Targeted Medical Pharma, Inc. announced the results of a second, double-blind clinical trial which confirmed that Theramine was shown not only to be more effective than ibuprofen in reducing low back pain, but also demonstrated a significant reduction in measures of inflammation. In this 28 day, multi-center trial, subjects taking Theramine as either a standalone medication or in conjunction with a low dose ibuprofen, demonstrated a significant reduction in both low back pain and inflammation when compared to baseline and ibuprofen. Ibuprofen alone did not impact back pain and showed increased inflammation when compared to baseline.

This trial examined the unique nutritional needs of patients with chronic back pain who at baseline showed reduced concentrations of the specific amino acids involved in reducing pain and inflammation. Subjects taking Theramine as a standalone medication showed significant improvements in plasma concentrations of these amino acids compared to baseline in addition to a reduction in pain and inflammation as measured by the Roland-Morris Pain Scale, Oswestry Disability Index, C-reactive protein (CRP) and Interleukin-6 (IL-6). Subjects taking ibuprofen alone showed no significant changes in these parameters.

The results of this trial suggest that addressing the unique amino acid deficiencies associated with chronic pain using an amino acid based medical food can be significantly more effective at reducing pain and inflammation than NSAID therapies.