Bipolar Disorder an over
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Roy Perlis, MD Bipolar Research Program Massachusetts General Hospital/Harvard Medical School Bipolar Disorder: an overview
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Key points in bipolar disorder Costly, common (1%+), treatable Defined by recurrent episodes of mania (or hypomania) and depression Often misdiagnosed New treatments FDA-approved, more on the way… … but older treatments can save lives, too.
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Case: B.P. 20 y.o. male college sophomore; Depressive episode, age 16 Won’t get out of bed, won’t go to school Resolves after several months without treatment Manic episode, age 20 No sleep for 1 week – busy with ‘projects’ Agitated, excited, talking rapidly about his ‘cure for cancer’ Convinced his roommates are scheming against him What’s at stake?
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The costs of bipolar disorder LIFE 8 years of effective function Risk of suicide death 29x general population >>$60 Billion
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(Peak onset age 15-19) Expectable Course, Untreated If onset at age 16, given median rate of recurrence by age 30, EXPECT ? 10 episodes Age 10 30 Episode Number
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A common disease Prevalence estimated between 1-3% (depends on diagnostic criteria) Males=females Found across cultures and ethnicities Strongly heritable
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Screening The Mood Disorder Questionnaire: 13 yes/no questions Available at: www.dbsalliance.org/questionnaire/screening_intro.asp
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Diagnosis There are no clinically useful lab tests which make a diagnosis of bipolar disorder blood tests: normal CT/MRI: normal* EEG: normal Thus, diagnosis rests on clinical evaluation – ideally by a psychiatrist or psychologist!
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AGE OF SYMPTOM ONSETNDMDA Survey N=500 LISH et al, J. Aff. Dis 1994 < 5 5-9 15-19 20-24 30% 20% 10% 10-14 25-29 30+ 28% 14% 12% 5% 15% 9% 16% Years of age
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Symptom % Depressed mood/hopelessness 33 Mania/hyperactivity 32 Lack of sleep 24 Mood swings 13 Anger/irritability 9 Delusions/paranoia 9 NDMDA = National Depressive and Manic-Depressive Association. Lish et al. J Affect Disord. 1994;31:281-94. NDMDA Survey: Initial Symptoms of Bipolar Disorder (N = 500)
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Mania DSM IV 7 days or more of elevated or irritable mood DIGFAST Marcus Unwellby, M.D. Massachusetts General Hospital Boston, MA 02114 M.D. Name _________________ Date __________ DEA # __________ Adapted from William Falk, M.D. D - Distractible I – Injudicious (impulsive) G - Grandiose F – Fast thoughts (Flight of ideas) A – Active (or agitation) S – Decreased need for sleep T – Talking fast
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Questions for Detecting Hypomania Do you have days of energy or ideas that come and go abruptly? On those days of energy, are you productive? Creative? Feel unconquerable? Convinced of your self-worth, talents abilities? Positive about the future? Talkative? Distinctly more social? Irritable? On those days of energy, do your thoughts feel as if they’re racing? Manning JS, et al. Arch Fam Med. 1998;6:63-71.
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Questions for Detecting Hypomania At these times, do you need less sleep? Continue to be productive? How many consecutive days does this period of increased energy and change in mood last? Do others notice the change in your mood or energy level? Manning JS, et al. Arch Fam Med. 1998;6:63-71.
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Questions for Detecting Hypomania During these “up” times, do you do things that you later regret? Make plans you find impossible to complete? Take on tasks that you later suddenly lose interest in? Are you particularly more depressed or lethargic immediately before or after these periods of energy? Does it feel like you “crash”? Does your body seem as if made of lead? Do you need excessive sleep? Manning JS, et al. Arch Fam Med. 1998;6:63-71.
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On average, bipolar patients spent about 1/3 of their time with symptoms of depression NIMH Collab Depression Study - Judd et al, Archives 6/2002 Mood states
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Beyond mania and depression A marathon, not a sprint!
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Case: B.P. 20 y.o. male college sophomore; Depressive episode, age 16 (no treatment) First manic episode, age 20 No sleep for 1 week – busy with ‘projects’ Agitated, excited about his ‘cure for cancer’ Convinced his roommates are scheming against him Discharged on hospital day 7 on a regimen of valproate (divalproex) and olanzapine. Arrives (30’ late) for follow-up appointment and announces, “There’s no way I’m taking this #$%@!”
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Most Common Reasons for Discontinuing an Effective Treatment in Bipolar Disorder: Weight Gain,Sedation
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“Systematic Treatment Enhancement Program – Bipolar Disorder” 5000 Bipolar Patients (n>3000 as of 6/1/03) 100-200 Treating Psychiatrists 15 Treatment Centers Common Disease Management Model STEP-BD: an effectiveness study
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BIPOLAR DISORDER:Standard & Novel Treatments Andrew L. Stoll, M.D. © 1998-2003 Psychopharmacology Research Laboratory McLean Hospital Harvard Medical School Alstoll@mclean.harvard.edu 617-855-2459 2003
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Bipolar Disorder:Current or Evolving Concepts of Treatment Polypharmacy is the rule, not the exception Mood Elevating Mood Stabilizers exist: Lamotrigine Some atypical antipsychotic agents Omega-3 fatty acids “Stabilizing the mood from below”1 Minimizing antidepressant use is now more practical Tolerability is now as important as efficacy Nutritional agents have a role Complementary & Alternative Medicine is here to stay 1Ketter and Calabrese, 2001
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MOOD STABILIZERS WITH CONTROLLED DATA(partial list) chlorpromazine lithium salts carbamazepine phosphatidylcholine valproate ECT Verapamil L-tryptophan hypermetabolic T4 risperidone omega-3 fatty acids lamotrigine olanzapine topiramate magnesium salts clozapine quetiapine ziprasidone
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LITHIUM SALTS(Lithobid, Eskalith CR) ADVANTAGES Extensive and long use Acute and chronic efficacy data Relative safety in Pregnancy Moderate antidepressant effects Demonstrated anti-suicide effects DISADVANTAGES Narrow therapeutic index Renal & thyroid toxicity Multiple “nuisance” side-effects Narrow spectrum of activity Occasional depression induction Stigma
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DIVALPROEX SODIUM(Depakote, Depakote ER) ADVANTAGES Strong acute efficacy data Some long-term data Broad activity spectrum “Loading” doses rapidly effective Effective for anxiety & migraine Less toxic than Li+ DISADVANTAGES Nausea (acute) Weight gain (chronic) “Nuisance” side-effects Possibly less effective for pure bipolar depression Neural tube defects (5-7%) Controversy over pancreatitis & polycystic ovary syndrome
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CARBAMAZEPINE(Tegretol) ADVANTAGES Strong acute efficacy data Broad activity spectrum Possible antidepressant effects in bipolar disorder Long history of use No weight gain DISADVANTAGES May lose effectiveness over the long-term Drug interactions (induction of CYP450 3A3/4) Blood dyscrasias Narrow therapeutic index Acute side-effects Usage: 200 mg BID initially. Gradually titrate to 300-400 mg BID, then check serum level. Titrate to highest tolerated dosage within therapeutic range. Due to CYP450 autoinduction, the dosage may have to be increased in several weeks.
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TRILEPTAL(Oxcarbazepine) Carbamazepine-like action More rapid dose titration possible FDA approved anti-epileptic Used in Europe since 1990 Milder adverse effect profile than carbamazepine Less bone marrow and liver effects Less drowsiness No labs required (except for sodium) Fewer drug interactions. Schachter et al. Neurology 1999;52:732-737. ADVANTAGES Limited data in bipolar disorder Drug interaction risk still present Reduced effectiveness of low-dose oral contraceptives Carbamazepine-like adverse effects ~ 1/3 the incidence dizziness, somnolence, diplopia Hyponatremia (low sodium) higher incidence (~ 2.5%) than carbamazepine Usually not clinically significant unless very low Correct slowly to prevent neurological complications DRAWBACKS
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Controlled data (N > 1300) Bipolar depression1 Rapid-cycling3 Prophylaxis Bipolar I and II Unipolar depression Very well-tolerated No weight gain No labs; No sedation No cognitive “dulling” Neuroprotective Blocks glutamatergic Na+ channels LAMOTRIGINE(Lamictal) Slow dosage titration limits acute utility Skin issues High rate of benign skin rashes (~10%) Fear of Stevens-Johnson syndrome (SJS) Increased SJS only if dosed too aggressively. Valproate will double Lamictal serum levels ADVANTAGES 1Calabrese et al. J Clin Psychiatry 1999;60:79-88. 2Ichim et al. Ann Clin Psychiatry 2000;12:5-10. 3Calabrese et al. J Clin Psychiatry 2000;61:841-850. DISADVANTAGES
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Patient education Warn patients not to change soaps, laundry detergents, OTC products, unusual foods, etc. - during 1st 6 weeks of lamotrigine titration Assess rash (severity, location, features) Discontinue if: a. Rash is severe, painful, or rapidly evolving b. Any blistering c. Systemic symptoms d. Mucous membrane involvement Early Dermatology consultation if unsure LAMOTRIGINE & SKIN RASH Safe Management
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Lamotrigine and Women’s Health No menstrual effects. No risk of PCO. No weight gain. No other neuroendocrine or other cosmetic effects. No interference with oral contraceptives metabolism No cognitive side-effects. Appears safe in pregnancy (registry data)1. 1Massachusetts General Hospital. AED Pregnancy Registry 1-888-233-2334 or 1-888-AED-AED4 (Toll free)
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Is “Polypharmacy” a Bad Thing? YES Poorly done polypharmacy may be ineffective and unsafe. NO Appropriate polypharmacy can be life-changing or even life-saving: ENHANCED EFFICACY: Improves the chance of a full syndromic recovery Improves the chance of a full functional recovery Can speed the time to response IMPROVED TOLERABILITY & SAFETY: Additive or synergistic effects of the proper combination permit lower dosages, leading to: Reduction of side-effects Lessened risk of toxicity
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Why is Polypharmacy Now So Common and Widely Accepted? Greater numbers and varieties of drugs and supplements available. Steadily growing knowledge about the risks and benefits of specific combinations. Accumulating data indicating the poor prognosis and outcome of inadequately treated illness. Higher consumer education and expectations for improved outcome. Big Pharma PR and advertising
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PHOTOTHERAPY ADVANTAGES Controlled data in SAD patients. Plausible neurochemical mechanism. Well-tolerated; Energizing. High patient acceptance. No ocular damage with quality boxes. Possible dampening of seasonal mood shifts if used year-round? Finances Light boxes now more affordable. some insurers are paying. DRAWBACKS Expensive. Compliance sometimes difficult. 20-60 minutes per day required. A.M. light best. Eye strain and headaches. Possible induction of hypomania and cycling. 10,000 lux box at ~18-22”. Face the direction of the box. Look at the box as often as you desire, or read, etc. 20-60” per day, preferably in the a.m. Many brands available: Alaska Northern Lights: 1-800-880-6953 or Northern Lights (Montreal):
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A traditional diet in the Arctic regions of North America provides 15-19 grams/day of EPA + DHA (omega-3 fatty acids ). In the U.S. < 1 gram/day of omega-3 fatty acids are consumed
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GENERAL HEALTH BENEFITS OF OMEGA-3 FATTY ACIDS Cardiac Reduced incidence of MI Improved survival if MI Gastrointestinal Improvement in Crohn’s disease & ulcerative colitis ? corticosteroid use in inflammatory bowel disease Rheumatology Improvement in rheumatoid arthritis symptoms ? corticosteroid use in rheumatoid arthritis Renal IgA nephropathy Improved outcome in renal transplant Neuropsychiatric Mood disorders Schizophrenia ADHD Dementia prevention
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Omega-3 Fatty Acids:AREAS OF ACTIVE RESEARCH Bipolar disorder Unipolar depression Schizophrenia Borderline personality disorder Post-partum depression ADHD Autism spectrum disorders Other developmental neuropsychiatric disorders
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POSSIBLE MECHANISMS OF ACTION OF OMEGA-3 FATTY ACIDS IN BIPOLAR DISORDER ? 2nd-messenger generation in PI system. Anti-kindling effects. Blockade of calcium channels. Inhibition of PKC. Altered receptor function. Altered CNS cytokine function. Altered arachadonic acid (n6) pathways.
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OMEGA-3 FATTY ACIDS IN BIPOLAR DISORDER: Study Design Double-blind placebo-controlled 4-month trial N = 30 bipolar outpatients (mostly Type I) All subjects had mania/hypomania within past 1 year Randomized to 9.6 g/day omega-3 vs. placebo (olive oil) Concomitant meds left unchanged N = 8 entered study on no other drug therapy Main outcome measures: Recurrence or lack of response SCID Status at end of trial
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OMEGA-3 IN BIPOLAR DISORDER: Survival Analysis 80 60 40 20 20 40 60 80 100 120 Time (days) 100 omega-3 olive oil N = 16 N = 14 p = 0.002 (Mantel-Cox) Number of patients remaining in study (%)
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80 60 40 20 20 40 60 80 100 120 Cumulative Survival (%) Time (days) 100 omega-3 olive oil N = 4 N = 4 p = 0.04 (Mantel-Cox) OMEGA-3 FATTY ACID MONOTHERAPY: Survival Curve
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4 double-blind, placebo-controlled trials DHA in unipolar depression (ineffective)1 EPA monotherapy in unipolar depression2 EPA add-on in recurrent unipolar depression3 EPA + DHA (3:2) in unipolar depression4 OMEGA-3 FATTY ACIDS in UNIPOLAR DEPRESSION Direct Evidence of Efficacy 1Marangell et al. DHA in unipolar major depression. Presented at ISSFAL, Tsukuba, Japan 2000. 2Peet et al. EPA for unipolar major depression. Abstr Biol Psychiatry. 2001. 3Nemets et al. Addition of omega-3 fatty acid to maintenance medication treatment for recurrent unipolar depressive disorder. Am J Psychiatry. 2002;159:477-9. 4Su et al. Omega-3 fatty acids in major depressive disorder: a preliminary double-blind placebo-controlled trial. Eur Neuropsychopharmacol. 2003;13:267-271.
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FISH CONSUMPTION AND MAJOR DEPRESSION AROUND THE WORLD 20 40 60 80 100 120 140 160 Apparent Per Capita Seafood Consumption (lbs/year) Annual Prevalence of Major depression (%) 6 5 4 3 2 1 ? ? ? ? ? ? ? ? ? Japan (0.12%) Korea (2.3%) Taiwan (0.8%) New Zealand (5.8%) France (4.5%) Canada (5.2%) Puerto Rico (3.0%) USA (3.0%) W. Germany (5.0%) r = -0.84 p < 0.005 Adapted from: Hibbeln JR. Lancet 1998
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OMEGA-3 FATTY ACID DEPLETION IN POST-PARTUM WOMEN After 1 child: Low DHA After 2 children: Lower DHA After 3 children: Lowest DHA Triplets > twins: Triplets: Lactation: At 16 weeks, decreased DHA
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FISH CONSUMPTION AND POSTPARTUM DEPRESSION 20 40 60 80 100 120 140 160 Apparent Per Capita Seafood Consumption (lbs/year) Postpartum depression (EPSD) point prevalence (%) ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? Japan (2.0%) Malaysia (3.0%) Spain (13.6%) Singapore (0.5%) Hong Kong (5.5%) Chile (5.5%) France (11.0%) Sweden (9.0%) Italy (15.0%) UK (14.4%) UAR (18.0%) Netherlands (14.0%) Switzerland (10.2%) Ireland (11.0%) Israel (12.4%) Canada (12.7%) USA (11.5%) ? ? ? ? ? ? Brazil (24.1%) Germany (20.0%) Australia (18.6%) New Zealand (17.4%) South Africa (24.5%) Hibbeln 1999 22 countries 25 20 15 10 5 2.5
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IDEAL CHARACTERISTICS OF A FISH OIL SUPPLEMENT Maximum concentration >90% now available No heavy metal or organic carcinogens Any concentrated fish oil (> 50%) is convincingly safe No fishy aftertaste, smell, or “repeat” Mitigated by encapsulating under nitrogen to minimize oxidation EPA >> DHA Virtually all the data points to EPA as the active ingredient Locke CA, Stoll AL. World Rev Nutr. 2001
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OMEGA-3 FATTY ACIDSUsage Guide Fish oil usually preferred over flaxseed oil. Calculate dosage based on EPA content. Start dosage: 1 gram/day EPA x 3-5 days. Usual dosage: 2-5 grams/day EPA Dosage schedule: Typically BID (qd or TID OK) Antioxidant vitamins are required: Vitamin E 400-800 IU/day Vitamin C 250-500 mg/day
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Omega-3 Fatty Acids: Side-Effects and Safety No known toxicity Arctic peoples ingest 15-20 g/d of EPA + DHA Heavy metals & organic carcinogens in fish (not fish oil) Weight neutral or weight loss. GI side-effects are the only common complaint Fishy aftertaste (“repeat”) Nausea Loose stools or diarrhea Only a theoretical risk of increased bleeding
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Omega-3 Fatty Acids: Drug Interactions No known interactions with psychotropic drugs. Adverse interactions with blood thinners very unlikely: Only a theoretical risk of increased bleeding EPA only partially inhibits platelet aggregation via a transient eicosanoid effect Aspirin inhibits platelets fully and irreversibly No well-documented cases of bleeding have ever been reported. A recent review of the literature revealed no bleeding episodes in >15,000 subjects in clinical trials of omega-3s
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OmegaBrite1 > 90% 7:1 +/- Omega-7002 60-70% 3:2 ++ 1Omega Natural Health, Inc. www.omegabrite.com 2Solgar Vitamin Co. Retail 3Nordic Naturals. www.nordicnaturals.com 4General Nutrition Centers. Retail Nordic Naturals3 50% 3:2 +++ MaxEPA4 > 30% 3:2 ++++ Product Comparison Chart Of Some Examples of Omega-3 Fatty Acids Brand Omega-3 EPA to DHA aftertaste concentration ratio
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OmegaBrite Supplement Facts Serving Size: 3 capsules Amount Per Serving % Daily Value Calories 15 Calories from fat 15 Total fat 1.5 g 2%* Polyunsaturated fat 1.5 g ? Cholesterol 0 g 0%* Vitamin E (as d-a-tocopherol) 3 IU 11% EPA (eicosapentanoic acid) 1,125 mg ? DHA (docosahexanoic acid) 165 mg ? Other omega-3 fatty acids 90 mg ? Omega-6 fatty acids 60 mg ? Other fatty acids 60 mg ? *Percent Daily Values are based on a 2,000 calorie diet. ?Daily value not established. Ingredients: fish oil, gelatin, glycerin and vitamin E (as d-a-tocopherol). Distributed by Omega Natural health Waltham, MA 02451 www.omegabrite.com 1125 mg ÷ 3 375 mg EPA (per 500 mg capsule)
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TERRESTRIAL SOURCES OF OMEGA-3 FATTY ACIDS Flaxmeal or flaxseed oil Perilla Oil Chia Borage seed oil Hemp oil: Too much omega-6 (n6:n3 = 4:1) Wild game Omega-3 enriched eggs1,2,3 1Lewis et al. Enriched eggs as a source of n-3 polyunsaturated fatty acids for humans. Poult Sci 2000;79:971-4. 2Three omega-3 enriched eggs = 1 serving fatty fish. 3The Country Hen. Box 333, Hubbardston, MA 01452 www.countryhen.com
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FLAX OIL (a-Linolenic acid) Advantages More palatable than fish oil Native flax oil more concentrated than native fish oil May be used in recipes (but not as a frying oil) Drawbacks No controlled data in neuropsychiatric disorders May cause more manic switch than fish oil Limited conversion to longer chain omega-3 Usage: 1 tablespoon (~7 g of ALA) qd-TID or use capsules. Omega-3 dosage with flax oil should be the same or higher as that used for fish oil, due to the incomplete conversion of ALA to EPA.
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Inexplicable link to prostate cancer: At least 4 epidemiological studies associated ALA content of blood with elevated rates of prostate cancer.1-4 In vitro data also suggests ALA promotes prostate cancer.5 Omega-6 fatty acids also promote tumorigenesis.5 Adequate EPA inhibits tumorigenesis.5 The seed husks of flaxseeds (also lima & cassava beans) contain cyanogen, which is converted thiocyanate. Thiocyanate inhibits iodine uptake by thyroid, possibly leading to goiter. Cyanogen is destroyed during cooking. Flaxseed oil is free of cyanogen.6 FLAXSEED TOXICITY? 1Giovannucci et al. J Natl Cancer Inst 1993;85:1571-1579. 2Godley et al. Cancer Epidemiol Biomarkers Prev 1996;5:889-895. 3Harvei et al. Int J Cancer 1997;71:545-551 4De Stefani et al. Cancer Epidemiol Biomarkers Prev 2000;9:335-338. 5Pandalai et al. Anticancer Res 1996;16:815-820. 6Simopoulos A. 1999
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IS FISH STILL A GOOD SOURCE OF OMEGA-3? Anchovies Bluefish Herring Lake trout Mackerel Pompano Salmon Striped Sea Bass Source: U.S.D.A., Agricultural Research Service. 2001. For the general population, the American Heart Association recommends at least two 3 oz servings of fatty fish per week.
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Pollutants, such as Hg, Cd, and PCBs, tend to be higher in large, long-lived, predatory fish having more dark meat: Shark, swordfish, king mackerel, and tilefish. The FDA has advised pregnant women and young children to avoid eating these types of fish: Hg in the meat may harm an unborn baby's developing nervous system. These fish contain ~1,000 ppb (parts per billion) of Hg: the FDA limit for human consumption Most other fish have about 10-30% of this amount. The EPA has advised that fresh-water fish may contain more mercury than commercially caught fish: Limit of 1 fresh-water fish meal (~ 6 ounces) per week. IS FISH STILL A GOOD SOURCE OF OMEGA-3?
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ConsumerLab.com, LLC. HERBALS Echinacea Ginkgo biloba Ginseng Red clover isoflavones Saw palmetto Soy isoflavones St. John’s wort Valerian VITAMINS & MINERALS Calcium Iron Multivitamins Multiminerals Vitamin C Vitamin E OTHER SUPPLEMENTS Chondroitin CoQ10 Creatine Fish oil Glucosamine MSM SAMe
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Journal Summaries Currents in Affective Illness 301-320-6915 7000 Carmichael Av, Bethesda, MD 20817 Biological Therapies In Psychiatry Newsletter
1-800-700-9589 Psychiatry Drug Alerts
1-973-898-1200 International Drug Therapy Newsletter Ayd Medical Communications. 1130 E. Cold Spring Lane, Baltimore, MD 21239 The Integrative medicine Consult
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USEFUL WEBSITES in PSYCHOPHARMACOLOGY Medline via “PubMed”
Pharmaceutical industry: R & D Directions.
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FINANCIAL DISCLOSUREAndrew L. Stoll, M.D.Dir., Psychopharmacology Research Lab., McLean Hospital Associate Professor of Psychiatry, Harvard Medical School Research Grant support: Abbott Laboratories, Janssen Pharmaceutica, Eli Lilly & Co., Solvay Pharmaceuticals, NIH, Harvard Medical School, The Stanley Foundation, The Poitras Charitable Fund, and the Hirschhorn Foundation. Speaker's Bureau: Abbott Laboratories, Astra-Zeneca, Bristol-Myers Squibb, Forest Laboratories, Glaxo, Janssen Pharmaceutica, Eli Lilly & Co., Organon, Pfizer (Parke-Davis), Smith-Kline Beecham, Wyeth-Ayerst. Consultant: Abbott Laboratories, Bristol-Myers Squibb, Glaxo, Eli Lilly & Co., Pfizer (Parke-Davis), and CX Research, Inc. Major Stockholder: None. Other: Dr. Stoll has a published a book on omega-3 fatty acids: "The Omega-3 Connection" (Simon and Schuster, 2001). His wife, Carol A. Locke, M.D. creates nutraceutical products for psychiatry and is the Founder and CEO of Omega Natural Health, Inc., the maker of OmegaBrite™. (www.omegabrite.com 1-888-43-OMEGA)
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J Clin Psychiatry 1999;60:79-88. 2Ichim et al. Ann Clin Psychiatry 2000;12:5-10. ..... Associate Pr
J Clin Psychiatry 1999;60:79-88. 2Ichim et al. Ann Clin Psychiatry 2000;12:5-10. ..... Associate Professor of Psychiatry, Harvard Medical School …www.familyaware.org/seminar/stoll-2003.ppt
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