Background Low back pain (LBP) causes more disability than any other condition worldwide. Significant proportion of severe chronic low back pain (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 severe LBP.
Objectives To study the efficacy and safety of GCS in the community management of severe 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). Severe LBP was defined as pain intensity at rest of greater than 6 on a 0-10 point 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. Of these, 2,166 subjects had severe LBP at rest (≥7 cm of VAS) (mean age 52.4 years, 65.6% women, mean BMI 27.8, mean duration of LBP 32.7 months). ITT analysis with worst observation carried forward (WOCF) in patients with severe LBP showed an improvement in pain at rest from mean (95%CI) of 7.67 (7.64 - 7.71) at study entry to 2.00 (1.92 - 2.09) at 3 months (p<0.0001, ANOVA for repeated measures). Pain at movement decreased from a mean (95% CI) of 8.37 (8.32 - 8.41) to 2.68 (2.59 - 2.77) (p<0.0001). The Oswestry disability index improved by almost 76%, from a mean (95% CI) of 27.94 (27.52 - 28.36) to 6.67 (6.36 - 6.98) (p<0.0001) at 3 months. NSAIDs were used by 71.3% of patients at study entry; at 3 months of treatment, only 9.5% of patients required NSAIDs for pain control (p<0.0001, McNemar's test). An adverse event (AE) was reported by 136 (6.3%) patients (mostly gastrointestinal in origin, such as nausea, abdominal pain and dry mouth) but only 51 (2.4%) 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 reductions in pain and disability, and in particular, a dramatic 87% reduction in NSAID consumption in patients with severe LBP treated with GCS. With its benign safety profile, GCS therapy deserves serious evaluation in the management of severe LBP in a prospective randomized double-blinded clinical trial.
Borenstein D. Does osteoarthritis of the lumbar spine cause chronic low back pain? Curr Pain Headache Rep. 2004; 8:512-517.
Disclosure of Interest G. Singh Grant/research support from: Unipharm, L. Alekseeva Grant/research support from: Unipharm, E. Nasonov Grant/research support from: Unipharm, A. Barinov Grant/research support from: Unipharm, D. Goriachev Grant/research support from: Unipharm