Transcript Lecture 14 Complementary and Alternative Medicine

Complementary and
Alternative Medicine, Dietary
Supplements, and Medications
1
Learning Objectives
• To define complementary and alternative
medicine (CAM) in relationship to
conventional medicine.
• To discuss characteristics of CAM users and
practitioners and their implications for primary
care clinicians.
2
Learning Objectives
• To review research in progress on CAM
modalities for common problems.
• To discuss issues CAM use raises for primary
care clinicians related to communication and
liability.
3
Complementary and Alternative
Medicine (CAM)
• a group of diverse medical and health care
systems, practices, and products that are not
presently considered to be part of
conventional medicine (1)
• healing therapies that typically fall outside the
Western biomedical model of disease,
diagnosis, and treatment (2)
(1) Eisenberg 1993; (2) Drivdahl 1998
4
Complementary and Alternative
Medicine (CAM)
The list of what is considered to be CAM
changes continually
as those therapies that are proven to be safe
and effective become adopted into
conventional health care and as new
approaches to health care emerge.
NCCAM 2003
5
Major Domains of CAM
•
•
•
•
Alternative medical systems
Mind-body interventions
Biologically-based treatments
Manipulative and body-based
methods
• Energy therapies
NCAAM 2003
6
Who uses CAM?
• Surveys show marked increase in past 50 years
in US and other industrialized countries (1).
• Between 1990 to 1997, increase from 34% to
42% of US households reporting CAM use (2).
• In 1997 in US, more visits to CAM practitioners
than to all primary care providers (2).
(1) Kessler 2001; (2) Eisenberg 1998
7
Who uses CAM?
• Surveys of primary care clinic populations
show 28-47% utilization of CAM.
• 21% of patients in primary care practices
reported using CAM for the same health
problem for which they sought conventional
care on that visit.
Palinkas 2000
8
Who uses CAM?
• Herbal therapy is used by 12-14% of the US
population, up from 2.5% in 1990.
• 16-18% of patients taking prescription
medications also take herbal remedies.
Kaufman 2002
9
Why do people use CAM?
• Desire for health and wellness (1)
• Prevention
• Pain
– Musculoskeletal pain accounted for 1/3 of
all CAM use among primary care patients
(2).
– Between 60 and 94% of rheumatic disease
patients use CAM (3).
(1) Wolsko 2002; (2) Palinkas 2000;
(3) Ramos-Remus 1999
10
Why do people use CAM?
• Very few individuals rely exclusively upon
alternative modalities (1).
• Most individuals who use CAM do so
because of preference, related to the
perception that the combination of CAM and
conventional treatments are superior to either
alone (2).
(1) Astin 1998; (2) Eisenberg 2001
11
Who practices CAM?
• Wide variation in background and
approach
• Diversity in training programs
Barrett 2000
12
Who practices CAM?
• No standardization of approach to
accreditation and licensure
• Controversies about regulation
Chez 1999
13
Who practices CAM?
•
•
•
•
Some common beliefs and values
The body has self-healing potential.
Body mind and spirit are all important.
Therapy must be individualized.
People are responsible for their own
healing.
Curtis 2003
14
Who practices CAM?
• More nonphysicians than physicians
practice CAM
• Increasing numbers of dual-trained MDs
– American Board of Medical Acupuncture
– American Board of Holistic Medicine
15
Who practices CAM?
How did I get to be
a “dual-trained MD”?
16
What about communication?
• Between 40 and 70% of CAM users do
not disclose their use to their
physician.
WHY?
• Patients usually say that they do not
report because they are not asked.
Eisenberg 2001
17
Why does this matter?
• The substantial overlap between use of
prescription medications and herbal
supplements raises concerns about
unintended interactions.
• Patient use of CAM is often a clue to
values and preferences that need to be
acknowledged.
Kaufman 2002
18
How can we communicate?
1. Always ask! “What else are you doing
for your health?”
2. Be open and nonjudgmental.
3. Consider patient preferences and
values.
4. Encourage self-monitoring of results.
Eisenberg 1997
19
How can we communicate?
5. Coordinate care as appropriate.
6. Be honest about your lack of
knowledge and open to education.
7. Monitor safety and efficacy, arrange
follow-up.
8. Document all discussions and advice.
Eisenberg 1997
20
EBM and CAM
While some scientific evidence exists regarding
some CAM therapies,
for most there are key questions that are yet to
be answered through well-designed
scientific studies—
questions such as whether they are safe and
whether they work for the diseases or
medical conditions for which they are used.
NCCAM 2003
21
Where are we now?
There is an urgent need for more and
better trials of CAM therapies!
There may be hope:
• OAM funding FY 1992: $2 M
• NCCAM funding FY 2003: $113.2 M
.
22
Research in Progress
NCCAM funded Research Centers Program
• 12 Centers for CAM Research, each with
focus on a particular condition
• 4 Centers for Dietary Supplements
Research
• Many clinical trials in progress, for example
– 18 on acupuncture
– 16 on cancer
www.nccam.nih.gov/clinicaltrials
23
Research in Progress
Biologically-based therapies
• Safety of “natural” products
• Efficacy of glucosamine and/or
chondroitin for pain of osteoarthritis
– NIH-GAIT www.nihgait.org
www.nccam.nih.gov/clinicaltrials
24
Research in Progress
Mind-body approaches
•
Some now mainstream
– Clinical hypnosis
– Cognitive therapy
– Biofeedback
•
Meditation for fibromyalgia
– Transcendental meditation
– Mindfulness meditation
– Relaxation response
Hadhazy 2000
25
Research in Progress
Manipulative therapies:
chiropractic
• Most accepted professional therapy
• Good review of safety
• Current trials of effectiveness for
– Chronic neck pain
– Low back pain
Stevinson 2002
26
Research in Progress
Manipulative therapies:
massage
Low back pain
•
•
Comparison with acupuncture & self-care (1)
Combined with education and exercise (2)
(1) Cherkin 2001; (2) Furlan 2002
27
Research in Progress
Alternative medical systems:
Traditional Chinese Medicine (TCM)
Current trials of acupuncture for
•
•
•
•
Fibromyalgia
Knee osteoarthritis
Repetitive stress disorder
TMJ pain
www.nccam.nih.gov/clinicaltrials
28
Research in Progress
“Frontier Medicine Program”
NCCAM initiative to encourage research on
widely used CAM practices for which there
is “no plausible biomedical explanation”
– Energy therapies
– Homeopathy
– Prayer
– Spiritual healing
www.nccam.nih.gov/clinicaltrials
29
Where does this leave us?
Many conventional treatments
• have been adopted without good
quality research
• are costly
• are invasive
• are likely to have adverse effects
• AND often provide inadequate relief.
30
Where does this leave us?
CAM interventions generally
• are low cost
• are low-risk
• are free of serious side effects
• AND are widely used.
31
Advising patients
about CAM
Use evidence for
 efficacy
 safety
to place therapy on continuum
recommend
accept
discourage
Weiger 2002
32
Towards Integration
Liability Risks Based on Evidence
• Support for safety and efficacy
• Support for safety, inconclusive for
efficacy
• Support for efficacy, inconclusive for
safety
• Indication of serious risk or inefficacy
Cohen 2002
33
Framework for approaching CAM
in clinical situations
•
•
•
•
Protect against dangerous practices.
Permit practices that are harmless and that
may help.
Promote and use practices that are safe
and effective.
Partner with patients and encourage
communication about CAM.
Jonas 2000
34
Framework for approaching CAM
in clinical situations
Question:
Is “permit” the right word here?
Do physicians have the power to
“permit” practices that their
patients choose?
35
Integrative Medicine
a combination of
mainstream medical therapies
and
CAM therapies
for which there is high-quality scientific
evidence of safety and effectiveness
NCCAM 2003
36
Integrative Medicine
requires a paradigm shift from
• the disease-centered approach of
conventional biomedicine
to
• an approach in which patient values
and participation of patients are
central.
Maizes 1999
37
Towards Integration
The satisfaction that patients report from
relationship-centered and
individualized CAM therapies serves to
remind us:
We can never know with certainty what
therapy- alternative or otherwise- will
work for an particular patient, no
matter what randomized controlled
clinical trials indicate.
38
Towards Integration
Our patients’ use of CAM invites us
• to ask and listen to our patients,
• to contribute what evidence based
medicine offers,
• to advocate for better evidence-based
research, and at the same time
• to acknowledge the existence of other
types of information that may be more
relevant to a given individual or for a
particular situation.
39
Framework for approaching CAM
in clinical situations
• Protect against dangerous practices.
• Permit practices that are harmless
and that may help.
• Promote and use practices that are
safe and effective.
• Partner with patients and encourage
communication about CAM.
Jonas 2000
40
Partner with patients and
communicate about CAM
• ASK!
• “Build” a history that includes CAM
use. (Don’t “take” one.)
• When patients tell, LISTEN!
Haidet 2003
41
Integrative Medicine
• an opportunity to bring together
strengths and balance weaknesses of
different systems of health care
• “a coming together of heart, head, and
hand”
Owen 2001
42
Integrative Medicine
“Could this be a healing process
in itself”?
Owen 2001
43
An Integrative Approach to
Complementary and Alternative
Medicine
in Primary Care Settings
Maureen A. Flannery MD, MPH
Department of Family Practice
University of Kentucky College of Medicine
44
Sports
Supplements
Andrew Gregory, MD
Assistant Professor, Orthopedics/
Pediatrics
Team Physician, Vanderbilt University
Jan. 10, 2002
Definition: Ergogenic
Aids
• Ergo = work
• Gennan = to produce
• Any substance or method used to
enhance performance through
increased energy utilization:
– production
– control
– efficiency
Classification
• Drugs:
–
–
–
–
–
Hormones
Stimulants
Narcotics
Diuretics
B-Blockers
• Supplements:
–
–
–
–
–
Prohormones?
Amino Acids
Metals
Antioxidants
Herbs
Prevalence:
• Estimated 11% of HS athletes,
college, and professional.
• Majority of Olympic swimmers,
cyclists, sprinters, & weight lifters
• 2/3 of the 1998 Tour de France
teams
• Billion Dollar Industry
Reasons:
•
•
•
•
•
Have to use them to be competitive
Need the edge
Not genetically gifted
Dissatisfaction with size/ weight
Peer/ Team Pressure
Hormones
•
•
•
•
HGH
EPO
BHCG
Steroids
Human Growth Hormone
• Normally secreted by the pituitary
• Normal function of GH is growth and
development of every body system,
including bone and muscle
• Can be stimulated by propanolol,
vasopressin, clonidine, and levodopa
• Synthetic growth hormone
Side Effects:
•
•
•
•
•
•
Acromegaly (may be irreversible)
Peripheral Neuropathy
Coronary Artery Disease
Cardiomyopathy
Diabetes, Hypothyroidism, arthritis
No available urine test available, but
banned by NCAA and IOC
Erythropoietin
• Hormone released by the kidneys in
response to low Hct
• Stimulates RBC production from bone
marrow
• Has recently been manufactured by
recombinant DNA technique
• Can increase Hct in renal patients by
up to 35%, lasting up to 7 months
• Used most by cyclists
Blood Doping
• Induced Erythrocythemia: An
increase in Hb following reinfusion of
an athlete’s blood
• Goal: to increase the oxygencarrying capacity of Hb
• Has been used as far back as 1947
• 1984: seven US Olympic cyclists
guilty
• Banned by IOC in 1985
Pathophysiology
• Muscles depend on ATP for energy
• Aerobic metabolism = breakdown of
glycogen in presence of O2 >>>ATP
• Aerobic metabolism-higher yield of
ATP
• More O2 carrying capacity>>more
ATP production, more energy to
muscle
• 1 U PRBC>>500 ml / min increase in
Methods:
• Autologous reinfusion method: 2
units blood removed 4-8 weeks prior
to competition & frozen c glycerol
• Hb / Hct returns to pre-transfusion
levels
• Reinfusion 1-7 days prior to event
• Can produce up to 25% improvement
in endurance, with poorer conditioned
athletes showing greatest benefits
Side Effects:
• Heterologous blood: transfusion rxn
(3-10%), Hepatitis (10%), HIV (?%)
• Autologous blood: bacterial
infections
• Polycythemia: increased viscosity
>>CHF, HTN, CVA
• Most young healthy athletes show no
side effects
Detection:
• Blood doping and Erythropoietin:
banned by IOC
• No known urine test to detect
• Testing: Measured Hct >50
• Measurement of serum Fe and
Bilirubin to detect hemolysis after
frozen PRBC transfusion
Anabolic Steroids
• The ultimate ergogenic aid aka
“Juice”
• Creates the Superhuman Athlete
• Testosterone derivatives
(cholesterol)
• Produced in the adrenal/ testes
Anabolic/Androgenic
Steroids
• Anabolism - Constructive
• Catabolism - Destructive
• Anabolic effects : inc. skeletal mm
mass
•
anticatabolism
• Androgenic effects: secondary
sexual characteristics - pubic hair,
genital size
• No Pure Anabolic Steroids
History of Steroids
•
•
•
•
•
First Available - 50’s (Dianabol)
Drug Banned - 60’s
Testing Initiated- ‘76
Athletes Banned - ‘83 Pan Am Games
Schedule III Controlled Substance ‘90 Anabolic Steroid Control Act
• US Dietary Supplement Act - ‘94
no FDA approval if no “drug intent”
Administration:
• Athletes may take up to 40-100x
therapeutic dose (200-2000 mg/ wk)
• IM adm bypasses the liver/ PO does
not
• “Stacking”: using various aids in
combination
• “Cycling” : gradual inc. then taper
over 6-10 weeks, 1-3 cycles /year,
“bridging” between
Desired Effects:
•
•
•
•
Increase in strength
Increase in weight
Increase in aggressiveness
Increased capability of sustaining
repetitive, high intensity workouts
• Enhanced performance
Side Effects:
• CV: MI - hypertension, inc. LDL, dec.
HDL, cardiac hypertrophy,
thrombosis
• Endocrine: virilization, testis
atrophy, azospermia, priapism,
prostatic hypertrophy/ CA,
gynecomastia, erectile dysfct, libido
• Liver : peliosis hepatitis, hyperplasia,
adenoma, no carcinoma, elevated
LFTs
Side Effects (cont’d):
• Skin: acne, hirsuitism, striae,
androgenic alopecia, inc. sebaceous
glands
• Metabolic: hypernatremia, kalemia,
phosphatemia, calcemia, “prediabetic”
• Psychiatric : aggressiveness, extreme
mood swings - depression/ mania,
dependence, other drug use, “Reverse
Anorexia”
Specific Side Effects
• Women
(Virilzation):
– Clitoril
enlargement,
Deepening of voice,
Male pattern
baldness, dec.
breast size, libido
• Children:
– premature closure
of growth plate in
long bones & thus
“Prohormones”
•
•
•
•
Androstenedione
DHEA
Androstenediol
Norandrostenedion
e
• Norandrostendiol
Androstenedione
• 1/2 of the “ Mark McGuire Special”
• A natural steroid hormone found in
all animals and some plants
• Metabolite of DHEA
• Precursor of testosterone
• Synthesized in Adrenals/ Gonads
• Metabolized in the liver to
testosterone
Effects:
• Benefits: Same as Testosterone
– Increased energy
– Enhanced recovery and growth from
exercise
– heightened sexual arousal and function
– greater sense of well-being
• Plasma levels of testosterone
increased from 140% to 330% of
normal levels after 50mg and 100mg
doses
DHEA
(Dehydroepiandrosterone
)
• What it is: A hormone produced by
adrenal gland
• Claims: Anabolic effect
• What is does: Increases
testosterone levels
• Banned by the NCAA, NFL
Stimulants
•
•
•
•
Caffeine
Amphetamines
Cocaine
Ephedrine
Amphetamines
• Have been used as far back as WWII
when soldiers used them to delay
fatigue
• First study in 1959 showed
significant improvement in
performance
• Available data suggest Amphetamines
can improve performance in sports
where speed, power and endurance
are required
Side Effects:
• Related to drugs’ effect on CNS:
insomnia, instability, agitation and
restlessness
• Confusion, paranoia, hallucinations
• Dyskinesias, especially in facial
muscles
• Cardiac complications: HTN,
arrhythmias
• GI disturbances
Caffeine
• A Methylxanthine: same class as
theophylline and theobromine
• Exerts its’ effects by:
– Translocation of Calcium for more
muscular availability
– Increase in cAMP by inhibition of
phosphodiesterase
– Blockage of adenosine receptors,
blocking the sedative properties of
adenosine
Caffeine (cont’d)
• Is banned by IOC and NCAA in large
doses
• Legal limit = 15 micrograms / ml
• Equal to 6-8 cups of coffee at one
sitting, with testing within 2-3 hours
• Beneficial most in endurance events,
such as cycling
• Doses up to 5 mg / kg were required
to see benefits. Doses of 17 mg/kg
Side Effects:
• Similar to s/e of other stimulants:
– insomnia, irritability, nervousness
– Tachcardia, arrthymias, and possibly
death!
Ephedrine
• What it is: Is a drug found in herbal
products containing Ma haung, antiasthmatic medications, and many cold
and cough products.
• Claims: Increases body fat loss
• What really does: Acts as a CNS
stimulant, delays fatigue by sparing
body glycogen reserves. Increase in
B/p respiratory, heart rate, insomnia,
and nervousness
Amino Acids
•
•
•
•
•
Creatine
L-Carnitine
Choline
Inosine
HMB (B-OH-BMethylbutyrate)
Amino Acids
• Essential amino acids: found in a
balanced diet
• Recommended protein intake: 0.8 g
/kg/day
• Athletes may benefit from up to 1.4 2.4 g/kg/day
• Most beneficial for athletes on a
poor diet, or vegetarians
• In endurance athletes, up to 10% of
Creatine
• The Other 1/2 of the “Mark Mcguire
Special” - The Creatine Craze - Sales
expected to reach $200 million in
1998
• Use has spread:
– 13% of HS athletes
– 80% of University of Nebraska football
team
– 50% of NFL players
– Vast majority of Olympic sprinters,
Creatine
• Methylguanidine-acetic acid - made
from glycine, arginine & methionine
• Estimated Daily requirement: 2gms
• Available in meats and fish (1/2 EDR)
• Sold as Creatine Monohydrate
• Stored in Skeletal MM
• 2000 NCAA banned distribution in
training rooms
Pathophysiology:
• Energy Substrate for muscle
contraction
• Creatine binds Phosphorus as
substrate for formation of ATP
(main source of energy of
contraction)
• PCr also buffers Lactic Acid
• After PCr is depleted must resort to
glycolysis for ATP production
Benefits:
• Improved performance in repeated
bouts of high intensity strength work
and sprints
• Single sprint activity results are
equivocal
• Does not enhance endurance exercise
• More work with less lactic acid
production
• No studies on competetion benefits
Dosing:
• Loading Phase: 20-30 gm/d, x 5 -7
days
• Maintenance phase: 2-5 gm/day
• Loading increases PCr stores by 1040%
• Normal resting levels of creatine:
100-150 mM/kg
• Most striking benefits occur in
subjects with lower resting Cr level
Side Effects:
•
•
•
•
•
Muscle Cramping
Diarrhea
Dizziness
Dehydration
Biggest danger: getting “impure”
creatine
• Significant WEIGHT GAIN common
2nd to water retention
The Perfect Supplement?
• “The secret is to find something that
is effective in improving
performance, but not against the
rules, and with no side effects”
• “…no clear evidence of harmful side
effects of creatine use has
emerged…”--The Physician and
Sportsmedicine, June 1998
• Long term effects of Creatine not
yet studied: Concerns focus on
Counseling your patients
• Creatine may or may not improve
performance
• Weight gain will occur
• Side effects (especially long-term)
not well known
• Need to have renal and liver fct.
Monitored
– should not be used in patients with
chronic kidney/ liver disease
L-Carnitine
• Synthesized in Liver/ Kidney from
Lysine & Methionine
• found in meats & dairy products
• Assists in Fat transportation into
muscle mitochondria for oxidation,
sparing Glycogen & may prevent lactic
acid accumulation
• Improved endurance performance not
shown in studies
HMB
• Metabolite of KIC (ketoisocaproate)
which is a metabolite of leucine
• Leucine & KIC found to have
anticatabolic effects
• decreased mm proteolysis, inc. lean
mm mass, inc. strength
• no known side effects
Choline
• Precursor for the neurotransmittor
Acetyl Choline & the lipoprotein
Lecithin (Phosphattidylcholine)
• choline depletion in marathoners
• no studies supporting
Inosine
• Increases myocardial contractility
• no performance enhancement in
runners/ cyclists
Metals/ Minerals
•
•
•
•
Chromium
Magnesium
Boron
Vanadium
Chromium
•
•
•
•
Insulin Cofactor
inc. AA uptake into mm cells
increase mm mass, dec. body fat
found in meats, grains, raisins, apples,
& mushrooms
• SE’s: anemia, chromosomal damage,
cognitive impairment & interstitial
nephritis in excessive doses
Magnesium
• Involved in ptn synthesis & mm
contraction
• + effects on oxygen consumption &
lactate production
• no change in performance
Boron
• Originally thought to inc.
testosterone levels
• not born out in studies
Vanadium
• What it is: Non-essential trace
mineral
• Claims: Anabolic effect, enhances
insulin action
• What it does: No studies to show
anabolic effect. Doses>10gms/day
causes abd. Pain, cramps, green
Antioxidants
• Vitamins E & C
• potential damage from free oxygen
radicals produced by lipid
peroxidation in exercise
• exercise performance is not
improved
Herbs
• Ginseng
• Yohimbe
• Tribulus
Terresteris
• Ma haung
Ginseng
• What it is: A root from an Asian
plant (panax ginseng).
• Claims: Enhanced performance.
Improved recovery rate.
• What it really does: Acts as an
adaptogen- may boost immune system
and protect cells. May cause
insomnia, and should not be used if
B/p is elevated.
Yohimbe
• What it is: Supplement derived from
tree bark.
• Claims: Anabolic effect, Increased
virility
• What it does: Stimulant effect, no
anabolic effect. Can cause
nervousness, HA, nausea, Vomiting,
increased B/P
Tribulus Terresteris
• What is it: A plant hormone
• Claims: Anabolic effect
• What it does: Increases
testosterone levels
• Banned by NFL
Miscellaneous:
• Bicarbinate
Loading
• Coenzyme Q
• Linoleic Acid
Bicarbonate Loading
• Used prior to competition to
neutralize lactic acid produced by
anaerobic activities
• Lactic acid>>lower pH>>fatigue
• May improve runners’times if taken
30 min prior to competition : best in
intermediate distances 800-1500
meter events
• 300mg/kg required
Conjugated
(coQ10,Ubloquinone) Linoleic
Acid
• Produced by the body in
mitochondria
• claims: Enhances
performance, delays
fatigue, prevents injury
• What really
does:Functions as an
antioxidant
• Safe levels:60200mg/day but
also$$$$$
• Naturally
occurring fatty
acid found in beef
,lamb and dairy
• claims: decreases
body fat
,increases muscle
gain,antioxidant
• What really does:
No effect on
performance
References
• Blue J, Lombardo J, Nutritional Aspects of
Excercise: Steroids & Steroid-like compounds,
Clinics in Sports Medicine, Vol 18, Num 3, July
1999, pp 667-689
• Stricker P, Other Ergogenic Agents, Sports
Pharmacology, Vol 17, Num 2, April 1998, pp283297
• Agee R, Ergogenic Aids, ASMI Lecture, Nov. 99
Useful Resources
• Organizations:
• A) Gatorade sports science Institute 800-616-4774
• B) Herb Research Foundation 303-449-2625
• C) USOC Drug Information Hotline 800-233-0393
• Web Sites:
•
•
•
•
•
•
FDA:http//vm.cfsan.fda.gov/~dms/aems.html
U.S. pharmacopeia:www.usp.org/did/mgraphs/botanica/index.htm
Dietary Supplements Reference: http://dietarysupplements.info.nih.gov
USOlympicCommittee: www.usoc.org
IOC: www.olympics.org
NCAA: www.ncaa.org