Amino Acids, Neurotransmitters and Pain Relief

Chronic pain is a complex condition that can change the way your body works. The natural chemicals (neurotransmitters) that your nervous system depends on to help manage pain and inflammation are in high demand, so making sure you have enough of them available is vital for proper relief.

Did you Know?

Amino acids and nutrients are the building blocks of  the neurotransmitters your nervous system uses to reduce the volume and frequency of pain and inflammatory signals. Addressing amino acid depletion with medical foods is a safe and easy way to restore the foundation of your nervous system’s health and an important part of any comprehensive pain management program.

Everyday Medications that Increase the Risk of Heart Attack

Data out of Stanford University suggest that Proton Pump Inhibitors (PPI’s) such as Prilosec, Prevacid, and Nexium are associated with a higher risk of heart attack.  Published in the journal PLOS One online, researchers looked over 2.9 million patients over a several year period to determine if patients who took PPI’s for gastro esophageal reflux had an increased risk for myocardial infarction than patients who did not.  Concern was raised when scientists discovered that PPI’s potentially reduced the antiplatelet effect of clopidogrel, a drug use to prevent clotting after a heart attack or stroke.  The clopidogrel is used after heart attack to prevent clotting which could lead another heart attack.  They were concerned that if heart attack was raised in this population, it could extend to lower risk patients.

The study showed that patients taking PPI’s had a 16% increased risk of heart attack.  H2 Blockers, such as Zantac and Pepcid were not associated with an increase risk.  Perhaps more importantly, the risk was not just associated with high risk categories such as having had a previous heart attack, the elderly or taking clopidogrel.  It was applicable to all ages and risk groups.

The study has several limitations including the attempt to look back at charts and determine what medications are being taken.  Often patients will take over the counter PPI’s and may not be accurately reporting it to their physician.  Also, retrospective analyses like this are subject to certain biases and are not as valuable as preplanned double-blind clinical trials.  However, the large number of patients reviewed does give the study significant credence.

PPI’s are one the most commonly used medications in the United States and around the world, with over 113 million prescriptions filled globally each year.  PPI’s are used to treat stomach and intestinal ulcers and heartburn, as well as to prevent gastrointestinal bleeding from NSAID’s in higher risk populations.  NSAID’s have been associated with a number of serious complications in addition to bleeding ulcers including kidney and liver issues, fluid retention with swelling in the legs, elevated blood pressure and possibly increasing the risk of heart attack.

Medications that are often used to treat or prevent the side effects of another medication create a potentially vicious cycle for patients who will ultimately end up taking more and more medications to manage an illness. The risk of adverse events increases with the number of medications prescribed, and the number of medications prescribed increases with age.

The avoidance of polypharmacy and therefore reducing the risk of dangerous medication side effects is crucial for patients and providers.  Alternative therapies, such as FDA regulated medical foods, which by definition must be on the FDA GRAS list (generally recognized as safe), may have similar efficacy to standard pharmaceuticals but without the side effects. Understanding the risks and benefits of medications is an important part of being a patient and a healthcare provider. Exploring the medication options that may be better tolerated is something every patient and physician should do.

 

Is Your OTC Pain Reliever Going to Kill You?

Although acetaminophen (Tylenol) is heavily marketed for its safety, FDA recommends health care professionals to discontinue prescribing and dispensing drug products with more than 325 mg of acetaminophen due to the high risk of liver injury.  Severe liver injury may occur in patients who:

  • Took more than the prescribed dose of an acetaminophen containing product in a 24 hour period.
  • Took more than one acetaminophen containing product at the same time.
  • Drank alcohol while taking acetaminophen products.

Acetaminophen is widely used as an over the counter pain reliever and fever medication and is often combined with other ingredients such as cough and cold ingredients.  Patients may be unaware that many products (both prescription and OTC) may contain acetaminophen, making it easy to accidentally take too much [1-5]. In fact,  acetaminophen poisoning accounts for approximately one-half of all cases of acute liver failure in the United States and Great Britain[16].

Ibuprofen (Motrin, Advil) is also widely used for pain and inflammation but not without risk.  Ibuprofen carries a black box warning from the FDA regarding the cardiovascular and gastrointestinal risks associated with its use.  Patients taking ibuprofen have an increased risk of serious cardiovascular thrombotic events including myocardial infarction and stroke. Researchers in Denmark observed a nearly threefold increase in the number of deaths from gastrointestinal bleeding within one year of ibuprofen prescription [14].  The risk of side effects is so high for elderly patients the American Geriatrics Society has recommended that patients over the age of 65 avoid NSAID use if at all possible [6-10].  This real risk was studied by RE Tarone who noted a marked rise in baseline rate of gastrointestinal bleed with advancing age with the large majority of cases occurring among persons age 65 or older.  The average relative increase in risk of gastrointestinal bleeding was found to be fourfold or slightly higher in NSAID users and six fold or higher at heavy prescription levels [15].

NSAID High Risk Groups

Medications such as Tylenol and ibuprofen, which are readily available over-the-counter, are perceived to be safe medications; but research has proven that they are not without risk.  Physicians, payers and patients are requesting a safe more effective alternative to treat pain which becomes increasingly important as the population ages.

Medical foods such as Theramine treat the dietary deficiencies that are associated with pain and inflammation.  Pain reduction is accomplished by moderating responsiveness to noxious stimuli, regulating the transmission of pain signals and controlling inflammation. The use of medical foods has been long standing and there have been no reports of GI bleed in over 10 years on the market.

Two multi-center double-blind clinical trials established the safety and efficacy of Theramine in the treatment of chronic back pain.  In a clinical study comparing the medical food Theramine and a non-steroidal anti-inflammatory medication, Theramine was shown to be more effective than low dose NSAIDs in treating low back pain.  Clinical data indicate significant reduction in back pain with the administration of Theramine alone, while administration of a low dose NSAID had no appreciable effect on pain.

An important observation by researchers EL Fosbol and L Kober note that, “Individual NSAIDs have different cardiovascular safety that needs to be considered when choosing appropriate treatment.  In particular, rofecoxib and diclofenac were associated with increased cardiovascular mortality and morbidity and should be used with caution in most individuals.  This notion is also valid for healthy individuals and underlines the importance of critical use of NSAID therapy in the general population and also that over-the-counter retail of NSAIDs should be reassessed.”[13]

 

REFERENCES

 

1.  Wolf M; King J; Jacobson K; et al “Risk of Unintentional Overdose with Non-prescription Acetaminophen Products”  J Gen Intern Med 2012 Dec; 27(12): 1587-1593

2.  “Acetaminophen Toxicity in Children” Pediatrics vol. 108 No. 4 Oct. 1 2001

3.  Farrell S; Tarabar A; et al “Acetaminophen Toxicity” Medscape June 24, 2011

4.  Plaisance K “Toxicities of Drugs Used in the Management of Fever” Clinical Infectious Diseases 2000 31 Supp 5: S219-S223

5.http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm

6.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm085282.htm

7.  Pilotto A; Franceschi M; Leandro G; Di Mario F; “NSAID and aspirin use by the elderly in general practice:  effect on gastrointestinal symptoms and therapies:  Drugs Aging 2003; 20(9): 701-10.

8.  Smith SG “Dangers of Non-steroidal Anti-inflammatory drugs in the elderly” Can Fam Physician vol. 35 March 1989

9.  American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults

10.  Gurwitz JH; Everitt DE; Monane M; Glynn RJ, Choodnovskiy I; Beaudet MP; Avorn J; “The impact of ibuprofen on the efficacy of antihypertensive treatment with  hydrochlorothiazide in elderly persons” J Gerontol A Biol Sci Med Sci 1996 Mar; 51 (2): M74-9

11.  Shell WE; Charuvastra E; DeWood M; May L; Bullias D; Silver D “ 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 of Ther 2010

12.  Shell WE; Pavlik S; Roth B; Silver M; Breitstein M; May L; Silver D “ Reduction in pain and inflammation associated with chronic low back pain with the use of the medical food Theramine”  Amer J of Ther 2014

13.  Fosbol EL; Kober L; Torp-Pedersen C; Gialason GH “ Cardiovascular safety of non-steroidal anti-inflammatory drugs among healthy individuals”  Expert Opin Drug Saf 2010 Nov; 9(6): 893-903

14.  Lipworth L; Friis S; Blot Wj; McLaughlin JK; Mellemkjaer L; Johnsen SP; Norgaard B Olsen JH “ A population based cohort study of mortality among users of ibuprofen in Denmark”  Am J Ther 2004 May-Jun; 11(3): 156-63

15.  Tarone RE; Blot WJ; McLaughlin JK “Nonselective non-aspirin non-steroidal anti-inflammatory drugs and gastrointestinal bleeding:  relative and absolute risk estimates from recent epidemiologic studies”  Am J Ther 2004 Jan-Feb; 11(1): 17-25

Safer Options for Pain Management

Pain is complex and there are several treatment options to choose from depending on the type of pain you are experiencing including medications, therapies and mind-body techniques.  The most common treatment consists of analgesics:  narcotic (opioid) and non-narcotic (non-opioid) analgesics.

Narcotics vs NSAIDS
Primary Differences Between Narcotics and NSAIDs

Narcotic analgesics are derived from or related to opium.  Opioids bind to opioid receptors which are present in many regions of the nervous system and are involved in pain signaling and control.  Opioid analgesics relieve pain by acting directly on the central nervous system.  They block incoming pain signals but also work in other parts of the brain, modulating pain receptors in the nervous system, primarily located in the brain and the spinal cord.

Non-opioid analgesics or NSAIDs work by blocking the production of prostaglandins by inhibiting the cyclooxygenase enzyme and therefore decreasing the formation of pain mediators in the peripheral nervous system.   Non-opioids work more directly on injured or inflamed body tissue. In a basic sense, opioids decrease the brain’s awareness of the pain whereas the non-opioids affect some of the chemical changes that normally take place wherever body tissues are injured or inflamed.

Although non-opioids are often preferred for certain types of chronic pain, they have two serious drawbacks.  The first is the ceiling effect; Non-opioids have an upper limit of pain relief that can be achieved.  Once the upper limit is achieved; increasing the dosage will not provide any further pain relief but may exacerbate side effects.  Opioids on the other hand tend not to have a ceiling.  The more you take, the more pain relief you will get.  The second major drawback of non-opioids is the side effects profile.  The side effects of NSAIDS make it impossible for certain patient populations to use NSAIDs such as those with history of peptic ulcer disease, cardiovascular disease and the elderly. In 2014, the American Academy of Neurology determined that the risks of opioids outweigh the benefits for certain chronic pain conditions.

Treatment of pain with the use of medical foods gives patients a safer option for pain management by approaching pain from a new perspective.  Medical foods treat the nutritional deficiencies that are found in patients with acute and chronic pain.  By restoring an optimal balance between the chemicals in the body, substances called neurotransmitters, that are responsible for transmitting and dampening pain signals, one can better manage pain.

Research has found low levels of the amino acids gluatamate, tryptophan, arginine, serine, and histidine in patients with chronic and acute pain.  The perception of pain can be modified by providing amino acids and nutrient precursors to the key neurotransmitters involved in the pain process. Amino acids are able to cross the blood brain barrier and are necessary to produce the appropriate neurotransmitters needed to reduce pain signals and lower inflammation. Increasing the intake of amino acids and nutrients lead to an increase in neurotransmitter levels [1].

The theory that the body’s need for amino acids and nutrients are modified by a disease has been long recognized and is supported by studies that reflect changes in plasma, urinary and tissue levels of nutrients with modified intakes of these nutrients [2].   There are various reasons for depletion of nutrient levels including diet, metabolic demands and genetics.  The required amount for each patient varies depending on the duration and severity of pain. Addressing the increased demand for amino acids and nutrients is a key component for improving clinical outcomes.

Two double-blind clinical trials compared Theramine, a medical food specially designed to address the increased amino acid and nutrient requirements of pain syndromes, to low dose naproxen and ibuprofen.  In both studies, Theramine showed statistically greater pain relief than either naproxen or ibuprofen.  This was measured by patient report and a reduction in the inflammatory markers C-reactive protein (CRP) and interleukin-6 (IL-6) [3, 4].  Treatment with amino acid precursors was associated with substantial improvement in chronic back pain and a reduction in inflammation.

Pain Reduction with TheramineThe improvement in pain directly correlated with increased amino acid precursors to neurotransmitters in the blood.

Theramine is designed using Targeted Cellular Technology (TCT), which facilitates the uptake and utilization of the neurotransmitters precursors that are used in the modulation of pain.  TCT allows for the production of neurotransmitters from ingestion of smaller amounts of amino acids to elicit the same response as larger amounts, making daily dosing more feasible and reducing the potential for tolerance.

At least 100 million adult Americans suffers from chronic pain, a safe and effective treatment option such as medical foods that do not treat symptoms alone but addresses the distinctive nutritional needs of adults who have different or altered physiologic requirements due to pain is vitally needed.

To date, Theramine has been in clinical use for over 10 years with no report of GI bleed or adverse side effects and the clinical trials of Theramine clearly support the theory that the nutritional management of pain syndromes is a safe and effective treatment for pain.

The Dangers of NSAIDs

The most commonly prescribed drugs for pain are Non-Steroidal Anti-Inflammatory drugs (NSAIDs).  Approximately 98 million prescriptions for NSAIDs were filled in the United States in 2012 [IMS 2012] and this number does not include NSAIDs that are purchased over the counter.  Although effective in treating pain and inflammation, NSAIDs are linked to adverse side effects which make them inappropriate for use in many patient populations.  There are several serious side effects and toxicity related to use of traditional NSAIDs. Toxic side effects of traditional NSAIDs include:

  • Stomach ulceration and/or bleeding
  • Kidney damage
  • Easy bruising because of loss of platelet function
  • Exacerbation of cardiovascular conditions

Recent studies have also highlighted a higher risk of atrial fibrillation with NSAID use [1] and an increase risk of bleeding and events such as heart attack, stroke or cardiovascular death with the use of NSAIDs in conjunction with antithrombotic therapy [2].

NSAIDs work to reduce pain and inflammation by inhibiting cyclooxygenase, an enzyme.  The action of inhibiting cyclooxygenases, reduces pain and inflammation but is also responsible for many of the side effects of NSAIDs.  This inhibition is problematic because it also inhibits some important functions such as the repair and maintenance of the stomach lining.  This is why stomach ulceration and irritation is so common with the use of NSAIDs.

Inhibition of cyclooxygenase is also associated with reductions in prostaglandin synthesis and is associated with less sodium being excreted in urine and constriction of blood vessels.  This effect of NSAIDs on blood pressure may increase mean arterial pressure by as much as 5 to 6 mm Hg in hypertensive patients.   This consequence may be of particular relevance in patients with preexisting hypertension, edema or congestive heart failure.

One study noted the rate of new-onset hypertension developing in elderly patients for whom nonselective NSAIDs were prescribed was 27% [3]

The extremely high risk of side effects with such commonly used medication resulted in a quest for an analgesic/anti-inflammatory that could provide therapeutic efficacy equivalent to that of traditional NSAIDs but without the gastrotoxicity.

The use of medical foods to treat the dietary deficiencies associated with pain and inflammation has proven to be a safe and effective method for pain control.  Two double-blind, randomized,  trials, which compared Theramine to low dose naproxen and ibuprofen demonstrated statistically significantly reduction in inflammation as measured by inflammatory markers, CRP and IL-6 as well as improvement in low back pain.  Theramine was shown to be an effective pain medication but also an effective anti-inflammatory agent without the risk of gastrointestinal bleeding or other serious side effects.

All of the ingredients in Theramine are GRAS (generally recognized as safe) products and carries no risk of addiction or attenuation.  Theramine has been on the market for 10 years without report of GI bleed or serious adverse side effects.

There are several patient populations that should avoid NSAIDs due to the high risk of side effects.

  • Patients over 65 years of age
  • Previous GI history such as peptic ulcers or previous GI bleed
  • Patients with cardiovascular disease
  • Patients with liver disease
  • Patients with kidney disease
  • Patients on anti-coagulants or low dose aspirin

The cumulative evidence of the danger of NSAIDs is an important reminder that the while NSAIDs can be helpful and at times necessary medications for satisfactory quality of life, use of these medications, particularly among high risk patients must be carefully considered.

 

1.  Gang Liu, MD, PhD, Yu-Peng Yan, MD, Xin-Xin Zheng, MD, Phd, Yan-Lu Xu, MD, Phd, Jie Lu, MD, Ru-Tai Hui, MD, Phd, Xiao-Hong Huang, MD, Phd “Meta-Analysis of Nonsteroidal Anti-Inflammatory Drug Use and Risk of Atrial Fibrillation” The American Journal of Cardiology Nov. 15, 2014 Vol. 114, Iss. 10

2. Anne-Marie Schjerning Olsen, Gunnar H. Gislason, Patricia McGettigan, Emil Fosbøl, Rikke Sørensen, Morten Lock Hansen, Lars Køber, Christian Torp-Pedersen, Morten Lamberts. Association of NSAID Use With Risk of Bleeding and Cardiovascular Events in Patients Receiving Antithrombotic Therapy After Myocardial Infarction. JAMA, 2015; 313 (8): 805

3.  Solomon DH, Schneeweiss S, Levin R, Avorn J. “Relationship between COX-2 specific inhibitors and hypertension” Hypertension. 2004; 44: 140–145

Pain Management in Lyme Disease

Lyme disease is spread through the bite of infected blacklegged ticks, also known as deer ticks.  Ticks can attach to any part of the human body, but tend to reach areas that are difficult to see such as the groin, armpits, or scalp.  Ticks must be attached for 36 hours or more before the Lyme disease bacterium, Borrelia burgdorferi, can be transmitted.

There are four stages in the progression of Lyme disease.  The first stage, known as the early localized stage, takes place between 3-30 days after the tick bite.  The infected person can experience fatigue, chills, fever, headache, muscle and joint aches, and swollen lymph nodes.  One of the most prominent signs of this stage is the Erythema migrans rash, also known as the bull’s-eye rash for its unique shape.  This rash occurs in 60% of infected individuals. (CDC)

The second stage is known as the early disseminated stage and it occurs days to a week after the tick bite if the bite is not treated within the early localized stage.  During this stage, a person starts to experience more noticeable and serious symptoms.  These symptoms include Facial or Bell’s palsy, additional erythema migrans rashes, and stiffness due to meningitis.  At this point, patients begin to feel shooting pains that can interfere with sleep as well as pain and swelling in the large joints.

If the disease is not treated, 60% of patients enter into the late disseminated stage which happens months to years post-tick bite.  These individuals typically develop arthritis with severe pain and swelling in the joints.  It is typically found in the larger joints, for example the knees.  Arthritis caused by Lyme disease exhibits itself differently than other causes of arthritis.  Lyme arthritis is similar to osteoarthritis because of stiffness due to painful swollen joints.  This happens because Lyme bacteria invade the joints and cause inflammation to the tissue that lines the joints, and eventually, if untreated, can cause the cartilage within the joints to become damaged.[1]

The final stage is the lingering symptoms after treatment.  About 10-20% of patients experience symptoms after the patient has taken antibiotics.  This is called Post-treatment Lyme disease syndrome (PTLDS).  Some evidence shows this is due to an autoimmune response, in which the immune system is continuing to respond after the infection has been cleared, causing damage to be done to a body’s tissues.  Symptoms of PTLDS can include muscle and joint pain, cognitive defects, sleep disturbance, and fatigue. (CDC)

The quicker a doctor is able to diagnose Lyme disease, the quicker they can treat it.  Patients can be prescribed antibiotics in order to rid their system of the bacteria.  Most patients who are prescribed the antibiotic during the early stages usually recover quickly and completely.

With the antibiotics working to take care of the bacteria, what is taking care of the pain associated with Lyme disease?  A patient can still be experiencing pain while taking these antibiotics, which progressively becomes worse throughout all the stages Lyme disease.  Patients who experience pain in association with Lyme disease are less likely to be active, sleep well, or eat properly due to pain.

Commonly prescribed pain medications are opioids and NSAIDs.  Both, although common, can be very dangerous.  According to a report released by the National Institute on Drug Abuse, there can be consequences when choosing to use an opioid.  Opioids are easy to abuse because of their addictive qualities.  Regular or long term use of opioids can lead to physical dependence and addiction. Once a patient stops using opioids, they can experience withdrawal symptoms such as restlessness, muscle and bone pain, insomnia, diarrhea, vomiting, cold flashes with goose bumps, and involuntary leg movements.  An overdose can cause severe respiratory depression and death. [2]

NSAIDs, although effective in treating pain and inflammation, are linked to adverse side effects which make them inappropriate for use in many patient populations.  There are several serious side effects and toxicity related to use of traditional NSAIDs which can lead to costly hospitalizations or death.  A study on the effects of NSAID induced side effects in the elderly reflected the average direct costs of GI side effects per patient-day on NSAIDs were 3.5 times higher than those of a patient-day not on NSAIDs. Seventy percent of the cost was attributed to GI events resulting from NSAID treatment.[3]  Treatment of GI problems alone caused by the use of NSAIDs is estimated to add over 40% to the cost of arthritis care.[4]

Stephen Harrod Buhner’s book “Healing Lyme Disease Coinfections” discusses an alternative to these common pain medications called Theramine®. Theramine is a medical food specifically designed for the dietary management of pain syndromes. This specialized natural product, provides the specific amino acids and nutrients required by the brain and nervous system to effectively reduce pain and inflammation. Theramine is non-addictive and is not associated with adverse GI or cardiovascular side effects.  It is used in clinical practice to reduce inflammation and improve pain perception by addressing the increased nutritional requirements of pain syndromes.  In two double blind, multi-center clinical studies comparing Theramine and an NSAID, Theramine was shown to be more effective at treating pain and inflammation than either naproxen or ibuprofen. Lyme disease can alter the metabolic requirements of the body, leading to specific amino acid and nutrient deficiencies. Effectively managing the increased demand for these essential physiologic components should be an integral part of any pain management protocol.

 


[1] American Academy of Orthopaedic Surgeons. “Effective treatment of Lyme-disease-related arthritis depends on proper diagnosis.” ScienceDaily. ScienceDaily, 2 February 2011.

<www.sciencedaily.com/releases/2011/02/110202132605.htm>.

[2] “Prescription Drugs: Abuse and Addiction” NIDA. October 2011. National Institute on Drug Abuse.

[3] Br J Clin Pharmacol. 2001 August; 52(2): 185–192. Cost of prescribed NSAID-related gastrointestinal adverse events in elderly patients

[4] Bloom, BS. Direct medical costs of disease and gastrointestinal side effects during treatment for arthritis. Am J Med. 1988; 84(2A): 20-24

Pain Management without Harmful Side Effects

The reduction and management of pain can involve many approaches: prescription medicines, over the counter medicines, medical foods, cognitive behavioral therapy, physical exercise, surgery, nutritional modification, pain education, massage, biofeedback, music, guided imagery, laughter, distraction, acupuncture, and nerve stimulation.  Two or more approaches combined can have a synergistic or additive effect that is greater than the sum of the parts.  One approach, medical foods, has medicinal value that is just beginning to be understood and can be used as a stand-alone therapy or adjacent treatment for chronic pain.

Due to its’ additive effect and low side-effect profile, Theramine®, a medical foods, can be used with high-risk patients over the age of 65 as an alternative to NSAIDs or narcotics.  Adding Theramine to a pain treatment protocol can lead to a reduction in previously prescribed narcotics and minimize the use of NSAIDs or both.  The ingredients in Theramine are Generally Recognized As Safe (GRAS) by the FDA, have no risk of addiction or adverse GI or cardiovascular side effects.  Reducing the burden of adverse side effects while improving clinical outcomes is critical for the overall patient care and a return to activities of daily living.

Two studies comparing Theramine to a low dose NSAIDs in adults 18 years of age and above found Theramine to be more effective than either naproxen or ibuprofen alone for inflammatory pain.  When Theramine was given in combination with the low dose of either product the results were even more beneficial.  Incorporating the use of Theramine into a clinical pain management protocol, allows physicians the flexibility to use less of a narcotic or NSAID pain reliever and potentially eliminate their use all together.

The two studies comparing the medical food Theramine and a non-steroidal anti-inflammatory medication, Theramine was shown to be more effective than low dose NSAIDs in treating low back pain.  Clinical data indicates significant reduction in back pain with the administration of Theramine alone, and as an adjunct therapy to a low dose NSAID, while administration of a low dose NSAID had no appreciable effect on pain. The use of Theramine as either a standalone or adjunct therapy can significantly improve pain perception.

Theramine is encapsulated with a patented technology that promotes the rapid cellular uptake and conversion of milligram amounts of amino acids and nutrients into the specific neurotransmitters responsible for modulating pain and inflammation.  This patented technology allows Theramine to be effective without losing efficacy over time.

Two multicenter double blind trials have established the safety and efficacy of Theramine in the treatment of chronic back pain. Pain fell by 63% with administration of Theramine and an NSAID as measured by the Roland- Morris Index (Figure 1), and by 62% as measured by The Oswestry Disability Index.

Pain Scale Graph

Traditional pain medication will always have its place in therapeutic treatment and, if used properly, is very effective.  However, physicians, insurance companies, employers and patients are requesting safer, more effective alternatives to treat pain without harmful and costly side effects. The rapidly increasing population of patients 65 years of age and older is a major concern for both physicians and insurance companies as the pain-related costs to overall U.S. health care expenses are likely to rise proportionally as well. The economic impact of pain is certain, as are the physical, emotional, and social impact for millions of people. Reducing the burden of treating chronic pain is a societal necessity, a medical challenge, and an economic requirement.

#medicalfoods #NSAIDs #theramine

The Rising Healthcare Costs of Pharmaceuticals

Prescription drug use and abuse in the United States, continues to rise at an alarming rate as consumers continue to rely on pharmaceuticals for managing disease symptoms. A recent Mayo Clinic study reports that nearly 70% of all Americans have used at least one prescription drug and more than half receive at least two prescriptions, a percentage that has grown over the last decade. A startling 13% of Americans are on painkilling opiods. Increased prescription writing for pharmaceuticals unfortunately results in more side effects, polypharmacy, fatal overdoses and frequent abuse. According the Centers for Disease Control and Prevention (CDC) The overall impact on healthcare expenditures on prescription drugs reached $259 billion in 2010, and accounted for 12 percent of the total personal health care expenditures and is expected to double over the next decade.

This dramatic increase in prescription drug use can be attributed to a number of factors. For example,  as the average lifespan of people increases so to does the incidence of chronic disease, many of which are conditions requiring more treatments and drugs for longer periods of time; patients expect that they will always receive a prescription when they go to a physician’s office which encourages doctors to overprescribe; hospitals and emergency rooms with little time for alternative treatments, want to help patients by giving them prescriptions to treat them expediently for pain, sleep and other issues; and since women on average visit a doctor more frequently than men do, women are often prescribed a narcotic or anti-anxiety drug more often than most men.

generic pills and bottleIncreased prescribing of drugs unfortunately results in more side effects and even fatal overdoses. According to the CDC, from 1999 to 2010, the number of fatal overdoses has increased fivefold among women and tripled among men. When abuse of prescriptions is considered, the problem can be described as epidemic.  Data from the National Survey on Drug Use and Health (NSDUH) show that nearly one-third of people aged 12 and over whom used drugs for the first time in 2009 began by using a prescription drug non-medically.

These escalations continue to put stress on America’s health care system.  Many studies point to the economic impact associated with the increased use of pharmaceuticals. In a recent study released by the Worker’s Compensation Research Institute, the average cost of treating an injured worker without an opiate is $13,000, compared to an average cost of $117,000 for a patient prescribed a long-acting opiate like OxyContin.  According to the Express Scripts 2012 Workers’ Compensation Drug Trend Report for each dollar spent on abused drugs, an additional $41 is used for associated medical treatment.

It’s no secret that more Americans want medical alternatives without the harmful side effects associated with certain pharmaceuticals.  Consumer demands have shifted away from traditional pharmaceuticals to natural alternatives such as plant based pharmaceuticals and more recently medical foods.  In fact, seventy-one percent of sleep-deprived Americans would rather use other means than pharmaceutical drugs to help them sleep, according to a 2013 Harris interactive Rx Sleep Survey.

In one pharmacoeconomic analysis published in the Journal of Pharmacy Research, it was determined that the actual cost of using the non-opiate pain medication, Theramine®, a prescription medical food with minimal side effects is considerably lower when compared to the total impact of NSAIDs.  Medical foods, once a novelty, are becoming mainstream for a variety of diseases. Since drugs and medical foods work along different pathways in the body, medical foods are often recommended as a complementary or adjunct medication to a reduced dosage of a drug, thereby minimizing the potential of harmful side effects associated with traditional, high dose medications. Medical foods offer an important alternative to traditional pharmaceuticals ultimately improving patient outcomes and reducing healthcare care costs.

The Nutritional Management of Disease

The connections among nutrition, disease prevention, and health maintenance are established and well accepted.  However, the nutritional aspects of certain disease states are less well understood. Patients suffering from PTSD, depression, Fibromyalgia, peripheral neuropathy, obesity, hypertension, pain syndromes, and even cognitive impairment often have metabolic abnormalities that affect how nutrients and amino acids are metabolized. Disease, exposure to certain toxic chemicals, stress, and even some pharmaceuticals can alter the nutritional requirements of an individual and exacerbate or prolong their condition (1) (2) (3). For patients suffering from disordered metabolic processes associated with a disease or toxic exposure, the modification of dietary intake is insufficent to meet the body’s increased demand for certain nutritional components.  Recognizing and correcting these deficits with specific formulations is an integral part of the medical management of certain disease states and potentially the most important component of clinical care.

The distinctive nutritional needs associated with a disease reflect the total amount needed by a healthy person to support life or maintain homeostasis, adjusted for the distinctive changes in the nutritional needs of the patient as a result of the effects of the disease process on absorption, metabolism and excretion. Medical foods such as Theramine® which is specifically formulated to address the altered metabolic processes associated with pain and inflammation, go beyond simple dietary interventions, and are specifically formulated to meet the distinctive nutritional requirements of a specific disease that cannot be met with a simple dietary shift. The increased nutritional requirements of a disease can be the result of inadequate ingestion of nutrients, malabsorption, impaired metabolism, loss of nutrients due to diarrhea, increased nutritional turnover rates inherent in certain disease states, or the impact of drug therapies. The nutritional requirements of an individual suffering from a disease can be considerably different from those of a healthy individual. Recognizing and managing these increased nutritional requirements is an integral part of the medical management of complex clinical conditions.

 

1. Blunted Circadian Variation in Autonomic Regulation of Sinus Node Function of Veterans with Gulf War Syndrome. Haley, RW et al. 2004, The American Journal of Medicine, pp. 469-478.
2. Perfusion deficit to cholinergic challenge in veterans with Gulf War Illness. Liu, P et al. 2011, NeuroToxicology, pp. 242-246.
3. Gulf War illness: Effects of repeated stress and pyridostigmine treatment on blood-brain barrier permeability and cholinesterase activity in rat brain. Amourette, C et al. 207-214, 2009, Vol. 203.