LAS VEGAS, NV—Theramine, a prescription-only amino acid food product, may offer a safe alternative to traditional pharmaceutical products used to treat chronic back pain, according to a presentation at PAINWeek 2012. Theramine is prescribed for patients with chronic pain, fibromyalgia, neuropathic pain, and inflammatory pain who cannot use conventional diets or supplements. It had been shown in a previous double-blind clinical trial to be effective in the treatment of chronic low back pain when compared with naproxen, a nonsteroidal anti-inflammatory drug (NSAID).
Fred McCall-Perez, PhD, from Targeted Medical Pharma, Inc., in Los Angeles, and colleagues reported the results of the randomized, double-blind, placebo-controlled that examined if medical foods can offer an alternative therapeutic approach for back pain, with fewer side effects. In 127 patients, the efficacy of Theramine for chronic back pain was compared with low-dose ibuprofen, an NSAID. Patients were randomized to one of three treatment arms: low-dose ibuprofen (n=42), Theramine (n=42), or a combination of Theramine and ibuprofen (n=43) for 28 days. Eligible patients had back pain >6 weeks. Acetaminophen was given as rescue therapy for pain, at a dosage of 650 mg–1,000 mg every 4–6 hours, for a total daily dose <4g.
Pain was assessed using the Roland-Morris Pain Scale (RMPS), Oswestry Disability Index (OST), and a Visual Analog Scale (VAS) at baseline and again at Day 28. On Days 7 and 14, VAS and patient breakthrough medication usage were evaluated. Patients randomized to the ibuprofen group were given 400 mg/day in the morning with a two-capsule dose of placebo (L-alanine) twice daily. In the Theramine group, subjects were given a two-capsule dose of Theramine twice daily and a single capsule of placebo in the morning. The group receiving combination therapy (Theramine and ibuprofen) received a two-capsule dose of Theramine twice daily and 400 mg of ibuprofen in the morning.
On the RMPS, the percent change from Baseline to Day 28 was statistically significant (P<0.01), showing improved pain ratings for both the Theramine and the combined Theramine with ibuprofen groups compared with the ibuprofen alone group (0.73, -50.3, -63.1 respectively). On the OST, the percent change from Baseline to Day 28 was statistically significant (P<0.01) for both the comparison of Theramine and combined groups vs. the ibuprofen alone group (-4.5, -41.9, -62.2 respectively) and for the comparison of combined group vs. Theramine (P<0.05). For CRC and IL-6, the percent change for both the Theramine and combined groups showed statistically significant reductions (P<0.01) compared to the ibuprofen alone group. Dr. McCall-Perez pointed out that high sensitivity C-reactive protein and interleukin-6 levels in the ibuprofen group increased over baseline levels.
The results of laboratory blood tests confirmed that administration of Theramine resulted in an increase in blood concentrations of the amino acid precursors associated with neurotransmitters involved in the modulation of pain. Study investigators concluded that Theramine reduces inflammatory markers and may provide safer pharmacologic alternative to traditional pharmaceuticals prescribed in the management of chronic back pain.