Transcript Herbal Medicines and Dietary Supplements

Herbal Medicines
and Dietary Supplements
The Hidden Dangers and Complications
What is a dietary supplement?
 In the Dietary Supplement Health and Education Act
(DSHEA) of 1994, a dietary supplement was defined as a
product taken by mouth that contains a “dietary
ingredient” intended to supplement the diet. The dietary
ingredient may include: vitamins, minerals, herbs or other
botanicals, amino acids, and substances such as enzymes,
organ tissues, glandulars, and metabolites. They can be
found in many forms such as tablets, capsules, gel caps,
liquids or powders. DSHEA puts dietary supplements in a
special category under the general umbrella of “foods,”
not drugs, and requires that every supplement be labeled
a dietary supplement.
Facts about Dietary Supplements
 The U.S. Food and Drug Administration (FDA) reports that
sales of herbal and botanical products totaled $3 billion
dollars in 1999, representing a 20% increase from 1995.
 Some of the highest selling herbal products include garlic,
ginseng, ginkgo biloba, and echinacea. Other common
supplements include ephedra, St. John’s Wort, kava, and
valerian.
 Clinical studies have proved some herbal supplements
safe and effective, but the effectiveness of many others
still hasn’t been established.
Concerns regarding some
popular supplements
 Popular herbal medications and supplements such as
echinacea, ephedra, ginkgo, ginseng, kava, and St. John’s
Wort may pose problems for patients during the
preioperative period as well as generally have potentially
serious, unwanted side effects.
 Another concern regarding these herbal supplements is
the lack of regulation in their production and marketing,
resulting in little standardization of potency and
concentrations as well as exemption from the safety and
efficacy requirements and regulations that prescription
and over-the-counter drugs must fulfill (ie, preclinical
animal studies, pre-marketing controlled clinical trials,
post marketing surveillance, etc.)
Popular Supplements and Potential
Risks Associated With Them
 Echinacea
 Member of the daisy family, often called purple coneflower, refers to
species of plants that are generally found in the Great Plains region of N.
America, often used to boost the immune system and fend of the
common cold and flu
 Has been shown to have immune-stimulating activity when administered
both orally and parenterally—it increases the number of leukocytes
(white blood cells) and splenocytes (white blood cells of the spleen) and
enhances the activity of granulocytes (granular white blood cells) and
phagocytes (cells that have the ability to ingest and destroy substances
such as bacteria, protozoa, and cell debris)
 Concerns:
 Since this herb stimulates the immune system it can interfere with
and diminish the effects of immunosuppressants such as
cyclosporine. Thus, patients who may require preioperative
immunosuppression (those awaiting organ transplantation, etc.)
should be counseled to avoid or discontinue use as far in advance of
surgery as possible. A history of long-term use (more than 8 weeks)
could possibly increase post-surgical complications such as poor
wound healing and opportunistic infections.
Echinacea (Continued)
 Concerns (continued):
 Also, it can be toxic to the liver and shouldn’t be combined
with other drugs that can cause liver damage, including such
things as anabolic steroids and Cordarone or Pacerone (used
to treat arrhythmia)
 Plus, it has been associated with allergic reactions, including
one reported case of anaphylaxis, therefore people with
asthma, atopy, or allergic rhinitis, should use it with caution.
Ephedra
 Background:
 Also known as ma huang in Chinese medicine, a shrub native
to central Asia
 Often used to promote weight loss, increase energy, and treat
respiratory tract conditions such as asthma and bronchitis
 Contains alkaloids, including ephedrine, pseudoephedrine,
norephedrine, methyephedrine, and norpseudoephedrine
 Concerns:
 Causes elevated blood pressure (hypertension) and rapid
heart rate (palpitation), and these effects have been
associated with more than 1070 reported adverse events
including fatal cardiac and central nervous system
complications (heart attacks, strokes, seizures, etc.).
Therefore, users should avoid other drugs such as caffeine,
decongestants, stimulants, heart drugs, and antidepressants,
which mixed with ephedra can make the supplement more
risky.
Ephedra (Continued)
 Concerns (Continued):
 Long-term use results in tachyphylaxis from depletion of
catecholamine stores and may contribute to perioperative
hemodynamic instability (risk of cardiovascular collapse from
the catecholamine depletion)
 Also, patients who have consumed ephedra and later are
anesthetized with halothane may be at risk of developing
intraoperative ventricular arrhythmias
 Due to the cardiovascular risks of ephedra (such as
myocardial infarction, stroke, and cardiovascular collapse)
patients taking this supplement are advised to discontinue
use at least 24 hours prior to surgery.
Ginkgo
 Background:
 Derived from the leaf of Ginkgo biloba
 Used for cognitive disorders, peripheral vascular disease, agerelated macular degeneration, vertigo
 Studies suggest that it may stabilize or improve cognitive
performance in patients with Alzheimer disease and dementia
 The compounds responsible for its pharmacological effects
are believed to be terpenoids and flavonoids
 This supplement is used by almost 11 million Americans to
improve their memory and increase blood circulation
Ginkgo (Continued)
 Concerns:
 Ginkgo appears to alter vasoregulation, act as an antioxidant,
modulate neurotransmitter and receptor activity, and inhibit
platelet-activating factor (reducing platelets which are needed
for blood to clot)
 By reducing platelets, ginkgo presents a serious concern
especially for patients undergoing surgery who, if are using
ginkgo, are susceptible to an increased risk of bleeding.
Therefore patients should discontinue taking ginkgo at least
36 hours prior to surgery.
 Also, users should avoid mixing ginkgo with such drugs as
aspirin, Ticlid, Plavix, Persantine, and Coumadin, since this
herb may augment the anticoagulation effect of these drugs
and may cause spontaneous and excessive bleeding.
Ginseng
 Background:
 Labeled an “adaptogen” since it reputedly protects the body
against stress and restores homeostasis
 Has antioxidant, antihepatotoxic (liver-protecting), and
hypoglycemic effects
 Wide range of possible therapeutic uses and applications with
weak, debilitated, stressed or elderly people
 Concerns:
 Potential therapeutic use has to do with the herb’s ability to
lower postprandial blood glucose but this effect may cause
unintended hypoglycemia, especially in patients who have
fasted before surgery.
 Also, shown to possibly inhibit platelet aggregation and
prolong coagulation time. Therefore, it should not be used
with warafin (Coumadin), an anticoagulant, because risk of
bleeding problems increases when combined.
 Also, if ginseng is abused, other serious side effects can occur
such as headaches, especially when mixed with phenelzine
sulfate (an anti-depressant), and skin problems; therefore
proper dosage for each person should be determined and
followed.
Other Supplements
and Potential Threats
 Kava
 Often used for insomnia and short-term reduction of stress
and anxiety
 Can be addictive and combined with sedatives, sleeping pills,
alcohol, antipsychotics, and drugs to treat anxiety it can
produce deep sedation and even coma, and it has been linked
to 25 cases of liver toxicity (including hepatitis, cirrhosis, and
liver failure)
 Due to the potential to an increase the effects of anesthetics
as associated with the use of kava, patients should discontinue
use of it at least 24 hours prior to surgery.
Other Supplements
and Potential Threats (Continued)
 St. John’s Wort (hypericum)
 Taken by more than 7.5 million Americans to treat anxiety,
depression, and sleep disorders
 Reported adverse interactions between SJW and the drugs
indinavir (a protease inhibitor used to treat HIV) and
cyclosporine (a drug used to reduce the risk of organ
transplant rejection). SJW has been shown to reduce the
effectiveness of these drugs
 Also may intensify or prolong the effects of some narcotic
drugs and anesthetic agents (can significantly increase the
metabolism of some drugs), thus users should avoid mixing
with any prescription medications like antidepressants
 Patients (especially transplant patients) are encouraged to
discontinue use at least 5 days prior to surgery.
Lack of Regulation:
Another Source of Concern About Dietary Supplements
 Background: FDA regulates dietary supplements under a
different set of regulations than those covering
conventional foods and drugs (prescription and over-thecounter). The dietary supplement manufacturer is
responsible for ensuring that a dietary supplement is safe
before it is marketed, but generally manufacturers do not
need to register with FDA nor get FDA approval before
producing or selling a product.
 The FDA is responsible for taking action against any
unsafe supplement after it reaches the market (must
show it is unsafe before it can be pulled from the market).
 However, the FTC does regulate dietary supplement
advertising.
Lack of Regulation: (Continued)
 Since there is little regulation of this market, there is no
standardization or enforcement on the preparation and
production of these supplements, including the level of active
ingredient contained in the supplement. Thus the potency of
herbal medications can vary from manufacturer to manufacturer
as well as from lot to lot within a manufacturer.
 Tests on selected herbal remedies have shown some products to
contain far less or even no amounts of the active ingredient
advertised, while others contained several times more of the
ingredient than is specified on the label. Thus dietary supplement
consumers are susceptible to being cheated or mislead as well as
unknowingly taking incorrect dosages which could result in
dangerous consequences, including overdosing of certain herbs
which can be harmful at too high of a dosage.
Lack of Regulation: (Continued)
 Also, plants may be misidentified or deliberately replaced
with cheaper or more readily available alternatives.
 Herbal supplements, especially those of Eastern origin,
can also be adulterated with heavy metals, pesticides, and
even conventional drugs.
 Plus, since there is no mechanism for post-marketing
surveillance (other than voluntary claims made by
consumers, etc.), the incidence and exact nature of
adverse reactions to herbal medications is not known or
fully understood or reported.
Are the problems posed by such
supplements a serious threat?
 More than 5000 suspected herb related adverse reactions
were reported to the World Health Organization before
1996.
 Between January 1993 and October 1998, 2621 adverse
events, including 101 deaths, associated with dietary
supplements were reported to the FDA. Plus, many
adverse events go unreported since there is no central
mechanism for mandatory reporting as this is for
conventional medications and patients are sometimes
reluctant to report or seek treatment for adverse
reactions.
What can be done?
Measures that physicians can take to prevent complications
 Since patients may not volunteer that they are taking
herbal medications in the preoperative evaluation,
physicians should be assertive in inquiring about and
documenting patient use of alternative medicines and
supplements.
 Physicians should be familiar with the potential
preioperative effects of the commonly used herbal
supplements to prevent, recognized, and treat potentially
serious problems associated with their use.
 They can work to have a better understanding of various
herbal supplements and work to make patients more
comfortable in seeking their advice so that patients make
more informed decisions.
 Document and report cases of complications and adverse
reactions in patients.
What can be done?
Measures that consumers can take to prevent complications
 Patients should follow the guidelines for discontinuing the use of some
supplements before any surgeries (in general, the ASA advises
patients to stop taking herbal medicines at least 2 to 3 weeks before
surgery).
 Patients should not fear discussing herbal supplements they may be
using with their doctors and should disclose any use of such
productions in preoperative evaluations as well as regular check-ups.
 People should consult their doctor before choosing an herbal therapy
or supplement.
 Consumers should file any complaints and adverse reactions to any
supplements to the FDA’s Center for Food Safety and Applied Nutrition.
 Consumers can also use reputable resources on the web to research
dietary supplements on their own; including the websites of such
groups as the FDA and the National Institute of Health’s National
Center for Complimentary and Alternative medicine which can provide
information on supplements, possible complications or drug
interactions, etc.
Other Measures to promote safety
in the use of dietary supplements
 More federal regulation of the production and marketing of
dietary supplements? (require FDA approval before
producing or selling supplements? Required warnings of
possible side-effects, complications, etc. on labels of
products? Etc.)
 Allow herbal medications to be patented? (since the
inability to patent such supplements discourages
manufacturers from conducting the costly research
required for conventional drugs)
 Should some herbs be banned from being sold in the U.S.
if shown to have harmful effects? How much evidence
should warrant such a ban? Who will conduct this
research?
Other View Points and Questions
 Are people just too cynical and simply don’t want to admit
that there are natural remedies to illnesses too?
 Does the government have the right to regulate the types
of supplements and herbal remedies that people choose to
use to treat themselves?
 Is there enough data to support the claims of those who
say some herbal supplements pose a health risk or
hazard?
References
“Anesthesiologists Warn: If You’re Taking Herbal Products, Tell Your Doctor
Before Surgery.” American Society of Anesthesiologists.
http://www.ASAhq.org/PublicEducation/herbal.html
Ang-Lee, Michael K., et al. “Herbal Medicines and Perioperative Care.” Jama:
Vol. 286 No. 2, July 11, 2001.
“Herb and drug interactions.” MayoClinic.com. April 19, 2001.
http://www.mayoclinic.com/invoke.cfm?id=SA00039
“Herbs and surgery.” MayoClinic.com.
http://www.mayoclinic.com/invoke.cfm?id=SA00040
“Kava Linked to Liver Toxicity.” National Center For Complementary and
Alternative Medicine. January 7, 2001.
http://nccam.nih.gov/fcp/kava/kava.htm
Melville, Nancy. “Bring Herbal Remedies Into Doctor Dialogue, Experts
Caution.” HealthScout News. Monday, February 18, 2002.
“Overview of Dietary Supplements.” U.S. Food and Drug Administration: Center
for Food Safety and Applied Nutrition. January 3, 2001.
http://www.cfsan.fda.gov/~dms/ds-oview.html
“Public Alert on St. John’s Wort.” National Institute of Mental Health.
February 20, 2001. http://www.nimh.nih.gov/events/stjohnwort.cfm
Taylor, Christine. “Letter to Health Care Professionals about FDA Seeking
Information on Liver Injury and Kava Products.” U.S. Food and Drug
Administration: Center for Food Safety and Applied Nutrition. December
19, 2001. http://www.cfsan.fda.gov/~dms/ds-ltr27.html