standardized
for 85% (272 mg) fatty acids] 320 mg, Cran-Max®
Cranberry (Vaccinium macrocarpon) Concentrate 50 mg, Pumpkin Seed Oil
[Palmitic Acid 32 mg, more...
Combination Saw Palmetto and Beta Sitosterol /
Phytosterol Products:
APPROVED
Best Option
for Combination
Life Extension® Ultra Prostate Formula
Dist. by Quality Supplements and Vitamins, Inc.
2 softgels
320 mg saw palmetto berry extract
180 mg beta-sitosterol
Found:
Fatty acids: 984 mg ✔ⓘ
Beta-sitosterol: 272 mg ✔
Total phytosterols: 272 mg
Formula includes 200 mg pumpkin seed oil and 160 mg phospholipids
which increase fatty acid levels.
Heavy Metals: NA
Take two (2) softgels daily divided between morning
and evening, with food, or ad recommended by a healthcare practitioner.
Large softgel
$0.79/2 softgels
$23.63/60 softgels
2 softgels
Stinging and dwarf nettle extracts 240 mg, pumpkin oil 200 mg, phospholipids
160 mg, pygeum extract 100 mg, ArexFlex®
Indian frankincense extract 70 mg, Graminex® flower
pollen extract™ and NAX™ paste 63 mg, proprietary enterolactone precursors
blend 20.15 mg, lycopene 10 mg, boron 3 mg
Gluten Free. Non-GMO.
2 softgels
Calories 15, Total Fat 1.5 g, Total Carbohydrate <1 g, Protein <1 g, Saw
Palmetto CO2 extract (fruit) [std. to 85% total fatty acids] 320 mg,
Stinging and dwarf nettle extracts (root) 240 mg, Pumpkin oil (seed) [std. 85%
total fatty acids] 200 mg, Beta-Sitosterol 180 mg, Phospholipids 160 mg, Pygeum extract (bark) 100 mg, ArexFlex®
Indian frankincense, more...
APPROVED
NOW® Clinical Strength Prostate Health
Dist. by Now Foods
3 softgels
320 mg saw palmetto berry extract
850 mg phytosterols
Found:
Fatty acids: 1,545 mg ✔ⓘ
Beta-sitosterol: 528 mg
Total phytosterols: 1,089 mg ✔
Contains 1,000 mg pumpkin seed oil which increases fatty acid
levels.
Heavy Metals: ⓘ
Take 3 softgels daily with food.
Very large softgel
$0.47/3 softgels
$28.04/180 softgels
3 softgels
Vitamin D-3 1.5 mcg (60 IU), zinc 15 mg, selenium 70 mcg, stinging nettle root
extract 240 mg, quercetin 200 mg, turmeric root extract 100 mg, pumpkin seed
oil 1,000 mg, lycopene 10 mg, green tea extract 100 mg, pomegranate extract 100
mg, trans-resveratrol 10 mg, LinumLife® complex 25 mg, more...
3 softgels
Calories 10, Total Fat 1 g, Vitamin D-3 (as Cholecalciferol) 1.5 mcg (60 IU),
Zinc (from Zinc Bisglycinate) (TRAACS™) 15 mg,
Selenium (from Selenium Glycinate Complex) (Albion™) 70 mcg, Saw Palmetto
Extract (Berry) (Serenoa repens) (min.
85% Fatty Acids) 320 mg, Phytosterols (Plant Sterols) (with Beta-Sitosterol)
850 mg, more...
APPROVED
Teraputics ProstatePro
Dist. by Teraputics
Inc.
2 capsules
200 mg saw palmetto berry extract (45% fatty acids)
(Relatively
low dose of saw palmetto)
120 mg beta-sitosterol in 300 mg of phytosterols
Found:
Fatty acids: 140.8 mg ✔
Beta-sitosterol: 162 mg ✔
Total phytosterols: 328 mg ✔
Heavy Metals: Pass
2 capsules daily preferably with meals or as directed by a healthcare
professional.
Large capsule
$0.44/2 capsules
$19.95/90 capsules
2 capsules
Vitamin E 20 IU, vitamin B-6 3.33 mg, zinc 10 mg, selenium 140 mcg, Copper 200
mcg, Pygeum africanum bark
powder 100 mg, red raspberry 50 mg, graviola leaf
powder 50 mg, green tea leaf 50 mg, cat's claw bark 30 mg, broccoli 4:1 extract
20 mg, tomato fruit powder 10 mg, more...
2 capsules
Vitamin E (d-Alpha tocopheryl succinate) 20 IU,
Vitamin B-6 (pyridoxine HCl) 3.33 mg, Zinc (oxide) 10 mg, Selenium (amino acid
chelate) 140 mcg, Copper (gluconate) 200 mcg, Saw Palmetto Berries (45%
extract) 200 mg, Plant Sterol Complex (40% Beta-sitosterol), more...
Beta Sitosterol / Phytosterol Products:
APPROVED
ProstaGenix™ Multiphase Prostate Support
Compound
Dist. by ProstaGenix™
3 capsules
1,050 mg phytosterols
Found:
Beta-sitosterol: 852 mg
Total phytosterols: 951 mg ✔
Heavy Metals: NA
Take three (3) capsules daily.
Large capsule
$1.47/3 capsules
$44.08/90 capsules
3 capsules
Vitamin D3 400 IU, iodine 150 mcg, zinc 15 mg, selenium 70 mcg, copper 2 mg,
manganese 2 mg, chromium 120 mcg, molybdenum 75 mcg, polyphenol super support
matrix™ 300 mg, silicon 10 mg, more...
3 capsules
Vitamin D3 (as Cholecalciferol) 400 IU, Iodine (as Potassium Iodide) 150 mcg,
Zinc (as Zinc Oxide) 15 mg, Selenium (as Amino Acid Chelate) 70 mcg, Copper (as
Copper Amino Acid Chelate) 2 mg, Manganese, more...
APPROVED
Top Pick
Pure Encapsulations® Beta-sitosterol
Mfd. by Pure Encapsulations
1 capsule
60 mg beta-sitosterol
Found:
Beta-sitosterol: 73 mg ✔
Total phytosterols: 152 mg
Heavy Metals: NA
Take 1 capsule, 1-2 times daily, with meals.
Large capsule
$0.18/capsule
$16.40/90 capsules
Gluten-free & Non-GMO.
Precaution: Contains soy.
1 capsule
Beta-sitosterol (from phytosterol complex) 60 mg.
Other Ingredients: Hypoallergenic plant fiber (cellulose), vegetarian capsule
(cellulose, water), ascorbyl palmitate.
APPROVED
Super Beta Prostate® Advanced
Dist. by New Vitality™
2 caplets
600 mg phytosterols
250 mg beta-sitosterol
Found:
Beta-sitosterol: 298 mg ✔
Total phytosterols: 618 mg ✔
Heavy Metals: NA
Disintegration: Pass
Take two (2) caplet daily, preferably one (1) caplet in the morning and one (1)
caplet in the evening, or as directed by a healthcare provider.
Large caplet
$1.15/2 caplets
$34.39/60 caplets
2 caplets
Vitamin D3 40 mcg (1,600 IU), calcium 40 mg, zinc 15 mg, selenium 70 mcg,
copper 2 mg, manganese 2 mg, chromium 120 mcg, molybdenum 75 mcg, lycopene 15
mg, more...
2 caplets
Vitamin D3 (as Cholecalciferol) 40 mcg (1,600 IU), Calcium (as Calcium
Carbonate) 40 mg, Zinc (as Zinc Oxide) 15 mg, Selenium (as Selenium Amino Acid
Chelate) 70 mcg, Copper (as Cupric Oxide) 2 mg, Manganese, more...
Unless otherwise noted, information about the
products listed above is based on the samples purchased by ConsumerLab.com (CL)
for this Product Review. Manufacturers may change ingredients and label
information at any time, so be sure to check labels carefully when evaluating
the products you use or buy. If a product's
ingredients differ from what is listed above, it may not necessarily be of the
same quality as what was tested.
The information contained in this report is
based on the compilation and review of information from product labeling and
analytic testing. CL applies what it believes to be the most appropriate
testing methods and standards. The information in this report does not reflect
the opinion or recommendation of CL, its officers or employees. CL cannot
assure the accuracy of information.
Copyright ConsumerLab.com, LLC, 2021 All
rights reserved. Not to be reproduced, excerpted, or cited in any fashion
without the express written permission of ConsumerLab.com LLC
ConsumerTips™:
What to
Consider When Buying:
Saw Palmetto
Consumers seeking products most similar to those used in clinical trials
(although the best trials failed so show much benefit) should select saw
palmetto berry extract products, although dried powdered berry
(non-extract) products are also available. Products should contain fatty acids
and sterols standardized for the specific compounds tested for in this Product
Review (see How Products Were Evaluated) and generally
summarized on labeling as a minimum of 85% fatty acids and a minimum of 0.15%
sterols. For example, a 160 mg pill of saw palmetto extract would have a
minimum of 136 mg of fatty acids and 0.24 mg of sterols per pill. Also shown to
work in a clinical trial was a powdered extract standardized to 45% fatty acids
and sterols taken at a higher dose than the 85% extract, as described further
below.
Be aware that saw palmetto tinctures generally do not provide
the high concentrations of fatty acids found in liquid and powdered saw
palmetto extracts. Liquid extracts (generally sold in softgels)
tend to have the highest concentrations of fatty acids, as well as sterols (Penugonda, Nutrients 2013). Extracts produced with
solvents such as ethanol or hexane will contain fatty acids as well as sterols
(also known as "liposterolic" extracts),
while extracts produced with CO2 extraction will contain fatty acids but, typically, no
detectable amount of sterols. The clinical
significance of the lack of sterols in a saw palmetto extract is not clear. The
U.S. market has largely shifted away from hexane-based extracts due to concerns
over potential neurotoxic effects of residual solvent (FDA Guidance for Industry 1999, EPA, 2016), but they
appear to remain in use in Europe.
Zinc is another mineral added to some
prostate formulas. The benefit, however, is unclear. A study of men in Greece
showed that those with higher intakes of zinc in their diets actually had a
greater risk of BPH (Lagiou, Urology 1999) and some studies have
shown an increase in prostate cancer with high-dose (more than 100 mg per day)
or long-term use of zinc supplements (Leitzmann, J Natl Cancer Inst 2003).
There is no evidence that saw palmetto (nor formulas
including selenium and/or zinc) is useful in preventing prostate cancer.
Furthermore, an analysis of 2,301 men with prostate cancer treated with
radiation therapy found that among the 10% who reported using supplements
marketed for "men's health" or "prostate health" (91% of
which contained saw palmetto), there were no statistically significant
differences in the rates of metastasis, survival, or toxicity following cancer
treatment (median follow up was 46 months) compared to men not taking such supplements
(Zaorsky, Intl J Rad Oncol - Supplement Abstract 2015).
Beta-sitosterol
Be sure to purchase a product designed for treating BPH rather than for
cholesterol-lowering — the dosage and use instructions will be quite different
(see dosage information below). Look for products that list the specific amount
of beta-sitosterol and not just total sterols. Some products loosely use the
term "beta-sitosterols" to refer to a
mixture of sterols, while others, as seen in this review, simply list a
"sterol complex" or "phytosterols" without listing an exact
amount of beta-sitosterols. It is acceptable that
other phytosterols (plant sterols) are in the product, but you may want to look
for a product in which beta-sitosterol specifically represents at least 50% of
the total sterols -- similar to products that that have shown clinical
effectiveness for symptoms of BPH.
What to Consider When Using:
Saw palmetto
The standard dosage of saw palmetto of an 85%-95% extract for BPH is 320 mg per
day, usually taken as 160 mg twice per day. Another type of saw palmetto
extract in supplements is a dried extract containing approximately 45% fatty
acids and sterols typically taken as 640 mg per day — 320 mg twice daily. For
powdered berry products (not extracts), the dosage is about one to two grams of
berry per day. Improvements (if any) can take from six to eight weeks to three
to four months before noticeable and further improvements may be seen
throughout the first 12 months.
Beta-sitosterol
Successful clinical trials with beta-sitosterol have generally used products
that contained a mixture of phytosterols but, incorrectly, have been reported
in summary articles as being beta-sitosterol. In fact, only about 50% to 70% of
the phytosterols in these products are specifically beta-sitosterol. One German
study (Berges, Lancet 1995)
used a product with 20 mg of phytosterols (of which 10 mg was beta-sitosterol)
given three times a day. Another German study (Klippel, Br J Urol 1997)
used a product with 65 mg of phytosterols (approximately 70% of which was
beta-sitosterol) given twice daily. The daily amount of beta-sitosterol used in
these studies, therefore, ranged from 30 mg to 91 mg. Some of the supplements
on the market suggest daily serving sizes yielding several hundred milligrams
of beta-sitosterol. It is not known if these higher amounts provide additional
benefit in treating BPH (although, as noted below, may help lower cholesterol
levels).
Effects usually take 4 weeks to develop. The dosage can be reduced to 10 to 65
mg daily after symptoms improve.
When using beta-sitosterol to reduce cholesterol-levels, it must be taken with
food. However, it is unclear whether or not this applies to its use in treating
symptoms of BPH, although taking it with food may reduce gastrointestinal side
effects and most products suggest taking it with food.
One popular beta-sterol supplement, Super
Beta Prostate (New Vitality/NAC Marketing Co.), provides 600 mg mixed
phytosterols, including 250 mg of beta-sitosterol, per recommended daily
serving -- a much higher dose of beta-sitosterol than used in many clinical
studies of BPH. It also contains 2 mg of pygeum bark
powder, but this is a much smaller dose than the 100 mg of a standardized pygeum bark extract that may help reduce symptoms of an
enlarged prostate. There do not appear to be any clinical studies investigating
the effects of Super Beta Prostate's formula on the symptoms
of an enlarged prostate. This supplement also includes a number of ingredients
that don't relieve prostate symptoms but do have the potential to reduce
prostate cancer risk if you are deficient in them. These include vitamin D (400 IU), zinc (80 mg), selenium (70 mcg) and boron (60 mg). [Be aware that the cost of
this supplement varies considerably by retailer: the price for one bottle
containing 60 caplets (a 30-day supply) can range from $19 at Amazon.com to
$29.99 at Walgreens.com to $39.95 at the company's website -- newvitality.com.
When ordering from the company's website or even just selecting a "free trial"
you will pay $6.99 shipping and handling, and be automatically shipped (and
charged for) a new bottle every 30 days, at cost of $39.95 plus $6.99 shipping
and handling.]
Beta-sitosterol taken at a much higher dosage (800 to 6,000 mg per day) along with
other sterols can help lower cholesterol levels. These sterols
work by competing with cholesterol absorption in the gut, so they must be taken
with or just before meals to be effective.
A product containing 200 mg of saw palmetto
extract and 50 of beta-sitosterol taken twice daily has shown some benefit
in androgenic alopecia (male-pattern baldness) — although some
participants in the trial reported loss of appetite, flatulence, diarrhea, and
worsening acne (Prager, J Alt Comp Med 2002).
Other ingredients
Several other natural ingredients have been used to treat symptoms of BPH and,
as noted above, are sometimes found in combination with saw palmetto or
beta-sitosterol in supplements, although it is not clear whether these
combinations provide any more benefit than saw palmetto or beta-sitosterol
alone.
·
Selenium: Selenium also appears as an ingredient in some
prostate supplements presumably based on the association between selenium and
lower rates of prostate cancer in some populations. However,
this benefit may only be realized in men who are selenium deficient.
Furthermore, as discussed in the Selenium Product Review, a study of selenium
and vitamin E for preventing prostate cancer was halted after early analysis of
the data found that selenium and vitamin E supplements, alone or together,
failed to prevent prostate cancer and slightly more cases of diabetes occurred
in men taking only selenium. It is best to avoid this ingredient unless you are
known to be deficient in selenium, which is uncommon in the U.S. and Canada.
Selenium in excess of the recommended daily allowance (55 mg for men) may
worsen prostate cancer outcomes (see Concerns and Cautions section of the
Selenium Supplements Review).
·
Pygeum bark: Pygeum bark
has been shown to provide moderate improvement in prostate symptoms,
particularly in reducing the frequency of urination at night (Ishani, Am J Med 2000).
The standard dosage for pygeum bark as a single
ingredient is 100 mg per day (at once or as 50 mg twice per day) of an extract
standardized to 14% triterpenes/sterols and 0.5% n-docosanol.
This is taken in cycles six to eight weeks in duration.
·
Pumpkin seed: The typical dose of pumpkin seed is 5 grams of
ground pumpkin seeds taken twice daily.
·
Stinging nettle root: Stinging nettle root may help with BPH symptoms,
although the research is preliminary (Schneider, Urologe A 2004).The
dose for nettle root is 4 to 6 grams daily of the whole root or an extract made
from the equivalent amount of nettle root — but be sure that you are using
nettle "root" and not nettle "leaf," which is used to treat
allergies.
Consumers
should check with a healthcare professional for a proper diagnosis before using
saw palmetto or beta-sitosterol, particularly as the typical symptoms of
enlarged prostate may signal other, more serious conditions that require prompt
treatment. Neither is a treatment for prostate cancer.
Saw Palmetto
Saw palmetto is generally recognized as safe. A one-year placebo-controlled
clinical trial using 160 mg twice daily of an extract showed no evidence of
toxicity or adverse events. However, in a limited number of individuals, saw
palmetto can cause nausea and abdominal pain — which can also
occur with pygeum bark, stinging nettle root, and
beta-sitosterol. Dizziness and headache have also been
reported. Saw palmetto may prolong bleeding time and reduce platelet
activity, which is why you should inform your doctor if you are taking saw
palmetto. Saw palmetto may increase the risk of bleeding in people with heart
failure (Page, Circulation 2016).
There have been case reports in which use of saw palmetto products was
linked to liver or pancreas inflammation, which reversed several
weeks after discontinuation of the products. It is not clear, however, if the
inflammation was caused by saw palmetto or something other else in the
products, one of which was reported to contain multiple herbs and other
ingredients. One case of pancreatitis was reported in a 64 year-old man who
also developed heart block (a dangerously slow heart rate due
to blocked electrical signals in the heart) after taking saw palmetto for
several weeks; his symptoms resolved within days of receiving treatment and
stopping supplementation (Jipescu, J Am Coll Cardiol
2017). Although the heart block was attributed to the saw
palmetto, this adverse effect has not been previously reported with saw
palmetto and a potential mechanism for this effect was not provided.
Rarely, erectile dysfunction has
been reported with use of saw palmetto-containing supplements, although it is
not clear what other ingredients were in the products (Agbabiaka, Drug Saf 2009).
In one case, a 49-year-old man in Italy experienced erectile dysfunction about
two months after he began taking a daily combination of saw palmetto (400 mg)
and stinging nettle (600 mg), which resolved after stopping supplementation and
receiving testosterone gel and injections to increase testosterone levels. As
noted in the case report, beta-sitosterol in saw palmetto can inhibit the
enzyme that transforms testosterone to its active form (which is how drugs for
treating male-pattern baldness, or androgenic alopecia, work), and this could
theoretically also negatively affect erectile function, libido, and ejaculation
(Gallo, Br J Clin Pharmacol 2021).
Saw
palmetto has hormonal activity and, therefore, should not be used by
pregnant or lactating women and could potentially interfere with
hormonal therapy and contraceptive drugs.
Beta-sitosterol
Like saw palmetto, beta-sitosterol is usually well tolerated but, in some
patients, it can cause nausea, indigestion, gas, diarrhea, or
constipation. Although rare, erectile dysfunction and/or loss of
libido were reported in 1% of men taking beta-sitosterol (20 mg three
times daily for 6 months) (Berges, Lancet 1995).
Beta-sitosterol may reduce
absorption and blood levels of alpha- and beta-carotene and vitamin E.
Beta-sitosterol is
contraindicated in patients with sitosterolemia, a rare disorder in
which total body stores of beta-sitosterol are significantly increased.
Information on this site
is provided for informational purposes only. It is not an endorsement of any
product nor is it meant to substitute for the advice provided by physicians or
other healthcare professionals. The information contained herein should not be
used for diagnosing or treating a health problem or disease. Consumers should
inform their healthcare providers of the dietary supplements they take.
Latest Clinical Research Updates for Prostate Supplements (Saw
Palmetto and Beta-Sitosterol)
11/09/2021
Does saw palmetto cause
sexual dysfunction? Get the details in the updated Concerns and Cautions section of our
Prostate Supplements Review.
8/03/2019
A recent clinical study
is the latest to evaluate the potential benefit of saw palmetto in reducing
symptoms of benign prostatic hypertrophy (BPH) in men. Find out what this, and
previous studies, have shown in the What It Does section
of the Prostate Supplements Review. Also see our Top Picks for saw palmetto and beta-sitosterol
supplements.
3/20/2018
Saw palmetto extract was
once popular for reducing symptoms of prostate enlargement, but studies
subsequently failed to find a benefit. A recent study assessed whether it could
boost the effectiveness of conventional medical treatment. Get the results in
the What It Does section
of the Saw Palmetto Supplements Review.
Trouble Reported With Saw Palmetto
5/06/2017
A 64
year-old man developed pancreatitis and heart block (dangerously slow
heart rate) after supplementing with saw palmetto, according to a recent
report. For details, see the "Cautions and Concerns"
section of the Prostate Supplements Review >>
Men's Health Supplements Don't Help Prostate Cancer
10/21/2015
While there is some
evidence that certain supplements may help relieve symptoms of prostate
enlargement (BPH), a recent study shows no benefit with regard to prostate
cancer treatment. Details are in the Prostate Supplements Review
>>
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