COMPLIMENTARY AND
ALTERNATIVE MEDICINE
GOALS
Course Description
“Complimentary
and Alternative Medicine” is a home study continuing education course for
rehabilitation professionals. This
course presents updated information about Complimentary and Alternative
Medicine (CAM) including sections on statistical usage, alternative medical
systems, mind body medicine, biologically based practices, energy therapies,
manipulative and body based practices, consumer issues, and research.
Course Rationale
The purpose
of this course is to present current information about Complimentary and
Alternative Medicine. Both therapists
and therapy assistants will find this information pertinent and useful when
providing care for individuals who receive, or may benefit from,
non-traditional health care.
Course Goals and
Objectives
Upon
completion of this course, the therapist or assistant will be able to
1. recognize current statistical
demographic trends of CAM usage in the
2. differentiate between the various
categories of
3. identify and differentiate the
practices that are categorized as alternative medicine systems.
4. identify and differentiate the
practices that are categorized as mind body medicine.
5. identify and differentiate the
practices that are categorized as biologically based practices.
6. identify and differentiate the
practices that are categorized as energy therapies.
7. identify and differentiate the
practices that are categorized as manipulative and body based practices.
8. locate and review current research
data and information specific to each of the various
9. recognize consumer issues relating to
Course Instructor
Michael
Niss PT
Target Audience
Occupational
Therapists, occupational therapist assistants, physical therapists, physical therapist
assistants
Course Educational Level
This course
is applicable for introductory learners.
Course Prerequisites
None
Criteria for issuance of Continuing Education Credits
A documented
score of 70% or greater on the written post-test.
Continuing Education
Credits
Four (4)
hours of continuing education credit (4 NBCOT PDUs/4 contact hours)
AOTA - .4 AOTA CEU, Category 1: Domain of OT – Client Factors, Context
Determination of
Continuing Education Contact Hours
“Complimentary
and Alternative Medicine” has been established to be a 4 hour continuing
education program. This determination is
based on an accepted standard for home-based self-study courses of 10-12 pages
of text (12 pt font) per hour. The
complete instructional text for this course is 49 pages (excluding Post-Test).
COURSE OUTLINE
Page(s)
Course
Goals and Objectives 1
Course
Outline 2
Introduction 3
Use of CAM
in the
Alternative
Medical Systems 10-16
Traditional Chinese Medicine 10-11
Acupuncture 11-12
Materia Medica 12-13
Ayurvedic Medicine 13
Naturopathy 13-14
Homeopathy 14-16
Mind Body
Medicine 17-20
Definition 17
Background 17-18
Interventions and Disease Outcomes 18-19
Influences on Immunity 19
Meditation and Imaging 19
Physiology of Expectancy 19-20
Stress and Wound Healing 20
Surgical Preparation 20
Biologically
Based Practices 21-29
Definition 21-22
History and Use 22-23
Research 23-26
Summary of Evidence 26-29
Energy
Therapies 29-35
Veritable Energy Medicine 30-33
Putative Energy Fields 33-35
Manipulative
and Body Based Practices 36-42
Introduction 36
Definitions 36-37
Chiropractic 37
Research 38-41
Risks 41
Utilization 41
Cost 41-42
Patient Satisfaction 42
Consumer
Issues 42-44
References 44-48
Alternative Medical Systems 44
Mind Body Medicine 45
Biologically Based Practices 45-47
Energy Therapies 47-48
Manipulative and Body Based
Practices 48-49
Post-Test 50-51
Complementary and
alternative medicine (
While some scientific
evidence exists regarding some
The Use of Complementary and
Alternative Medicine in the
The most comprehensive and
reliable findings to date on Americans' use of CAM were released in May 2004 by
the
The survey included
questions on various types of CAM therapies commonly used in the
Acupuncture
Ayurveda
Biofeedback
Chelation therapy
Chiropractic care
Deep breathing exercises
Diet-based therapies
Vegetarian
diet
Macrobiotic diet
Atkins diet
Pritikin diet
Ornish diet
Zone diet
Energy healing therapy
Folk medicine
Guided imagery
Homeopathic treatment
Hypnosis
Massage
Meditation
Megavitamin therapy
Natural products
(nonvitamin
and nonmineral, such as herbs and other products from plants, enzymes, etc.)
Naturopathy
Prayer for health reasons
Prayed
for own health
Others ever prayed for your health
Participate in prayer group
Healing ritual for self
Progressive relaxation
Qi gong
Reiki
Tai chi
Yoga
In the

Women than men
People with
higher educational levels
People who have
been hospitalized in the past year
Former smokers,
compared with current smokers or those who have never smoked
This survey was the first
to yield substantial information on

When prayer is included in
the definition of

Prayer specifically for health
reasons was the most commonly used

As shown in figure 4, about
19% (or one-fifth) of the people surveyed used natural products. See figure 5
for the most commonly used natural products and for the percentages of natural
product users who took those products.

People
use

The survey asked people to
select from five reasons to describe why they used
Conventional medical treatments would not help: 28%
A conventional medical professional suggested trying
Conventional medical treatments are too expensive:
13%
The survey found that most
people use

The NHIS did not include
questions on spending on health care, but the report authors cited spending
figures from national surveys conducted in 1997. Those surveys found the
following:
The
Of this amount, between $12 billion and $20 billion
was paid out-of-pocket for the services of professional
These fees represented more than the public paid
out-of-pocket for all hospitalizations in 1997 and about half of what it paid
for all out-of-pocket physician services.
$5 billion of out-of-pocket spending was on herbal
products.
Categories of
NCCAM classifies
1. Alternative Medical Systems
Alternative medical systems are built upon
complete systems of theory and practice. Often, these systems have evolved
apart from and earlier than the conventional medical approach used in the
2. Mind-Body Interventions
Mind-body medicine uses a variety of
techniques designed to enhance the mind's capacity to affect bodily function
and symptoms. Some techniques that were considered
3. Biologically Based Therapies
Biologically based therapies in
4. Energy Therapies
Energy therapies involve the use of energy
fields. They are of two types:
Biofield therapies are intended to affect energy fields that
purportedly surround and penetrate the human body. The existence of such fields
has not yet been scientifically proven. Some forms of energy therapy manipulate
biofields by applying pressure and/or manipulating the body by placing the
hands in, or through, these fields. Examples include qi gong, Reiki, and
Therapeutic Touch.
Bioelectromagnetic-based therapies involve the unconventional use of electromagnetic
fields, such as pulsed fields, magnetic fields, or alternating-current or
direct-current fields.
5. Manipulative and Body-Based Methods
Manipulative and body-based methods in
Alternative Medical Systems
Alternative medical systems involve complete systems
of theory and practice that have evolved independently from or parallel to
allopathic (conventional) medicine. Many are traditional systems of medicine that
are practiced by individual cultures throughout the world. Major Eastern whole
medical systems include traditional Chinese medicine (TCM) and Ayurvedic
medicine, one of
TCM is a complete system of
healing that dates back to 200 B.C. in written form.
Treatments in TCM are typically
tailored to the subtle patterns of disharmony in each patient and are based on
an individualized diagnosis. The diagnostic tools differ from those of
conventional medicine. There are three main therapeutic modalities:
Although TCM proposes that
natural products catalogued in Chinese Materia Medica or acupuncture can be
used alone to treat virtually any illness, quite often they are used together
and sometimes in combination with other modalities (e.g., massage, moxibustion,
diet changes, or exercise).
Acupuncture
Acupuncture is one of the
oldest, most commonly used medical procedures in the world. Originating in
The term acupuncture
describes a family of procedures involving stimulation of anatomical points on
the body by a variety of techniques. American practices of acupuncture
incorporate medical traditions from
Acupuncture needles are
metallic, solid, and hair-thin. People experience acupuncture differently, but
most feel no or minimal pain as the needles are inserted. Some people are
energized by treatment, while others feel relaxed. Improper needle placement,
movement of the patient, or a defect in the needle can cause soreness and pain
during treatment. This is why it is important to seek treatment from a
qualified acupuncture practitioner.
The U.S. Food and Drug
Administration (FDA) approved acupuncture needles for use by licensed
practitioners in 1996. The FDA requires that sterile, nontoxic needles be used
and that they be labeled for single use by qualified practitioners only.
Relatively few
complications from the use of acupuncture have been reported to the FDA in
light of the millions of people treated each year and the number of acupuncture
needles used. Still, complications have resulted from inadequate sterilization
of needles and from improper delivery of treatments. Practitioners should use a
new set of disposable needles taken from a sealed package for each patient and
should swab treatment sites with alcohol or another disinfectant before
inserting needles. When not delivered properly, acupuncture can cause serious
adverse effects, including infections and punctured organs.
The report from a Consensus
Development Conference on Acupuncture held at the National Institutes of Health
(NIH) in 1997 states that acupuncture is being "widely" practiced--by
thousands of acupuncturists, physicians, dentists, and other practitioners--for
relief or prevention of pain and for various other health conditions.1
In terms of the evidence at that time, acupuncture was considered to have
potential clinical value for nausea/vomiting and dental pain, and limited
evidence suggested its potential in the treatment of other pain disorders,
paralysis and numbness, movement disorders, depression, insomnia,
breathlessness, and asthma.
Preclinical studies have
documented acupuncture's effects, but they have not been able to fully explain
how acupuncture works within the framework of the Western system of medicine.
It is proposed that
acupuncture produces its effects by the conduction of electromagnetic signals
at a greater-than-normal rate, thus aiding the activity of pain-killing
biochemicals, such as endorphins and immune system cells at specific sites in
the body. In addition, studies have shown that acupuncture may alter brain
chemistry by changing the release of neurotransmitters and neurohormones and
affecting the parts of the central nervous system related to sensation and
involuntary body functions, such as immune reactions and processes whereby a
person's blood pressure, blood flow, and body temperature are regulated.2,
3
Chinese Materia Medica
Chinese Materia Medica is a standard reference book of information on medicinal
substances that are used in Chinese herbal medicine.4 Herbs or
botanicals usually contain dozens of bioactive compounds. Many factors--such as
geographic location, harvest season, post-harvest processing, and
storage--could have a significant impact on the concentration of bioactive
compounds. In many cases, it is not clear which of these compounds underlie an
herb's medical use. Moreover, multiple herbs are usually used in combinations
called formulas in TCM, which makes the standardization of herbal preparations
very difficult. Further complicating research on TCM herbs, herbal compositions
and the quantity of individual herbs in a classic formula are usually adjusted
in TCM practice according to individualized diagnoses.
In the past decades, major
efforts have been made to study the effects and effectiveness of single herbs
and of combinations of herbs used in classic TCM formulas. The following are
examples of such work:
Artemisia annua. Ancient Chinese physicians identified that this herb controls fevers.
In the 1970s, scientists extracted the chemical artemisinin from Artemisia
annua. Artemisinin is the starting material for the semi-synthetic
artemisinins that are proven to treat malaria and are widely used.5
Tripterygium wilfordii Hook F (Chinese Thunder God
vine). Thunder God vine has been
used in TCM for the treatment of autoimmune and inflammatory diseases. The
first small randomized, placebo-controlled trial of a Thunder God vine extract
in the United States showed a significant dose-dependent response in patients
with rheumatoid arthritis.6 In larger, uncontrolled studies,
however, renal, cardiac, hematopoietic, and reproductive toxicities of Thunder
God vine extracts have been observed.
Ayurveda, which literally means
"the science of life," is a natural healing system developed in
Naturopathy is a system of
healing, originating from
The core modalities
supporting these principles include diet modification and nutritional
supplements, herbal medicine, acupuncture and Chinese medicine, hydrotherapy,
massage and joint manipulation, and lifestyle counseling. Treatment protocols
combine what the practitioner deems to be the most suitable therapies for the
individual patient.8
In the late 1700s, Samuel
Hahnemann, a physician, chemist, and linguist in
Hahnemann was interested in
developing a less-threatening approach to medicine. The first major step
reportedly was when he was translating an herbal text and read about a
treatment (cinchona bark) used to cure malaria. He took some cinchona bark and
observed that, as a healthy person, he developed symptoms that were very
similar to malaria symptoms. This led Hahnemann to consider that a substance
may create symptoms that it can also relieve. This concept is called the
"similia principle" or "like cures like." The similia
principle had a prior history in medicine, from Hippocrates in Ancient
Greece--who noted, for example, that recurrent vomiting could be treated with
an emetic (such as ipecacuanha) that would be expected to make it worse--to
folk medicine. Another way to
view "like cures like" is that symptoms are part of the body's
attempt to heal itself--for example, a fever can develop as a result of an
immune response to an infection, and a cough may help to eliminate mucus--and
medication may be given to support this self-healing response.
Hahnemann tested single,
pure substances on himself and, in more dilute forms, on healthy volunteers. He
kept meticulous records of his experiments and participants' responses, and he
combined these observations with information from clinical practice, the known
uses of herbs and other medicinal substances, and toxicology, eventually
treating the sick and developing homeopathic clinical practice.
Hahnemann added two
additional elements to homeopathy:
A concept that became "potentization,"
which holds that systematically diluting a substance, with vigorous shaking at
each step of dilution, makes the remedy more, not less, effective by extracting
the vital essence of the substance. If dilution continues to a point where the
substance's molecules are gone, homeopathy holds that the "memory" of
them--that is, the effects they exerted on the surrounding water molecules--may
still be therapeutic.
A concept that treatment should be selected based
upon a total picture of an individual and his symptoms, not solely upon
symptoms of a disease. Homeopaths evaluate not only a person's physical
symptoms but her emotions, mental states, lifestyle, nutrition, and other
aspects. In homeopathy, different people with the same symptoms may receive
different homeopathic remedies.
Hans Burch Gram, a
Boston-born doctor, studied homeopathy in Europe and introduced it into the
In the late 19th and early
20th centuries, numerous medical advances were made, such as the recognition of
the mechanisms of disease; Pasteur's germ theory; the development of antiseptic
techniques; and the discovery of ether anesthesia. In addition, a report (the
so-called "Flexner Report") was released that triggered major changes
in American medical education. Homeopathy was among the disciplines negatively
affected by these developments. Most homeopathic medical schools closed down,
and by the 1930s others had converted to conventional medical schools.
In the 1960s, homeopathy's
popularity began to revive in the
Persons using homeopathy do
so to address a range of health concerns, from wellness and prevention to
treatment of injuries, diseases, and conditions. Studies have found that many
people who seek homeopathic care seek it for help with a chronic medical
condition. Many users of homeopathy treat themselves with homeopathic products
and do not consult a professional.
Since homeopathy is
administered in minute or potentially nonexistent material dosages, there is a
skepticism in the scientific community about its efficacy. Nonetheless, the
medical literature provides evidence of ongoing research in the field. Studies
of homeopathy's effectiveness involve three areas of research:
Five systematic reviews and
meta-analyses evaluated clinical trials of the effectiveness of homeopathic
remedies as compared with placebo. The reviews found that, overall, the quality
of clinical research in homeopathy is low. But when high-quality studies were
selected for analysis, a surprising number showed positive results.13-17
Overall, clinical trial
results are contradictory, and systematic reviews and meta-analyses have not
found homeopathy to be a definitively proven treatment for any medical
condition.
While whole medical systems differ in their
philosophical approaches to the prevention and treatment of disease, they share
a number of common elements. These systems are based on the belief that one's
body has the power to heal itself. Healing often involves marshalling multiple
techniques that involve the mind, body, and spirit. Treatment is often
individualized and dependent on the presenting symptoms. To date, NCCAM's
research efforts have focused on individual therapies with adequate
experimental rationale and not on evaluating whole systems of medicine as they
are commonly practiced. 18
Mind-Body Medicine
Mind-body medicine focuses
on the interactions among the brain, mind, body, and behavior, and the powerful
ways in which emotional, mental, social, spiritual, and behavioral factors can
directly affect health. It regards as fundamental an approach that respects and
enhances each person's capacity for self-knowledge and self-care, and it
emphasizes techniques that are grounded in this approach.
Mind-body medicine
typically focuses on intervention strategies that are thought to promote
health, such as relaxation, hypnosis, visual imagery, meditation, yoga,
biofeedback, tai chi, qi gong, cognitive-behavioral therapies, group support,
autogenic training, spirituality, and prayer. The field views illness as an
opportunity for personal growth and transformation, and health care providers
as catalysts and guides in this process.
Mind-body
interventions constitute a major portion of the overall use of
The concept that the mind
is important in the treatment of illness is integral to the healing approaches
of traditional Chinese and Ayurvedic medicine, dating back more than 2,000
years. It was also noted by Hippocrates, who recognized the moral and spiritual
aspects of healing, and believed that treatment could occur only with
consideration of attitude, environmental influences, and natural remedies (ca.
400 B.C.). While this integrated approach was maintained in traditional healing
systems in the East, developments in the Western world by the 16th and 17th
centuries led to a separation of human spiritual or emotional dimensions from
the physical body. This separation began with the redirection of science,
during the Renaissance and Enlightenment eras, to the purpose of enhancing
humankind's control over nature. Technological advances (e.g., microscopy, the
stethoscope, the blood pressure cuff, and refined surgical techniques)
demonstrated a cellular world that seemed far apart from the world of belief
and emotion. The discovery of bacteria and, later, antibiotics further
dispelled the notion of belief influencing health. Fixing or curing an illness became
a matter of science (i.e., technology) and took precedence over, not a place
beside, healing of the soul. As medicine separated the mind and the body, scientists
of the mind formulated concepts, such as the unconscious, emotional impulses,
and cognitive delusions, that solidified the perception that diseases of the
mind were not "real," that is, not based in physiology and
biochemistry.
In the 1920s, Walter
Cannon's work revealed the direct relationship between stress and
neuroendocrine responses in animals. 2 Coining the phrase
"fight or flight," Cannon described the primitive reflexes of
sympathetic and adrenal activation in response to perceived danger and other
environmental pressures (e.g., cold, heat). Hans Selye further defined the
deleterious effects of stress and distress on health. 3 At the same time, technological
advances in medicine that could identify specific pathological changes, and new
discoveries in pharmaceuticals, were occurring at a very rapid pace. The
disease-based model, the search for a specific pathology, and the
identification of external cures were paramount, even in psychiatry.
During World War II, the
importance of belief reentered the web of health care. On the beaches of
Since the 1960s, mind-body
interactions have become an extensively researched field. The evidence for
benefits for certain indications from biofeedback, cognitive-behavioral
interventions, and hypnosis is quite good, while there is emerging evidence
regarding their physiological effects. Less research supports the use of other,
more clearly
Mind-Body Interventions and Disease
Outcomes
Over the past 20 years,
mind-body medicine has provided considerable evidence that psychological
factors can play a substantive role in the development and progression of
coronary artery disease. There is evidence that mind-body interventions can be
effective in the treatment of coronary artery disease, enhancing the effect of
standard cardiac rehabilitation in reducing all-cause mortality and cardiac
event recurrences for up to 2 years. 5
Mind-body interventions
have also been applied to various types of pain. Clinical trials indicate that
these interventions may be a particularly effective adjunct in the management
of arthritis, with reductions in pain maintained for up to 4 years and reductions
in the number of physician visits. 6 When applied to more general acute and chronic pain management,
headache, and low-back pain, mind-body interventions show some evidence of
effects, although results vary based on the patient population and type of
intervention studied. 7
Evidence from multiple
studies with various types of cancer patients suggests that mind-body
interventions can improve mood, quality of life, and coping, as well as
ameliorate disease- and treatment-related symptoms, such as chemotherapy-induced
nausea, vomiting, and pain. 8 Some studies have suggested that mind-body interventions can alter
various immune parameters, but it is unclear whether these alterations are of
sufficient magnitude to have an impact on disease progression or prognosis. 9, 10
There is considerable
evidence that emotional traits, both negative and positive, influence people's
susceptibility to infection. Following systematic exposure to a respiratory
virus in the laboratory, individuals who report higher levels of stress or
negative moods have been shown to develop more severe illness than those who
report less stress or more positive moods. 11 Recent studies suggest that the tendency to report positive, as opposed
to negative, emotions may be associated with greater resistance to objectively
verified colds. These laboratory studies are supported by longitudinal studies
pointing to associations between psychological or emotional traits and the
incidence of respiratory infections. 12
Meditation, one of the most
common mind-body interventions, is a conscious mental process that induces a
set of integrated physiological changes termed the relaxation response.
Functional magnetic resonance imaging (fMRI) has been used to identify and
characterize the brain regions that are active during meditation. This research
suggests that various parts of the brain known to be involved in attention and
in the control of the autonomic nervous system are activated, providing a
neurochemical and anatomical basis for the effects of meditation on various
physiological activities. 13 Recent studies involving imaging are
advancing the understanding of mind-body mechanisms. For example, meditation
has been shown in one study to produce significant increases in left- sided
anterior brain activity, which is associated with positive emotional states.
Moreover, in this same study, meditation was associated with increases in
antibody titers to influenza vaccine, suggesting potential linkages among
meditation, positive emotional states, localized brain responses, and improved
immune function. 14
Placebo effects are
believed to be mediated by both cognitive and conditioning mechanisms. Until
recently, little was known about the role of these mechanisms in different
circumstances. Now, research has shown that placebo responses are mediated by
conditioning when unconscious physiological functions such as hormonal
secretion are involved, whereas they are mediated by expectation when conscious
physiological processes such as pain and motor performance come into play, even
though a conditioning procedure is carried out.
Positron emission
tomography (PET) scanning of the brain is providing evidence of the release of
the endogenous neurotransmitter dopamine in the brain of Parkinson's disease
patients in response to placebo. 15 Evidence indicates that the placebo effect in these patients is
powerful and is mediated through activation of the nigrostriatal dopamine
system, the system that is damaged in Parkinson's disease. This result suggests
that the placebo response involves the secretion of dopamine, which is known to
be important in a number of other reinforcing and rewarding conditions, and
that there may be mind-body strategies that could be used in patients with
Parkinson's disease in lieu of or in addition to treatment with
dopamine-releasing drugs.
Individual differences in
wound healing have long been recognized. Clinical observation has suggested
that negative mood or stress is associated with slow wound healing. Basic
mind-body research is now confirming this observation. Matrix
metalloproteinases (MMPs) and the tissue inhibitors of metalloproteinases
(TIMPs), whose expression can be controlled by cytokines, play a role in wound
healing. 16 Using
a blister chamber wound model on human forearm skin exposed to ultraviolet
light, researchers have demonstrated that stress or a change in mood is
sufficient to modulate MMP and TIMP expression and, presumably, wound healing. 17 Activation
of the hypothalamic-pituitary-adrenal (HPA) and sympathetic-adrenal medullary
(SAM) systems can modulate levels of MMPs, providing a physiological link among
mood, stress, hormones, and wound healing. This line of basic research suggests
that activation of the HPA and SAM axes, even in individuals within the normal
range of depressive symptoms, could alter MMP levels and change the course of
wound healing in blister wounds.
Mind-body interventions are
being tested to determine whether they can help prepare patients for the stress
associated with surgery. Initial randomized controlled trials--in which some
patients received audiotapes with mind-body techniques (guided imagery, music,
and instructions for improved outcomes) and some patients received control
tapes--found that subjects receiving the mind-body intervention recovered more
quickly and spent fewer days in the hospital. 18
Behavioral interventions
have been shown to be an efficient means of reducing discomfort and adverse
effects during percutaneous vascular and renal procedures. Pain increased
linearly with procedure time in a control group and in a group practicing
structured attention, but remained flat in a group practicing a self-hypnosis
technique. The self-administration of analgesic drugs was significantly higher
in the control group than in the attention and hypnosis groups. Hypnosis also
improved hemodynamic stability. 19
Evidence from randomized
controlled trials and, in many cases, systematic reviews of the literature,
suggest that:
Mechanisms may exist by which the brain and central
nervous system influence immune, endocrine, and autonomic functioning, which is
known to have an impact on health.
Multicomponent mind-body interventions that include
some combination of stress management, coping skills training,
cognitive-behavioral interventions, and relaxation therapy may be appropriate
adjunctive treatments for coronary artery disease and certain pain-related
disorders, such as arthritis.
Multimodal mind-body approaches, such as
cognitive-behavioral therapy, particularly when combined with an
educational/informational component, can be effective adjuncts in the
management of a variety of chronic conditions.
An array of mind-body therapies (e.g., imagery,
hypnosis, relaxation), when employed presurgically, may improve recovery time
and reduce pain following surgical procedures.
Neurochemical and anatomical bases may exist for some
of the effects of mind-body approaches.
Mind-body approaches have
potential benefits and advantages. In particular, the physical and emotional
risks of using these interventions are minimal. Moreover, once tested and
standardized, most mind-body interventions can be taught easily. Finally,
future research focusing on basic mind-body mechanisms and individual
differences in responses is likely to yield new insights that may enhance the
effectiveness and individual tailoring of mind-body interventions. In the
meantime, there is considerable evidence that mind-body interventions, even as
they are being studied today, have positive effects on psychological
functioning and quality of life, and may be particularly helpful for patients
coping with chronic illness and in need of palliative care. 20
Biologically Based
Practices
Definition
The
Dietary supplements are a
subset of this
The Food and Drug
Administration (FDA) regulates dietary supplements differently than drug
products (either prescription or over-the-counter). First, drugs are required
to follow defined good manufacturing practices (GMPs). The FDA is developing
GMPs for dietary supplements. However, until they are issued, companies must
follow existing manufacturing requirements for foods. Second, drug products
must be approved by the FDA as safe and effective prior to marketing. In
contrast, manufacturers of dietary supplements are responsible only for
ensuring that their products are safe. While the FDA monitors adverse effects
after dietary supplement products are on the market, newly marketed dietary
supplements are not subject to pre-market approval or a specific post-market
surveillance period. Third, while DSHEA requires companies to substantiate
claims of benefit, citation of existing literature is considered sufficient to
validate such claims. Manufacturers are not required, as they are for drugs, to
submit such substantiation data to the FDA; instead, it is the Federal Trade
Commission that has primary responsibility for monitoring dietary supplements
for truth in advertising. A 2004 Institute of Medicine (IOM) report on the
safety of dietary supplements recommends a framework for cost-effective and
science-based evaluation by the FDA. 2
History and Demographic Use
Dietary supplements reflect some of humankind's first attempts to improve the
human condition. The personal effects of the mummified prehistoric "Ice
Man" found in the Italian Alps in 1991 included medicinal herbs. By the
Middle Ages, thousands of botanical products had been inventoried for their
medicinal effects. Many of these, including digitalis and quinine, form the
basis of modern drugs.