Medical Evidence

Efficacy and Safety of Glucosamine Sulfate in Osteoarthritis of the Spine: A Placebo-Controlled, Randomized, Double-Blind Study. K.K. Fšrster, K. Schmid, G. Giacovelli, L.C. Rovati. Dept. of Clinical Research, OPFERMANN Arzneimittel GmbH, Wahl, Germany

Summary: Aim of the study was to assess efficacy and safety of oral glucosamine sulfate in the control of symptoms of cervical and/or lumbar spondylarthrosis in comparison with placebo, over 6 weeks of treatment plus 4 weeks of follow-up. The study was performed following a multicentre, placebo-controlled, randomised, double-blind, parallel-group design in patients with cervical and/or lumbar spondyloarthrosis, demonstrated by pain and movement limitation for at least 6 months and positive radiology. Clinic visits were performed at enrollment, after three weeks, at the end of the 6 weeks of treatment (1,500 mg glucosamine sulfate or placebo, once daily) as well as 4 weeks after drug discontinuation. Main parameter of evaluation was the overall judgement by the clinical investigator at the end of treatment, secondary parameters were patient's global assessment, pain severity, measured by a visual analogue scale (VAS), functional limitation, measured by several functional tests, morning stiffness, interference with daily activities, as well as, concerning safety, adverse events and laboratory parameters.

Results: 160 patients were enrolled (verum group: 66 women, 14 men. placebo group: 65 women, 15 men; mean age: 64.2 and 62.0 years, respectively) and completed the study. 40 % of them showed cervical, about 40 % lumbar and about 20 % both localizations of spondyloarthrosis. Concerning the investigator's global judgement, 52.5 % glucosamine sulfate patients were either "definetely improved" or "improved", vs 33.7 % of the placebo group patients (p=0.034). Concerning the patient's global assessment, figures were higher: 67.5 % vs. 58.8 % (n.s.). Glucosamine sulfate induced a more pronounced (in part, statistically significant) decrease in severity of all pain parameters, and this was maintained after drug discontinuation. A similar pattern was found concerning movement limitation. Morning stiffness and interference with daily activities was positively and in a greater extent influenced by glucosamine sulfate. Tolerability was comparably good (16. 3 % vs. 10.0 % mild and transient adverse events; n.s.).

Conclusions: As already well established in osteoarthritis of the knee (Müller-Fab bender and Bach 1990; Noack at al. 1994; Reichelt at al. 1994), glucosamine sulfate has a significantly better symptomatic effect than placebo in controlling pain and movement limitation in spondyloarthrosis. This effect lasts on after discontinuation of treatment, whereby safety of glucosamine sulfate all in all is good and comparable to that of placebo.

Source: Osteoarthritis and Cartilage (1999) 7 (supplement A), S32. ©1999 OsteoArthritis Research Society International

Dr. Theo’s Comments: Here’s yet another very well-designed study to prove that glucosamine is effective, not only during the treatment, but for a period of time afterwards.