THU0530 Chronic Low Back Pain and Depression: Significant Decrease with Glucosamine-Chondroitin Sulfate Treatment in a Large, Community-Based, Pilot, Open Prospective Interventional Study

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 Chronic low back pain can often lead to depression. Data on 1 90 593 community-dwelling adults aged ≥18 years from the World Health Survey (WHS) 2002–2004 in 43 Low and middle-income countries show a strong correlation between chronic back pain and depression.2 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 depression in patients with chronic low back pain in a large 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) in a single-arm, open-label prospective interventional study. Major exclusion criteria were the presence of fibromyalgia, degenerative spondylolisthesis, and alcohol and/or drug abuse. All patients were treated with a combination of glucosamine hydrochloride 500 mg and chondroitin sulfate 500 mg in tablet form (Unipharm Inc.) at a dose of 1 tablet bid for the first month and then 1 tablet daily for the next two months. The primary endpoint was pain intensity (at rest and movement) as measured on a 0–10 point VAS. Depression was measured by the 13-questionnaire Beck’s Depression Inventory (BDI). There are 13 questions in this score with highest possible score of 39 (5–7 is mild depression; 8–15 moderate depression, 16 and over severe depression).3 Results A total of 8598 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. Previously-reported 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). Baseline BDI scores showed a highly significant correlation with baseline pain scores at rest and movement (p<0.0001 for both). After 12 weeks of GCS treatment, the mean BDI score dropped from 8.7 (95% CI 8.6 to 8.9) to 2.9 (95% CI 2.8–3.0) (paired-test 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 pilot community-based study shows dramatic reductions in pain and depression 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 randomised double-blinded clinical trial. References [1] Global Burden of Disease Study, C. Lancet2015;386(9995): 743–800. [2] Stubbs B, et al. Gen Hosp Psychiatry2016;43:63–70. [3] Beck AT, Beck RW. Postgrad Med1972;52(6): 81–5. Disclosure of Interest G. Singh Consultant for: Unipharm, L. Alexeeva Consultant for: Unipharm, D. Goryachev Consultant for: Unipharm, A. Barinov Consultant for: Unipharm, A. Mithal: None declared