0 Dietary Management of Disease & Chronic Pain: A New Frontier
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Dynamic Chiropractic – April 1, 2023, Vol. 41, Issue 04

Dietary Management of Disease & Chronic Pain: A New Frontier

How Encapsulated "Medical Foods" Can Make a Difference

By Michael Sinel, MD and Daniel C. Mizzi, RPh, PharmD

Medical foods are an FDA-regulated category between pharmaceuticals and supplements utilizing targeted nutrition to treat diseases and conditions with GRAS (generally recognized as safe) ingredients.1-4 Supplements are intended for the nutritional support and maintenance of good health in healthy patients and are unable to make disease claims; whereas medical foods can make claims regarding the dietary management of specific diseases and symptoms.

Pharmaceutical medications and medical foods are similar in that they both must have scientific evidence to substantiate their efficacy and disease claims.1-4 However, because all the ingredients in medical foods are GRAS, they do not require pre-market FDA safety approval and do not require a prescription.

Furthermore, medical foods are known to be extremely safe compared to the common side effects and drug interactions associated with pharmaceuticals.

Medical foods are defined by the FDA Orphan Drug Act (1988) as foods specifically formulated and intended for the specific dietary management of a disease or condition, for which distinctive nutritional requirements based on recognized scientific principles are established by medical evaluation. Medical foods are consumed or administered enterally and require physician supervision, as well as current good manufacturing practices (cGMP).1-4

Potential Uses and Therapeutic Benefits in Chiropractic Practice

Several encapsulated medical foods have strong human clinical data, including published double-blind studies against common nonsteroidal anti-inflammatory drugs (NSAIDs). They have demonstrated use as both standalone products and as adjuncts with pharmaceutical medication, often allowing much lower dosing (and thereby considerably reducing side effects).

Encapsulated medical foods are now available to treat many of the most common symptoms seen in a chiropractic practice, including chronic pain and inflammation, sleep disorders, neuropathy, obesity, fatigue, and cognitive decline.

The increased metabolic demands associated with these chronic conditions result in a relative deficiency of amino acids and neurotransmitters, which can be addressed utilizing encapsulated medical foods. This targeted nutritional approach to disease offers practitioners an opportunity to bridge the gap between dietary supplements and pharmaceuticals with a safe, medically validated, nutrient-based tool.

This opportunity to enhance natural healing should complement all chiropractic treatment modalities, improving overall patient care.

Chronic Pain: Definition, Demographics, Economic Burden

Chronic pain is defined as pain that persists or recurs for more than three months and is responsible for widespread suffering. It is estimated to affect more than 30% of people worldwide, with a much greater prevalence seen in the elderly (up to 83% of elderly in nursing-home facilities).5-10

However, unlike acute / subacute pain, which have a biological value by protecting us from further bodily harm, chronic pain has no biological value and persists even after the injury / illness that triggered it has healed or gone away.8-12

Additionally, chronic pain is responsible for enormous health care expenditures and loss of productivity which are more than the annual costs of cancer ($243 billion) and heart disease ($309 billion) combined (annual costs of pain in the United States estimated to be 635 billion USD/year).9-10, 13-14

The Limitations / Dangers of Traditional Analgesics

Commonly, traditional analgesic medications such as nonsteroidal anti-inflammatory drugs (NSAIDs), opioids and acetaminophen are administered to patients with chronic pain as part of their treatment regimen to optimize functionality by reducing pain and discomfort.

However, these medications have significant therapeutic limitations, especially when utilized long-term because of risks for adverse side effects / events and the potential for drug interactions (especially due to polypharmacy in the elderly).

NSAIDs are known to cause significant gastrointestinal (GI), cardiovascular and renal toxicity including increasing the risk of bleeds (GI / intercranial), especially when combined with blood thinners or newer-generation antidepressants.15-21 NSAIDS also contribute to more than 100,000 hospitalizations for GI complications and at least 16,500 NSAID-related deaths each year in the U.S.22-23

In fact, as a consequence of NSAIDs' well-established side effects, the American Geriatric Society recommends great caution and only supports their use for short periods of time in the elderly (>65 years old).24 Furthermore, new research also suggests NSAIDs may actually delay recovery and contribute to the development of chronic pain.25-26

Opioids are associated with the development of dependence (misuse / abuse), rapid tolerance to their analgesic effects, respiratory depression, constipation, sexual dysfunction, myocardial infarction, and overdose / death; and increase the risk of falls / fractures due to sedation, orthostatic hypotension and dizziness (especially in the elderly).27-28

Paradoxally, opioids may also cause "hyperalgesia" (increase in the perception of pain) in some patients, rather than providing an antinociceptive effect.29

Sadly, the use of prescription opioid medications for chronic pain has contributed greatly to the current "opioid crisis," which has led to countless deaths, numerous opioid-related hospitalizations, devastated families and hundreds of billions of dollars in economic burden.30-32

Acetaminophen, despite being widely regarded as one of the safest pain drug choices in patients with cardiovascular disease and a first-line pain management drug for the elderly, is also the most common cause of acute liver failure and liver transplant in the United States, and the second most common cause of liver transplant worldwide.33-37

In addition, a recent meta-analysis found that acetaminophen was ineffective in the treatment of low back pain and provided only minimal short-term benefit for people with osteoarthritis.38

Based on all the above, finding safe and cost-effective approaches for the treatment of chronic pain is not only a medical necessity and challenge, but also an economic requirement.

"Medical Foods" for Chronic Pain: Effectiveness and Rationale

Two double-blind clinical trials compared a medical food to ibuprofen and naproxen as dietary management of chronic pain and inflammation in patients with chronic low back pain. The research showed that the medical food significantly reduced pain and inflammation when utilized as a stand-alone therapy or in combination with a low-dose NSAID.39-40

The rationale behind addressing pain and inflammatory conditions surrounds the understanding that patients with chronic pain syndromes have increased nutritional requirements and deficiencies in certain amino acids like tryptophan, choline, GABA, L-serine, L-arginine and L-histidine that are precursors for the neurotransmitters (i.e. serotonin, acetylcholine, GABA, D-serine, nitric oxide and brain histamine) that help dampen pain and also help reduce inflammation.39-40

This provides practitioners with a clinically proven, nutrient-based intervention that is a safe and cost-effective alternative / complement to traditional analgesics.

References

  1. Isaacson R. "Medical Foods: Overview of an Emerging Science." http://targetedmedicalpharma.com/docs/Medical-Foods-by-issacson.pdf
  2. Li S, et al. Medical foods in USA at a glance. J Future Foods, Dec 2021;1(2): 141-145.
  3. Guidance for Industry: Frequently Asked Questions about Medical Foods; Second Edition. U.S. Department of Health and Human Services Food and Drug Administration Center for Food Safety and Applied Nutrition, May 2016.
  4. Klein GL, et al. Medical foods: a distinct class of therapeutic agents. J Clin Trials, 2012;2(3).
  5. "IASP Announces Revised Definition of Pain." International Association for the Study of Pain, 16 July 2020.
  6. International Classification of Diseases 11th Revision. World Health Organization.
  7. Treede R-D, et al. Chronic pain as a symptom or a disease: the IASP classification of chronic pain for the International Classification of Diseases (ICD-11). Pain, January 2019;160(1):19-27.
  8. Nicholas M, et al. The IASP classification of chronic pain for ICD-11: chronic primary pain. Pain, January 2019;160(1):28-37.
  9. Cohen SP, et al. Chronic pain: an update on burden, best practices, and new advances. Lancet, 2021 May 29; 397(10289):2082-2097.
  10. Cravello L, et al. Chronic pain in the elderly with cognitive decline: a narrative review. Pain Therapy, 2019;8:53-65.
  11. Acute Pain. International Association for the Study of Pain.
  12. Acute vs. Chronic Pain. Cleveland Clinic.
  13. Pitcher MH, et al. Prevalence and profile of high-impact chronic pain in the United States. J Pain, 2019 Feb;20(2):146-160.
  14. Gaskin DJ, Richard P. The economic costs of pain in the United States. J Pain, 2012 Aug; 13(8):715-24.
  15. Varga Z, et al. Cardiovascular risk of nonsteroidal anti-inflammatory drugs: an under-recognized public health issue. Cureus, 2017 Apr;9(4):e1144.
  16. "NSAIDs: How Dangerous Are They for Your Heart?" Harvard Health Publishing, Jan. 7, 2019.
  17. Sostres C, et al. Nonsteroidal anti-inflammatory drugs and upper and lower gastrointestinal mucosal damage. Arthr Res Ther, 2013;15(Suppl 3):S3.
  18. Hsu C-C, et al. Use of nonsteroidal anti-inflammatory drugs and risk of chronic kidney disease in subjects with hypertension. Hypertension, 2015;66:524-533.
  19. "Bad Mix: Blood Thinners and NSAIDs." Harvard Health Publishing. Dec. 16, 2019
  20. Hou P-C, et al. Risk of intracranial hemorrhage with concomitant use of antidepressants and nonsteroidal anti-inflammatory drugs: a nested case-control study. Ann Pharmacother, 2021 Aug; 55(8):941-948.
  21. Islam MM, et al. Risk of hemorrhagic stroke in patients exposed to nonsteroidal anti-inflammatory drugs: a meta-analysis of observational studies. Neuroepidemiol, 2018;51:166-176.
  22. "Ask the Expert: Do NSAIDs Cause More Deaths Than Opioids?"Pract Pain Manag, 2013;13(10).
  23. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med, 1998 Jul 27;105(1B):31S-38S.
  24. Ali A, et al. Managing chronic pain in the elderly: an overview of the recent therapeutic advancements. Cureus, 2018 Sep;10(9):e3293.
  25. McGill University. "New Side Effects of Popular Medicines Discovered: Anti-Inflammatory Drugs Could Cause Chronic Pain." SciTechDaily, June 8, 2022.
  26. Cariz J. "Anti-inflammatory Medications Raise Risk of Chronic Back Pain in Patients." American Association for the Advancement of Science, May 12, 2022.
  27. Chou R, et al. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Int Med, 17 Feb 2015.
  28. Dumas EO, Pollack DM. Opioid tolerance development: a pharmacokinetic/pharmacodynamic perspective. AAPS J, 2008 Dec;10(4):537.
  29. Lee M, et al. A comprehensive review of opioid-induced hyperalgesia. Pain Physician, 2011 Mar-Apr;14(2):145-61.
  30. Vadivelu N, et al. The opioid crisis: a comprehensive overview. Curr Pain Headache Rep, 2018;22:16.
  31. McCarthy N. "The Financial Cost of America's Opioid Crisis." Statista, Oct. 21, 2019.
  32. Opioid Facts and Statistics. U.S. Department of Health and Human Services.
  33. Caparrotta TM, et al. Are some people at increased risk of paracetamol-induced liver injury? A critical review of the literature. Eur J Clin Pharmacol, 2018;74(2):147-160.
  34. Tittarelli R, et al. Hepatotoxicity of paracetamol and related fatalities. Eur Rev Med Pharmacol Sci, 2017;21(1 Suppl):95-101.
  35. Rose VL. "Guidelines from the American Geriatric Society Target Management of Chronic Pain in Older Persons." Guidelines published in Am Fam Physician, 1998;58(5):1213-1215.
  36. Watson KE. "Regular Acetaminophen Use Might Increase Blood Pressure in Hypertensive Patients." NEJM Journal Watch, March 9, 2022.
  37. MacIntyre IM, et al. Regular acetaminophen use and blood pressure in people with hypertension: The PATH-BP trial. Circulation, 2022 Feb 8;145:416.
  38. Machado GC, et al. Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials. BMJ, 2015 Mar 31;350:h1225.
  39. Shell WE, et al. Reduction in pain and inflammation associated with chronic low back pain with the use of the medical food Theramine. Am J Ther, Nov/Dec 2016;23(6):e1353-e1362.
  40. Shell WE, et al. A double-blind controlled trial of a single dose naproxen and an amino acid medical food Theramine for the treatment of low back pain. Am J Ther, 2012;19:108-114.
  41. Shell WE, Charuvastra E. Composition and Method to Augment and Sustain Neurotransmitter Production (patent). https://patents.google.com/patent/US20070160690A1/en

Dr. Michael Sinel graduated from State University New York at Downstate Medical Center (MD degree); completed his residency at Cornell University Medical Center & Memorial Sloan Kettering in New York; and served as director of outpatient physical medicine at Cedars Sinai Medical Center. As an assistant clinical professor at the UCLA School of Medicine, he was also privileged to work closely with chiropractors, and owned several medical / chiropractic integrative clinics. The owner of Physician Therapeutics (https://www.medicalfoods.com), Dr. Sinel is passionate about reducing the side effects of pharmaceuticals by bringing safe, scientifically proven encapsulated medical foods as natural alternatives for pain, sleep, obesity, neuropathy, fatigue and cognitive decline.

Daniel C. Mizzi is a clinical pharmacist with hospital, alternate site care, and industry (pharmaceutical and medical food) experience who enjoys sharing his clinical knowledge to help optimize patient outcomes and minimize medical misadventures. He is a graduate of State University of New York (SUNY) at Buffalo College of Pharmacy (BS in Pharmacy) and the Massachusetts College of Pharmacy and Allied Health (Doctor of Pharmacy). Daniel is the international project manager and provides medical information support for Physician Therapeutics.

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