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

The Nutrient Management of Hypertension

Hypertension, or high blood pressure, is a chronic medical condition in which the blood pressure in the arteries is elevated.  Blood pressure measures the force pushing outward on your arterial walls.  Since your body needs oxygen to survive, it is carried throughout the body.  Every time that your heart beats it is pumping oxygen through a network of blood vessels and capillaries.  There are two forces to every heart beat.  The first force occurs as blood pumps out of the heart and into the arteries that are part of the circulatory system, also known as systolic pressure.  The second force is created as the heart rests in between heartbeats, also known as diastolic pressure.  These are the two numbers that a person can see in a blood pressure reading.  Problems arise when there is too much force on the heart.  This can lead to conditions such as vascular weaknesses, vascular scarring, increased risk of blood clots, increased plaque build-up, tissue and organ damage from narrowed and blocked arteries, and increased workload on the circulatory system.  When cholesterol or plaque builds up because of scarring, the heart has to work harder in order to pump blood to the arteries.  This can eventually result in damage to the heart which can ultimately lead to heart failure.  This disease affects 76.4 million adults in the United States and can lead to heart attack, heart failure, stroke, and kidney failure.

Hypertension is usually a symptomless condition with complications.  Usually people only feel symptoms in extreme readings, for example if their systolic reading is 180 or their diastolic is 110.  This is what is known as a hypertensive crisis.  It is important that adults be familiar with their blood pressure numbers on a consistent basis in order to prevent this disease from causing serious health issues.

There are simple ways to help control a person’s blood pressure.  According to the American Heart Association, there are 8 main ways to adopt a healthy lifestyle.  Eat a better diet (including reducing salt), regular physical activity, maintain a healthy weight, manage stress, avoid tobacco smoke, comply with medication prescriptions, limit alcohol, and understand hot tub safety.

Prescription medication is commonly used to help patients manage hypertension effectively.  One of the most commonly prescribed medications is lisinopril, a type of ACE Inhibitor that helps relax blood vessels keeping blood pressure low.  As with any drug therapy, there are good and bad side effects associated with lisinopril.  For example, lisinopril and other ACE inhibitors can cause a wide range of side effects, some less serious than others such as cough, dizziness, weakness, headaches, or nausea.  More serious side effects include swelling, difficulty breathing or swallowing, fever, fainting, and chest pain. Any patient taking this class of drugs should be aware of these side effects and monitor themselves at the onset of therapy and periodically throughout the course of therapy to ensure that the medication is more beneficial than harmful.

Another popular prescription option for patients with hypertension, are calcium channel blockers.  Calcium channel blockers relax and open up narrowed blood vessels by preventing calcium from entering the smooth muscle cells of the heart and arteries. The common side effects of this class of medications include headache, swelling, dizziness, flushing, fatigue, nausea, and palpitations.

Diuretics are also commonly prescribed and help expel excess sodium and fluid from the body in order to help control blood pressure.  Some of the side effects associated with diuretics are arrhythmia, extreme tiredness or weakness, muscle cramps, dizziness, fever, and dehydration.

Beta-blockers are also commonly used to treat hypertension. This class of medication is used to reduce heart rate, the heart’s workload, and the heart’s output of blood by preventing certain hormones from stimulating the heart. Side effects of beta blockers include diarrhea, depression, vomiting, depression, nightmares, and hallucinations.  One of the main dangers of beta-blockers is that if they are withdrawn suddenly conditions like angina can worsen, causing heart attacks or sudden death.

Doctors often hesitated to prescribe ACE inhibitors, beta blockers and diuretics until a patient’s blood pressure reaches 160/100. Anything below that level is deemed “mild hypertension” and not considered imminently dangerous, so a drugs’ potential side effects might outweigh their benefits. For patients with mild to moderate hypertension, nutritional interventions are commonly used in an effort to prevent the disease from progressing to a life threatening state.

A safe alternative for Hypertension is a medical food like Hypertensa® which are commonly used to expand blood vessels and improve blood flow through a natural pathway.  This class of medications addresses the increased nutritional demands of hypertension.  It uses specific amino acids and nutrients that are responsible for regulating blood pressure and vascular function.  Unlike drugs, medical foods address the production of the specific neurotransmitters that drive all the automatic functions of your body including heart rate and blood pressure.  Hypertension and many drugs that treat hypertension can alter the way the body uses these substances which are derived from both the diet and internal metabolic processes, creating deficiencies which cannot be fixed by altering diet alone.  By addressing the increased metabolic requirements of hypertension with nutritional interventions, the body will have the tools that it needs to help regulate blood pressure and heart rate.

The Second Brain

It’s 10 pm and you are stressed.  All of the sudden your stomach starts churning and you remember that half eaten carton of Ben and Jerry’s left in your freezer.  Before you know it the ice cream is gone and you are left hoping that it will settle the butterflies in your stomach.  We have all had that feeling, but then the question arises.  What makes us have that “gut feeling”?  Why are our stomachs controlling our emotions, and therefore controlling our eating patterns?

Your gut can work independently without any input from your brain, unlike any other organ in the human body.  This is how the stomach got its name of “the second brain”.  The stomach is controlled by the enteric nervous system (ENS) which is made up of 100 million neurons.  The ENS is used to control the movement and absorption of food through the intestines.  The stomach has the ability to send signals to the brain that can affect certain feelings, such as sadness or stress, as well as influence memory, learning, and decision-making.  The stomach relies on 30 neurotransmitters in order to function that are identical to those in the brain.  The ENS communicates with the central nervous system (CNS) through the parasympathetic and sympathetic nervous system, but does not rely on it in order to function.  Studies have shown that the ENS continues to function, even after the vagus nerve, which connects the CNS to the ENS, has been severed.

Different foods can affect emotions differently.  Specific components of food can influence neurohormones in the gut that are responsible for signaling the brain.  What a person eats affects their mood.  Fatty acids reduce feelings of sadness and hunger.  This is why most people in times of stress and sadness will turn to the help of “comfort foods” to help them feel better.  Ghrelin, a hormone manufactured by the gut, stimulates hunger in the brain and is one of the neurochemicals that sends messages back and forth between the ENS and CNS in order to affect mood. Every time a meal is consumed ghrelin levels fall, and then continue to rise again until the next meal. Obese people tend to have higher levels of ghrelin even after eating, which can leave them feeling hungry more often. High-fat foods stimulate dopamine production and can enhance mood/euphoria, thus encouraging the brain and stomach to seek out more high fat food.

Measuring the beerbelly

During gastric bypass surgery, the part of the stomach which produces the most ghrelin is isolated in order to make the patient less hungry.  The doctor then attaches the stomach to a section of the small intestine called the ileum which produces PPY, a hormone that makes you feel full.  PPY typically takes 20 minutes to send the message to the brain to let it know that the stomach is full.  Making these two sections of the stomach closer together allows the brain to receive the signal quicker in order to encourage the body to eat less.

Surgery is an expensive and drastic solution to fighting a problem such as obesity.  People try to diet, which if done safely and combined with exercise can be effective. One important thing to note is that people dieting will also have increased levels of grehlin, increasing hunger levels.   This is one reason why people find dieting to be so difficult. Food affects mood due and increased cravings caused by certain hormones can be difficult to control.  Perhaps this is why your co-worker who is on a 3-day juice cleanse is in such a sour mood.

If exercise and dietary changes fail to make a dent in hunger, weight and BMI then a more targeted approach can help people interested in managing appetite and controlling food intake. Medical foods is certainly one option that should be explored. As a safe and effective class of medications medical foods deliver the specific neurotransmitter precursors required by nervous system to help reduce appetite and promote early satiety As stated earlier, your stomach uses neurotransmitters just as the brain does.  Using these neurotransmitters help your stomach become more satisfied and helps manage your mood and cravings, helping you manage appetite safely and effectively.  Clinical trials show that a medical food as an adjunct to a weight loss diet and exercise plan can help increase weight loss and decrease BMI.

Ten Foods that May Help Curb Appetite:

  1. Avocados – Composed of monounsaturated fats, which take longer to digest, avocados help suppress ghrelin production and appetite.  The soluble fiber in avocados slow digestion by forming a thick gel as it travels throughout the gut.
  2. Greek Yogurt – A high-protein appetite buster.  Since it is thick, you feel fuller faster.
  3. Legumes – High in soluble fiber, resistant starch, and oligosaccharides.  These complex carbs help slow digestion.
  4. Cottage Cheese –  A good source of protein which helps suppress appetite.
  5. Oatmeal – Contains beta-glucans, a soluble fiber, that helps it travel slowly through the digestive track.
  6. Nuts – Nuts contain healthy fats and fiber which help you digest more slowly.
  7. Fruit – high in fiber, which helps to slow digestion and keep you feeling full longer.
  8. Wasabi – suppresses appetite and also contains anti-inflammatory qualities.
  9. Salmon – Salmon is high in omega-3 fatty acids, which helps the body increase leptin, a hormone used for suppressing hunger.
  10. Cinnamon – Cinnamon helps lower blood sugar which helps control appetite.

Safe Alternative Therapies for Post-traumatic Stress Disorder

Post-traumatic Stress Disorder (PTSD) can occur after a person has been through a traumatic event, such as combat exposure, a terror attack, a serious accident, a natural disaster, or sexual or physical assault or abuse.  Not everyone who experiences a traumatic event will be diagnosed PTSD.  About 60% of men and 50% of women experience trauma in their lives and it is estimated that about  7-8% of the entire U.S. population will have PTSD during their lifetime.[1]  People who have been diagnosed with PTSD can experience  a variety of psychological and physical symptoms which include reliving the event, avoidance, negative changes in beliefs and feelings, hyperarousal, sleeplessness, muscle fatigue, and digestion disorders.

PTSD is such a complex disease, affecting the body and brain in such a way that makes standardizing treatment very difficult.  The current treatment protocols available for people suffering from PTSD can be effective but are also limited.  One of the most effective treatment protocols currently used to manage PTSD, is cognitive behavioral therapy (CBT).  There are different types of CBT, including Cognitive Processing Therapy (CPT) which is used to help a person understand how trauma can change thoughts and feelings. Prolonged Exposure Therapy (PE), which is designed to condition or desensitize a person with PTSD, by helping them relive the experience through talk therapy repeatedly until the memories are no longer upsetting.  This may also include physically going to the location where the traumatic event occurred that may be intentionally avoided.[2]

Medications are often prescribed as an adjunct to CBT and other therapies used for treating PTSD. According to the Department of Veterans Affairs, “Benzodiazepines and atypical antipsychotics should generally be avoided for PTSD treatment because they do not treat the core PTSD symptoms.” Pain medications are also often used to treat pain associated with PTSD, but can be very dangerous and addicitve. A recent study by a VA researcher found that veterans with PTSD were two times as likely to be prescribed opioids as those without mental-health problems. They were more likely to get two or more opioid painkillers at the highest doses. Veterans with PTSD were more than twice as likely to suffer bad outcomes like injuries and overdoses if they were prescribed opioid painkillers, the study found.

As the intelligence about the causes and effects of PTSD has improved, attention has been directed towards specific abnormalities associated with the human nervous system, particularly the parasympathetic autonomic nervous system. The parasympathetic nervous system is the “rest and digest” part of the nervous system and it is responsible for many restorative functions. The parasympathetic nervous system is responsible for many of the automatic body functions such as heart rate, breathing and digestion.  According to numerous studies in patients with PTSD, there appears to be a blunting of total autonomic activity, marked in particular by a reduction of nighttime parasympathetic activity. The inability of PTSD patients to effectively initiate parasympathetic activity can lead to an imbalance of nervous system activity and yield symptoms including anxiety, rapid heartbeat, panic spells and increased sweating. Parasympathetic suppression can also cause sleep dysfunction, abnormal dreams and memory disturbances. There is an emerging consensus that sleep disturbance may be a core feature of PTSD.

Improving nervous system health and balancing parasympathetic and sympathetic activity is a key component in the successful treatment of PTSD. Providing clinically validated alternatives to the currently prescribed medications is essential to improving the treatment of PTSD.   There are currently natural medication options available that can help to manage the increased physiologic and metabolic demands of PTSD. Recent studies involving the medical foods  Sentra AM® (acetyl l-carnitine HCL, choline bitartrate, l-glutamic acid) and Sentra PM® (acetyl l-carnitine HCL, choline Bitartrate, 5-HTP, l-glutamic acid)  have yielded very positive results in patients suffering from symptoms related to PTSD. These products are specially formulated using amino acids, nutrients and certain botnaicals and are believed to influence the production and absorption of neurotransmitters essential to autonomic nervous system function. They may be particularly effective at targeting symptoms of PTSD and provide a new, safe treatment option for this condition.[3] Civilians, active service and military veterans are often reluctant to seek treatment for PTSD symptoms because of the perceived stigma associated with a psychiatric diagnosis and psychiatric medications. Medical foods like Sentra AM and Sentra PM provides patients and providers with a safe, effective and reliable therapeutic alternative to the current drug protocols being prescribed.



[1] Gradus, Jamie L. “Epidemiology of PTSD” ptsd.va.gov.  January 30 2014.  Web.  June 2014.  http://www.ptsd.va.gov/professional/PTSD-overview/epidemiological-facts-ptsd.asp

[2] “What is PTSD?” ptsd.va.gov. January 17 2014. Web. June 2014. http://www.ptsd.va.gov/public/PTSD-overview/basics/what-is-ptsd.asp

[3]Targeted Medical Pharma, Inc.. Administration of an Amino Acid-Based Regimen for the Management of Autonomic Nervous System Dysfunction Related to Combat Induced Illness. Publication Pending. Print.

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

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

The Nutritional Needs of Autism Spectrum Disorders (ASD) May Not Be Met By Diet and Supplements Alone

While autism is a complex neurodevelopmental disorder influenced by genetic and environmental factors, researchers and families are increasingly focusing on the nutritional deficiencies associated with the disorder. Researchers are finding specific nutritional insufficiencies and metabolic abnormalities associated with ASD while parents aggressively try a variety of diets and supplements despite a lack of formal data.

There are currently no safe and effective treatment options for the three core characteristics of ASD, so many parents seek out alternative methods for managing the symptoms of the disease. In many cases, certain foods such as casein (milk protein) and gluten (wheat protein) are excluded from diets in an attempt to modify behavior. This approach, although sometimes effective, does raise concerns about potential nutritional deficiencies that can affect brain and body development. Others provide supplements without any assurance that the nutrients are adequately absorbed. Scientists working with Medical Foods are convinced that by offering a combination of amino acid precursors to specific neurotransmitters, provided under a physician’s supervision, there might be a solution. Based on positive preliminary investigational results, they are designing clinical studies to prove their hypothesis.

The history of nutrition and autism begins with the knowledge that vitamins, minerals and amino acids are critical to human health and that poor diet is a major contributing factor to many child health problems, including rickets (calcium/vitamin D deficiency), anemia (low iron), hypothyroid (low iodine), and scurvy (vitamin C deficiency). Research has demonstrated that there are nutritional deficiencies associated with developmental disabilities such as attention deficit disorder and intellectual development. Those with ASD have the same needs for calcium and protein and in addition were found to have more essential amino acid deficiencies consistent with poor protein nutrition than an age/gender matched control group.[i] Those on restricted diets tended to have lower plasma levels of essential acids including the neurotransmitter precursors tyrosine and tryptophan than both controls and children with autism on unrestricted diets.  A 2013 study of 55 children with ASD found Low levels of biotin, plasma glutathione, and plasma tryptophan and several other measures; and also high levels of oxidative stress markers and plasma glutamate.[ii] Work continues examining the role of glutathione – a small peptide derived from the amino acids glutamic acid, glycine and cysteine and the body’s chief detoxifier.

Understanding the nutritional status of ASD means not just looking at diet and intake, but also examining digestion, absorption, metabolic processing, metabolic demand, metabolic turn over rate and elimination. Each of these plays a role in nutritional insufficiency and altered metabolic turnover rates. For example, the use of nutritional supplements without taking into account the processing capacity of receptors involved in the metabolism of these nutrients or their ability to get beyond the blood brain barrier can result in uneven absorption or simply generate a nutrient-rich urine without clinical benefit or long-term improvement in behavior.Female_Scientific_Research

Scientists at Targeted Medical Pharma, a Los Angeles based biotechnology company are convinced that the patented technology behind their medical foods, Targeted Cellular Technology (TCT) addresses these issues. TCT is an integrated molecular system that facilitates the uptake and utilization of nutrients by target cells within the nervous system. This patented five step system consists of (1) specific neurotransmitter precursors such as amino acids and nutrients; (2) a stimulus for the neuronal uptake of these precursors by specific neurons; (3) an adenosine antagonist that blocks the inhibitory effect of adenosine on neuronal activity (adenosine brake); (4) a stimulus to trigger the release of the required neurotransmitters from targeted neurons; and (5) a mechanism to prevent attenuation of the precursor response, a well known phenomenon associated with amino acid, nutrient and drug administration. Use of Targeted Cellular Technology improves the metabolic efficiency of neurotransmitter synthesis, thereby reducing the amounts of precursors needed to correct neurotransmitter imbalances. TCT synchronizes the availability of the neurotransmitter precursor supply with the fluctuating demand for the corresponding neurotransmitters.

A recent investigator initiated clinical observation looked at 26 children who were diagnosed with ASD or suffering from related symptoms including explosive behavior, social isolation, and mood disorder, treated for a time period ranging between 30 days and one year using an amino acid based formulation of TCT based medical foods. The investigator reported significant improvement with regards to decreased disruptive outbursts, improved socialization, improved mood and reduction in drug dose. Scientists hypothesized that nutritional insufficiency and metabolic imbalances that play a role in ASD may be dramatically improved using the approach of certain medical foods. They are now using an autism-specific formulation with milligram amounts of amino acid precursors and other biogenic ingredients designed to correct nutritional deficiencies associated with ASD. They plan test their hypothesis in a placebo-controlled, randomized, double-blind study.


 

[i] Arnold, et al. Plasma amino acids profiles in children with autism: potential risk of nutritional deficiencies. J Autism Dev Disord. 2003 Aug;33(4):449-54.

[ii] Adams, J. Summary of Dietary, Nutritional, and Medical Treatments for Autism. Arizona State University, Autism Research Institute.

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.

 

 

 

 

 

 

 

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.