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Safety considerations in integrative mental health care Presented to: Integrative Mental Health Care of Oregon James Lake M.D. www.IntegrativeMentalHealth.net.

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Presentation on theme: "Safety considerations in integrative mental health care Presented to: Integrative Mental Health Care of Oregon James Lake M.D. www.IntegrativeMentalHealth.net."— Presentation transcript:

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2 Safety considerations in integrative mental health care Presented to: Integrative Mental Health Care of Oregon James Lake M.D. Clinical Assistant Professor Stanford Psychiatry

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4 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

5 Safety In integrative mental health care

6 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

7 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.

8 More considerations When recommending a natural product suggest specific reputable brands Useful resources for comparing brands: and United States Pharmacopeia Non-biological Rx have few safety problems and usually safe to combine with conventional or non-conventional biol. Rx

9 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.

10 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. (Natural Medicines Comprehensive Database)

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12 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

13 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.

14 Planning integrative treatment Always begins with assessing risk

15 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?

16 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

17 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).

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19 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

20 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)

21 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

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23 Safety issues for major categories of CAM Rx Non-pharmacological biological therapies Somatic therapies Mind-body practices Energy therapies validated by Western science Energy therapies not validated by Western science

24 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)

25 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

26 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 reports product recalls and warnings. No fee. Consumer Labs available on subscription but free monthly e-newsletter, rates product quality and safety

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28 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

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30 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.

31 Herbals used to treat mental illness Golden root (Rhodiola rosea)—No serious adverse effects reported when used alone or in combination with conventional antidepressants.

32 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

33 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

34 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

35 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

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37 Non-herbal supplements Safety issues

38 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

39 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

40 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

41 Somatic and energy-information therapies Safety issues

42 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.

43 Energy-information modalities Biofeedback—uses weak electrical current. caution with patients who have pace- makers/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)

44 Non-biological CAM modalities Acupuncture—transient pain, tiredness, bruising. Rare cases of infection, pneumothorax Biofeedback—uses weak electrical current. caution with patients who have pace- makers/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

45 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

46 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

47 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. (Natural Medicines Comprehensive Database)

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