Reduction in Pain and Inflammation Associated With Chronic Low Back Pain With the Use of the Medical Food Theramine

Abstract

Management of chronic back pain is a challenge for physicians. Although standard treatments exert a modest effect, they are associated with narcotic addiction and serious side effects from nonsteroidal antiinflammatory agents. Moreover, neurotransmitter depletion from both the pain syndrome and therapy may contribute to a poor treatment outcome. Neurotransmitter deficiency may be related both to increased turnover rate and inadequate neurotransmitter precursors from the diet, particularly for essential and semi-essential amino acids. Theramine, an amino acid blend 68405-1 (AAB), is a physician-prescribed only medical food. It contains neurotransmitter precursors and systems for increasing production and preventing attenuation of neurotransmitters. A double-blind controlled study of AAB, low-dose ibuprofen, and the coadministration of the 2 agents were performed. The primary end points included the Roland Morris index and Oswestry disability scale. The cohort included 122 patients aged between 18 and 75 years. The patients were randomized to 1 of 3 groups: AAB alone, ibuprofen alone, and the coadministration of the 2 agents. In addition, C-reactive protein, interleukin 6, and plasma amino acid concentrations were measured at baseline and 28 days time points. After treatment, the Oswestry Disability Index worsened by 4.52% in the ibuprofen group, improved 41.91% in the AAB group, and improved 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. C-reactive protein in the ibuprofen group increased by 60.1%, decreased by 47.1% in the AAB group, and decreased by 36% in the combination group. Similar changes were seen in interleukin 6. Arginine, serine, histidine, and tryptophan levels were substantially reduced before treatment in the chronic pain syndrome and increased toward normal during treatment. There was a direct correlation between improvement in amino acid concentration and treatment response. Treatment with amino acid precursors was associated with substantial improvement in chronic back pain, reduction in inflammation, and improvement in back pain correlated with increased amino acid precursors to neurotransmitters in blood.

FIGURE 1.

Percent change in Roland Morris Disability Questionnaire Pain Scale from day 1 to day 28. Ibu n = 43, AAB n = 41, and combination n = 38. Roland Morris Disability Index fell 63.1% between baseline and day 28 in the combination therapy group, and fell 50.3% in the AAB-alone group, while there was no significant effect on chronic back pain in the ibuprofen-alone treatment group.

FIGURE 2.

Percent change in Oswestry Disability Index from day 1 to day 28. Ibu n = 43, AAB n = 41, and combination n = 38. Oswestry Disability Index fell 62.15% between baseline and day 28 in the combination therapy group, and fell 41.91% in the AAB-alone group, while there was no significant effect on chronic back pain in the ibuprofen-alone treatment group.

FIGURE 3.

Percent change in CRP from day 1 to day 28. Ibu n = 43, AAB n = 41, and combination n = 38. The CRP levels fell 35.99% for combination theory group and 47.05% for the AAB-alone group, while levels rose 60.1% for the ibuprofen-alone group.

FIGURE 4.

Percent change in IL-6 from day 1 to day 28. Ibu n = 43, AAB n = 41, and combination n = 38. The IL-6 levels fell 43.1% for combination theory group and 23.55% for the AAB-alone group, while levels rose 12.65% for the ibuprofen-alone group.

FIGURE 5.

Plasma amino acid concentrations were calculated at day 1 and day 28 in 44 of 122 patients. Plasma amino acids were analyzed using liquid chromatography–tandem mass spectrometry methodology. The assay had a variance of ±5%.

FIGURE 6.

The needed breakthrough medication usage was statistically significant in the AAB group verses the ibuprofen-alone group.