Transcript In integrative psychiatry

Establishing a Methodology for
Integrative psychiatry: from research
to clinical applications
Groningen, The Netherlands
3 December, 2008
James Lake M.D.
www.IntegrativeMentalHealth.net
Clinical Asst. Professor, Stanford
Psychiatry
Clinical Asst. Professor, Program in
Integrative Medicine, University of
Arizona
Third Conference on Integrated Psychiatry—
New Perspectives on Body and Mind
3 December 2008
James Lake M.D.
www.IntegrativeMentalHealth.net
Clinical Assistant Professor, Stanford Psychiatry
Clinical Assistant Professor, University of Arizona
Program in Integrative Medicine
The future of psychiatry
and the evolution of integrative
medicine
Third Conference on Integrated Psychiatry—
New Perspectives on Body and Mind
3 December 2008
James Lake M.D.
www.IntegrativeMentalHealth.net
Clinical Assistant Professor, Stanford Psychiatry
Clinical Assistant Professor, University of Arizona
Program in Integrative Medicine
Financial interests
• none
Methodology in integrative
psychiatry
I. Premises—framing the issues
II. Philosophical problems
III. Evidence in medicine
IV. Research methodology issues
V. Clinical integrative methodology
VI. Integrative management of depression
VII. Integrative management of anxiety
Starting points
• Premises: the emerging context of
integrative psychiatry
• Philosophical issues determine meanings
of evidence
• Evidence standards determine
methodology
• Methodology biases beliefs and
understandings about specific clinical
approaches
Premises
One person’s assumptions about
how things are today
Premises
• Integrative mental health care is now the de
facto standard approach used by the majority of
mentally ill patients in the U.S.
• Context—limited conventional choices,
increasing safety and efficacy concerns
• Decisions about non-drug Rx are made with little
or no evidence
• There is no established methodology for
planning integrative treatments
Integrative perspective
• Many conventional Rx are often beneficial
and safe
• Some conventional Rx are not effective
and have signicant safety problems
• Many non-conventional Rx are beneficial
and safe
• Some non-conventional Rx are not
effective and have significant safety issues
The emerging context for
integrative psychiatry
• Integrative healthcare is patient-centered
and individualized
• Integrative medicine engages patient’s
active participation to improve wellness
rather than treat a “disorder” (Barrett
2003).
• Limitations of conventional Rx of mental
illness invite rigorous evaluation of
promising CAM Rx
Context for integrative Rx
• Integrative medicine offers a reasonable
“middle way” in mental health care
incorporating advantages of conventional
and non-conventional approaches while
ideally minimizing limitations and risks of
either approach alone.
Philosophical issues
implications for integrative
medicine and psychiatry
Philosophical issues
• Methodologies in medicine reflect a priori
epistemological and ontological
assumptions about health and illness
• Beliefs and traditions in medicine are
implicit in methodologies used in research
and clinical practice
• Therefore, there is no objective
methodology: clinical approaches in
disparate systems of medicine are not and
cannot be validated using objective
empirical means alone
In other words…
• Many systems of medicine do not use or
require “objective methods” to
demonstrate the existence of a putative
mechanism of action or verify claimed
outcomes because the truth of a claim that
a mechanism of action is present or that
an outcome takes place is implicit within
the conceptual framework that embodies
the system of medicine.
What is “true” depends on
accepted methodology
• Truth claims of some non-conventional
modalities have not been verified by
contemporary Western science (eg,
Acupuncture, “energy medicine”)
• The same is also true of some
conventional treatments in widespread use
(eg, Buproprion, anti-seizure medications
for Bipolar Disorder)
Consensus vs “objective” methods
• Beliefs about the effectiveness of
treatments in medicine have as much to
do with professional consensus and
economic factors as with rigorous
“objective” methods for assessing
empirical evidence (Kuhn, Structure of
Scientific Revolutions).
Philosophical problems have
practical consequences
• These philosophical and ideological issues
must be taken into account when
developing a methodology for constructing
practical integrative strategies combining
approaches from disparate non-Western
systems of medicine.
Philosophical problems of
nosology and evidence
• Establishing ontology of phenomena associated
with illness or health and corresponding typology
of legitimate medical practices (ie, for which
verifiable truth claims can be made).
• Establishing standards of evidence for verifying
claims of a putative mechanism of action or a
reported outcome.
• Establishing a framework for a “hierarchy of
evidence” for comparing disparate modalities on
the basis of objective and subjective criteria.
Evidence in medicine
EBM and beyond
NOTE: following slides need
major edits and shortening
Evidence-based medicine (EBM)
• Uses “hierarchy of evidence” model to
assess significance of findings viz study
design
• Relies on systematic reviews of peerreviewed literature to “guide judicious use
of current best evidence in making
decisions about the care of individual
patients (Sacket 1996)”
• Derives Rx decisions on a case-by-case
basis following review of “best evidence” in
the context of physician’s expertise and
patient preferences
Limitations of EBM
• Brings rigor to analysis of findings and
offers valuable Rx planning tool
• However…most biomedical Rx do not
adhere to EBM standards
• Few M.D.s practice EBM because they
don’t know methods or don’t have time or
resources to review literature
• Most M.D.s recommend Rx based on
clinical experience or expert opinions
EBM—limitations
• Evidence-based Complementary and
Alternative Medicine (CAM) working
group created to find ways to apply
EBM to the evaluation of CAM
modalities…however…
• EBM excludes relevant research and
clinical data and uses hierarchy of
evidence biased in favor of traditional
biomedical research designs
EBM—limitations
• Assumes relevant data only obtained
using statistical measures describing
directly observable “outcomes” isolated
from all possible confounding variables
• Assumes “legitimate” Rx have discrete
identifiable mechanisms of action and
causal relationship between Rx effects,
mechanism of action, and statistical
measures of “outcomes.”
• Equates “causes” and “effects” with
mechanisms
EBM—limitations
• Does not acknowledge relevance of
emerging paradigms to medicine
• Claims findings “rigorous” only after
sequential “significant” outcomes
obtained from identical study designs
using identical statistical methods.
• Assumes averaged results of
systematic reviews of several “well
designed” studies can be generalized
to individuals to guide Rx planning
EBM implicitly biased against CAM
• EBM assumptions about valid
methods for obtaining data implicitly
biased against CAM
• Consequence: most CAM Rx ranked
at lowest “level” of evidence hierarchy
and many CAM Rx dismissed before
the “evidence” appraised
Integrative medicine optimizes
EBM methodology
Utilizing both quantitative and
qualitative information
Quantitative criteria used to assess
evidence
• Numbers and kinds of studies (in vitro
studies, RPCT, cohort studies, case
series, etc.) and significance ratings
• Systematic reviews or narrative reviews
and significance ratings
• Studies in progress, objectives and
preliminary findings
• Specificity of findings by symptom (ie,
does Dx or Rx enhance Dx accuracy or
improve Rx outcomes?)
Qualitative criteria used to evaluate
evidence
• Unresolved research issues influencing
study design
• Safety, availability, cost, insurance
coverage, etc.
• Described uses of specified modality in
conjunction with other Rx for specified
symptom
• Best information resources for patients or
clinicians
• Patient preferences and attitudes toward
Rx
Kinds of evidence: creating
evidence hierarchies
• Efficacy verified and mechanism of action
verified
• Efficacy verified and mechanism of action not
verified
• Efficacy verified and mechanism of action
refuted
• Efficacy refuted and mechanism of action
refuted
• Efficacy verified and mechanism of action
unverifiable
• Efficacy unverified and mechanism of action
unverifiable
• Efficacy refuted and mechanism of action
unverifiable
Levels of evidence
• “N of 1” trials or systematic reviews of
RCTs
• RCTs where follow-up is greater than 80%
• Cohort studies
• Case control studies or observational
studies
• Expert opinion (often most authoritative)
Combined quantitative/qualitative
evidence
• Four “levels” of evidence viz
combinations of different quantitative
and qualitative evidence for use of
particular Rx for specified sx
• In some cases quality studies done
but not analyzed in systematic review
• In some cases studies on-going,
recently concluded but not published,
or published but not reviewed
Quantitative-qualitative model
• Quantitative-qualitative model
provides balanced methodology
for weighing evidence for both
conventional and CAM Rx when
different levels and kinds of
evidence support different Rx
Integrative methodology
expands EBM methods
• Includes rigorous analysis of quantitative
findings
• Includes analysis of qualitative findings
• Takes into account both limitations and
relevance of quantitative and qualitative,
objective and subjective information
Three kinds of modalities
• Conventional and non-conventional
modalities fall into three general classes:
– empirically-derived—relies on empirical test
of truth claims
– consensus-based—relies on shared
professional agreement about mechanism or
outcomes
– intuitive—shared agreement and not
susceptible to empirical validation.
Integrative medicine will incorporate
empirically-derived, consensus-based and
intuitive Rx
• Novel empirically derived, consensusbased and intuitive methods will continue
to emerge
• Certain consensus-based methods will
become validated, others refuted
• Certain intuitive methods will become
validated, others refuted
Examining quantitative and qualitative
evidence when planning integrative
management
4 levels
Substantiated—IN CURRENT USE AND EFFECTIVE
•
•
•
•
Systematic review findings strongly support
claims that the treatment results in consistent
positive outcomes for a specified symptom
OR three or more rigorously conducted
double-blind randomized controlled trials
support claims of outcomes of the modality
for a specified symptom
AND the modality is in current use for the
treatment of a specified symptom
AND the use of the modality for a specified
symptom is endorsed by a relevant
professional association.
Provisional—in current use and probably
effective
• Systematic review findings are positive but not
compelling, or have not been conducted
because of insufficient numbers of studies or
uneven quality of completed studies
• OR three or more rigorously conducted doubleblind randomized controlled trials yield positive
but not compelling findings
• AND the modality is in current use for the
treatment of a specified symptom pattern
• AND the use of the modality with respect to a
specified symptom pattern may be endorsed by
a relevant professional association.
Possibly effective—in current use and
possibly effective
•
•
•
•
•
Fewer than three studies or poorly designed studies
have been done to determine whether a particular
modality results in consistent positive outcomes with
respect to a specified symptom.
AND research findings or anecdotal reports are
limited or inconsistent
AND there are insufficient quality studies on which to
base a systematic review or meta-analysis
AND the modality is in current use but remains
controversial
AND may be endorsed by a relevant professional
association.
Refuted—may be in current use but
refuted by evidence
• For a particular treatment modality findings of three or
more rigorously conducted studies or at least one
systematic review consistently show that the modality
does not result in beneficial outcomes with respect to a
specified symptom
• OR the conclusions of one or more systematic reviews
or meta-analyses refute claims made for the treatment
modality with respect to a specified symptom.
• AND usually not in current use or use is highly
controversial
• AND not endorsed by a relevant professional society
Research methodology issues
Verifying mechanisms of action
and measuring outcomes
Verifying outcomes—not
mechanism of action
• The same methodology can be used to
establish the effectiveness of any modality
regardless of differences between parent
systems of medicine.
• This is true because effectiveness is
determined on basis of (subjective or
objective) outcomes only—ie, there is no
epistemological requirement of a proof of a
postulated mechanism of action.
Problems inherent in measuring
symptoms and outcomes
• Mental and emotional complaints are
intrinsically subjective
• Diagnostic criteria continue to change
• Limitations of study designs
• High placebo response rates of most
psychiatric disorders to conventional
treatments are consistently high
Rigor and Relevance
• Because of unreliability of quantitative methods
for comparing outcomes, measures of rigor and
relevance can be used (Richardson 2002).
• “Rigor” is strength of evidence used to establish
claims that a specified modality actually works—
ie, outcomes claims are true.
• “Relevance” is appropriateness of a specified
modality viz needs and preferences of a
particular patient.
Rigor and Relevance
• In integrative medicine the clinician’s goal
is to find a “balance” between rigor and
relevance that adequately addresses the
presenting complaint, is realistic, and is
acceptable to the patient.
Clinical integrative psychiatry
The intake, assessment, formulation,
treatment and follow-up
Planning integrative Rx involves
• Making practical clinical recommendations
– Based on “highest level” of quantitative and
qualitative evidence
• While taking into account
– Practitioner training and skill level
– patient preferences
– Patient cultural and social beliefs and values
– Cost and insurance coverage
– Available resources
The integrative clinician must
address five basic issues:
• Obtain complete hx: clarify sx that are focus of clinical
attention; prev Rx and response; medical, psychiatric,
psycho-social, cultural and spiritual factors
• Determine causes or meanings of core symptoms
• Determine reasonable treatment approaches based
on evidence review
• Identify practical constraints: cost, availability,
preferences and values that constrain the “shape” of a
realistic and acceptable integrative strategy
• Implement rx plan, schedule follow-up care, and make
appropriate changes depending on progress and
assessment findings
The intake interview
In integrative mental health care
The integrative intake
• Chief complaint (sx type, severity &
duration)
• Nutrition, exercise, life style
• Medical, social and family hx
• Previous Rx and response (conventional
and CAM)
• Relationship history and problems
• Cultural, religious and spiritual issues
• Medications and supplements
Integrative assessment
In mental health care
Conventional assessment
Structured clinical interviews
• Hamilton depression inventory (HamD)
• Hamilton anxiety inventory (Ham-A)
• Beck depression inventory (BDI)
• Brief psychiatric rating scale (BPRS)
• Yale-Brown obsessive-compulsive
scale (YBOCS)
Neuropsychological testing
•
•
•
•
Thematic aperception test
Bender-Gestalt Test
Wechsler adult intelligence scale
Wisconsin card sorting test
Biological assays
•
•
•
•
•
•
Complete blood count
Serum iron levels
Fasting glucose
Urinalysis
Electrolytes
Thyroid (and other hormone) serum levels
Brain imaging studies
• CT scan showing structure
• Magnetic resonance imaging (MRI)
showing brain structure
• Functional magnetic resonance imaging
(fMRI) showing both structure and function
• Single photon emission computed
tomography (SPECT) showing regional
blood flow in brain
• Positron emission tomography (PET)
showing regional metabolic brain activity
Limitations of conventional
assessment 1
• Western medical theory based on chemistry and
biology
• Most non-Western systems of medicine based
on philosophical or spiritual traditions and beliefs
• Still no dominant model of mental illness In
Western psychiatry but disparate psychological,
social, genetic, and neurobiological theories.
• Symptom rating scales and laboratory tests
explain psychological and social meanings and
biological causes of certain symptoms but fail to
clarify causes or meanings of many others
Limitations of conventional
assessment 2
• Conventional assessment has limited accuracy
and reliability and does not evaluate possible
causes of mental illness viz latest scientific
advances in brain research and medicine.
• Mechanisms of action of many psychotropic
drugs still poorly understood at the level of
specific neurotransmitter systems
• This suggests that Western medical theory in its
current form cannot adequately explain the
causes of mental illness.
Non-conventional assessment
In integrative psychiatry
Non-conventional assessment
Three kinds of approaches
Non-conventional assessment
• Quantitative measures of biological
species or activity (eg, Functional
medicine)
• Measurement of classically described
energy or information (eg, QEEG and
HRV)
• Detecting postulated forms of energy
or information not described by science
(eg: analysis of VAS; Chinese pulse dx;
homeopathic assessment)
Potential benefits of nonconventional assessment
• Clarifying underlying causes of symptoms
when the diagnosis is unclear or
incomplete history
• Conventional assessment does not yield
useful clinical information
• Obtaining information about possible
biological, somatic or energetic causes of
symptoms provides clues about the most
effective integrative treatment
Benefits of non-conventional
assessment
• In some cases referring clients to Chinese
medical practitioners, homeopaths, energy
healers or non-conventional practitioners
for formal assessment of “energetic
imbalances” may help clarify important
energetic causes of symptoms that are not
addressed by mainstream Western
medicine.
Non-conventional assessment
Clinical applications in psychiatry
Non-conventional assessment
• Depressed mood: serum folate, B-12,
omega-3 EFAs, cholesterol. QEEG.
• Bipolar disorder: RBC folate; QEEG;
analysis of the VAS
• Anxiety: serum cholesterol; QEEG; EDST
• ADHD: abnormal low serum zinc, ferritin
levels; QEEG
Non-conventional assessment
• Psychosis: RBC AA and DHA levels;
niacin challenge
• MCI and dementia: serum zinc and
magnesium; QEEG; VR testing
environments
• Alcohol and drug abuse: serum A, C, B
vitamins; QEEG
• Insomnia and fatigue: serum C, folate, B12, E; food allergies; random gluclose
Formulation in integrative
psychiatry
Based on comlete history and
assessment findings
The integrative formulation
• Weaves history and assessment findings
into multi-dimensional “hypothesis” of
causes or meanings of symptom pattern
• Includes psychological, social, cultural,
biological, energetic and spiritual factors
• Points to treatment strategies addressing
postulated causes or meanings of sx
• Is flexible and open to new hx and findings
A “good” formulation
• Correctly identifies causes and/or
meanings of core symptoms
• Suggests conventional and CAM Rx most
likely to work
• Continues to evolve as you work with
patient (ie, remains open to new
information pointing to new Rx)
• Increases chances for good outcomes
Planning treatment in
integrative psychiatry
Towards a middle ground
Biomedical treatments of mental
illness—what we use today
• Biological treatments
– Synthetic drugs
– Hormones
– Some vitamins and amino acids (or precursors
• Classical forms of energy or information
– ECT and TMS
– Vagal nerve stimulation
– Bright light exposure
• Psychotherapy
– CBT, insight, existential, etc.
Advantages of conventional
biomedical Rx
• Offers clinicians and patients many
efficacious treatment choices
• Is generally safe when practiced
judiciously
• Employs treatments based on well
described mechanisms of action
• Is validated by a strong research base
However…
• Conventional biomedical psychiatry does
not provide adequate solutions to mental
health problems because of…
• Concerns over safety
• Limited efficacy of some treatments
• Cost and insurance issues
• Limitations on availability in many world
regions
Integrative psychiatry
Toward a middle ground
Planning integrative
management
Treatment category and levels of
evidence
CAM Rx categories
•
•
•
•
Biological (eg, herbs, vitamins, Omega-3s)
Somatic (exercise, massage)
Mind-body practices (yoga, taichi)
Rx based on scientifically validated forms of
energy or information (light, sound, electricity)
• Rx based on postulated forms of energy or
information not validated by current Western
science (qigong, Reiki, prayer)
Three levels of evidence
• Substantiated—positive systematic
review, strongly endorsed,widely used (for
target sx)
• Provisional—at least 3 large well
designed studies and widely used (for
target sx)
• Possibly effective—few or small studies,
inconsistent findings, not strongly
endorsed or widely used (for target sx)
• Refuted (disproved and not used)
The integrative clinician must
address five basic issues:
• Identifying the symptom pattern that is the focus of
clinical attention
• Clarifying the patient’s history of response to previous
treatments for similar complaint
• Determining specific treatment approaches to consider
• Considering practical issues of cost, availability, patient
preferences and values that determine the “shape” of a
realistic and acceptable integrative strategy
• Establishing criteria for assessing outcomes
Towards a methodology
For planning integrative mental
health care
Integrative methodology
• Foundations
• Important decision points
• Questions to ask when considering integrative
strategies
• Getting started
• Moving from idealized to realistic Rx plan
• Treating one vs two or more core sx
• Single Rx vs two or more Rx
• Making referrals
• Follow-up, maintenance and termination
Fundamentals
• Based on evidence (but not strictly EBM)
• SI/HI or acute medical problem refer to ER
• Review patient history
– Conventional Rx and response
– Non-drug Rx and response
– Significant cultural and spiritual issues
• Formulation points to idealized Rx plan
• Modify idealized plan to realistic Rx plan
Important decision points
• Safety always foremost—low threshold for
ER referral (acute medical or psychiatric sx)
• Formal assessment indicated? Sx? Approach?
• Target one core Sx vs two or more core Sx?
• Biological (including drugs) vs non-biological Rx
(psychotherapy, mind-body, somatic, energyinformation)?
• Single Rx delivered in sequence vs parallel Rx?
• Compatibility issues: neutral vs synergistic?
Questions when planning
integrative treatment
• Which Rx enhance outcomes and shorten
response times?
• Which assessment approaches may enhance
accuracy, reliability or predictive power of
findings?
• Will use of particular assessment or Rx
approach enhance assessment accuracy or
treatment outcomes?
• Can two or more specified Rx be combined to
ensure the compatibility or synergy?
Integrative treatment: overview 1
• Document responses to previous Rx,
practical constraints of location and cost,
your knowledge, and patient preferences
• Begin with most substantiated approaches
for target symptom(s)
• Systematically move from substantiated to
provisional and possibly effective
modalities
Integrative treatment planning:
overview 2
• More substantiated Rx have failed, are
refused, unavailable or unaffordable
• Anecdotal evidence suggests a particular
Rx may improve outcome
• Continuing more substantiated Rx that is
synergistic
• BUT…always encourage patient to first
try most substantiated Rx for target Sx
Getting started
• Always begin from formulation
• Construct ideal Rx strategy focusing on
core symptoms
• Decision points: planning Rx
– Biological vs non-biological (eg,
psychotherapy, mind-body, energyinformation) vs integrative Rx
– Conventional Rx (medications,
psychotherapy) vs CAM (natural product vs
mind-body, energy-information)
Move from optimum to realistic plan
• After constructing ideal integrative Rx plan
modify to realistic plan based on:
– Your clinical competence in various CAM and
conventional Rx modalities
– Local availability of CAM practitioners, quality
brands of CAM Rx, etc.
– Patient preferences and values (cultural,
spiritual, etc.)
– Constraints on patient finances, insurance
coverage, etc.
Integrative Rx planning 1
• Review evidence for conventional and
CAM Rx viz formulation
• Identify relevant Rx modalities starting with
most substantiated
• Initiate treatment recs consistent with your
training or clinical experience
• Refer to conventionally trained or CAM
practitioner if indicated
Integrative Rx planning 2
• When substantiated Rx ineffective confirm client
followed directions
• Modify Rx plan viz values, preferences,
constraints, and availability of CAM practitioner
• For moderate Sx emphasize life style changes,
nutrition, mind-body practices, exercise and
supplements
• For severe Sx emphasize biological Rx:
medications and CAM biological modalities and
encourage regular follow-up with medical
practitioner managing care.
Integrative Rx planning 3
• Offer psychotherapy depending on
patient’s insight and motivation.
• Answer questions about safety associated
with conventional, CAM or integrative Rx
• Recommend resources patient can use to
obtain reliable safety information
• Discuss realistic expectations and timeframe of Rx course and clinical
improvement
Targeting one vs two or more
core Sx
• Focus on Sx causing greatest distress or
impairment
• When two or more core Sx consider targeting Sx
most responsive to Rx
• Often practical to prioritize Rx plan by core sx
(more severe then less severe)
• Use single Rx for two or more sx when possible
to simplify Rx plan and optimize outcomes (eg,
exercise or SSRI for anxiety and depression;
DHEA for psychosis and depressed mood)
Combining Rx modalities:
considerations
• Decision tree when planning integrative Rx
– One core sx or two or more core sx?
– Symptom severity and Rx urgency?
– Single modality substantiated, available? (if so may
be preferred starting point)
– Evidence for safety and efficacy when combining 2 or
more modalities?
– Risk of AEs when combining (biological) Rx vs.
treatment delays when using single Rx in sequence?
– Patient motivation, resources?
Combining modalities:
foundations
• When rigor and relevance have been achieved
and two or more Rx are reasonable choices:
– problem of compatibility and synergy between
disparate modalities is addressed.
• Potential Rx combinations are: synergistic,
neutral or incompatible
• Best combinations are synergistic (mutually
reinforcing Rx effects)
• Acceptable combinations are neutral in
combinations (safe but not reinforcing)
• Unacceptable combinations result in potential
toxicities.
Single versus multipe Rx 1
• When two or more substnatiated Rx have equivalent
efficacy, select and prioritize Rx based on:
– Efficacy and tolerability (for patient) if Rx used before
– Availability of qualified CAM practitioner
– Affordability of Rx (cost is deciding factor when two Rx have
equivalent efficacy)
• When all affordable, available and substantiated Rx have
been tried and failed consider provisional Rx (adjunctive
vs stand-alone)
• Use same criteria for determining the order of
precedence of provisional Rx
• Consider combining substantiated and provisional Rx if
synergistic effects likely
Single vs multiple Rx 2
• Discontinue ineffective Rx unless
reasonable to expect synergistic effects
with next Rx
• Consider Rx supported by limited findings
(“possibly effective”) when:
– substantiated and provisional Rx that
are available, affordable and acceptable
have been tried without success, or
– when “possibly effective” Rx may have
adjuvant benefits when combined with
on-going Rx (eg, zinc plus stimulants in
ADHD)
Single vs multiple Rx 3
• In cases where “possibly effective” Rx
tried
• Use N=1 method to evaluate Rx on caseby-case basis
• Open protocol for several weeks followed
by washout period vs placebo (repeated
until efficacy confirmed or refuted)
• Continue to modify integrative Rx plan
until optimum strategy achieved that is
affordable and acceptable to patient
Making referrals
Indications for urgent vs routine
referrals
Emergency medical referral
• Medical problem that is rapidly evolving or
potentially life-threatening
• Patient is suicidal, homicidal or gravely
disabled (PES evaluation and 5150)
• Patient is acutely intoxicated or
withdrawing from EtOH or drugs and
requires hospitalization for observation
and stabilization
Non-urgent medical referral
• Un-diagnosed medical problem possibly
confounding psychiatric DDx (eg,
hypothyroidism, CAD, pulmonary dz,
neurologic sx)
• Known medical problem poorly managed
(non-compliance, patient refuses care;
patient not resonding to on-going Rx)
• Chronic alcohol or substance abuse
Follow-up
• Review changes in Sx; address issues
interfering with Rx adherence
• If patient seen by other M.D. or CAM
practitioner leave message with changes
in Rx, adverse effects and suggestions for
assessment
• If indicated, refer to conventionally trained
or CAM practitioner for specialized
assessment
Follow-up
• Interpret new pertinent new laboratory
data or other assessment findings to help
patient understand significance
• Discuss any changes in integrative
management (if any) viz new findings or
changes in sx
• Make referrals for specialized consultation
if indicated
Maintenance vs termination
• Long-term maintenance includes self-care
and professional Rx
• On-going maintenance reasonable when
recurrence risk with termination outweighs
AE risks with continued Rx (eg, moderate
to severe sx responding to Rx, and Rx is
tolerable and affordable)
• Consider termination when Rx effective for
mild-moderate sx, low relapse risk with
patient self-care
Remarks on safety
In integrative psychiatry
General considerations
• Different safety issues for selfadministered vs professionallyadministered Rx.
• Self-administered Rx –review risks, give
advice about reputable brands
• Professionally administered Rx—
ongoing supervision to monitor for AEs,
discuss progress/problems with CAM
practitioner.
Safety—general
• When recommending a natural product
suggest specific reputable brands
• Useful resources for comparing brands:
www.consumerlab.com and United States
Pharmacopeia www.usp-dsvp.org
• Non-biological Rx have few safety
problems and usually safe to combine with
conventional or non-conventional biol. Rx
Safety
• Always consult reliable resources before
combining western herbs with
conventional drugs
• Excellent resources on herbal and natural
product safety include Bratman 2003;
McGuffin 1997; Brinker 1998; Harkness
2003 (full citations in bibliography).
Safety
• Provide handouts with basic information or
a clearly written note listing common
safety issues or AEs when a conventional
Rx or natural product is taken alone or in
combination with other biologically active
substances, including herbals, natural
supplements, and certain foods.
Limited safety data for integrative Rx
• Limited information about potential
interactions between many widely used
natural products and conventional drugs.
• Integrative Rx combining medications and
Chinese herbal medicines pose special
problems (Lake 2004).
Safety—primum non nocere
• Where particular combinations of
conventional or non-conventional
treatments are associated with known
safety problems, those treatments or
combinations should be avoided, or
implemented in a way that minimizes
risk after written informed consent has
been obtained.
Legal and ethical issues
In integrative psychiatry
Legal and ethical issues
• Current legal-ethical framework is highly
ambiguous:
– Absence of professional ethical practice
guidelines for M.D.s and CAM practitioners
– Absence of federal or State laws defining
scope of practice (viz practicing integrative
medicine) or liability (viz making referrals) for
physicians or CAM practitioners (Adams
2002; Cohen 1998).
Assumptions: scope of practice
• All healthcare providers should have legal
and ethical duty to patients.
• This duty should includes:
– Demonstration of professional competence
when treating patients
– Exercise of sound judgment when referring a
patient for consultation
Legal and ethical: scope of practice
• Western physicians who use CAM or integrative
Rx:
– should learn applicable restrictions imposed by the
State Medical Board (or country) on scope of medical
practices within their medical sub-specialty.
• Caution: performing CAM Rx regarded as
legitimate in one State (or national) jurisdiction
may be cause for probation or other disciplinary
action in other States (countries).
Assumptions: legal-ethical
obligations: making referrals
• When patient’s medical or mental health
problem is outside of the scope of your
expertise and experience…
• You are ethically obligated to refer patient
to appropriate and competent provider.
Legal-ethical: making referrals
• When M.D. refers patient to CAM practitioner
they assume liability for negative outcomes
resulting from the referral, including harmful
effects of treatment.
• It is ethically defensible to refer patients to
non-conventionally trained practitioners only
after confirming good reputation and
qualified to practice specialty (eg: completed
rigorous training, passed State exam,
licensed and no law suits or complaints).
Legal-ethical: making referrals
• When CAM practitioner is the primary
provider:
– And CAM Rx has failed to result in sx relief
– Refer patient to primary care physician or
medical specialist (eg, psychiatrist,
neurologist) for evaluation of possible
undiagnosed medical problem
Part II
The integrative management of
depressed mood
Case vignette
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•
•
•
57 year old retired stock broker
Recovering alcoholic with 11 yrs sobriety
Elevated cholesterol on statin
First MDE age 18: fatigue, hopelessness,
hypersomnolence, frequent SI (resolved
without Rx after 3 months)
• Subsequent MDEs approx. every 3 to 5
years: vegetative sx, frequent SI
Treatment Hx
• First treated age 30 Prozac 20mg with
significant improvement but discontinued
p. 1 yr due to sexual AEs and weight gain
• Recurring MDE 3 yrs later Zoloft 150mg,
worsened, SI, hospitalized: LiCO3
augmentation with significant improvement
• Discontinued Lithium after 3 months:
tremor, weight gain, nausea.
Treatment Hx
• Subsequent therapeutic trials on Paxil, Serzone,
Celexa, Lexapro, Effexor, with initial positive
results
• Now on Remeron 15mg “munchies” and weight
gain
• “They work for a while…then peter out”
• No previous CAM or integrative Rx
• Retired last year and moved to suburbs
• Found integrative clinic and “open” to new
approaches
Integrative Rx—Assessment and
Formulation
• M.D./L.Ac. Does conventional assessment and
Chinese medical assessment
• Med-psych, social and spiritual hx incl. detailed
hx of previous conventional and CAM Rx
• Conventional Dx is MDE, recurrent, now with
moderate depressed mood, consider
depressed mood due to low cholesterol
• Chinese Dx (pulses, tongue) ascribes mood sx
to stagnant liver qi
• Labs: serum total cholesterol and triglycerides,
RBC folate level, and thyroid studies
Integrative treatment planning
• Review of substantiated non-conventional
approaches for moderate depressed mood
including life style changes, acupuncture,
and other therapies that improve
moderate depressed mood when used
alone or in combination with conventional
antidepressants.
Treatment planning—patient
preferences
• Patient skeptical about Chinese medicine
which is not pursued
• Patient has strong interest in supplements
and exercise
• Both approaches are beneficial for
moderate depressed mood
• Both are available options, affordable and
realistic for patient
Treatment—initial integrative
recommendations
• Initial plan: continue current dose of
mirtazepine (15mg), start trial on
adjunctive SAMe with gradual taper to
400mg BID, vitamin supplements (B-12,
folate), daily aerobic exercise, improved
diet and regular stress management.
• Document informed consent of SAMe trial
p. reviewing AE risks
3 week follow-up
• “nothing is working…going downhill fast…”
• Still craving sweets, “sad” all the time,
demoralized and not exercising
• RBC folate low-normal, serum total cholesterol
155mg/dl (low NL). Thyroid studies WNL.
• No change in Liver qi stagnation
• Takes B vitamins, SAMe 200mg/am only
(inferior brand)
• Working in garden, listening to music
Modified plan
• Change to quality brand of SAMe and
continue with initial titration schedule to
400mg BID
• Encourage daily work in garden and
aerobic workouts if motivated
• Encourage listening to music for stress
• Review option of tapering/DC Remeron if
significant response to SAMe
2 week follow-up
•
•
•
•
•
Significantly “brighter”
Exercising almost daily
SAMe 400mg BID with mild GI distress
“munchies” still a problem
Family practice MD reduced statin dose,
repeat total serum cholesterol now 180
(protective HDL/LDL ratio)
One month follow-up
•
•
•
•
•
•
Mood still improved
Gradual weight loss
Sustained exercise program
Good compliance with SAMe, minimal AEs
Night-time craving sweets continues
New Rx recommendation: hold Remeron
pending continued euthymic mood while
on maintenance SAMe with B-vitamins
On-going care
• Regular 4-6 week FU X 6 months then quarterly
pending euthymic on present regimen
• Follow serum cholesterol q 6 months adjust
statin PRN (DC pending cont’d weight loss)
• Serial energetic assessment (pulse dx)
• Maintenance SAMe on-going (MDE recurrent)
• Encourage continued exercise, healthy diet and
life-style changes
• Consider supportive psychotherapy
Integrative management of
anxiety