Establishing a Methodology for Integrative psychiatry: from research

to clinical applications

Groningen, The Netherlands3 December, 2008

James Lake M.D.www.IntegrativeMentalHealth.net Clinical Asst. Professor, Stanford

PsychiatryClinical 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 PsychiatryClinical 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 PsychiatryClinical 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 peer-reviewed 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, consensus-based 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 double-blind 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 (Ham-D)

• 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 non-conventional 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, B-12, 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, energy-information)?

• 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, energy-information) 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 time-frame 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 case-

by-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 self-administered vs professionally-administered 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

• 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