Targeted Medical Pharma, Inc. reported that the prescription only medical food Theramine is an effective medication for reducing inflammation associated with pain syndromes. Theramine has been the subject of two large double-blind, randomized, multi-center trials, which compared Theramine to low dose naproxen and ibuprofen. 256 subjects participated in the two studies across 20 independent sites that were randomized for treatment to receive Theramine alone (two capsules twice daily), NSAID or a combination of both.

In both studies, Theramine showed statistically significantly reduction in inflammation as measured by inflammatory markers and improvement in low back pain than either naproxen at 250 mg daily or ibuprofen at 400 mg daily. In the first of the two trials, published in the March, 2012 American Journal of Therapeutics, Theramine when administered as a standalone medication lowered CRP (C-reactive protein) 65% and when administered in combination with a 250 mg naproxen lowered CRP 33% compared to baseline. In this study, a 68% increase in CRP levels was seen in the naproxen alone group compared to baseline.

The second of the two double blind trials compared Theramine to ibuprofen for the treatment of low back pain, which was presented in September, 2012 at PainWeek in Las Vegas, Nevada and will be presented at the 118(th) Annual Meeting of AMSUS in Phoenix, Arizona on November 13, 2012. In this study, Theramine when administered as a standalone medication lowered CRP 47% and IL-6 23% and when administered in combination with a once daily 400 mg ibuprofen lowered CRP 36% and IL-6 41% compared to baseline. In this study, a 60% increase in CRP was measured in the ibuprofen alone group compared to baseline.

No serious side effects were reported in both trials.