The Trust for America’s Health, a nonprofit organization, reported that in 2013 over 44,000 Americans died as a result of drug overdose. Drug overdoseshave been rising since 2009, despite federal and state efforts to better monitor and control use of narcotics and other potentially addictive medications. Over half of these deaths were related to prescription drugs and in fact, in 36 states more people died from a Rx drug overdose than from automobile accidents. These numbers are staggering, especially when you consider that drugs such as narcotics (Vicodin, Percocet, etc.) do not cure any disease, they only mask a symptom, pain.
Physicians are under increased scrutiny for prescribing these dangerous drugs and are constantly looking for reliable, clinically proven alternatives. Until recently, options were limited to NSAIDs, such as ibuprofen and naproxen, which can have significant side effects most specifically on the gastrointestinal tract, and medications used to treat other conditions such as SSRIs, anti-epileptics, and SNRIs, but that may also help pain as well. The efficacy of these options are limited at best and often cause significant side effects without providing adequate pain relief.
Evidence Based Options for Patients and Providers
Theramine, a amino acid based treatment for pain, has been shown in multi-center clinical trials to significantly reduce pain in patients with chronic low back pain without any appreciable side effects better than over the counter doses of ibuprofen or naproxen. Theramine is regulated as a medical food by the FDA and is manufactured in the United States at a cGMP facility using ingredients that are Generally Recognized as Safe. As a medical food, Theramine is subject to much tighter regulatory oversight than dietary supplements, providing patients and providers with piece of mind knowing that the formulations are tested and evaluated for efficacy. There have been over 40 million individual doses of Theramine administered since 2004, without a single reported GI bleed, adverse cardiac event or stroke reported the most commonly known side effects of NSAIDs. Theramine is not addictive and can be taken with other medications or medical conditions. Theramine provides chronic pain patients a safe, effective and proven alternative to other potentially more dangerous pain medications.
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.
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 prostaglandinsby 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, theAmerican Academy of Neurology determined that the risks of opioids outweigh the benefits for certain chronic pain conditions.
Treatment of pain with the use ofmedical 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 .
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 . 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 trialscompared 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.
The 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.