Title: PharmaNote
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Permanent Link: http://ufdc.ufl.edu/UF00087345/00040
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Title: PharmaNote
Series Title: PharmaNote
Physical Description: Serial
Creator: University of Florida College of Pharmacy
Publisher: College of Pharmacy, University of Florida
Publication Date: May 2006
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Bibliographic ID: UF00087345
Volume ID: VID00040
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Gwen Schroeder, Pharm.D. Candidate

Heart disease is the leading cause of death for
both men and women in the United States. In 2003,
23.5 million new cases of heart disease were diag-
nosed and nearly 700,000 deaths were attributed to
heart disease.1 In 2002, approximately 163,000 pa-
tients died from stroke, making it the number three
leading cause of death.1 Combine these figures and
account for unreported cardiovascular deaths, and it
becomes evident that cardiovascular disease leads to
nearly 1 million deaths in the U.S. per year. Athero-
sclerosis is the major contributor to both heart dis-
ease and stroke, making it an important target for
decreasing the global burden of cardiovascular dis-
Atorvastatin (Lipitor) and simvastatin
(Zocor) were the top two prescribed drugs in the
United States in 2003, accounting for a combined
total of 13.3 billion dollars in prescription drug sales.
These two agents grossed roughly 43% of the reve-
nue produced by the top ten prescribed drugs.2 As
popular and as proven as these drugs may be, the
cost of taking them as prescribed is often out of

reach for many average citizens. Estimated cash
prices for atorvastatin and simvastatin are $290 and
$360 respectively for a 90-day supply.3 Even those
patients with prescription drug coverage may have to
pay substantial co-pays (sometimes $50 or more per
month) for these drugs depending on the insurance
company's drug formulary. Furthermore, the major-
ity of patients for whom these drugs are prescribed
are elderly and may have suboptimal prescription
drug coverage. While Medicare Part D is promising
and has the potential to save these patients thousands
of dollars, most beneficiaries will still be paying for
their drug benefit. Depending on the plan, some sen-
iors will still have to pay over $5,000 out of pocket
per year, including the premiums charged, deducti-
bles, and the gap in coverage into which many pa-
tients will fall.4'5'6
When cost is analyzed from a patient's point
of view, an over the counter herbal product which
promises to achieve similar results as their prescrip-
tion drug at a lower cost appears attractive. In 2004,
retail sales within the consumer packaged goods
health and wellness industry grossed an astounding
$68.6 billion in revenue.7 This industry is not slow-

rIa U I

PharmaNote Volume 21, Issue 8, May 2006




Volume 21, Issue 8, May 2006


Table 1: Adverse Events and Possible Herb-Drug/Herb-Disease Interactions.
Herbal Product Adverse Events Possible Interactions Warnings and Contraindications

Red Yeast
Rice Extract

Headache, mild gastro-
intestinal upset

Weight loss, polyuria,
Policosanol insomnia polyphagia,
head ache, dizziness

One case of rhabdo-
myolysis reported.
Guggul Rash, abdominal dis-
Extract comfort, diarrhea, nau-
sea, headache, restless-
ness, and hiccups

Fenugreek Mild gastrointestinal
Seeds upset (flatulence, nau-
sea, diarrhea)

Increased flatulence,
allergic reaction

Breath and body odor,
heartburn, flatulence,
Garlic nausea, vomiting, diar-
rhea, rhinitis, conjuncti-
vitis, and urticaria,

Normally well tolerated
Constipation, bloating,
Soy nausea; rarely supple-
ments may cause mi-

Normally well tolerated
English Stools may become
Walnut softer, mild bloating;
beware of nut allergies

Pycnogenol None reported

Grape Seed

Normally well tolerated
Headache, abdominal
pain, sore throat, nau-
sea, and cough

None identified. Theoretically, con-
sider drug interactions for stations
(e.g. gemfibrozil, cyclosporine, ke-
toconazole, erythromycin, etc.)

May have antiplatelet effect (caution
with warfarin, clopidogrel, etc.).

Decreased bioavailability of pro-
pranolol and diltiazem.
Fibrinolytic activity may lead to
increased risk of bleeding in patients
taking anticoagulants or antiplatlet

Might increase effects of beta-
blockers, calcium channel blockers,
and cardiac glycosides
May have antiplatelet effect (caution
with warfarin, clopidogrel, etc.)
Might contribute to hypoglycemic
episodes with large doses (caution
with antidiabetic agents)

None known

Anticoagulant or antiplatelet drugs,
contraceptive medications, cyc-
losporine, CYP 3A4 substrates, non-
nucleoside reverse transcriptase
inhibitors, and saquinavir

Estrogen replacement therapy, ta-
moxifen (anti-estrogen effects)
Warfarin (may decrease INR)

None known

May interfere with immunosuppres-
sant drugs because of its immu-
nostimulant activity

Warfarin (may increase the INR) or
any other drugs metabolized via the
CYP 1A2 pathway as their plasma
levels may decrease.

None identified. Theoretically, consider pre-
cautions for stations (e.g. pregnancy, breast-
feeding, hepatic, and/or renal impairment)

None known

Thyroid disorders (lowers TSH by increasing
production of T3)
Avoid in women who have had breast, uter-
ine, or ovarian cancer, endometriosis, and
uterine fibroids (might be an agonist on estro-
gen-a and progesterone receptors)
Pregnancy (stimulates menstrual flow)

Caution use in diabetic patients (may cause
hypoglycemia in large doses)

Bile duct obstruction, gallstones (might in-
crease bile flow)
Cross allergenicity (ragweed, chrysanthe-
mums, marigolds, daisies, and many other

Bleeding disorders (may increase the risk of
Gastrointestinal irritation

Use with caution in patients who have
asthma, allergic rhinitis, estrogen sensitive
cancers, venous thrombosis, cystic fibrosis,
hypothyroidism, renal failure, kidney stones,
or bladder cancer

None known

Patients with multiple sclerosis, lupus, rheu-
matoid arthritis, or other autoimmune disor-
ders due to its immunostimulant activity

None known

Phrm~oe olme21 Isu 8 My 00

Volume 21, Issue 8, May 2006


ing down; therefore, it is important for all health care
providers to familiarize themselves with these prod-
ucts, especially given the potential for herb-drug and
herb-disease interactions. This article will analyze
evidence, discuss mechanisms of action, dosing, cost,
interactions, as well as decipher fact from fiction sur-
rounding several herbal products with lipid-
modifying potential.

Red Yeast Rice Extract
Red yeast rice has been used in Asia for cen-
turies as a food preservative, food colorant, and for
medicinal purposes. It is made by fermenting rice
with red yeast (Monascus purpureus). During this
process, ten different monacolins, all of which are
naturally occurring hydroxymethylglutaryl-CoA
(HMG-CoA) reductase inhibitors, are formed. Merck
& Co isolated monacolin K and patented it as Me-
vacor lovastatinn). Other active ingredients include
sterols, isoflavones, and monounsaturated fatty ac-
The proposed mechanism of action is similar
to the HMG-CoA reductase inhibitors: blocking the
synthesis of cholesterol in hepatic cells. There have
been several clinical trials performed testing the
lipid-lowering effects of red yeast rice extract. All of
these randomized trials discovered significant reduc-
tions in total cholesterol of 16% to 31%) low-density
lipoprotein (LDL) of 21%-32%, and triglycerides of
16%-34%) when compared with baseline, placebo,
or control.94 Furthermore, an increase in high-
density lipoprotein (HDL) of 15%-20% was shown
in three of the studies.9'12'14 While these studies seem
promising, none of the human trials were conducted
for longer than three months, and almost all of them
simultaneously implemented a regimented low fat,
low cholesterol diet.
Although larger, longer randomized con-
trolled trials are needed to ensure a low toxicity pro-
file, current evidence has not revealed toxicity con-
cerns. Studies conducted in animals for as long as
four months report no adverse events or toxicities
while being administered red yeast rice extract. Stud-
ies conducted in humans have failed to show eleva-
tions in liver enzymes or renal impairment; potential
side effects documented by researchers have been
limited to gastrointestinal discomfort and headaches.
Supplementation of Coenzyme Q10 may be consid-

ered if a patient plans to take the red yeast rice ex-
tract long term, because HMG-CoA reductase inhibi-
tors can reduce its production, though the ability of
this strategy to prevent toxicity is unclear.10
In conclusion, red yeast rice can significantly
lower total and LDL cholesterol levels, as well as
lower triglycerides when used for 8-12 weeks. The
dose most commonly used is 2.4 grams per day;
however, a dose of 1.2 grams per day provides some
benefit. Red yeast rice should be used cautiously in
patients with known contraindications to HMG-CoA
reductase inhibitors.8

Policosanol is a mixture of eight cyclic alco-
hols derived from sugar cane wax and beeswax. Oc-
tacosanol is the prominent alcohol found in the
herbal product, comprising approximately 63% of
the compound; triacontanol (13%) and hexacosanol
(6%) are the other two major components. The com-
bination of these alcohols has demonstrated choles-
terol-lowering abilities equal to station drugs. Polico-
sanol may also reduce platelet aggregation, endothe-
lial damage and foam cell formation, as well as
lower total and LDL cholesterol.15
The exact mechanism of action is yet to be
determined. It appears that policosanol lowers LDL
and total cholesterol synthesis prior to the formation
of mevalonate. Furthermore, it increases the binding,
uptake, and degradation of LDL in the endoplasmic
reticulum, which is independent of its effect on cho-
lesterol synthesis. Policosanol's antiplatelet effects
are exhibited through its ability to decrease levels of
thromboxane A2 and increase levels of prostacyclin.
Numerous policosanol studies have been conducted
in recent years. All of them, both short-term and
long-term, have shown statistically significant lipid
lowering effects when taken in doses of 5 mg to 10
mg per day. In two short-term studies (eight and six
weeks), the cholesterol lowering effect of taking 5
mg per day and 5 mg twice daily was 17.7% and
21.5% for LDL and 13.1% and 16.2% for total cho-
lesterol respectively. Long-term studies show even
more promise, especially with respect to increasing
HDL levels. In two such studies (52 and 104 weeks),
5 mg twice daily lowered total cholesterol and LDL
by a range of 16.3% to 18.3%, and 24.8% to 27.5%,
respectively. Furthermore, policosanol raised HDL
cholesterol by 11.2% to 25.9%.15 Head-to-head stud-

PharmaNote Volume 21, Issue 8, May 2006

Volume 21, Issue 8, May 2006


Table 2: Safety vs. Efficacy of Natural Products*

Efficacy Likely Safe Possibly Safe


- So\
- \\ V lnLsl

- Re

Possibly Garc Ar
Effective Pol
Insufficient -Grape Seed
Evidence -P. cinoecnol
Consider recommending this product
Don't recommend using this product

d Yeast Rice


Recommend against using this product
*Adapted from The Natural Medicines Database

ies with policosanol versus station drugs have also
been completed. A meta-analysis that reviewed thirty
policosanol trials found that overall, there was a
23.7% reduction in LDL level and 10.6% increase in
HDL levels. These findings are similar to those ob-
served with other lipid lowering drug therapies, and
this analysis cites policosanol as slightly more effec-
tive than fibric acid derivatives and similar in effi-
cacy to low-dose stations1 6 One specific trial com-
pared policosanol 10 mg daily to lovastatin 20 mg
daily in fifty-three patients for twelve weeks.17 Poli-
cosanol lowered LDL and total cholesterol by 20.4%
and 14.2% (p < 0.0001), respectively, while lovas-
tatin lowered LDL and total cholesterol by 16.8% (p
< 0.01) and 14.0% (p < 0.001), respectively. Polico-
sanol increased HDL by 7.5% (p < 0.01), and lovas-
tatin lowered HDL 2.8% (not significant).17 Similar
results were obtained during a trial that compared
policosanol 10 mg daily to pravastatin 10 mg daily
for eight weeks.18 With findings such as these, more
studies should be performed to assess its safety in the
general population.
In summary, policosanol taken in doses of 5
to 10 mg per day seems to significantly decrease to-
tal and LDL cholesterol, and increase HDL choles-
terol. Products should be used with caution in pa-
tients who are taking anti-platelet or anticoagulant
drugs, as this product may have additive effects.
Since the exact mechanism of action of policosanol
is unknown, it should not be given concurrently with
stations. Furthermore, its safety and efficacy has not



been studied in pregnant and lactating women.8

Guggul Extract
Guggul is made from the oleogum resin of
the Cammiphora mukul tree which is native to India.
It has been credited with impacting the lipid profile,
possibly due to the guggulsterone content. It has
also been promoted for use in obesity, osteoarthritis,
and nodulocystic acne. Several mechanisms have
been theorized for the effects of this herbal agent.
Guggul may increase the breakdown of LDL by de-
creasing hepatic steroid production.23 A second pro-
posed mechanism of action is that guggulsterones E
and Z may increase hepatic binding sites for LDL,
leading to increased LDL clearance. A recent review
suggested that guggulsterones act as antagonists at
the farnesoid X receptor and the bile acid receptor,
two key hormone receptors involved in the regula-
tion of bile acid production and cholesterol metabo-
lism. By antagonizing this receptor, 7a-hydroxylase
is released, activating the catabolism and subsequent
excretion of cholesterol.19
There have been several trials testing the
lipid-lowering effects of guggulipid. Most of these
studies, however, were too small and not well de-
signed or reported. Clinical studies conducted in In-
dia have shown that a standardized extract of guggul
can lower total, LDL and triglycerides, as well as
raise HDL in both healthy and hyperlipidemic sub-
jects. Many of these studies also placed subjects on
fruit- and vegetable-enriched diets, and the results
between guggul and placebo were often not statisti-
cally significant.9 In a recent trial, guggul did not ap-
pear to improve cholesterol levels; in fact, LDL in-
creased by 9% to 10% during the eight week trial
period.20 This discrepancy might be caused by differ-
ences in the diet of the subjects studied. Although
this seemingly provides evidence against the efficacy
of guggul for hypercholesterolemia, due to the prece-
dent of prior research and historical use, further
study is necessary before a definitive conclusion can
be reached. More rigorous studies need to be con-
ducted in larger patient populations in order to prove
both its safety and efficacy.
Guggul extract in doses of 3 to 6 grams per
day seems to lower total cholesterol, LDL, and
triglycerides in Indian populations. However, in the
studies that have been conducted in populations eat-
ing Western diets, guggul does not seem to lower
total cholesterol or triglycerides, or raise HDL cho-

Volume 21, Issue 8, May 2006

lesterol. Guggul should be used with caution in pa-
tients with thyroid disorders, women who have had
hormone sensitive cancers, and women who are

Fenugreek Seeds
Fenugreek (Trigonella foenum graecum),
grown originally in Asia, is now widely cultivated in
India, Argentina, Egypt and the Mediterranean. Of-
ten referred to as 'Methi,' it is commonly used as a
cooking condiment in India. The seeds contain many
nutrients including protein, carbohydrates, polyun-
saturated fats, vitamins and minerals, fiber, trigonel-
line, 4-hydroxyisoleucine, sotolon, saponin, and
other constituents. Fiber and saponin have been the
components of greatest interest in this herbal product,
as these have been shown to have the most choles-
terol-lowering activity.21
Several different mechanisms of action have
been theorized for fenugreek's hypocholesterolemic
effect. It is thought to lower cholesterol by enhancing
the excretion of bile acids and neutral sterols, while
simultaneously decreasing cholesterol stores in the
liver (by converting the cholesterol into bile salts).
The fiber component of fenugreek potentially re-
duces the rate of diffusion of glucose and cholesterol
towards the mucosal surface of the gut. Fiber has
also been shown to increase the viscosity of food,
thereby inhibiting uptake of cholesterol and bile ac-
ids.21 Of note, about 80% of the amino acids present
in the seeds are 4-hydroxyisoleucine, which appears
to directly stimulate insulin. This action, combined
with the decrease in glucose absorption stimulated by
fiber may cause patients with diabetes mellitus who
are treated with oral hypoglycemics or insulin to ex-
perience episodes of hypoglycemia.8
The quality of most of the clinical trials that
have been performed to evaluate the efficacy of
fenugreek have been poor. Five fenugreek seed stud-
ies reviewed in a meta-analysis showed statistically
significant reductions in total cholesterol of 15% to
33% compared with baseline. Similar to the guggul
trials, all but one of these studies was conducted in
India; therefore, it is unknown how much diet and
other confounders may have contributed to these re-
There is conflicting evidence regarding the
use of fenugreek for use as a cholesterol-lowering
agent. Doses of 0.6 to 2.5 grams of fenugreek 2 twice
daily with meals has been used in an effort to lower

lipids. Fenugreek should be used cautiously in pa-
tients who are taking medications for diabetes, be-
cause this herbal product might cause hypoglycemia.
Counsel patients taking this herbal product to sepa-
rate its ingestion by two to four hours from other
medications, since fenugreek could affect their ab-

There are many other alternative medicinal
agents which are being used to lower cholesterol;
however, due to either their extensive review else-
where or insufficient evidence, they will only be
mentioned briefly below.

Artichoke Extract
Artichoke, Cynara Scolymus, has been used
as an ancient herbal remedy for a variety of diseases;
it has been used mainly for the treatment of dyspep-
sia, but in recent years, artichoke extract has also
been used for the treatment of hyperlipidemia. In ani-
mal studies, it seems to increase bile flow and inhibit
hepatocyte cholesterol biosynthesis. During studies
conducted in humans, a moderate hypocholes-
terolemic effect has been shown. It also seems to
possess antioxidant properties in endothelial cells
and monocytes, and contributes to the antagonism of
lipid peroxidation.22 There is a small body of evi-
dence that supports the theory that artichoke extract,
when taken in divided doses of 1800 mg to 1920 mg
per day, seems to modestly reduce total and LDL
cholesterol over six to twelve weeks of treatment.
Artichoke extract looks promising, but further study
is warranted before recommending it for most pa-
tients. Artichoke should be used cautiously in pa-
tients that have gallstones or bile duct obstruction.8

Garlic has been studied thoroughly, and
there is significant controversy surrounding its effi-
cacy. Many different trials have tried to either prove
or disprove garlic's effectiveness in the treatment of
hyperlipidemia. Many of the pharmacological effects
of garlic are attributed to allicin. Bulbs contain an
odorless sulfur-containing amino acid derivative
called alliin. When the bulbs are crushed, the enzyme
allinase is released; allinase converts alliin to allicin.
Garlic's proposed mechanism of action in lowering
cholesterol is by acting similarly to an HMG-CoA
reductase inhibitor. There is also some evidence that
S-allyl-L-cysteine (a component in garlic) might be

PharmaNote Volume 21, Issue 8, May 2006

Volume 21, Issue 8, May 2006


Table 3: Comparison of Lipid Lowering Agents.*


Bile acid sequestrants




Red Yeast Rice


Guggul Extract


Aritchoke Extract



I up to 55%

1 10% to 30%

1 18% to 24%

1 10% to 15%

Variable; sometimes T

121% to 32%

1 11% to 31%

Variable, sometimes t

I up to 38%

I up to 23%

1 4% to 12%


1 8% to 16%


T 6% to 14% 1 15% to 35%

Variable; some-
times T


S35% 20% to 50%

T 5% to 15%

T 15% to 20%

S7% to 9%

S16% to 34%

14% to 7%



Grape Seed Extract

I 1%to 3%

Variable depending on
Variable depending on



Variable depending on

1.2 2.4g/day


3 6g/d

0.6 2.5g/day

1.8- 1.9g/day


Variable (use based on
Variable (use based on


40 300mg/d

*Adapted from The Natural Medicines Database. t Cost varies according to manufacturer and quality and purity of the component. t To date, studies have not con-
cluded range of effects on lipid profiles

an inhibitor of hepatic cholesterol synthesis.23
There is disagreement over the effectiveness
of taking garlic orally for hyperlipidemia. Doses of
900 mg per day seems to slow the development of
atherosclerosis in both aortic and femoral arteries
when ingested over a four-year period.23 Conversely,
studies have also shown no significant benefit when
used for 6 months or longer. Products should be used
with caution in patients that have bleeding disorders,
those who have had recent surgery (garlic may in-
crease the risk of bleeding), or those who have gas-
trointestinal irritation. There are potential drug inter-
actions in patients taking anticoagulant or antiplate-
let drugs, contraceptive medications, cyclosporine,
CYP 3A4 substrates (e.g. calcium channel blockers,
chemotherapeutic agents, ketoconazole, itraconazole,


glucocorticoids, cisapride, fentanyl, lidocaine, losar-
tan, fexofenadine, midazolam, and others), non-
nucleoside reverse transcriptase inhinbitors, or saqui-
navir. Concomitant use of garlic and saquinavir has
been shown to decrease saquinavir concentrations by
up to 50%.8

Soy protein preparations reduce total choles-
terol and LDL levels in both hypercholesterolemic
and normocholesterolemic men and women. Re-
placement of dietary animal protein with soy protein
decreases total cholesterol by 9%, LDL cholesterol
by 13%, and triglycerides by 11% after one to two
months; the effect on HDL is inconsistent. Soy prod-
ucts should be used with caution in patients who are

Volume 21, Issue 8, May 2006

Cost 3t














taking antibiotics, estrogen replacement therapy, ta-
moxifen, or warfarin. Also use with caution in pa-
tients that have the following disease states: asthma
(inhaled soy dust can trigger symptoms), allergic
rhinitis, estrogen sensitive cancers, cystic fibrosis,
hypothyroidism, renal failure, kidney stones, or blad-
der cancer. 8,23

English Walnut
English walnuts contain high amounts of the
polyunsaturated fatty acids, linoleic acid and alpha-
linolenic acid. It also contains significant amounts of
fiber, phosphorus, potassium, and folate. Theoreti-
cally, other constituents such as fiber, vitamin E, and
folate might contribute to the seemingly beneficial
effect on cardiovascular disease risk. Clinical re-
search also suggests walnuts might improve endothe-
lial function, which might be beneficial in preventing
atherosclerosis. In addition to alpha-linolenic acid,
walnuts contain significant amounts of arginine, a
precursor amino acid of the endogenous vasodilator
nitric oxide.8 When English walnuts are added to a
low fat diet in doses of approximately 8-11 walnuts
per meal24 (substituted for other dietary fats), total
cholesterol may be decreased by 4% to 12% and
LDL may be decreased by 8% to 16%. There are no
known disease or drug interactions when using this
product; however, warn against using this substitu-
tion when the patient has an allergy to nuts.8

Pycnogenol is found in the extract from the
bark of the French maritime pine tree. Pycnogenol
contains several active constituents including flavon-
oid monomers such as catechin, epicatechin, and
taxifolin. It also contains condensed flavonoids or
proanthocyanidins.26 As far as hyperlipidemia is con-
cerned, there is some evidence that pycnogenol 120
mg three times daily lowers LDL. Pycnogenol is
used for a variety of other disorders for which there
is greater evidence to support its use: asthma, en-
hanced athletic performance, chronic venous insuffi-
ciency, hypertension, and retinopathy. Interestingly,
pycnogenol inhibits the oxidation of LDL, inhibits
epinephrine induced platelet aggregation, and also
inhibits angiotensin converting enzyme.26 It might
also increase nitric oxide production from vascular
endothelial cells. It should be used with caution in
patients who are taking immunosuppressants or pa-
tients who have autoimmune diseases.8

Grape Seed Extract
Grape flavonoids have a wide variety of ef-
fects including antioxidant, vasodilating, anti-
lipoperoxidant activity, and antiplatelet properties
that might prevent heart disease. Ingestion of purple
grape products, such as purple grape juice, grape
seed extract, and red wine, might improve endothe-
lium-dependent vasodilation, prevent LDL oxidation,
and suppress platelet-mediated thrombosis.27 Theo-
retically, consumption of these products long-term
might reduce the risk of cardiovascular disease. It
has been suggested that initially, patients would take
grape seed extract in doses between 75-300 mg daily
for three weeks followed by a maintenance dose of
40-80 mg daily. Use with caution in patients taking
warfarin (may increase the INR) or any other drugs
metabolized via the CYP 1A2 pathway (e.g. amitrip-
tyline, chlordiazepoxide, clopidogrel, cycloben-
zaprine, diazepam, estradiol, mirtazapine, naproxen,
propranolol, theophylline, verapamil, etc.), as their
plasma levels may decrease.8

Of the herbal preparations discussed, the saf-
est and most likely to be effective are soy products or
walnuts substituted for fats in the diet. These can be
recommended for the majority of patients initiating
therapeutic lifestyle changes. Red yeast rice is likely
effective at lowering LDL cholesterol. While garlic
is likely safe, and possibly effective, there is contro-
versy surrounding garlic and its efficacy; therefore,
its use is not recommended. Both artichoke extract
and policosanol are possibly safe and effective.
Pycnogenol and grape seed extract are well tolerated
but there is insufficient evidence to support recom-
mending its use. Guggul and fenugreek seeds have
are possibly ineffective at treating hyperlipidemia.
Their use cannot be recommended.
A major drawback for the vast majority of
herbal preparations is the inconsistency of the prod-
uct from one bottle to the next. There is currently no
regulation over the companies who create and market
these products.
There is conflicting data on herbals and hy-
perlipidemia. Many of the trials cited were not meth-
odologically sound. Even more were conducted in
foreign countries, where the diet is considerably dif-
ferent than that of an American. While there is little
doubt that some of these agents exhibit beneficial

Phrm~oe olme21 Isu 8 My 00

Volume 21, Issue 8, May 2006


effects on lipid parameters, their efficacy is tempered
by the lack of long term studies, variable product
quality, and difficulties extrapolating the data to
other populations More studies conducted in larger,
more diverse populations are needed to prove the
safety and efficacy of all of these agents.

1. Centers For Disease Control FastStats A-Z.
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Estimates: 2003 Top 10 Prescribed Drugs, by Total Ex-
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3. DrugStore.com. Drug and Herbal Pricing.
www.drugstore.com (accessed January 10, 2006)
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Nov 15.2005 http://www.washingtonpost.com/
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6. American Pharmacists Association. Medicare Prescrip-
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online January 13, 2006)
7. Natural News Wire. New Study from NMI Reports
2004 Health & Wellness Industry Sales at $68 Billion.
http://www.naturalnewswire.com/2005/0 1/
newstudy from_.html (accessed January 15, 2006)
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www.naturaldatabase.com (accessed January 10, 2006)
9. Thompson Coon, J., Ernst, E. Herbs for serum choles-
terol reduction: A systematic review. Journal of Family
Practice 2003;52:468-478
10. Monascus purpureus (Red Yeast Rice) Monograph. Al-
ternative Medicine Review 2004;9:208-210
11. Herber, D., et al. Cholesterol lowering effects of a pro-
prietary Chinese red yeast rice dietary supplement. Am
J Clin Nutr 1999;69:201-204.
12. Wang, J., et al. Multicenter clinical trial of the serum
lipid-lowering effects of a Monascus purpureus (red
yeast) rice preparation from traditional Chinese medi-
cine. Curr Ther Res 1997; 58:964-978.
13. Keithley, J. et al. A pilot study of the safety and effi-
cacy of Cholestin in treating HIV-related dyslipidemias.
Nutrition 2002;18:201-204
14. Rippe, J. et al. A multi-center self-controlled study on
Cholestin in subjects with elevated cholesterol. 39th An-
nual Conference on Cardiovascular Disease Epidemiol-
ogy and Prevention. Orlando, FL: 1999. Abstract ac-
cessed at www.umm.edu/altmed/conssupplements/
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The PharmaNote is Published by:
The Department of Pharmacy
Services, UF Family Practice Medical
Group, Departments of Community
Health and Family Medicine and
Pharmacy Practice
University of Florida

John G. Gums
Pharm.D. Editor

R. Whit Curry, M.D. Associate Editor

Benjamin J. Epstein Assistant Editor
Pharm.D., BCPS

PharmaNote Volume 21, Issue 8, May 2006

Volume 21, Issue 8, May 2006


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