Transcript Safety Considerations when recommending non

Safety considerations in integrative
mental health care
Presented to:
Integrative Mental Health Care of Oregon
James Lake M.D.
www.IntegrativeMentalHealth.net
Clinical Assistant Professor
Stanford Psychiatry
CAM Safety in Context of Conventional
Pharmacological Rx
• Significant unresolved safety problems with
conventional medications
– Antidepressants—weight gain, libido loss (unclear
efficacy)
– Benzodiazepines—excess sedation, dependence
– Mood stabilizers—weight gain, sedation (est. 50%
discontinue within 3-6 months due to AEs)
– Antipsychotics—metabolic syndrome,
arrhythmias, neurological AEs
Safety
In integrative mental health care
Thinking about safety
• What kind of CAM treatment
– Biological (vitamins, herbals, Omega-3s, etc)
– Somatic (exercise, massage)
– Mind-body (yoga, tai-chi)
– Energy-information (light exposure, EEG
biofeedback, VRGET, etc.)
• What the patient is already taking
– Conventional medications (mechanism)
– Natural products
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.
More considerations
• 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
Know resources
• 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.
Resources on Safety
• Bratman, S. & Girman, A.M. (2003). Mosby’s
Handbook of Herbs and Supplements and
their Therapeutic Uses. St. Louis: Mosby, Inc
• Harkness, R. & Bratman, S. (2003) Mosby’s
Handbook of Drug-Herb and Drug-Supplement
Interactions. St. Louis: Mosby, Inc.
• www.naturaldatabase.com (Natural Medicines
Comprehensive Database)
• www.healthnotes.com
Handouts
• Provide handouts with basic information or a
clearly written note that covers:
– common safety issues associated with
recommended natural product
– Described interactions when natural product
taken in combination specific medication your
client is taking
– Reliable consumer resources on safety
information (eg: www.Consumerlab.com )
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.
Planning integrative treatment
Always begins with assessing risk
Complete history minimizes risk
• Complete list of conventional medications and
doses, times taken
• Complete list of natural products and doses
• Other conventional and non-conventional
therapies used? (eg, light exposure, Reiki, EEG
biofeedback)
• Patient managed by trained CAM practitioner
or self-treated?
Assess current safety issues
• Always assess current safety problems before
adding therapies
– Known CAM Rx or medication AEs
– Described CAM Rx or medication interactions
• Make changes that maximize treatment
response with minimum additional risk
• Avoid combinations where known safety risks
or contra-indications
Limited safety data for many integrative Rx
• Limited information (largely case reports)
about potential interactions between widely
used natural products and conventional drugs.
• Safety issues of combining single herbal with
single medication can sometimes be assessed
• Integrative Rx combining medications and
Chinese herbal medicines pose special
problems (Lake 2004).
Compatibility issues
• Consult references before combining any
(biological) CAM Rx with conventional
medications
• Mechanism of action is key
– What is known
– What can be reasonably inferred
• Best combinations are synergistic
– Folate and SSRI or SAMe for depression
– Melatonin and benzodiazepine for insomnia
Compatibility issues
• Acceptable combinations have different
mechanisms of action and no or minimum
potential negative interactions
– Mind-body plus biological Rx (daily yoga plus SSRI
or kava for generalized anxiety)
– Energy Rx plus somatic Rx (bright light exposure
plus regular exercise for depression)
Integrative strategies minimize risk
• Combining different kinds of modalities often
safer than combining pharmacological Rx
– Pharmacological (conventional medications) with
natural product
– Somatic (exercise, massage) with pharmacological
– Energy (light, music) with natural product
– Mind-body (yoga, medication) with diet
• Patient must be motivated
• Cost issues often determine realistic plan
Safety issues for major categories of
CAM Rx
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Non-pharmacological biological therapies
Somatic therapies
Mind-body practices
Energy therapies validated by Western science
Energy therapies not validated by Western
science
Non-conventional biological therapies
Safety issues
• Many herbals used, few studies done and
many findings inconclusive
• Herbals are complex mixtures of bioactive
constituents acting at different sites—difficult
to study effects or characterize mechanisms
• Therefore, with few exceptions, little known
about potential interactions with conventional
medications (single molecule/single receptor)
Progress in natural product safety
• Collaborative government-private program working to
increase safety standards of natural products used as
medicinal agents.
• FDA’s National Center for Toxicology Research and NIH
Office of Dietary Supplements, NCCAM, DHHS National
Toxicology Program, and the National Center for
Natural Products Research at University of Mississippi
are collaborating to improve standards of quality and
safety of natural products.
• Recent improvements in GMP requirements from FDA
www.fda.gov/bbs/topics/news/2004/NEW01130.html.
Resources
• Always recommend quality brands or resources
for finding them when recommending any natural
product.
• Best brands approved by the United States
Pharmacopeia (USP) United States Pharmacopeia
http://usp-dsvp.org reports product recalls and
warnings. No fee.
• Consumer Labs available on subscription but free
monthly e-newsletter, rates product quality and
safety http://www.consumerlab.com
Herbals used to treat mental illness
• Ginkgo biloba—anti-platelet activity increases
bleeding risk (conta-indicated before surgery
and in patients on anti-coagulants); rare
reports of seizures in epilepsy patients.
• Kava kava (Piper methysticum)—GI distress,
headache, mild rash common. Rare case
reports of hepatotoxicity
• Rhodiola rosea—no serious AEs reported
when taken alone or with antidepressants
Herbals used to treat mental illness
• St. John’s wort (Hypericum perforatum)
commonly mild skin rash, restlessness, mild GI
distress; rarely photosensitivity, mania; one
report of possible serotonin syndrome
• Valerian (Valeriana officinalis) commonly
morning grogginess, reports of impaired
concentration 1-2 hours after use (advise
against driving), one case report of withdrawal
syndrome with delirium.
Herbals used to treat mental illness
• Golden root (Rhodiola rosea)—No serious
adverse effects reported when used alone or
in combination with conventional
antidepressants.
Herbals that alleviate symptoms can
also cause symptoms
• Certain herbals cause psychiatric sx
–St. John’s wort—hypomania or mania
–Ephedra—psychosis
–Ginseng—nervousness, insomnia
–Kava—excess sedation, extrapyramidal
symptoms
Contra-indications when
recommending herbals
• Phenothiazine antipsychotics and kava or
SJW—photosensitivity
• Benzodiazepines and valerian—excessive
sedation
• Ephedra, Ginseng or guarana in schizophrenics
or other psychotic disorders—worsening of
psychosis, agitation, insomnia
• Ginseng (other stimulant herbals) and
MAOIs—hypertensive crisis
Contra-indications (2)
• Mood stabilizers or anti-psychotics and
guarana—agitation, insomnia, worsening of
psychosis.
• Any herbal tincture (up to 75% alcohol) and
sedatives or anxiolytics—potentiate sedation
• Lithium and herbal diuretics (in OTC weight
loss preparations)—reduced renal clearance
and lithium toxicity
Contra-indications (3)
• MAOIs and St. John’s wort or Ginseng—
hypertensive crisis
• Stimulant medications and Ginseng or
guarana—agitation, increased anxiety,
insomnia
• Compound Chinese herbal formulas and
compound Ayurvedic herbal formulas should
not be combined with conventional
psychotropic medications—unknown risks
Non-herbal supplements
Safety issues
Non-herbal supplements
• 5-HTP—mild GI distress, dry mouth, sedation
• L-tryptophan—resolved concerns re. EMS
(late ‘80s) single contaminated batch. No
subsequent reports. Better to use 5-HTP.
• Omega-3 fatty acids—nausea, loose stools at
higher doses. Use purified pharmaceutical
grade to avoid contaminants
• SAMe—mild GI distress, anxiety/insomnia,
case reports of mania in bipolar patients
Contra-indications when
recommending herbals
• Phenothiazine antipsychotics and kava or SJW—
photosensitivity
• SJW and immunosuppressive agents, OCP
• Benzodiazepines and valerian—excessive
sedation
• Ephedra, Ginseng or guarana in schizophrenics or
other psychotic disorders—worsening of
psychosis, agitation, insomnia
• Ginseng (other stimulant herbals) and MAOIs—
hypertensive crisis
Contra-indications (2)
• Mood stabilizers or anti-psychotics and
guarana—agitation, insomnia, worsening of
psychosis.
• Any herbal tincture (up to 75% alcohol) and
sedatives or anxiolytics—potentiate sedation
• Lithium and herbal diuretics (in OTC weight
loss preparations)—reduced renal clearance
and lithium toxicity
Somatic and energy-information
therapies
Safety issues
Somatic therapies (exercise,
chiropractic, massage, etc.)
• Potentially injurious if practiced excessively, in an
unskilled way or without skilled supervision
• Always refer patients to qualified body therapists
or mind-body (yoga, taichi) instructors
• Consult with family physician when pre-existing
medical problems: chronic pain, and heart or lung
disease, before starting a rigorous exercise
program or strenuous mind-body practice.
Energy-information modalities
• Biofeedback—uses weak electrical current.
caution with patients who have pacemakers/defibrillators
• Music and binaural sound—none reported
• Bright light exposure—jitteriness, headaches,
nausea; rare reports of hypomania in BPD
• High density negative ions—none reported
• Virtual reality graded exposure therapy
(VRGET)
Non-biological CAM modalities
• Acupuncture—transient pain, tiredness,
bruising. Rare cases of infection, pneumothorax
• Biofeedback—uses weak electrical current.
caution with patients who have pacemakers/defibrillators
• Virtual reality exposure therapy—dizziness,
simulator sickness, rare dissociative sx
• Homeopathy—no toxic reactions reported over
200 years.
• Qigong—transient psychosis in schizophrenics or
severe personality disorders
Safety fundamentals
• Know main AEs of commonly used herbals and
other supplements
• Avoid contra-indicated combinations of
common herbals and psychotropics
• Plan CAM or integrative treatment to
maximize compatibility and minimize risk
• Use web resources and authoritative books on
safety, interactions
Reducing your liability
• Ask patients about CAM Rx and document
• Advise patients about known adverse
effects or contra-indications
• Advise against CAM Rx or integrative Rx
where known safety issues
• Document informed consent when patient
wishes to use CAM Rx with known AEs
• Use reliable resources to keep informed
Resources on Safety
• Bratman, S. & Girman, A.M. (2003). Mosby’s
Handbook of Herbs and Supplements and
their Therapeutic Uses. St. Louis: Mosby, Inc
• Harkness, R. & Bratman, S. (2003) Mosby’s
Handbook of Drug-Herb and Drug-Supplement
Interactions. St. Louis: Mosby, Inc.
• www.naturaldatabase.com (Natural Medicines
Comprehensive Database)
• www.healthnotes.com