Background The Global Burden of Diseases, Injuries, and Risk Factors Study 2010 identified low back pain as the leading cause of Years Lived with Disability (YLD) worldwide. In 2010, low back pain (LBP) accounted for over 83 million YLDs, and was the number one cause of YLD in all developed countries in the world (1). LBP continues to create diagnostic and therapeutic challenges due to its unclear etiology and multiple interventions of uncertain efficacy. Significant proportion of LBP may be attributed to osteoarthritis (OA) and degenerative changes in the spine (2). Glucosamine-chondroitin sulfate (GCS) combination is widely used in the treatment of OA, despite conflicting evidence of its efficacy; however there are few prospective scientific investigations of its therapeutic merits in the management of LBP.
Objectives To study the efficacy and safety of GCS in the community management of LBP in a large-scale open pilot prospective observational study.
Methods We enrolled patients between 40 and 65 years of age who had LBP for at least 12 weeks with a pain intensity >3 on a 0-10 point visual analogue scale (VAS). Major exclusion criteria were the presence of fibromyalgia, degenerative spondylolisthesis, and alcohol and/or drug abuse. All patients were treated with ARTRA (combination of glucosamine hydrochloride 500 mg and chondroitin sulfate 500 mg in tablet form; Unipharm Inc.) at a dose of 1 tab bid for the first month and then 1 tab daily for the next two months. The primary endpoint was pain intensity (at rest and movement) as measured on a 0-10 point VAS. Secondary endpoints included the Oswestry Disability Index, patient global assessment of efficacy (0-5 scale) and NSAID consumption.
Results We present results from a planned interim analysis of the study in the first 2,344 patients (mean age 52.1 years, 67% women). Patients reported an improvement in pain at rest from mean (± SD) of 5.2 ± 2.6 at study entry to 1.4±1.6 at 3 months (p<0.01). Pain at movement decreased from 6.7±1.7 to 2.3 ±1.8 (p<0.01). The Oswestry disability index improved by almost 75%, from 20.8±9.4 to 5.7±6.3 (p<0.01) at 3 months. NSAIDs were used by 63.5% of patients at study entry; at 3 months of treatment, only 6.7% of patients required NSAIDs for pain control. An adverse event (AE) was reported by 156 (6.7%) patients (mostly gastrointestinal in origin, such as nausea, abdominal pain and dry mouth) but only 2 patients deemed the AE to be severe enough to discontinue therapy.
Conclusions Although open and uncontrolled, this pilot, community-based efficacy and safety study shows dramatic reductions in pain and disability, and in particular, a 90% reduction in NSAID consumption in patients with LBP treated with GCS. With its benign safety profile, GCS therapy deserves serious evaluation in the management of LBP in a prospective randomized double-blinded clinical trial.
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Acknowledgements Supported by a research grant from Unipharm Inc.
Disclosure of Interest G. Singh Grant/research support from: Unipharm, L. Alekseeva Grant/research support from: Unipharm, V. Alekseev Grant/research support from: Unipharm, G. Triadafilopoulos: None Declared