Background Low back pain (LBP) is second only to common cold as the most frequent reason for seeking medical care and is the leading cause of Years Lived with Disability (YLD) worldwide (1). LBP often creates a therapeutic challenge 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. 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 interventional 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 A total of 8,598 subjects (mean age 52.1 years, 67.3% women, mean BMI 27.4) were enrolled in the study, and formed the intent-to-treat (ITT) population. All but 95 subjects (1.1%) completed the study. ITT analysis with worst observation carried forward (WOCF) showed an improvement in pain at rest from mean (± SD) of 5.2 ± 1.9 at study entry to 1.4±1.6 at 3 months (p<0.0001). Pain at movement decreased from 6.8±1.6 to 2.2 ±1.8 (p<0.0001). The Oswestry disability index improved by almost 75%, from 21.1±9.7 to 5.3±6.0 (p<0.0001) at 3 months. NSAIDs were used by 63.4% of patients at study entry; at 3 months of treatment, only 7.4% of patients required NSAIDs for pain control (p<0.0001). An adverse event (AE) was reported by 604 (7.0%) patients (mostly gastrointestinal in origin, such as nausea, abdominal pain and dry mouth) but only 85 (1.0%) patients deemed it severe enough to discontinue therapy.
Conclusions Although open and uncontrolled, this large community-based study shows dramatic reductions in pain and disability, and in particular, a 88% 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.
Vos T, Flaxman A, Naghavi M et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012; 380:2163-96.
Acknowledgements Research grant Unipharm Inc.
Disclosure of Interest : G. Singh Grant/research support: Unipharm, L. Alekseeva Grant/research support: Unipharm, V. Alekseev Grant/research support: Unipharm, A. Barinov Grant/research support: Unipharm, D. Goriachev Grant/research support: Unipharm, E. Nasonov Grant/research support: Unipharm