Background Low back pain (LBP) is the leading cause of Years Lived with Disability worldwide (1). The number of people suffering from LBP grew more than 50% from 1990 to 2013, to 651 million (1). Glucosamine-chondroitin sulfate (GCS) combination is widely used in the treatment of OA; however there are few prospective scientific investigations of its therapeutic merits in severe LBP.
Objectives To study the efficacy of GCS in the decreasing disability in patients with severe disability due to chronic low back pain in a large open pilot prospective observational study.
Methods We studied patients 40–65 years of age who had severe disability (Oswestry Score >40) due to LBP. The Oswestry scale contains ten sections on pain intensity, lifting, ability to care for oneself, walking, sitting, standing, sexual function, social life, sleep quality, and ability to travel. Each question is scored on a scale of 0–5 with the scores for all questions summed, then multiplied by two to obtain the index (range 0 to 100). Scores above 40 indicate severe disability. 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. Oswestry index was measured at enrollment into the study and then after 1 month, 2 months and 3 months of starting therapy.
Results The study population included a total of 4,588 patients with Oswestry index of 40 or more (mean age 52.9±7.4 years, 66% women, mean BMI 27.7±5.4, median of duration of LBP 6 months, LQ-4.0; UQ-20.0). Intent-to-Treat (ITT) analysis with worst observation carried forward (WOCF) showed an improvement in disability Oswestry Scale mean (95%CI) from 58.4 (57.9 -58.7) to 13.9 (13.5–14.3) (p<0.0001, ANOVA for repeated measures). Significant improvement was also observed in pain scores: pain at rest improved from mean (95%CI) of 5.93 (5.87–5.98) at study entry to 1.49 (1.45–1.55) at 3 months (p<0.0001). Pain at movement decreased from 7.53 (7.49–7.57) to 2.36 (2.31–2.42) (p<0.0001). NSAIDs were used by 74.9% of patients at study entry; at 3 months of treatment, only 9.9% of patients required NSAIDs for pain control (p<0.0001, McNemar's test).
An adverse event (AE) was reported by 311 (6.8%) patients (mostly GI in origin, such as nausea, abdominal pain and dry mouth) but only 134 (2.9%) 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 in patients with severe disability as measured with Oswestry index. With its benign safety profile, GCS therapy deserves serious evaluation in the management of severe LBP in a prospective randomized double-blinded clinical trial.
Vos T et al. Lancet. 2015; 386(9995): 743–800.
Acknowledgement 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, D. Goriachev Grant/research support from: Unipharm, A. Barinov Grant/research support from: Unipharm, E. Nasonov Grant/research support from: Unipharm, A. Mithal: None declared, S. Pyanykh Employee of: Unipharm