Overview of Dietary Supplements
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Made 5/2025 -- Used Chapter 74 and tables 74-1 and 74-2 from "McGraw Hill's NAPLEX Review Guide, 5th Edition (2025)"
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Scientific name(s) of Black Cohosh
Actaea racemose OR Cimicifuga racemosa
Primary use of Black Cohosh
manage postmenopausal symptoms (such as host flashes)
Mechanism of action of Black Cohosh
it affects vasovagal and thermoregulatory system for host flash suppression
may or may not have some minimal estrogen-modulator effects
Dosage and product considerations of Black Cohosh
20mg extract standardized to contain 1mg 27-deoxyactein (or 2.5% triterpene glycosides) twice daily — this may be increased to 40mg of extract twice daily if sufficient benefit is not seen
most studies with positive results have used the German “Remifemin” brand extract
Side effects and recommended monitoring of Black Cohosh
It is well-tolerated by most, with mild GI effects being most common, and allergic reactions and rashes are also possible
rare reports of hypotension, bradycardia, and hepatic issues are controversial
monitoring of liver function is advised for now
regular well-woman gynecologic exams should continue
Contraindications and interactions of Black Cohosh
do not use in liver disease or bradycardia, or with hepatotoxic agents or estragenic/anti-estrogenic agents
may have additive effects with antihypertensive agents
may inhibit CYP450 2D6 (use with caution)
Key knowledge of Black Cohosh
it may take up to 8 weeks for full onset of effects
treatment is not likely to reduce hot flush frequency and severity to the same extent as hormone therapy
is not known to have significant beneficial effects on bone health in postmenopausal women
a glucosaminoglycan that has slight anti-inflammatory action, stimulates chondrocytes to produce cartilage, serves as a sulfur source for generation of molecular bonds within cartilage, and inhibits leukocyte elastase (enzyme responsible for cartilage degradation)
REGARDLESS OF ALONE OR USED IN COMBINATION WITH GLUCOSAMINE dose is 1200 mg/day in one or divided doses
Chondroitin is usually produced from cattle trachea, meaning little to no risk of bovine spongiform encephalopathy (because trachea tissue does not normally contain neural matter) -- HOWEVER, microbial contamination is a possibility
Only high-quality products should be used—those participating in a quality seal program or tested by a third-party laboratory
generally well-tolerated
headache and GI symptoms are most commonly reported -- taking with food and dividing doses may alleviate these side effects
Case reports exist of increased international normalized ratio (INR) and bleeding when used with warfarin
use with any anticoagulant/antiplatelet agents should be avoided or closely monitored
Due to the MOA, chondroitin must be used for several months before any benefits can be expected to be observed -- trial periods should be at least 6 months before any decision regarding efficacy is made
Chondroitin is an expensive product and cheap versions are very likely to not contain chondroitin in labeled amounts
In general, combination use with glucosamine is preferred over monotherapy (see glucosamine in deck)
MULTIPLE ACTIVITIES INVOLVED IN IMMUNE SYSTEM FUNCTION
increased phagocytosis by macrophages
increased lymphocytic and natural killer cell activity
increased cytokine (interferon, interleukins) secretion
Mild anti-inflammatory effects may exist via cyclooxygenase and 5-lipooxygenase inhibition
Antiviral action on certain respiratory illness viruses has been reported
Very recent information links some of the beneficial activities to bacteria living within the plants, rather than echinacea itself
Data does not support one type of echinacea product or dose
Products with the most clinical evidence for benefits are not always available in the United States
Extracts are preferable to whole plant or root products and should be standardized to alkamide, chicoric acid, or echinoside content
For prevention, manufacturers’ directions may be followed, while an increased dosing regimen of three to four times daily may be used for treatment -- treatment must begin at the very first onset of symptoms for best efficacy
Generally well-tolerated
Mild GI symptoms and headaches are most common
allergic reactions of varying severities, including anaphylaxis, have been reported
Contraindicated in patients with severe allergy to Asteracea/Compositae plants (chrysanthemums, ragweed) and patients with autoimmune diseases
Drug interactions are primarily minimal, although concomitant use with CYP1A2 substrates should be avoided or closely monitored
Avoid use with immunosuppressants
A prospective trial demonstrated no fetal harm from echinacea use in the first trimester -- HOWEVER, the limited information available (one trial and two retrospective reviews) prevents a recommendation of use during pregnancy -- any use during pregnancy should be discussed with the primary healthcare provider
Start echinacea at the very first sign of a cold or upper respiratory infection
To minimize adverse event risk, use for prevention should be limited to times when there is known exposure to an ill person
Only products participating in a quality seal program or that have been tested by a third-party laboratory should be recommended
VARYING USES
atopic dermatitis
cyclic mastalgia
fibromyalgia
chronic fatigue syndrome
asthma
Evening primrose seeds contain oil with omega-6 fatty acids (primarily linoleic and gammalinolenic acids)
In general, anti-inflammatory effects are achieved by influencing the balance of anti-inflammatory and pro-inflammatory cytokines through the production cascades
The gammalinolenic component inhibits the pro-inflammatory effects of arachidonic acid's production of leukotrienes
Most studies have used an EPO product containing at least 9% gamma-linolenic acid
For atopic dermatitis -- dosage is 3 to 4 g/day for adults and 0.5 to 3 g/day for children (topical 10% EPO cream is generally used twice daily)
For cyclic mastalgia, fibromyalgia, and chronic fatigue syndrome -- dosage is 3 to 6 g/day
generally well-tolerated
increased bleeding time is possible
Metabolic drug interactions are primarily theoretical and minor
Use with anticoagulants and antiplatelet agents should be avoided or occur only with low doses and careful monitoring
One report of seizure occurred in a patient taking several botanical therapies -- use in seizure disorders or with anticonvulsant agents is best avoided
Should not be used in pregnancy, especially in the last trimester, due to potential for delivery complications and adverse effects on the newborn
EPO is a supplement with theoretical potential that has not been demonstrated in clinical trials
Because EPO has a good safety profile, patients who wish to try do not need to be discouraged unless there is a strict contraindication
Education should include the limited benefits likely in most individuals
A source of the omega-3 fatty acids (O3FA), docosahexaenoic acid (DHA), and eicosapentaenoic acid (EPA)
Resolvins and protectins from O3FA decrease inflammation of arterial plaque -- leading to decrease in cholesterol absorption and inhibition of enzymes responsible for low-density lipoprotein (LDL) production (therefore improving lipid profiles, especially triglycerides)
The increased DHA and EPA levels variously influence production of multiple cytokines having anti-inflammatory effects
To normalize dietary intake -- 1 g/day
For triglyceride reduction -- 2 to 4 g/day
Concerns over mercury and heavy metal contamination in fish generally do not extend to fish oil, because oil is expressed from fish skin, while contaminants are concentrated in the fish flesh
Use of a high-quality product is recommended: products either participating in the USP Dietary Supplement Verification program or tested by a third-party laboratory (Note: although labeled amounts of DHA and EPA will not equal the total amount of fish oil per capsule, these amounts should consist of a fairly high percentage of the total in a high-quality product)
generally well-tolerated
"fish burp" is the most common adverse effect -- alleviated or minimized by used of enteric-coated capsules and/or freezing the capsules
reported side effects do include fishy halitosis, heartburn, nausea, and loose stools
Because of possible antiplatelet effects, doses >3 g/day should be used very cautiously in patients on anticoagulants or antiplatelet agents
Administration of orlistat and fish oil should be separated by 2 to 3 hours
Monitor blood pressure in patients on antihypertensives (due to possible slight additive effects)
Fish oil can help lower lipid levels, especially triglycerides, but the benefit for overall cardiovascular risk reduction is likely modest.
Icosapent ethyl (Vascepa):
An ethyl ester of EPA used as an adjunct to diet to reduce triglycerides in adults with severe hypertriglyceridemia (≥500 mg/dL).
Dosage: 4 g/day — either four 0.5g capsules or two 1g capsules taken twice daily with food.
Capsules should be swallowed whole (do not break open, crush, dissolve, or chew).
Patients should follow a lipid-lowering diet and exercise regimen before and during treatment.
Underlying conditions such as diabetes mellitus, hypothyroidism, or alcohol use that contribute to lipid abnormalities should be addressed.
Medications that worsen hypertriglyceridemia (e.g., β-blockers, thiazides, estrogens) should be discontinued or changed, if possible, before starting triglyceride-lowering therapy.
Omega-3-acid ethyl esters (Lovaza):
Contains ethyl esters of EPA and DHA, used as an adjunct to diet for adults with severe hypertriglyceridemia (≥500 mg/dL).
Dosage: 4 g/day — either a single 4-g dose (4 capsules) or two 2-g doses (2 capsules twice daily).
Capsules should be swallowed whole (do not break open, crush, dissolve, or chew).
Though garlic contains multiple active components, the primary marker compound is allicin, which is produced from alliin when the enzyme alliinase is released upon damage to garlic bulb cells
Alliin and S-allylcysteine have antioxidant properties (preventing lipid oxidation) and exhibit anti-platelet and anti-microbial effects
Antihypertensive effects are partly due to increased hydrogen sulfide, which dilates vasculature
Aged garlic extracts with a minimum of 1.2 mg of S-allylcysteine daily (aged garlic extracts may be more effective option)
Powdered garlic providing 3 to 5 mg of allicin daily
Use of raw garlic and garlic oils are not supported
Halitosis is the most common side effect
GI effects including heartburn and reflux are more prevalent with therapy initiation or with high doses
Garlic does affect platelet function -- garlic use must be stopped 10 to 14 days before any elective surgeries or dental procedures (due to common reports of excessive bleeding)
Supplement amounts should be avoided or used under close monitoring in patients on anti-thrombotic/anti-coagulants Garlic can enter breast milk, affecting taste and altering nursing time
Very limited and contradictory information is available for use in pregnancy (NOTE: garlic does cross the placental barrier, so use is best avoided)
Contradictory information indicates that garlic may induce some CYP450 enzymes to varying extent (2D6 and 3A4 notably) -- Use with saquinavir and isoniazid should be avoided while effects of other drugs during concomitant use should be closely monitored
Effect sizes for reductions of both blood pressure and lipid levels are small, so garlic is only appropriate for MILD hyperlipidemia and hypertension, and in patients who are making additional lifestyle changes to reduce their risks
However, due to the mild safety profile, patients with more severe disease wishing to use garlic do not have to be discouraged unless a specific contraindication exists
Like chondroitin, glucosamine stimulates chondrocytes to synthesize cartilage while functioning as a source of building blocks, but also stimulates the product of synovial fluid
It reduces both inflammatory cytokines and matrix metalloproteinase (an enzyme involved in cartilage degradation)
There are differences in salt forms -- glucosamine sulfate reduces bone resorption to a greater extent than glucosamine hydrochloride (HCl)
There are significant differences between glucosamine sulfate and glucosamine hydrochloride
If monotherapy is used, then only glucosamine sulfate is recommended (1500 mg/daily in one or divided doses)
If combined with chondroitin, then either glucosamine sulfate or glucosamine HCl is appropriate at the same 1500 mg/daily dose
A crystalline form of glucosamine made by Rotta Laboratories was used in many of the clinical trials with successful results (NOTE: it is possible that other forms of glucosamine may not be as effective due to absorption differences)
GI symptoms are most reported
splitting doses and taking with food can assuage discomfort
Glucosamine is commonly produced from the chitin of shellfish (structural polysaccharide found in the shell), and although products are highly processed and the likelihood of any remaining allergenic proteins is very low, patients with severe allergic reactions to shellfish should not use glucosamine
Although not demonstrated in clinical trials, there have been multiple case reports of increased international normalized ratio (INR) in patients on warfarin who began glucosamine -- this combination should be avoided
Because of the MOA, full benefits will not be evident for several months
patients trying glucosamine for OA, either monotherapy or with chondroitin, should use for a minimum of 6 months before assessing efficacy
Monotherapy should utilize only glucosamine sulfate, while glucosamine hydrochloride is acceptable for combination therapy with chondroitin
Anxiety disorders or occasional insomnia
Beverage preparations are used for ceremonial purposes and for social relaxation in much of Micronesia
enhances dopamine
inhibits noradrenaline
increases expression of gammaaminobutyric acid (GABA) receptors in the brain, preferentially in the limbic area of the brain
Varies depending upon the product
the most tested extract is WS1490 (standardized to 70% kavalactones) with dose of 50 to 100 mg three times daily for anxiety
Because of significant concerns about toxicity and possible contamination of extracts, it is imperative that only products participating in a quality seal program or tested by a third-party laboratory be utilized by patients
MAY LEAD TO HEPATOTOXICITY
Liver effects were not reported in any medical literature until the late 1990s when kava became very popular and both production and use vastly expanded -- cases of liver failure and death have occurred (Adverse events may have been a result of use of other plant parts, contamination by other plants, or contamination with pesticides)
A genetic risk exists: individuals who are poor CYP2D6 metabolizers are at much higher risk of adverse events
After further research into the realistic extent of risks, Canada, France, and Germany recently lifted sales restrictions instituted by multiple countries a few years prior.
Until more is known about the true causes of hepatotoxicity, kava should not be recommended by health care professionals and use should be actively discouraged
Frequent monitoring of liver function is essential in patients who choose to use kava despite a negative recommendation
Other side effects include headache, GI effects, extrapyramidal effects, drowsiness, dizziness, and difficulty with eye movements
Despite good evidence of efficacy for anxiety, kava cannot currently be recommended (especially in the United States)
European nations that have lifted kava sales bans regulate the quality of botanical medicine production far more rigorously
Kava is impairing -- patients should not drive or operate heavy machinery while under its influence
It is produced and secreted by the pituitary gland in response to darkness to aid in controlling circadian rhythm
It also functions as a hormone, aiding in ovulation and triggering sexual maturation at puberty
“Natural” melatonin extracted from bovine pituitary glands should be AVOIDING due to the small risk of contamination with bovine spongiform encephalitis
For insomnia -- 0.3 to 5 mg dose 30 to 60 minutes prior to bedtime
For jet lag -- 2 to 5 mg in the evening (510 pm) of arrival day at the destination, followed by use at bedtime for 5 days
It is very well tolerated
all side effects reported are rare: GI, headache, tachycardia or other rhythm changes, morning sleepiness, changes in depression status (worsening or improving)
Use in adolescents should only occur under the direction and supervision of a primary care provider
Melatonin may have the potential to decrease adverse effects of some cancer chemotherapy or radiotherapy treatments but may interfere with others (Because information on these interactions changes rapidly, patients should discuss use with their oncologists)
Melatonin does not generally create a sleepy feeling but use over time allows sleep attempts to be more successful, so chronic insomnia patients will benefit more than those with occasional sleeplessness
May be more effective for jet lag on return flights than for destination flights and for eastward rather than westward travel (as you are trying to go to sleep faster; EX: LAX [6:00pm PT] = ATL [9:00pm EST])
The red-tinged yeast that grows on rice contains naturally occurring lovastatin (called monacolin K -- an HMG coreductase inhibitor)
Additional mechanisms are present, including increased bile acid secretion
1.2 to 2.4 g per day given once or twice daily
A high-quality product must be used, due to the possibility of contamination with citrinin (a toxin that may form during the fermentation process)
It is generally well-tolerated
Dizziness and GI effects such as bloating, and gas occur
Rarely, muscle pain and rhabdomyolysis have been reported with higher doses
Monitor liver function after 3 to 4 weeks of use, then regularly
Absolutely contraindicated in pregnancy -- women of reproductive potential should use birth control
Red yeast rice should not be used by patients who have experienced severe reactions to statins, with liver disease, or who use alcohol heavily (>2 drinks/day)
Do not use with fibric acids, niacin, or cyclosporine (due to increased risk of myopathies)
Monacolin K is a CYP3A4 substrate, so use with potent inhibitors or inducers could affect levels of that component
Effective for mild to moderate hyperlipidemia, but may not decrease cardiovascular risk
Many of the cautions and monitoring are due to the lovastatin/monacolin K component
Some patients who cannot tolerate statins may be able to use RYR successfully, but those who have had very severe reactions to statins should avoid RYR use
depression
also used for seasonal affective disorder, anxiety, and post-menopausal symptoms
Hyperforin affects the intra and extracellular sodium gradients in neural synapses to influence the sodium pumps used for reuptake of serotonin, norepinephrine, dopamine, and other neurotransmitters
may also affect serotonin receptor binding
Hypericin antagonizes GABA and other receptors
Other mechanisms are possible
900 to 1800 mg/day of extract standardized to 5% hyperforin OR to 0.3% hypericin in two to three divided doses
Phototoxicity -- sunscreen should be used at all times
Serotonin syndrome has been reported
Most common effects are mild GI symptoms, dry mouth, and headache
Sleep disturbances such as vivid dreaming and insomnia are reported and may be minimized by morning administration
Mania and hypomania are reported -- use in bipolar patients is best avoided
St. John's wort is a potent CYP3A4 inducer, which severely limits usefulness in therapy
induces 2C9 and 1A2 to a lesser extent
also increases p-glycoprotein transporter activity
Avoid use with serotonergic agents to avoid increased risk of serotonin syndrome
Depression is not a self treatable disease -- patients using SJW should be monitored by their primary care provider
Avoid use with oral contraceptives, antiretroviral agents, and immunosuppressive agents -- use with any prescription drugs should be closely monitored
Inhibits both subtypes of 5-α-reductase
competitively inhibits dihydrotestosterone receptor binding
has anti-inflammatory activity
May have anti-estrogenic activity
Does NOT decrease prostate size
Well tolerated
most common side effects are mild GI and headache
Reports exist for both worsening and improving erectile dysfunction and libido
Increased bleeding time has been reported at least twice
Absolutely contraindicated in pregnancy and lactation due to hormonal effects (although most often used in men for prostate issues, saw palmetto is frequently found in combination supplements for women marketed to “increase bust size”)
Metabolic drug interactions are theoretical but use with anti-platelet agents or anti-coagulants is best avoided
Due to hormonal effects, use with estrogenic or anti-estrogenic therapies should be avoided
Most appropriate for mild BPH symptoms
Does not decrease prostate size, so benefit for obstructive symptoms may be less than for irritative symptoms
Patients wishing to use for urinary symptoms must have a diagnosis of BPH and have ruled out prostate cancer, due to the possibility of masking worsening cancer symptoms
What is the common intended use of echinacea?
decreases duration and intensity of cold symptoms
What is the common intended use of ephedra (Ma Huang)?
banned as a supplement by FDA
treatment of respiratory ailments such as bronchitis and asthma
CNS stimulant
What is the common intended use of garlic?
for cholesterol-lowering and atherosclerosis
What is the common intended use of gingko?
treatment of intermittent claudication, cerebral insufficiency, and dementia
What is the common intended use of ginseng?
improvement of physical and mental performance
What is the common intended use of milk thistle?
limitation of hepatic injury and as an antidote to Amanita mushroom poisoning
What is the common intended use of saw palmetto?
improvement in symptoms of benign prostatic hyperplasia
What is the common intended use of St. John’s wort?
treatment of mild-to-moderate depression
What is the common intended use of coenzyme Q10 (CoQ-10)?
improvement of ischemic heart disease and for Parkinson’s disease
What is the common intended use of glucosamine?
reduction of pain associated with osteoarthritis (sulfate formulation)
What is the common intended use of melatonin?
decrease jet lag symptoms and as a sleep aid
1A2 inhibitor
3A4 inhibitor and/or inducer
3A4 inducer
2E1 inhibitor
2D6 inducer
Preliminary and contradicting evidence regarding CYP (1A2, 2C9, 2C19, 2D6, and 3A4) and p-glycoprotein interactions with kava
1A2 substrate -- Concomitant use with other CYP1A2 substrates can alter metabolism of either agent
1A2 inducers/inhibitors can alter melatonin metabolism
Note 
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