Could A Medical Food be Better than Ibuprofen for Neck Pain?

A new study has found that a blend of amino acids (which make up proteins) could be better than ibuprofen for reducing inflammation and relieving back pain. The research was carried out to determine the efficacy and safety of Theramine, a medical food that could be free from side effects, unlike the commonly used NSAID, ibuprofen.

Theramine, as the name suggests, is designed to be a therapeutic amino acid blend 68405-1 (AAB) that works by modulating levels of neurotransmitters involved in the sensation of pain. Previous research has found that people who suffer from chronic pain often have a deficiency of amino acids that are needed to create neurotransmitters that guard against pain.


This might lead some to think that simply switching up protein sources and increasing levels of individual amino acids in the diet can beat pain, but the science suggests that it’s a little more complicated, especially in conditions such as fibromyalgia, which is a major cause of chronic neck pain. This is because significant alterations in amino acid intake often involve dietary changes that can produce adverse gastrointestinal effects, and the amino acids may not be properly absorbed. Amino acids in food can also get deaminated in the liver and might not cross the blood-brain barrier to get taken up by neurons.

Amino Acids for Pain Relief

Theramine is, therefore, designed as a medical food that contains an amino acid blend that specifically targets precursors to neurotransmitters involved in pain and inflammation. These neurotransmitters include acetylcholine, histamine, serotonin, D-serine, and nitric oxide.

Such therapy has now been found in two studies to be effective at relieving pain and inflammation, without the significant side effects associated with the use of non-steroidal anti-inflammatories ibuprofen and naproxen. NSAIDs are the most commonly prescribed medications for treating back pain, a condition which affects up to 90% of people at some point in life. NSAIDs do nothing to help address the underlying conditions causing pain, and may actually inhibit healing processes and increase pain sensitivity over time.

Theramine for Joint Pain?

Theramine is unlikely to have any specific benefits for healing damaged joint tissue or encouraging bone health, but it is also not thought to have any inhibitory effects on these processes, nor to have any addictive qualities. This makes it an exciting prospect for people with chronic neck pain from fibromyalgia, where neurotransmitter dysfunction, rather than specific joint damage, is thought to play a key role in the disease.

As Theramine is classed as a medical food, its manufacturers (Targeted Medical Pharma Inc.) do not need to obtain preapproval from the United States Food and Drug Administration (US FDA) before marketing the product. The ingredients do, however, need to have GRAS status (Generally Recognized as Safe). Theramine’s purpose in supplying a nutritional need not able to be met by the diet, means that clinical trial data is necessary for the product to claim medical food status, unlike nutritional supplements that are not able to make certain health claims or be deemed effective for medical purposes.

More than 60% Improvement in Disability Symptoms

The latest study was published in the American Journal of Therapeutics and involved 122 patients aged between 18 and 75. These patients had at least moderate back pain that had persisted for 6 weeks or more and which affected them for 10 days or more out of every 14 days.

In this double-blind controlled study, AAB was compared to low-dose ibuprofen, and to combined use of AAB and ibuprofen for the relief of inflammation and pain in people with chronic low back pain. The researchers used the Roland Morris index and Oswestry disability scale to determine the effects of the interventions, as well as measures of C-reactive protein and interleukin 6 (markers for inflammation), and plasma amino acid concentrations at baseline and at 28 days.

In the ibuprofen group, the Oswestry Disability Index worsened by 4.52%, while improvements of 41.91% were seen in the AAB group, and improvements of 62.15% in the combination group. The Roland Morris Index worsened by 0.73% in the ibuprofen group, improved by 50.3% in the AAB group, and improved 63.1% in the combination group.

Markers for inflammation (C-reactive protein and interleukin 6) increased by around 60.1% in the ibuprofen group, decreased by 47.1% in the AAB group, and decreased by 36% in the combination group.

As expected, levels of arginine, serine, histidine, and tryptophan were substantially reduced before treatment in the chronic pain syndrome, with treatment increasing these levels and a direct correlation seen between the degree of normalization of amino acids and symptom relief.

Further Study Needed

The study was funded by the manufacturer of Theramine, Targeted Medical Pharma Inc., which has caused some clinicians to raise questions over the promotion of Theramine for pain relief without independent study by impartial researchers.

Interestingly, amino acid therapy has also been used with some success in treating post-traumatic stress disorder (PTSD) in military personnel. In a study published in the Journal of Central Nervous System Disease in October, two amino acid based medical foods given to 21 military veterans with moderate to severe PTSD symptoms led to an average 17 point decrease on the Physician Checklist – Military (PCL-M) showing a reduction in PTSD symptoms. The patients’ mental health scores on the Short Form General Health Survey (SF-36) increased by 57% on average, leading to recommendations that this pilot study be extended to a larger, double-blind, randomized, placebo-controlled trial.

References

Shell WE, Charuvastra EH, DeWood MA, May LA, Bullias DH, Silver DS. A double-blind controlled trial of a single dose naproxen and an amino acid medical food theramine for the treatment of low back pain. Am J Ther. 2012 Mar;19(2):108-14.

Shell WE, Pavlik S, Roth B, Silver M, Breitstein ML, May L, Silver D. Reduction in Pain and Inflammation Associated With Chronic Low Back Pain With the Use of the Medical Food Theramine. Am J Ther. 2014 Sep 18. [Epub ahead of print]