The Dietary Management of Chronic Pain with Medical Foods
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The CDC recently released guidelines regarding the use of opioid medications in the treatment of chronic pain. The CDC recommends that clinicians should consider nonpharmacologic therapies like medical foods as a first line therapy to safely and effectively treat chronic pain.
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The Dietary Management of Chronic Pain with Medical Foods
- 1. 1www.tmedpharma.com The Dietary Management of Chronic Pain Presented By: Marcus Charuvastra Vice President of Marketing Targeted Medical Pharma, Inc.
- 2. 2www.tmedpharma.com • 100 Million Americans Affected • Almost 35% of the US Population • $635 Billion a Year in Costs • By 2029, 20% of the US Population will be 65 Years or Older The Epidemic of Chronic Pain in America
- 3. Persistent Pain Lasting Longer than 12 weeks www.tmedpharma.com 3 Defining Chronic Pain A Disease of the Nervous System A Maladaptive Physiologic Response
- 4. 4www.tmedpharma.com Low Back Pain Migraine Pain Neck Pain Facial Pain Arthritic Pain Neuropathic Pain Idiopathic Pain Most Common Types of Chronic Pain
- 5. 5www.tmedpharma.com Most Common Drug Classes for Chronic Pain Drug Class Example Adverse Side Effects NSAIDs Ibuprofen, naproxen, meloxicam GI Bleed, Heart Attack, Stroke, Renal Toxicity Narcotics hydrocodone, oxycodone, fentanyl Addiction, Constipation, Drowsiness Anticonvulsants Gabapentin, Lyrica, Topamax Clumsiness, Restlessness, Trouble Breathing, Depression SSRI (Tricyclics) Nortriptyline, Amitriptyline Blurred Vision, Constipation, Weight Gain, Increased HR SNRI Effexor, Cymbalta Headache, Drowsiness, Loss of Appetite, Agitation
- 6. • Altered Protein Metabolism • Increased Amino Acid Turnover 1 • Increased Neurotransmitter Turnover • Impaired GI Motility • Nutritional Deficiencies • Altered Central Nervous System Function 6www.tmedpharma.com 1. Shell, et al. American Journal of Therapeutics; 2012 108-114 ; Theramine ibuprofen trial 2010, Unpublished. Physiologic Impact of Chronic Pain
- 7. 7www.tmedpharma.com Chronic Pain Changes Brain Function and Chemistry • Chronic Back Pain Impacts the Cortex and Thalamus • Gray Matter Atrophy Caused by CBP is 5-11% per Year Compared to 0.5% in the Normal Aging Process • CBP Atrophy is Equivalent to 10-20 Years of Aging* * Apkarian AV et al. J Neurosci. 2004;24:10410-10415 ©2004 by Society for Neuroscience
- 8. 8www.tmedpharma.com Chronic Back Pain Altering Amino Acid Metabolism 0 5 10 15 20 25 30 35 Arginine Serine Histidine Tryptophan mg%ofProtein CBP Change in Blood Concentration of Amino Acids2 Day 1 Day 28 Normal N=25 Patients with chronic pain syndromes have documented deficiencies of certain amino acids.1 Patients with chronic low back pain commonly present with lower levels of the amino acids required for producing pain modulating neurotransmitters compared to healthy subjects. 2 1. Russell IJ, Michalek JE, Vipraio GA, Fletcher EM, Wall K. Serum amino acids in fibrositis/fibromyalgia syndrome. J Rheumatol Suppl 1989;19:158-163 2. Shell, et al., “A Double-Blind Controlled Trial of a Single Dose Ibuprofen and an Amino Acid Medical Food Theramine for the Treatment of Low Back Pain; Publication pending, 2010.
- 9. 9www.tmedpharma.com Expanding and Augmenting Chronic Pain Treatments with Medical Foods Medical Foods work through a different pathway from drugs, addressing the distinct physiologic and metabolic needs of chronic pain. Manipulation vs. Creation
- 10. 10www.tmedpharma.com Nutritional Requirements of Pain Syndromes The altered metabolic processes associated with pain syndromes require additional amounts of 1-2 : • Arginine Nitric Oxide • Choline Acetylcholine • GABA GABA • Glutamine Glutamate, GABA, Glutathione • Histidine Histamine • Tryptophan Serotonin • Serine d-Serine 1. Wurtman RJ. Nutrients affecting brain composition and behavior. Integr Psychiatry 1987;5:226-238. 2. Russell IJ, Michalek JE, Vipraio GA, Fletcher EM, Wall K. Serum amino acids in fibrositis/fibromyalgia syndrome. J Rheumatol Suppl 1989;19:158-163.
- 11. 11www.tmedpharma.com Amino Acid Concentrations Affect the Ability of the Nervous System to Regulate Pain Choline Acetylcholine Potentiates NO and Serotonin Inhibits NMDA receptor activity Tryptophan 5-HTP Serotonin Inhibits Substance P and NMDA receptor activity Decreases Pain Signals in CNS Serine d-Serine Regulates NMDA receptor activity Sensitizes opioid receptors Arginine Nitric Oxide Inhibits afferent pain signals in CNS Vasodilator and opioid activator Histidine Histamine Stimulates production of glucocorticoids Modulates inflammation GABA GABA Inhibits NMDA receptor activity Dampens Pain Signals
- 12. 12www.tmedpharma.com Medical Foods for the Dietary Management of Pain and Osteoarthritis Product NAME Manufacturer Indication Theramine® Targeted Medical Pharma Clinical Dietary Management of Pain Disorders and Inflammatory Conditions Limbrel® Primus Pharmaceuticals Clinical Dietary Management of the Metabolic Processes of Osteoarthritis Trepadone® Targeted Medical Pharma Clinical Dietary management of the altered metabolic processes associated with pain and inflammation related to joint disorders. (JD) Percura™ Targeted Medical Pharma Clinical dietary management of the altered metabolic processes associated with pain, inflammation and loss of sensation due to peripheral neuropathy.
- 13. 13www.tmedpharma.com Theramine® for the dietary management of pain disorders and inflammatory conditions “Naproxen and an Amino Acid Medical Food Theramine for the Treatment of Low Back Pain” American Journal of Therapeutics 2010. Double-blind, multicenter, randomized 3 arm trial conducted at independent facilities in the USA with 129 subjects over 28 days. 44% reduction in back pain over 28 days. 65% reduction in back pain when combined with low dose naproxen 17% reduction in CRP “Reduction in Pain and Inflammation Associated with Chronic Low Back Pain with the use of the Medical Food Theramine” American Journal of Therapeutics 2014. Double-blind, multicenter, randomized 3 arm trial conducted at independent facilities in the USA with 122 subjects over 28 days. 41% reduction in back pain over 28 days. 62% reduction in back pain when combined with low dose ibuprofen 24% reduction in IL-6
- 14. 14www.tmedpharma.com Limbrel® for the clinical dietary management of the metabolic processes of osteoarthritis “Safety, efficacy and acceptability of flavocoxid (Limbrel®) compared with naproxen in subjects with osteoarthritis of the knee: A Pilot Study” Osteoarthritis and Cartilage Vol. 15. Double-blind randomized trial conducted at facilities in Russia with 103 subjects for 30 days. Significant reduction in the signs and symptoms of knee OA. Equivalent efficacy to 500mg naproxen in controlling the signs and symptoms of OA “ Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee.” Advances in Therapy, 2010. Double-blind, multicenter randomized trial conducted at independent facilities in the USA with 220 subjects for 12 weeks. 90% of subjects responded positively Equivalent efficacy to 500mg naproxen, with far fewer UGI and renal AEs
- 15. 15www.tmedpharma.com Comprehensive Pain Management with Medical Foods Reduce: Adjunct Therapy Poly-pharmacy, drug dose, and treatment duration Replace: Standalone Therapy Ineffective or dangerous drugs Restore: Amino acid, nutrient and neurotransmitter levels, minimizing co-morbidities of chronic pain
- 16. 16www.tmedpharma.com Medical Foods as an Adjunct to Low Dose Analgesics 2.95 -44 -65 -80 -60 -40 -20 0 20 Percent(%) Reduction of Pain – Roland Morris Index Naproxen Theramine Both p<0.05 n=126 0.73 -50.3 -63.1-70 -60 -50 -40 -30 -20 -10 0 10 Percent(%) Reduction of Pain - Roland-Morris Index Ibuprofen n = 43 Theramine n = 41 Combination n = 38 p<0.01 Optimize Drug Dosages Minimize Attenuation Reduce Harmful Side Effects Improve Clinical Outcomes
- 17. 17www.tmedpharma.com Benefits to Providers and Pharmacists •Generally Recognized as Safe Ingredients •Most Side Effects Comparable to Placebo •FDA Regulation and Oversight •Non-Addictive Safety Profile •Supported by Multiple Double Blind Efficacy Studies •Individual Ingredient Efficacy •Fills the Treatment Gap that Drugs Cannot •Replacement/Adjuct Therapy for High Risk Narcotics & NSAIDs Efficacy Profile •Encapsulated for Easy Use •Improved Tolerability •No Serious Side Effects Adherence and Compliance
- 18. 18www.tmedpharma.com Benefits to Patients and Caregivers •Comparable to and More Effective than NSAIDs •Compliment to or Replacement for Narcotic Analgesics, SSRI, SNRI •Reduces Pain and Inflammation Alternative Therapy •Non-Addictive •Non-Sedative •Addresses Underlying Metabolic Demands of Pain Disorders Natural Therapy •Physician Oversight •No Serious Side Effects •Over 15 years of Professional Clinical Use Safe & Effective
- 19. 19www.tmedpharma.com Understanding the Market Potential 30 billion OTC tablets sold annually in the USA 70 million annual NSAID prescriptions in the USA 127 Million annual narcotic prescriptions in the USA 100 million Americans with from chronic pain 27 Million people with OA in USA 76 Million Baby Boomers in the USA 16,500 NSAID Related Deaths Annually 16,651 Deaths Due to Rx Narcotics in 2010 Patients 65 and older should not take NSAIDs
- 20. 20www.tmedpharma.com The Future of Pain Management • Pain • Inflammation • Co-morbidities • Poly-pharmacy • NSAIDs Reduce • Amino Acids and Neurotransmitters depleted by disease • Dangerous and Addictive Drugs • Ineffective Therapies Replace • Nervous System Function • Pain Control • Daily Function • Homeostasis Restore
- 21. 21www.tmedpharma.com E-MAIL: info@tmedpharma.com PHONE: (844) 474-3111 For More Information
Editor's Notes
- Lynette Add Notes Here Common drugs do not address many of these issues and can exacerbate them.
- Affect of Chronic Back Pain Pain on Brain Morphology. Given that normal whole-brain gray matter atrophy is 0.5% per year of aging and that atrophy caused by CBP is 5–11%, the magnitude of brain gray matter atrophy caused by CBP is equivalent to 10 –20 years of aging. However, this analogy only holds for the overall magnitude, because the regional specificity of atrophy in CBP is distinct from that seen with aging Patients with CBP showed 5-11% less neocortical gray matter volume than control subjects. The magnitude of this decrease is equivalent to the gray matter volume lost in 10-20 years of normal aging. The decreased volume was related to pain duration, indicating a 1.3 cm3 loss of gray matter for every year of chronic pain. CBP is accompanied by brain atrophy and suggests that the pathophysiology of chronic pain includes thalamocortical processes.
- Data from a double blind , multicenter study published in the American Journal of Therapeutics indicates the relationship between CBP and amino acid deficiency.
- Drugs treat the symptoms of pain and do not address the underlying physiologic, metabolic and cellular changes that result from chronic pain. In many cases drugs can exacerbate the symptoms of a disease by depleting neurotransmitters and their receptors. Ex. Benzodiazapines Ex. SSRI depleting serotonin without replacing tryptophan Medical Foods provide the nervous system with the cellular tools/fuel it needs to mitigate pain and inflammatory signals
- Example Continued: Decrease in Choline means decreased parasympathetic autonomic nervous system activity due to pain disorder. Decrease in choline causes increased creatine phosphokinase and alanine transaminase, and must be addressed. Administration of choline increases production of acetylcholine which reduces transmission of pain signals and inhibits proinflammatory cytokines and substance P release without noxious side effects related to harmful drugs
- Nociception or pain signaling are propagated and mitigated by a series of chemical and electrical processes involving amino acids, nutrients and neurotransmitters. Amino acid deficiencies in Chronic pain patients can lead to complex pain conditions such as hyperalgisia and allodynia. Because the nervous system is using the same amino acids and neurotransmitters to operate multiple systems, patients with chronic pain often suffer from other co-morbiditiess such as sleep disorders and depression.
- In addition to a variety of open label and post market studies Theramine has been the subject of 2 double blind studies.
- In addition to a variety of open label and post market studies Theramine has been the subject of 2 double blind studies.
- The risk of adverse events increases with the number of medications prescribed, and the number of medications prescribed increases with age.
- In multiple clinical trials the co-administration of a low dose drug and a medical food have proven to be effective at treating symptoms and improving clinical outcomes without dangerous side effects.
- Providers and pharmacists have a natural, clinically effective tool that they can educate patients about. A medication that works as a standalone and as an adjunct therapy. A complimentary therapy that helps manage a disease without harmful side effects. Since many side effects are dose dependent, MF can help a provider have flexibility in his/her dosing of a drug.
- Addressing the distinct nutritional requirements of a patient suffering from chronic pain is a vital part of COMPREHENSIVE pain mgmt. Offering patients a non-sedative, non-addictive pain management option that can be an adjunct to current pain regimes or used as a standalone medication is often well received. Offer pateints better or comparable efficacy without the dangerous side effects.
- 70 million prescriptions and more than 30 billion over-the counter tablets sold annually in the United States alone 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone. The figures of all NSAID users would be overwhelming, yet the scope of this problem is generally under-appreciated.”