Low back pain affects nearly everyone at some point in their lives regardless of age or gender. It occurs in similar proportions in all cultures, interfers with quality of life and work performance, and is the most common reason for medical consultations.

Disability due to low back pain has risen more than 50% since 1990 and is now the leading cause of disability worldwide.

A recent paper in The Lancet by an international team of researchers found that low back pain is often treated with bad advice, inappropriate testing, rest, ineffective opioids, spinal injections, and risky surgery without clear evidence as to efficacy in reducing back-related disability, or impact on its long-term consequences.

“The majority of cases of low back pain respond to simple physical and psychological therapies that keep people active and enable them to stay at work,” series co-author Rachelle Buchbinder said in a journal news release. “Often, however, it is more aggressive treatments of dubious benefit that are promoted and reimbursed.”

According to a 2010 study, in the United States, low back pain results in 2.6 million emergency room visits each year and opioids were prescribed in about 60 percent of such cases.

“Theramine addresses the metabolic changes associated with chronic pain, and fills the void that pharmaceuticals cannot address,” said Dr. Silver.

Over-prescription and reliance on ineffectual treatment has prompted some physicians to seek out alternative therapies for their patients.

“The biggest challenge for both patients and physicians is finding a therapy that works to alleviate the issues caused by chronic pain without causing harmful side effects,” said Dr. David Silver, MD, Chief Chief Medical Officer at Targeted Medical Pharma Inc., and former Clinical Chief of Rheumatology at Cedars-Sinai Medical Center.

Dr. Silver has long been a proponent of “medical foods,” which the FDA defines as “intended for specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

Dr. Silver authored a study looking at Theramine, a medical food containing an amino acid blend (AAB). It found Theramine significantly improved chronic low back pain and reduced inflammation compared with low-dose ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), or a combination of these two treatments.

According to Dr. William E. Shell, MD, the study’s co-author, current pain therapies do not 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.

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.

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