The Promise Pitfalls of Intravenous Micronutrient Therapy: From Practice to Theory, Back Again

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The Promise & Pitfalls of Intravenous Micronutrient Therapy: From Practice to Theory, & Back Again David Katz, MD, MPH, FACPM, FACP Yale Prevention Research Center Yale University School of Medicine ACAM Dallas, TX 5-4-06 www.davidkatzmd.com

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History of Myers' Cocktail (shaken, not mixed) Treatment spearheaded by John Myers – a doctor from Baltimore Myers did not leave any distributed or print material on the creation of the IV treatment It gives the idea that he utilized a blend of magnesium chloride, calcium gluconate, thiamine, vitamin B6, vitamin B12, calcium pantothenate, vitamin B complex, vitamin C, and weaken hydrochloric corrosive Current plans have been adjusted to by Dr. Alan Gaby who assumed control care of Dr Myers' patients after his passing in 1984

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Popular blend Members from an extensive variety of national therapeutic affiliations report utilization of IVMT, including: The American College for Advancement in Medicine (ACAM) The American Association of Naturopathic Physicians (AANP) The American Holistic Medical Association (AHMA) The American Academy of Pain Management (AAPM) The Great Lakes College of Clinical Medicine (GLCCM) and International Society of Orthomolecular Medicine (ISOM)

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The Myers' Cocktail Myers' Cocktail Composition-Magnesium chloride hexahydrate (20%) 5 ml Calcium gluconate (10%) 3 ml Hydroxocobalamin (1,000 mcg/ml) 1 ml Pyridoxine hydrochloride (100 mg/ml) 1 ml Dexpanthenol (250 mg/ml) 1 ml B-complex 100* 1 ml Vitamin C (500 mg/ml) 5 ml Sterile Water 20 ml

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Composition, cont. B-Complex 100 contains the accompanying per every ml: Thiamine HCl 100mg Riboflavin 2mg Pyridoxine HCl 2mg Panthenol 2mg Niacinamide 100mg Benxyl Alcolhol 2%

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Theories, from a certain point of view Higher Serum Concentrations IV organization of supplements accomplishes serum fixations much higher than those accomplished by oral or IM organization E.g. Most astounding serum dosage accomplished after oral organization of pharmacological measurements of vitamin C is 9.2mg/dL. IV organization of 50 g/day of vitamin C brought about a mean pinnacle plasma level of 80 mg/dL

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Pharmacological Effects of Nutrients Various supplements may apply pharmacological impacts just in focuses accomplished through IV organization Eg. Antiviral impact of Vitamin C exhibited at a convergence of 10-15 mg/dL – a level accomplished through IV treatment just

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Correcting Intracellular Nutrient Deficits Higher intracellular supplement fixation vital sometimes to keep up appropriate cell work E.g. Magnesium fixation 10 times higher in myocardial cells when contrasted with additional cell focuses in certain sickness conditions cell layer ability to keep up high fixations might be traded off IV organization of Mg may prompt to a noteworthy however transient increment in Mg levels

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Therapeutic Applications of IVMT has been successful in treating - Asthma - M igraines - Fatigue (counting constant weakness syndrome) - Fibromyalgia - Acute muscle fit - Upper respiratory tract contaminations - Chronic sinusitis - Seasonal hypersensitive rhinitis - Cardiovascular ailment

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Asthma IV magnesium can prematurely end intense asthma assaults Skobeloff EM, Spivey WH, McNamara RM, Greenspon L. Intravenous magnesium sulfate for the treatment of intense asthma in the crisis office. JAMA 1989;262:1210-1213. Bloch H, Silverman R, Mancherje N, et al. Intravenous magnesium sulfate as an extra in the treatment of intense asthma. Mid-section 1995;107:1576-1581. Ciarallo L, Brousseau D, Reinert S. Higher-dosage intravenous magnesium treatment for youngsters with direct to extreme intense asthma. Curve Pediatr Adolesc Med 2000;154:979-983. Ciarallo L, Sauer AH, Shannon MW. Intravenous magnesium treatment for direct to serious pediatric asthma: aftereffects of a randomized, fake treatment controlled trial. J Pediatr 1996;129:809-814. Rowe BH, Bretzlaff JA, Bourdon C, et al. Intravenous magnesium sulfate treatment for intense asthma in the crisis division: a methodical survey of the writing. Ann Emerg Med 2000;36:181-190.

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Migraine Beneficial impact of IVMT in treatment of headache has been shown in some clinical trials Mauskop An, Altura BT, Cracco RQ, Altura BM. Intravenous magnesium sulfate soothes headache assaults in patients with low serum ionized magnesium levels: a pilot think about. Clin Sci 1995;89:633-636. (29.) Demirkaya S, Vural O, Dora B, Topcuoglu MA. Adequacy of intravenous magnesium sulfate in the treatment of intense headache assaults. Migraine 2001;41: 171-177. (30.) Mauskop An, Altura BT, Cracco RQ, Altura BM. Intravenous magnesium sulfate soothes group migraines in patients with low serum ionized magnesium levels. Cerebral pain 1995;35:597-600.

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Fatigue Duration of advantage from few days to couple of months Manuel y Keenoy B, Moorkens G, Vertommen J, et al. Magnesium status and parameters of the oxidant-cancer prevention agent adjust in patients with constant weariness: impacts of supplementation with magnesium. J Am Coll Nutr 2000;19:374-382 Howard JM, Davies S, Hunnisett A. Magnesium and incessant exhaustion disorder. Lancet 1992;340:426. Howard JM, Davies S, Hunnisett A. Magnesium and ceaseless weakness disorder. Lancet 1992;340:426. Clague JE, Edwards RH, Jackson MJ. Intravenous magnesium stacking in unending weariness disorder. Lancet 1992;340:124-125 Ellis FR, Nasser S. A pilot investigation of vitamin B12 in the treatment of tiredness. Br J Nutr 1973;30:277-283.

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What is Fibromyalgia (FMS)? Clinical disorder of obscure etiology and pathogenesis Characterized by musculoskeletal agony, non helpful rest and weariness, psychiatric, neurological and different side effects

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Epidemiology 3.7 million people ages 18 more established or 2% of the populace influenced in US 0.5 - 5% of the populace influenced overall 4-7 times more regular in grown-up ladies than men; most noteworthy predominance in ladies 50-60 years old Ethnic, hereditary, social and social components may impact FMS inclination

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Pathophysiology Considered-4 hypotheses of pathophysiology have developed: Neurogenic (Central Nervous System) - summed up torment - increment in CSF substance P - diminish in serum and CSF serotonin - expanded focal sharpening

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Pathophysiology, cont. Muscle Pathology - diminished oxygen pressure and blood stream - unusual muscle biopsies - shortcoming

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Pathophysiology, cont. Psychopathology - uneasiness, sorrow Immune-intervened ailment - activated by different contaminations, for example, Lyme sickness

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Clinical Presentation Pain (musculoskeletal delicacy) Lightheadedness, unsteadiness, syncope Fatigue Chronic a sleeping disorder; rest aggravation Cognitive shortages/fleeting memory misfortune Depression/tension Numbness, dysesthesia in hands and feet

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Diagnosis Based on the 1990 ACR characterization rules: 1 chronicled include + 1 physical discovering Historical component = across the board (pivotal) torment of 3 months or more Physical discovering = torment in no less than 3 of the 4 body portions + a finding of no less than 11 delicate focuses on advanced palpation of 18 assigned delicate focuses

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Tr eatment Patient Education - perusing materials, recordings, care groups Physical Exercise - second rate (muscle extends, oxygen consuming molding) Pharmacologic Therapies - tricyclic antidepressants, NSAIDS, topical capsaicin, opioids* *Drug treatments have been utilized with fluctuating degrees of accomplishment in treating fibromyalgia

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Treatment, cont. Reciprocal Treatments - Mind body mediations - Homeopathy - Acupuncture - Nutriceuticals

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Practice looking for hypothesis (truck, looking for stallion… ) Myers' mixed drink has been a well known "option" treatment for a considerable length of time No trials for FMS have been distributed The episodic support is solid

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Necessity is the mother of… examination. Current medicines don't enough address FMS side effects in many patients The clear guarantee of the Myers' Cocktail (IVMT) got out for testing

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Tribulations, preceding Trial-Lack of hypothetical justification Empirical proof just Toxicity concerns Need for IND status

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First RCT of IVMT for FMS (the letters in order gets a workout!) Study Design - Randomized, twofold visually impaired, fake treatment controlled trial Inclusion criteria - Musculoskeletal torment for 3 months - Pain in 11 of 18 delicate point destinations on advanced palpation

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Methods 40 subjects randomized to treatment or control assemble Treatment 8 week by week medications performed at one week interims Control Placebo/IV saline implantation Assessments Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Index (BDI), Visual Analog Scale (VAS) and Health Status Questionnaire (HSQ 2.0)

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Evaluation Primary result: The Tender Point Index (TPI) The seriousness of torment, surveyed by an algometer with a drive of 4 Kg, dictated by a scoring framework running from 0 (no reported delicacy) to 4+ (extreme torment). The TPI is the composite of scores at 18 delicate point locales. At pattern (taking after 2-week keep running in period) One-week post mediation period 3-months taking after the intercession Results are presently pending; trial is nearing culmination

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From Practice, to Theory-Theoretical Pathway Predisposing Factor HLA Susceptibility OR Precipitating Factors ( Trauma/Medical ailment) - Autoimmune Disorder: Formation of autoantibodies to surface proteins on myocytes or endothelial cells - Deficiency in Nitric Oxide Production OR Impaired Release of, or Response to, Nitric Oxide - Vasomotor Dysregulation - Muscle Hypoperfusion - Impaired intracellular energetics - Induction of Pain Katz DL et al. The P

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