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

Alternatives to Opioid Pain Medications for Injured Workers

Workplace injuries affect approximately 4.1 million Americans annually (1) .  More than half of these injured individuals will have to miss work and receive long-term medical care.  Worker’s compensation plans provide partial wages during the time of injury and recovery period in addition to covering the cost of medical care.  The recent trend among physicians treating work related injuries has been the practice of prescribing high and sometimes dangerous doses of opioid pain medications for extended periods of time.  Data from 2005-2008 in 17 states showed an average number of 1,599 cases requiring narcotics for non-surgical cases, with more than seven work days missed due to injury(2).  Additionally, in an average of 6% of these cases, the narcotics were prescribed for long-term periods of time.  These drugs may include but are not limited to hydrocodone, fentanyl, methadone, and oxycodone.  Approximately 50-90% of injured workers will receive narcotics for chronic pain conditions (3).  Opioid pain medications can have deadly side effects and the increased availability and dosages of these medications can be detrimental to an injured worker and prolong the time it takes to return to work.

Opioid pain medications are the most commonly prescribed medication in the United States(4).  They work to decrease the perception of pain and increase pain threshold.  While these drugs are helpful to decrease overall pain of various injuries and conditions, they are highly addictive and only address a portion of the pain process.  Common side effects may be mild such as constipation and fatigue, however, they have also been linked to more severe side effects including sleep apnea, decreased hormone production, and increased falls and broken bones among the elderly population(4).  Additionally patients taking opioid pain medications for long periods of time can become addicted and experience serious symptoms of withdrawal which include nausea, shaking, chills, and sweating when finishing a course of these medications (5).  Lately there has also been in an increase in drug overdose leading to death.  In a study that observed 10,000 patients who were prescribed opioids for 90 days, 51% experienced at least one overdose, and six individuals died as a result of overdose 6.  In 2008 the number of deaths resulting from overdose reached nearly 15,000 individuals(1).

Increased availability and access to opioid pain medications is one of the main problems leading to addiction and overdose among injured workers.  Some physicians are prescribing these medications to treat acute and long-term pain disorders such as arthritis and musculoskeletal pain.  Oftentimes high doses are prescribed and the dosage continues to increase over time as tolerance to the effects of the medications increases.  Instead of treating the underlying physiological conditions causing the painful condition, opioid pain medications are prescribed to help manage and mask the pain associated with a work related injury. They are prescribed for many reasons, however, a few of the most common are pressure from patients to prescribe a strong medication that will lead to decreased pain, as well as pressure from insurance companies to prescribe the most cost-effective generic pain medications. Patients may experience temporary pain relief while on these medications, however chronic pain may persist long after the injury has healed.

Prescribing high dose opioid pain medications for work related injuries often leads to other injuries and physiologic impairments.  In many cases, patients remain out of work for much longer than individuals who are not prescribed opioids, as they often develop new health conditions and require more medications.  In the study conducted by the Danish Health Interview Survey in 2000 observing 10,434 individuals, patients who were not prescribed opioid pain medications to treat their injuries recovered four times more often than individuals prescribed opioid pain medications(7).  Additionally, in this study patients taking opioid pain medications were shown to have a lower quality of life and higher death risk than those patients managing pain without opioids.

Some patients who are prescribed opioid pain medications, especially long-term, may develop other serious conditions such as obesity, mood disorders, and depression.  An injured worker who is taking medication for a pain condition may not be able to exercise regularly and weight gain is fairly common.  Opioid pain medications can also have an effect on overall mood and quality of life.  If an individual takes these medications long-term it can be very hard to stop taking them.  The patient can experience large amounts of anxiety and depression when decreasing the dosage or attempting to discontinue the medication all together.  Research has found that of the 1.9 million workers claims that were filed between 2007-2008, those who previously had or developed a co-morbidity as a result of injury such as depression, obesity, or hypertension, experienced more costly treatments and often longer treatment plans all together(8).

Work related injuries will continue to be an issue for insurers and employers.  The overprescribing of opioid pain medications in this country must be addressed by physicians, insurance companies, and drug manufacturers.   The conversion of acute pain to chronic pain associated with a work related injury can be managed in a more efficient way that will allow an injured worker to return to work as soon as they are healed without the burden of addiction or other opioid pain medication related side effects.  Theramine can be used as a complimentary or standalone therapy among this vulnerable population and can provide treating physicians with the ability to prescribe the lowest effective dose of an opioid pain medication while addressing the underlying pathology of the pain process.

Theramine is a prescription only medication regulated by the FDA as a medical food. Medical foods are prescription only medications which address the underlying pathology of pain associated with the work related injury or illness.  Theramine is clinically proven to correct amino acid deficiencies associated with chronic pain syndromes, and improve the overall perception of pain(9).  Theramine is designed to manage the increased nutritional requirements associated with acute or chronic pain conditions.  Theramine is a proprietary amino acid formulation that, by providing neurotransmitter precursors, helps stimulate production of neurotransmitters that are often deficient in pain conditions.  The ingredients in Theramine are Generally Recognized as Safe by the FDA, and are specially formulated utilizing a proprietary Targeted Cellular Technology to facilitate the uptake and metabolizing of milligram quantities of amino acids and other nutrients.  There have been no reported adverse side effects associated with the clinical application of over 50 million individual doses of Theramine. The most common side effects associated with amino acid therapies are headache, dry mouth, and upset stomach and are often short term, and can be decreased with increased fluid intake.  Theramine can be administered in conjunction with the lowest effective doses of an opiate or NSAID pain medication without loss of efficacy(10).  Treating work related injuries with Theramine may prove to be one possible medication solution to control pain and help decrease the quantity and dosages of opioid pain medications administered in the United States.

1)      http://www.workers-comp-news.com/injury_stats.php

2)      http://www.wcrinet.org/studies/public/books/WCRI_2012_Annual_Report.pdf

3)      http://ehstoday.com/health/workers-compensation/injured-workers-opiate-addiction-0209/

4)      http://www.nytimes.com/2012/04/09/health/opioid-painkiller-prescriptions-pose-danger-without-oversight.html?pagewanted=all

5)      http://www.opiates.com/opiate-withdrawal.html

6)      http://www.crcotp.com/crcotp_featured/even-when-prescribed-opioids-can-cause-addiction-and-overdose.php

7)      A Population-based Cohort Study on Chronic Pain:The Role of Opioids Per Sjøgren, MD, DMSC,* Morten Grønbæk, PhD, Vera Peuckmann, PhD,  and Ola Ekh-+olm, PhDw, Lippincott Williams & Wilkins, 2010.

8)      http://coventrywcs.com/web/groups/public/@cvty_workerscomp_coventrywcs/documents/webcontent/c054910.pdf

9)      Shell WE, Silver D, Charuvastra E, Pavlik S, Bullias D; “Theramine and Ibuprofen for the treatment of chronic low back pain double blind clinical trial”, 2010 Targeted Medical Pharma Inc.

10)   Shell WE et al.; “Theramine and Naproxen for the treatment of low back pain, a double bind clinical trial”; Americal Journal of Therapeutics April,2012.

The Cost of Pain

Pain and the treatment of pain affect every sector of our society with at least 100 million adult Americans reportedly suffering  from common chronic pain conditions, a conservative estimate because it does not include acute pain of children.[1]  The proliferation of pain in the United States has resulted in a sharp increase over the past decade in the overuse of narcotics. The prescribing of narcotics has become a popular option for the treatment of chronic pain associated with back injuries, headaches, arthritis, and fibromyalgia.

Chronic pain takes an enormous personal toll on millions of patients and their families, and leads to increased health care costs. Patients with chronic pain have more hospital admissions, longer hospital stays, and unnecessary trips to the emergency department. Such inefficient and even wasteful treatment for pain is contributing to the rapid rise in health care costs in the United States.

The prevalence of pain has a tremendous impact on business.  A recent report by the Institute of Medicine indicated that the annual value of lost productivity in 2010 dollars ranged between $297.4 billion to $335.5 billion. The value of lost productivity is based on three estimates: days of work missed (ranging from $11.6 to $12.7 billion); hours of work lost (from $95.2 to $96.5 billion); and lower wages (from $190.6 billion to $226.3 billion)[2]. This billion dollar annualized price tag will likely climb as the U.S. population ages.

The cost of pain also includes the cost of treating side effects. The most commonly prescribed drug for pain is Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).  Approximately 98 million prescriptions for NSAIDs were filled in the United States in 2012 (IMS 2012).  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 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]

NSAIDs Image

Treatment of GI problems alone caused by the use of NSAIDs is estimated to add over 40% to the cost of arthritis care[4]

From the perspective of the healthcare system, minor GI side-effects and prophylactic gastroprotection against NSAID-related side-effects may consume even more healthcare resources than severe events because of their high prevalence.

Opioid use has resulted in increased hospitalizations, increased spending on opioid addiction and increased workplace costs.  The cost of the average lost time claim with long acting opioids is 900% higher than those without the use of opioids. U.S. emergency room visits have also increased.  The number of cases in which an opioid other than heroin was cited as a reason for an emergency room treatment in  2004 was 299,498 and in 2011 was 885,348, an almost 300% increase.[5]

While many assume that increase spending and use of pharmaceuticals for pain has had a positive effect on the overall mitigation of pain, there is little scientific data on the relationship between spending on pharmaceutical agents and pain resolution.  Simply treating the symptoms of pain have not proven to be effective nor cost saving in the long run. However, it is increasingly clear that there may be a positive relationship between the use of non-pharmaceutical interventions with or without the use of pharmaceutical and the resolution of pain.

#medicalfoods #NSAIDs #opiods #sideeffects


[1] IMS Health Data, California Workers’ Compensation Institute

[2] Institute of Medicine of the National Academies Report. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research, 2011. The National Academies Press, Washington DC

[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

[5] IMS Health Data, California Workers’ Compensation Institute

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

Sleepless in America

Eighty three percent of Americans say they do not always get a good night’s sleep on a regular basis, according to the 2013 Rx Sleep Survey conducted by Harris Interactive. The results also revealed that forty-eight percent of Americans say stress and anxiety prevent them from getting a good night’s sleep on a regular basis.  There are gender differences with more women than men are likely to have difficulty falling and staying asleep and to experience more daytime sleepiness. According to the Harris survey more women (88 percent) than men (78 percent) suffer from lack of sleep or sleep disorders, Fifty-six percent of women say anxiety and stress are the leading reasons for lack of restful sleep, compared to 40 percent of men. For all the other top reasons Americans do not always get a good night’s sleep more woman than men report:

  • Inability to turn off thoughts (16% more women than men)
  • Pain (13% more women than men)
  • Being overtired (22% more women than men)
  • Background noise (25% more women than men)
  • Children or pets (33% more women than men)

It is unclear why more women than men report sleep disorders. It is possible that women may require more sleep than men or that they may simply have greater physiological consequences to lack of sleep than men. Pregnancy and menopause too can dramatically alter sleep patterns. What is known is that the consequences of too little sleep on women are dangerous. According to a recent study conducted by Duke University, women who get too little sleep have a higher risk of developing heart disease, depression or other psychological problems. They are also more likely to develop blood clots which put them at greater risk for stroke.

Regarding treatment, the results revealed that while overall 25 percent of Americans would be willing to take a prescription sleep aid to improve sleep quality, the majority of Americans (71 percent) would rather use other means to get a good night’s rest. When it comes to treatment for sleep disorders the gender disparities continue.  More women (29 percent) than men (20 percent) would be willing to take a prescription sleep aid. The survey also found that women (68 percent) are less inclined than men (75 percent) to use other means than prescription sleep aids to help them sleep. These results are supported by research on inflammatory markers showing that women experience chronic pain more frequently, with greater intensity and longer duration than do men.  Having more pain during the day, the ease and facility of pharmaceutical solutions may be most appealing to women.

According to the CDC, the number of prescriptions for pharmaceutical sleep aids has increased dramatically in the past 10 years with more than 9 million Americans or 1 in 25 are using such aids.  While not a cause of death, recent studies suggest that patients taking prescription drugs for sleep were nearly five times as likely as non-users to die over a period of two and a half years. Sleep drugs have very serious side effects which can impair daily function and overall quality of life. The popular misconception of these drugs is that they improve overall sleep quality, when in reality they often interfere with a patient’s ability to achieve meaningful restorative sleep and normal physiologic function. The FDA recently ordered a label change for the popular sleep drug zolpidem (ambien) because women are more susceptible to next-morning impairment. With issues such as addiction, rebound insomnia, morning grogginess and memory loss, many providers are encouraging both men and women to seek alternatives to prescription drugs for sleep.

Alternatives to Prescription Sleep Drugs

There are many non-pharmacologic therapeutic options for patients affected by sleep disorders including educating patients about sleep, sleep hygiene, aerobic exercise and cognitive behavioral therapy. One new and rapidly expanding field of treatment is the use of medical foods to manage the specific amino acid and neurotransmitter deficiencies associated with sleep disorders. Medical foods are a well defined FDA regulatory category established by the Orphan Drug Act of 1988. Medical foods work on a different pathway from other prescription drugs and contain ingredients that are Generally Recognized as Safe (GRAS) by the FDA.

Rather than focusing on a single receptor site or molecule, medical foods work on multiple pathways providing depleted cells with the amino acids and specific nutrients that are needed to help fall asleep and achieve restorative sleep, many of which cannot be replaced by simple dietary alterations or supplements alone. For example, insomnia is often a co-morbidity of anxiety and of chronic pain. These specific conditions alter the metabolic processes of the nervous system resulting in a relative nutritional deficiency. Correcting the nutritional deficiencies is an approach that has shown to be effective with minimal to no side effects. The management of sleep is a complex process that is influenced by other diseases and conditions, and even gender. Talk to your healthcare professional about alternatives to prescription drugs for sleep.

 

 

 

 

 

 

 

Opioid Receptors Impaired in Fibromyalgia Patients

µ-Opioid Receptors Impaired in Fibromyalgia Patients

Chronic idiopathic pain associated with fibromyalgia is complex to manage and is often associated with other co-morbidities such as depression. A recently published University of Michigan study looked closely at µ-opioid receptor availability in fibromyalgia patients, providing sound physiologic data confirming the widespread consensus that the inability of these patients to process pain signals effectively is largely due to the inability of receptors in key areas of the central nervous system to bind to analgesic opioids.

The clinical management of fibromyalgia is very complex and requires a multi-modal approach to pain management that is specific to the individual patient.  Narcotic pain medications are largely ineffective at mitigating idiopathic pain in fibromyalgia patients and often lead to many more serious side-effects that can exacerbate and prolong the condition. The widespread use of narcotics to manage non-malignant chronic pain is a serious problem in the United States and there is no medical evidence showing that these drugs actually work to treat the chronic pain of fibromyalgia. The study’s results are further evidence for clinicians that the use of non-narcotic interventions for pain management of fibromyalgia are more effective treatment options.

Medical foods are a good example of a therapeutic alternative for the treatment of fibromyalgia.  These prescription-only medications treat the nutritional deficiencies in chronic disease and not just the symptoms.  Patients diagnosed with fibromyalgia, for example, may have an increased need for precursors of the neurotransmitters nitric oxide, GABA (gamma-amino butyric acid), serotonin, and acetylcholine.  These include amino acids and nutrients such as arginine, glutamate, tryptophan, acetyl-L-carnitine, and choline. The clinical dietary management of fibromyalgia contains the specific elements the body requires to stimulate production of the neurotransmitters required to support effective pain control.

As a practicing board-certified rheumatologist and internist, I have prescribed medical foods to patients for the treatment of fibromyalgia for a number of years.  Healthcare providers and patients interested in a more efficacious treatment for fibromyalgia with little or no side effects should familiarize themselves with the class of medications regulated by the FDA as medical foods.

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.