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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.

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Presentation on theme: "The Promise & Pitfalls of Intravenous Micronutrient Therapy: From Practice to Theory, & Back Again David Katz, MD, MPH, FACPM, FACP Yale Prevention Research."— Presentation transcript:

1 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

2 History of Myers Cocktail (shaken, not stirred) Treatment pioneered by John Myers – a physician from Baltimore Myers did not leave any published or print material on the composition of the IV treatment It appears that he used a combination of magnesium chloride, calcium gluconate, thiamine, vitamin B6, vitamin B12, calcium pantothenate, vitamin B complex, vitamin C, and dilute hydrochloric acid Current formulations have been modified to by Dr. Alan Gaby who took over care of Dr Myers patients after his death in 1984

3 Popular brew- Members from a wide range of national medical associations report use of IVMT, including: Members from a wide range of national medical associations report use of IVMT, including: The American College for Advancement in Medicine (ACAM)The American College for Advancement in Medicine (ACAM) The American Association of Naturopathic Physicians (AANP)The American Association of Naturopathic Physicians (AANP) The American Holistic Medical Association (AHMA)The American Holistic Medical Association (AHMA) The American Academy of Pain Management (AAPM)The American Academy of Pain Management (AAPM) The Great Lakes College of Clinical Medicine (GLCCM) andThe Great Lakes College of Clinical Medicine (GLCCM) and International Society of Orthomolecular Medicine (ISOM)International Society of Orthomolecular Medicine (ISOM)

4 The Myers Cocktail Myers Cocktail Composition- Myers Cocktail Composition- Magnesium chloride hexahydrate (20%)5 ml Magnesium chloride hexahydrate (20%)5 ml Calcium gluconate (10%)3 ml Calcium gluconate (10%)3 ml Hydroxocobalamin (1,000 mcg/ml)1 ml Hydroxocobalamin (1,000 mcg/ml)1 ml Pyridoxine hydrochloride (100 mg/ml)1 ml Pyridoxine hydrochloride (100 mg/ml)1 ml Dexpanthenol (250 mg/ml)1 ml Dexpanthenol (250 mg/ml)1 ml B-complex 100*1 ml B-complex 100*1 ml Vitamin C (500 mg/ml) 5 ml Vitamin C (500 mg/ml) 5 ml Sterile Water20 ml Sterile Water20 ml

5 B-Complex 100 contains the following per each ml: B-Complex 100 contains the following per each ml: Thiamine HCl100mg Thiamine HCl100mg Riboflavin 2mg Riboflavin 2mg Pyridoxine HCl 2mg Pyridoxine HCl 2mg Panthenol 2mg Panthenol 2mg Niacinamide100mg Niacinamide100mg Benxyl Alcolhol 2% Benxyl Alcolhol 2% Composition, cont.

6 Theories, at least in theory- Higher Serum Concentrations IV administration of nutrients achieves serum concentrations much higher than those achieved by oral or IM administration E.g. Highest serum dose achieved after oral administration of pharmacological dose of vitamin C is 9.2mg/dL. IV administration of 50 g/day of vitamin C resulted in a mean peak plasma level of 80 mg/dL

7 Pharmacological Effects of Nutrients Various nutrients may exert pharmacological effects only in concentrations achieved through IV administration Eg. Antiviral effect of Vitamin C demonstrated at a concentration of 10-15 mg/dL – a level achieved through IV therapy only

8 Correcting Intracellular Nutrient Deficits Higher intracellular nutrient concentration necessary in some cases to maintain proper cellular function E.g. Magnesium concentration 10 times higher in myocardial cells as compared to extra-cellular concentrations in certain disease conditions cell membrane capacity to maintain high concentrations may be compromised IV administration of Mg may lead to a significant though transient increase in Mg levels

9 Therapeutic Applications of IVMT IVMT has been effective in treating IVMT has been effective in treating ----- Asthma ----- Migraines ----- Fatigue (including chronic fatigue syndrome) ----- Fibromyalgia ----- Acute muscle spasm ---- Upper respiratory tract infections ----- Chronic sinusitis ----- Seasonal allergic rhinitis ----- Cardiovascular disease

10 Asthma IV magnesium can abort acute asthma attacks IV magnesium can abort acute asthma attacks 1. Skobeloff EM, Spivey WH, McNamara RM, Greenspon L. Intravenous magnesium sulfate for the treatment of acute asthma in the emergency department. JAMA 1989;262:1210-1213. 2. Bloch H, Silverman R, Mancherje N, et al. Intravenous magnesium sulfate as an adjunct in the treatment of acute asthma. Chest 1995;107:1576-1581. 3. Ciarallo L, Brousseau D, Reinert S. Higher-dose intravenous magnesium therapy for children with moderate to severe acute asthma. Arch Pediatr Adolesc Med 2000;154:979-983. 4. Ciarallo L, Sauer AH, Shannon MW. Intravenous magnesium therapy for moderate to severe pediatric asthma: results of a randomized, placebo-controlled trial. J Pediatr 1996;129:809-814. 5. Rowe BH, Bretzlaff JA, Bourdon C, et al. Intravenous magnesium sulfate treatment for acute asthma in the emergency department: a systematic review of the literature. Ann Emerg Med 2000;36:181-190.

11 Migraine Beneficial effect of IVMT in treatment of migraine has been demonstrated in some clinical trials 1. 1. Mauskop A, Altura BT, Cracco RQ, Altura BM. Intravenous magnesium sulphate relieves migraine attacks in patients with low serum ionized magnesium levels: a pilot study. Clin Sci 1995;89:633-636. 2. 2. (29.) Demirkaya S, Vural O, Dora B, Topcuoglu MA. Efficacy of intravenous magnesium sulfate in the treatment of acute migraine attacks. Headache 2001;41: 171-177. 3. 3. (30.) Mauskop A, Altura BT, Cracco RQ, Altura BM. Intravenous magnesium sulfate relieves cluster headaches in patients with low serum ionized magnesium levels. Headache 1995;35:597-600.

12 Fatigue Duration of benefit from few days to few months Duration of benefit from few days to few months 1. 1. Manuel y Keenoy B, Moorkens G, Vertommen J, et al. Magnesium status and parameters of the oxidant-antioxidant balance in patients with chronic fatigue: effects of supplementation with magnesium. J Am Coll Nutr 2000;19:374-382 2. 2. Howard JM, Davies S, Hunnisett A. Magnesium and chronic fatigue syndrome. Lancet 1992;340:426. 3. 3. Howard JM, Davies S, Hunnisett A. Magnesium and chronic fatigue syndrome. Lancet 1992;340:426. 4. 4. Clague JE, Edwards RH, Jackson MJ. Intravenous magnesium loading in chronic fatigue syndrome. Lancet 1992;340:124-125 5. 5. Ellis FR, Nasser S. A pilot study of vitamin B12 in the treatment of tiredness. Br J Nutr 1973;30:277-283.

13 What is Fibromyalgia (FMS)? Clinical syndrome of unknown etiology and pathogenesis Clinical syndrome of unknown etiology and pathogenesis Characterized by musculoskeletal pain, non restorative sleep and fatigue, psychiatric, neurological and other symptoms Characterized by musculoskeletal pain, non restorative sleep and fatigue, psychiatric, neurological and other symptoms

14 Epidemiology 3.7 million persons ages 18 older or 2% of the population affected in US 3.7 million persons ages 18 older or 2% of the population affected in US 0.5 -5% of the population affected worldwide 0.5 -5% of the population affected worldwide 4-7 times more common in adult women than men; highest prevalence in women 50-60 years of age 4-7 times more common in adult women than men; highest prevalence in women 50-60 years of age Ethnic, genetic, social and cultural factors may influence FMS predispositionEthnic, genetic, social and cultural factors may influence FMS predisposition

15 Pathophysiology Considered- 4 theories of pathophysiology have emerged: 4 theories of pathophysiology have emerged: Neurogenic (Central Nervous System) Neurogenic (Central Nervous System) --- --- generalized pain --- increase in CSF substance P --- decrease in serum and CSF serotonin --- increased central sensitization

16 Pathophysiology, cont. Muscle Pathology Muscle Pathology --- decreased oxygen tension and blood flow --- abnormal muscle biopsies --- weakness

17 Pathophysiology, cont. Psychopathology Psychopathology --- --- anxiety, depression Immune-mediated disease Immune-mediated disease --- triggered by other infections, such as Lyme disease --- triggered by other infections, such as Lyme disease

18 Clinical Presentation Pain (musculoskeletal tenderness) Lightheadedness, dizziness, syncope Fatigue Chronic insomnia; sleep disturbance Cognitive deficits/short-term memory loss Depression/anxiety Numbness, dysesthesia in hands and feet

19 Diagnosis Based on the 1990 ACR classification guidelines: 1 historical feature + 1 physical finding Historical feature = widespread (axial) pain of 3 months or more Physical finding = pain in at least 3 of the 4 body segments + a finding of at least 11 tender points on digital palpation of 18 designated tender points

20 Tr eatment Patient Education --- reading materials, videos, support groups Physical Exercise --- low-grade (muscle stretches, aerobic conditioning) Pharmacologic Therapies --- tricyclic antidepressants, NSAIDS, topical capsaicin, opioids* *Drug therapies have been used with varying degrees of success in treating fibromyalgia

21 Treatment, cont. Complementary Treatments Complementary Treatments --- Mind body interventions --- Mind body interventions --- Homeopathy --- Homeopathy --- Acupuncture --- Acupuncture --- Nutriceuticals --- Nutriceuticals

22 Practice seeking theory (cart, seeking horse…) Myers cocktail has been a popular alternative treatment for decades Myers cocktail has been a popular alternative treatment for decades No trials for FMS have been published No trials for FMS have been published The anecdotal support is strong The anecdotal support is strong

23 Necessity is the mother of… investigation. Current treatments do not adequately address FMS symptoms in most patients Current treatments do not adequately address FMS symptoms in most patients The apparent promise of the Myers Cocktail (IVMT) called out for testing The apparent promise of the Myers Cocktail (IVMT) called out for testing

24 Tribulations, prior to Trial- Lack of theoretical rationale Lack of theoretical rationale Empirical evidence onlyEmpirical evidence only Toxicity concerns Toxicity concerns Need for IND status Need for IND status

25 First RCT of IVMT for FMS (the alphabet gets a workout!) Study Design Study Design --- Randomized, double blind, placebo controlled trial --- Randomized, double blind, placebo controlled trial Inclusion criteria Inclusion criteria --- Musculoskeletal pain for 3 months --- Musculoskeletal pain for 3 months --- Pain in 11 of 18 tender point sites on digital palpation --- Pain in 11 of 18 tender point sites on digital palpation

26 Methods Methods 40 subjects randomized to treatment or control group 40 subjects randomized to treatment or control group Treatment Treatment 8 weekly treatments performed at one week intervals 8 weekly treatments performed at one week intervals Control Control Placebo / IV saline infusion Placebo / IV saline infusion Assessments Fibromyalgia Impact Questionnaire (FIQ), Beck Depression Index (BDI), Visual Analog Scale (VAS) and Health Status Questionnaire (HSQ 2.0)

27 Evaluation Primary outcome: The Tender Point Index (TPI) Primary outcome: The Tender Point Index (TPI) The severity of pain, assessed by an algometer with a force of 4 Kg, determined by a scoring system ranging from 0 (no reported tenderness) to 4+ (severe pain). The TPI is the composite of scores at 18 tender point sites.The severity of pain, assessed by an algometer with a force of 4 Kg, determined by a scoring system ranging from 0 (no reported tenderness) to 4+ (severe pain). The TPI is the composite of scores at 18 tender point sites. At At baseline (following 2-week run-in period) One-week post intervention period 3-months following the intervention Results are now pending; trial is nearing completion

28 From Practice, to Theory- Theoretical Pathway Theoretical Pathway Predisposing Factor HLA Susceptibility OR Precipitating Factors ( Predisposing Factor HLA Susceptibility OR Precipitating Factors (Trauma/Medical illness) --- 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 Pain of Fibromyalgia Syndrome is due to Muscle Hypoperfusion Induced by Regional Vasomotor Dysregulation. Medical Hypotheses: In press Katz DL et al. The Pain of Fibromyalgia Syndrome is due to Muscle Hypoperfusion Induced by Regional Vasomotor Dysregulation. Medical Hypotheses: In press

29 And Theory to Practice: Arginine Precursor to NO production Vasodilatory influence Ameliorates endothelial function Also: Promotes production of growth hormone. FM patients have an abnormal sleep pattern involving stages 3 and 4 of non REM sleep. As GH is secreted predominantly during stages 3 and 4 of non-REM sleep, it was originally hypothesized that FM patients may have impaired GH secretion

30 Other Nutriceuticals Guai Guai Theory: FMS may be caused by an excess of intracellular phosphate, and possibly oxalic acid, which build up in the cells and depress the formation of energy (ATP) in the cell's mitochondria. Based on biochemical results, guai intake results in elimination of excess phosphate and calcium from the system Dose – Determined by individual response 300 mgm to 3,600 mgm/day 300 mgm to 3,600 mgm/day

31 Other nutriceuticals, cont. Vitamin B3 and B6 Theory: FMS patients may be deficient in serotonin because the tryptophan obtained from food metabolizes into kynurenin rather than to tryptophan and 5-htp. For this reason, 5-htp is likely to be more efficient than L-tryptophan in boosting serotonin. A combination of Vitamin B3 and B6 plus tryptophan and magnesium addresses serotonin deficiency.

32 Other nutriceuticals, cont. Zinc and calcium supplements Zinc and calcium supplements Improves sleep patternsImproves sleep patterns B Complex plus Vitamin C Improvement of overall nutritional status Antioxidants Theory: Inflammatory response creates damage to tissues. Antioxidants minimize the damage. Natural carotenoids (carotenes, lycopenes and others), vitamin A (retinol), bioflavonoids like rutin, hesperidin, quercetin, catechin and the proanthocyanidins (grape seed extract, pine bark extract or pycnogenols)

33 Other nutriceuticals, cont. Malic acid Theory: FMS is the result of local hypoxia to the muscles. Patients with fibromyalgia have low muscle-tissue oxygen pressure in affected muscles. Muscle biopsies from affected areas showed muscle tissue glycolysis is inhibited, reducing ATP synthesis. This stimulates the process of gluconeogenesis, which results in muscle tissue breakdown and mitochondrial damage. Malic acid reverses hypoxia induced inhibition of glycolysis and energy production, possibly improving energy production in fibromyalgia, and reversing the negative effect of the relative hypoxia

34 Conclusions The needs of FMS patients are not fully met at present The needs of FMS patients are not fully met at present CAM / Nutriceuticals show promise CAM / Nutriceuticals show promise Promising results from practice must be tested in trials Promising results from practice must be tested in trials Practice may inform theory; theory may then serve to advance practice Practice may inform theory; theory may then serve to advance practice If a causal pathway for FMS can be established, we can better direct our efforts at breaking the links If a causal pathway for FMS can be established, we can better direct our efforts at breaking the links

35 Conclusions, cont. IVMT appears promising for treatment of FMS sysmptoms; trial results will be available soon IVMT appears promising for treatment of FMS sysmptoms; trial results will be available soon Larger trial is planned for follow-up, to include assessment of mechanism Larger trial is planned for follow-up, to include assessment of mechanism Use of IVMT/Myers Cocktail is justified at present, although still over the line of evidence Use of IVMT/Myers Cocktail is justified at present, although still over the line of evidence Future efforts will need to move further upstream Future efforts will need to move further upstream

36 Conclusions, cont. If promise of IVMT for fibromyalgia is realized, a similar approach to other conditions will be warranted: If promise of IVMT for fibromyalgia is realized, a similar approach to other conditions will be warranted: Delineation of theoretical causal pathwaysDelineation of theoretical causal pathways Controlled testing of interventionsControlled testing of interventions Evidence, not conviction, will best advance the causeEvidence, not conviction, will best advance the cause

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42 Thank you. David L. Katz, MD, MPH, FACPM, FACP Director, Yale Prevention Research Center 130 Division Street Derby, CT 06418 David.katz@yale.edu www.davidkatzmd.com


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