22 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Targeted Medical Pharma 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 it to low dose naproxen and ibuprofen.
Around 256 subjects participated in the two studies across 20 independent sites that were randomized for treatment to receive Theramine alone (two capsules twice daily), non-steroid anti inflammatory drug (NSAID) or a combination of both. In both studies, Theramine showed statistically significantly reduction in inflammation as measured by markers and improvement in low back pain as compared to either naproxen at 250mg daily or ibuprofen at 400mg daily.
In the first of the two trials, published in the March 2012, in the American Journal of Therapeutics, it was showed that Theramine when administered as a standalone medication lowered CRP (C-reactive protein) by 65 percent and when administered in combination with a 250mg naproxen lowered CRP by 33 percent as compared to baseline. In this study, a 68 percent 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, US, and will be presented at the 118th Annual Meeting of AMSUS in Phoenix, US, on November 13, 2012. In this study, Theramine when administered as a standalone medication lowered CRP by 47 percent and IL-6 by 23 percent and when administered in combination with a once daily 400mg ibuprofen lowered CRP 36 percent and IL-6 by 41 percent as compared to the baseline. In this study, a 60 percent increase in CRP was measured in the ibuprofen alone group as compared to baseline. No serious side effects were reported in both trials.
"These studies indicate that Theramine is not only an effective pain medication but also an effective anti-inflammatory agent for pain and associated with chronic back pain without the concern of gastrointestinal bleeding or other serious side effects such as hypertension," said Dr David Silver, co-author of the study and executive vice president, medical and scientific affairs, Targeted Medical Pharma.