Transcript Cautions

KING ABDULAZIZ UNIVERSITY
By the end of the lecture you will:

Objective
Be familiar with the dietary supplementation.
 Know the meaning of phytotherapy and their different
formulations.
 Understand the regulations of supplementations.
 Be aware of the classification of herbs.
 Be familiar with the most common uses of herbs.
 Know the efficacy of herbs and the corresponding
databases.
Recognise the tools needed to evaluate patients.
Dietary Supplements
Is intended to supplement the diet that contains one or more
of the following dietary ingredients:
• Vitamins
• Minerals
• Herbs or botanicals (Phytotherapy)
• Amino acids
 Dietary supplements are intended to be taken in pill, capsule,
or liquid form.
Dietary supplements should be labeled as a "dietary
supplement“ and carry the dietary supplement facts label.
Phytotherapy (Herbs)
It is the science of using plant-derived substances to treat and prevent illness.
It includes plant leaves, flowers, or roots.
The terms herbs and botanicals are often used.
Facts about the Herbal Supplementation
They have been used for thousands of years.
They are available without prescription and may carry function claims.
There is no data suggesting that herbs are more beneficial than conventional
drugs for treating illnesses.
Products that are described as “natural” are not always safe. They can have
drug-like effects.
Facts about the Herbal Supplementation (Cont.)
Herbal supplements are not required to go through the same strict testing as
over the counter (OTC) and prescribed medicine, and are not regulated as
closely by the Food and Drug Administration (FDA).
For many botanical products, the active ingredients and the mode of action
have been defined; others are still being researched. Botanical medicine can
be investigated with the same scientific tools as prescription drugs (double
blind, placebo-controlled clinical trials).
Botanical Formulations
They are available in many forms including:
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•
•
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Bulk herbs
Beverages
Extracts
Pills
Topical application of botanicals and/or nutrients in the form of creams or essential
oils are not classified as dietary supplements under the current regulations.
Regulation
Herbals and botanicals are sold as dietary supplements and regulated
differently than pharmaceutical drugs.
The Food and Drug Administration (FDA) does not test herbs for safety or
efficacy.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) is a law
that clarifies marketing regulations for botanicals and reclassifies them as
dietary supplements, distinct from food or drugs.
No claims about the prevention or cure of specific conditions can be made.
For example, a product manufacturer cannot claim that a dietary supplement
“prevents heart disease”; however, it can be said that a product “ helps to
increase blood flow to the heart.”
Regulation (Cont.)
All products must display the following disclaimer: “ This statement has not
been evaluated by the food and drug administration. This product is not
intended to diagnose, treat, cure, or prevent any disease.” So, in the USA it is
the consumers’ responsibility to educate themselves.
In the European market, especially in Germany, botanicals are considered
drugs and are prescribed by physicians and dispensed by pharmacists.
Common problems that have been reported since the
passage of DSHEA
Misrepresentation of product contents.
Different recommended dosages among products.
Inadequate information about a company’s herbs are grown and processed.
Poor standards of quality product safety, or activity of ingredients.
As a result: governments and industries are working to develop high-quality
manufacturing guidelines Good Manufacturing Practices (GMP) for all dietary
supplements, including botanical products.
Classification of herbs
A helpful safety rating classification has been developed by the American
Herbal Products Association and is listed in the table below:
Saudi FDA
Most commonly used herbs
• Echinacea
• Garlic
• Ginger
• Ginkgo
• Ginseng
• Hawthorn
• Milk Thistle
• Saw Palmetto
• St. John's Wort
• Valerian
Echinacea (‫)حشيشة القنفذ األرجوانية‬
Source: Purple flower
Indication:
Prevent or moderate the symptoms of colds and flu
Chronic infection of the upper respiratory tract.
Action:
Immune-stimulating activity including high and low molecular weight
flavonoids and caffeic acid derivatives. (not single compound).
Cautions: Avoid if immunosuppressive drugs taken and do not use frequently.
Class 1 botanical
Garlic (‫)الثوم‬
Source: Garlic plant
Indication: Hyperlipidemia, hypertension, useful against bacterial, fungal, and
viral infections.
Action: Chewing or crushing activates sulfur containing compounds.
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Moderate reductions in blood pressure.
Modest reductions in blood cholesterol levels.
Inhibition of blood clot formation.
Relaxing the smooth muscle of blood vessels.
Cautions:
• More than five cloves produce:
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•
•
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Heartburn
Mild allergic reactions
GI symptoms
Interaction when using aspirin or other anticoagulant drugs such as warfarin,
antiplatelet aggregation drugs, omega-3 fatty acid.
Class 2c botanical
Ginger (‫)الزنجبيل‬
Source: Ginger plant
Indication:
Treatment for digestive system problems, especially nausea and vomiting.
Ease the symptoms of arthritis, cardiovascular disease, and other
inflammatory disorders.
Antiemetic
Action: Anti-inflammatory properties
Cautions:
Gastrointestinal upset
Dermatitis
Heart burn
Increase the risk of bleeding when combined with blood thinning agents
May interfere with blood pressure and blood sugar regulating medication.
Class 1 botanical
Ginkgo (‫)الجنكه‬
Source: Ginkgo tree
Indication:
• Treat age-related decline in mental (short-term memory loss, poor concentration)
• Alzheimer’s type may also be improved by the use of the extract.
Action:
• Antioxidant activity, protect cells against free radical damage, particularly damage
to the lipid layer of the cell membrane.
• Increasing blood flow and enhancing circulation.
Cautions:
• Should not be combined with blood thinning medications (aspirin).
• Should not be combined with blood thinning supplementations ( omega-3 fatty
acids, ginger, garlic).
• Interferes with diabetes medication.
Class 2d botanical
Ginseng (‫(الجنسنج‬
Source: Slow growing plant that takes at least 6 years
Indication:
Helps the body cope with stress
Improves energy levels
Increases circulation
Treats fatigue
Action:
Effect on blood pressure
Mild action on the central nervous system
Cautions:
Do not take with caffeine; may cause overstimulation and gastrointestinal distress.
Affects blood sugar or blood pressure and interferes with blood coagulation or affects
the heart rate.
Class 2d botanical
Hawthorn (‫)الزعرور البري‬
Source: Hawthorn tree (leaves, berries, and blossoms).
Indication:
Improves blood flow in circulatory disorders such as heart failure and
improves heartbeat.
Action:
Dilates the coronary vessels to lower blood pressure.
Improves the metabolic processes of the heart.
Increases nerve conductivity and heart muscle contractibility.
Cautions:
Side effects are rare; however, a person with heart disease should consult a
health care provider.
No adverse reactions with medication
Caution when combining with cardio active drugs or with blood pressure
lowering medication or supplementation.
Class 1 botanical
Milk Thistle )‫حرشف بري (عكوب أو شوك اللبن‬
Source: Tall plant with prickly leaves and milky sap
Indication:
To treat mild to moderate liver disease
Action:
Protects hepatocytes from toxins and increases the ability of liver cells to regenerate
by stimulating protein synthesis.
Cautions:
Mild laxative effect in the first few days.
May reduce the activity of drug-metabolizing enzymes in the intestine and liver.
Class 1 botanical
Saw Palmetto (‫)عشب المنشار‬
Source: Saw palmetto palm tree
Indication:
Reduces the incidence of benign prostatic hyperplasia
Increases urinary frequency
Action: Not clear
Cautions:
Contains phytoestrogens that mimic the effects of the animal hormone estrogen and
potentially could interfere with estrogen therapy, progesterone therapy, and oral
contraceptives.
Class 1 botanical
St. John’s Wort (‫)عشبة القديس يوحنا‬
Source: Small yellow flowers.
Indication: Mild to moderate depression.
Action:
Inhabitation of the reuptake of the neurotransmitters serotonin,
norepinephrine.
Cautions:
• Oral contraceptives
• LDL cholesterol
Class 2d botanical
Valerian (‫(الناردين‬
Source: White and red flowers.
Indication: Sleep aid, anxiety, and insomnia.
Action:
Binds to receptor sites to depress central nervous system activity.
Cautions:
No side effect if used at the recommendations level.
Class 1 botanical
Recommended times for discontinuation of select common
dietary supplements
Health care professionals should also be aware that people typically do not
inform their health care practitioners of their use of botanicals or other dietary
supplements.
It is particularly important that dietary supplement use be discussed before
surgery.
Table below lists recommended discontinuation time before surgery for eight
common botanicals.
FDA provides a warning for the following herbs which are considered
toxic, and given their side effects, should be avoided:
• Chapparal: irreversible liver damage.
• Comfrey: liver toxicity, carcinogenic effects, and damage to fetus if used during pregnancy.
• Ephedra: hypertension, myocardial infarction (MI), seizure, stroke, psychosis. 155 deaths and over 16,000
side effects.
• Germander: liver damage and death.
• Kava: liver damage, especially risky for those with liver problems.
• Lobelia: breathing problems, rapid heartbeat, low blood pressure, coma, or death.
• Willow bark: Reye’s syndrome in children, and allergic reaction in adults.
• Wormwood: seizures, numbness of legs and arms, delirium, and kidney failure.
• Yohimbe: hypotension (low blood pressure), heart conduction disorders, kidney disorders, nervous system
disorders, death.
Clinical efficacy of herbs
For several dietary supplements enough evidence has accumulated to justify
an evidence assessment report by multidisciplinary teams of scientific experts
under:
1- The Agency for Healthcare Research and Quality (AHRQ,
http://www.ahrq.org).
2- The preparation of a Cochrane Database Review (CDR,
http://www/Cochrane.org/reviews).
3- National Center for Complementary and /alternative Medicine (NIH,
https://nccih.nih.gov/).
Commonly used dietary supplements and related information
regarding clinical efficacy in the form of CDR.
Evaluation strategy for health professional care
Evaluation strategy for health professional care
Evidence-based dietary supplement resources
Evidence-based dietary supplement resources
The best prescription for
disease prevention is a
healthy lifestyle
Contact
• Dr. Areej Alkhaldy
• E-mail: [email protected]
• Room: 1218
• Ext no: 23983