Physician Therapeutics conducted a  28-day double-blind randomized controlled trial in 129 patients to study the safety and efficacy of a medical food (Theramine) in the treatment of low back pain. In this study, 43 patients were randomly assigned to receive a medical food alone, 42 patients received once a day 250 mg naproxen alone, and 44 patients received both a medical food and a once a day 250 mg naproxen. All patients were assessed by using Roland–Morris Disability Questionnaire, Oswestry Low Back Pain Scale, and a Visual Analog Scale Evaluation. The company also conducted laboratory analysis performed at the start of the trial and at  the 28 day mark for assessing the safety and impact on inflammatory markers, which included complete blood counts, C-Reactive protein (CRP), and liver function (alkaline phosphatase, aspartate transaminase, and alanine transaminase).

At the start of the trial, there were no statistically significant differences in low back pain when assessed by these widely accepted scales nor were there any differences in the blood markers of inflammation. At the day 28 measurement, both the medical food group and combined therapy group (medical food with naproxen) had significant reduction in lower back pain as compared to the naproxen-alone group. The medical food and naproxen group also showed improvement of not only pain perception but functionality too when compared to the naproxen-alone group.

The naproxen-alone group showed significant elevations in CRP, alanine transaminase, and aspartate transaminase when compared with the other groups, which indicates that the NSAID actually increased overall inflammation in the body. The medical food alone or when administered with naproxen showed no significant change in liver function tests or CRP. This data implies that the medical food potentially mitigates the pro-inflammatory effects of naproxen alone. The medical food (Theramine) appeared to be effective in relieving back pain without causing any significant side effects and may provide a safe alternative to presently available therapies. This trial was published in the American Journal of Therapeutics, November 2010. This trial was also repeated a year later using the same methodology except the company used once daily 250 mg ibuprofen in the place of naproxen and the company also measured interleukin 6 as well. The results of this second trial have not been published yet, but yielded near identical results to the initial trial. To read the Theramine and Naproxen trial in detail visit www.ptlcentral.com.