Theramine, a “medical food” containing an amino acid blend (AAB), significantly improves chronic low back pain and reduces inflammation compared with low-dose ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), or a combination of these 2 treatments, results of a double-blind clinical study show.

This is the second study looking at Theramine for the dietary management of chronic low back pain. The first (Am J Ther. 2012;19:108-114) compared this medical food with another NSAID, naproxen.

“We have completed 2 multicenter, double-blind trials showing the effectiveness of Theramine, not only on pain but also inflammation, and we are not seeing significant side effects,” commented study author David S. Silver, MD, Chief Medical Officer at Targeted Medical Pharma Inc, Los Angeles, California. This study, which was published in the American Journal of Therapeutics can be viewed here.

Low Back Pain

Low back pain (LBP) has a major economic impact in the United States, with total costs related to this condition exceeding $100 billion per year[i]. According to Dr. Silver, NSAIDs are frequently prescribed to treat chronic back pain, and among these, ibuprofen is one of the most commonly prescribed. It’s believed that patients with chronic pain have decreased levels of neurotransmitters responsible for pain inhibition and control of inflammation, the authors note. According to study data there is evidence in plasma of a deficiency of certain amino acids that are precursors to the neurotransmitters responsible for pain and inflammation modulation, said Dr. Silver, a rheumatologist who has treated patients with fibromyalgia in his Los Angeles, California, practice.

It’s not possible to treat pain by boosting amino acids through the diet, Dr. Silver said. “You can’t just eat more protein and hope that you’re going to produce neurotransmitters” to control pain, he said. Dietary amino acids may not be adequately absorbed, may be deaminated by the liver before crossing the blood-brain barrier, and may not be taken up by the appropriate neurons, he noted. According to the study author, current pain therapies don’t adequately address these components of the pain cascade. NSAIDs, for example, are only moderately effective in relieving pain and are associated with significant gastrointestinal and cardiovascular adverse effects. Other pain treatments, including muscle relaxants and opioid analgesics, have limited efficacy, may produce sedation and constipation, can be used inappropriately, or can lead to addiction issues.  “Theramine addresses the metabolic changes associated with chronic pain, and fills the void that pharmaceuticals cannot address,” said Dr. Silver. This three-arm study was funded by Targeted Medical Pharma. It included 122 patients aged 18 to 75 years who had back pain lasting longer than 6 weeks, with pain present on 10 of 14 days, and evidence of at least moderate pain.

The individual study sites were entirely responsible for recruiting study participants, said Dr. Silver.  Patients were not paid to participate in the study and were reimbursed only for reasonable expenses, such as travel costs.

The patients were randomly assigned to one of three groups: two Theramine tablets twice a day with one ibuprofen placebo; ibuprofen (400 mg once daily) with two Theramine placebos twice a day; or two Theramine tablets twice daily with ibuprofen (400 mg once a day).

The researchers used the lowest recommended dose of ibuprofen because, explained Dr Silver, “we didn’t feel that utilizing placebo for patients with chronic pain was ethical, and we didn’t want to expose patients to a higher risk of NSAID-induced complications by using high-dose therapy.”

After 28 days, participants were evaluated by using the Roland-Morris Disability Index and the Oswestry Disability Scale (primary endpoints), as well as a visual analogue scale (VAS).

The study showed that in both the Theramine and combined therapy groups, pain assessments were considerably and statistically significantly improved compared with the ibuprofen-alone group. In the Theramine-alone group, the Roland-Morris Disability Index score fell by 50.3% and the Oswestry Disability Scale score fell by 41.91% (P < .05 for both vs ibuprofen).

In the combination group, the Roland-Morris Index fell by 63.1% and the Oswestry Disability Scale score fell by 62.15%(P < .05 for both vs ibuprofen). Similar results were observed with use of the VAS.

The study also showed improvements in measurements of inflammation in patients taking Theramine. From blood samples, researchers found that in the Theramine-alone group, the C-reactive protein (CRP) level fell by 47.05% and the interleukin-6 (IL-6) level fell by 23.55% (P < .001 for both vs ibuprofen). In the combined group, CRP fell by 35.99% and IL-6 fell by 43.1% (P < .001 for both).

Interestingly, in the ibuprofen alone group, levels of CRP rose by 60.1% and IL-6 rose by 12.65%.

Dr. Silver noted that the previous head-to-head study of Theramine and naproxen also showed a reduction in inflammatory markers in persons taking the medical food.

It’s not clear why inflammatory markers increased in patients taking ibuprofen in this study, said Dr. Silver. Again, this was the second time that his research group has shown this effect. None of the patients taking Theramine in this study experienced any significant adverse effects, said Dr. Silver. No gastrointestinal adverse effects were observed or reported.

The overall results suggest that Theramine can be used as a primary therapy or an adjunct to ibuprofen, said the authors.

Theramine is a medical food and is specifically indicated for the dietary management of pain and inflammatory conditions. Theramine is not intended to treat, prevent of cure a disease.

[i] Crow T. Journal of the American Osteopathic Association. Vol 109, 2009.

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